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New Generics

Anastrazole tablets (generic Arimidex)¹

Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²

Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³

Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴

Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵

Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶

Tacrolimus 5-mg capsules (generic Prograf)⁷

Trandolapril/verapamil tablets (generic Tarka)⁸

Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹

Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.

Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.

Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³

Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.

HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.

Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

GlaxoSmithKline has received reports of dispensing errors related to rosiglitazone (Avandia), glimepiride (Amaryl), rosiglitazone/metformin (Avandamet), candesartan (Atacand), and warfarin (Coumadin). In some instances, the patient received the wrong medication (one severe case led to impaired mental status). Errors likely occurred due to illegible written prescriptions and/or incorrectly interpreted, labeled, and filled prescriptions. Some of these products have similar dosage strengths and also look alike, leading to the errors.²¹

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.

Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.

APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.

Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.

Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.

Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.

Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.

Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.

Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.

Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.

Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.

Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.

Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.

FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.

Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.

FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.

Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.

Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.

Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.

Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.

Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.

New Jersey State Board of Pharmacy News, April 2010;24:2-3.

Issue

The Hospitalist - 2010(10)

Publications

Topics

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generics

Anastrazole tablets (generic Arimidex)¹

Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²

Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³

Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴

Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵

Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶

Tacrolimus 5-mg capsules (generic Prograf)⁷

Trandolapril/verapamil tablets (generic Tarka)⁸

Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹

Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.

Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.

Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³

Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.

HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.

Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.

Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.

APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.

Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.

Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.

Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.

Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.

Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.

Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.

Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.

Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.

Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.

Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.

FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.

Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.

FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.

Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.

Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.

Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.

Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.

Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.

New Jersey State Board of Pharmacy News, April 2010;24:2-3.

New Generics

Anastrazole tablets (generic Arimidex)¹

Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²

Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³

Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴

Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵

Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶

Tacrolimus 5-mg capsules (generic Prograf)⁷

Trandolapril/verapamil tablets (generic Tarka)⁸

Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹

Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.

Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.

Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³

Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.

HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.

Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.

Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.

APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.

Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.

Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.

Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.

Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.

Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.

Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.

Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.

Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.

Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.

Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.

FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.

Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.

FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.

Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.

Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.

Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.

Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.

Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.

New Jersey State Board of Pharmacy News, April 2010;24:2-3.

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Innovators Descend on Annual Pediatric HM Conference

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Fri, 09/14/2018 - 12:30

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Innovators Descend on Annual Pediatric HM Conference

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Shawn Ralston, MD

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.

Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

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Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.

Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

References

Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.

Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

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Ulises A. Perez, MD

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

Ultrasound-guided central line insertion;

PICC line insertion;

Endotracheal intubation;

Advanced airway management;

Thoracostomy tube insertion;

Arterial-line insertion;

Transvenous pacing wire insertion;

Lumbar puncture;

Thoracentesis; and

Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

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Ultrasound-guided central line insertion;

PICC line insertion;

Endotracheal intubation;

Advanced airway management;

Thoracostomy tube insertion;

Arterial-line insertion;

Transvenous pacing wire insertion;

Lumbar puncture;

Thoracentesis; and

Paracentesis.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

Ultrasound-guided central line insertion;

PICC line insertion;

Endotracheal intubation;

Advanced airway management;

Thoracostomy tube insertion;

Arterial-line insertion;

Transvenous pacing wire insertion;

Lumbar puncture;

Thoracentesis; and

Paracentesis.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

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Jeff Wiese, MD, SFHM

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

Most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

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Most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The ACGME

MedPAC and GME Funding

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

Most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The ACGME

MedPAC and GME Funding

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

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New Drugs, Indications, Dosage Forms, and Approvals

Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.¹ This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.

IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.² It is in early-stage clinical trials.

Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.³ It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.⁴

Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.⁵ Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.⁶ Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.

Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.⁷ At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.

Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.⁸

Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.⁹ Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.

Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).¹⁰ Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.

Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.¹¹ It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.

Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).¹² This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.¹³

Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.¹⁴ According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.

Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.¹⁵ It is in Phase 3 clinical trials for treating asthma. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.

ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.

CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.

Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.

Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.

Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.

Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.

INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.

Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.

Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.

Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.

Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.

Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.

US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.

Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.

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New Drugs, Indications, Dosage Forms, and Approvals

Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.¹ This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.

IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.² It is in early-stage clinical trials.

Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.³ It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.⁴

Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.⁵ Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.⁶ Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.

Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.⁷ At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.

Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.⁸

Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.⁹ Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.

Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).¹⁰ Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.

Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.¹¹ It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.

Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).¹² This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.¹³

Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.¹⁴ According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.

Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.¹⁵ It is in Phase 3 clinical trials for treating asthma. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.

ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.

CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.

Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.

Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.

Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.

Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.

INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.

Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.

Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.

Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.

Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.

Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.

US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.

Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.

New Drugs, Indications, Dosage Forms, and Approvals

Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.¹ This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.

IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.² It is in early-stage clinical trials.

Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.³ It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.⁴

Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.⁵ Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.⁶ Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.

Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.⁷ At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.

Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.⁸

Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.⁹ Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.

Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).¹⁰ Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.

Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.¹¹ It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.

Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).¹² This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.¹³

Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.¹⁴ According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.

Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.¹⁵ It is in Phase 3 clinical trials for treating asthma. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.

ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.

CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.

Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.

Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.

Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.

Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.

INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.

Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.

Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.

Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.

Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.

Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.

US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.

Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.

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Larry Beresford

Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.

Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.¹

“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].

“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”

OnLine Exclusives

Listen to Arpana Vidyarthi, MD, Anuj Dalal, MD, and Sunil Kripalani, MD, MSc, discuss care transitions.

Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.

No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.

