Anecdotal evidence can be valuable evidence. The Epilepsy Foundation (in the United States) conducted an online survey to gather input on what people experienced after their drug prescriptions were changed. The purpose wasn't to get a representative sample -- it was to get specific examples to include with a set of policy recommendations. Results appear in the report In Their Own Words: Epilepsy Patients’ Experiences Changing The Formulation of The Drugs They Use to Prevent Seizures: Findings from the Epilepsy Foundation's Survey of Patient Experiences, Nov 2006- Mar 2009 (17-page pdf).
More than 1,000 epilepsy patients (and parents of children with epilepsy) participated in the web survey. They raised numerous issues, including problems that arise when prescriptions are changed without the knowledge of patients -- or their physicians. (Epilepsy and seizures affect millions of Americans, often with debilitating consequences. As a volunteer, I advise the Epilepsy Foundation of Colorado on technology strategy. If you're looking for a cause to support, this one is very worthwhile.)
In their own words. The report says people "have for years reported experiencing seizures and other harmful side effects after switching from one version of an anti-epileptic drug (AED) to another, whether the switch was brand-to-generic, generic-to-brand, or generic-to-generic. By law, the amount of medication delivered by one AED may differ from the amount delivered by another AED that the FDA deems 'equivalent,' and it may deliver the medication at a different rate. Amid growing evidence that these variations, however slight, can mean the difference between controlled epilepsy and breakthrough seizures or other negative consequences, the Epilepsy Foundation asked to hear patients’ experiences."
Combining anecdotes with formal research. Along with survey responses, the report includes numerous references to more traditional evidence that supports the foundation's recommendations. I think it's an interesting approach -- the quotes from patients may be anecdotal evidence, but they *are* hard evidence. Clearly there can be hidden costs, and not-so-hidden consequences.
The survey responses revealed that::
- 15% of those who reported switching from a generic to a brand-name AED reported worse seizures; 18% reported worse side effects.
- 59% of respondents who switched from a brand-name to a generic reported worse seizures; 49% reported worse medication side effects.
- Over 25% of participants reported problems when switching between different generic formulations.
Research and policy recommendations. The report includes several specific recommendations for U.S. policymakers and also for patients, pharmacists, and health care providers. These include:
- FDA should research whether brand-name and generic AEDs are truly therapeutically equivalent. Methodology considerations should include determining whether test groups appropriately represent the patient population, and requiring individual bioequivalence measures.
- FDA should "require drug manufacturers to make all the bioequivalence information of their generic and brand-name AED products available to physicians the scientific community" and to "carry out post-marketing surveillance for all generic and brand-e AEDs, and should take all necessary steps to ensure broader reporting of adverse reactions to switching."
- Patients and pharmacists should discuss with physicians the appropriateness of substitution before switching among different versions of the same AEDs. Patients should provide informed consent prior to any change in medication. Pharmacists should be educated on the unique nature of epilepsy, and the need for caution when switching AEDs.
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