Responding to FDA Alerts: How to Reduce Risks and Liability

May 2008, Vol 1, No 4 - Meeting Highlights, Conference Highlights AMCP
Sandy Paton
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Based on a presentation by Kathleen Orrico, PharmD, at the Academy of Managed Care Pharmacy Annual Meeting, April 17, 2008, San Francisco, CA.

Snafu, a common term used to describe a situation marked by error or confusion, has been adopted by the Palo Alto Medical Foundation as the title of a committee dedicated to reducing risks and liability by providing prompt response to US Food and Drug Administration (FDA) drug safety warnings, medical product recalls, and other drug and device safety issues. Through their Safety, Notification, and Follow-up (SNAFU) Committee, the Palo Alto Medical Foundation serves as a conduit for these FDA alerts to pharmacists, physicians, and patients.

The SNAFU Committee is made up of pharmacists, physicians, directors of materials management and clinical services, nursing and patient safety officers, and public relations department to address toxicity issues (both possible and probable) and device warnings. The selection of committee members was based on constructing a global view of safety activities.

The process begins by reviewing the FDA MedWatch alerts to determine how and where to disseminate information that will contribute to patient safety. Only alerts worthy of notice are sent to avoid unnecessary noise. Email conversations are initiated as soon as an alert is identified. A plan can then be quickly developed and an action voted on. For example, when the MedWatch Public Health Advisory posted a problem concerning liver toxicity associated with telithromycin (Paxil) in 2006, the SNAFU Committee had first to determine the extent of risk to the patient population, which prescribers and patients to notify, whether specialists should be involved, and what materials should be developed. The time to implement these tasks was an important part of the picture, including whether preventive action should be taken. The chosen plan of action included an e-mail alert to member physicians, who could then decide the next course of action based on their patient base. In matters of pressing issues, phone call follow-ups are also conducted, alerting physicians to check their websites and Outlook postings. In this case, a follow-up e-mail further recommended avoiding use of the drug. After the 2 warnings, alerts were issued. Only 4 patients met Palo Alto's internal guidelines for antibiotic failure and multi-drug resistance. Of 21 patients who received telithromycin, 13 had received it as a sample.

This finding prompted further scrutiny into why a broad-spectrum antibiotic was being sampled in the first place. The SNAFU Committee recommended that such samples be disallowed and requested that the Pharmacy & Therapeutics (P&T) Committee add this prohibition to the sample policy.
 

Provider, Patient Notification


Information imparted to providers must be concise, offer important facts, and suggest a course of action and support tools. In addition, it must be determined "who needs to know." The Committee is rarely hampered by privacy concerns based on Health Insurance Portability and Accountability Act compliance issues. Thus, when patients need to know, patients are notified. At times, however, there are areas of sensitivity. For example, when paroxetine was contraindicated in pregnant women, notification was sent to all women of possible childbearing age (12 to 55 years). They attempted to cast a wide net to patients but a narrow net to providers. Patients were advised to self-monitor for signs and symptoms. Only 1 pregnant woman was taking paroxetine. The overall goal was to reduce the possibility of harm to a patient and lessen the risk of liability to the medical group.
 

Implementing a SNAFU


Assigning committees already in existence (eg, P&T, patient safety, drug information service) to assist in the effort is recommended. Each person would receive and review the MedWatch E-List (Listserv) notifications. They would also subscribe to the automatic message-delivering system sponsored by the National Institutes of Health (http://www.fda.gov/medwatch.elist.html). Patients can be alerted to the process by website postings, newsletters, letters, emails, or handouts at the point of care.

Dr Orrico urges organizations to map out an internal communication plan to ensure a consistent message to patients and staff, including front-line personnel. Materials should be richly referenced and MedWatch findings should be incorporated into the process. The importance of maintaining current distribution lists should be emphasized. As a plan of action, allowing MedWatch to do the work is suggested; let them sort out the problems, but make noise as you notice possible problems in the workplace such as fatalities, increased hospitalizations, and medically significant events.

Adverse events can also be reported to the Vaccine Adverse Event Reporting System (www.fda.gov/medwatch.elist.html), the United States Pharmacopeia and Institute for Safe Medication Practices (www.ismp.org), the pharmaceutical company itself, and the in-house risk manager.

Important recommendations include signing up for the MedWatch Listserv, booking an appointment to check and read the MedWatch site weekly, knowing the drugs used in your organizations daily practice, and, first and foremost, thinking preventatively (ie, determining which measures might be put in place to reduce risk).

Reporting unsafe practices, citing heparin vials that look identical; scrutinizing off-label usage of drugs; and following evidence-based guidelines (eg, maintaining recommended hemoglobin/hematocrit levels for erythropoietin) are further encouraged.

Table
Table

Identifying patients affected by a drug or a device is not an easy task, and keeping track of sampling is important. If at all possible, Dr Orrico urges providers to document distribution of samples on electronic health records. Having a log of who has received a sample can save time and energy later. Maintaining effective communication is essential. In 2007 alone, there were more than 150 safety alerts for drugs and biologics, medical devices, and dietary supplements (Table), and the number of MedWatch postings is increasing dramatically every year.
 

 

Recommendations Summary


It is important not to hurry an investigation or rush needlessly into action. The following actions are recommended:

  • Overcommunicate to be on the safe side, but be sure the message is well crafted
  • When necessary, convene your SNAFU Committee quickly either by phone, e-mail, or in person
  • For large issues, use a tracking form to avoid missing or overlooking loose ends
  • Create a searchable and accessible electronic health record
  • Have a wide array of expertise to call on
  • Always hold a debriefing session with your committee.

Knowing what patients want and what makes sense to them adds to the success of a program.


Kathleen Orrico, PharmD, is Health Sciences Assistant Clinical Professor, University of California at San Francisco.

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