Under the Microscope

Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.²

This is a complex problem and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

—Arpana Vidyarthi, MD, University of California at San Francisco

Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.

Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.³

Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.⁴ The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.

Dr. Arora

“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.

Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.⁵ Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.⁶ Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.

Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.

“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.

OnLine Exclusive

Dr. Arora and colleagues at the University of Chicago are using a virtual training program to improve handoffs.

The System Must Change

“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.

Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”

That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”

What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.

—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston

Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.

“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”

Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”

Dr. Vidyarthi (right) routinely speaks about solutions to transitions. She says hospitals and HM groups need systems that allow people—or forces them—to do the “right thing.”

Innovative Strategies

One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.

“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”

Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.

Re-Engineered Discharges

The basic components of the PROJECT RED checklist:

Educate the patient about his or her diagnosis throughout the hospital stay.

Schedule appointments for clinician follow-up and post-discharge testing.

Discuss with the patient any tests or studies that have been completed in the hospital and discuss who will be responsible for following up the results.

Organize post-discharge services.

Confirm the medication plan.

Reconcile the discharge plan with national guidelines and critical pathways.

Review the appropriate steps for what to do if a problem arises.

Expedite transmission of the discharge resume (summary) to the physicians (and other services, i.e., visiting nurses) accepting responsibility for the patient’s care after discharge.

Assess the degree of understanding by asking them to explain in their own words the details of the plan.

Give the patient a written discharge plan at the time of discharge.

Provide telephone reinforcement of the discharge plan and problem-solving two to three days after discharge.

For more detailed information, visit the-hospitalist.org for the complete checklist.

Source: Jack BW, Chetty VK, Anthony D. The Re-Engineered Discharge: A RCT of a comprehensive hospital discharge program. Ann Int Med. 2009;150:178-187.

Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.⁷ The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.

“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”

Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.

“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.⁸ It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.

Technology and Transitions

Dr. Chopra

Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.

“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”

One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”

Who Else Is Looking at Transitions of Care?

Dr. Zadzam

SHM convened the Handoffs Task Force in 2006. The team systematically reviewed the literature and published recommendations in the September 2009 Journal of Hospital Medicine.⁹ The recommendations are aimed at both community and academic hospitals, as well as hospitalists and other healthcare providers. A new collaborative designed to supplement Project BOOST for hospitalist group handoffs and help put the guidelines into practice is in the works, says Dr. Arora, the task force’s chair.

SHM and five medical groups, including the American College of Physicians, issued a Transitions of Care Consensus Statement, published in the July 2009 issue of the Journal of Hospital Medicine.⁵ Guiding principles relate to education, measurement, accountability, timely interchange of information, inclusion of patient and family, respect for the medical home, and the need for national standards.

The Joint Commission’s Center for Transforming Health Care, established in 2009 to solve healthcare’s most critical safety and quality problems, has made handoff communications its second major target, and is now working with 10 healthcare systems. Standardized handoff processes and communications were the subject of the Joint Commission’s 2006 National Patient Safety Goal, while the Comprehensive Accreditation Manual for Hospitals also specifies that before a hospital discharges or transfers a patient, it should inform and educate the patient about his or her follow-up care and services.

“We now have a safety goal under review dealing with medication reconciliation, and there are relevant standards related to culturally sensitive communication and low-literacy-level communication,” says Deborah Zadzam, PhD, RN, FAAN, director of international quality and performance measures for Joint Commission Resources. “The essential message the Joint Commission has for hospitalists is to communicate clearly, effectively and thoroughly; don’t assume you are understood or that you understand.”—LB

Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.

“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”

Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.

“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”

Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”

Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH

Larry Beresford is a freelance writer based in Oakland, Calif.

References

Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.

Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.

Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.

2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.

Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.

Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.

Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.

Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.

Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.

Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.

Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.

Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.

Care Transition Tips for Hospitalists and Groups

Active listening is key to effective discharges: stay focused, limit interruptions, and take notes.

One recognized key to effective internal handoffs is the face-to-face verbal update, with opportunities to ask questions, priority given to sicker patients, and a written backup filling in the blanks with information that might become important as the patient’s condition changes. But if that is not practical for your HM group, what tools and processes will come closest to the ideal?

A key to effective discharge from the hospital is connection with the PCP, although face-to-face encounters with PCPs are highly unlikely. Hospitalists say there are levels of connection with PCPs, from the urgent (“I need to talk to someone right now”) to the routine (“It’s OK if they get this information tomorrow”). Many often wonder if there should be two levels of discharge communication with PCPs: an immediate message relaying crucial information and a formal discharge summary coming later.

For HM groups, the following is a list of suggestions from transitions-of-care researchers:

Keep accurate and up-to-date contact information, including preferred communication medium, on referring physicians; survey them on their satisfaction with the discharge communications they receive from hospitalists.

Partner with hospital administrators and with patient-safety and quality officers to address handoff issues.

Partner with IT staff to help bridge the divide between clinicians and information technology.

Track such outcomes as rehospitalization rates.

Offer formal training on handoffs, discharges, and effective communication to physicians and other providers.

Standardize the signout process, with computerized tools when appropriate, and create automated systems for following up on tests and lab results that come back after discharge.

Structure shifts and their overlaps to help facilitate signouts.

Consider implementing a discharge checklist.¹⁰

Develop a strategy for medication reconciliation, with someone assigned to the process, be that a hospitalist, pharmacist or nurse.¹¹

Advocate for a post-discharge call-back policy by assigned staff at defined intervals, either for every patient discharged or for those targeted as higher-risk.¹²

Consider creating a post-discharge clinic and/or a phone number that discharged patients can call to clarify post-discharge questions and concerns.

