Self-monitoring of blood glucose is a critical part of diabetes management, with many benefits. It promotes personal responsibility and provides opportunities for better control. It allows for detection of blood glucose extremes, thus helping to reduce blood glucose fluctuations. It also helps both the patient and the provider make informed decisions and can help reduce microvascular and macrovascular complications.

Studies have shown that hemoglobin A_1c levels are lower if glucose is tested more frequently.¹ Most people with type 1 diabetes and many with type 2 diabetes self-monitor their blood glucose levels.

This article discusses who should monitor their blood glucose and how often, types of meters and supplies available, advances in technology, and limitations of current blood glucose meters.

WHETHER AND HOW OFTEN TO MONITOR

In clinical practice, advice about whether patients should monitor their blood glucose levels and how often to do it depends on the type of diabetes therapy, the need to titrate the dose or change the regimen, and the patient’s preferences, dexterity, and visual acuity. The frequency of testing also often depends on financial considerations and insurance coverage.

In patients with type 1 diabetes and insulin-treated type 2 diabetes, the role of glucose self-monitoring is clear. The American Diabetes Association (ADA) recommends that patients receiving multiple insulin injections daily or on an insulin pump measure their blood glucose at least before meals and snacks, occasionally after meals, at bedtime, before exercise, when they suspect their blood glucose level is low, after treating low blood glucose until they are normoglycemic, and before critical tasks such as driving.²

Most patients with type 1 diabetes and many with type 2 self-monitor

The Diabetes Control and Complications Trial (DCCT)³ and the DCCT/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study⁴ showed that intensive insulin therapy effectively delays the onset and slows the progression of microvascular and macrovacscular disease. Self-monitoring of blood glucose is an integral part of intensive insulin therapy, allowing for dose adjustments based on immediate blood glucose readings, thereby reducing the risks of hyperglycemia and hypoglycemia.

For patients taking a single daily dose of basal insulin, fasting blood glucose values are often used to titrate the basal insulin dose.³

Patients with type 2 diabetes on oral hypoglycemic agents such as sulfonylureas and meglitinides are at risk of hypoglycemia. Although a review of the literature could find no studies to support recommendations for specific testing frequency for patients taking these medications, it stands to reason that the potential for hypoglycemia would indicate a clear need for regular self-monitoring. Checking the blood glucose once or twice daily, typically fasting, 2 hours after the largest meal or at bedtime, provides useful data points for the patient and the provider. As with patients on insulin, testing before driving also reduces the risk of a motor vehicle accident caused by hypoglycemia.

In any patient who is testing one or two times per day, staggering the testing time on different days can give valuable insight into glucose control at different times of day, including after meals and at night.

In patients on nonintensive regimens and at low risk of hypoglycemia, glucose self-monitoring may be less critical. Nonintensive regimens with a low risk of hypoglycemia include diet and exercise alone and diet and exercise with a medication that is not insulin or an insulin secretagogue. In these cases, self-monitoring is often not seen as clinically useful or cost-effective, and hemoglobin A_1c is used as a marker.

Admittedly, few randomized controlled trials have been done in which patients were treated according to identical protocols except for glucose self-monitoring, but outcomes from the published studies support the use of structured self-monitoring of blood glucose for improvement in clinical outcomes and quality of life when self-monitoring is incorporated into a comprehensive management plan.^5–9 By providing feedback, self-monitoring encourages patients to actively participate in controlling and treating their disease. It helps them to recognize the impact of blood glucose on their own self-management decisions in the areas of diet, exercise, stress management, and medications. Therefore, the ADA recommends that healthcare providers encourage their patients to perform self-monitoring even if on nonintensive regimens. For these patients, checking even two or three times per week can help them to learn about the factors that affect their blood glucose.²

BLOOD GLUCOSE TARGETS

The ADA­² recommends the following glycemic goals for most nonpregnant adults:

• Fasting and premeal—80–130 mg/dL
• 2-hour postprandial—less than 180 mg/dL
• Bedtime—100–150 mg/dL.

However, diabetes management should be individualized on the basis of age and other comorbidities. For example, geriatric patients who have frequent episodes of hypoglycemia are prone to more harm than benefit from intensifying therapy to achieve these targets. Consequently, they may be candidates for more relaxed goals to avoid episodes of dangerous hypoglycemia.

When discussing blood glucose targets, an important but often overlooked concern is how the patient perceives the results. Providers and patients alike often describe readings as “good” or “bad.” This interpretation can lead to feelings of disappointment and failure in the patient and frustration in the provider. Instead, high blood glucose readings should be viewed as a way to identify opportunities for change. Patients may be more willing to check and even log their blood glucose levels if they see this information as an instrument to be used in the collaborative relationship with their provider.

CHOOSING A BLOOD GLUCOSE METER

Barring any special needs of the patient, meters are often selected on the basis of the patients’ insurance coverage for self-monitoring supplies (test strips and lancets), because of the high cost of test strips when purchased out-of-pocket. Meters themselves are usually relatively inexpensive, since the manufacturers commonly give them away as free samples to providers, who pass them along to patients. They also can often be purchased using coupons at a significant discount.

Without insurance coverage, test strips can cost $0.83 to $1.76 per strip for the most popular brands of meters. For patients without insurance coverage for supplies, the lowest-cost test strips currently available are for the ReliOn Prime Blood Glucose Monitoring System (ie, meter) sold at Walmart. Although ReliOn meters are not given out as samples in providers’ offices, the manufacturer’s suggested retail price is $16.24. More importantly, the suggested retail price for ReliOn Prime test strips is $9.00 for a bottle of 50 strips, or $0.18 per strip.¹⁰

For patients with special needs

For patients with special needs, there are meters that can make self-monitoring more convenient. For a patient who has problems with dexterity, grasping small test strips may be difficult. Two options are:

• Accu-Chek Compact Plus, which uses a 17-strip drum loaded into the meter
• Bayer Breeze2, which uses a 10-strip disk.

Both of the above dispense one strip at a time and eliminate the need to handle individual test strips.

Patients with poor visual acuity also face challenges with self-monitoring. Meters with options such as a backlight, a color screen, or a large display can help. Other meters talk, allowing patients to hear settings and blood glucose results. Examples are:

• Prodigy Autocode
• Prodigy Voice
• Embrace.

Test results are not ‘good’ or ‘bad’—they are opportunities for change

Other meter options depend on patient preference. Features that can affect patient choice include the ability to flag readings (eg, premeal, postmeal, exercise) and transfer data to other devices, blood sample size, meter size, touchscreen, meter memory and storage, rechargeable vs replaceable batteries, and the time it takes the meter to display the glucose reading.

Meters with advanced functions

For patients who want or need more advanced options, meters are now offering more feedback.

The OneTouch Verio family of meters helps patients spot patterns in their blood glucose levels. In addition, the Verio Flex and Verio Sync meters can sync with the OneTouch Reveal mobile app, which provides reports for the patient to view and send to the healthcare provider.

The Accu-Chek Aviva Expert has a bolus calculation function. Settings such as carbohydrate ratios, insulin sensitivity, targets, and active insulin can be programmed into the meter, which uses this information to give the patient dosing suggestions for rapid-acting insulin when carbohydrate intake is entered or blood glucose levels are checked. Another Accu-Chek meter, the Aviva Connect, can wirelessly transmit blood glucose results to the Accu-Chek Connect mobile app.

For a complete and regularly updated list of meters and their features, we encourage patients and healthcare providers to refer to the ADA’s Diabetes Forecast magazine. The magazine publishes a consumer guide every January that includes a comprehensive list of blood glucose meters. Past issues of the guide are available at www.diabetesforecast.org/past-issues-archive.html.

METER ACCURACY

Even though patients and providers use glucose self-monitoring results to make important decisions about diabetes management, the meters have limitations in accuracy. Accuracy comparisons from third-party sources are rare due to the cost of accuracy testing. However, the US Food and Drug Administration (FDA) requires all home glucose meters to meet accuracy standards set by the International Organization for Standardization (ISO). Currently, the FDA uses ISO standard 15197:2003, but ISO has published a revision, ISO standard 15197:2013, with stricter guidelines that have yet to be adopted by the FDA.^10,11 Current and future guidelines are shown in Table 1.¹⁰

In addition to variations in accuracy that are deemed acceptable by the FDA, there are other more controllable factors that can further affect the accuracy of glucose meter results. Expired test strips, unwashed hands, poor sampling technique, storage of test strips in extreme temperatures or humidity, and a low hematocrit level all can cause inaccurate readings.

If the patient has a low hematocrit, consider recommending a meter proven to have stable performance in the setting of low hematocrit. These meters are highlighted in a 2013 study by Ramljak et al.¹²

LANCETS, LANCING DEVICES, AND TECHNIQUES

Along with a variety of meters, patients also have an array of lancets and lancing devices from which to choose. Many patients use the brand of lancet device and lancets that come in their meter starter kit, but they can use other brands if desired. For cost-conscious patients, lancets are significantly more affordable than test strips, even for those without insurance coverage. Prices can be as low as $0.03 per lancet for some store-brand 33-gauge lancets. Name-brand lancets are more expensive than store-brand, but at $0.06 to $0.16 per lancet, many patients will even find these to be affordable if they must pay out of pocket.

Special needs may also prompt patients to choose a different lancet device than the one that came with their meter. For patients who have poor dexterity or are afraid to look at needles, the Accu-Chek FastClix lancing device uses drums with six preloaded lancets, eliminating the need to see and handle individual lancets. The FastClix device is included in the starter kits for the Accu-Chek Nano and Accu-Chek Connect meters and can also be ordered separately at pharmacies.

Reducing pain when testing

A common complaint about glucose self-monitoring is that it hurts. Below are some tips for reducing pain when testing:

• Use a new lancet for each blood glucose check.
• Choose a lancet device with a depth gauge and select the lowest setting that allows for a sufficient sample size.
• Lancets come in a variety of sizes, typically from 28 gauge to 33 gauge, so choose a lancet with a smaller gauge (ie, a higher gauge number).
• Poke the side of the fingertip instead of the end or the middle.
• Alternate the fingers instead of repeatedly using the same finger.
• To minimize pain from forceful squeezing of the fingertip to get a sufficient blood sample, start squeezing the palm and push the blood progressively into the fingertip.
• Consider alternate-site testing, especially if you have painful upper-extremity neuropathy.

LOGGING BLOOD GLUCOSE READINGS

Although many meters can automatically transfer their data to mobile devices or computers, patients are still encouraged to log their glucose readings manually. Not only does this give feedback to the provider in the event that the downloading software is not available in that provider’s office, it also allows patients to learn how to identify patterns in their readings and make changes in their diabetes self-management.

In the past, all logging was done on paper forms or in log books, but today’s technology offers other options. Several meters offer downloading software for home use that displays the data in a usable format. Some smartphone apps allow patients to enter glucose readings and other useful diabetes information such as food intake and exercise. Below are examples of smartphone apps that can help patients track glucose levels and much more:

• mySugr (iPhone and Android)
• Glucose Buddy (iPhone and Android)
• OnTrack Diabetes (Android)
• Glucool Diabetes (Android) (also available in a premium version).
• Glooko (iPhone and Android). This app requires purchase of a compatible cable to connect the patient’s phone to the meter, which then allows readings to be transferred directly to the app.

THE ROLE OF THE CERTIFIED DIABETES EDUCATOR

One of the most useful resources available to providers is the assistance of a certified diabetes educator, who can teach a patient the basic operation of a blood glucose meter and educate the patient on all topics discussed in this article and more.

