FDA Patient Safety News: Show #45, November 2005

Stronger Risk Management Program for Accutane (isotretinoin)

Revised October 28, 2005: The implementation dates of the iPLEDGE program have been revised. The date by which wholesalers and pharmacies must be registered /activated in IPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed isotretinoin. Patients can begin registering and qualifying on December 30, 2005.

FDA has developed stronger requirements to prevent fetal exposure to the drug Accutane (isotretinoin) along with its generic equivalents, such as Amnesteem, Sotret and Claravis. Isotretinoin is used to treat severe, recalcitrant, nodular acne, but it can cause serious birth defects if taken by pregnant women.

These requirements are now going into effect in a new program called iPLEDGE. Under this program, wholesalers, prescribers, pharmacies and patients, both men and women, must register. Also, women who are capable of becoming pregnant must have two negative pregnancy tests before isotretinoin can be dispensed to them. They also must have a negative pregnancy test each month while taking the drug.

Isotretinoin is now a restricted distribution drug. This means that wholesalers won't be able to distribute the drug, pharmacists won't be able to dispense it, physicians won't be able to prescribe it, and patients won't be able to receive it unless they register. Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE either online or by telephone at 1-866-495-0654.

There is also a possible link between taking this drug and depression, suicidality, and psychosis. And for that reason, FDA has strengthened the labeling to help practitioners and patients identify and manage these risks.

Any patient being treated with this drug should be carefully monitored for symptoms of depression, or suicidalility or psychosis. Patients should be told to stop the drug and contact their health professional if they experience any of these symptoms. Stopping the drug by itself, however, may not be sufficient. Psychiatric evaluation and intervention may be needed to prevent patients from harming themselves.

Additional Information:

FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108473.htm


Stronger Risk Management Program for Accutane (isotretinoin)

Revised October 28, 2005: The implementation dates of the iPLEDGE program have been revised. The date by which wholesalers and pharmacies must be registered /activated in IPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed isotretinoin. Patients can begin registering and qualifying on December 30, 2005.

FDA has developed stronger requirements to prevent fetal exposure to the drug Accutane (isotretinoin) along with its generic equivalents, such as Amnesteem, Sotret and Claravis. Isotretinoin is used to treat severe, recalcitrant, nodular acne, but it can cause serious birth defects if taken by pregnant women.

These requirements are now going into effect in a new program called iPLEDGE. Under this program, wholesalers, prescribers, pharmacies and patients, both men and women, must register. Also, women who are capable of becoming pregnant must have two negative pregnancy tests before isotretinoin can be dispensed to them. They also must have a negative pregnancy test each month while taking the drug.

Isotretinoin is now a restricted distribution drug. This means that wholesalers won't be able to distribute the drug, pharmacists won't be able to dispense it, physicians won't be able to prescribe it, and patients won't be able to receive it unless they register. Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE either online or by telephone at 1-866-495-0654.

There is also a possible link between taking this drug and depression, suicidality, and psychosis. And for that reason, FDA has strengthened the labeling to help practitioners and patients identify and manage these risks.

Any patient being treated with this drug should be carefully monitored for symptoms of depression, or suicidalility or psychosis. Patients should be told to stop the drug and contact their health professional if they experience any of these symptoms. Stopping the drug by itself, however, may not be sufficient. Psychiatric evaluation and intervention may be needed to prevent patients from harming themselves.

Additional Information:

FDA MedWatch Safety Alert - Accutane and generic isotretinoin. 2005.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150553.htm


Stronger Risk Management Program for Accutane (isotretinoin)

Revised October 28, 2005: The implementation dates of the iPLEDGE program have been revised. The date by which wholesalers and pharmacies must be registered /activated in IPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed isotretinoin. Patients can begin registering and qualifying on December 30, 2005.

FDA has developed stronger requirements to prevent fetal exposure to the drug Accutane (isotretinoin) along with its generic equivalents, such as Amnesteem, Sotret and Claravis. Isotretinoin is used to treat severe, recalcitrant, nodular acne, but it can cause serious birth defects if taken by pregnant women.