For individual hospitalists:

Contribute to The Hospitalist

Have a story idea or a clinical question you’d like answered? We’d like to hear about it. Send your questions and story ideas to Editor Jason Carris, [email protected], or to Physician Editor Jeff Glasheen, MD, SFHM, [email protected].

Understand the transition process, where it fails, and why.

Be open to changing the way you do things. Be accountable for transitions, and a role model for others.

Focus on the present—today’s baseline, current to-do items, and what to expect next in the patient’s care.

Track patients and their future discharge needs from the day of admission. What’s the likely date for going home? What does the patient need to learn in the meantime? Help nurses focus on achieving those needs and, if possible, schedule the initial outpatient clinic appointment before the patient leaves the hospital.

Take time to talk your patients, listen to their concerns and confirm their understanding of what lies ahead.

For hospitalists on the receiving end of transition messages:

Actively listen—stay focused, limit interruptions, take notes.

Ask questions to ensure your understanding and read back what you understand to be the communication.

Have a system for keeping track of to-do items requiring follow-up.—LB

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The Hospitalist - 2010(07)

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Author(s)

OnLine Exclusives

Listen to Arpana Vidyarthi, MD, Anuj Dalal, MD, and Sunil Kripalani, MD, MSc, discuss care transitions.

Under the Microscope

This is a complex problem and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

—Arpana Vidyarthi, MD, University of California at San Francisco

Dr. Arora

OnLine Exclusive

Dr. Arora and colleagues at the University of Chicago are using a virtual training program to improve handoffs.

The System Must Change

—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston

Innovative Strategies

Re-Engineered Discharges

The basic components of the PROJECT RED checklist:

Educate the patient about his or her diagnosis throughout the hospital stay.

Schedule appointments for clinician follow-up and post-discharge testing.

Discuss with the patient any tests or studies that have been completed in the hospital and discuss who will be responsible for following up the results.

Organize post-discharge services.

Confirm the medication plan.

Reconcile the discharge plan with national guidelines and critical pathways.

Review the appropriate steps for what to do if a problem arises.

Expedite transmission of the discharge resume (summary) to the physicians (and other services, i.e., visiting nurses) accepting responsibility for the patient’s care after discharge.

Assess the degree of understanding by asking them to explain in their own words the details of the plan.

Give the patient a written discharge plan at the time of discharge.

Provide telephone reinforcement of the discharge plan and problem-solving two to three days after discharge.

For more detailed information, visit the-hospitalist.org for the complete checklist.

Source: Jack BW, Chetty VK, Anthony D. The Re-Engineered Discharge: A RCT of a comprehensive hospital discharge program. Ann Int Med. 2009;150:178-187.

Technology and Transitions

Dr. Chopra

Who Else Is Looking at Transitions of Care?

Dr. Zadzam

Larry Beresford is a freelance writer based in Oakland, Calif.

References

Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.

Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.

Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.

2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.

Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.

Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.

Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.

Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.

Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.

Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.

Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.

Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.

Care Transition Tips for Hospitalists and Groups

For HM groups, the following is a list of suggestions from transitions-of-care researchers:

Keep accurate and up-to-date contact information, including preferred communication medium, on referring physicians; survey them on their satisfaction with the discharge communications they receive from hospitalists.

Partner with hospital administrators and with patient-safety and quality officers to address handoff issues.

Partner with IT staff to help bridge the divide between clinicians and information technology.

Track such outcomes as rehospitalization rates.

Offer formal training on handoffs, discharges, and effective communication to physicians and other providers.

Standardize the signout process, with computerized tools when appropriate, and create automated systems for following up on tests and lab results that come back after discharge.

Structure shifts and their overlaps to help facilitate signouts.

Consider implementing a discharge checklist.¹⁰

Develop a strategy for medication reconciliation, with someone assigned to the process, be that a hospitalist, pharmacist or nurse.¹¹

Advocate for a post-discharge call-back policy by assigned staff at defined intervals, either for every patient discharged or for those targeted as higher-risk.¹²

Consider creating a post-discharge clinic and/or a phone number that discharged patients can call to clarify post-discharge questions and concerns.

For individual hospitalists:

Contribute to The Hospitalist

Understand the transition process, where it fails, and why.

Be open to changing the way you do things. Be accountable for transitions, and a role model for others.

Focus on the present—today’s baseline, current to-do items, and what to expect next in the patient’s care.

Track patients and their future discharge needs from the day of admission. What’s the likely date for going home? What does the patient need to learn in the meantime? Help nurses focus on achieving those needs and, if possible, schedule the initial outpatient clinic appointment before the patient leaves the hospital.

Take time to talk your patients, listen to their concerns and confirm their understanding of what lies ahead.

For hospitalists on the receiving end of transition messages:

Actively listen—stay focused, limit interruptions, take notes.

Ask questions to ensure your understanding and read back what you understand to be the communication.

Have a system for keeping track of to-do items requiring follow-up.—LB

OnLine Exclusives

Listen to Arpana Vidyarthi, MD, Anuj Dalal, MD, and Sunil Kripalani, MD, MSc, discuss care transitions.

Under the Microscope

This is a complex problem and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

—Arpana Vidyarthi, MD, University of California at San Francisco

Dr. Arora

OnLine Exclusive

Dr. Arora and colleagues at the University of Chicago are using a virtual training program to improve handoffs.