Certified diabetes educators are instrumental in helping patients understand blood glucose targets, the rationale for glucose self-monitoring, logging, pattern management, special features in meters, control testing, and alternate-site testing, and using the results of testing to make meaningful changes in how they self-manage their diabetes. Education should include discussions about topics such as meal planning, exercise, and medications to help patients fully grasp the impact of their daily decisions on their blood glucose control.

Self-monitoring of blood glucose is a critical part of diabetes management, with many benefits. It promotes personal responsibility and provides opportunities for better control. It allows for detection of blood glucose extremes, thus helping to reduce blood glucose fluctuations. It also helps both the patient and the provider make informed decisions and can help reduce microvascular and macrovascular complications.

Studies have shown that hemoglobin A_1c levels are lower if glucose is tested more frequently.¹ Most people with type 1 diabetes and many with type 2 diabetes self-monitor their blood glucose levels.

This article discusses who should monitor their blood glucose and how often, types of meters and supplies available, advances in technology, and limitations of current blood glucose meters.

WHETHER AND HOW OFTEN TO MONITOR

In clinical practice, advice about whether patients should monitor their blood glucose levels and how often to do it depends on the type of diabetes therapy, the need to titrate the dose or change the regimen, and the patient’s preferences, dexterity, and visual acuity. The frequency of testing also often depends on financial considerations and insurance coverage.

In patients with type 1 diabetes and insulin-treated type 2 diabetes, the role of glucose self-monitoring is clear. The American Diabetes Association (ADA) recommends that patients receiving multiple insulin injections daily or on an insulin pump measure their blood glucose at least before meals and snacks, occasionally after meals, at bedtime, before exercise, when they suspect their blood glucose level is low, after treating low blood glucose until they are normoglycemic, and before critical tasks such as driving.²

Most patients with type 1 diabetes and many with type 2 self-monitor

The Diabetes Control and Complications Trial (DCCT)³ and the DCCT/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study⁴ showed that intensive insulin therapy effectively delays the onset and slows the progression of microvascular and macrovacscular disease. Self-monitoring of blood glucose is an integral part of intensive insulin therapy, allowing for dose adjustments based on immediate blood glucose readings, thereby reducing the risks of hyperglycemia and hypoglycemia.

For patients taking a single daily dose of basal insulin, fasting blood glucose values are often used to titrate the basal insulin dose.³

Patients with type 2 diabetes on oral hypoglycemic agents such as sulfonylureas and meglitinides are at risk of hypoglycemia. Although a review of the literature could find no studies to support recommendations for specific testing frequency for patients taking these medications, it stands to reason that the potential for hypoglycemia would indicate a clear need for regular self-monitoring. Checking the blood glucose once or twice daily, typically fasting, 2 hours after the largest meal or at bedtime, provides useful data points for the patient and the provider. As with patients on insulin, testing before driving also reduces the risk of a motor vehicle accident caused by hypoglycemia.

In any patient who is testing one or two times per day, staggering the testing time on different days can give valuable insight into glucose control at different times of day, including after meals and at night.

In patients on nonintensive regimens and at low risk of hypoglycemia, glucose self-monitoring may be less critical. Nonintensive regimens with a low risk of hypoglycemia include diet and exercise alone and diet and exercise with a medication that is not insulin or an insulin secretagogue. In these cases, self-monitoring is often not seen as clinically useful or cost-effective, and hemoglobin A_1c is used as a marker.

Admittedly, few randomized controlled trials have been done in which patients were treated according to identical protocols except for glucose self-monitoring, but outcomes from the published studies support the use of structured self-monitoring of blood glucose for improvement in clinical outcomes and quality of life when self-monitoring is incorporated into a comprehensive management plan.^5–9 By providing feedback, self-monitoring encourages patients to actively participate in controlling and treating their disease. It helps them to recognize the impact of blood glucose on their own self-management decisions in the areas of diet, exercise, stress management, and medications. Therefore, the ADA recommends that healthcare providers encourage their patients to perform self-monitoring even if on nonintensive regimens. For these patients, checking even two or three times per week can help them to learn about the factors that affect their blood glucose.²

BLOOD GLUCOSE TARGETS

The ADA­² recommends the following glycemic goals for most nonpregnant adults:

• Fasting and premeal—80–130 mg/dL
• 2-hour postprandial—less than 180 mg/dL
• Bedtime—100–150 mg/dL.

However, diabetes management should be individualized on the basis of age and other comorbidities. For example, geriatric patients who have frequent episodes of hypoglycemia are prone to more harm than benefit from intensifying therapy to achieve these targets. Consequently, they may be candidates for more relaxed goals to avoid episodes of dangerous hypoglycemia.

When discussing blood glucose targets, an important but often overlooked concern is how the patient perceives the results. Providers and patients alike often describe readings as “good” or “bad.” This interpretation can lead to feelings of disappointment and failure in the patient and frustration in the provider. Instead, high blood glucose readings should be viewed as a way to identify opportunities for change. Patients may be more willing to check and even log their blood glucose levels if they see this information as an instrument to be used in the collaborative relationship with their provider.

CHOOSING A BLOOD GLUCOSE METER

Barring any special needs of the patient, meters are often selected on the basis of the patients’ insurance coverage for self-monitoring supplies (test strips and lancets), because of the high cost of test strips when purchased out-of-pocket. Meters themselves are usually relatively inexpensive, since the manufacturers commonly give them away as free samples to providers, who pass them along to patients. They also can often be purchased using coupons at a significant discount.

Without insurance coverage, test strips can cost $0.83 to $1.76 per strip for the most popular brands of meters. For patients without insurance coverage for supplies, the lowest-cost test strips currently available are for the ReliOn Prime Blood Glucose Monitoring System (ie, meter) sold at Walmart. Although ReliOn meters are not given out as samples in providers’ offices, the manufacturer’s suggested retail price is $16.24. More importantly, the suggested retail price for ReliOn Prime test strips is $9.00 for a bottle of 50 strips, or $0.18 per strip.¹⁰

For patients with special needs

For patients with special needs, there are meters that can make self-monitoring more convenient. For a patient who has problems with dexterity, grasping small test strips may be difficult. Two options are:

• Accu-Chek Compact Plus, which uses a 17-strip drum loaded into the meter
• Bayer Breeze2, which uses a 10-strip disk.

Both of the above dispense one strip at a time and eliminate the need to handle individual test strips.

Patients with poor visual acuity also face challenges with self-monitoring. Meters with options such as a backlight, a color screen, or a large display can help. Other meters talk, allowing patients to hear settings and blood glucose results. Examples are:

• Prodigy Autocode
• Prodigy Voice
• Embrace.

Test results are not ‘good’ or ‘bad’—they are opportunities for change

Other meter options depend on patient preference. Features that can affect patient choice include the ability to flag readings (eg, premeal, postmeal, exercise) and transfer data to other devices, blood sample size, meter size, touchscreen, meter memory and storage, rechargeable vs replaceable batteries, and the time it takes the meter to display the glucose reading.

Meters with advanced functions

For patients who want or need more advanced options, meters are now offering more feedback.

The OneTouch Verio family of meters helps patients spot patterns in their blood glucose levels. In addition, the Verio Flex and Verio Sync meters can sync with the OneTouch Reveal mobile app, which provides reports for the patient to view and send to the healthcare provider.

The Accu-Chek Aviva Expert has a bolus calculation function. Settings such as carbohydrate ratios, insulin sensitivity, targets, and active insulin can be programmed into the meter, which uses this information to give the patient dosing suggestions for rapid-acting insulin when carbohydrate intake is entered or blood glucose levels are checked. Another Accu-Chek meter, the Aviva Connect, can wirelessly transmit blood glucose results to the Accu-Chek Connect mobile app.

For a complete and regularly updated list of meters and their features, we encourage patients and healthcare providers to refer to the ADA’s Diabetes Forecast magazine. The magazine publishes a consumer guide every January that includes a comprehensive list of blood glucose meters. Past issues of the guide are available at www.diabetesforecast.org/past-issues-archive.html.

METER ACCURACY

Even though patients and providers use glucose self-monitoring results to make important decisions about diabetes management, the meters have limitations in accuracy. Accuracy comparisons from third-party sources are rare due to the cost of accuracy testing. However, the US Food and Drug Administration (FDA) requires all home glucose meters to meet accuracy standards set by the International Organization for Standardization (ISO). Currently, the FDA uses ISO standard 15197:2003, but ISO has published a revision, ISO standard 15197:2013, with stricter guidelines that have yet to be adopted by the FDA.^10,11 Current and future guidelines are shown in Table 1.¹⁰

In addition to variations in accuracy that are deemed acceptable by the FDA, there are other more controllable factors that can further affect the accuracy of glucose meter results. Expired test strips, unwashed hands, poor sampling technique, storage of test strips in extreme temperatures or humidity, and a low hematocrit level all can cause inaccurate readings.

If the patient has a low hematocrit, consider recommending a meter proven to have stable performance in the setting of low hematocrit. These meters are highlighted in a 2013 study by Ramljak et al.¹²

LANCETS, LANCING DEVICES, AND TECHNIQUES

Along with a variety of meters, patients also have an array of lancets and lancing devices from which to choose. Many patients use the brand of lancet device and lancets that come in their meter starter kit, but they can use other brands if desired. For cost-conscious patients, lancets are significantly more affordable than test strips, even for those without insurance coverage. Prices can be as low as $0.03 per lancet for some store-brand 33-gauge lancets. Name-brand lancets are more expensive than store-brand, but at $0.06 to $0.16 per lancet, many patients will even find these to be affordable if they must pay out of pocket.

Special needs may also prompt patients to choose a different lancet device than the one that came with their meter. For patients who have poor dexterity or are afraid to look at needles, the Accu-Chek FastClix lancing device uses drums with six preloaded lancets, eliminating the need to see and handle individual lancets. The FastClix device is included in the starter kits for the Accu-Chek Nano and Accu-Chek Connect meters and can also be ordered separately at pharmacies.

Reducing pain when testing

A common complaint about glucose self-monitoring is that it hurts. Below are some tips for reducing pain when testing:

• Use a new lancet for each blood glucose check.
• Choose a lancet device with a depth gauge and select the lowest setting that allows for a sufficient sample size.
• Lancets come in a variety of sizes, typically from 28 gauge to 33 gauge, so choose a lancet with a smaller gauge (ie, a higher gauge number).
• Poke the side of the fingertip instead of the end or the middle.
• Alternate the fingers instead of repeatedly using the same finger.
• To minimize pain from forceful squeezing of the fingertip to get a sufficient blood sample, start squeezing the palm and push the blood progressively into the fingertip.
• Consider alternate-site testing, especially if you have painful upper-extremity neuropathy.

LOGGING BLOOD GLUCOSE READINGS

Although many meters can automatically transfer their data to mobile devices or computers, patients are still encouraged to log their glucose readings manually. Not only does this give feedback to the provider in the event that the downloading software is not available in that provider’s office, it also allows patients to learn how to identify patterns in their readings and make changes in their diabetes self-management.

In the past, all logging was done on paper forms or in log books, but today’s technology offers other options. Several meters offer downloading software for home use that displays the data in a usable format. Some smartphone apps allow patients to enter glucose readings and other useful diabetes information such as food intake and exercise. Below are examples of smartphone apps that can help patients track glucose levels and much more:

• mySugr (iPhone and Android)
• Glucose Buddy (iPhone and Android)
• OnTrack Diabetes (Android)
• Glucool Diabetes (Android) (also available in a premium version).
• Glooko (iPhone and Android). This app requires purchase of a compatible cable to connect the patient’s phone to the meter, which then allows readings to be transferred directly to the app.

THE ROLE OF THE CERTIFIED DIABETES EDUCATOR

One of the most useful resources available to providers is the assistance of a certified diabetes educator, who can teach a patient the basic operation of a blood glucose meter and educate the patient on all topics discussed in this article and more.