These requirements are now going into effect in a new program called iPLEDGE. Under this program, wholesalers, prescribers, pharmacies and patients, both men and women, must register. Also, women who are capable of becoming pregnant must have two negative pregnancy tests before isotretinoin can be dispensed to them. They also must have a negative pregnancy test each month while taking the drug.

Isotretinoin is now a restricted distribution drug. This means that wholesalers won't be able to distribute the drug, pharmacists won't be able to dispense it, physicians won't be able to prescribe it, and patients won't be able to receive it unless they register. Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE either online or by telephone at 1-866-495-0654.

There is also a possible link between taking this drug and depression, suicidality, and psychosis. And for that reason, FDA has strengthened the labeling to help practitioners and patients identify and manage these risks.

Any patient being treated with this drug should be carefully monitored for symptoms of depression, or suicidalility or psychosis. Patients should be told to stop the drug and contact their health professional if they experience any of these symptoms. Stopping the drug by itself, however, may not be sufficient. Psychiatric evaluation and intervention may be needed to prevent patients from harming themselves.

Additional Information:

iPLEDGE Committed to Pregnancy Prevention.
https://www.ipledgeprogram.com/


Recall of Certain Injectable Drugs

Central Admixture Pharmacy Services (CAPS) is recalling certain injectable drug products because they may not be sterile. Using non-sterile injectables could lead to life-threatening patient injury or even death.

The recall covers all injectable products made by CAPS at the company's Lanham, Maryland location. They include:
• cardioplegia solutions
• oxytocin injectables
• dialysate solutions
• TPN products
• magnesium-containing injectable products
• promethazine
• bupivicaine
• diltiazem
• norepinephrine
• cefazolin
• heparin replacement solutions

The company distributed the affected products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. At this time, only injectables made at the CAPS Lanham site are included in this recall.

CAPS has directly notified known hospital customers about the recall, but FDA is urging hospitals, physicians, and health care workers to examine their supplies for any CAPS injectable products made at the Lanham, MD facility. If you have these products, stop using them immediately and quarantine them. Also, please notify FDA of any complaints or problems with these products.

Additional Information:

FDA MedWatch Safety Alert - Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153095.htm


Avoiding Fatal Errors with the Gambro Prisma Hemodialysis System

FDA has issued a Public Health Notification about the Gambro Prisma Continuous Renal Replacement System, which is used for hemodialysis in critically ill patients. Several serious injuries and deaths have occurred when health care personnel did not respond adequately to one of the system's three alarms that indicate “Incorrect Weight Change Detected.” This resulted in excessive ultrafiltration, where too much fluid was removed from the patient's body.

These alarms are intended to alert the user when a potential fluid imbalance has occurred during therapy, and both the FDA and the manufacturer are warning that you should never ignore or over-ride the alarms without first identifying and removing the cause of the alarm. If you're using one of these devices, refer to the Operator's Manual for detailed instructions on what each of the alarms means, and how to respond to it.

Additional Information:

FDA MedWatch Safety Alert - Prisma Continuous Renal Replacement System.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153047.htm


Avoiding Fatal Errors with the Gambro Prisma Hemodialysis System

FDA has issued a Public Health Notification about the Gambro Prisma Continuous Renal Replacement System, which is used for hemodialysis in critically ill patients. Several serious injuries and deaths have occurred when health care personnel did not respond adequately to one of the system's three alarms that indicate “Incorrect Weight Change Detected.” This resulted in excessive ultrafiltration, where too much fluid was removed from the patient's body.

These alarms are intended to alert the user when a potential fluid imbalance has occurred during therapy, and both the FDA and the manufacturer are warning that you should never ignore or over-ride the alarms without first identifying and removing the cause of the alarm. If you're using one of these devices, refer to the Operator's Manual for detailed instructions on what each of the alarms means, and how to respond to it.

