Patient & Survivor Care

NEW ORLEANS – Dexamethasone was more effective than was placebo in relieving cancer-related fatigue in a double-blind randomized trial of patients with advanced cancer.

After 14 days of treatment, scores on the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue subscale improved by nearly 6 points in the dexamethasone group (9.0 vs. 3.1; P = .008).

Patrice Wendling/IMNG Medical Media

"[Treatment] duration is very important in our patient population because when they are referred to us, it’s very late. They typically have a survival of just 28 to 7 days," Dr. Sriram Yennu said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Although 20%-50% of palliative care patients receive some form of corticosteroid, no steroid study to date has used cancer-related fatigue (CRF) as a primary outcome or assessed CRF with a validated outcome measure, he said. Fatigue is ubiquitous, however, contributing up to one-third of symptom distress in patients with advanced cancer.

The study enrolled 132 outpatients with a life expectancy of at least 4 weeks with three or more cancer-related symptoms (fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance), and randomly assigned them to oral dexamethasone 4 mg twice daily or placebo for 14 days.

The most common diagnosis was head and neck/lung cancer in 45 patients, followed by gastrointestinal cancer in 39, breast cancer in 13, and genitourinary in 10. Median patient age was 60; 81 patients were white, and the average FACIT fatigue score was 19.6, where 52 denotes no fatigue and 0 is severe fatigue.

Among 84 evaluable patients, total scores on FACIT favored the dexamethasone group (18.16 vs. 7.87; P = .03), as did scores on its physical subscale (5.25 vs. 1.32; P = .002), said Dr. Yennu of the department of palliative care and rehabilitation medicine, University of Texas MD Anderson Cancer Center, Houston.

Scores on the physical domain of the Edmonton Symptom Assessment Scale (ESAS) were better in the dexamethasone group than in the placebo group (–10.15 vs. –5.39; P = .04), according to the study, which earned Dr. Yennu a young investigator award.

Notably, scores were similar between the dexamethasone and placebo groups on the emotional subscale of FACIT (1.85 vs. 1.18; P = .49) and the ESAS psychological subscale (–1.48 vs. –2.08; P = .76). The emotional domain of the FACIT-F is measured by six items using a 0-4 scale where 0 is "not at all" and 4 includes statements like "I am losing hope in the fight against my illness." The finding suggests that the improvement in fatigue was likely not just a euphoric effect, as observed before in other steroid trials, Dr. Yennu said.

He expressed concern that corticosteroid use would increase toxicity, particularly insomnia, but no significant differences were observed between the dexamethasone and placebo groups regarding insomnia (3 vs. 4), overall adverse events (41 vs. 44) or serious adverse events (17 vs. 11).

Larger, long-term safety and efficacy studies are needed to address steroid dose and duration, and whether dexamethasone should be coupled with interventions targeting the psychological domain, he said. A 3-point difference in the FACIT is considered clinically important, but research in press in the Journal of Clinical Oncology, by Dr. Yennu and his colleagues, suggests a 10-point difference is more meaningful.

The American Cancer Society supported the study. Dr. Yennu reported having no financial disclosures.

[email protected]

NEW ORLEANS – Dexamethasone was more effective than was placebo in relieving cancer-related fatigue in a double-blind randomized trial of patients with advanced cancer.

After 14 days of treatment, scores on the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue subscale improved by nearly 6 points in the dexamethasone group (9.0 vs. 3.1; P = .008).

Patrice Wendling/IMNG Medical Media

"[Treatment] duration is very important in our patient population because when they are referred to us, it’s very late. They typically have a survival of just 28 to 7 days," Dr. Sriram Yennu said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Although 20%-50% of palliative care patients receive some form of corticosteroid, no steroid study to date has used cancer-related fatigue (CRF) as a primary outcome or assessed CRF with a validated outcome measure, he said. Fatigue is ubiquitous, however, contributing up to one-third of symptom distress in patients with advanced cancer.

The study enrolled 132 outpatients with a life expectancy of at least 4 weeks with three or more cancer-related symptoms (fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance), and randomly assigned them to oral dexamethasone 4 mg twice daily or placebo for 14 days.

The most common diagnosis was head and neck/lung cancer in 45 patients, followed by gastrointestinal cancer in 39, breast cancer in 13, and genitourinary in 10. Median patient age was 60; 81 patients were white, and the average FACIT fatigue score was 19.6, where 52 denotes no fatigue and 0 is severe fatigue.

Among 84 evaluable patients, total scores on FACIT favored the dexamethasone group (18.16 vs. 7.87; P = .03), as did scores on its physical subscale (5.25 vs. 1.32; P = .002), said Dr. Yennu of the department of palliative care and rehabilitation medicine, University of Texas MD Anderson Cancer Center, Houston.

Scores on the physical domain of the Edmonton Symptom Assessment Scale (ESAS) were better in the dexamethasone group than in the placebo group (–10.15 vs. –5.39; P = .04), according to the study, which earned Dr. Yennu a young investigator award.

Notably, scores were similar between the dexamethasone and placebo groups on the emotional subscale of FACIT (1.85 vs. 1.18; P = .49) and the ESAS psychological subscale (–1.48 vs. –2.08; P = .76). The emotional domain of the FACIT-F is measured by six items using a 0-4 scale where 0 is "not at all" and 4 includes statements like "I am losing hope in the fight against my illness." The finding suggests that the improvement in fatigue was likely not just a euphoric effect, as observed before in other steroid trials, Dr. Yennu said.

He expressed concern that corticosteroid use would increase toxicity, particularly insomnia, but no significant differences were observed between the dexamethasone and placebo groups regarding insomnia (3 vs. 4), overall adverse events (41 vs. 44) or serious adverse events (17 vs. 11).

Larger, long-term safety and efficacy studies are needed to address steroid dose and duration, and whether dexamethasone should be coupled with interventions targeting the psychological domain, he said. A 3-point difference in the FACIT is considered clinically important, but research in press in the Journal of Clinical Oncology, by Dr. Yennu and his colleagues, suggests a 10-point difference is more meaningful.

The American Cancer Society supported the study. Dr. Yennu reported having no financial disclosures.

[email protected]

NEW ORLEANS – Dexamethasone was more effective than was placebo in relieving cancer-related fatigue in a double-blind randomized trial of patients with advanced cancer.

After 14 days of treatment, scores on the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue subscale improved by nearly 6 points in the dexamethasone group (9.0 vs. 3.1; P = .008).

Patrice Wendling/IMNG Medical Media

"[Treatment] duration is very important in our patient population because when they are referred to us, it’s very late. They typically have a survival of just 28 to 7 days," Dr. Sriram Yennu said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Although 20%-50% of palliative care patients receive some form of corticosteroid, no steroid study to date has used cancer-related fatigue (CRF) as a primary outcome or assessed CRF with a validated outcome measure, he said. Fatigue is ubiquitous, however, contributing up to one-third of symptom distress in patients with advanced cancer.

The study enrolled 132 outpatients with a life expectancy of at least 4 weeks with three or more cancer-related symptoms (fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance), and randomly assigned them to oral dexamethasone 4 mg twice daily or placebo for 14 days.

The most common diagnosis was head and neck/lung cancer in 45 patients, followed by gastrointestinal cancer in 39, breast cancer in 13, and genitourinary in 10. Median patient age was 60; 81 patients were white, and the average FACIT fatigue score was 19.6, where 52 denotes no fatigue and 0 is severe fatigue.

Among 84 evaluable patients, total scores on FACIT favored the dexamethasone group (18.16 vs. 7.87; P = .03), as did scores on its physical subscale (5.25 vs. 1.32; P = .002), said Dr. Yennu of the department of palliative care and rehabilitation medicine, University of Texas MD Anderson Cancer Center, Houston.

Scores on the physical domain of the Edmonton Symptom Assessment Scale (ESAS) were better in the dexamethasone group than in the placebo group (–10.15 vs. –5.39; P = .04), according to the study, which earned Dr. Yennu a young investigator award.

Notably, scores were similar between the dexamethasone and placebo groups on the emotional subscale of FACIT (1.85 vs. 1.18; P = .49) and the ESAS psychological subscale (–1.48 vs. –2.08; P = .76). The emotional domain of the FACIT-F is measured by six items using a 0-4 scale where 0 is "not at all" and 4 includes statements like "I am losing hope in the fight against my illness." The finding suggests that the improvement in fatigue was likely not just a euphoric effect, as observed before in other steroid trials, Dr. Yennu said.

He expressed concern that corticosteroid use would increase toxicity, particularly insomnia, but no significant differences were observed between the dexamethasone and placebo groups regarding insomnia (3 vs. 4), overall adverse events (41 vs. 44) or serious adverse events (17 vs. 11).

Larger, long-term safety and efficacy studies are needed to address steroid dose and duration, and whether dexamethasone should be coupled with interventions targeting the psychological domain, he said. A 3-point difference in the FACIT is considered clinically important, but research in press in the Journal of Clinical Oncology, by Dr. Yennu and his colleagues, suggests a 10-point difference is more meaningful.

The American Cancer Society supported the study. Dr. Yennu reported having no financial disclosures.

[email protected]

The Death with Dignity program, a pioneering program that includes medically assisted suicide for competent, terminally ill adults treated at a comprehensive cancer center in Seattle, has been well accepted by patients, families, and clinicians, according to a report published online April 11 in the New England Journal of Medicine.

The report details the experience in 2009-2011 with the Death with Dignity program at the Seattle Cancer Care Alliance, which serves all of the Pacific Northwest. The program, "designed to adhere to legal regulations, maintain safety, and ensure the quality of patient care," allows patients with a life expectancy of 6 months or less because of a diagnosed medical condition (usually cancer) to request and self-administer lethal medication prescribed by a physician.

This experience may help to inform efforts to introduce similar programs in other states. At present, Hawaii, Pennsylvania, and Vermont are all considering pertinent legislation, said Dr. Elizabeth Trice Loggers of the Fred Hutchinson Cancer Research Center, Seattle, and her associates.

The program’s policy – written by the Seattle Cancer Care Alliance’s medical director and approved by a majority of the medical executive committee members, as with any clinical policy – requires that patients request information about medically assisted suicide from their physicians, or that these clinicians raise the topic, to be considered for referral. Participation is entirely voluntary for medical staff and faculty members.

Every patient who is a potential participant is first assigned an advocate, a licensed social worker employed by the Alliance, who assists patients, family members, pharmacists, and physicians throughout a multistep process of participating. This advocate also tracks compliance with required documentation for the state Department of Health.

The advocate, as well as the attending physician, ensures that all potential participants are aware of alternatives to medically assisted suicide, such as palliative care and hospice care. The patient’s terminal status is verified, and if the attending physician doesn’t wish to participate, a prescribing physician and a consulting physician are chosen from a group of willing providers.

Psychosocial and psychological assessments are required to ensure the patient’s competence to make the choice of assisted suicide and to identify any depression, which would make the patient ineligible to participate. The patient’s preferences for interventions and health-care directives are documented. Grief support, legacy support, and bereavement support are offered through periodic calls and visits.

The patient and his or her family meet with the prescribing clinician and the consulting clinician to review the diagnosis, prognosis, treatment alternatives, and end-of-life issues. After a mandatory waiting period of 15 days, a written prescription is then sent to the pharmacy, and the pharmacist schedules another appointment with the patient and family to discuss preparation of the drug(s), potential side effects, and the concomitant use of prescription antiemetics.

Patients are then free to fill the prescription or not and to take the drug(s) or not, as they wish.

To date, 114 patients have inquired about the Death with Dignity program, and 44 (38%) either did not pursue the matter further or were deemed ineligible to participate.

Thirty patients (26%) have made a first oral request to initiate the process but either decided not to participate or died before completing the process. Forty patients (35% of those who made an initial inquiry) received prescriptions for lethal medication, and all 40 have died. Twenty-four chose to die by ingesting the medication (secobarbital).

Thus, only 21% of the participants actually used assisted suicide. Death with Dignity participants accounted for 2.4% of all annual deaths among patients at the Seattle Cancer Center Alliance.*

The reasons patients gave most often for participating in the assisted-suicide program were loss of autonomy (97%), inability to engage in enjoyable activities (89%), and loss of dignity (75%).

"We have not received any complaints from family members or caregivers regarding our process or the manner of death. Anecdotally, families describe the death as peaceful (even when death has taken longer than the average of approximately 35 minutes)," Dr. Loggers and her associates wrote physician (N. Engl. J. Med. 2013 April 11;368:1417-24 [doi:10.1056/NEJMsa1213398]).

"Both patients and families frequently express gratitude after the patient received the prescription, regardless of whether it is ever filled or ingested, typically referencing an important sense of control in an uncertain situation," they noted.

Opponents of medically assisted suicide have argued that legislation would disproportionately affect vulnerable populations, such as racial or ethnic minorities, low-income groups, or cognitively impaired patients. The Death with Dignity experience refutes this argument, as most participants were white, male, and well educated, the investigators said.

There have been no unexpected complications among patients who chose assisted suicide, but one patient remained alive for a day after taking the medication. This protracted dying process caused distress to both the family members and the clinicians involved. Similar cases have been reported previously, they added.

*Correction, 4/12/13: An earlier version of this story described findings from a study (citation) in the New England Journal of Medicine. That study misstated the percentage of Death with Dignity patients among all annual patient deaths reported at the Seattle Cancer Center Alliance.

The Death with Dignity program, a pioneering program that includes medically assisted suicide for competent, terminally ill adults treated at a comprehensive cancer center in Seattle, has been well accepted by patients, families, and clinicians, according to a report published online April 11 in the New England Journal of Medicine.

The report details the experience in 2009-2011 with the Death with Dignity program at the Seattle Cancer Care Alliance, which serves all of the Pacific Northwest. The program, "designed to adhere to legal regulations, maintain safety, and ensure the quality of patient care," allows patients with a life expectancy of 6 months or less because of a diagnosed medical condition (usually cancer) to request and self-administer lethal medication prescribed by a physician.

This experience may help to inform efforts to introduce similar programs in other states. At present, Hawaii, Pennsylvania, and Vermont are all considering pertinent legislation, said Dr. Elizabeth Trice Loggers of the Fred Hutchinson Cancer Research Center, Seattle, and her associates.

The program’s policy – written by the Seattle Cancer Care Alliance’s medical director and approved by a majority of the medical executive committee members, as with any clinical policy – requires that patients request information about medically assisted suicide from their physicians, or that these clinicians raise the topic, to be considered for referral. Participation is entirely voluntary for medical staff and faculty members.

Every patient who is a potential participant is first assigned an advocate, a licensed social worker employed by the Alliance, who assists patients, family members, pharmacists, and physicians throughout a multistep process of participating. This advocate also tracks compliance with required documentation for the state Department of Health.

The advocate, as well as the attending physician, ensures that all potential participants are aware of alternatives to medically assisted suicide, such as palliative care and hospice care. The patient’s terminal status is verified, and if the attending physician doesn’t wish to participate, a prescribing physician and a consulting physician are chosen from a group of willing providers.

Psychosocial and psychological assessments are required to ensure the patient’s competence to make the choice of assisted suicide and to identify any depression, which would make the patient ineligible to participate. The patient’s preferences for interventions and health-care directives are documented. Grief support, legacy support, and bereavement support are offered through periodic calls and visits.