Certified diabetes educators are instrumental in helping patients understand blood glucose targets, the rationale for glucose self-monitoring, logging, pattern management, special features in meters, control testing, and alternate-site testing, and using the results of testing to make meaningful changes in how they self-manage their diabetes. Education should include discussions about topics such as meal planning, exercise, and medications to help patients fully grasp the impact of their daily decisions on their blood glucose control.

Self-monitoring of blood glucose is a critical part of diabetes management, with many benefits. It promotes personal responsibility and provides opportunities for better control. It allows for detection of blood glucose extremes, thus helping to reduce blood glucose fluctuations. It also helps both the patient and the provider make informed decisions and can help reduce microvascular and macrovascular complications.

Studies have shown that hemoglobin A_1c levels are lower if glucose is tested more frequently.¹ Most people with type 1 diabetes and many with type 2 diabetes self-monitor their blood glucose levels.

This article discusses who should monitor their blood glucose and how often, types of meters and supplies available, advances in technology, and limitations of current blood glucose meters.

WHETHER AND HOW OFTEN TO MONITOR

In clinical practice, advice about whether patients should monitor their blood glucose levels and how often to do it depends on the type of diabetes therapy, the need to titrate the dose or change the regimen, and the patient’s preferences, dexterity, and visual acuity. The frequency of testing also often depends on financial considerations and insurance coverage.

In patients with type 1 diabetes and insulin-treated type 2 diabetes, the role of glucose self-monitoring is clear. The American Diabetes Association (ADA) recommends that patients receiving multiple insulin injections daily or on an insulin pump measure their blood glucose at least before meals and snacks, occasionally after meals, at bedtime, before exercise, when they suspect their blood glucose level is low, after treating low blood glucose until they are normoglycemic, and before critical tasks such as driving.²

Most patients with type 1 diabetes and many with type 2 self-monitor

The Diabetes Control and Complications Trial (DCCT)³ and the DCCT/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study⁴ showed that intensive insulin therapy effectively delays the onset and slows the progression of microvascular and macrovacscular disease. Self-monitoring of blood glucose is an integral part of intensive insulin therapy, allowing for dose adjustments based on immediate blood glucose readings, thereby reducing the risks of hyperglycemia and hypoglycemia.

For patients taking a single daily dose of basal insulin, fasting blood glucose values are often used to titrate the basal insulin dose.³

Patients with type 2 diabetes on oral hypoglycemic agents such as sulfonylureas and meglitinides are at risk of hypoglycemia. Although a review of the literature could find no studies to support recommendations for specific testing frequency for patients taking these medications, it stands to reason that the potential for hypoglycemia would indicate a clear need for regular self-monitoring. Checking the blood glucose once or twice daily, typically fasting, 2 hours after the largest meal or at bedtime, provides useful data points for the patient and the provider. As with patients on insulin, testing before driving also reduces the risk of a motor vehicle accident caused by hypoglycemia.

In any patient who is testing one or two times per day, staggering the testing time on different days can give valuable insight into glucose control at different times of day, including after meals and at night.

In patients on nonintensive regimens and at low risk of hypoglycemia, glucose self-monitoring may be less critical. Nonintensive regimens with a low risk of hypoglycemia include diet and exercise alone and diet and exercise with a medication that is not insulin or an insulin secretagogue. In these cases, self-monitoring is often not seen as clinically useful or cost-effective, and hemoglobin A_1c is used as a marker.

Admittedly, few randomized controlled trials have been done in which patients were treated according to identical protocols except for glucose self-monitoring, but outcomes from the published studies support the use of structured self-monitoring of blood glucose for improvement in clinical outcomes and quality of life when self-monitoring is incorporated into a comprehensive management plan.^5–9 By providing feedback, self-monitoring encourages patients to actively participate in controlling and treating their disease. It helps them to recognize the impact of blood glucose on their own self-management decisions in the areas of diet, exercise, stress management, and medications. Therefore, the ADA recommends that healthcare providers encourage their patients to perform self-monitoring even if on nonintensive regimens. For these patients, checking even two or three times per week can help them to learn about the factors that affect their blood glucose.²

BLOOD GLUCOSE TARGETS

The ADA­² recommends the following glycemic goals for most nonpregnant adults:

• Fasting and premeal—80–130 mg/dL
• 2-hour postprandial—less than 180 mg/dL
• Bedtime—100–150 mg/dL.

However, diabetes management should be individualized on the basis of age and other comorbidities. For example, geriatric patients who have frequent episodes of hypoglycemia are prone to more harm than benefit from intensifying therapy to achieve these targets. Consequently, they may be candidates for more relaxed goals to avoid episodes of dangerous hypoglycemia.

When discussing blood glucose targets, an important but often overlooked concern is how the patient perceives the results. Providers and patients alike often describe readings as “good” or “bad.” This interpretation can lead to feelings of disappointment and failure in the patient and frustration in the provider. Instead, high blood glucose readings should be viewed as a way to identify opportunities for change. Patients may be more willing to check and even log their blood glucose levels if they see this information as an instrument to be used in the collaborative relationship with their provider.

CHOOSING A BLOOD GLUCOSE METER

Barring any special needs of the patient, meters are often selected on the basis of the patients’ insurance coverage for self-monitoring supplies (test strips and lancets), because of the high cost of test strips when purchased out-of-pocket. Meters themselves are usually relatively inexpensive, since the manufacturers commonly give them away as free samples to providers, who pass them along to patients. They also can often be purchased using coupons at a significant discount.

Without insurance coverage, test strips can cost $0.83 to $1.76 per strip for the most popular brands of meters. For patients without insurance coverage for supplies, the lowest-cost test strips currently available are for the ReliOn Prime Blood Glucose Monitoring System (ie, meter) sold at Walmart. Although ReliOn meters are not given out as samples in providers’ offices, the manufacturer’s suggested retail price is $16.24. More importantly, the suggested retail price for ReliOn Prime test strips is $9.00 for a bottle of 50 strips, or $0.18 per strip.¹⁰

For patients with special needs

For patients with special needs, there are meters that can make self-monitoring more convenient. For a patient who has problems with dexterity, grasping small test strips may be difficult. Two options are:

• Accu-Chek Compact Plus, which uses a 17-strip drum loaded into the meter
• Bayer Breeze2, which uses a 10-strip disk.

Both of the above dispense one strip at a time and eliminate the need to handle individual test strips.

Patients with poor visual acuity also face challenges with self-monitoring. Meters with options such as a backlight, a color screen, or a large display can help. Other meters talk, allowing patients to hear settings and blood glucose results. Examples are:

• Prodigy Autocode
• Prodigy Voice
• Embrace.

Test results are not ‘good’ or ‘bad’—they are opportunities for change

Other meter options depend on patient preference. Features that can affect patient choice include the ability to flag readings (eg, premeal, postmeal, exercise) and transfer data to other devices, blood sample size, meter size, touchscreen, meter memory and storage, rechargeable vs replaceable batteries, and the time it takes the meter to display the glucose reading.

Meters with advanced functions

For patients who want or need more advanced options, meters are now offering more feedback.

The OneTouch Verio family of meters helps patients spot patterns in their blood glucose levels. In addition, the Verio Flex and Verio Sync meters can sync with the OneTouch Reveal mobile app, which provides reports for the patient to view and send to the healthcare provider.

The Accu-Chek Aviva Expert has a bolus calculation function. Settings such as carbohydrate ratios, insulin sensitivity, targets, and active insulin can be programmed into the meter, which uses this information to give the patient dosing suggestions for rapid-acting insulin when carbohydrate intake is entered or blood glucose levels are checked. Another Accu-Chek meter, the Aviva Connect, can wirelessly transmit blood glucose results to the Accu-Chek Connect mobile app.

For a complete and regularly updated list of meters and their features, we encourage patients and healthcare providers to refer to the ADA’s Diabetes Forecast magazine. The magazine publishes a consumer guide every January that includes a comprehensive list of blood glucose meters. Past issues of the guide are available at www.diabetesforecast.org/past-issues-archive.html.

METER ACCURACY

Even though patients and providers use glucose self-monitoring results to make important decisions about diabetes management, the meters have limitations in accuracy. Accuracy comparisons from third-party sources are rare due to the cost of accuracy testing. However, the US Food and Drug Administration (FDA) requires all home glucose meters to meet accuracy standards set by the International Organization for Standardization (ISO). Currently, the FDA uses ISO standard 15197:2003, but ISO has published a revision, ISO standard 15197:2013, with stricter guidelines that have yet to be adopted by the FDA.^10,11 Current and future guidelines are shown in Table 1.¹⁰

In addition to variations in accuracy that are deemed acceptable by the FDA, there are other more controllable factors that can further affect the accuracy of glucose meter results. Expired test strips, unwashed hands, poor sampling technique, storage of test strips in extreme temperatures or humidity, and a low hematocrit level all can cause inaccurate readings.

If the patient has a low hematocrit, consider recommending a meter proven to have stable performance in the setting of low hematocrit. These meters are highlighted in a 2013 study by Ramljak et al.¹²

LANCETS, LANCING DEVICES, AND TECHNIQUES

Along with a variety of meters, patients also have an array of lancets and lancing devices from which to choose. Many patients use the brand of lancet device and lancets that come in their meter starter kit, but they can use other brands if desired. For cost-conscious patients, lancets are significantly more affordable than test strips, even for those without insurance coverage. Prices can be as low as $0.03 per lancet for some store-brand 33-gauge lancets. Name-brand lancets are more expensive than store-brand, but at $0.06 to $0.16 per lancet, many patients will even find these to be affordable if they must pay out of pocket.

Special needs may also prompt patients to choose a different lancet device than the one that came with their meter. For patients who have poor dexterity or are afraid to look at needles, the Accu-Chek FastClix lancing device uses drums with six preloaded lancets, eliminating the need to see and handle individual lancets. The FastClix device is included in the starter kits for the Accu-Chek Nano and Accu-Chek Connect meters and can also be ordered separately at pharmacies.

Reducing pain when testing

A common complaint about glucose self-monitoring is that it hurts. Below are some tips for reducing pain when testing:

• Use a new lancet for each blood glucose check.
• Choose a lancet device with a depth gauge and select the lowest setting that allows for a sufficient sample size.
• Lancets come in a variety of sizes, typically from 28 gauge to 33 gauge, so choose a lancet with a smaller gauge (ie, a higher gauge number).
• Poke the side of the fingertip instead of the end or the middle.
• Alternate the fingers instead of repeatedly using the same finger.
• To minimize pain from forceful squeezing of the fingertip to get a sufficient blood sample, start squeezing the palm and push the blood progressively into the fingertip.
• Consider alternate-site testing, especially if you have painful upper-extremity neuropathy.

LOGGING BLOOD GLUCOSE READINGS

Although many meters can automatically transfer their data to mobile devices or computers, patients are still encouraged to log their glucose readings manually. Not only does this give feedback to the provider in the event that the downloading software is not available in that provider’s office, it also allows patients to learn how to identify patterns in their readings and make changes in their diabetes self-management.

In the past, all logging was done on paper forms or in log books, but today’s technology offers other options. Several meters offer downloading software for home use that displays the data in a usable format. Some smartphone apps allow patients to enter glucose readings and other useful diabetes information such as food intake and exercise. Below are examples of smartphone apps that can help patients track glucose levels and much more:

• mySugr (iPhone and Android)
• Glucose Buddy (iPhone and Android)
• OnTrack Diabetes (Android)
• Glucool Diabetes (Android) (also available in a premium version).
• Glooko (iPhone and Android). This app requires purchase of a compatible cable to connect the patient’s phone to the meter, which then allows readings to be transferred directly to the app.