The System Must Change

—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston

Innovative Strategies

Re-Engineered Discharges

The basic components of the PROJECT RED checklist:

Educate the patient about his or her diagnosis throughout the hospital stay.

Schedule appointments for clinician follow-up and post-discharge testing.

Discuss with the patient any tests or studies that have been completed in the hospital and discuss who will be responsible for following up the results.

Organize post-discharge services.

Confirm the medication plan.

Reconcile the discharge plan with national guidelines and critical pathways.

Review the appropriate steps for what to do if a problem arises.

Expedite transmission of the discharge resume (summary) to the physicians (and other services, i.e., visiting nurses) accepting responsibility for the patient’s care after discharge.

Assess the degree of understanding by asking them to explain in their own words the details of the plan.

Give the patient a written discharge plan at the time of discharge.

Provide telephone reinforcement of the discharge plan and problem-solving two to three days after discharge.

For more detailed information, visit the-hospitalist.org for the complete checklist.

Source: Jack BW, Chetty VK, Anthony D. The Re-Engineered Discharge: A RCT of a comprehensive hospital discharge program. Ann Int Med. 2009;150:178-187.

Technology and Transitions

Dr. Chopra

Who Else Is Looking at Transitions of Care?

Dr. Zadzam

Larry Beresford is a freelance writer based in Oakland, Calif.

References

Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.

Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.

Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.

2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.

Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.

Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.

Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.

Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.

Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.

Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.

Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.

Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.

Care Transition Tips for Hospitalists and Groups

For HM groups, the following is a list of suggestions from transitions-of-care researchers:

Keep accurate and up-to-date contact information, including preferred communication medium, on referring physicians; survey them on their satisfaction with the discharge communications they receive from hospitalists.

Partner with hospital administrators and with patient-safety and quality officers to address handoff issues.

Partner with IT staff to help bridge the divide between clinicians and information technology.

Track such outcomes as rehospitalization rates.

Offer formal training on handoffs, discharges, and effective communication to physicians and other providers.

Standardize the signout process, with computerized tools when appropriate, and create automated systems for following up on tests and lab results that come back after discharge.

Structure shifts and their overlaps to help facilitate signouts.

Consider implementing a discharge checklist.¹⁰

Develop a strategy for medication reconciliation, with someone assigned to the process, be that a hospitalist, pharmacist or nurse.¹¹

Advocate for a post-discharge call-back policy by assigned staff at defined intervals, either for every patient discharged or for those targeted as higher-risk.¹²

Consider creating a post-discharge clinic and/or a phone number that discharged patients can call to clarify post-discharge questions and concerns.

For individual hospitalists:

Contribute to The Hospitalist

Understand the transition process, where it fails, and why.

Be open to changing the way you do things. Be accountable for transitions, and a role model for others.

Focus on the present—today’s baseline, current to-do items, and what to expect next in the patient’s care.

Track patients and their future discharge needs from the day of admission. What’s the likely date for going home? What does the patient need to learn in the meantime? Help nurses focus on achieving those needs and, if possible, schedule the initial outpatient clinic appointment before the patient leaves the hospital.

Take time to talk your patients, listen to their concerns and confirm their understanding of what lies ahead.

For hospitalists on the receiving end of transition messages:

Actively listen—stay focused, limit interruptions, take notes.

Ask questions to ensure your understanding and read back what you understand to be the communication.

Have a system for keeping track of to-do items requiring follow-up.—LB

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Jeff Glasheen, MD, SFHM

The headline was as biting as it was inciting. “Frustrations with hospitalist care: Need to improve transitions and communication,” it screamed from the cover of a recent issue of the Annals of Internal Medicine.1 Reading on the run, I thumbed to page 469 and glanced at the first few paragraphs, my mind spinning with the implications.

The article was an editorial following a recent thought piece by a primary-care physician (PCP) frustrated with his interactions with the HM model—mainly around the lack of communication from hospitalists about his patients, his marginalized role with his patients’ hospital care, and the lack of information transfer around transitions.2

I have a simple challenge for you: For one week, join me in committing to calling 100% of the available PCPs on patient discharge. I can guarantee you this will prove to be a hard, time-consuming, and, at times, migraine-inducing process.

Frustrations and Slapstick Comedy

Frustration with hospitalist care? Is this how PCPs see us? Are we really “frustrating” our outpatient colleagues? To an outsider, this presented a one-sided view of the issue—the side that sounds simplistically negative. What if someone important to our group should read this article, someone like my hospital CEO? I didn’t have to wonder for long as I looked up from my elevator reading to note my hospital CEO entering.

What followed eerily resembled one of those scenes from a slapstick comedy, as the boob, played perfectly by me, obviously fumbles something he intends to hide from his boss behind his back to escape the knowing eye of said boss. And, like a pornographic-magazine-sniffing parent, my CEO knowingly diagnosed the situation.

“Whatcha reading?” he sagely queried.

“Nothing,” I replied unconvincingly.

“Nothing? It sure looks like you hastily stuffed a magazine or something down the back of your pants as I walked in.”

“Oh, this?” I responded, unearthing a large medical journal from my pants, leaving an untucked shirt in its wake. “This is just a medical journal. You know, lots of medical stuff. It’s pretty complex. Probably hard for nonmedical types to understand,” I replied, employing a bit of professorial condescension to throw him off track.