Additional Information:

FDA Updated Public Health Notification: Gambro Prisma Continuous Renal Replacement System.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062100.htm


Recall of Trypan Blue Ophthalmic Solution

Custom RX Compounding Pharmacy of Richfield, Minnesota is recalling Trypan Blue 0.06% Ophthalmic Solution, which is used in cataract surgery. This solution may be contaminated with Pseudomonas aeruginosa. If applied to the eye, the product could cause serious infection and possible blindness.

This dark blue solution is packaged in one cc sterile tuberculin syringes, and was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, Pennsylvania and Washington D.C. If you have this product, you should stop using it immediately and return all unused syringes to the company for destruction.

Additional Information:

FDA MedWatch Safety Alert - Trypan Blue 0.6% Ophthalmic Solution.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152731.htm


Updated Cardiotoxicity Data for Herceptin

Genentech is notifying healthcare professionals about updated cardiotoxicity information related to Herceptin (trastuzumab). Herceptin is used to treat patients with metastatic breast cancer whose tumors over-express the HER2 protein.

The labeling for Herceptin already contained a boxed warning that use of the drug can result in ventricular dysfunction and congestive heart failure in some patients. Genentech's letter now provides additional information about that risk based on a preliminary analysis of data from the National Surgical Adjuvant Breast and Bowel Project. The new information includes how often these adverse events occur and when they occur in relation to starting treatment.

Additional Information:

FDA MedWatch Safety Alert - Herceptin (trastuzumab).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151512.htm


Caution on Accidentally Giving Nimodipine Intravenously

In a recent Medication Safety Alert, ISMP warns about inadvertently administering nimodipine, or Nimotop, intravenously. This has resulted in patient deaths and serious injuries. Nimodipine is a calcium channel blocker that's used to prevent vasospasm in patients with subarachnoid hemorrhage.

Nimodipine capsules are given by mouth, but for patients who can't swallow, the contents of an oral capsule can be extracted into a syringe and then injected into the nasogastric tube.

Although putting it into an NG tube is still not the same as giving it IV, once it’s in a parenteral syringe, accidents can happen. ISMP notes that several incidents have occurred when a patient has been injected IV, and then suffered severe hypotension, cardiac arrest, and death.

ISMP recommends that pharmacists warn patient care personnel about the danger of IV administration each time nimodipine is dispensed. ISMP also notes that some pharmacies are trying to prevent this problem by preparing nimodipine in advance for patients who can't swallow, rather than having it prepared in the patient care area. They're packaging the drug in amber oral syringes, and labeling them “for oral (NG) use only.”

Additional Information:

ISMP Medication Safety Alert - Take steps to avoid inadvertent IV administration of nimodipine. July 28, 2005.
http://www.ismp.org/MSAarticles/calendar/July05.htm#28


Packaging Change for NovoLog Products to Help Prevent Mix-ups

Novo Nordisk recently notified pharmacists about a packaging change that's designed to help prevent mix-ups when dispensing two of the company's insulin products: NovoLog, a rapid-acting insulin analog, and NovoLog Mix 70/30, a premixed insulin analog.

Until recently, the packaging for NovoLog and NovoLog Mix 70/30 looked very similar. Both boxes were white with a blue band. The current packaging for NovoLog Mix 70/30 looks similar to the previous packaging and it remains white with a blue band. But the packaging for NovoLog has been changed to white with an orange band.

The company's letter also makes several recommendations to help pharmacists avoid dispensing errors. For example, if you remove the insulin from the box for any reason, be sure to put it back in the exact same box. Store medications with similar names separately from one another. Ensure that patients know the insulin name and type that was prescribed for them. And then have patients check the name and type when picking up their prescriptions.

Additional Information:

FDA MedWatch Safety Alert 2005 - NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])/NovoLog (insulin aspart [rDNA origin] injection).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151948.htm


What to Tell Patients about Flu Vaccine

There are two types of flu vaccine available: the traditional flu shot, given intramuscularly, which contains killed or inactivated virus, and a nasal spray, which contains attenuated live virus. The injection is approved for various ages and population groups, but the nasal spray is approved only for healthy people between the ages of 5 and 49.