The patient and his or her family meet with the prescribing clinician and the consulting clinician to review the diagnosis, prognosis, treatment alternatives, and end-of-life issues. After a mandatory waiting period of 15 days, a written prescription is then sent to the pharmacy, and the pharmacist schedules another appointment with the patient and family to discuss preparation of the drug(s), potential side effects, and the concomitant use of prescription antiemetics.

Patients are then free to fill the prescription or not and to take the drug(s) or not, as they wish.

To date, 114 patients have inquired about the Death with Dignity program, and 44 (38%) either did not pursue the matter further or were deemed ineligible to participate.

Thirty patients (26%) have made a first oral request to initiate the process but either decided not to participate or died before completing the process. Forty patients (35% of those who made an initial inquiry) received prescriptions for lethal medication, and all 40 have died. Twenty-four chose to die by ingesting the medication (secobarbital).

Thus, only 21% of the participants actually used assisted suicide. Death with Dignity participants accounted for 2.4% of all annual deaths among patients at the Seattle Cancer Center Alliance.*

The reasons patients gave most often for participating in the assisted-suicide program were loss of autonomy (97%), inability to engage in enjoyable activities (89%), and loss of dignity (75%).

"We have not received any complaints from family members or caregivers regarding our process or the manner of death. Anecdotally, families describe the death as peaceful (even when death has taken longer than the average of approximately 35 minutes)," Dr. Loggers and her associates wrote physician (N. Engl. J. Med. 2013 April 11;368:1417-24 [doi:10.1056/NEJMsa1213398]).

"Both patients and families frequently express gratitude after the patient received the prescription, regardless of whether it is ever filled or ingested, typically referencing an important sense of control in an uncertain situation," they noted.

Opponents of medically assisted suicide have argued that legislation would disproportionately affect vulnerable populations, such as racial or ethnic minorities, low-income groups, or cognitively impaired patients. The Death with Dignity experience refutes this argument, as most participants were white, male, and well educated, the investigators said.

There have been no unexpected complications among patients who chose assisted suicide, but one patient remained alive for a day after taking the medication. This protracted dying process caused distress to both the family members and the clinicians involved. Similar cases have been reported previously, they added.

*Correction, 4/12/13: An earlier version of this story described findings from a study (citation) in the New England Journal of Medicine. That study misstated the percentage of Death with Dignity patients among all annual patient deaths reported at the Seattle Cancer Center Alliance.

The Death with Dignity program, a pioneering program that includes medically assisted suicide for competent, terminally ill adults treated at a comprehensive cancer center in Seattle, has been well accepted by patients, families, and clinicians, according to a report published online April 11 in the New England Journal of Medicine.

The report details the experience in 2009-2011 with the Death with Dignity program at the Seattle Cancer Care Alliance, which serves all of the Pacific Northwest. The program, "designed to adhere to legal regulations, maintain safety, and ensure the quality of patient care," allows patients with a life expectancy of 6 months or less because of a diagnosed medical condition (usually cancer) to request and self-administer lethal medication prescribed by a physician.

This experience may help to inform efforts to introduce similar programs in other states. At present, Hawaii, Pennsylvania, and Vermont are all considering pertinent legislation, said Dr. Elizabeth Trice Loggers of the Fred Hutchinson Cancer Research Center, Seattle, and her associates.

The program’s policy – written by the Seattle Cancer Care Alliance’s medical director and approved by a majority of the medical executive committee members, as with any clinical policy – requires that patients request information about medically assisted suicide from their physicians, or that these clinicians raise the topic, to be considered for referral. Participation is entirely voluntary for medical staff and faculty members.

Every patient who is a potential participant is first assigned an advocate, a licensed social worker employed by the Alliance, who assists patients, family members, pharmacists, and physicians throughout a multistep process of participating. This advocate also tracks compliance with required documentation for the state Department of Health.

The advocate, as well as the attending physician, ensures that all potential participants are aware of alternatives to medically assisted suicide, such as palliative care and hospice care. The patient’s terminal status is verified, and if the attending physician doesn’t wish to participate, a prescribing physician and a consulting physician are chosen from a group of willing providers.

Psychosocial and psychological assessments are required to ensure the patient’s competence to make the choice of assisted suicide and to identify any depression, which would make the patient ineligible to participate. The patient’s preferences for interventions and health-care directives are documented. Grief support, legacy support, and bereavement support are offered through periodic calls and visits.

The patient and his or her family meet with the prescribing clinician and the consulting clinician to review the diagnosis, prognosis, treatment alternatives, and end-of-life issues. After a mandatory waiting period of 15 days, a written prescription is then sent to the pharmacy, and the pharmacist schedules another appointment with the patient and family to discuss preparation of the drug(s), potential side effects, and the concomitant use of prescription antiemetics.

Patients are then free to fill the prescription or not and to take the drug(s) or not, as they wish.

To date, 114 patients have inquired about the Death with Dignity program, and 44 (38%) either did not pursue the matter further or were deemed ineligible to participate.

Thirty patients (26%) have made a first oral request to initiate the process but either decided not to participate or died before completing the process. Forty patients (35% of those who made an initial inquiry) received prescriptions for lethal medication, and all 40 have died. Twenty-four chose to die by ingesting the medication (secobarbital).

Thus, only 21% of the participants actually used assisted suicide. Death with Dignity participants accounted for 2.4% of all annual deaths among patients at the Seattle Cancer Center Alliance.*

The reasons patients gave most often for participating in the assisted-suicide program were loss of autonomy (97%), inability to engage in enjoyable activities (89%), and loss of dignity (75%).

"We have not received any complaints from family members or caregivers regarding our process or the manner of death. Anecdotally, families describe the death as peaceful (even when death has taken longer than the average of approximately 35 minutes)," Dr. Loggers and her associates wrote physician (N. Engl. J. Med. 2013 April 11;368:1417-24 [doi:10.1056/NEJMsa1213398]).

"Both patients and families frequently express gratitude after the patient received the prescription, regardless of whether it is ever filled or ingested, typically referencing an important sense of control in an uncertain situation," they noted.

Opponents of medically assisted suicide have argued that legislation would disproportionately affect vulnerable populations, such as racial or ethnic minorities, low-income groups, or cognitively impaired patients. The Death with Dignity experience refutes this argument, as most participants were white, male, and well educated, the investigators said.

There have been no unexpected complications among patients who chose assisted suicide, but one patient remained alive for a day after taking the medication. This protracted dying process caused distress to both the family members and the clinicians involved. Similar cases have been reported previously, they added.

*Correction, 4/12/13: An earlier version of this story described findings from a study (citation) in the New England Journal of Medicine. That study misstated the percentage of Death with Dignity patients among all annual patient deaths reported at the Seattle Cancer Center Alliance.

Three compounding pharmacies in as many weeks have issued voluntary recalls of their sterile products, heightening concerns about the safety of compounded drugs and infusion products.

Cancer patients are among those at risk. Med Prep Consulting Inc. issued its recall after a Connecticut hospital reported particulates, later identified as fungus, floating in five 50 mL bags of magnesium sulfate IV solution. The fungus was spotted during routine surveillance of intravenous bag preparation by an oncology nurse at Smilow Cancer Hospital at Yale-New Haven (Conn.).

"We bought quite a number of medicines from Med Prep, and we removed all its products immediately from circulation across the hospital following the discovery of this particle," hospital spokesperson Robert Hutchison said in an interview.

The contaminated product did not reach patients at the hospital, but last year’s deadly meningitis outbreak from contaminated methylprednisolone, manufactured by the New England Compounding Center, highlights the dangers of contaminants that aren’t visible. Yale-New Haven Hospital is working closely with state and federal regulatory agencies on how best to move forward while seeking alternative sources for the roughly 40 different products purchased from Med Prep.

"Like many other hospitals, at Yale-New Haven we purchase certain medicines from these pharmacies because our hospital base pharmacies cannot produce the quantity of certain medicines that we require to treat our patients," Mr. Hutchinson said.

The corticosteroid dexamethasone and the antibiotics gentamicin and vancomycin were among those voluntarily recalled by Med Prep.

Societies not taking positions

The American Society of Clinical Oncology reported not being aware of any cancer patients directly affected by the recalls, but has expressed concerns that frail, immunocompromised cancer patients could be receiving contaminated products. ASCO, which has taken a strong role in the oncology drug shortage, is looking into the compounding issue but has not set a date for completing its "due diligence."*

The Hematology/Oncology Pharmacy Association also has not formulated a position on pharmacy compounding, said immediate past-president Lisa M. Holle, PharmD.

The American Cancer Society is unlikely to take up the issue unless it becomes cancer specific, said Dr. J. Leonard Lichtenfeld, deputy chief medical officer. When hospitals go to the grey market for medications, they should be able to do so with confidence that the products they receive are produced in good faith. He pointed to a counterfeit version of the cancer drug bevacizumab recently distributed in the United States without any active ingredient.

Large drug companies are not immune to recalls. Hospira Inc. issued a nationwide recall March 29 for 0.9% sodium chloride injection because brass particulates were found in the product.

Although compounding pharmacies produce only 2%-3% of U.S. prescriptions, some 70% of hospitals have outsourced at least one product, according to Christopher Topoleski, director of federal regulatory affairs for the American Society of Health System Pharmacists (ASHSP), which represents some 40,000 hospital-based pharmacists.

The society held a summit in February along with other stakeholders, including the American Hospital Association, to discuss solutions for the issues surrounding sterile compounding. It also recommended in a letter to the U.S. Department of Health and Human Services a list of characteristics – such as volume, risk level of the compound being prepared, absence of a patient and health care professional relationship, and interstate shipment – that could be used to identify compounders in need of federal oversight.

Although it’s a good starting point, Mr. Topoleski acknowledged that it won’t be easy defining this new breed of nontraditional compounder. For example, small compounding pharmacies may engage in interstate commerce in metropolitan areas like Washington D.C. that span multiple states, while multihospital systems also centrally compound and distribute across state lines. Legal ambiguity also needs to be clarified over when the Food and Drug Administration has authority under the federal Food, Drug, and Cosmetic Act and when individual states’ responsibilities pick up.

"It’s not going to be a clear cut black-and-white line," he said. "There will still be cases that will need to be looked at individually, but I think it’s going to be additional legislation we’ll need to address."

Greater regulation needed

Regulatory agencies and the pharmaceutical industry are promoting track-and-trace systems as one way to fight counterfeit drugs and to ensure that the quality-control chain of compounded products has not been broken.

"Clearly, at the provider end, it is absolutely essential that we have important drugs available to help our patients treat their cancer, manage their symptoms, and deal with any other medical conditions they have and to do it with absolute safety. Those are requirements, they’re not options," said Dr. Maurie Markman, senior vice president of clinical affairs and national director of medical oncology at Cancer Treatment Centers of America in Philadelphia. "It’s a complicated process because we’re at the giving end to the patient, but [regarding] what comes to us, we’re on the receiving end from some commercial entity. I think all of this is very disturbing. That’s all I can say."

Dr. Markman described the increasing reliance on compounding pharmacies as the flip side of the coin to drug shortages that have hit oncology patients hard, particularly shortages of generic, sterile injectable drugs. Compounding pharmacies have traditionally created custom-made products for individual patients, but they also fill gaps in the supply chain when drugs aren’t available from mainstream drug companies.

Some compounders are producing medications in advance of or without a prescription and distributing them across state lines, creating a "new breed" of specialty pharmacy compounding that "has outgrown the law, and can pose a threat to the health of the public," Food and Drug Administration Commissioner Margaret Hamburg wrote in a blog.

She argued for greater federal oversight including such "basic protections" as clear authority to examine compounding pharmacy records and prohibit compounding of "the most complex and highest risk products," including biologics.

The FDA has no data on how many compounded drugs and infusion products are earmarked for cancer patients because, under current law, compounding pharmacies that meet certain conditions are generally not required to register with the FDA or to list the drugs they compound, FDA spokesperson Christopher Kelly said.

The agency came under sharp criticism last fall for failing to take action during the meningitis outbreak, which killed 53 people in 20 states.

The FDA is targeting "higher-risk" compounding pharmacies and has issued multiple warning letters detailing violations found during 30 inspections over the last 2 months.

The FDA issued warning letters to Med Prep Consulting in 2001 and again in July 2010 after an inspection revealed the firm was repackaging sterile drugs without a patient-specific prescription, eliciting concerns about potential microbial contamination. Further details are not being released at this time because of the ongoing investigation, Mr. Kelly said.

Several regulatory proposals were recently floated in Massachusetts, including a bill by Gov. Deval Patrick that requires compounding pharmacies to obtain a special state license and creates whistleblower protections for pharmacy workers.

Last November, Rep. Edward Markey (D-Mass.) introduced the VALID ACT in an effort to strengthen federal regulations for compounding pharmacies. "It was a casualty of a completely inept session of Congress" but will be introduced again in the next 6-12 weeks, Mr. Markey’s communications director Eben Burnham-Snyder said.

The accreditation option

The American Society of Health System Pharmacists is also calling for unaccredited compounding facilities to seek accreditation by a "nationally credible accreditation body." The Pharmacy Compounding Accreditation Board (PCAB) is one possibility, but it’s up to the FDA and Congress to make an endorsement, Mr. Topoleski said.

Of the roughly 3,000 compounding pharmacies in the United States, 171 were accredited by the PCAB at the end of March. Accreditation applications during the first 2.5 months of 2013 outpaced applications for the first half of 2012, said Cindy Freberg, PCAB director of operations. Still, that is only nine more than during the height of the meningitis outbreak. Ms. Freberg said that the voluntary process takes time and involves U.S. Pharmacopeia Chapter 797 compliance for most of the PCAB standards.

"They’re looking for compliance in all of our standards," she said. "It’s not just a matter of picking one or two things."

PCAB accreditation is not recognized in the federal Food, Drug, and Cosmetic Act and "is of no regulatory significance to the FDA," noted Mr. Kelly.

Latest recall update

To date, there have been no injuries or illnesses reported to the FDA related to the Med Prep recall or to the March 25 recall of 16 sterile compounded products by Boston-based Pallimed Solutions just 5 days after Med Prep. The repackaging of bevacizumab (Avastin) into individual doses for off-label ophthalmic use, which has been a long-standing problem for the compounding industry, was tied to five serious eye infections and sparked a recall March 20 by Clinical Specialties Compounding Pharmacy. None of the three compounding pharmacies was accredited by PCAB, according to a search on its website.

*Correction, 4/11/2013: An earlier version of this story misattributed the source of this information.

[email protected]

Three compounding pharmacies in as many weeks have issued voluntary recalls of their sterile products, heightening concerns about the safety of compounded drugs and infusion products.

Cancer patients are among those at risk. Med Prep Consulting Inc. issued its recall after a Connecticut hospital reported particulates, later identified as fungus, floating in five 50 mL bags of magnesium sulfate IV solution. The fungus was spotted during routine surveillance of intravenous bag preparation by an oncology nurse at Smilow Cancer Hospital at Yale-New Haven (Conn.).

"We bought quite a number of medicines from Med Prep, and we removed all its products immediately from circulation across the hospital following the discovery of this particle," hospital spokesperson Robert Hutchison said in an interview.

The contaminated product did not reach patients at the hospital, but last year’s deadly meningitis outbreak from contaminated methylprednisolone, manufactured by the New England Compounding Center, highlights the dangers of contaminants that aren’t visible. Yale-New Haven Hospital is working closely with state and federal regulatory agencies on how best to move forward while seeking alternative sources for the roughly 40 different products purchased from Med Prep.

"Like many other hospitals, at Yale-New Haven we purchase certain medicines from these pharmacies because our hospital base pharmacies cannot produce the quantity of certain medicines that we require to treat our patients," Mr. Hutchinson said.

