Glastonbury woman advocating for the increased timely awareness and communication of FDA postmarketed prescription label warning updates.

Stacy Abbott, RDH has joined forces in collaborating with the FDA MedWatch program and is currently training as an FDA Patient Representative that will serve on their numerous advisory committees, consult for their review divisions and act as a presenter of regulatory health policy issues.  As part of the Office of Health Constituent Affairs, the network was created in 2012 through the FDA to help patients, patient advocates, and health professionals connect with FDA science and policy staff.  She is particularly looking forward to working with the Advanced Regulatory Science Initiative that was launched in February of 2010, and to help promote advanced patient care in regards to more timely awareness and communication of postmarket drug safety/warning updates and labeling.  She is also communicating with the American Society of Health System Pharmacist's (ASHP) in Bethesda, Maryland whose organization shares the common goal of actively seeking the FDA to change the way it classifies postmarketing safety issues.

This need for change is now.  At the end of August 2012, the FDA's Adverse Events Recording System(AERS) has logged over 7 million adverse events since 1969, with an increased prevalence each year.  According to the AERS 2010 report of data collected over a 10 year period between 2000-2010, there is a demonstrated  marked 66.7% increase in deaths, and a 77.5% increase in serious adverse reactions to prescriptions.   These statistics are increasing annually with 2nd quarter reports dated Jan 1-June 30 2012 recording 540,381 events and a projected annual figure to be over a million for that same year.  This represents a significant public health problem that is, for the most part, preventable.

Ms. Abbott's committment is initiated by her own recent experience of having had several interactions with a  prescription generic drug she had been taking over a several year period.  Unknowingly, it wasn't until a year after taking the medication that the 1st FDA postmarket toxicity warning came out on the precription she had been taking.  By this time she had already experienced what appeared to be 2 separate unrelated concomitant reactions where her prescription interacted with common OTC medicine.  When her medical records were reviewed, a pattern of reactions became evident most recently.  Having had 2 reactions several years back, and then 2 just recently-this time within a week of each other.  These new reactions made clear the similarity of the adverse interactions.  A second ER visit confirmed she was experiencing a drug interaction similar to a previous ER visit several years ago when she had taken certain common OTC remedies(different each time), while also taking her generic prescription.

She later found out that there were 2 additional warnings posted in 2011, and 2012 by the FDA on her prescription for the toxic syndrome she was experiencing(which at the time of interaction temporarily results from an overstorage of the drug in the body).  This may not necessarily be recognised in some cases until the signs and symptoms become a pattern or repetitious.  The FDA Medwatch system also tracks and looks for such patterns when considering changes to a drug's labeling system regarding its safety.

This is why it is so critical to report any adverse reactions immediately to your physician.  Stacy feels fortunate that her reaction was reversible once the interaction period ended.  Her formal complaint has been filed with the FDA MedWatch program as well as the prescription manufacturer in regards to her reactions.

It is expected with  the launching of Obamacare that there will be a greater use of generic drugs.  About 80% of US prescriptions are filled with generic medicine.  In June of 2013, the US Supreme Court ruled in a narrow margin of 5-4,  that generic drug makers cannot be sued under state law for adverse drug reactions.   Prior to this, a 2011 ruling also found that pharmaceudical companies that make branded drugs are liable for inadequecies in saftety warnings of a medicine's label, but not the makers of generics(cheaper copies) of those drugs.  A response  from the American Association of Justice called this ruling "disasterous" for consumers, and the groups President Gibson Vance's response was that "patients will now be taking generic drugs at their own risk".   The Public Citizen's Health Research Group also stated in an interview in response to this, that the "court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillence system in place to detect adverse events that pose a threat to patients." Stacy adds that there are several internet sites that offer services to track drug safety trends.  Since the alerts in the United States come from the FDA, she encourages their free of charge service to consumers through it's Medwatch system where you can sign up for these up to the minute alerts.