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CDER 2007 Update
Modernizing Drug Safety
We take very seriously our response to safety-related issues raised by consumers, health professionals and academic researchers. We use emerging science and technology to develop better tools for our drug safety program. We are strengthening the drug safety system with three key efforts in science, communications and operations.
Strengthening the science of drug safety
- We are developing scientific approaches to detecting, understanding, predicting and preventing adverse events.
- We are developing and incorporating quantitative tools in the assessment of benefit and risk.
- We are conducting a pilot program to review the safety profiles of selected new molecular entities on a regular basis.
Improving communications
- We are conducting a comprehensive review of current public communication tools and developing a comprehensive risk communication strategic plan.
- We conducted focus group testing with consumers and pharmacists of our risk communication tools.
- We issued a guidance document, “Drug Safety Information-FDA’s Communication to the Public,” in March 2007 which describes our current approach to communicating drug safety information to the public.
- We plan to conduct assessments of the effectiveness of specific risk minimization action plans.
- We established a new advisory committee to help improve communication of drug risks to the public.
Improving operations and management
- We have engaged external management consultants to help us develop a comprehensive strategy for improving organizational culture.
- We made specific organizational and management changes to increase communications among review and safety staff. We have pilot programs to involve safety experts in the application review process.
- We have a central tracking system that enables staff to track the progress and outcome of safety evaluations.
- We created an associate center director position for safety policy and communication, and elevated the Office of Surveillance and Epidemiology to report directly to the center director.
- We are improving the use of advisory committees, including making the selection process of committee members more transparent.
Our response to Institute of Medicine (IOM) report
We requested in 2005 that the Institute of Medicine convene an expert panel to assess the U.S. drug safety system and to make recommendations to improve risk assessment, surveillance and the safe use of drugs. The IOM report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, recognizes specific progress and reform already underway and makes substantive recommendations about additional steps to improve our drug safety program.
In January 2007, we completed our review of the IOM recommendations and issued a response to each of the recommendations. One example of the more than 40 improvements underway is our Risk Communication Advisory Committee (RCAC) comprised of highly qualified individuals who are mostly academicians, several of whom are familiar with the perspectives of patients, consumers and health-care professionals. Recommendations from RCAC will play a vital role in helping people understand and appropriately respond to our health messages. This understanding will significantly bolster our capacity to protect and promote public health.
Drug Safety Communication Channels
We use a broad range of methods to communicate drug safety information to the public. Some of our most common forms of communications are:
- Professional labeling for prescription drugs. Summary of essential information needed for the safe and effective use of a drug by health-care providers.
- Patient-directed labeling for prescription drugs (patient package inserts and Medication Guides). Summary of essential information needed for safe and effective use of the drug by patients.
- Over-the-counter “Drug Facts” labeling. Summary of essential information needed for the safe and effective use of a drug by consumers.
- Public health advisory. Information and advice regarding an emerging drug safety issue or other important public health information targeted to the general public.
- Patient information sheet. Concise summary in plain language of the most important information about a particular drug. Includes an alert when appropriate to communicate an important and often an emerging drug-safety issue to patients, consumers, lay caregivers and interested members of the general public.
- Health-care professional sheet. Concise summary of an important, and often emerging, drug safety issue, with background information about the detection of the issue and points to consider for clinical decision-making by health-care professionals
- Alerts on patient information and health-care professional sheets. Summary of an important and, often, emerging drug-safety issue. Alerts are tailored to the needs of the primary target audience for each type of information sheet. Health-care professionals, patient, consumers, lay caregivers and interested members of the general public require this information.
Prescription drug information
We strive to make prescription drug information more useful and available by using:
- Revised format for prescription drug labeling. Our January 2006 final regulation amends the content and format of information in professional labeling for prescription drugs, commonly called the package insert. The new label provides the most important information about new and recently approved prescription drugs and new uses in a format that is better understood, easily accessible and easier for physicians to remember.
- DailyMed public database of drug information. TheNational Library of Medicine will provide an up-to-date electronic repository of all medication labeling so that physicians will have easy access to the latest labeling.
- Electronic submission of drug labeling. This allows physicians to quickly search and access specific information they need before prescribing a treatment.
Medication guides
Medication guides are printed information sheets dispensed with some prescription medicines to help patients avoid serious adverse events.
We require medication guides when we determine that any or all of these apply:
- The information is necessary to prevent serious adverse effects.
- Patient decision-making should be informed by information about a known serious side effect.
- Patient adherence to directions for using a product is essential to its effectiveness.
Public health advisories and early communications in 2007
We issued 16 public health advisories and early communications to alert health-care providers and consumers about:
- The dangers, including death, of using topical anesthetics for cosmetic procedures.
- A study that was stopped early because interferon gamma 1b did not help idiopathic pulmonary fibrosis patients.
- Patients who receive erythropoiesis-stimulating agents may have a higher chance of serious and life-threatening side effects including death.
- Pergolide being withdrawn from the market due to the potential for heart valve damage.
- Zelnorm being withdrawn from the market due to the chance of heart attack and stroke.
- Caution using cough and cold products in children under 2 years of age, and the need to properly measure liquids and follow label directions.
- The possibility of heart problems in patients taking proton-pump inhibitors, omeprazole and esomeprazole. Later data showed that the risk of heart problems was not confirmed.
- The increased risk of morphine overdose in infants of nursing mothers taking codeine who are rapid metabolizers.
- The report of a death of a patient with cystic fibrosis who inhaled colistimethate, an antibiotic made for intravenous use, that was compounded by a pharmacy.
- Reports of deaths and life-threatening side effects in patients who incorrectly used buccal fentanyl tablets.
- The possibility of an association between the use of bisphosphonates, drugs used to treat osteoporosis and atrial fibrillation.
- Results of a study that showed patients who receive the antibiotic cefepime may be at increased risk for death compared to patients who receive similar antibiotics.
- Reports of suicidal thoughts, aggressive and erratic behavior, and drowsiness in patients who have taken varenicline.
- Important information on the safe use of the fentanyl transdermal system to minimize the possibility of life-threatening side effects and death.
Podcasts of public health advisories
We are now broadcasting audio versions of our public health advisories. Our advisories are short, to the point, fact-based and provide emerging safety information about drugs.
In 2007, we produced 12 podcasts. These audio advisories serve as an alternative to finding this information on our Web site, reading about it in the newspapers or hearing about it from patients.
Patient Safety News broadcasts of public health advisories and early communications
FDA Patient Safety News is a televised series for health-care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It is also available on FDA’s website. The subjects of some stories are the emerging safety information about drugs described in our public health advisories and early communications.
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Date created: July 31, 2008 |
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