The corticosteroid dexamethasone and the antibiotics gentamicin and vancomycin were among those voluntarily recalled by Med Prep.

Societies not taking positions

The American Society of Clinical Oncology reported not being aware of any cancer patients directly affected by the recalls, but has expressed concerns that frail, immunocompromised cancer patients could be receiving contaminated products. ASCO, which has taken a strong role in the oncology drug shortage, is looking into the compounding issue but has not set a date for completing its "due diligence."*

The Hematology/Oncology Pharmacy Association also has not formulated a position on pharmacy compounding, said immediate past-president Lisa M. Holle, PharmD.

The American Cancer Society is unlikely to take up the issue unless it becomes cancer specific, said Dr. J. Leonard Lichtenfeld, deputy chief medical officer. When hospitals go to the grey market for medications, they should be able to do so with confidence that the products they receive are produced in good faith. He pointed to a counterfeit version of the cancer drug bevacizumab recently distributed in the United States without any active ingredient.

Large drug companies are not immune to recalls. Hospira Inc. issued a nationwide recall March 29 for 0.9% sodium chloride injection because brass particulates were found in the product.

Although compounding pharmacies produce only 2%-3% of U.S. prescriptions, some 70% of hospitals have outsourced at least one product, according to Christopher Topoleski, director of federal regulatory affairs for the American Society of Health System Pharmacists (ASHSP), which represents some 40,000 hospital-based pharmacists.

The society held a summit in February along with other stakeholders, including the American Hospital Association, to discuss solutions for the issues surrounding sterile compounding. It also recommended in a letter to the U.S. Department of Health and Human Services a list of characteristics – such as volume, risk level of the compound being prepared, absence of a patient and health care professional relationship, and interstate shipment – that could be used to identify compounders in need of federal oversight.

Although it’s a good starting point, Mr. Topoleski acknowledged that it won’t be easy defining this new breed of nontraditional compounder. For example, small compounding pharmacies may engage in interstate commerce in metropolitan areas like Washington D.C. that span multiple states, while multihospital systems also centrally compound and distribute across state lines. Legal ambiguity also needs to be clarified over when the Food and Drug Administration has authority under the federal Food, Drug, and Cosmetic Act and when individual states’ responsibilities pick up.

"It’s not going to be a clear cut black-and-white line," he said. "There will still be cases that will need to be looked at individually, but I think it’s going to be additional legislation we’ll need to address."

Greater regulation needed

Regulatory agencies and the pharmaceutical industry are promoting track-and-trace systems as one way to fight counterfeit drugs and to ensure that the quality-control chain of compounded products has not been broken.

"Clearly, at the provider end, it is absolutely essential that we have important drugs available to help our patients treat their cancer, manage their symptoms, and deal with any other medical conditions they have and to do it with absolute safety. Those are requirements, they’re not options," said Dr. Maurie Markman, senior vice president of clinical affairs and national director of medical oncology at Cancer Treatment Centers of America in Philadelphia. "It’s a complicated process because we’re at the giving end to the patient, but [regarding] what comes to us, we’re on the receiving end from some commercial entity. I think all of this is very disturbing. That’s all I can say."

Dr. Markman described the increasing reliance on compounding pharmacies as the flip side of the coin to drug shortages that have hit oncology patients hard, particularly shortages of generic, sterile injectable drugs. Compounding pharmacies have traditionally created custom-made products for individual patients, but they also fill gaps in the supply chain when drugs aren’t available from mainstream drug companies.

Some compounders are producing medications in advance of or without a prescription and distributing them across state lines, creating a "new breed" of specialty pharmacy compounding that "has outgrown the law, and can pose a threat to the health of the public," Food and Drug Administration Commissioner Margaret Hamburg wrote in a blog.

She argued for greater federal oversight including such "basic protections" as clear authority to examine compounding pharmacy records and prohibit compounding of "the most complex and highest risk products," including biologics.

The FDA has no data on how many compounded drugs and infusion products are earmarked for cancer patients because, under current law, compounding pharmacies that meet certain conditions are generally not required to register with the FDA or to list the drugs they compound, FDA spokesperson Christopher Kelly said.

The agency came under sharp criticism last fall for failing to take action during the meningitis outbreak, which killed 53 people in 20 states.

The FDA is targeting "higher-risk" compounding pharmacies and has issued multiple warning letters detailing violations found during 30 inspections over the last 2 months.

The FDA issued warning letters to Med Prep Consulting in 2001 and again in July 2010 after an inspection revealed the firm was repackaging sterile drugs without a patient-specific prescription, eliciting concerns about potential microbial contamination. Further details are not being released at this time because of the ongoing investigation, Mr. Kelly said.

Several regulatory proposals were recently floated in Massachusetts, including a bill by Gov. Deval Patrick that requires compounding pharmacies to obtain a special state license and creates whistleblower protections for pharmacy workers.

Last November, Rep. Edward Markey (D-Mass.) introduced the VALID ACT in an effort to strengthen federal regulations for compounding pharmacies. "It was a casualty of a completely inept session of Congress" but will be introduced again in the next 6-12 weeks, Mr. Markey’s communications director Eben Burnham-Snyder said.

The accreditation option

The American Society of Health System Pharmacists is also calling for unaccredited compounding facilities to seek accreditation by a "nationally credible accreditation body." The Pharmacy Compounding Accreditation Board (PCAB) is one possibility, but it’s up to the FDA and Congress to make an endorsement, Mr. Topoleski said.

Of the roughly 3,000 compounding pharmacies in the United States, 171 were accredited by the PCAB at the end of March. Accreditation applications during the first 2.5 months of 2013 outpaced applications for the first half of 2012, said Cindy Freberg, PCAB director of operations. Still, that is only nine more than during the height of the meningitis outbreak. Ms. Freberg said that the voluntary process takes time and involves U.S. Pharmacopeia Chapter 797 compliance for most of the PCAB standards.

"They’re looking for compliance in all of our standards," she said. "It’s not just a matter of picking one or two things."

PCAB accreditation is not recognized in the federal Food, Drug, and Cosmetic Act and "is of no regulatory significance to the FDA," noted Mr. Kelly.

Latest recall update

To date, there have been no injuries or illnesses reported to the FDA related to the Med Prep recall or to the March 25 recall of 16 sterile compounded products by Boston-based Pallimed Solutions just 5 days after Med Prep. The repackaging of bevacizumab (Avastin) into individual doses for off-label ophthalmic use, which has been a long-standing problem for the compounding industry, was tied to five serious eye infections and sparked a recall March 20 by Clinical Specialties Compounding Pharmacy. None of the three compounding pharmacies was accredited by PCAB, according to a search on its website.

*Correction, 4/11/2013: An earlier version of this story misattributed the source of this information.

[email protected]

Three compounding pharmacies in as many weeks have issued voluntary recalls of their sterile products, heightening concerns about the safety of compounded drugs and infusion products.

Cancer patients are among those at risk. Med Prep Consulting Inc. issued its recall after a Connecticut hospital reported particulates, later identified as fungus, floating in five 50 mL bags of magnesium sulfate IV solution. The fungus was spotted during routine surveillance of intravenous bag preparation by an oncology nurse at Smilow Cancer Hospital at Yale-New Haven (Conn.).

"We bought quite a number of medicines from Med Prep, and we removed all its products immediately from circulation across the hospital following the discovery of this particle," hospital spokesperson Robert Hutchison said in an interview.

The contaminated product did not reach patients at the hospital, but last year’s deadly meningitis outbreak from contaminated methylprednisolone, manufactured by the New England Compounding Center, highlights the dangers of contaminants that aren’t visible. Yale-New Haven Hospital is working closely with state and federal regulatory agencies on how best to move forward while seeking alternative sources for the roughly 40 different products purchased from Med Prep.

"Like many other hospitals, at Yale-New Haven we purchase certain medicines from these pharmacies because our hospital base pharmacies cannot produce the quantity of certain medicines that we require to treat our patients," Mr. Hutchinson said.

The corticosteroid dexamethasone and the antibiotics gentamicin and vancomycin were among those voluntarily recalled by Med Prep.

Societies not taking positions

The American Society of Clinical Oncology reported not being aware of any cancer patients directly affected by the recalls, but has expressed concerns that frail, immunocompromised cancer patients could be receiving contaminated products. ASCO, which has taken a strong role in the oncology drug shortage, is looking into the compounding issue but has not set a date for completing its "due diligence."*

The Hematology/Oncology Pharmacy Association also has not formulated a position on pharmacy compounding, said immediate past-president Lisa M. Holle, PharmD.

The American Cancer Society is unlikely to take up the issue unless it becomes cancer specific, said Dr. J. Leonard Lichtenfeld, deputy chief medical officer. When hospitals go to the grey market for medications, they should be able to do so with confidence that the products they receive are produced in good faith. He pointed to a counterfeit version of the cancer drug bevacizumab recently distributed in the United States without any active ingredient.

Large drug companies are not immune to recalls. Hospira Inc. issued a nationwide recall March 29 for 0.9% sodium chloride injection because brass particulates were found in the product.

Although compounding pharmacies produce only 2%-3% of U.S. prescriptions, some 70% of hospitals have outsourced at least one product, according to Christopher Topoleski, director of federal regulatory affairs for the American Society of Health System Pharmacists (ASHSP), which represents some 40,000 hospital-based pharmacists.

The society held a summit in February along with other stakeholders, including the American Hospital Association, to discuss solutions for the issues surrounding sterile compounding. It also recommended in a letter to the U.S. Department of Health and Human Services a list of characteristics – such as volume, risk level of the compound being prepared, absence of a patient and health care professional relationship, and interstate shipment – that could be used to identify compounders in need of federal oversight.

Although it’s a good starting point, Mr. Topoleski acknowledged that it won’t be easy defining this new breed of nontraditional compounder. For example, small compounding pharmacies may engage in interstate commerce in metropolitan areas like Washington D.C. that span multiple states, while multihospital systems also centrally compound and distribute across state lines. Legal ambiguity also needs to be clarified over when the Food and Drug Administration has authority under the federal Food, Drug, and Cosmetic Act and when individual states’ responsibilities pick up.

"It’s not going to be a clear cut black-and-white line," he said. "There will still be cases that will need to be looked at individually, but I think it’s going to be additional legislation we’ll need to address."

Greater regulation needed

Regulatory agencies and the pharmaceutical industry are promoting track-and-trace systems as one way to fight counterfeit drugs and to ensure that the quality-control chain of compounded products has not been broken.

"Clearly, at the provider end, it is absolutely essential that we have important drugs available to help our patients treat their cancer, manage their symptoms, and deal with any other medical conditions they have and to do it with absolute safety. Those are requirements, they’re not options," said Dr. Maurie Markman, senior vice president of clinical affairs and national director of medical oncology at Cancer Treatment Centers of America in Philadelphia. "It’s a complicated process because we’re at the giving end to the patient, but [regarding] what comes to us, we’re on the receiving end from some commercial entity. I think all of this is very disturbing. That’s all I can say."

Dr. Markman described the increasing reliance on compounding pharmacies as the flip side of the coin to drug shortages that have hit oncology patients hard, particularly shortages of generic, sterile injectable drugs. Compounding pharmacies have traditionally created custom-made products for individual patients, but they also fill gaps in the supply chain when drugs aren’t available from mainstream drug companies.

Some compounders are producing medications in advance of or without a prescription and distributing them across state lines, creating a "new breed" of specialty pharmacy compounding that "has outgrown the law, and can pose a threat to the health of the public," Food and Drug Administration Commissioner Margaret Hamburg wrote in a blog.

She argued for greater federal oversight including such "basic protections" as clear authority to examine compounding pharmacy records and prohibit compounding of "the most complex and highest risk products," including biologics.

The FDA has no data on how many compounded drugs and infusion products are earmarked for cancer patients because, under current law, compounding pharmacies that meet certain conditions are generally not required to register with the FDA or to list the drugs they compound, FDA spokesperson Christopher Kelly said.

The agency came under sharp criticism last fall for failing to take action during the meningitis outbreak, which killed 53 people in 20 states.

The FDA is targeting "higher-risk" compounding pharmacies and has issued multiple warning letters detailing violations found during 30 inspections over the last 2 months.

The FDA issued warning letters to Med Prep Consulting in 2001 and again in July 2010 after an inspection revealed the firm was repackaging sterile drugs without a patient-specific prescription, eliciting concerns about potential microbial contamination. Further details are not being released at this time because of the ongoing investigation, Mr. Kelly said.

Several regulatory proposals were recently floated in Massachusetts, including a bill by Gov. Deval Patrick that requires compounding pharmacies to obtain a special state license and creates whistleblower protections for pharmacy workers.

Last November, Rep. Edward Markey (D-Mass.) introduced the VALID ACT in an effort to strengthen federal regulations for compounding pharmacies. "It was a casualty of a completely inept session of Congress" but will be introduced again in the next 6-12 weeks, Mr. Markey’s communications director Eben Burnham-Snyder said.

The accreditation option

The American Society of Health System Pharmacists is also calling for unaccredited compounding facilities to seek accreditation by a "nationally credible accreditation body." The Pharmacy Compounding Accreditation Board (PCAB) is one possibility, but it’s up to the FDA and Congress to make an endorsement, Mr. Topoleski said.

Of the roughly 3,000 compounding pharmacies in the United States, 171 were accredited by the PCAB at the end of March. Accreditation applications during the first 2.5 months of 2013 outpaced applications for the first half of 2012, said Cindy Freberg, PCAB director of operations. Still, that is only nine more than during the height of the meningitis outbreak. Ms. Freberg said that the voluntary process takes time and involves U.S. Pharmacopeia Chapter 797 compliance for most of the PCAB standards.

"They’re looking for compliance in all of our standards," she said. "It’s not just a matter of picking one or two things."

PCAB accreditation is not recognized in the federal Food, Drug, and Cosmetic Act and "is of no regulatory significance to the FDA," noted Mr. Kelly.

Latest recall update

To date, there have been no injuries or illnesses reported to the FDA related to the Med Prep recall or to the March 25 recall of 16 sterile compounded products by Boston-based Pallimed Solutions just 5 days after Med Prep. The repackaging of bevacizumab (Avastin) into individual doses for off-label ophthalmic use, which has been a long-standing problem for the compounding industry, was tied to five serious eye infections and sparked a recall March 20 by Clinical Specialties Compounding Pharmacy. None of the three compounding pharmacies was accredited by PCAB, according to a search on its website.

*Correction, 4/11/2013: An earlier version of this story misattributed the source of this information.

[email protected]

NEW ORLEANS – Futile and duplicate medications remain a significant burden among patients at the end of life, according to a blinded, prospective cohort study of 397 consecutive hospice patients.

At some point in their end of life care, 39% of patients received futile medications such as statins, and 19% received duplicate medications.

Patrice Wendling/IMNG Medical Media

Reducing futile and duplicate medications provides not only a cost benefit, but also a morbidity benefit because many of these patients are frail and sometimes unable to swallow, and these medications increase pill burden and may actually exacerbate the very symptoms you’re trying to treat, Nehal Munshi said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Based on the medical literature and personal experience, the patients’ medications were independently ranked by two expert palliative care physicians and one pharmacist as appropriate, questionable, futile, duplicate, or not enough patient data to support a ranking. Consensus was achieved where there were discrepancies.

Medications in the hospice emergency kit, also known as the e-kit, were omitted from the analysis. Duplication medications were defined as two agents prescribed for the same indication when one would have sufficed.

