StreetRx at the 2014 National Harm Reduction Conference
Mike and Nab recently joined a panel at the 2014 Nation Harm Reduction Conference in Baltimore, MD. Mike presented an intro to streetRx, focusing on its value as a ‘magnet content’ tool to share health and wellness information with people who use drugs.
Harm Reduction, Magnet Content, and the Future of Health Promotion
Meeting people who use drugs ‘where they’re at’ is a core principle in the practice of harm reduction. Programs are carefully designed to be culturally competent, respectful of dignity, and non-judgmental in their effort to reduce harms associated with drug use. One of the challenges facing the harm reduction community is that health promotion information often comes in the form of media that are health-specific, and that rely upon their audience’s interest and engagement in health-seeking behaviors.
“Yang” food no longer safe? : Major U.S. food producers are headlining in China’s latest food safety turmoil
Chinese food manufactures have been involved in a series of food safety incidents in the past few years, including the Melamine-tainted infant formula case in 2008 and the alleged production of toxic chicken jerky treats that injured or killed thousands of American pets. As a result, people are turning to “Yang” food, a Chinese term for foreign-brand food. Despite much higher prices than their Chinese counterparts, these food products are increasingly welcomed in Chinese families due to their good safety record. But what happened this past month might have changed Chinese people’s idea about “Yang” food.
The revolution will not be televised, but it may be posted on Twitter and Facebook
We are pleased to announce that our social media monitoring and analytics platform, MedWatcher Social, has been featured in an article on The Pink Sheet, “Adverse Events In Social Media: FDA Expects Signal Detection ‘Revolution.’” Sarah Karlin describes how the FDA expects to expand on its traditional adverse event collection process by utilizing data from social media spaces like Facebook and Twitter to assist in post-market surveillance. Karlin also discusses how our team at Epidemico has worked with the FDA to provide them with the necessary technology for such surveillance using our… Read More
FDA post-market evaluation results, 2013
All drugs, devices and vaccines must undergo several phases of clinical trials before they are approved and brought to market; the process of evaluating a medical product’s safety profile, however, does not stop at approval. The FDA conducts what are called post-market evaluations to determine if any unforeseen side effects occur once a drug has been used by the general population either 18 months after approval or by the time the the drug has been used by 10,000 individuals (whichever is later). The data for several drugs were evaluated in 2013. While… Read More
ICYMI: FDA’s biggest announcements from 2013
January – lowers recommended dose for certain sleep drugs containing zolpidem (e.g. Ambien, Zolpimist); approves 3 new drug txs for type 2 diabetes (Nesina, Kazano, Oseni); approves new orphan drug Kynamro to treat inherited cholesterol disorder February – approves first retinal implant for adults with rare genetic eye disease; approves new treatment Kadcyla for late-stage breast cancer March – approves Invokana to treat type 2 diabetes, Tecfidera new tx for MS; TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients April – approves Plan B One-Step emergency… Read More
Why Report via MedWatcher?
When you report your side effects to MedWatcher, you’re not only formally documenting your experience with the FDA but you’re also letting other MedWatcher users know, anonymously. We work in real-time, sharing adverse event reports with the MedWatcher community as soon as we can format them. Your knowledge of side effects could provide valuable information to other users who may be researching a new prescription or wondering if a side effect they’re experiencing themselves is common or not. When you report to MedWatcher, you’re also reporting to the MedWatcher community.
Why Report? (part 2)
Many reports describing a single side effect experienced from the same product by different people can signal a problem to the FDA. This signal could lead to further investigation which in turn could lead to label changes, dose modifications or even a product recall, leading to increase patient safety.
When a drug is being developed, it goes through several clinical trials. These trials typically test the safety and efficacy of the drug on a smaller, more homogenous population than that which actually ends up using the drug when it is approved. Post-market surveillance helps provide a more complete understanding of a product’s safety profile and what side effects might occur.