For 2013, Pharmacy Today is partnering with the National Council on Patient Information and Education (NCPIE) to bring pharmacists and other health care providers valuable counseling tips aimed at enhancing communication with patients. One of NCPIE’s key missions is to empower patients to be more informed about and active in decisions affecting their use of medicines by stimulating communication between patients and providers on the safe and appropriate use of medicines.
Each monthly column will focus on different issues that may affect patients, such as the benefits of reporting adverse events via FDA’s MedWatch, how to buy medications online safely, and the role of Risk Evaluation and Mitigation Strategies in enhancing patient safety. This month’s column deals with addressing patient concerns when medications are discussed in an alarming or sensationalist fashion by the media.
We often turn on the evening news and hear stories discussing emerging safety concerns with specific medications. Extreme examples that come to mind include the withdrawal of drugs like Merck’s Vioxx (rofecoxib) and Searle’s Bextra (valdecoxib) because of increased cardiovascular events and the restricted distribution of GlaxoSmithKline’s Avandia (rosiglitazone) for similar reasons.
More common, however, are stories that focus on negative results from a key clinical trial or the addition of a boxed warning or new precaution on marketed therapies. When patients or the caregivers of patients who are taking these medications hear these news stories, they may have numerous questions about the risks of prescribed treatments and how these new developments relate to them.
Before talking with patients, educate yourself. Understanding the data associated with a safety alert will allow providers to address patient concerns more effectively. Whether the news story is based on an FDA safety communication with a small number of patients or on a large, landmark clinical trial, evaluating the strength of the evidence will help providers put the story into a more realistic perspective for patients.
Tell concerned patients not to panic and not to stop prescribed therapies abruptly. Patients may wonder why the safety concerns came to light after FDA deemed the drug to be safe and effective. Educate them on the FDA approval and safety communication processes and inform them that studies used for approval are controlled, generally contain a limited number of patients, and usually lack long-term safety data.
Explain to patients that once a drug is approved and used by thousands of patients over a longer duration, the likelihood of detecting more rare adverse events increases. This may reassure patients, as you can explain that the safety alert may be related to a rare adverse event that only occurs in a very small percentage of patients.
If the news story is related to emerging study data, review information such as baseline demographics with patients to see if the results apply to them and discuss limitations that affect the interpretation of results. Give patients information on other published trials with differing conclusions to help them make the most educated decision about the risks and benefits of treatment.
Encourage patients to contact their pharmacist or doctor to discuss news stories about medications. Examples of questions that patients may want to ask include the following:
Patients seeking additional information can be referred to online materials, such as NCPIE’s educational resources. The brochures “Think It Through: A Guide to Managing the Benefits and Risks of Medicines” and “When You Are Prescribed an Off-Label Medicine: What You Need to Know” may be helpful when discussing safety-related news stories with patients.