“Annals of Internal Medicine,” he replied. “What a coincidence. I just received an e-mail from a friend with an Annals article about the issues of transitions of care with the hospitalist model. Sounds like a real problem. Maybe our new electronic health records will fix that. If not, you should fix it. Let’s chat about it soon.”

“Right,” I said as the elevator doors swished behind him, leaving me disheveled in both appearance and thoughts.

Testimonials?

The more recent Annals editorial summarized—and then printed—a few of the many online responses to the original thought piece.3 The responses ranged from outrage with the HM model of care to more measured discussions of the limitations of the “old” model it replaced. However, the tone and implications were clear: At least some, if not many, PCPs are displeased with the HM model.

One writer related a recent example in which his elderly patient was admitted unbeknownst to him. After receiving a query from a family member, he called the hospitalist on duty, who was uninformed about the patient details, had made questionable therapeutic changes, and was “unapologetic” about her team’s lack of communication, arguing that the ED physician “should have called.” That led this PCP to conclude that the system is “disjointed and isolating,” leaving “patients feeling abandoned.” Another writer commented that the current system of communication results in “potentially detrimental and demoralizing degrees of separation.” A response by a hospitalist detailed how they were able to put a system in place to contact PCPs with whom they are contracted 80% of the time.

The Annals editors concluded that the letters they received in response to the first article “reflect a schism that exists in internal medicine about the positive and negative effects of hospitalist care,” noting that “the evidence is still deficient about how to deliver care optimally when complex, seriously-ill patients must transition between multiple providers in diverse health care settings.” The authors go on to call for “intensive research and productive debates” about the HM model of care.

A Challenge to You

“Disjointed and isolating”? … “Detrimental and demoralizing”? … Lauding 80% PCP contact rates? … “Intensive research and debate”?

I get that this is a complex issue and that healthcare in the U.S. is fragmented to the point of fracture. To wit, it can be agonizingly time-consuming to track down PCPs and wade through their automated phone systems. And this assumes that your patient has a PCP, can identify that PCP, and has their phone number. If they don’t, you’re left to sift through online phone books, clinic websites, or Google searches with the hopes that you can summon the right Dr. Davis, Davies, or Daves—the patient’s not quite sure of the spelling but knows “she’s a nice lady doctor.” I know firsthand the tension between taking the time to make that PCP call and getting home in time for dinner with my family—I’m often guilty of choosing dinner.

However, I’m not sure “intensive research” is the answer. Nor is this a problem that can wait for technological solutions. I don’t want to diminish the great strides that have been made or understate the need to continue to innovate around transitions—this needs to be an area of ongoing study. But this is a problem that has at least one relatively simple, short-term solution: Just pick up the phone. As one Annals writer rightly questions: “How has inter-physician communication come to be regarded as an unexpected courtesy rather than an obligation?”

Good question.

So, I have a simple challenge for you: For one week, join me in committing to calling 100% of the available PCPs on patient discharge. I can guarantee you this will prove to be a hard, time-consuming, and, at times, migraine-inducing process. But it is an intervention that will make a difference, can be launched tomorrow, and does not require “intensive research and debate.”

We’ll no doubt gain some insight into our patients’ current therapeutic regimens, enlist PCPs’ help with the treatment decisions, and ensure that our patients’ transitions are as safe as possible. My guess is that we’ll also find it valuable to the point it becomes habit.

Start by committing with me to just one week.

Then go home and have dinner. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

Frustrations with hospitalist care: need to improve transitions and communication. Ann Intern Med. 2010;152(7):469.

Beckman H. Three degrees of separation. Ann Intern Med. 2009;151(12):890-891.

The relationship between hospitalists and primary care physicians. Ann Intern Med. 2010;152(7):474-6.

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The Hospitalist - 2010(06)

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Jeff Glasheen, MD, SFHM

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Jeff Glasheen, MD, SFHM

Frustrations and Slapstick Comedy

“Whatcha reading?” he sagely queried.

“Nothing,” I replied unconvincingly.

“Nothing? It sure looks like you hastily stuffed a magazine or something down the back of your pants as I walked in.”

“Right,” I said as the elevator doors swished behind him, leaving me disheveled in both appearance and thoughts.

Testimonials?

A Challenge to You

“Disjointed and isolating”? … “Detrimental and demoralizing”? … Lauding 80% PCP contact rates? … “Intensive research and debate”?

Good question.

Start by committing with me to just one week.

Then go home and have dinner. TH

References

Frustrations with hospitalist care: need to improve transitions and communication. Ann Intern Med. 2010;152(7):469.

Beckman H. Three degrees of separation. Ann Intern Med. 2009;151(12):890-891.

The relationship between hospitalists and primary care physicians. Ann Intern Med. 2010;152(7):474-6.

Frustrations and Slapstick Comedy

“Whatcha reading?” he sagely queried.

“Nothing,” I replied unconvincingly.

“Nothing? It sure looks like you hastily stuffed a magazine or something down the back of your pants as I walked in.”

“Right,” I said as the elevator doors swished behind him, leaving me disheveled in both appearance and thoughts.

Testimonials?

A Challenge to You

“Disjointed and isolating”? … “Detrimental and demoralizing”? … Lauding 80% PCP contact rates? … “Intensive research and debate”?

Good question.

Start by committing with me to just one week.

Then go home and have dinner. TH

References

Frustrations with hospitalist care: need to improve transitions and communication. Ann Intern Med. 2010;152(7):469.