THE ROLE OF THE CERTIFIED DIABETES EDUCATOR

One of the most useful resources available to providers is the assistance of a certified diabetes educator, who can teach a patient the basic operation of a blood glucose meter and educate the patient on all topics discussed in this article and more.

Certified diabetes educators are instrumental in helping patients understand blood glucose targets, the rationale for glucose self-monitoring, logging, pattern management, special features in meters, control testing, and alternate-site testing, and using the results of testing to make meaningful changes in how they self-manage their diabetes. Education should include discussions about topics such as meal planning, exercise, and medications to help patients fully grasp the impact of their daily decisions on their blood glucose control.

AMSTERDAM – Infection is a major cause of death among patients waiting for a liver transplant, killing more than half of those who contracted one.

Infection also was the biggest reason that patients with end-stage liver disease withdrew from the transplant waiting list, a 9-year-long study has shown. Patients who developed an infection were six times more likely to withdraw than were those who did not, Dr. Loes Alferink wrote in a poster presented at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

“We need to focus on better prophylactic antibiotic strategies to save lives in patients with end-stage liver disease who are on the waiting list,” said Dr. Alferink of Erasmus Medical Center, Rotterdam, the Netherlands.

She and her colleagues examined the effect of infections on 312 patients who were waiting for a transplant at Erasmus Medical Center from the period of 2006-2013. During that time, a total of 317 infections developed in 144 patients. The infections were fatal in 58% of these patients.

These included spontaneous primary cholangitis (75); spontaneous bacterial peritonitis (61); urogenital (38), respiratory (30), and skin (25) infections; as well as primary bacteremia (22). Also, there were 18 cases of gastroenteritis and 12 cases of Candida esophagitis. The remainder were unspecified infections.

The death rate was highest in primary bacteremia, which killed about 40% of those who developed it. The rate was about 25% in respiratory infections, 20% in spontaneous primary bacteremia, 15% in esophagitis, 10% in gastroenteritis and urinary tract infections, and 10% in patients with multiple site infections.

The pathogens were gram negative (70) and gram positive (37) bacteria; Enterococcus faecium (15) and faecalis (3); yeasts (13); viruses (7); and mold (2). The remainder of the infections yielded a negative culture.

In 24 patients, multiple pathogens were identified. These patients had the highest rate of mortality, with almost half of them dying from their infection; one of the two patients with a mold infection also died. The death rate was 20% in patients with yeast infections, 18% in those with E. faecium, 15% in gram-positive infections, and 10% in gram-negative infections.

A multivariate analysis found several factors that increased the risk of dying from an infection. For every 10 years of increasing age, the risk of infection-related mortality doubled (odds ratio, 2); worse MELD (Model for End-Stage Liver Disease) scores increased the risk by 12%.

Patients with hepatic encephalopathy were 76% more likely to die from an infection, and those with refractory ascites faced a 2.5-fold increased risk. Mechanical ventilation was associated with more than a fivefold increased risk (OR, 5.72).

Patients who developed an infection were almost six times more likely to be withdrawn from the transplant waiting list (hazard ratio, 5.87). The regression analysis for withdrawal identified several factors that significantly increased the risk, including age, MELD score, and serum albumin. The biggest risk factor for withdrawal related to infection was refractory ascites, which more than doubled the risk (HR, 2.2).

Dr. Alferink had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

AMSTERDAM – Infection is a major cause of death among patients waiting for a liver transplant, killing more than half of those who contracted one.

Infection also was the biggest reason that patients with end-stage liver disease withdrew from the transplant waiting list, a 9-year-long study has shown. Patients who developed an infection were six times more likely to withdraw than were those who did not, Dr. Loes Alferink wrote in a poster presented at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

“We need to focus on better prophylactic antibiotic strategies to save lives in patients with end-stage liver disease who are on the waiting list,” said Dr. Alferink of Erasmus Medical Center, Rotterdam, the Netherlands.

She and her colleagues examined the effect of infections on 312 patients who were waiting for a transplant at Erasmus Medical Center from the period of 2006-2013. During that time, a total of 317 infections developed in 144 patients. The infections were fatal in 58% of these patients.

These included spontaneous primary cholangitis (75); spontaneous bacterial peritonitis (61); urogenital (38), respiratory (30), and skin (25) infections; as well as primary bacteremia (22). Also, there were 18 cases of gastroenteritis and 12 cases of Candida esophagitis. The remainder were unspecified infections.

The death rate was highest in primary bacteremia, which killed about 40% of those who developed it. The rate was about 25% in respiratory infections, 20% in spontaneous primary bacteremia, 15% in esophagitis, 10% in gastroenteritis and urinary tract infections, and 10% in patients with multiple site infections.

The pathogens were gram negative (70) and gram positive (37) bacteria; Enterococcus faecium (15) and faecalis (3); yeasts (13); viruses (7); and mold (2). The remainder of the infections yielded a negative culture.

In 24 patients, multiple pathogens were identified. These patients had the highest rate of mortality, with almost half of them dying from their infection; one of the two patients with a mold infection also died. The death rate was 20% in patients with yeast infections, 18% in those with E. faecium, 15% in gram-positive infections, and 10% in gram-negative infections.

A multivariate analysis found several factors that increased the risk of dying from an infection. For every 10 years of increasing age, the risk of infection-related mortality doubled (odds ratio, 2); worse MELD (Model for End-Stage Liver Disease) scores increased the risk by 12%.

Patients with hepatic encephalopathy were 76% more likely to die from an infection, and those with refractory ascites faced a 2.5-fold increased risk. Mechanical ventilation was associated with more than a fivefold increased risk (OR, 5.72).

Patients who developed an infection were almost six times more likely to be withdrawn from the transplant waiting list (hazard ratio, 5.87). The regression analysis for withdrawal identified several factors that significantly increased the risk, including age, MELD score, and serum albumin. The biggest risk factor for withdrawal related to infection was refractory ascites, which more than doubled the risk (HR, 2.2).

Dr. Alferink had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

AMSTERDAM – Infection is a major cause of death among patients waiting for a liver transplant, killing more than half of those who contracted one.

Infection also was the biggest reason that patients with end-stage liver disease withdrew from the transplant waiting list, a 9-year-long study has shown. Patients who developed an infection were six times more likely to withdraw than were those who did not, Dr. Loes Alferink wrote in a poster presented at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

“We need to focus on better prophylactic antibiotic strategies to save lives in patients with end-stage liver disease who are on the waiting list,” said Dr. Alferink of Erasmus Medical Center, Rotterdam, the Netherlands.

She and her colleagues examined the effect of infections on 312 patients who were waiting for a transplant at Erasmus Medical Center from the period of 2006-2013. During that time, a total of 317 infections developed in 144 patients. The infections were fatal in 58% of these patients.

These included spontaneous primary cholangitis (75); spontaneous bacterial peritonitis (61); urogenital (38), respiratory (30), and skin (25) infections; as well as primary bacteremia (22). Also, there were 18 cases of gastroenteritis and 12 cases of Candida esophagitis. The remainder were unspecified infections.

The death rate was highest in primary bacteremia, which killed about 40% of those who developed it. The rate was about 25% in respiratory infections, 20% in spontaneous primary bacteremia, 15% in esophagitis, 10% in gastroenteritis and urinary tract infections, and 10% in patients with multiple site infections.

The pathogens were gram negative (70) and gram positive (37) bacteria; Enterococcus faecium (15) and faecalis (3); yeasts (13); viruses (7); and mold (2). The remainder of the infections yielded a negative culture.

In 24 patients, multiple pathogens were identified. These patients had the highest rate of mortality, with almost half of them dying from their infection; one of the two patients with a mold infection also died. The death rate was 20% in patients with yeast infections, 18% in those with E. faecium, 15% in gram-positive infections, and 10% in gram-negative infections.

A multivariate analysis found several factors that increased the risk of dying from an infection. For every 10 years of increasing age, the risk of infection-related mortality doubled (odds ratio, 2); worse MELD (Model for End-Stage Liver Disease) scores increased the risk by 12%.

Patients with hepatic encephalopathy were 76% more likely to die from an infection, and those with refractory ascites faced a 2.5-fold increased risk. Mechanical ventilation was associated with more than a fivefold increased risk (OR, 5.72).

Patients who developed an infection were almost six times more likely to be withdrawn from the transplant waiting list (hazard ratio, 5.87). The regression analysis for withdrawal identified several factors that significantly increased the risk, including age, MELD score, and serum albumin. The biggest risk factor for withdrawal related to infection was refractory ascites, which more than doubled the risk (HR, 2.2).

Dr. Alferink had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

A simple, hospital-wide “avoid heparin” intervention dramatically cut the rate of suspected heparin-induced thrombocytopenia by 42%, that of positive ELISA screens for HIT by 63%, that of adjudicated HIT by 79%, and that of HIT with thrombosis by 91%, while also reducing the costs of HIT-related care by 83% at one large university hospital.

The medical literature has focused on early recognition and treatment of heparin-induced thrombocytopenia, “but its prevention has been largely overlooked,” noted Dr. Kelly E. McGowan of Sunnybrook Health Sciences Centre and the University of Toronto and her associates.

Sunnybrook introduced an “avoid heparin” program in 2006 in which most intravenous and subcutaneous unfractionated heparin was replaced with low-molecular-weight heparin (LMWH) in prophylactic or therapeutic doses; heparinized saline in arterial and central venous lines was replaced with saline flushes; order sets were modified to exclude unfractionated heparin options; and unfractionated heparin stores were removed from most nursing units.

Unfractionated heparin remained available for use in hemodialysis, cardiovascular surgery, and certain cases of acute coronary syndrome. Most hospital clinicians were unaware that LMWH was being substituted for unfractionated heparin, and none were aware that the effects of this change were being studied.

The investigators assessed all 1,118 cases of suspected heparin-induced thrombocytopenia that occurred during a 10-year period before and after this intervention was implemented. The use of LMWH rose fourfold after the program was initiated, but the annual rate of HIT associated with LMWH remained constant at 0.9 cases per 10,000 admissions over the course of the study.

The annual incidence of suspected HIT decreased from 85.5 per 10,000 admissions per year before the intervention to 49.0 afterward (relative risk reduction, 41.7%). The rate of positive ELISA screens for the disorder dropped from 16.5 to 6.1 per 10,000 (RRR, 62.9%), the rate of adjudicated HIT decreased from 10.7 to 2.2 per 10,000, and the rate of HIT with thrombosis declined from 4.6 to 0.4 per 10,000.

The program’s greatest impact was on cardiac surgery, but the burden of HIT also markedly decreased in other surgical and medical patients. HIT decreased by 77% in cardiovascular surgeries, 77% in other surgeries, 75% in cardiology patients, and 62% in medical patients, Dr. McGowan and her associates said (Blood 2016 Apr 21;127[16]:1954-9).

Patients with HIT during the preintervention years more often developed thrombosis (43%), usually venous thromboembolism, compared with those who had HIT in the postintervention years (19%), and median length of stay declined accordingly. The average estimated costs of HIT care per year dropped by about $267,000 dollars per year, from $322,000 before the program was implemented to $55,000 afterward.

The investigators added that this is the first study ever to show the success of an HIT prevention strategy. Their findings indicate that a hospital-wide “avoid heparin” program can substantially reduce morbidity, mortality, and costs associated with HIT. “The heparin avoidance strategy that we used was not complex or costly and would be feasible in other centers,” they noted.

A simple, hospital-wide “avoid heparin” intervention dramatically cut the rate of suspected heparin-induced thrombocytopenia by 42%, that of positive ELISA screens for HIT by 63%, that of adjudicated HIT by 79%, and that of HIT with thrombosis by 91%, while also reducing the costs of HIT-related care by 83% at one large university hospital.