Patients in the study were drawn from six hospice agencies in Louisiana over a 6-month period. Their median age was 80 (range 23-107), 58% were women, 72% were white, 23% black, and 0.5% Hispanic. More than one-third of patients (37.3%) died within 2 weeks of study entry.

Vitamins and minerals including calcium, iron, and fish oil supplements made up the bulk of futile medications (67%), followed by statins (21%), and other medications (12%) including allopurinol (Zyloprim and generics), Imodium, megestrol acetate (Megace), Metamucil, epoetin alfa (Epogen), alendronate sodium (Fosamax), cholestyramine (Questran), and silodosin (Rapaflo), Mr. Munshi reported.

Questionable medications were anticoagulants/antiplatelets (36%), Alzheimer’s medications (18%), electrolytes (14%), appetite stimulants (9%), and other (23%) including acetaminophen, ranitidine (Zantac), methylphenidate (Ritalin), amphetamine and dextroamphetamine (Adderall), cetirizine (Zyrtec), and Sudafed.

Prior to hospice admission, patients were on a median of 7 medications, but as many as 27 separate medications, said Mr. Munshi, a fourth-year medical student at Tulane Medical School in New Orleans. It was not possible to determine whether the average number of medications was lower for those entering hospice after being cared for by a palliative care physician.

Hospices appeared to make little headway in reducing pill burden. Only 7.3% of patients with futile medications prior to hospice admission had such medications withdrawn in hospice care.

Stripping away unnecessary medications can actually increase well being among patients entering hospice, a phenomenon known as the "hospice bounce," Dr. Louis Lux, medical director of Hospice Compassus in Austin, and director of the internal medicine clerkship at Texas A&M Health Science Center in Round Rock, both in Texas, said during a discussion of the study. He suggested that it helps patients to understand that their bodies are changing and that you’re not taking away medications, but trying to improve their quality of life.

"Sometimes it’s a choice between being able to swallow a statin or an antiemetic," he said.

At the same time, Dr. Lux cautioned that many patients are invested in their medications, and that studies have shown that abrupt cessation of statins can increase the risk of cardiovascular events in some people.

Mr. Munshi agreed that medication reduction "needs to be a team approach" including the patient, the family, community physicians, specialists, and hospice providers, but suggested that policy and practice modifications aimed at reducing futile and duplication medications, not only after the transition to hospice but potentially much earlier or prior to starting a treatment, could yield substantial benefits.

The authors reported no relevant conflicts of interest.

[email protected]

NEW ORLEANS – Futile and duplicate medications remain a significant burden among patients at the end of life, according to a blinded, prospective cohort study of 397 consecutive hospice patients.

At some point in their end of life care, 39% of patients received futile medications such as statins, and 19% received duplicate medications.

Patrice Wendling/IMNG Medical Media

Reducing futile and duplicate medications provides not only a cost benefit, but also a morbidity benefit because many of these patients are frail and sometimes unable to swallow, and these medications increase pill burden and may actually exacerbate the very symptoms you’re trying to treat, Nehal Munshi said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Based on the medical literature and personal experience, the patients’ medications were independently ranked by two expert palliative care physicians and one pharmacist as appropriate, questionable, futile, duplicate, or not enough patient data to support a ranking. Consensus was achieved where there were discrepancies.

Medications in the hospice emergency kit, also known as the e-kit, were omitted from the analysis. Duplication medications were defined as two agents prescribed for the same indication when one would have sufficed.

Patients in the study were drawn from six hospice agencies in Louisiana over a 6-month period. Their median age was 80 (range 23-107), 58% were women, 72% were white, 23% black, and 0.5% Hispanic. More than one-third of patients (37.3%) died within 2 weeks of study entry.

Vitamins and minerals including calcium, iron, and fish oil supplements made up the bulk of futile medications (67%), followed by statins (21%), and other medications (12%) including allopurinol (Zyloprim and generics), Imodium, megestrol acetate (Megace), Metamucil, epoetin alfa (Epogen), alendronate sodium (Fosamax), cholestyramine (Questran), and silodosin (Rapaflo), Mr. Munshi reported.

Questionable medications were anticoagulants/antiplatelets (36%), Alzheimer’s medications (18%), electrolytes (14%), appetite stimulants (9%), and other (23%) including acetaminophen, ranitidine (Zantac), methylphenidate (Ritalin), amphetamine and dextroamphetamine (Adderall), cetirizine (Zyrtec), and Sudafed.

Prior to hospice admission, patients were on a median of 7 medications, but as many as 27 separate medications, said Mr. Munshi, a fourth-year medical student at Tulane Medical School in New Orleans. It was not possible to determine whether the average number of medications was lower for those entering hospice after being cared for by a palliative care physician.

Hospices appeared to make little headway in reducing pill burden. Only 7.3% of patients with futile medications prior to hospice admission had such medications withdrawn in hospice care.

Stripping away unnecessary medications can actually increase well being among patients entering hospice, a phenomenon known as the "hospice bounce," Dr. Louis Lux, medical director of Hospice Compassus in Austin, and director of the internal medicine clerkship at Texas A&M Health Science Center in Round Rock, both in Texas, said during a discussion of the study. He suggested that it helps patients to understand that their bodies are changing and that you’re not taking away medications, but trying to improve their quality of life.

"Sometimes it’s a choice between being able to swallow a statin or an antiemetic," he said.

At the same time, Dr. Lux cautioned that many patients are invested in their medications, and that studies have shown that abrupt cessation of statins can increase the risk of cardiovascular events in some people.

Mr. Munshi agreed that medication reduction "needs to be a team approach" including the patient, the family, community physicians, specialists, and hospice providers, but suggested that policy and practice modifications aimed at reducing futile and duplication medications, not only after the transition to hospice but potentially much earlier or prior to starting a treatment, could yield substantial benefits.

The authors reported no relevant conflicts of interest.

[email protected]

NEW ORLEANS – Futile and duplicate medications remain a significant burden among patients at the end of life, according to a blinded, prospective cohort study of 397 consecutive hospice patients.

At some point in their end of life care, 39% of patients received futile medications such as statins, and 19% received duplicate medications.

Patrice Wendling/IMNG Medical Media

Reducing futile and duplicate medications provides not only a cost benefit, but also a morbidity benefit because many of these patients are frail and sometimes unable to swallow, and these medications increase pill burden and may actually exacerbate the very symptoms you’re trying to treat, Nehal Munshi said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Based on the medical literature and personal experience, the patients’ medications were independently ranked by two expert palliative care physicians and one pharmacist as appropriate, questionable, futile, duplicate, or not enough patient data to support a ranking. Consensus was achieved where there were discrepancies.

Medications in the hospice emergency kit, also known as the e-kit, were omitted from the analysis. Duplication medications were defined as two agents prescribed for the same indication when one would have sufficed.

Patients in the study were drawn from six hospice agencies in Louisiana over a 6-month period. Their median age was 80 (range 23-107), 58% were women, 72% were white, 23% black, and 0.5% Hispanic. More than one-third of patients (37.3%) died within 2 weeks of study entry.

Vitamins and minerals including calcium, iron, and fish oil supplements made up the bulk of futile medications (67%), followed by statins (21%), and other medications (12%) including allopurinol (Zyloprim and generics), Imodium, megestrol acetate (Megace), Metamucil, epoetin alfa (Epogen), alendronate sodium (Fosamax), cholestyramine (Questran), and silodosin (Rapaflo), Mr. Munshi reported.

Questionable medications were anticoagulants/antiplatelets (36%), Alzheimer’s medications (18%), electrolytes (14%), appetite stimulants (9%), and other (23%) including acetaminophen, ranitidine (Zantac), methylphenidate (Ritalin), amphetamine and dextroamphetamine (Adderall), cetirizine (Zyrtec), and Sudafed.

Prior to hospice admission, patients were on a median of 7 medications, but as many as 27 separate medications, said Mr. Munshi, a fourth-year medical student at Tulane Medical School in New Orleans. It was not possible to determine whether the average number of medications was lower for those entering hospice after being cared for by a palliative care physician.

Hospices appeared to make little headway in reducing pill burden. Only 7.3% of patients with futile medications prior to hospice admission had such medications withdrawn in hospice care.

Stripping away unnecessary medications can actually increase well being among patients entering hospice, a phenomenon known as the "hospice bounce," Dr. Louis Lux, medical director of Hospice Compassus in Austin, and director of the internal medicine clerkship at Texas A&M Health Science Center in Round Rock, both in Texas, said during a discussion of the study. He suggested that it helps patients to understand that their bodies are changing and that you’re not taking away medications, but trying to improve their quality of life.

"Sometimes it’s a choice between being able to swallow a statin or an antiemetic," he said.

At the same time, Dr. Lux cautioned that many patients are invested in their medications, and that studies have shown that abrupt cessation of statins can increase the risk of cardiovascular events in some people.

Mr. Munshi agreed that medication reduction "needs to be a team approach" including the patient, the family, community physicians, specialists, and hospice providers, but suggested that policy and practice modifications aimed at reducing futile and duplication medications, not only after the transition to hospice but potentially much earlier or prior to starting a treatment, could yield substantial benefits.

The authors reported no relevant conflicts of interest.

[email protected]

NEW ORLEANS – That which we call a rose by any other name would smell as sweet. Perhaps not, if the conversation turns to palliative care.

A telephone survey of 169 patients with advanced cancer found that those randomized to hear the term "supportive care" instead of "palliative care" rated their understanding, overall impressions and future perceived need for those services significantly higher.

Patrice Wendling/IMNG Medical Media

In contrast, there was no significant difference in outcomes when patients heard either a "patient-centered" or "traditional" description of palliative/supportive care services, Rachael Maciasz said at the annual meeting of the American Association of Hospice and Palliative Medicine.

"It may be that ‘palliative care’ is so loaded with advanced cancer patients because of family members’ or friends’ experiences with this in the past that [they think] their family member is going to die," she said. "Perhaps what comes after that, no matter how you describe it, you can’t change that impression."

Patients with stage IV solid tumors or refractory/recurrent hematologic malignancies were recruited from 20 oncologists at two comprehensive cancer centers in Pittsburgh, and randomized to one of four survey groups: "palliative care/patient-centered," "palliative care/traditional," "supportive care/patient-centered," and "supportive care/traditional." Outcomes were measured using 10-point Likert scales, with 0 meaning "do not understand at all," or impression "not favorable at all" or "strongly disagree with" a need for services.

The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%).

The majority (63%) of patients were female, 95% were white, 88% were Catholic/Christian, 4% Jewish, and 7% other religion or agnostic. The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%). Their average age was 62 and roughly 11% had prior exposure to palliative care services.

The supportive care groups had significantly higher mean ratings than did the palliative care groups for overall understanding of what the service had to offer (7.7 vs. 6.8) and for overall favorable impressions (8.4 vs. 7.3), said Ms. Maciasz, a fourth-year medical student and a Doris Duke Clinical Research Fellow at the University of Pittsburgh.

Patients rated their current need for supportive and palliative care services equally, but were significantly more likely to perceive a future need for supportive services for themselves or family (8.6 vs. 7.7).

All patients rated their willingness to see a supportive/palliative care specialist as higher if their oncologist recommended it rather than if they had to ask their oncologist whether they could see a specialist on their own (8.6 vs. 6.0).

In a robust multivariable regression model that adjusted for term, description, and all significant variables in univariate analyses, the term supportive care was again significantly associated with more favorable impressions (correlation coefficient 1.24) and higher future perceived need (correlation coefficient 0.93), Ms. Maciasz said.

The qualitative results also paralleled the quantitative results.

"I had the impression that fewer patients went in with an impression of palliative care and that if you could explain it in ways that made perfect sense and described how awesome it is, that it wouldn’t matter if it was [called] palliative or supportive," Ms. Maciasz said in an interview. "I think it’s just loaded, but I don’t think it’s unique to patients."

Research data have shown that some oncologists don’t like the term palliative care. "I think there’s something about the term palliative care that means I can’t give you everything you need," she suggested.

Ms. Maciasz and her coauthors reported having no financial disclosures.

[email protected]

NEW ORLEANS – That which we call a rose by any other name would smell as sweet. Perhaps not, if the conversation turns to palliative care.

A telephone survey of 169 patients with advanced cancer found that those randomized to hear the term "supportive care" instead of "palliative care" rated their understanding, overall impressions and future perceived need for those services significantly higher.

Patrice Wendling/IMNG Medical Media

In contrast, there was no significant difference in outcomes when patients heard either a "patient-centered" or "traditional" description of palliative/supportive care services, Rachael Maciasz said at the annual meeting of the American Association of Hospice and Palliative Medicine.

"It may be that ‘palliative care’ is so loaded with advanced cancer patients because of family members’ or friends’ experiences with this in the past that [they think] their family member is going to die," she said. "Perhaps what comes after that, no matter how you describe it, you can’t change that impression."

Patients with stage IV solid tumors or refractory/recurrent hematologic malignancies were recruited from 20 oncologists at two comprehensive cancer centers in Pittsburgh, and randomized to one of four survey groups: "palliative care/patient-centered," "palliative care/traditional," "supportive care/patient-centered," and "supportive care/traditional." Outcomes were measured using 10-point Likert scales, with 0 meaning "do not understand at all," or impression "not favorable at all" or "strongly disagree with" a need for services.

The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%).

The majority (63%) of patients were female, 95% were white, 88% were Catholic/Christian, 4% Jewish, and 7% other religion or agnostic. The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%). Their average age was 62 and roughly 11% had prior exposure to palliative care services.

The supportive care groups had significantly higher mean ratings than did the palliative care groups for overall understanding of what the service had to offer (7.7 vs. 6.8) and for overall favorable impressions (8.4 vs. 7.3), said Ms. Maciasz, a fourth-year medical student and a Doris Duke Clinical Research Fellow at the University of Pittsburgh.

Patients rated their current need for supportive and palliative care services equally, but were significantly more likely to perceive a future need for supportive services for themselves or family (8.6 vs. 7.7).

All patients rated their willingness to see a supportive/palliative care specialist as higher if their oncologist recommended it rather than if they had to ask their oncologist whether they could see a specialist on their own (8.6 vs. 6.0).

In a robust multivariable regression model that adjusted for term, description, and all significant variables in univariate analyses, the term supportive care was again significantly associated with more favorable impressions (correlation coefficient 1.24) and higher future perceived need (correlation coefficient 0.93), Ms. Maciasz said.

The qualitative results also paralleled the quantitative results.

"I had the impression that fewer patients went in with an impression of palliative care and that if you could explain it in ways that made perfect sense and described how awesome it is, that it wouldn’t matter if it was [called] palliative or supportive," Ms. Maciasz said in an interview. "I think it’s just loaded, but I don’t think it’s unique to patients."

Research data have shown that some oncologists don’t like the term palliative care. "I think there’s something about the term palliative care that means I can’t give you everything you need," she suggested.

Ms. Maciasz and her coauthors reported having no financial disclosures.

[email protected]

NEW ORLEANS – That which we call a rose by any other name would smell as sweet. Perhaps not, if the conversation turns to palliative care.

A telephone survey of 169 patients with advanced cancer found that those randomized to hear the term "supportive care" instead of "palliative care" rated their understanding, overall impressions and future perceived need for those services significantly higher.

Patrice Wendling/IMNG Medical Media

In contrast, there was no significant difference in outcomes when patients heard either a "patient-centered" or "traditional" description of palliative/supportive care services, Rachael Maciasz said at the annual meeting of the American Association of Hospice and Palliative Medicine.