Beckman H. Three degrees of separation. Ann Intern Med. 2009;151(12):890-891.

The relationship between hospitalists and primary care physicians. Ann Intern Med. 2010;152(7):474-6.

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Richard Quinn

NATIONAL HARBOR, Md.—It’s happened to every hospitalist who has pushed for a quality improvement (QI) project in their hospital: A chief says no because there’s no money for it. Doesn’t matter if it was the chief medical officer, chief operating officer, or the chief financial officer—the answer is no, no, no.

The best way to change the answer? Change the question.

“Think like they do,” said Mahalakshmi K. Halasymani, MD, SFHM, vice president for quality and systems improvement at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Think about how healthcare is paid for. … [Administrators are] much more likely to release resources if it matters to the institution’s ability to collect money, or get a better survey next time.”

Hospitalists raise their hands during a quality assessment exercise.

Dr. Halasymani, an SHM board member, co-led the session “The Value Proposition to C-Suites: Aligning Hospital Resources to Support Hospitalist QI” with hospitalist Mark Novotny, MD, FHM, who held several C-suite positions at Southwestern Vermont Medical Center in Bennington, Vt., before parting ways with the hospital in early April. Both physicians urge getting organized before taking any case to hospital or health system administrators. Some of their tips:

Define the scope of your proposal. Tackling too many issues can appear over-reaching. Attain a reasonable goal and build on success; that works better than swinging and missing with loftier goals.

Attack topic areas with metrics. QI projects are only as good as the data they produce.

Be interactive. Bring a C-suite member along on daily rounds for a week to showcase the problem you hope to address. When an administrator sees a need for improvement in real time, the issue is personalized. If administrators won’t come to rounds, go to them wherever they are—medical executive committee meetings, patient safety sessions, etc.

“Create a compelling story so people can see you not as an enemy, but as an ally,” Dr. Halasymani said. “To do that, you have to be where the conversations take place.” HM10

More from the HM10 Special Report

National Imperative

Hospitalists challenged to keep making healthcare better

SHM's new president talks about his vision for the next generation of hospitalists

Quality Control

As specialty matures, annual meeting flourishes with practical, educational, and social takeaways

Wachter’s World

HM pioneer says healthcare reform offers HM the chance to define cost savings, QI for future generations

Professional Advice

First-class faculty make HM10 pre-courses highly educational, practical

ONLINE EXCLUSIVE: Audio interview with ABIM Learning Session Director Julius Yang

Dr. Yang discusses the HM10 pre-course that prepares hospitalists for ABIM recertification.

Jam-Packed & Well Worth It

A day in the life of one hospitalist’s annual meeting

ONLINE EXCLUSIVE: Audio interview with Nasim Afsarmanesh

Dr. Afsarmanesh discusses the events of her dawn-to-dusk Day 2 at HM10 in National Harbor, Md.

Core Competencies Lay Pediatric HM Foundation

Framework in place, PHM’s future is in the hands of hospitalists

Special Interests

From IT to education to community issues, hospitalists want to be part of the healthcare solution

WORKSHOP WRAPUP

“The Case for Unit-Based Hospitalists: Benefits and Challenges”

“Hospitalist NPPs 301—Advanced Concepts”

"The Patient Experience: What Hospitalists Need to Know About Measuring, Reporting, and Benchmarking"

"Controversies in Anticoagulation and Thrombosis"

DOWNLOAD THE COMPLETE HM10 SPECIAL REPORT SUPPLEMENT

"The New C. Diff"

Quality Session

"Quality Improvement Curriculum: How to Get Started and to Keep Going"

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in pdf format (2.3 MB).

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The best way to change the answer? Change the question.

Define the scope of your proposal. Tackling too many issues can appear over-reaching. Attain a reasonable goal and build on success; that works better than swinging and missing with loftier goals.

Attack topic areas with metrics. QI projects are only as good as the data they produce.

Be interactive. Bring a C-suite member along on daily rounds for a week to showcase the problem you hope to address. When an administrator sees a need for improvement in real time, the issue is personalized. If administrators won’t come to rounds, go to them wherever they are—medical executive committee meetings, patient safety sessions, etc.

“Create a compelling story so people can see you not as an enemy, but as an ally,” Dr. Halasymani said. “To do that, you have to be where the conversations take place.” HM10

More from the HM10 Special Report

National Imperative

Hospitalists challenged to keep making healthcare better

SHM's new president talks about his vision for the next generation of hospitalists

Quality Control

As specialty matures, annual meeting flourishes with practical, educational, and social takeaways

Wachter’s World

HM pioneer says healthcare reform offers HM the chance to define cost savings, QI for future generations

Professional Advice

First-class faculty make HM10 pre-courses highly educational, practical

ONLINE EXCLUSIVE: Audio interview with ABIM Learning Session Director Julius Yang

Dr. Yang discusses the HM10 pre-course that prepares hospitalists for ABIM recertification.

Jam-Packed & Well Worth It

A day in the life of one hospitalist’s annual meeting

ONLINE EXCLUSIVE: Audio interview with Nasim Afsarmanesh

Dr. Afsarmanesh discusses the events of her dawn-to-dusk Day 2 at HM10 in National Harbor, Md.