The medical literature has focused on early recognition and treatment of heparin-induced thrombocytopenia, “but its prevention has been largely overlooked,” noted Dr. Kelly E. McGowan of Sunnybrook Health Sciences Centre and the University of Toronto and her associates.

Sunnybrook introduced an “avoid heparin” program in 2006 in which most intravenous and subcutaneous unfractionated heparin was replaced with low-molecular-weight heparin (LMWH) in prophylactic or therapeutic doses; heparinized saline in arterial and central venous lines was replaced with saline flushes; order sets were modified to exclude unfractionated heparin options; and unfractionated heparin stores were removed from most nursing units.

Unfractionated heparin remained available for use in hemodialysis, cardiovascular surgery, and certain cases of acute coronary syndrome. Most hospital clinicians were unaware that LMWH was being substituted for unfractionated heparin, and none were aware that the effects of this change were being studied.

The investigators assessed all 1,118 cases of suspected heparin-induced thrombocytopenia that occurred during a 10-year period before and after this intervention was implemented. The use of LMWH rose fourfold after the program was initiated, but the annual rate of HIT associated with LMWH remained constant at 0.9 cases per 10,000 admissions over the course of the study.

The annual incidence of suspected HIT decreased from 85.5 per 10,000 admissions per year before the intervention to 49.0 afterward (relative risk reduction, 41.7%). The rate of positive ELISA screens for the disorder dropped from 16.5 to 6.1 per 10,000 (RRR, 62.9%), the rate of adjudicated HIT decreased from 10.7 to 2.2 per 10,000, and the rate of HIT with thrombosis declined from 4.6 to 0.4 per 10,000.

The program’s greatest impact was on cardiac surgery, but the burden of HIT also markedly decreased in other surgical and medical patients. HIT decreased by 77% in cardiovascular surgeries, 77% in other surgeries, 75% in cardiology patients, and 62% in medical patients, Dr. McGowan and her associates said (Blood 2016 Apr 21;127[16]:1954-9).

Patients with HIT during the preintervention years more often developed thrombosis (43%), usually venous thromboembolism, compared with those who had HIT in the postintervention years (19%), and median length of stay declined accordingly. The average estimated costs of HIT care per year dropped by about $267,000 dollars per year, from $322,000 before the program was implemented to $55,000 afterward.

The investigators added that this is the first study ever to show the success of an HIT prevention strategy. Their findings indicate that a hospital-wide “avoid heparin” program can substantially reduce morbidity, mortality, and costs associated with HIT. “The heparin avoidance strategy that we used was not complex or costly and would be feasible in other centers,” they noted.

A simple, hospital-wide “avoid heparin” intervention dramatically cut the rate of suspected heparin-induced thrombocytopenia by 42%, that of positive ELISA screens for HIT by 63%, that of adjudicated HIT by 79%, and that of HIT with thrombosis by 91%, while also reducing the costs of HIT-related care by 83% at one large university hospital.

The medical literature has focused on early recognition and treatment of heparin-induced thrombocytopenia, “but its prevention has been largely overlooked,” noted Dr. Kelly E. McGowan of Sunnybrook Health Sciences Centre and the University of Toronto and her associates.

Sunnybrook introduced an “avoid heparin” program in 2006 in which most intravenous and subcutaneous unfractionated heparin was replaced with low-molecular-weight heparin (LMWH) in prophylactic or therapeutic doses; heparinized saline in arterial and central venous lines was replaced with saline flushes; order sets were modified to exclude unfractionated heparin options; and unfractionated heparin stores were removed from most nursing units.

Unfractionated heparin remained available for use in hemodialysis, cardiovascular surgery, and certain cases of acute coronary syndrome. Most hospital clinicians were unaware that LMWH was being substituted for unfractionated heparin, and none were aware that the effects of this change were being studied.

The investigators assessed all 1,118 cases of suspected heparin-induced thrombocytopenia that occurred during a 10-year period before and after this intervention was implemented. The use of LMWH rose fourfold after the program was initiated, but the annual rate of HIT associated with LMWH remained constant at 0.9 cases per 10,000 admissions over the course of the study.

The annual incidence of suspected HIT decreased from 85.5 per 10,000 admissions per year before the intervention to 49.0 afterward (relative risk reduction, 41.7%). The rate of positive ELISA screens for the disorder dropped from 16.5 to 6.1 per 10,000 (RRR, 62.9%), the rate of adjudicated HIT decreased from 10.7 to 2.2 per 10,000, and the rate of HIT with thrombosis declined from 4.6 to 0.4 per 10,000.

The program’s greatest impact was on cardiac surgery, but the burden of HIT also markedly decreased in other surgical and medical patients. HIT decreased by 77% in cardiovascular surgeries, 77% in other surgeries, 75% in cardiology patients, and 62% in medical patients, Dr. McGowan and her associates said (Blood 2016 Apr 21;127[16]:1954-9).

Patients with HIT during the preintervention years more often developed thrombosis (43%), usually venous thromboembolism, compared with those who had HIT in the postintervention years (19%), and median length of stay declined accordingly. The average estimated costs of HIT care per year dropped by about $267,000 dollars per year, from $322,000 before the program was implemented to $55,000 afterward.

The investigators added that this is the first study ever to show the success of an HIT prevention strategy. Their findings indicate that a hospital-wide “avoid heparin” program can substantially reduce morbidity, mortality, and costs associated with HIT. “The heparin avoidance strategy that we used was not complex or costly and would be feasible in other centers,” they noted.

Many emergency department cases deemed “nonurgent” by triage personnel actually are indistinguishable from those deemed “urgent,” according to a Research Letter to the Editor published in JAMA Internal Medicine.

To examine whether a triage determination of nonurgent status really rules out the possibility of serious pathology, researchers analyzed data from the National Hospital Ambulatory Medical Care Survey, a representative annual probability sample survey of ED visits categorized by level of urgency. They focused on 59,293 ED visits by patients aged 18-64 years during a 3-year period, which were representative of 240 million ED visits across the country. An estimated total of 218.5 million of these visits (92.5%) were categorized as urgent and 17.8 million (7.5%) as nonurgent by triage personnel, said Dr. Renee Y. Hsia of the department of emergency medicine and the Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, and her associates.

Patients required diagnostic services such as blood tests, electrocardiograms, or imaging in 8.45 million “nonurgent” visits (48%), and patients required procedures such as intravenous fluids, casting, or splinting in 5.76 million “nonurgent” visits (32%). More than 775,000 “nonurgent” visits (4%) resulted in hospital admission, including 126,000 admissions to critical care units. And in 1.19 million “nonurgent” visits (7%), patients arrived by ambulance.

In addition, half of the top 10 diagnoses from “nonurgent” visits were identical to those from urgent visits, the investigators said (JAMA Int Med. 2016 April 18. doi: 10.1001/jamainternmed.2016.0878).

“Certainly, not all of these data necessarily indicate that these services were required, and they could signal overuse or a lack of availability of primary care physicians. However, to some degree, our findings indicate that either patients or health care professionals do entertain a degree of uncertainty that requires further evaluation before diagnosis,” Dr. Hsia and her associates said.

Triage was never intended to completely rule out the possibility of severe illness in patients considered nonurgent, but was meant to predict the amount of time a patient could safely wait to be seen in the ED. However, over time, “the term ‘nonurgent’ has been often politicized to mean ‘inappropriate,’ ” they noted.

“Our findings highlight the lack of certainty of nonurgent status even when it is determined prospectively by a provider at triage, and suggest that caution must be taken when using triage scores beyond their intended purpose,” the investigators said.

Many emergency department cases deemed “nonurgent” by triage personnel actually are indistinguishable from those deemed “urgent,” according to a Research Letter to the Editor published in JAMA Internal Medicine.

To examine whether a triage determination of nonurgent status really rules out the possibility of serious pathology, researchers analyzed data from the National Hospital Ambulatory Medical Care Survey, a representative annual probability sample survey of ED visits categorized by level of urgency. They focused on 59,293 ED visits by patients aged 18-64 years during a 3-year period, which were representative of 240 million ED visits across the country. An estimated total of 218.5 million of these visits (92.5%) were categorized as urgent and 17.8 million (7.5%) as nonurgent by triage personnel, said Dr. Renee Y. Hsia of the department of emergency medicine and the Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, and her associates.

Patients required diagnostic services such as blood tests, electrocardiograms, or imaging in 8.45 million “nonurgent” visits (48%), and patients required procedures such as intravenous fluids, casting, or splinting in 5.76 million “nonurgent” visits (32%). More than 775,000 “nonurgent” visits (4%) resulted in hospital admission, including 126,000 admissions to critical care units. And in 1.19 million “nonurgent” visits (7%), patients arrived by ambulance.

In addition, half of the top 10 diagnoses from “nonurgent” visits were identical to those from urgent visits, the investigators said (JAMA Int Med. 2016 April 18. doi: 10.1001/jamainternmed.2016.0878).

“Certainly, not all of these data necessarily indicate that these services were required, and they could signal overuse or a lack of availability of primary care physicians. However, to some degree, our findings indicate that either patients or health care professionals do entertain a degree of uncertainty that requires further evaluation before diagnosis,” Dr. Hsia and her associates said.

Triage was never intended to completely rule out the possibility of severe illness in patients considered nonurgent, but was meant to predict the amount of time a patient could safely wait to be seen in the ED. However, over time, “the term ‘nonurgent’ has been often politicized to mean ‘inappropriate,’ ” they noted.

“Our findings highlight the lack of certainty of nonurgent status even when it is determined prospectively by a provider at triage, and suggest that caution must be taken when using triage scores beyond their intended purpose,” the investigators said.

Many emergency department cases deemed “nonurgent” by triage personnel actually are indistinguishable from those deemed “urgent,” according to a Research Letter to the Editor published in JAMA Internal Medicine.

To examine whether a triage determination of nonurgent status really rules out the possibility of serious pathology, researchers analyzed data from the National Hospital Ambulatory Medical Care Survey, a representative annual probability sample survey of ED visits categorized by level of urgency. They focused on 59,293 ED visits by patients aged 18-64 years during a 3-year period, which were representative of 240 million ED visits across the country. An estimated total of 218.5 million of these visits (92.5%) were categorized as urgent and 17.8 million (7.5%) as nonurgent by triage personnel, said Dr. Renee Y. Hsia of the department of emergency medicine and the Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, and her associates.

Patients required diagnostic services such as blood tests, electrocardiograms, or imaging in 8.45 million “nonurgent” visits (48%), and patients required procedures such as intravenous fluids, casting, or splinting in 5.76 million “nonurgent” visits (32%). More than 775,000 “nonurgent” visits (4%) resulted in hospital admission, including 126,000 admissions to critical care units. And in 1.19 million “nonurgent” visits (7%), patients arrived by ambulance.

In addition, half of the top 10 diagnoses from “nonurgent” visits were identical to those from urgent visits, the investigators said (JAMA Int Med. 2016 April 18. doi: 10.1001/jamainternmed.2016.0878).

“Certainly, not all of these data necessarily indicate that these services were required, and they could signal overuse or a lack of availability of primary care physicians. However, to some degree, our findings indicate that either patients or health care professionals do entertain a degree of uncertainty that requires further evaluation before diagnosis,” Dr. Hsia and her associates said.

Triage was never intended to completely rule out the possibility of severe illness in patients considered nonurgent, but was meant to predict the amount of time a patient could safely wait to be seen in the ED. However, over time, “the term ‘nonurgent’ has been often politicized to mean ‘inappropriate,’ ” they noted.

“Our findings highlight the lack of certainty of nonurgent status even when it is determined prospectively by a provider at triage, and suggest that caution must be taken when using triage scores beyond their intended purpose,” the investigators said.