Patients sometimes ask why the supply of vaccine during each year's flu season seems so unpredictable, and shortages sometimes arise. Part of the reason for this is because the virus mutates making each year's vaccine different from preceding years. That means that a batch of vaccine can't be kept and used the following year. Early each year, a public health committee has to decide which three strains of the virus will be included in that year's vaccine. The goal is to be sure that the strains in the vaccine are similar to the ones that will be in circulation for that particular flu season.

To complicate the picture, it takes at least six months to produce a flu vaccine using the present method, which involves using millions of live eggs to grow the virus. In the future, we hope that new methods using cell cultures or recombinant protein, or DNA-based vaccines, will make the process shorter, but it will be years before those technologies can be used to mass-produce a flu vaccine.

While it's still too early to predict how much vaccine will be available for the upcoming flu season, FDA recently approved a new inactivated vaccine called Fluarix for immunizing adults 18 and older. This will offer an additional vaccine supplier for the upcoming flu season and help increase the number of doses available.

Additional Information:

CDC – Influenza Prevention and Control.
http://www.cdc.gov/flu/


Preventing Bleeding with Vacuum-assisted Wound Closure

Vacuum-assisted wound closure, also known as negative pressure wound therapy, can help heal certain non-healing wounds by removing fluids and infectious material from the site. The therapy is applied to a special foam dressing packed in the wound cavity or over a flap or graft. A recent FDA article in Nursing2005 highlights the importance of carefully selecting and monitoring patients being treated with this therapy.

The article describes a patient who had his leg amputated after being seriously injured in a fall. During his recovery, he was prescribed anticoagulants to prevent venous thromboembolism. Two weeks after the amputation, he began treatment with vacuum-assisted wound closure to promote healing.

During a dressing change while undergoing the therapy, he experienced serious bleeding from several areas in the wound. He later died, reportedly from severe hemorrhage and possible acute myocardial infarction. Further follow-up revealed that complications associated with bleeding had begun at the time of surgery, before the vacuum-assisted closure therapy was started.

The article lists several precautions to help prevent this kind of bleeding in patients undergoing vacuum-assisted wound closure therapy. For example, certain patients should be closely monitored for overt and occult bleeding. This includes those who are actively bleeding, on anticoagulants, or who have weakened, irradiated, or sutured blood vessels or organs that are close to the wound.

Use protective barriers such as gauze impregnated with petrolatum to protect vulnerable blood vessels or organs. And follow the device manufacturer's instructions for use, including selecting the correct negative pressure recommended for that type of wound.

Additional Information:

Malli, S. "Keep A Close Eye On Vacuum-Assisted Wound Closure". Nursing2005 35(7).
http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/UCM070192.pdf


Caution on Accidentally Giving Nimodipine Intravenously

In a recent Medication Safety Alert, ISMP warns about inadvertently administering nimodipine, or Nimotop, intravenously. This has resulted in patient deaths and serious injuries. Nimodipine is a calcium channel blocker that's used to prevent vasospasm in patients with subarachnoid hemorrhage.

Nimodipine capsules are given by mouth, but for patients who can't swallow, the contents of an oral capsule can be extracted into a syringe and then injected into the nasogastric tube.

Although putting it into an NG tube is still not the same as giving it IV, once it’s in a parenteral syringe, accidents can happen. ISMP notes that several incidents have occurred when a patient has been injected IV, and then suffered severe hypotension, cardiac arrest, and death.

ISMP recommends that pharmacists warn patient care personnel about the danger of IV administration each time nimodipine is dispensed. ISMP also notes that some pharmacies are trying to prevent this problem by preparing nimodipine in advance for patients who can't swallow, rather than having it prepared in the patient care area. They're packaging the drug in amber oral syringes, and labeling them “for oral (NG) use only.”

Additional Information:

FDA MedWatch Safety Alert 2006 - Nimotop (nimodipine).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150728.htm



FDA Patient Safety News is available at www.fda.gov/psn