"It may be that ‘palliative care’ is so loaded with advanced cancer patients because of family members’ or friends’ experiences with this in the past that [they think] their family member is going to die," she said. "Perhaps what comes after that, no matter how you describe it, you can’t change that impression."

Patients with stage IV solid tumors or refractory/recurrent hematologic malignancies were recruited from 20 oncologists at two comprehensive cancer centers in Pittsburgh, and randomized to one of four survey groups: "palliative care/patient-centered," "palliative care/traditional," "supportive care/patient-centered," and "supportive care/traditional." Outcomes were measured using 10-point Likert scales, with 0 meaning "do not understand at all," or impression "not favorable at all" or "strongly disagree with" a need for services.

The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%).

The majority (63%) of patients were female, 95% were white, 88% were Catholic/Christian, 4% Jewish, and 7% other religion or agnostic. The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%). Their average age was 62 and roughly 11% had prior exposure to palliative care services.

The supportive care groups had significantly higher mean ratings than did the palliative care groups for overall understanding of what the service had to offer (7.7 vs. 6.8) and for overall favorable impressions (8.4 vs. 7.3), said Ms. Maciasz, a fourth-year medical student and a Doris Duke Clinical Research Fellow at the University of Pittsburgh.

Patients rated their current need for supportive and palliative care services equally, but were significantly more likely to perceive a future need for supportive services for themselves or family (8.6 vs. 7.7).

All patients rated their willingness to see a supportive/palliative care specialist as higher if their oncologist recommended it rather than if they had to ask their oncologist whether they could see a specialist on their own (8.6 vs. 6.0).

In a robust multivariable regression model that adjusted for term, description, and all significant variables in univariate analyses, the term supportive care was again significantly associated with more favorable impressions (correlation coefficient 1.24) and higher future perceived need (correlation coefficient 0.93), Ms. Maciasz said.

The qualitative results also paralleled the quantitative results.

"I had the impression that fewer patients went in with an impression of palliative care and that if you could explain it in ways that made perfect sense and described how awesome it is, that it wouldn’t matter if it was [called] palliative or supportive," Ms. Maciasz said in an interview. "I think it’s just loaded, but I don’t think it’s unique to patients."

Research data have shown that some oncologists don’t like the term palliative care. "I think there’s something about the term palliative care that means I can’t give you everything you need," she suggested.

Ms. Maciasz and her coauthors reported having no financial disclosures.

[email protected]

MIAMI BEACH – Calls for a ban on the use of tanning beds by minors in the United States have thus far gone unheeded, but medical organizations are increasingly supporting such a ban – and with good reason, according to Alan Geller of the Harvard School of Public Health, Boston.

The data linking tanning bed use and melanoma are consistent and convincing. A 2010 University of Minnesota case-control study, for example, demonstrated that melanoma risk was significantly increased among users, compared with nonusers, of UVB-enhanced tanning devices (adjusted odds ratio, 2.86) and primarily UVA-emitting devices (AOR, 4.44), Mr. Geller said at the annual meeting of the American Academy of Dermatology.

©Vidmantas Goldbergas/iStockphoto.com

The risk increased as tanning bed use increased (Cancer Epidemiol. Biomarkers Prev. 2010;19:1557-68).

A more recent study demonstrated that with every visit to a tanning bed, the risk of melanoma increased by 1.8% – and the risk was even greater among those who started tanning at a younger age (BMJ 2012;345:e4757).

"We are clearly in the throes of a modern-day epidemic, particularly among teenage white girls and young women between the ages of 18 and 25," Mr. Geller said, noting that study after study shows that about a third of white teenage girls and about 20% of all teenage girls use a tanning bed by the age of 17.

And yet only five states restrict the use of tanning beds by those under age 18. Others have parental consent restrictions, but these have been shown to have no effect on tanning bed use by minors. That means that in 45 states, children aged 15 years and younger are free to visit tanning salons with no restrictions, he said, noting that a Washington University in St. Louis survey released in February showed that 65% of Missouri tanning salon owners would allow preteens aged 10-12 years to use their tanning beds – and that 43% of tanning salon employees believe indoor tanning poses no health risks.

Data show that 7% of girls use tanning beds by age 14 years. This doubles from age 14 to 15, and doubles again from age 15 to 17, he said, noting that girls are about five to six times more likely than boys to use tanning beds.

Of particular concern, not only are girls using tanning beds early, but they are using them more often.

A Centers for Disease Control and Prevention survey showed that while the rate of use (20% among all girls) has remained constant in recent years, the "prom phenomenon" – the occasional use of tanning beds before a special event – is no longer the norm; the average yearly number of uses of tanning beds among those surveyed was 28.

"We’re way past the prom phenomenon," Mr. Geller said, noting that one reason for this is that tanning salons "do a wonderful job of selling giant packages of use for very little money."

"When people are beginning to think of some kind of restrictions on the tanning bed industry, that would be one we could surely consider," he said, noting that based on the data showing a 1.8% increase in melanoma risk with each tanning bed use, the risk would be 54%-90% in a teen who starts tanning at age 18 and quits at age 19.

That’s a conservative estimate, because most teens start before age 18 and don’t stop at age 19, he said.

Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute show that the risk of melanoma has doubled among women aged 20-24 years since the 1980s, while the risk in men has declined in some age groups, and remained the same in others.

"You have to ask what’s happened during that time," Mr. Geller said, adding that there is concern about the late effects of tanning bed use, especially given that sun exposure time hasn’t changed in that age group over time.

As for what can be done from a public health perspective to reduce tanning bed use, Mr. Geller said a number of research, legislative, and public health campaigns are underway.

"We know from doing qualitative work, that indoor tanning is largely socially driven. "When [girls] are not tanning, they talk about tanning, they blog about tanning," he said, explaining that "the tanning culture involves some kind of socially driven bonds."

The key is to figure out how to break up those bonds.

"If one girl in a social group quits tanning, will this have an effect on the others? We don’t know," he said, adding that this is among the areas that require further research.

Researchers are also studying the effects of antitanning campaigns and legislation in other countries, a number of which have restricted access to tanning beds for minors. A recent web-based advertising campaign in Denmark targeted teens, and, along with legislation restricting access, resulted in a substantial drop in tanning bed use there, he said.

The results of campaigns and legislative efforts like these are being closely monitored so that the lessons learned about if and how they work can be incorporated into efforts here.

Lessons from the campaign against smoking launched three decades ago also are being incorporated into the current effort to reduce tanning, he said.

Although the link between tanning and melanoma isn’t quite as strong as the link between smoking and lung cancer, the seven key principles that made the antismoking campaign a success can be adapted for this purpose. These are surveillance, taxation, legal strategies, public health advertising campaigns, educational programs, legislation, and "some move to mandate enforcement," he said.

Some progress has been made with respect to these principles. For example, state-by-state surveillance and scoring of states’ level of compliance with existing regulations are underway, a 10% tax has been imposed on tanning salons, cost-efficacy studies are being planned, and lawsuits have been filed in multiple states. However, most of these efforts are in their infancy, Mr. Geller said.

For now, what exists across the United States is a "patchwork quilt of pretty crummy regulations," he said.

While intense pressure is on the Food and Drug Administration to ban tanning bed use by those under age 18 – including pressure from the American Academy of Dermatology – and while the agency is cognizant of the risks and has acknowledged a need for more regulations, "politics have prevailed, and at this point we don’t have the ban," he said.

The FDA website does, however, indicate plans for revising regulations and strengthening warning labels to make consumers more aware of the risks, he noted.

"This is good, but I think it’s a really faulty response to everything that we know about the link between tanning beds and melanoma," he said.

Despite the slow progress toward a ban for those under age 18, there have been some successes in the antitanning campaign. For one, numerous organizations have taken up the cause, including the World Health Organization, the American Academy of Pediatrics, the American Medical Association, the Society of Surgical Oncology, and the Canadian Pediatric Society.

Also, thanks to a Federal Trade Commission crackdown in 2010, the tanning industry is no longer allowed to claim that tanning has certain health benefits, such as reducing the risks of some types of cancers. And in 2012, the U.S. Preventive Services Task Force issued its first guidelines on tanning, stating that the evidence is strong enough to recommend that women aged 10-24 years who have fair skin should avoid prime-time sun exposure and tanning beds.

Additionally, a wellness provision of the Patient Protection and Affordable Care Act that will go into effect in May provides for full reimbursement to health care providers for counseling about skin cancer prevention and tanning bed reduction.

"We want to study this because we think this will have a huge effect on increasing the rate of counseling," he said.

Mr. Geller reported having no disclosures.

MIAMI BEACH – Calls for a ban on the use of tanning beds by minors in the United States have thus far gone unheeded, but medical organizations are increasingly supporting such a ban – and with good reason, according to Alan Geller of the Harvard School of Public Health, Boston.

The data linking tanning bed use and melanoma are consistent and convincing. A 2010 University of Minnesota case-control study, for example, demonstrated that melanoma risk was significantly increased among users, compared with nonusers, of UVB-enhanced tanning devices (adjusted odds ratio, 2.86) and primarily UVA-emitting devices (AOR, 4.44), Mr. Geller said at the annual meeting of the American Academy of Dermatology.

©Vidmantas Goldbergas/iStockphoto.com

The risk increased as tanning bed use increased (Cancer Epidemiol. Biomarkers Prev. 2010;19:1557-68).

A more recent study demonstrated that with every visit to a tanning bed, the risk of melanoma increased by 1.8% – and the risk was even greater among those who started tanning at a younger age (BMJ 2012;345:e4757).

"We are clearly in the throes of a modern-day epidemic, particularly among teenage white girls and young women between the ages of 18 and 25," Mr. Geller said, noting that study after study shows that about a third of white teenage girls and about 20% of all teenage girls use a tanning bed by the age of 17.

And yet only five states restrict the use of tanning beds by those under age 18. Others have parental consent restrictions, but these have been shown to have no effect on tanning bed use by minors. That means that in 45 states, children aged 15 years and younger are free to visit tanning salons with no restrictions, he said, noting that a Washington University in St. Louis survey released in February showed that 65% of Missouri tanning salon owners would allow preteens aged 10-12 years to use their tanning beds – and that 43% of tanning salon employees believe indoor tanning poses no health risks.

Data show that 7% of girls use tanning beds by age 14 years. This doubles from age 14 to 15, and doubles again from age 15 to 17, he said, noting that girls are about five to six times more likely than boys to use tanning beds.

Of particular concern, not only are girls using tanning beds early, but they are using them more often.

A Centers for Disease Control and Prevention survey showed that while the rate of use (20% among all girls) has remained constant in recent years, the "prom phenomenon" – the occasional use of tanning beds before a special event – is no longer the norm; the average yearly number of uses of tanning beds among those surveyed was 28.

"We’re way past the prom phenomenon," Mr. Geller said, noting that one reason for this is that tanning salons "do a wonderful job of selling giant packages of use for very little money."

"When people are beginning to think of some kind of restrictions on the tanning bed industry, that would be one we could surely consider," he said, noting that based on the data showing a 1.8% increase in melanoma risk with each tanning bed use, the risk would be 54%-90% in a teen who starts tanning at age 18 and quits at age 19.

That’s a conservative estimate, because most teens start before age 18 and don’t stop at age 19, he said.

Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute show that the risk of melanoma has doubled among women aged 20-24 years since the 1980s, while the risk in men has declined in some age groups, and remained the same in others.

"You have to ask what’s happened during that time," Mr. Geller said, adding that there is concern about the late effects of tanning bed use, especially given that sun exposure time hasn’t changed in that age group over time.

As for what can be done from a public health perspective to reduce tanning bed use, Mr. Geller said a number of research, legislative, and public health campaigns are underway.

"We know from doing qualitative work, that indoor tanning is largely socially driven. "When [girls] are not tanning, they talk about tanning, they blog about tanning," he said, explaining that "the tanning culture involves some kind of socially driven bonds."

The key is to figure out how to break up those bonds.

"If one girl in a social group quits tanning, will this have an effect on the others? We don’t know," he said, adding that this is among the areas that require further research.

Researchers are also studying the effects of antitanning campaigns and legislation in other countries, a number of which have restricted access to tanning beds for minors. A recent web-based advertising campaign in Denmark targeted teens, and, along with legislation restricting access, resulted in a substantial drop in tanning bed use there, he said.

The results of campaigns and legislative efforts like these are being closely monitored so that the lessons learned about if and how they work can be incorporated into efforts here.

Lessons from the campaign against smoking launched three decades ago also are being incorporated into the current effort to reduce tanning, he said.

Although the link between tanning and melanoma isn’t quite as strong as the link between smoking and lung cancer, the seven key principles that made the antismoking campaign a success can be adapted for this purpose. These are surveillance, taxation, legal strategies, public health advertising campaigns, educational programs, legislation, and "some move to mandate enforcement," he said.

Some progress has been made with respect to these principles. For example, state-by-state surveillance and scoring of states’ level of compliance with existing regulations are underway, a 10% tax has been imposed on tanning salons, cost-efficacy studies are being planned, and lawsuits have been filed in multiple states. However, most of these efforts are in their infancy, Mr. Geller said.

For now, what exists across the United States is a "patchwork quilt of pretty crummy regulations," he said.

While intense pressure is on the Food and Drug Administration to ban tanning bed use by those under age 18 – including pressure from the American Academy of Dermatology – and while the agency is cognizant of the risks and has acknowledged a need for more regulations, "politics have prevailed, and at this point we don’t have the ban," he said.

The FDA website does, however, indicate plans for revising regulations and strengthening warning labels to make consumers more aware of the risks, he noted.

"This is good, but I think it’s a really faulty response to everything that we know about the link between tanning beds and melanoma," he said.

Despite the slow progress toward a ban for those under age 18, there have been some successes in the antitanning campaign. For one, numerous organizations have taken up the cause, including the World Health Organization, the American Academy of Pediatrics, the American Medical Association, the Society of Surgical Oncology, and the Canadian Pediatric Society.

Also, thanks to a Federal Trade Commission crackdown in 2010, the tanning industry is no longer allowed to claim that tanning has certain health benefits, such as reducing the risks of some types of cancers. And in 2012, the U.S. Preventive Services Task Force issued its first guidelines on tanning, stating that the evidence is strong enough to recommend that women aged 10-24 years who have fair skin should avoid prime-time sun exposure and tanning beds.

Additionally, a wellness provision of the Patient Protection and Affordable Care Act that will go into effect in May provides for full reimbursement to health care providers for counseling about skin cancer prevention and tanning bed reduction.

"We want to study this because we think this will have a huge effect on increasing the rate of counseling," he said.

Mr. Geller reported having no disclosures.

MIAMI BEACH – Calls for a ban on the use of tanning beds by minors in the United States have thus far gone unheeded, but medical organizations are increasingly supporting such a ban – and with good reason, according to Alan Geller of the Harvard School of Public Health, Boston.

The data linking tanning bed use and melanoma are consistent and convincing. A 2010 University of Minnesota case-control study, for example, demonstrated that melanoma risk was significantly increased among users, compared with nonusers, of UVB-enhanced tanning devices (adjusted odds ratio, 2.86) and primarily UVA-emitting devices (AOR, 4.44), Mr. Geller said at the annual meeting of the American Academy of Dermatology.

©Vidmantas Goldbergas/iStockphoto.com

The risk increased as tanning bed use increased (Cancer Epidemiol. Biomarkers Prev. 2010;19:1557-68).