GLASGOW – Children with Down syndrome are at increased risk for arthritis that often goes unrecognized and leads to treatment delays and potential chronic disability.

Research presented at the British Society for Rheumatology annual conference highlighted how Down arthropathy is not only more prevalent than idiopathic juvenile arthritis (JIA), but also has distinct clinical and radiographic features.

“Our research to date has shown that there is a significant increased risk of arthritis in children with trisomy 21, and higher than that previously reported,” said Dr. Charlene Foley, a research fellow at Our Lady’s Children’s Hospital in Dublin.

©DenKuvaiev/thinkstockphotos.com

“There is a significant delay in diagnosis, which may be a cause of the x-ray changes at diagnosis, or it may be in fact that Down arthropathy is more aggressive,” than other childhood forms of arthritis, she observed.

Dr. Foley noted that Down arthropathy was first reported in the medical literature about 30 years ago and crude estimates suggested a prevalence of around 8.7 cases per 1,000 children versus 1 per 1,000 for JIA. However, the research she presented put the crude point prevalence at 18-21 per 1,000 children.

Dr. Foley presented the findings of an observational study conducted in the Republic of Ireland in which children with trisomy 21 and their families were identified from a variety of sources and invited to participate. After completion of a screening questionnaire and an appointment local to the participants, children who were suspected of having arthritis were invited to attend a consultant appointment. They underwent a clinical management pathway developed for JIA because no specific pathway had been developed for the children at that time, with follow-up appointments held every 3-6 months depending on the child’s needs.

Over an 18-month period, 503 children with trisomy 21 and a mean age of 8 years were screened. They had a range of musculoskeletal anomalies, the most common of which were flat feet in almost all the children (91.1%), inflammatory arthritis in 7.1%, and scoliosis in 4.8%. Many other problems occurred, with an incidence of 1.5% or less for each.

A total of 22 new cases of Down arthropathy have been identified to date, in addition to 11 at the clinic who predated the start of the study. About 75% have come through the screening clinics and the rest through pediatricians’ referral.

“It is a challenging disease both in terms of diagnosis and management,” Dr. Foley said. Of all the identified children, 91% had poor language skills or nonverbal communication and 15% had autism spectrum disorder.

On average, the time to diagnosis of the arthropathy was 1.7 years versus 0.74 years for a control group of 33 children with JIA. This is likely an underestimation, however, as 42% of the children or parents in the Down arthropathy cohort were unable to give a date on which symptoms had started.

Dr. Foley reported that the majority of trisomy 21 children had presented with polyarticular arthritis, mostly involving the proximal interphalangeal joints of the hands (78.6% of cases), or the wrists (53.6% of cases). There was significant small joint involvement (88% vs. 43% of the JIA cohort), and higher restricted joint counts (4.5 vs. 2.0). There were also differences in erythrocyte sedimentation rate and C-reactive protein at diagnosis, with these being “barely raised” in children with Down arthropathy versus children with JIA, so unlikely to aid a diagnosis. Children were also found to be rheumatoid factor negative.

Two-thirds of Down arthropathy cases had x-ray changes at presentation versus 24% of the JIA group, of which 29% versus 9.5% were erosive.

Treatment is complicated by drug-related side effects, with many children unable to tolerate methotrexate, Dr. Foley said. In the Irish cohort, treatment with methotrexate led to nausea in 75%, compared with 7.1% of the JIA children. Although reports are limited, methotrexate intolerance has been shown in children with trisomy 21, so there could be a genetic or metabolic reason behind this. Dr. Foley noted that they manage this problem by starting methotrexate on the lowest possible doses (10 mg/m²) and co-administering the antiemetic ondansetron. They have a low threshold for switching to an anti-TNF drug if needed, and have also started giving biologic drugs to some newly diagnosed children.

“The take-home message is to think outside of the Down syndrome box and don’t just blame everything on Down syndrome,” Dr. Foley said. As it may be challenging to examine a child, she suggested looking at the hands first because they are the most likely to be affected.

“We feel that a musculoskeletal assessment should be part of the annual surveillance for all children with Down syndrome,” she concluded.

As for who should conduct such an assessment, Dr. Foley suggested that general pediatricians who are regularly seeing these children for other health checks should perform it. However, as one delegate observed, nonrheumatology professionals may need a little training and guidance, as musculoskeletal assessments can be difficult. Looking only at the hands, and potentially the feet, may be one solution.

The study has raised a number of questions and future research will be needed to further characterize the arthritis and to determine how best to diagnose and treat it, noted Dr. Foley, who indicated that she had no conflicts of interest.

GLASGOW – Children with Down syndrome are at increased risk for arthritis that often goes unrecognized and leads to treatment delays and potential chronic disability.

Research presented at the British Society for Rheumatology annual conference highlighted how Down arthropathy is not only more prevalent than idiopathic juvenile arthritis (JIA), but also has distinct clinical and radiographic features.

“Our research to date has shown that there is a significant increased risk of arthritis in children with trisomy 21, and higher than that previously reported,” said Dr. Charlene Foley, a research fellow at Our Lady’s Children’s Hospital in Dublin.

©DenKuvaiev/thinkstockphotos.com

“There is a significant delay in diagnosis, which may be a cause of the x-ray changes at diagnosis, or it may be in fact that Down arthropathy is more aggressive,” than other childhood forms of arthritis, she observed.

Dr. Foley noted that Down arthropathy was first reported in the medical literature about 30 years ago and crude estimates suggested a prevalence of around 8.7 cases per 1,000 children versus 1 per 1,000 for JIA. However, the research she presented put the crude point prevalence at 18-21 per 1,000 children.

Dr. Foley presented the findings of an observational study conducted in the Republic of Ireland in which children with trisomy 21 and their families were identified from a variety of sources and invited to participate. After completion of a screening questionnaire and an appointment local to the participants, children who were suspected of having arthritis were invited to attend a consultant appointment. They underwent a clinical management pathway developed for JIA because no specific pathway had been developed for the children at that time, with follow-up appointments held every 3-6 months depending on the child’s needs.

Over an 18-month period, 503 children with trisomy 21 and a mean age of 8 years were screened. They had a range of musculoskeletal anomalies, the most common of which were flat feet in almost all the children (91.1%), inflammatory arthritis in 7.1%, and scoliosis in 4.8%. Many other problems occurred, with an incidence of 1.5% or less for each.

A total of 22 new cases of Down arthropathy have been identified to date, in addition to 11 at the clinic who predated the start of the study. About 75% have come through the screening clinics and the rest through pediatricians’ referral.

“It is a challenging disease both in terms of diagnosis and management,” Dr. Foley said. Of all the identified children, 91% had poor language skills or nonverbal communication and 15% had autism spectrum disorder.

On average, the time to diagnosis of the arthropathy was 1.7 years versus 0.74 years for a control group of 33 children with JIA. This is likely an underestimation, however, as 42% of the children or parents in the Down arthropathy cohort were unable to give a date on which symptoms had started.

Dr. Foley reported that the majority of trisomy 21 children had presented with polyarticular arthritis, mostly involving the proximal interphalangeal joints of the hands (78.6% of cases), or the wrists (53.6% of cases). There was significant small joint involvement (88% vs. 43% of the JIA cohort), and higher restricted joint counts (4.5 vs. 2.0). There were also differences in erythrocyte sedimentation rate and C-reactive protein at diagnosis, with these being “barely raised” in children with Down arthropathy versus children with JIA, so unlikely to aid a diagnosis. Children were also found to be rheumatoid factor negative.

Two-thirds of Down arthropathy cases had x-ray changes at presentation versus 24% of the JIA group, of which 29% versus 9.5% were erosive.

Treatment is complicated by drug-related side effects, with many children unable to tolerate methotrexate, Dr. Foley said. In the Irish cohort, treatment with methotrexate led to nausea in 75%, compared with 7.1% of the JIA children. Although reports are limited, methotrexate intolerance has been shown in children with trisomy 21, so there could be a genetic or metabolic reason behind this. Dr. Foley noted that they manage this problem by starting methotrexate on the lowest possible doses (10 mg/m²) and co-administering the antiemetic ondansetron. They have a low threshold for switching to an anti-TNF drug if needed, and have also started giving biologic drugs to some newly diagnosed children.

“The take-home message is to think outside of the Down syndrome box and don’t just blame everything on Down syndrome,” Dr. Foley said. As it may be challenging to examine a child, she suggested looking at the hands first because they are the most likely to be affected.

“We feel that a musculoskeletal assessment should be part of the annual surveillance for all children with Down syndrome,” she concluded.

As for who should conduct such an assessment, Dr. Foley suggested that general pediatricians who are regularly seeing these children for other health checks should perform it. However, as one delegate observed, nonrheumatology professionals may need a little training and guidance, as musculoskeletal assessments can be difficult. Looking only at the hands, and potentially the feet, may be one solution.

The study has raised a number of questions and future research will be needed to further characterize the arthritis and to determine how best to diagnose and treat it, noted Dr. Foley, who indicated that she had no conflicts of interest.

GLASGOW – Children with Down syndrome are at increased risk for arthritis that often goes unrecognized and leads to treatment delays and potential chronic disability.

Research presented at the British Society for Rheumatology annual conference highlighted how Down arthropathy is not only more prevalent than idiopathic juvenile arthritis (JIA), but also has distinct clinical and radiographic features.

“Our research to date has shown that there is a significant increased risk of arthritis in children with trisomy 21, and higher than that previously reported,” said Dr. Charlene Foley, a research fellow at Our Lady’s Children’s Hospital in Dublin.

©DenKuvaiev/thinkstockphotos.com

“There is a significant delay in diagnosis, which may be a cause of the x-ray changes at diagnosis, or it may be in fact that Down arthropathy is more aggressive,” than other childhood forms of arthritis, she observed.

Dr. Foley noted that Down arthropathy was first reported in the medical literature about 30 years ago and crude estimates suggested a prevalence of around 8.7 cases per 1,000 children versus 1 per 1,000 for JIA. However, the research she presented put the crude point prevalence at 18-21 per 1,000 children.

Dr. Foley presented the findings of an observational study conducted in the Republic of Ireland in which children with trisomy 21 and their families were identified from a variety of sources and invited to participate. After completion of a screening questionnaire and an appointment local to the participants, children who were suspected of having arthritis were invited to attend a consultant appointment. They underwent a clinical management pathway developed for JIA because no specific pathway had been developed for the children at that time, with follow-up appointments held every 3-6 months depending on the child’s needs.

Over an 18-month period, 503 children with trisomy 21 and a mean age of 8 years were screened. They had a range of musculoskeletal anomalies, the most common of which were flat feet in almost all the children (91.1%), inflammatory arthritis in 7.1%, and scoliosis in 4.8%. Many other problems occurred, with an incidence of 1.5% or less for each.

A total of 22 new cases of Down arthropathy have been identified to date, in addition to 11 at the clinic who predated the start of the study. About 75% have come through the screening clinics and the rest through pediatricians’ referral.

“It is a challenging disease both in terms of diagnosis and management,” Dr. Foley said. Of all the identified children, 91% had poor language skills or nonverbal communication and 15% had autism spectrum disorder.

On average, the time to diagnosis of the arthropathy was 1.7 years versus 0.74 years for a control group of 33 children with JIA. This is likely an underestimation, however, as 42% of the children or parents in the Down arthropathy cohort were unable to give a date on which symptoms had started.

Dr. Foley reported that the majority of trisomy 21 children had presented with polyarticular arthritis, mostly involving the proximal interphalangeal joints of the hands (78.6% of cases), or the wrists (53.6% of cases). There was significant small joint involvement (88% vs. 43% of the JIA cohort), and higher restricted joint counts (4.5 vs. 2.0). There were also differences in erythrocyte sedimentation rate and C-reactive protein at diagnosis, with these being “barely raised” in children with Down arthropathy versus children with JIA, so unlikely to aid a diagnosis. Children were also found to be rheumatoid factor negative.

