Thursday, March 05, 2015

FDA Develops a Mobile App for Reporting Drug Shortages. But Wouldn't an App for Adverse Events Better Fit the Agency's Mission?

FDA/CDER launched its first and only mobile app on iTunes: DrugShortages (see logo on left).

The iTunes blurb suggests the public would find this information important:

"Access to drug shortage information is now easier and faster. FDA has developed an app that allows users to quickly identify current drug shortages, resolved shortages, and discontinuations of drug products. This app was developed to accelerate public access to important – and sometimes critical -- information about drug shortages. The application uses a searchable database to provide real-time information to key stakeholders, including health care practitioners and pharmacists."

I'm not sure how useful this app is for the public versus HCPs who definitely would like easy access to such information. According to the blurb, the app "helps health care practitioners make quick decisions about patient treatment."

More importantly, the app "provides information on how to report a shortage or supply issue, and links to other resources from FDA". Of course, the general public would not find this feature of the app very useful.

But an app that would be VERY useful for HCPs and patients is an app that provides easy access to adverse event data and that allows users to report adverse events. This, I believe, would better fulfill FDA's mission: to "protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices..."

What would such an app look like? I used the DrugShortages screen to create what I call "DrugAE," a concept for a mobile app that I hope the will FDA launch on iTunes soon. Here's my concept:

Tuesday, March 03, 2015

In a Major Turnaround, FDA Now Requires "Low-T" Drug Label Changes & Safety Studies: Warns of Stroke & Heart Attack, Inappropriate Prescribing

FDA characterizes today's Safety Announcement requiring label changes for drugs that treat "low testosterone" merely "an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014." But it is obviously much more.

According to today's announcement,
  1. FDA is "requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone."

  2. "[FDA is] also requiring manufacturers [ of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products."
This is worlds apart from what the FDA said on January 31, 2014 regarding this issue. It is also worlds apart from what Public Citizen petitioned the FDA to do in February, 2014.

Friday, February 27, 2015

A KOL By Any Other Name Would Smell As Sour

Nearly two-thirds (62%) of medical experts (physicians who could be deemed genuine experts) believe the pharmaceutical industry should replace the term Key Opinion Leader (KOL) – according to the results of a new international online survey to be presented today at the Medical Affairs Leaders Forum in Berlin, Germany. The survey was conducted by System Analytic, a company that helps pharmaceutical teams to "identify, map, and engage with their medical experts and key stakeholders."

According to the Pharma Marketing Glossary, Key Opinion Leaders are physicians who influence their peers' medical practice, including but not limited to prescribing behavior.

"Pharmaceutical companies hire KOL's to consult for them, to give lectures, to conduct clinical trials, and occasionally to make presentations on their behalf at regulatory meetings or hearings." (see "The Secret Lives of Big Pharma's 'Thought Leaders'").

It's a well-known fact that KOLs often are chosen more for their high prescribing habits than for their knowledge or other attributes that would enable them to influence their peers. The recommendation to change the name follows concerns by the senior medical community (who participated in the research) that the term ‘KOL’ is too ‘closely associated with the world of marketing’ and is often ‘used inappropriately’ for people who do not necessarily warrant the title.

But how do pharmaceutical executives feel about changing the name? What name should be used instead? And, most importantly, will changing the name really change the game?

Wednesday, February 25, 2015

Lack of Adherence: A Haiku for Pharma

HealthPrize, a company that offers rewards to patients who take their medications, challenged ePharma Summit attendees and Twitter followers (hashtag: #epharma) to a Haiku contest.

The challenge is to write a Haiku - a 17-syllable verse form consisting of three metrical units (lines) of 5, 7, and 5 syllables. The catch? The topic must be medication adherence.

UPDATE: I won! The prize was a $100 Amazon.com gift certificate.

Here's my Adherence Haiku:


What do I mean by this?

Tuesday, February 24, 2015

Impact of mHealth on Adherence and Patient Outcomes Needs Improving. How "Open, Crowdsourced" Data from Pharma Can Help

A study just published in the Journal of Medical Internet Research (JMIR) concludes that "there is potential for mHealth tools to better facilitate adherence to chronic disease management, but the evidence supporting its current effectiveness is mixed. Further research should focus on understanding and improving how mHealth tools can overcome specific barriers to adherence."

The study was a systematic review of 107 studies published in peer-reviewed journals. It aimed to evaluate the effectiveness of mHealth in supporting adherence of patients to chronic disease management -- which the authors call “mAdherence” -- and the usability, feasibility, and acceptability of mAdherence tools and platforms for chronic disease management.

The authors classified mAdherence tools and platforms into four main categories: SMS; phone plus software or application; phone plus specific instrument (medical device connected to phone via a cord); or phone plus wireless or Bluetooth-compatible device (see figure below):

Types of mobile tools used in mAdherence. Click on image to enlarge.

What were the results and how can the pharmaceutical industry help?

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