Core Competencies Lay Pediatric HM Foundation

Framework in place, PHM’s future is in the hands of hospitalists

Special Interests

From IT to education to community issues, hospitalists want to be part of the healthcare solution

WORKSHOP WRAPUP

“The Case for Unit-Based Hospitalists: Benefits and Challenges”

“Hospitalist NPPs 301—Advanced Concepts”

"The Patient Experience: What Hospitalists Need to Know About Measuring, Reporting, and Benchmarking"

"Controversies in Anticoagulation and Thrombosis"

DOWNLOAD THE COMPLETE HM10 SPECIAL REPORT SUPPLEMENT

"The New C. Diff"

Quality Session

"Quality Improvement Curriculum: How to Get Started and to Keep Going"

You may also

in pdf format (2.3 MB).

The best way to change the answer? Change the question.

Define the scope of your proposal. Tackling too many issues can appear over-reaching. Attain a reasonable goal and build on success; that works better than swinging and missing with loftier goals.

Attack topic areas with metrics. QI projects are only as good as the data they produce.

Be interactive. Bring a C-suite member along on daily rounds for a week to showcase the problem you hope to address. When an administrator sees a need for improvement in real time, the issue is personalized. If administrators won’t come to rounds, go to them wherever they are—medical executive committee meetings, patient safety sessions, etc.

“Create a compelling story so people can see you not as an enemy, but as an ally,” Dr. Halasymani said. “To do that, you have to be where the conversations take place.” HM10

More from the HM10 Special Report

National Imperative

Hospitalists challenged to keep making healthcare better

ONLINE EXCLUSIVE: Audio interview with SHM President Jeff Wiese

SHM's new president talks about his vision for the next generation of hospitalists

Quality Control

As specialty matures, annual meeting flourishes with practical, educational, and social takeaways

Wachter’s World

HM pioneer says healthcare reform offers HM the chance to define cost savings, QI for future generations

Professional Advice

First-class faculty make HM10 pre-courses highly educational, practical

ONLINE EXCLUSIVE: Audio interview with ABIM Learning Session Director Julius Yang

Dr. Yang discusses the HM10 pre-course that prepares hospitalists for ABIM recertification.

Jam-Packed & Well Worth It

A day in the life of one hospitalist’s annual meeting

ONLINE EXCLUSIVE: Audio interview with Nasim Afsarmanesh

Dr. Afsarmanesh discusses the events of her dawn-to-dusk Day 2 at HM10 in National Harbor, Md.

Core Competencies Lay Pediatric HM Foundation

Framework in place, PHM’s future is in the hands of hospitalists

Special Interests

From IT to education to community issues, hospitalists want to be part of the healthcare solution

WORKSHOP WRAPUP

“The Case for Unit-Based Hospitalists: Benefits and Challenges”

“Hospitalist NPPs 301—Advanced Concepts”

"The Patient Experience: What Hospitalists Need to Know About Measuring, Reporting, and Benchmarking"

"Controversies in Anticoagulation and Thrombosis"

DOWNLOAD THE COMPLETE HM10 SPECIAL REPORT SUPPLEMENT

"The New C. Diff"

Quality Session

"Quality Improvement Curriculum: How to Get Started and to Keep Going"

You may also

in pdf format (2.3 MB).

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Continuity Conundrum

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John Nelson, MD, FHM, FACP

Editor’s note: Third of a three-part series.

In the two monthly columns preceding this one, I’ve provided an overview of some ways hospitalist groups distribute new referrals among the providers. This month, I’ll review things that cause some groups to make exceptions to their typical method of distributing patients, and turn from how patients are distributed over 24 hours to thoughts about how they might be assigned over the course of consecutive days worked by a doctor.

Equitable Exceptions

There are a number of reasons groups decide to depart from their typical method of assigning patients. These include:

“Bouncebacks”;

One hospitalist is at the cap, others aren’t;

Consult requested of a specific hospitalist;

Hospitalists with unique skills (e.g., ICU expertise); and

A patient “fires” the hospitalist.

There isn’t a standard “hospitalist way” of dealing with these issues, and each group will need to work out its own system. The most common of these issues is “bouncebacks.” Every group should try to have patients readmitted within three or four days of discharge go back to the discharging hospitalist. However, this proves difficult in many cases for several reasons, most commonly because the original discharging doctor might not be working when the patient returns.

The Alpha & Omega

Nearly every hospitalist practice makes some effort to maximize continuity between a single hospitalist and patient over the course of a hospital stay. But the effect of the method of patient assignment on continuity often is overlooked.

A reasonable way to think about or measure continuity is to estimate the portion of patients seen by the group that see the same hospitalist for each daytime visit over the course of their stay. (Assume that in most HM groups the same hospitalist can’t make both day and night visits over the course of the hospital stay. So, just for simplicity, I’ve intentionally left night visits, including an initial admission visit at night, out of the continuity calculation.) Plug the numbers for your practice into the formula (see Figure 1, right) and see what you get.

If a hospitalist always works seven consecutive day shifts (e.g., a seven-on/seven-off schedule) and the hospitalist’s patients have an average LOS of 4.2 days, then 54% of patients will see the same hospitalist for all daytime visits, and 46% will experience at least one handoff. (To keep things simple, I’m ignoring the effect on continuity of patients being admitted by an “admitter” or nocturnist who doesn’t see the patient subsequently.)