Two-thirds of Down arthropathy cases had x-ray changes at presentation versus 24% of the JIA group, of which 29% versus 9.5% were erosive.

Treatment is complicated by drug-related side effects, with many children unable to tolerate methotrexate, Dr. Foley said. In the Irish cohort, treatment with methotrexate led to nausea in 75%, compared with 7.1% of the JIA children. Although reports are limited, methotrexate intolerance has been shown in children with trisomy 21, so there could be a genetic or metabolic reason behind this. Dr. Foley noted that they manage this problem by starting methotrexate on the lowest possible doses (10 mg/m²) and co-administering the antiemetic ondansetron. They have a low threshold for switching to an anti-TNF drug if needed, and have also started giving biologic drugs to some newly diagnosed children.

“The take-home message is to think outside of the Down syndrome box and don’t just blame everything on Down syndrome,” Dr. Foley said. As it may be challenging to examine a child, she suggested looking at the hands first because they are the most likely to be affected.

“We feel that a musculoskeletal assessment should be part of the annual surveillance for all children with Down syndrome,” she concluded.

As for who should conduct such an assessment, Dr. Foley suggested that general pediatricians who are regularly seeing these children for other health checks should perform it. However, as one delegate observed, nonrheumatology professionals may need a little training and guidance, as musculoskeletal assessments can be difficult. Looking only at the hands, and potentially the feet, may be one solution.

The study has raised a number of questions and future research will be needed to further characterize the arthritis and to determine how best to diagnose and treat it, noted Dr. Foley, who indicated that she had no conflicts of interest.

ORLANDO – The hematologic cancer drug ruxolitinib seems to be associated with cases of aggressive nonmelanoma skin cancer.

After treating a very aggressive squamous cell carcinoma in a 55-year-old man treated with ruxolitinib for polycythemia vera, and hearing firsthand of three other similar cases, Dr. Fiona Zwald is collecting additional data on the association. She intends to publish these cases in a monograph as a warning to dermatologists, hematologists, oncologists, and other physicians who manage patients with hematologic malignancies, she said at the annual meeting of the American College of Mohs Surgery.

The prescribing information for ruxolitinib (Jakafi, Incyte Pharmaceuticals; Jakavi, Novartis) was updated in 2014 to warn that patients taking the drug face an increased risk of nonmelanoma skin cancers. The label also recommends that physicians inspect the skin regularly and urge patients to be alert for and report any new or changing lesions.

Despite the warnings and recommendations, cases are occurring – and some are quite serious, said Dr. Zwald, a Mohs surgeon in Atlanta.

“People should know this is actually happening. If you have experience with this medication, please let us know so we can compile this report. We are trying to assess the number of skin cancers before and after initiating this medication,” she said.

Courtesy Dr. Fiona Zwald

Ruxolitinib is an inhibitor of Janus kinase with a special affinity for the JAK1 and JAK2 subtypes. Like other cytokine-signaling molecules, their function depends on cell context; it may inhibit cell growth in one setting, and, in another, stimulate it. Ruxolitinib was initially approved in 2011 for the treatment of intermediate- and high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.

In 2014, indications for ruxolitinib were expanded to include treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Dr. Zwald’s patient had a 10-year history of polycythemia vera. He was initially well controlled on the standard hydroxyurea treatment. In the meantime, he began working as a caddy at a major U.S. golf club. He developed many facial squamous cell carcinomas that were treated with excision and radiation. A year before he presented to Dr. Zwald, he stopped responding to hydroxyurea and was placed on ruxolitinib.

The patient presented with a 4-cm ulcerated lesion over part of his right temple and to the right helical crus; the lesion had developed over 3 months. Dr. Zwald consulted with the patient’s medical oncologist; treatment with ruxolitinib continued, albeit at a reduced dosage in light of recent events.

She performed Mohs surgery on the patient. It was a challenging case, she said, not the least because adequate anesthesia could not be achieved with local anesthetic. Preoperative staging showed no nodal spread.

“He did, unfortunately demonstrate a large, indurated mass located over one branch of the superficial temporal artery. At the helical crus there was an area of bound-down, fixed tumor. Knowing that I would not be able to fully resect this, I passed him on to the operating room,” Dr. Zwald said. “This tumor was found to extend down to the parotid capsule, but margins were clear.” The surgical defect was successfully repaired with a split-thickness skin graft.

The tumor recurred about 3 months later, and the patient underwent another surgery.

“This time we could not get clear surgical margins, and the tumor was approaching the external auditory meatus. Surgery was abandoned due to fears of complications to that area,” she said.

She presented the case at tumor board, during which she and her colleagues discussed adjuvant radiation. They initially abandoned this idea because he had already had so much radiation to his face. After the second surgery, they decide to proceed with radiation. “The next conversation we have will be whether to add another adjuvant therapy to treatment.”

She sent out the case and requests for feedback to the International Transplant Skin Cancer Collaborative, an 800-member consortium of dermatologists and Mohs surgeons who take care of transplant patients. She received information on three additional cases of aggressive squamous cell carcinoma (SCC) associated with ruxolitinib treatment:

• A patient with myelodysplastic syndrome with aggressive scalp SCC with cutaneous metastases.

• A patient with undifferentiated pleomorphic sarcoma of the scalp, several cutaneous SCCs.

• A patient with a myelodysplastic syndrome with in-transit metastases and explosive cutaneous SCCs. The patient has had the ruxolitinib dose reduced and may be switched to capecitabine.

Dr. Zwald noted that her patient was at risk for aggressive skin cancers for reasons in addition to ruxolitinib treatment.

“He was already immunosuppressed from his malignancy. He was on hydroxyurea, a drug that’s a cumulative phototoxin, and he’s out in the sun playing golf every day, and then was put on ruxolitinib. But the question we face now is how to try and stop this medication so we can get better treatment for him which will, of course, be very difficult.”

To contribute to Dr. Zwald’s case series, please email her at [email protected].

She had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

ORLANDO – The hematologic cancer drug ruxolitinib seems to be associated with cases of aggressive nonmelanoma skin cancer.

After treating a very aggressive squamous cell carcinoma in a 55-year-old man treated with ruxolitinib for polycythemia vera, and hearing firsthand of three other similar cases, Dr. Fiona Zwald is collecting additional data on the association. She intends to publish these cases in a monograph as a warning to dermatologists, hematologists, oncologists, and other physicians who manage patients with hematologic malignancies, she said at the annual meeting of the American College of Mohs Surgery.

The prescribing information for ruxolitinib (Jakafi, Incyte Pharmaceuticals; Jakavi, Novartis) was updated in 2014 to warn that patients taking the drug face an increased risk of nonmelanoma skin cancers. The label also recommends that physicians inspect the skin regularly and urge patients to be alert for and report any new or changing lesions.

Despite the warnings and recommendations, cases are occurring – and some are quite serious, said Dr. Zwald, a Mohs surgeon in Atlanta.

“People should know this is actually happening. If you have experience with this medication, please let us know so we can compile this report. We are trying to assess the number of skin cancers before and after initiating this medication,” she said.

Courtesy Dr. Fiona Zwald

Ruxolitinib is an inhibitor of Janus kinase with a special affinity for the JAK1 and JAK2 subtypes. Like other cytokine-signaling molecules, their function depends on cell context; it may inhibit cell growth in one setting, and, in another, stimulate it. Ruxolitinib was initially approved in 2011 for the treatment of intermediate- and high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.

In 2014, indications for ruxolitinib were expanded to include treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Dr. Zwald’s patient had a 10-year history of polycythemia vera. He was initially well controlled on the standard hydroxyurea treatment. In the meantime, he began working as a caddy at a major U.S. golf club. He developed many facial squamous cell carcinomas that were treated with excision and radiation. A year before he presented to Dr. Zwald, he stopped responding to hydroxyurea and was placed on ruxolitinib.

The patient presented with a 4-cm ulcerated lesion over part of his right temple and to the right helical crus; the lesion had developed over 3 months. Dr. Zwald consulted with the patient’s medical oncologist; treatment with ruxolitinib continued, albeit at a reduced dosage in light of recent events.

She performed Mohs surgery on the patient. It was a challenging case, she said, not the least because adequate anesthesia could not be achieved with local anesthetic. Preoperative staging showed no nodal spread.

“He did, unfortunately demonstrate a large, indurated mass located over one branch of the superficial temporal artery. At the helical crus there was an area of bound-down, fixed tumor. Knowing that I would not be able to fully resect this, I passed him on to the operating room,” Dr. Zwald said. “This tumor was found to extend down to the parotid capsule, but margins were clear.” The surgical defect was successfully repaired with a split-thickness skin graft.

The tumor recurred about 3 months later, and the patient underwent another surgery.

“This time we could not get clear surgical margins, and the tumor was approaching the external auditory meatus. Surgery was abandoned due to fears of complications to that area,” she said.

She presented the case at tumor board, during which she and her colleagues discussed adjuvant radiation. They initially abandoned this idea because he had already had so much radiation to his face. After the second surgery, they decide to proceed with radiation. “The next conversation we have will be whether to add another adjuvant therapy to treatment.”

She sent out the case and requests for feedback to the International Transplant Skin Cancer Collaborative, an 800-member consortium of dermatologists and Mohs surgeons who take care of transplant patients. She received information on three additional cases of aggressive squamous cell carcinoma (SCC) associated with ruxolitinib treatment:

• A patient with myelodysplastic syndrome with aggressive scalp SCC with cutaneous metastases.

• A patient with undifferentiated pleomorphic sarcoma of the scalp, several cutaneous SCCs.

• A patient with a myelodysplastic syndrome with in-transit metastases and explosive cutaneous SCCs. The patient has had the ruxolitinib dose reduced and may be switched to capecitabine.

Dr. Zwald noted that her patient was at risk for aggressive skin cancers for reasons in addition to ruxolitinib treatment.

“He was already immunosuppressed from his malignancy. He was on hydroxyurea, a drug that’s a cumulative phototoxin, and he’s out in the sun playing golf every day, and then was put on ruxolitinib. But the question we face now is how to try and stop this medication so we can get better treatment for him which will, of course, be very difficult.”

To contribute to Dr. Zwald’s case series, please email her at [email protected].

She had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

ORLANDO – The hematologic cancer drug ruxolitinib seems to be associated with cases of aggressive nonmelanoma skin cancer.

After treating a very aggressive squamous cell carcinoma in a 55-year-old man treated with ruxolitinib for polycythemia vera, and hearing firsthand of three other similar cases, Dr. Fiona Zwald is collecting additional data on the association. She intends to publish these cases in a monograph as a warning to dermatologists, hematologists, oncologists, and other physicians who manage patients with hematologic malignancies, she said at the annual meeting of the American College of Mohs Surgery.

The prescribing information for ruxolitinib (Jakafi, Incyte Pharmaceuticals; Jakavi, Novartis) was updated in 2014 to warn that patients taking the drug face an increased risk of nonmelanoma skin cancers. The label also recommends that physicians inspect the skin regularly and urge patients to be alert for and report any new or changing lesions.

Despite the warnings and recommendations, cases are occurring – and some are quite serious, said Dr. Zwald, a Mohs surgeon in Atlanta.

“People should know this is actually happening. If you have experience with this medication, please let us know so we can compile this report. We are trying to assess the number of skin cancers before and after initiating this medication,” she said.