A more recent study demonstrated that with every visit to a tanning bed, the risk of melanoma increased by 1.8% – and the risk was even greater among those who started tanning at a younger age (BMJ 2012;345:e4757).

"We are clearly in the throes of a modern-day epidemic, particularly among teenage white girls and young women between the ages of 18 and 25," Mr. Geller said, noting that study after study shows that about a third of white teenage girls and about 20% of all teenage girls use a tanning bed by the age of 17.

And yet only five states restrict the use of tanning beds by those under age 18. Others have parental consent restrictions, but these have been shown to have no effect on tanning bed use by minors. That means that in 45 states, children aged 15 years and younger are free to visit tanning salons with no restrictions, he said, noting that a Washington University in St. Louis survey released in February showed that 65% of Missouri tanning salon owners would allow preteens aged 10-12 years to use their tanning beds – and that 43% of tanning salon employees believe indoor tanning poses no health risks.

Data show that 7% of girls use tanning beds by age 14 years. This doubles from age 14 to 15, and doubles again from age 15 to 17, he said, noting that girls are about five to six times more likely than boys to use tanning beds.

Of particular concern, not only are girls using tanning beds early, but they are using them more often.

A Centers for Disease Control and Prevention survey showed that while the rate of use (20% among all girls) has remained constant in recent years, the "prom phenomenon" – the occasional use of tanning beds before a special event – is no longer the norm; the average yearly number of uses of tanning beds among those surveyed was 28.

"We’re way past the prom phenomenon," Mr. Geller said, noting that one reason for this is that tanning salons "do a wonderful job of selling giant packages of use for very little money."

"When people are beginning to think of some kind of restrictions on the tanning bed industry, that would be one we could surely consider," he said, noting that based on the data showing a 1.8% increase in melanoma risk with each tanning bed use, the risk would be 54%-90% in a teen who starts tanning at age 18 and quits at age 19.

That’s a conservative estimate, because most teens start before age 18 and don’t stop at age 19, he said.

Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute show that the risk of melanoma has doubled among women aged 20-24 years since the 1980s, while the risk in men has declined in some age groups, and remained the same in others.

"You have to ask what’s happened during that time," Mr. Geller said, adding that there is concern about the late effects of tanning bed use, especially given that sun exposure time hasn’t changed in that age group over time.

As for what can be done from a public health perspective to reduce tanning bed use, Mr. Geller said a number of research, legislative, and public health campaigns are underway.

"We know from doing qualitative work, that indoor tanning is largely socially driven. "When [girls] are not tanning, they talk about tanning, they blog about tanning," he said, explaining that "the tanning culture involves some kind of socially driven bonds."

The key is to figure out how to break up those bonds.

"If one girl in a social group quits tanning, will this have an effect on the others? We don’t know," he said, adding that this is among the areas that require further research.

Researchers are also studying the effects of antitanning campaigns and legislation in other countries, a number of which have restricted access to tanning beds for minors. A recent web-based advertising campaign in Denmark targeted teens, and, along with legislation restricting access, resulted in a substantial drop in tanning bed use there, he said.

The results of campaigns and legislative efforts like these are being closely monitored so that the lessons learned about if and how they work can be incorporated into efforts here.

Lessons from the campaign against smoking launched three decades ago also are being incorporated into the current effort to reduce tanning, he said.

Although the link between tanning and melanoma isn’t quite as strong as the link between smoking and lung cancer, the seven key principles that made the antismoking campaign a success can be adapted for this purpose. These are surveillance, taxation, legal strategies, public health advertising campaigns, educational programs, legislation, and "some move to mandate enforcement," he said.

Some progress has been made with respect to these principles. For example, state-by-state surveillance and scoring of states’ level of compliance with existing regulations are underway, a 10% tax has been imposed on tanning salons, cost-efficacy studies are being planned, and lawsuits have been filed in multiple states. However, most of these efforts are in their infancy, Mr. Geller said.

For now, what exists across the United States is a "patchwork quilt of pretty crummy regulations," he said.

While intense pressure is on the Food and Drug Administration to ban tanning bed use by those under age 18 – including pressure from the American Academy of Dermatology – and while the agency is cognizant of the risks and has acknowledged a need for more regulations, "politics have prevailed, and at this point we don’t have the ban," he said.

The FDA website does, however, indicate plans for revising regulations and strengthening warning labels to make consumers more aware of the risks, he noted.

"This is good, but I think it’s a really faulty response to everything that we know about the link between tanning beds and melanoma," he said.

Despite the slow progress toward a ban for those under age 18, there have been some successes in the antitanning campaign. For one, numerous organizations have taken up the cause, including the World Health Organization, the American Academy of Pediatrics, the American Medical Association, the Society of Surgical Oncology, and the Canadian Pediatric Society.

Also, thanks to a Federal Trade Commission crackdown in 2010, the tanning industry is no longer allowed to claim that tanning has certain health benefits, such as reducing the risks of some types of cancers. And in 2012, the U.S. Preventive Services Task Force issued its first guidelines on tanning, stating that the evidence is strong enough to recommend that women aged 10-24 years who have fair skin should avoid prime-time sun exposure and tanning beds.

Additionally, a wellness provision of the Patient Protection and Affordable Care Act that will go into effect in May provides for full reimbursement to health care providers for counseling about skin cancer prevention and tanning bed reduction.

"We want to study this because we think this will have a huge effect on increasing the rate of counseling," he said.

Mr. Geller reported having no disclosures.

WASHINGTON – A new policy statement aims to help cancer patients to quit using tobacco and encourage more physicians to consider tobacco use as a measure in trials and as a key vital sign.

"Today, we call on the oncology community in this statement to assess and document tobacco use by, and to provide cessation support to all cancer patients," Dr. Roy S. Herbst said at a press briefing April 9 at the annual meeting of the American Association for Cancer Research.

Dr. Herbst is a member of the AACR Tobacco and Cancer Subcommittee that wrote the statement, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven in Conn.

The report’s two main recommendations:

• Patients with cancer, participants in cancer trials, and patients being screened for cancer and who use tobacco or who have recently quit, should be given evidence-based tobacco-cessation assistance, ideally within an oncology practice.

• Tobacco use should be comprehensively and repeatedly documented in all cancer patients – both in practices and in trials – so as to gauge the effect of tobacco on treatment, disease progression, comorbidities, and survival.

Addressing tobacco use is urgent because up to a third of all cancer-related deaths and 87% of lung cancer deaths are because of tobacco use, Dr. Herbst said. Tobacco use plays a role in 18 different cancers. Prevention is the goal, but it’s also important to urge people who have cancer – or who have survived it – to stop using tobacco, he said.

Patients who use tobacco have worse outcomes and more difficult treatment. According to the policy statement, tobacco use decreases the effectiveness of chemotherapies and interferes with drug metabolism. The data also shows that it decreases survival in cancer of the lung, head and neck, breast, prostate, colon, esophagus, cervix, bladder, and ovaries and in leukemia.

Evidence-based tobacco cessation models developed by the U.S. Public Health Service are endorsed by the AACR, the American Society of Clinical Oncology, and others, and yet few clinicians offer cessation services.

The AACR committee also reported that only 38% of National Cancer Institute–designated Cancer Centers record smoking as a vital sign and less than half have dedicated tobacco cessation personnel. And, in a survey by the International Association for the Study of Lung Cancer, only about 40% of lung cancer specialists said they discussed medication or offered cessation support to patients.

Tobacco assessment in cancer patients may be underperformed in part because of physician and patient perceptions that it’s too late to have an impact, Dr. Herbst said. "There is the feeling that someone’s smoking, they already have cancer, why worry about it."

There is also the issue of payment.

Smoking cessation generally has been not covered in the past, although Medicare covers up to eight visits a year for counseling. The Affordable Care Act requires coverage of tobacco cessation by all insurers starting in 2014.

"It’s true that reimbursement in the past was very poor," said Benjamin A. Toll, Ph.D., a psychiatrist and program director of the smoking cessation service at Smilow Cancer Hospital at Yale-New Haven. "It’s still not particularly high, but it’s getting better," he said, at the briefing.

Clinicians and researchers also have not been diligent about assessing tobacco use in trials. A survey of 155 NCI Cooperative Group Trials showed that only 29% of trials assessed tobacco use at enrollment; far fewer recorded smoking status during the trial. Less than 5% followed up subsequently on tobacco use status during or after the trial.

None of the studies evaluated nicotine dependence or the patient’s interest in quitting.

"It really is incredible that so many of these NCI trials are done and these data are not recorded," said Dr. Herbst.

"Assessing Tobacco Use in Cancer Patients and Facilitating Cessation" is the third statement on tobacco use by the AACR, published online in Clinical Cancer Research (2013;19:1-8).

The statement was Dr. Herbst reported that he received consulting fees from Biothera, Diatech, and Quintiles. Mr. Toll reported that he received support from Pfizer, for medicine only.

[email protected]

On Twitter @aliciaault

WASHINGTON – A new policy statement aims to help cancer patients to quit using tobacco and encourage more physicians to consider tobacco use as a measure in trials and as a key vital sign.

"Today, we call on the oncology community in this statement to assess and document tobacco use by, and to provide cessation support to all cancer patients," Dr. Roy S. Herbst said at a press briefing April 9 at the annual meeting of the American Association for Cancer Research.

Dr. Herbst is a member of the AACR Tobacco and Cancer Subcommittee that wrote the statement, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven in Conn.

The report’s two main recommendations:

• Patients with cancer, participants in cancer trials, and patients being screened for cancer and who use tobacco or who have recently quit, should be given evidence-based tobacco-cessation assistance, ideally within an oncology practice.

• Tobacco use should be comprehensively and repeatedly documented in all cancer patients – both in practices and in trials – so as to gauge the effect of tobacco on treatment, disease progression, comorbidities, and survival.

Addressing tobacco use is urgent because up to a third of all cancer-related deaths and 87% of lung cancer deaths are because of tobacco use, Dr. Herbst said. Tobacco use plays a role in 18 different cancers. Prevention is the goal, but it’s also important to urge people who have cancer – or who have survived it – to stop using tobacco, he said.

Patients who use tobacco have worse outcomes and more difficult treatment. According to the policy statement, tobacco use decreases the effectiveness of chemotherapies and interferes with drug metabolism. The data also shows that it decreases survival in cancer of the lung, head and neck, breast, prostate, colon, esophagus, cervix, bladder, and ovaries and in leukemia.

Evidence-based tobacco cessation models developed by the U.S. Public Health Service are endorsed by the AACR, the American Society of Clinical Oncology, and others, and yet few clinicians offer cessation services.

The AACR committee also reported that only 38% of National Cancer Institute–designated Cancer Centers record smoking as a vital sign and less than half have dedicated tobacco cessation personnel. And, in a survey by the International Association for the Study of Lung Cancer, only about 40% of lung cancer specialists said they discussed medication or offered cessation support to patients.

Tobacco assessment in cancer patients may be underperformed in part because of physician and patient perceptions that it’s too late to have an impact, Dr. Herbst said. "There is the feeling that someone’s smoking, they already have cancer, why worry about it."

There is also the issue of payment.

Smoking cessation generally has been not covered in the past, although Medicare covers up to eight visits a year for counseling. The Affordable Care Act requires coverage of tobacco cessation by all insurers starting in 2014.

"It’s true that reimbursement in the past was very poor," said Benjamin A. Toll, Ph.D., a psychiatrist and program director of the smoking cessation service at Smilow Cancer Hospital at Yale-New Haven. "It’s still not particularly high, but it’s getting better," he said, at the briefing.

Clinicians and researchers also have not been diligent about assessing tobacco use in trials. A survey of 155 NCI Cooperative Group Trials showed that only 29% of trials assessed tobacco use at enrollment; far fewer recorded smoking status during the trial. Less than 5% followed up subsequently on tobacco use status during or after the trial.

None of the studies evaluated nicotine dependence or the patient’s interest in quitting.

"It really is incredible that so many of these NCI trials are done and these data are not recorded," said Dr. Herbst.

"Assessing Tobacco Use in Cancer Patients and Facilitating Cessation" is the third statement on tobacco use by the AACR, published online in Clinical Cancer Research (2013;19:1-8).

The statement was Dr. Herbst reported that he received consulting fees from Biothera, Diatech, and Quintiles. Mr. Toll reported that he received support from Pfizer, for medicine only.

[email protected]

On Twitter @aliciaault

WASHINGTON – A new policy statement aims to help cancer patients to quit using tobacco and encourage more physicians to consider tobacco use as a measure in trials and as a key vital sign.

"Today, we call on the oncology community in this statement to assess and document tobacco use by, and to provide cessation support to all cancer patients," Dr. Roy S. Herbst said at a press briefing April 9 at the annual meeting of the American Association for Cancer Research.

Dr. Herbst is a member of the AACR Tobacco and Cancer Subcommittee that wrote the statement, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven in Conn.

The report’s two main recommendations:

• Patients with cancer, participants in cancer trials, and patients being screened for cancer and who use tobacco or who have recently quit, should be given evidence-based tobacco-cessation assistance, ideally within an oncology practice.

• Tobacco use should be comprehensively and repeatedly documented in all cancer patients – both in practices and in trials – so as to gauge the effect of tobacco on treatment, disease progression, comorbidities, and survival.

Addressing tobacco use is urgent because up to a third of all cancer-related deaths and 87% of lung cancer deaths are because of tobacco use, Dr. Herbst said. Tobacco use plays a role in 18 different cancers. Prevention is the goal, but it’s also important to urge people who have cancer – or who have survived it – to stop using tobacco, he said.

Patients who use tobacco have worse outcomes and more difficult treatment. According to the policy statement, tobacco use decreases the effectiveness of chemotherapies and interferes with drug metabolism. The data also shows that it decreases survival in cancer of the lung, head and neck, breast, prostate, colon, esophagus, cervix, bladder, and ovaries and in leukemia.

Evidence-based tobacco cessation models developed by the U.S. Public Health Service are endorsed by the AACR, the American Society of Clinical Oncology, and others, and yet few clinicians offer cessation services.

The AACR committee also reported that only 38% of National Cancer Institute–designated Cancer Centers record smoking as a vital sign and less than half have dedicated tobacco cessation personnel. And, in a survey by the International Association for the Study of Lung Cancer, only about 40% of lung cancer specialists said they discussed medication or offered cessation support to patients.

Tobacco assessment in cancer patients may be underperformed in part because of physician and patient perceptions that it’s too late to have an impact, Dr. Herbst said. "There is the feeling that someone’s smoking, they already have cancer, why worry about it."

There is also the issue of payment.

Smoking cessation generally has been not covered in the past, although Medicare covers up to eight visits a year for counseling. The Affordable Care Act requires coverage of tobacco cessation by all insurers starting in 2014.

"It’s true that reimbursement in the past was very poor," said Benjamin A. Toll, Ph.D., a psychiatrist and program director of the smoking cessation service at Smilow Cancer Hospital at Yale-New Haven. "It’s still not particularly high, but it’s getting better," he said, at the briefing.

Clinicians and researchers also have not been diligent about assessing tobacco use in trials. A survey of 155 NCI Cooperative Group Trials showed that only 29% of trials assessed tobacco use at enrollment; far fewer recorded smoking status during the trial. Less than 5% followed up subsequently on tobacco use status during or after the trial.

None of the studies evaluated nicotine dependence or the patient’s interest in quitting.

"It really is incredible that so many of these NCI trials are done and these data are not recorded," said Dr. Herbst.