Changing the number of consecutive day shifts a hospitalist works has the most significant impact on continuity, but just how many consecutive days can one work routinely before fatigue and burnout—not too mention increased errors and decreased patient satisfaction—become a problem? (Many hospitalists make the mistake of trying to stuff what might be a reasonable annual workload into the smallest number of shifts possible with the goal of maximizing the number of days off. That means each worked day will be very busy, making it really hard to work many consecutive days. But you always have the option of titrating out that same annual workload over more days so that each day is less busy and it becomes easier to work more consecutive days.)

An often-overlooked way to improve continuity without having to work more consecutive day shifts is to have a hospitalist who is early in their series of worked days take on more new admissions and consults, and perhaps exempt that doctor from taking on new referrals for the last day or two he or she is on service. Eric Howell, MD, FHM, an SHM board member, calls this method “slam and dwindle.” This has been the approach I’ve experienced my whole career, and it is hard for me to imagine doing it any other way.

Here’s how it might work: Let’s say Dr. Petty always works seven consecutive day shifts, and on the first day he picks up a list of patients remaining from the doctor he’s replacing. To keep things simple, let’s assume he’s not in a large group, and during his first day of seven days on service he accepts and “keeps” all new referrals to the practice. On each successive day, he might assume the care of some new patients, but none on days six and seven. This means he takes on a disproportionately large number of new referrals at the beginning of his consecutive worked days, or “front-loads” new referrals. And because many of these patients will discharge before the end of his seven days and he takes on no new patients on days six and seven, his census will drop a lot before he rotates off, which in turn means there will be few patients who will have to get to know a new doctor on the first day Dr. Petty starts his seven-off schedule.

This system of patient distribution means continuity improved without requiring Dr. Petty to work more consecutive day shifts. Even though he works seven consecutive days and his average (or median) LOS is 4.2, as in the example above, his continuity will be much better than 54%. In fact, as many as 70% to 80% of Dr. Petty’s patients will see him for every daytime visit during their stay.

Other benefits of assigning more patients early and none late in a series of worked days are that on his last day of service, he will have more time to “tee up” patients for the next doctor, including preparing for patients anticipated to discharge the next day (e.g., dictate discharge summary, complete paperwork, etc.), and might be able to wrap up a little earlier that day. And when rotating back on service, he will pick up a small list of patients left by Dr. Tench, maybe fewer than eight, rather than the group’s average daily load of 15 patients per doctor, so he will have the capacity to admit a lot of patients that day.

I think there are three main reasons this isn’t a more common approach:

Many HM groups just haven’t considered it.

HM groups might have a schedule that has all doctors rotate off/on the same days each week. For example, all doctors rotate off on Tuesdays and are replaced by new doctors on Wednesday. That makes it impossible to exempt a doctor from taking on new referrals on the last day of service because all of the group’s doctors have their last day on Tuesday. These groups could stagger the day each doctor rotates off—one on Monday, one on Tuesday, and so on.

Every doctor is so busy each day that it wouldn’t be feasible to exempt any individual doctor from taking on new patients, even if they are off the next day.

Despite the difficulties implementing a system of front-loading new referrals, I think most hospitalists would find that they like it. Because it reduces handoffs, it reduces, at least modestly, the group’s overall workload and probably benefits the group’s quality and patient satisfaction. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.

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Editor’s note: Third of a three-part series.

Equitable Exceptions

There are a number of reasons groups decide to depart from their typical method of assigning patients. These include:

“Bouncebacks”;

One hospitalist is at the cap, others aren’t;

Consult requested of a specific hospitalist;

Hospitalists with unique skills (e.g., ICU expertise); and

A patient “fires” the hospitalist.

The Alpha & Omega

I think there are three main reasons this isn’t a more common approach:

Many HM groups just haven’t considered it.

HM groups might have a schedule that has all doctors rotate off/on the same days each week. For example, all doctors rotate off on Tuesdays and are replaced by new doctors on Wednesday. That makes it impossible to exempt a doctor from taking on new referrals on the last day of service because all of the group’s doctors have their last day on Tuesday. These groups could stagger the day each doctor rotates off—one on Monday, one on Tuesday, and so on.

Every doctor is so busy each day that it wouldn’t be feasible to exempt any individual doctor from taking on new patients, even if they are off the next day.

Editor’s note: Third of a three-part series.

Equitable Exceptions

There are a number of reasons groups decide to depart from their typical method of assigning patients. These include:

“Bouncebacks”;

One hospitalist is at the cap, others aren’t;

Consult requested of a specific hospitalist;

Hospitalists with unique skills (e.g., ICU expertise); and

A patient “fires” the hospitalist.

The Alpha & Omega

I think there are three main reasons this isn’t a more common approach:

Many HM groups just haven’t considered it.

HM groups might have a schedule that has all doctors rotate off/on the same days each week. For example, all doctors rotate off on Tuesdays and are replaced by new doctors on Wednesday. That makes it impossible to exempt a doctor from taking on new referrals on the last day of service because all of the group’s doctors have their last day on Tuesday. These groups could stagger the day each doctor rotates off—one on Monday, one on Tuesday, and so on.

Every doctor is so busy each day that it wouldn’t be feasible to exempt any individual doctor from taking on new patients, even if they are off the next day.

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Pipeline Drugs

Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.

Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.

FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5

Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.

Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.

Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.

Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.

FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.

FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.

Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.

Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.

Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.

Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

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Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.

Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.

FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5

Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.

Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.

Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.

Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.

FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.

FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.

Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.

Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.

Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.

Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Pipeline Drugs

Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.

Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.

FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5

Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.

Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.

Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.

Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.

FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.

FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.

Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.

Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.

Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.

Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

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