Courtesy Dr. Fiona Zwald

Ruxolitinib is an inhibitor of Janus kinase with a special affinity for the JAK1 and JAK2 subtypes. Like other cytokine-signaling molecules, their function depends on cell context; it may inhibit cell growth in one setting, and, in another, stimulate it. Ruxolitinib was initially approved in 2011 for the treatment of intermediate- and high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.

In 2014, indications for ruxolitinib were expanded to include treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Dr. Zwald’s patient had a 10-year history of polycythemia vera. He was initially well controlled on the standard hydroxyurea treatment. In the meantime, he began working as a caddy at a major U.S. golf club. He developed many facial squamous cell carcinomas that were treated with excision and radiation. A year before he presented to Dr. Zwald, he stopped responding to hydroxyurea and was placed on ruxolitinib.

The patient presented with a 4-cm ulcerated lesion over part of his right temple and to the right helical crus; the lesion had developed over 3 months. Dr. Zwald consulted with the patient’s medical oncologist; treatment with ruxolitinib continued, albeit at a reduced dosage in light of recent events.

She performed Mohs surgery on the patient. It was a challenging case, she said, not the least because adequate anesthesia could not be achieved with local anesthetic. Preoperative staging showed no nodal spread.

“He did, unfortunately demonstrate a large, indurated mass located over one branch of the superficial temporal artery. At the helical crus there was an area of bound-down, fixed tumor. Knowing that I would not be able to fully resect this, I passed him on to the operating room,” Dr. Zwald said. “This tumor was found to extend down to the parotid capsule, but margins were clear.” The surgical defect was successfully repaired with a split-thickness skin graft.

The tumor recurred about 3 months later, and the patient underwent another surgery.

“This time we could not get clear surgical margins, and the tumor was approaching the external auditory meatus. Surgery was abandoned due to fears of complications to that area,” she said.

She presented the case at tumor board, during which she and her colleagues discussed adjuvant radiation. They initially abandoned this idea because he had already had so much radiation to his face. After the second surgery, they decide to proceed with radiation. “The next conversation we have will be whether to add another adjuvant therapy to treatment.”

She sent out the case and requests for feedback to the International Transplant Skin Cancer Collaborative, an 800-member consortium of dermatologists and Mohs surgeons who take care of transplant patients. She received information on three additional cases of aggressive squamous cell carcinoma (SCC) associated with ruxolitinib treatment:

• A patient with myelodysplastic syndrome with aggressive scalp SCC with cutaneous metastases.

• A patient with undifferentiated pleomorphic sarcoma of the scalp, several cutaneous SCCs.

• A patient with a myelodysplastic syndrome with in-transit metastases and explosive cutaneous SCCs. The patient has had the ruxolitinib dose reduced and may be switched to capecitabine.

Dr. Zwald noted that her patient was at risk for aggressive skin cancers for reasons in addition to ruxolitinib treatment.

“He was already immunosuppressed from his malignancy. He was on hydroxyurea, a drug that’s a cumulative phototoxin, and he’s out in the sun playing golf every day, and then was put on ruxolitinib. But the question we face now is how to try and stop this medication so we can get better treatment for him which will, of course, be very difficult.”

To contribute to Dr. Zwald’s case series, please email her at [email protected].

She had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

To promote achievable solutions in the ongoing debate on drug financing, Anthem, Inc. and Eli Lilly and Company are offering two policy proposals, which are detailed in “Discovering New Medicines and New Ways to Pay for Them,” published on the Health Affairs blog.

The first proposal calls for clarifying federal regulation to reduce perceived barriers impeding conversations between health benefit companies and biopharmaceutical companies about drugs prior to the drugs being approved for sale.

The second proposal calls for changes to federal laws and regulations to mitigate the barriers that make it difficult to move toward value-based contracting.

“A change in policies could open the door to new opportunities for hospitalists and their employers to create more high-value care,” says Sam Nussbaum, MD, Anthem clinical advisor. “Today, hospitals are paid for seeing patients. What if hospitals participated in a value-based arrangement with manufacturers and insurers that included treating patients with a specific condition with a new therapy proven to be more effective in producing better health outcomes, including keeping patients out of the hospital?”

Reference

1. Nussbaum S, Ricks D. Discovering new medicines and new ways to pay for them. Health Policy Lab. Available at: http://healthaffairs.org/blog/2016/01/29/discovering-new-medicines-and-new-ways-to-pay-for-them/. Accessed February 15, 2016.

To promote achievable solutions in the ongoing debate on drug financing, Anthem, Inc. and Eli Lilly and Company are offering two policy proposals, which are detailed in “Discovering New Medicines and New Ways to Pay for Them,” published on the Health Affairs blog.

The first proposal calls for clarifying federal regulation to reduce perceived barriers impeding conversations between health benefit companies and biopharmaceutical companies about drugs prior to the drugs being approved for sale.

The second proposal calls for changes to federal laws and regulations to mitigate the barriers that make it difficult to move toward value-based contracting.

“A change in policies could open the door to new opportunities for hospitalists and their employers to create more high-value care,” says Sam Nussbaum, MD, Anthem clinical advisor. “Today, hospitals are paid for seeing patients. What if hospitals participated in a value-based arrangement with manufacturers and insurers that included treating patients with a specific condition with a new therapy proven to be more effective in producing better health outcomes, including keeping patients out of the hospital?”

Reference

1. Nussbaum S, Ricks D. Discovering new medicines and new ways to pay for them. Health Policy Lab. Available at: http://healthaffairs.org/blog/2016/01/29/discovering-new-medicines-and-new-ways-to-pay-for-them/. Accessed February 15, 2016.

To promote achievable solutions in the ongoing debate on drug financing, Anthem, Inc. and Eli Lilly and Company are offering two policy proposals, which are detailed in “Discovering New Medicines and New Ways to Pay for Them,” published on the Health Affairs blog.

The first proposal calls for clarifying federal regulation to reduce perceived barriers impeding conversations between health benefit companies and biopharmaceutical companies about drugs prior to the drugs being approved for sale.

The second proposal calls for changes to federal laws and regulations to mitigate the barriers that make it difficult to move toward value-based contracting.

“A change in policies could open the door to new opportunities for hospitalists and their employers to create more high-value care,” says Sam Nussbaum, MD, Anthem clinical advisor. “Today, hospitals are paid for seeing patients. What if hospitals participated in a value-based arrangement with manufacturers and insurers that included treating patients with a specific condition with a new therapy proven to be more effective in producing better health outcomes, including keeping patients out of the hospital?”

Reference

1. Nussbaum S, Ricks D. Discovering new medicines and new ways to pay for them. Health Policy Lab. Available at: http://healthaffairs.org/blog/2016/01/29/discovering-new-medicines-and-new-ways-to-pay-for-them/. Accessed February 15, 2016.

Procedures are the most expensive item in healthcare, but tremendous variation remains in quality.

“In part that’ s because we have weak systems of peer support and in part because medicine sanctions a physician to do procedures, and then for the next 40 or 50 years, a surgeon can receive no input and not change their technique even though the field changes,” says Martin Makary, MD, MPH, professor of surgery and health policy and management at Johns Hopkins University in Baltimore.

Video could be used to address this, he suggests in an editorial called “Video Transparency: A Powerful Tool for Patient Safety and Quality Improvement” in the January 2016 BMJ Quality & Safety.

“In areas of excellence outside of medicine—football, aviation—they use video and video feedback for educational purposes. In healthcare, we can also use video to learn,” he says. “In surgical care, we can actually predict outcomes based on independent review of procedure video, but we just choose not to record videos because we don’ t have the infrastructure set up to provide feedback.”

When it has been done, he says, it’ s been received with enthusiasm. This doesn’ t mean cameras in primary-care clinics monitoring physicians.

“We’ re talking about the video-based procedures being recorded, not being erased with the next procedure that’ s done,” he says. “In the past, we couldn’ t do this with videotapes, but now with the capacity of memory and video data storage, there’ s an opportunity to leave the ‘ record’ button on on the video-based procedures that are already taking place.”

Reference

1. Joo S, Xu T, Makary MA. Video transparency: a powerful tool for patient safety and quality improvement [published online ahead of print January 12, 2016]. BMJ Qual Saf,doi:10.1136/bmjqs-2015-005058.

Procedures are the most expensive item in healthcare, but tremendous variation remains in quality.

“In part that’ s because we have weak systems of peer support and in part because medicine sanctions a physician to do procedures, and then for the next 40 or 50 years, a surgeon can receive no input and not change their technique even though the field changes,” says Martin Makary, MD, MPH, professor of surgery and health policy and management at Johns Hopkins University in Baltimore.

Video could be used to address this, he suggests in an editorial called “Video Transparency: A Powerful Tool for Patient Safety and Quality Improvement” in the January 2016 BMJ Quality & Safety.

“In areas of excellence outside of medicine—football, aviation—they use video and video feedback for educational purposes. In healthcare, we can also use video to learn,” he says. “In surgical care, we can actually predict outcomes based on independent review of procedure video, but we just choose not to record videos because we don’ t have the infrastructure set up to provide feedback.”

When it has been done, he says, it’ s been received with enthusiasm. This doesn’ t mean cameras in primary-care clinics monitoring physicians.

“We’ re talking about the video-based procedures being recorded, not being erased with the next procedure that’ s done,” he says. “In the past, we couldn’ t do this with videotapes, but now with the capacity of memory and video data storage, there’ s an opportunity to leave the ‘ record’ button on on the video-based procedures that are already taking place.”

Reference

1. Joo S, Xu T, Makary MA. Video transparency: a powerful tool for patient safety and quality improvement [published online ahead of print January 12, 2016]. BMJ Qual Saf,doi:10.1136/bmjqs-2015-005058.

Procedures are the most expensive item in healthcare, but tremendous variation remains in quality.

“In part that’ s because we have weak systems of peer support and in part because medicine sanctions a physician to do procedures, and then for the next 40 or 50 years, a surgeon can receive no input and not change their technique even though the field changes,” says Martin Makary, MD, MPH, professor of surgery and health policy and management at Johns Hopkins University in Baltimore.

Video could be used to address this, he suggests in an editorial called “Video Transparency: A Powerful Tool for Patient Safety and Quality Improvement” in the January 2016 BMJ Quality & Safety.

“In areas of excellence outside of medicine—football, aviation—they use video and video feedback for educational purposes. In healthcare, we can also use video to learn,” he says. “In surgical care, we can actually predict outcomes based on independent review of procedure video, but we just choose not to record videos because we don’ t have the infrastructure set up to provide feedback.”

When it has been done, he says, it’ s been received with enthusiasm. This doesn’ t mean cameras in primary-care clinics monitoring physicians.

“We’ re talking about the video-based procedures being recorded, not being erased with the next procedure that’ s done,” he says. “In the past, we couldn’ t do this with videotapes, but now with the capacity of memory and video data storage, there’ s an opportunity to leave the ‘ record’ button on on the video-based procedures that are already taking place.”

Reference

1. Joo S, Xu T, Makary MA. Video transparency: a powerful tool for patient safety and quality improvement [published online ahead of print January 12, 2016]. BMJ Qual Saf,doi:10.1136/bmjqs-2015-005058.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).

The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.

About the EUA

The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.

This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.

Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).

About the test

Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.

The Zika RT-PCR test is intended for use by clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.

Within the US, positive results of this test must be reported to the CDC.

The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:

• Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
• Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
• Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
• Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.

For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).

The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.

About the EUA

The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.

This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.

Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).

About the test

Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.

The Zika RT-PCR test is intended for use by clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.

Within the US, positive results of this test must be reported to the CDC.

The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:

• Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
• Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
• Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
• Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.

For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).

The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.

About the EUA

The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.

This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.

Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).

About the test

Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.

The Zika RT-PCR test is intended for use by clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.

Within the US, positive results of this test must be reported to the CDC.

The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:

• Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
• Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
• Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
• Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.

For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.