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Drug Safety Oversight Board Meeting, July 21, 2011

Public Summary

The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on Drug Safety Communications posted and in development since the June 16, 2011 meeting. The following is a list of the posted risk communications:

Drug Safety Communications Posted since the June 16, 2011 meeting:

  • July 18, 2011: CardioGen-82: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans: FDA issued a DSC alerting the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82. FDA received reports of two patients who received more radiation than expected from CardioGen-82; the excess radiation was due to strontium isotopes which may have been inadvertently injected into the patients due to a “strontium breakthrough” problem with CardioGen-82. http://www.fda.gov/Drugs/DrugSafety/ucm263112.htm
  • July 11, 2011: Tamiflu: Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension: FDA issued a communication informing the public of important product safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension.  These changes are being made to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.   http://www.fda.gov/Drugs/DrugSafety/ucm261686.htm
  • June 30, 2011: Valproate: Children born to mothers who took valproate products while pregnant may have impaired cognitive development: FDA issued a communication informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproate acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.    http://www.fda.gov/Drugs/DrugSafety/ucm261543.htm 
  • June 24, 2011: ESA’s: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease: FDA issued a communication informing healthcare professionals of modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) to improve the safe use of these drugs. http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm 
  • June 16, 2011: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease: FDA issued a communication notifying the public that the smoking cessation aid Chantix (varencline) may be associated with a small, but increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.  http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm     

The DSB discussed four topics:

  1. MedWatch: Translating Drug Safety Communications into Patient Safety
  2. Recalls and Notifications
  3. REMS and the Federal Partners
  4. The Health Resources and Services Administration’s Role in Healthcare Delivery

The views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency or institution.


The Board heard a presentation from the director of FDA’s Office of Special Issues regarding background and current information about MedWatch, which communicates drug, device, and biologic safety alerts to healthcare professionals and the public. There are now about 15 MedWatch alerts per month plus about 50 drug safety labeling changes per month.  Alerts provide timely, actionable safety information to the MedWatch e-list of about 200 000 subscribers based on reports voluntarily submitted via Form 3500 and from other sources of benefit-risk data.  In addition, the alerts are often transmitted through secondary sites such as Medscape, Drugs.com and others.

The board invited two guest experts for the MedWatch topic: Joyce Generali, clinical professor and Director of Drug Information at the University of Kansas Hospital and Cynthia Reilly, Director of the Practice Development Division of the American Society of Health-System Pharmacists (ASHP).

Joyce Generali spoke about how the University of Kansas Hospital, an academic medical center, receives MedWatch communications on drug safety issues and translates them into drug safety programs in the hospital. She noted that the medical center receives non-FDA and MedWatch safety alerts, and then stratifies the alert into an action status or a notification-only status. A global action plan involving the information technology pharmacy group and a clinical decision support committee help with both an outpatient and inpatient plan to address the drug safety alert. Links are embedded in the formulary web system that may be drug-specific links to MedWatch Alerts or an RSS feed regarding the MedWatch Alerts. A Pharmacy and Therapeutics Committee issues a monthly report of the MedWatch Alerts. A follow-up blog or newsletter and a reminder email notification are also utilized. Some recent examples that required coordinated communications across the medical center involved Simply Thick, a medical food product now contraindicated for use in premature infants, and simvastatin, a widely-used statin drug with new restrictions, contraindications and dosage limitations.

Joyce Generali also noted how the University of Kansas Hospital incorporates MedWatch alerts regarding drug labels into its comprehensive boxed warning website.  The website, developed in 2001, reflects FDA’s boxed warnings, Medication Guides, and REMS programs:  http://blackboxrx.com disclaimer icon

Cynthia Reilly discussed how the ASHP incorporates MedWatch communications into publications and communications to its 35 000 members representing hospital and health-system pharmacists, residents, and students. She noted that pharmacists submit about 20 000 MedWatch reports every year, some through a direct link to MedWatch on the ASHP website. The American Hospital Formulary Service (AHFS) is an evidence-based reference available in print, electronic and web-based formats as a compendium for medically-accepted uses of medications through federal legislation under Medicare and Medicaid programs. ASHP uses MedWatch notices to revise the content to AFHS publications for professionals and consumers. The ASHP targets information from MedWatch notices and amplifies it by sending it to specific member areas of ASHP, such as clinical specialists, inpatient and ambulatory care practitioners, via e-newsletters and special alerts. Some recent examples of MedWatch communications amplified by the ASHP to their members are the recall of an erythropoietin stimulating agent due to contamination with glass flakes, and the simvastatin drug label changes noted above. 

The Board discussed the following:

    • An overview of the MedWatch Program, how it has evolved since its inception, and potential future directions
    • The types of incoming reports: serious adverse events, product quality, medication and device errors, and therapeutic failures
    • How MedWatch safety alerts are amplified by various individuals within healthcare settings and professional organizations
    • How packaging and rapid releasing a drug or device safety communication as a MedWatch safety alert can help promote patient safety, as exemplified within an academic medical center  

Recalls and Notifications
The Board heard presentations from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) regarding recalls and the notification about those recalls to healthcare professionals and the public.
The Board discussed:

  • The types of drug and device recalls and where recalls may be found on the FDA website:
  • The classifications of drug and device recalls as Class I, II, or III and how these may be communicated to the public through MedWatch
  • How a recall differs from a market withdrawal and how understanding the root cause for a recall can help FDA convey meaningful feedback to industry
  • The top reasons for drug recalls, such as deviations from good manufacturing processes, impurities and degradation of the drug product, and lack of assured sterility
  • The top reasons for device recalls, such as battery failure, alarms don’t sound, software errors, leaking of tubing or a container, too much radiation exposure (e.g. with an xray machine)
  • The role of policy and precedent in determining the class of a device recall
  • The role of a Health Hazard Evaluation in assessing the risk to a patient if a device is defective

REMS and the Federal Partners

The Board heard a presentation on the REMS program, including the challenges associated with ensuring the safe use of the drugs with Elements to Assure Safe Use (ETASU).  The Federal Partners considered some questions regarding their experiences with the REMS program and provided follow-up for FDA.

The Board discussed the following:

  • Background information regarding the REMS program, including Elements to Assure Safe Use (ETASU)
  • The goals the REMS ETASU , including to assure access and minimizing the burden on patients and providers while making use of the drug safer
  • The various aspects of implementation systems related to ETASU, which may include certification of pharmacies and hospitals
  • The concerns and suggestions about the REMS from patients, providers, and healthcare systems. Some of the concerns including the growing number of REMS, no compensation for complying with REMS, and privacy issue. Some suggestions include standardizing the REMS so they are not all unique, and integrating the REMS into existing healthcare systems
  • The elements and various challenges and successes with REMS for the Transmucosal Immediate-Release Fentanyl (TIRF) products, Erythropoeitin Stimulating Agents (ESAs), and the ambrisentan (Letairis) REMS
  • A framework for standardizing REMS, for example including articulating criteria for determining whether a REMS is needed and what elements are needed and integrating REMS into electronic health records (EHR) and e-prescribing
  • How prescribing and dispensing of medications are integrated in many areas of the healthcare environment, but various inpatient and outpatient systems may operate differently, which presents challenges but also opportunities for assistance in implementing REMS programs 
  • How to develop and communicate about metrics for assessing the success of a REMS program in enhancing safe use of a drug

The Health Resources and Services Administration’s (HRSA) Role in Healthcare

The Board heard a presentation about the Health Resources and Services Administration and their role in healthcare delivery across the nation. HRSA provides healthcare services to for people who are uninsured, isolated or medically vulnerable.