Drug Safety Oversight Board Meeting, June 16, 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 May 19, 2011 meeting. The following is a list of the posted risk communications:

Drug Safety Communications Posted since the May 19, 2011 meeting:

• 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 (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease
• June 15, 2011: Actos - The U.S. Food and Drug Administration (FDA) issued a communication informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
  
• June 13, 2011: Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip): FDA issued a communication alerting the public to medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized
• June 9, 2011: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer: FDA issued a DSC informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI)class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer.
• June 8, 2011: Simvastatin - New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury: FDA issued a DSC recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80mg) because of the risk of muscle damage. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).
• June 2, 2011: Angiotensin Receptor Blockers - No increase in risk of cancer with certain blood pressure drugs: FDA completed a review of the potential risk of cancer associated with a class of medications known as angiotensin receptor blockers (ARBS). FDA has concluded that treatment with an ARB medication does not increase a patient’s risk of developing cancer.
• May 31, 2011: Drospirenone - Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone: FDA issued a DSC informing the public about new information that is being assessed as part of FDA’s on going safety review of birth control pills containing drospirenone. This review will further evaluate the risk of blood clots in women who use these products.
• May 18, 2011: Rosiglitazone - Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl: FDA issued a DSC informing the public of new restrictions to the prescribing and use of rosigilitazone-containing medicines. These medicines treat type II diabetes and patients and healthcare providers must enroll in a special program in order to receive and prescribe these drugs

The DSB conducted a business meeting and discussed four topics:
1.  A Draft Drug Safety Communication
2.  2-year follow-up of DSB Meetings and Board Recommendations
3.  The DSB Path Forward and Potential Topics for Discussion
4.  Abstral REMS

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

Draft Drug Safety Communication (DSC)

The board discussed a draft DSC involving medication used in the treatment of anemia in patients with chronic kidney disease.

2-year Follow-up of DSB Meetings and Board Recommendations

Board members reviewed the topics discussed at DSB meetings since September 2009, including recommendations from the board and subsequent follow-up by FDA. The DSB staff discussed highlights from the October 2010 meeting in which the board discussed Patient Medication Information (PMI) and a separate topic, Pre-filled Glass Syringes and Incompatibility with Certain Intravenous Connectors.

Regarding Patient Medication Information (PMI), the Board discussed background and follow-up considerations since the October 2010 meeting, including:

• the role for web-based PMI in addition to printed material handed to patients about their medication
• a potential pilot program of single-document PMI
• the need for an assessment plan to see if single-document PMI is useful to patients
• personalized PMI, and the advantages and challenges it might create. An advantage might be clarity and a better understanding for the patients and a challenge might be that personalized PMI is not universal and should not be shared
• the role of Medication Guides with single-document PMI
• Interactions with the Engelberg Center for Health Care Reform, a Brookings program, on PMI: http://www.brookings.edu/events/2011/0223_PMI_pilots.aspx

Regarding Pre-filled Glass Syringes and Incompatibility with Certain Intravenous Connectors, the Board discussed background and follow-up considerations since the October 2010 meeting including:

• a November 2010 Letter to Stakeholders describing the problem with some pre-filled glass syringes and a potential alternative
• a Drug Safety Communication released on May 6, 2011 in which FDA noted that it had received additional reports of clogging and malfunction with some pre-filled glass syringes with adenosine and amiodarone

DSB Path Forward and Potential Topics for Discussion

Board members offered suggestions for topics to discuss at meetings in the next year. Areas considered included:

• Communications, including areas of best practice from other agencies, how to assess the impact of communications, and sharing of drafts
• REMS-related topics, including assessments of REMS effectiveness and advertisements for drugs with REMS
• Drug-related topics of interest to other government healthcare agencies
• Topics with broad impact on Safe Use of drugs

Abstral REMS

The Board heard a presentation on the Abstral REMS program, including the challenges associated with ensuring the safe use of Abstral, a potent transmucosal opioid (fentanyl) drug. FDA approved Abstral on January 7, 2011 with a REMS program to ensure safe use of the drug and to reduce the chance for abuse or misuse. The Federal Partners considered some questions regarding their experiences with the Abstral REMS program and will provide follow-up for FDA.

The Board discussed the following:

• Background information regarding the Abstral REMS program
• The goals of the Abstral REMS program, which is designed to enhance safe use of Abstral and reduce abuse and misuse
• The concept of a “pharmacy switch” which facilitates communication with the dispensing pharmacy and the Abstral REMS Program
• The sponsor’s role in the Abstral REMS Program
• The concept of “hard stops” and “soft stops” in the chain of pharmacy practice management systems from the time the patient is given a prescription for Abstral to when the patient receives the medication. A “soft stop” provides an alert to a pharmacist, while a “hard stop” requires that the pharmacist take action (e.g., to review the prescription and make sure all requirements of the pharmacy benefit management system and the REMS program are being fulfilled).
• Identifying potential barriers to patient access to Abstral in integrated pharmacy systems, such as with some government healthcare facilities
• Potential solutions to any barriers to patient access to Abstral
• 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