Patient Safety

The pharmacy news section of the MPA Web site is designed to provide members with immediate access to timely and relevant information about pharmacy and our Association. In this section, you will find information on MPA activities, Association members, the latest issues impacting the pharmacy profession and press releases from MPA and its affiliates.

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Patient Safety

Patient safety news, including recalls and safety alerts, important consumer information and updates on safe medication practices.

"Fight the Fakes" Global Drug Campaign Adds New Partners
Fight the Fakes, a global advocacy campaign to raise awareness about counterfeit medications, recently added 11 new partners, bringing the total number of member organizations to 25. The new partners, representing pharmacists, mobile app services, wholesalers, coalitions for consumer protection and generic pharmaceutical manufacturers, add to the standing partners, including health care professionals, research institutes, nonprofits and the private sector. The announcement was made following the campaigns six-month anniversary. Please visit and the Twitter page (@FightTheFakes) to learn more.
Posted in: Patient Safety
Adverse Event Reporting: A Step Toward Improving Patient Safety
by Caitlin Early, Pharm.D.

Working as an intern at a retail pharmacy over the last four years has afforded me the opportunity to practice the skills I have learned in the classroom to counsel patients on their new medications. In doing so, I spend time discussing both common and serious side effects, advising patients to contact their physician if they experience any of these symptoms as well as to call the pharmacy with any additional questions. At the end of the conversation, I smile, say goodbye and go back to my work. Throughout the 1,500+ hours I have completed as an intern, both through my job and my Advanced Pharmacy Practice Experiences (APPEs), I have counseled patients in different settings on medications representing a variety of therapeutic classes. Amongst the differences that exist between these conversations, what remains constant is my direction to patients to follow-up with their physician if they experience any adverse symptoms. Prior to last September, I had not thought twice about what happens when a patient contacts their doctor to report an adverse effect, or worse yet, if they end up hospitalized. It was not until I completed an APPE rotation at the U.S. Food and Drug Administration (FDA) that I gained a clear understanding of the MedWatch program and the impact of serious adverse event reporting.

The MedWatch system was founded in 1993 and serves as a tool for both health care professionals and the general public to report serious adverse events from both medications and medical devices. These adverse event reports are then stored into a database, the FDA’s Adverse Events Reporting System (FAERS), which currently contains more than 7,000,000 reports. It is through searching this system for patterns and associations that the FDA determines whether a safety signal exists. If a signal is found, this indicates a possible concern for an association between an adverse event and a drug, and clinical reviewers at the Center for Drug Evaluation and Research (CDER) investigate the matter further. Depending on the results of the investigation, the FDA may decide to take action by changing the wording on the drug product label, communicating safety information to the public or even removing a drug from the market.

Throughout the five weeks I spent at the FDA, the majority of my time was devoted to sifting through hundreds of MedWatch reports in order to identify the presence of a safety signal. While completing this project, I was surprised by how few reports were completed by health care professionals as well as how much valuable information was missing from the reports. In 2011, the FDA received 874,116 reports, but only 3.2 percent were reports received directly from the public through the MedWatch system. Although drug manufacturers are required to report adverse drug events to the FDA, while health care providers and patients are only encouraged to do so, the disparity in the reporting was much larger than I expected. As health care professionals, we can increase awareness about this program and participate ourselves by reporting adverse events directly to the FDA through MedWatch.

Having easy access to a serious adverse event reporting system gives us an opportunity to participate in improving patient safety. Not only can we contribute by providing complete reports with as much clinical data surrounding the event that we know, but we can also educate patients and health care providers about the program. I encourage you to familiarize yourself with the electronic form, found at, in order to educate others on where to access it and how to complete it correctly. As pharmacists, it is our responsibility to promote patient safety, and with this simple reporting system, we can utilize individual experiences to positively impact the patient population as a whole.

References available upon request from MPA office.
Posted in: Patient Safety
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