The Pharmacist’s Role
All drugs can have side-effects that are not seen in clinical trials. Researchers at the Yale School of Medicine recently found that nearly one in three drugs approved between 2001 and 2010 had major safety issues after approval.2
Part of the problem the STAT investigation found is that many health-care providers have little idea how to handle a patient’s complaints that they are having a health problem connected to a drug they are taking. Most health-care workers either brush off the complaint or prescribe another drug. Most of the time the patient is wrong, but what about when the patient is right?
A pharmacist should remember that the FDA “views a report regarding an adverse event to be for any undesirable experience associated with the use of a medical product in a patient,” said Mohamed Jalloh, PharmD, an APhA Spokesperson and Assistant Professor at Touro University California College of Pharmacy, Vallejo, CA. “Therefore, an adverse event report may be about serious drug side effects, product use errors, product quality problems, and therapeutic failures, among other potential issues.”
The FDA told Drug Topics in an email that the agency has received around 13 million adverse event reports since 1968, and the number of reports is growing every year. Since 2013, they said, the FDA has received more than one million reports per year.
However, in spite of the vast number of reports, the FDA says that “there is substantial underreporting of adverse events.” Only about 5% of the reports the FDA receives are from patients or health-care professionals. The FDA said that it encourages health-care providers, including pharmacists, to talk to their patients about safety concerns. The majority of the adverse event reports come from drug manufacturers, because they are required by law to submit reports.
These reports are vital according to the FDA, because “in order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of suspected adverse events to conduct investigations. [The] FDA uses these data to maintain our safety surveillance of drug these products. These reports may be the critical action that prompts a modification in use of the product, improves [or] better defines its safety profile, and leads to increased patient safety and more informed use of the drug.”
To help determine if a patient is indeed experiencing adverse effects, Jalloh said that pharmacists can use the Naranjo Scale (Figure 1). This allows the pharmacist to determine the probability of an adverse reaction.
If an adverse reaction is diagnosed, Jalloh stressed that there are several options available for reporting adverse effects. The pharmacist can file FDA form 3500A for voluntarily reporting online, and patients can use form 3500B. Additionally, pharmacists can request a reporting form, then complete and mail it in, or submit it by fax.
It is important to note that the FDA does not require a causal link between the product and an adverse event to accept a report. The FDA said that “reports do not always contain enough detail to properly evaluate an event.”
Perhaps the best way to help a patient with details is to help the patient fill out a report. “The pharmacist can personally help patients report adverse effects by either contacting the manufacturer or [the] FDA on a patient’s behalf,” Jalloh said. “This will be helpful for patients who have a low health literacy or lack access for communication devices. [The] FDA’s voluntary reporting form is relatively quick to complete, but patients may not be aware of it or have difficulty completing certain questions.”
Manufacturers have requirements about what they must report to the FDA, Jalloh added, so contacting them directly could be a good option. He also added that there are websites such as iodine.com where patients can report effects, but these may or may not report adverse effects to the FDA.
Even if a pharmacist sees multiple patients suffering from the same unlabeled side-effect, Jalloh warned that he is “not aware of any mandate that requires that pharmacists must warn patients of a non-label adverse effect. If any mandate were to exist, it would likely be state specific.” Even so, he added, it would be “inappropriate” to warn a patient unless guided by an organization such as the CDC or FDA or other credible organizations.
“Personally,” he added, “it would be inappropriate to make a generalized recommendation to all of my patients based upon a few patient cases at my pharmacy—especially where the majority of other patients may not experience the same adverse event.”
1. Piller C. Hundreds died while taking an arthritis drug, but nobody alerted patients. STAT. https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/. Published June 21, 2017. Accessed June 22, 2017.
2. Downing NS, Shah ND, Aminawung JA, et al. Postmarket Safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317(18):1854. doi:10.1001/jama.2017.5150.