Regulatory Focus™ > News Articles > Study: Letters to Doctors Have Varied Impact on Utilization

Study: Letters to Doctors Have Varied Impact on Utilization

Posted 19 January 2012 | By Alexander Gaffney, RAC 

A study to be published later today in the journal Medical Care finds that Dear Doctor letters, public health advisories, safety alerts and Black Box REMS warnings have variable impacts on utilization, with some working well and immediately, while others caused delayed reactions or no reactions in the utilization of health care, reports Ed Silverman of PharmaLot.

Public health advisories were the most effect forms of communication used by the US Food and Drug Administration (FDA), though their effects were far from consistent.

The study looked at 1,432 FDA communications, and divided them in to four categories: greater clinical or lab monitoring, contra-indications due to drug-drug interactions (DDI), avoiding use in subpopulations and general caution regarding a medication.

Lab monitoring communications resulted in little to no sustained impact, while contra-indication communications tended to have a delayed impact. Notices recommending that products not be used in subpopulations or in the general public had a modest effect, but were also accompanied by negative spillover effects in some cases.

"I do think there may be opportunities for the FDA to more strategically target their communications - I believe they are increasingly using social media platforms, but I also think that there are opportunities to focus messaging using the same principles of market segmentation that are used so effectively to promote and market these very same therapies," wrote the co-author of the study, G. Caleb Alexander. "We know from other settings that communications are most likely to be successful if they are simple, specific, where alternatives are available, and where they are reinforced over time."



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