"Assessing Tobacco Use in Cancer Patients and Facilitating Cessation" is the third statement on tobacco use by the AACR, published online in Clinical Cancer Research (2013;19:1-8).

The statement was Dr. Herbst reported that he received consulting fees from Biothera, Diatech, and Quintiles. Mr. Toll reported that he received support from Pfizer, for medicine only.

[email protected]

On Twitter @aliciaault

Mortality is twice as high for cancer survivors undergoing cardiac surgery to correct damage done by thoracic radiation therapy as it is among matched patients who are undergoing the same procedures but who haven’t been exposed to radiotherapy, according to a report published online April 8 in Circulation.

In what they described as "the largest study to assess long-term survival in this population undergoing complex cardiac surgery and compare them to a well-matched comparison population," investigators found that mortality was 55% in the patients who had received radiation therapy, compared with 28% in the nonexposed controls. At least half of the deaths among the cancer survivors were attributed to cardiopulmonary disease, while only 5% were due to recurrent malignancy.

"Surgical intervention should be applied cautiously to patients who have had significant thoracic radiation previously," including survivors of breast, lung, hematologic, thyroid, and other cancers.

Trying to gauge mortality risk in such patients solely by using their preoperative scores on standard risk-prediction measures is inaccurate at best. In this study population, the survivors of breast, lung, hematologic, thyroid, and other cancers would have been deemed at intermediate risk for undergoing cardiac surgery, with an expected mortality of only 3%-5% based on their preoperative assessments – 10 times lower than their actual postoperative mortality, said Dr. Willis Wu and his associates at the Heart and Vascular Institute at the Cleveland Clinic.

"Our findings suggest that surgical intervention should be applied cautiously to patients who have had significant thoracic radiation previously," they wrote. Cardiac surgery that is considered conventional or even routine in most patients – including coronary artery bypass graft, valve repair, valve replacement, vascular surgery, pericardiectomy, left ventricular assist device implantation, and myectomy – may actually worsen the condition of radiation-exposed patients.

"It seems appropriate to examine other types of treatment options in patients with radiation heart disease who have significant valvular, coronary, or myocardial disease," the researchers noted.

Dr. Wu and his associates performed their retrospective observational study because of the dearth of information regarding long-term outcomes in cancer survivors who were exposed to chest irradiation. This knowledge gap makes treatment decisions "especially difficult" once radiation-related heart disease is discovered.

Such patients are known to have high rates of coronary artery, valvular, pericardial, myocardial, and conduction disease that progresses over time and may not become evident until decades after cancer treatment was completed.

Surgery is often thought necessary to effectively address these cardiac complications of prior radiation therapy. "These patients have multiple cardiac lesions and [often] have comorbidities such as pulmonary or vascular disease related to radiation," the investigators said.

They analyzed the medical records of 478 patients undergoing cardiac surgery at their tertiary care center in 2000-2003. A total of 173 had a prior history of malignancy treated with chest irradiation; the remaining 305 patients had no such history and were matched to the radiation group for age, sex, type of surgery, and date of surgery.

The patients exposed to radiation were relatively young but had advanced symptoms. Forty-five percent had obstructive proximal coronary artery disease; one-fourth had already undergone open heart surgery, including 16% who had prior coronary artery bypass graft surgery. There also was a high prevalence of valvular disease, with 51% of patients showing at least moderate mitral regurgitation, 6% showing severe mitral stenosis, 29% showing at least moderate aortic regurgitation, 23% showing severe aortic stenosis, and 34% showing at least moderate tricuspid regurgitation.

The mean interval between the current cardiac surgery and the last thoracic radiation treatment was 18 years. Approximately 53% of the study patients had survived breast cancer, 27% had survived Hodgkin’s lymphoma, 7% had survived lung cancer, 6% had survived non-Hodgkin’s lymphoma, and 8% had survived other malignancies including thyroid and testicular cancers.

Approximately 75% of both study groups were women.

During a mean follow-up of 7.6 years, overall mortality was 37%. Despite the success of the cardiac procedures, a significantly higher proportion of radiation-exposed patients died (55%), compared with the unexposed patients (28%), for a hazard ratio of 2.54, Dr. Wu and his colleagues said (Circulation 2013 April 8; doi:10.1161/CIRCULATIONAHA.13.001435).

Mortality was significantly higher across all subgroups of patients exposed to radiation. In particular, it was high among patients expected to have low mortality: 43% in patients aged younger than 65 years and 45% in those with lower preoperative risk scores. In fact, the youngest patients in the radiation group fared worse than the oldest patients in the comparison group.

Mortality also was significantly higher for the radiation-exposed patients than for controls across all types of cardiac surgery.

The cause of death was not known for a substantial proportion of subjects in this study, but cardiopulmonary causes were implicated in at least half of the deaths among radiation-exposed patients. "Why this should be the case in a group of patients who received potentially life-preserving revascularization, valve, and other procedures is unknown at present," Dr. Wu and his associates said.

In addition, patients with radiation-related heart disease had longer hospital stays, were more likely to develop atrial fibrillation after surgery, were more likely to require pacemaker implantation after surgery, had higher rates of ventricular dysfunction and of valvular regurgitation following surgery, and had higher 30-day mortality.

The finding that radiation-exposed patients "remained in hospital for a considerable period after their surgery" suggests that the procedures and postoperative courses were complicated.

"Radiation patients frequently develop pulmonary complications as a result of open heart surgery, not the least of which are recurrent pleural effusions and severe restrictive lung disease. It is our experience that respiratory complications may significantly compromise function and survival in patients with extensive prior radiation," the researchers said.

"Additionally, the presence of myocardial disease either as a result of the underlying cardiac condition (potentially exacerbated by prior chemotherapy) or as a consequence of a restrictive-type cardiomyopathy produced by the effects of radiation may play a role in impaired survival and is not necessarily improved by valvular or revascularization surgery," they said.

The radiation-exposed patients’ poor long-term survival after conventional cardiac surgery indicates that other, nonsurgical treatments may be necessary for this complex patient population, they added.

No relevant financial conflicts were reported.

Mortality is twice as high for cancer survivors undergoing cardiac surgery to correct damage done by thoracic radiation therapy as it is among matched patients who are undergoing the same procedures but who haven’t been exposed to radiotherapy, according to a report published online April 8 in Circulation.

In what they described as "the largest study to assess long-term survival in this population undergoing complex cardiac surgery and compare them to a well-matched comparison population," investigators found that mortality was 55% in the patients who had received radiation therapy, compared with 28% in the nonexposed controls. At least half of the deaths among the cancer survivors were attributed to cardiopulmonary disease, while only 5% were due to recurrent malignancy.

"Surgical intervention should be applied cautiously to patients who have had significant thoracic radiation previously," including survivors of breast, lung, hematologic, thyroid, and other cancers.

Trying to gauge mortality risk in such patients solely by using their preoperative scores on standard risk-prediction measures is inaccurate at best. In this study population, the survivors of breast, lung, hematologic, thyroid, and other cancers would have been deemed at intermediate risk for undergoing cardiac surgery, with an expected mortality of only 3%-5% based on their preoperative assessments – 10 times lower than their actual postoperative mortality, said Dr. Willis Wu and his associates at the Heart and Vascular Institute at the Cleveland Clinic.

"Our findings suggest that surgical intervention should be applied cautiously to patients who have had significant thoracic radiation previously," they wrote. Cardiac surgery that is considered conventional or even routine in most patients – including coronary artery bypass graft, valve repair, valve replacement, vascular surgery, pericardiectomy, left ventricular assist device implantation, and myectomy – may actually worsen the condition of radiation-exposed patients.

"It seems appropriate to examine other types of treatment options in patients with radiation heart disease who have significant valvular, coronary, or myocardial disease," the researchers noted.

Dr. Wu and his associates performed their retrospective observational study because of the dearth of information regarding long-term outcomes in cancer survivors who were exposed to chest irradiation. This knowledge gap makes treatment decisions "especially difficult" once radiation-related heart disease is discovered.

Such patients are known to have high rates of coronary artery, valvular, pericardial, myocardial, and conduction disease that progresses over time and may not become evident until decades after cancer treatment was completed.

Surgery is often thought necessary to effectively address these cardiac complications of prior radiation therapy. "These patients have multiple cardiac lesions and [often] have comorbidities such as pulmonary or vascular disease related to radiation," the investigators said.

They analyzed the medical records of 478 patients undergoing cardiac surgery at their tertiary care center in 2000-2003. A total of 173 had a prior history of malignancy treated with chest irradiation; the remaining 305 patients had no such history and were matched to the radiation group for age, sex, type of surgery, and date of surgery.

The patients exposed to radiation were relatively young but had advanced symptoms. Forty-five percent had obstructive proximal coronary artery disease; one-fourth had already undergone open heart surgery, including 16% who had prior coronary artery bypass graft surgery. There also was a high prevalence of valvular disease, with 51% of patients showing at least moderate mitral regurgitation, 6% showing severe mitral stenosis, 29% showing at least moderate aortic regurgitation, 23% showing severe aortic stenosis, and 34% showing at least moderate tricuspid regurgitation.

The mean interval between the current cardiac surgery and the last thoracic radiation treatment was 18 years. Approximately 53% of the study patients had survived breast cancer, 27% had survived Hodgkin’s lymphoma, 7% had survived lung cancer, 6% had survived non-Hodgkin’s lymphoma, and 8% had survived other malignancies including thyroid and testicular cancers.

Approximately 75% of both study groups were women.

During a mean follow-up of 7.6 years, overall mortality was 37%. Despite the success of the cardiac procedures, a significantly higher proportion of radiation-exposed patients died (55%), compared with the unexposed patients (28%), for a hazard ratio of 2.54, Dr. Wu and his colleagues said (Circulation 2013 April 8; doi:10.1161/CIRCULATIONAHA.13.001435).

Mortality was significantly higher across all subgroups of patients exposed to radiation. In particular, it was high among patients expected to have low mortality: 43% in patients aged younger than 65 years and 45% in those with lower preoperative risk scores. In fact, the youngest patients in the radiation group fared worse than the oldest patients in the comparison group.

Mortality also was significantly higher for the radiation-exposed patients than for controls across all types of cardiac surgery.

The cause of death was not known for a substantial proportion of subjects in this study, but cardiopulmonary causes were implicated in at least half of the deaths among radiation-exposed patients. "Why this should be the case in a group of patients who received potentially life-preserving revascularization, valve, and other procedures is unknown at present," Dr. Wu and his associates said.

In addition, patients with radiation-related heart disease had longer hospital stays, were more likely to develop atrial fibrillation after surgery, were more likely to require pacemaker implantation after surgery, had higher rates of ventricular dysfunction and of valvular regurgitation following surgery, and had higher 30-day mortality.

The finding that radiation-exposed patients "remained in hospital for a considerable period after their surgery" suggests that the procedures and postoperative courses were complicated.

"Radiation patients frequently develop pulmonary complications as a result of open heart surgery, not the least of which are recurrent pleural effusions and severe restrictive lung disease. It is our experience that respiratory complications may significantly compromise function and survival in patients with extensive prior radiation," the researchers said.

"Additionally, the presence of myocardial disease either as a result of the underlying cardiac condition (potentially exacerbated by prior chemotherapy) or as a consequence of a restrictive-type cardiomyopathy produced by the effects of radiation may play a role in impaired survival and is not necessarily improved by valvular or revascularization surgery," they said.

The radiation-exposed patients’ poor long-term survival after conventional cardiac surgery indicates that other, nonsurgical treatments may be necessary for this complex patient population, they added.

No relevant financial conflicts were reported.

Mortality is twice as high for cancer survivors undergoing cardiac surgery to correct damage done by thoracic radiation therapy as it is among matched patients who are undergoing the same procedures but who haven’t been exposed to radiotherapy, according to a report published online April 8 in Circulation.

In what they described as "the largest study to assess long-term survival in this population undergoing complex cardiac surgery and compare them to a well-matched comparison population," investigators found that mortality was 55% in the patients who had received radiation therapy, compared with 28% in the nonexposed controls. At least half of the deaths among the cancer survivors were attributed to cardiopulmonary disease, while only 5% were due to recurrent malignancy.

"Surgical intervention should be applied cautiously to patients who have had significant thoracic radiation previously," including survivors of breast, lung, hematologic, thyroid, and other cancers.

Trying to gauge mortality risk in such patients solely by using their preoperative scores on standard risk-prediction measures is inaccurate at best. In this study population, the survivors of breast, lung, hematologic, thyroid, and other cancers would have been deemed at intermediate risk for undergoing cardiac surgery, with an expected mortality of only 3%-5% based on their preoperative assessments – 10 times lower than their actual postoperative mortality, said Dr. Willis Wu and his associates at the Heart and Vascular Institute at the Cleveland Clinic.

"Our findings suggest that surgical intervention should be applied cautiously to patients who have had significant thoracic radiation previously," they wrote. Cardiac surgery that is considered conventional or even routine in most patients – including coronary artery bypass graft, valve repair, valve replacement, vascular surgery, pericardiectomy, left ventricular assist device implantation, and myectomy – may actually worsen the condition of radiation-exposed patients.

"It seems appropriate to examine other types of treatment options in patients with radiation heart disease who have significant valvular, coronary, or myocardial disease," the researchers noted.

Dr. Wu and his associates performed their retrospective observational study because of the dearth of information regarding long-term outcomes in cancer survivors who were exposed to chest irradiation. This knowledge gap makes treatment decisions "especially difficult" once radiation-related heart disease is discovered.

Such patients are known to have high rates of coronary artery, valvular, pericardial, myocardial, and conduction disease that progresses over time and may not become evident until decades after cancer treatment was completed.

Surgery is often thought necessary to effectively address these cardiac complications of prior radiation therapy. "These patients have multiple cardiac lesions and [often] have comorbidities such as pulmonary or vascular disease related to radiation," the investigators said.

They analyzed the medical records of 478 patients undergoing cardiac surgery at their tertiary care center in 2000-2003. A total of 173 had a prior history of malignancy treated with chest irradiation; the remaining 305 patients had no such history and were matched to the radiation group for age, sex, type of surgery, and date of surgery.

The patients exposed to radiation were relatively young but had advanced symptoms. Forty-five percent had obstructive proximal coronary artery disease; one-fourth had already undergone open heart surgery, including 16% who had prior coronary artery bypass graft surgery. There also was a high prevalence of valvular disease, with 51% of patients showing at least moderate mitral regurgitation, 6% showing severe mitral stenosis, 29% showing at least moderate aortic regurgitation, 23% showing severe aortic stenosis, and 34% showing at least moderate tricuspid regurgitation.

The mean interval between the current cardiac surgery and the last thoracic radiation treatment was 18 years. Approximately 53% of the study patients had survived breast cancer, 27% had survived Hodgkin’s lymphoma, 7% had survived lung cancer, 6% had survived non-Hodgkin’s lymphoma, and 8% had survived other malignancies including thyroid and testicular cancers.

Approximately 75% of both study groups were women.

During a mean follow-up of 7.6 years, overall mortality was 37%. Despite the success of the cardiac procedures, a significantly higher proportion of radiation-exposed patients died (55%), compared with the unexposed patients (28%), for a hazard ratio of 2.54, Dr. Wu and his colleagues said (Circulation 2013 April 8; doi:10.1161/CIRCULATIONAHA.13.001435).

Mortality was significantly higher across all subgroups of patients exposed to radiation. In particular, it was high among patients expected to have low mortality: 43% in patients aged younger than 65 years and 45% in those with lower preoperative risk scores. In fact, the youngest patients in the radiation group fared worse than the oldest patients in the comparison group.

Mortality also was significantly higher for the radiation-exposed patients than for controls across all types of cardiac surgery.

The cause of death was not known for a substantial proportion of subjects in this study, but cardiopulmonary causes were implicated in at least half of the deaths among radiation-exposed patients. "Why this should be the case in a group of patients who received potentially life-preserving revascularization, valve, and other procedures is unknown at present," Dr. Wu and his associates said.

In addition, patients with radiation-related heart disease had longer hospital stays, were more likely to develop atrial fibrillation after surgery, were more likely to require pacemaker implantation after surgery, had higher rates of ventricular dysfunction and of valvular regurgitation following surgery, and had higher 30-day mortality.

The finding that radiation-exposed patients "remained in hospital for a considerable period after their surgery" suggests that the procedures and postoperative courses were complicated.

"Radiation patients frequently develop pulmonary complications as a result of open heart surgery, not the least of which are recurrent pleural effusions and severe restrictive lung disease. It is our experience that respiratory complications may significantly compromise function and survival in patients with extensive prior radiation," the researchers said.

"Additionally, the presence of myocardial disease either as a result of the underlying cardiac condition (potentially exacerbated by prior chemotherapy) or as a consequence of a restrictive-type cardiomyopathy produced by the effects of radiation may play a role in impaired survival and is not necessarily improved by valvular or revascularization surgery," they said.

The radiation-exposed patients’ poor long-term survival after conventional cardiac surgery indicates that other, nonsurgical treatments may be necessary for this complex patient population, they added.

No relevant financial conflicts were reported.

Community Oncology Editor-in-Chief Dr. David Henry and Dr. Linda Bosserman, an Editor on the journal, present a round-up of the top-notch clinical and supportive presentations at the Oncology Practice Summit in Las Vegas.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. Dr. Abraham was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology, and The Oncology Report.

Community Oncology Editor-in-Chief Dr. David Henry and Dr. Linda Bosserman, an Editor on the journal, present a round-up of the top-notch clinical and supportive presentations at the Oncology Practice Summit in Las Vegas.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. Dr. Abraham was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology, and The Oncology Report.

Community Oncology Editor-in-Chief Dr. David Henry and Dr. Linda Bosserman, an Editor on the journal, present a round-up of the top-notch clinical and supportive presentations at the Oncology Practice Summit in Las Vegas.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. Dr. Abraham was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology, and The Oncology Report.

Oncology drug shortages in 2011 undermined patient care, increased costs and stalled cancer research, a survey reports.

Anecdotally, the supply picture is beginning to improve, but fluctuations continue and new agents are now in jeopardy, according to study coauthor Lisa Holle, Pharm.D.

Courtesy National Cancer Institute

"For example, we received a notice recently about vinblastine being on short supply and that was not one of the drugs that came up during our survey as being in short supply," said Dr. Holle, immediate past-president of the Hematology/Oncology Pharmacy Association (HOPA), the study’s sponsor.

As seen in other studies, liposomal doxorubicin was the most difficult chemotherapy medication to obtain when the study was conducted in September and October 2011, followed by fluorouracil, leucovorin, paclitaxel, cytarabine, and doxorubicin. Shortages of nitrogen mustard, which had been linked to a greater risk of relapse for some young Hodgkin lymphoma patients, were reported by only two respondents.

Of the 243 respondents, 97% reported a delay in administering chemotherapy or having to change to a different treatment regimen for one or more disease. Delays were most frequent among patients with ovarian cancer (52%), colorectal cancer (51%), breast cancer (49%) and acute myeloid leukemia (35%), reported Dr. Hoppe, a Board-certified oncology pharmacist with the University of Connecticut, Storrs.

The results provide some alarming details on the impact of drug shortages across the United States including the use of unproved alternative regimens, dose reductions to conserve supplies and even stockpiling of medications.

In the treatment of breast cancer patients, for example, 20% of participants reported changing to another regimen when the cornerstone drug paclitaxel was scarce, 5% said they omitted the drug altogether without a substitution, and 4% reduced the paclitaxel dosage.

Scarcities of cytarabine, a drug that has no therapeutic equivalent for acute myeloid leukemia (AML), forced 12% of respondents to change to another regimen for their AML patients, 10% to omit the drug without substitution and 11% to reduce cytarabine doses in an effort to conserve the supply for future doses or other patients.

Use of these less-familiar medications can lead to medication errors or patient harm, warn the study authors, led by Ali McBride, Pharm.D., of Ohio State University in Columbus.

Indeed, 16% of respondents reported near-miss medication errors because of an oncology drug shortage, 6% said the error reached the patient and 16% said their patients experienced adverse outcomes such as increased toxicity (50%), cancer progression (15%), cardiac events (5%) and emotional distress (3%).

Two patients were reported to have developed encephalopathy during a shortage of an intravenous multivitamin, while one patient reportedly died from incorrect medication dosing after switching to epirubicin therapy during a daunorubicin shortage.

Importantly, 44% of institutions reported that drug shortages affected clinical trials. Typically, this meant delays in patient enrollment (44%) or not enrolling patients at all (67%), but participants also reported changing medications used in a trial, completely omitting a medication from a protocol, and stockpiling drugs "often at the expense of nonresearch patient(s)" to ensure that a clinical trial could be completed.

Failure to enroll patients or changing agents in the active or comparator arm has serious consequences not only for the patients involved in the trial, but can stymie research because investigators don’t fully understand what the results of those trials mean because not all the patients received the same therapy, Dr. Holle said.

"It can potentially delay effective regimens from becoming the standard of care because either there aren’t enough patients to complete the trials or the analyses have to be considered with these changes that occur," she said.

This is particularly detrimental in a disease state that relies more heavily than others on clinical trials to advance and improve patient care, she added.

Finally, 85% of respondents said oncology drug shortages resulted in increased costs for their institution and 34% reported spending an extra 20 hours a week managing the drug shortages.

Roughly 28% resorted to buying drugs on the grey market – supply channels that are unofficial, unauthorized, or unintended by the original manufacturer – with 14% reporting they paid at least 100% more than fair market value.

The Food and Drug Administration Safety and Innovation Act, often referred to as the FDA user fee reauthorization, contains several provisions aimed at mitigating drug shortages including expedited review and inspections by the FDA when necessary and adjustments in the quotas for controlled substances. When it was signed into law in July 2012, drug manufacturers were also required to notify the FDA at least 6 months in advance of any discontinuation or interruption in the production of lifesaving or life-supporting drugs, but there are no penalties for noncompliance.

"It’s definitely a step in the right direction, but I think we’d agree that some other legislation would be needed," Dr. Hoppe said.

Full details of the survey are available in the American Journal of Health-System Pharmacy (Am. J. Health-Syst. Pharm. 2013 April 1;70:609-17).

[email protected]

Oncology drug shortages in 2011 undermined patient care, increased costs and stalled cancer research, a survey reports.

Anecdotally, the supply picture is beginning to improve, but fluctuations continue and new agents are now in jeopardy, according to study coauthor Lisa Holle, Pharm.D.

Courtesy National Cancer Institute

"For example, we received a notice recently about vinblastine being on short supply and that was not one of the drugs that came up during our survey as being in short supply," said Dr. Holle, immediate past-president of the Hematology/Oncology Pharmacy Association (HOPA), the study’s sponsor.

As seen in other studies, liposomal doxorubicin was the most difficult chemotherapy medication to obtain when the study was conducted in September and October 2011, followed by fluorouracil, leucovorin, paclitaxel, cytarabine, and doxorubicin. Shortages of nitrogen mustard, which had been linked to a greater risk of relapse for some young Hodgkin lymphoma patients, were reported by only two respondents.

Of the 243 respondents, 97% reported a delay in administering chemotherapy or having to change to a different treatment regimen for one or more disease. Delays were most frequent among patients with ovarian cancer (52%), colorectal cancer (51%), breast cancer (49%) and acute myeloid leukemia (35%), reported Dr. Hoppe, a Board-certified oncology pharmacist with the University of Connecticut, Storrs.

The results provide some alarming details on the impact of drug shortages across the United States including the use of unproved alternative regimens, dose reductions to conserve supplies and even stockpiling of medications.

In the treatment of breast cancer patients, for example, 20% of participants reported changing to another regimen when the cornerstone drug paclitaxel was scarce, 5% said they omitted the drug altogether without a substitution, and 4% reduced the paclitaxel dosage.

Scarcities of cytarabine, a drug that has no therapeutic equivalent for acute myeloid leukemia (AML), forced 12% of respondents to change to another regimen for their AML patients, 10% to omit the drug without substitution and 11% to reduce cytarabine doses in an effort to conserve the supply for future doses or other patients.

Use of these less-familiar medications can lead to medication errors or patient harm, warn the study authors, led by Ali McBride, Pharm.D., of Ohio State University in Columbus.

Indeed, 16% of respondents reported near-miss medication errors because of an oncology drug shortage, 6% said the error reached the patient and 16% said their patients experienced adverse outcomes such as increased toxicity (50%), cancer progression (15%), cardiac events (5%) and emotional distress (3%).

Two patients were reported to have developed encephalopathy during a shortage of an intravenous multivitamin, while one patient reportedly died from incorrect medication dosing after switching to epirubicin therapy during a daunorubicin shortage.

Importantly, 44% of institutions reported that drug shortages affected clinical trials. Typically, this meant delays in patient enrollment (44%) or not enrolling patients at all (67%), but participants also reported changing medications used in a trial, completely omitting a medication from a protocol, and stockpiling drugs "often at the expense of nonresearch patient(s)" to ensure that a clinical trial could be completed.

Failure to enroll patients or changing agents in the active or comparator arm has serious consequences not only for the patients involved in the trial, but can stymie research because investigators don’t fully understand what the results of those trials mean because not all the patients received the same therapy, Dr. Holle said.

"It can potentially delay effective regimens from becoming the standard of care because either there aren’t enough patients to complete the trials or the analyses have to be considered with these changes that occur," she said.

This is particularly detrimental in a disease state that relies more heavily than others on clinical trials to advance and improve patient care, she added.

Finally, 85% of respondents said oncology drug shortages resulted in increased costs for their institution and 34% reported spending an extra 20 hours a week managing the drug shortages.

Roughly 28% resorted to buying drugs on the grey market – supply channels that are unofficial, unauthorized, or unintended by the original manufacturer – with 14% reporting they paid at least 100% more than fair market value.

The Food and Drug Administration Safety and Innovation Act, often referred to as the FDA user fee reauthorization, contains several provisions aimed at mitigating drug shortages including expedited review and inspections by the FDA when necessary and adjustments in the quotas for controlled substances. When it was signed into law in July 2012, drug manufacturers were also required to notify the FDA at least 6 months in advance of any discontinuation or interruption in the production of lifesaving or life-supporting drugs, but there are no penalties for noncompliance.

"It’s definitely a step in the right direction, but I think we’d agree that some other legislation would be needed," Dr. Hoppe said.

Full details of the survey are available in the American Journal of Health-System Pharmacy (Am. J. Health-Syst. Pharm. 2013 April 1;70:609-17).

[email protected]

Oncology drug shortages in 2011 undermined patient care, increased costs and stalled cancer research, a survey reports.

Anecdotally, the supply picture is beginning to improve, but fluctuations continue and new agents are now in jeopardy, according to study coauthor Lisa Holle, Pharm.D.

Courtesy National Cancer Institute

"For example, we received a notice recently about vinblastine being on short supply and that was not one of the drugs that came up during our survey as being in short supply," said Dr. Holle, immediate past-president of the Hematology/Oncology Pharmacy Association (HOPA), the study’s sponsor.

As seen in other studies, liposomal doxorubicin was the most difficult chemotherapy medication to obtain when the study was conducted in September and October 2011, followed by fluorouracil, leucovorin, paclitaxel, cytarabine, and doxorubicin. Shortages of nitrogen mustard, which had been linked to a greater risk of relapse for some young Hodgkin lymphoma patients, were reported by only two respondents.

Of the 243 respondents, 97% reported a delay in administering chemotherapy or having to change to a different treatment regimen for one or more disease. Delays were most frequent among patients with ovarian cancer (52%), colorectal cancer (51%), breast cancer (49%) and acute myeloid leukemia (35%), reported Dr. Hoppe, a Board-certified oncology pharmacist with the University of Connecticut, Storrs.

The results provide some alarming details on the impact of drug shortages across the United States including the use of unproved alternative regimens, dose reductions to conserve supplies and even stockpiling of medications.

In the treatment of breast cancer patients, for example, 20% of participants reported changing to another regimen when the cornerstone drug paclitaxel was scarce, 5% said they omitted the drug altogether without a substitution, and 4% reduced the paclitaxel dosage.

Scarcities of cytarabine, a drug that has no therapeutic equivalent for acute myeloid leukemia (AML), forced 12% of respondents to change to another regimen for their AML patients, 10% to omit the drug without substitution and 11% to reduce cytarabine doses in an effort to conserve the supply for future doses or other patients.

Use of these less-familiar medications can lead to medication errors or patient harm, warn the study authors, led by Ali McBride, Pharm.D., of Ohio State University in Columbus.

Indeed, 16% of respondents reported near-miss medication errors because of an oncology drug shortage, 6% said the error reached the patient and 16% said their patients experienced adverse outcomes such as increased toxicity (50%), cancer progression (15%), cardiac events (5%) and emotional distress (3%).

Two patients were reported to have developed encephalopathy during a shortage of an intravenous multivitamin, while one patient reportedly died from incorrect medication dosing after switching to epirubicin therapy during a daunorubicin shortage.

Importantly, 44% of institutions reported that drug shortages affected clinical trials. Typically, this meant delays in patient enrollment (44%) or not enrolling patients at all (67%), but participants also reported changing medications used in a trial, completely omitting a medication from a protocol, and stockpiling drugs "often at the expense of nonresearch patient(s)" to ensure that a clinical trial could be completed.

Failure to enroll patients or changing agents in the active or comparator arm has serious consequences not only for the patients involved in the trial, but can stymie research because investigators don’t fully understand what the results of those trials mean because not all the patients received the same therapy, Dr. Holle said.

"It can potentially delay effective regimens from becoming the standard of care because either there aren’t enough patients to complete the trials or the analyses have to be considered with these changes that occur," she said.

This is particularly detrimental in a disease state that relies more heavily than others on clinical trials to advance and improve patient care, she added.

Finally, 85% of respondents said oncology drug shortages resulted in increased costs for their institution and 34% reported spending an extra 20 hours a week managing the drug shortages.

Roughly 28% resorted to buying drugs on the grey market – supply channels that are unofficial, unauthorized, or unintended by the original manufacturer – with 14% reporting they paid at least 100% more than fair market value.

The Food and Drug Administration Safety and Innovation Act, often referred to as the FDA user fee reauthorization, contains several provisions aimed at mitigating drug shortages including expedited review and inspections by the FDA when necessary and adjustments in the quotas for controlled substances. When it was signed into law in July 2012, drug manufacturers were also required to notify the FDA at least 6 months in advance of any discontinuation or interruption in the production of lifesaving or life-supporting drugs, but there are no penalties for noncompliance.

"It’s definitely a step in the right direction, but I think we’d agree that some other legislation would be needed," Dr. Hoppe said.

Full details of the survey are available in the American Journal of Health-System Pharmacy (Am. J. Health-Syst. Pharm. 2013 April 1;70:609-17).

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