Many doctors keep up to date on drug safety, especially regarding the drugs they typically prescribe, by reading scientific publications, attending meetings, conferring with pharmacy specialists, and trading safety notes with other doctors. However, it is also widely appreciated that many physicians and providers simply do not have the extra time needed to scour the literature and attend the multiple conferences that could keep them continuously informed about the ever-changing world of drug safety. In 1999 the Director of the National Library of Medicine commented on the volume of medical literature by stating, “If I read and memorized two medical journal articles each night, at the end of the year I’d be 400 years behind.”
Over the decade since that statement was made, the amount of literature has grown even faster. There is simply no way for anyone to stay completely current by reading medical journals. Indeed, time and information-overload constraints force many healthcare providers to obtain safety information from sources that may be significantly biased (pharmaceutical sales representatives) or have limited influence (FDA alerts).
Pharmaceutical sales reps: trained to influence
It is well known that pharmaceutical sales representatives, and their ubiquitous offering of “samples,” can significantly affect what drugs a given doctor prescribes. This influence can be dangerous for patients. In fact, a recent study showed that representatives adequately addressed safety issues regarding the drugs they pitch only 2-6% of the time.
One study directly queried physicians for their opinions on the power of sales representatives. 84% of doctors stated that their colleagues were influenced. However, and tellingly for how effective the tactics are, only 39% of respondents believed that representatives swayed them.
A blistering exposé by a former pharmaceutical sales representative for a major pharmaceutical company goes into great detail regarding exactly how some pharmaceutical representatives push the prescribing behavior of physicians.
The article contains many revelations about how representatives are trained. Two of the most interesting disclosures, with regard to how such practices may compromise patient safety, are: 1) “reps provide samples only of the most promoted, usually most expensive, drugs, and patients given a sample for part of a course of treatment almost always receive a prescription for the same drug,” and 2) “an industry survey found that more than half of “high-prescribing” doctors cited drug reps as their main source of information about new drugs.”
Indeed, a study by the Office of Inspector General and the Department of Health and Human Services found that the top 3% of high-prescribers in Medicare’s prescription drug benefit plan accounted for a staggering 50% of all prescriptions written.
Given that high-prescribing physicians account for a disproportionality large percent of prescriptions in this country, point number 2, above, is a troubling statistic with regard to patient safety.
FDA regulatory advisories such as their “Safety Alerts” are meant to update consumers and practitioners about new side effects (not already disclosed in the drug’s safety labeling) that have emerged in post-marketing use. FDA Safety Alerts can take many forms. Most are warnings about a new side effect and may include FDA-mandated label change(s). Serious Alerts include “Black Box” warnings, product withdrawals, and recalls. In general, the seriousness of the alert corresponds to the size of the impact.
Any FDA Alert can have a significant impact on a drug and its manufacturer – including changed prescription behavior and declining sales. As in most areas of risk communication, warnings and alerts are most effective when they are specific, offer alternative options, and are repeated.
In a recent review of the impact FDA alerts have on healthcare providers and prescribing metrics, Dusetzina and colleagues examined 49 studies. Conclusions to be made from the review and related studies are that the effectiveness of FDA alerts mirrors the general risk communication guidelines mentioned early – i.e. alerts produce results when they are specific and actionable.
This is an excerpt from our new white paper, Post FDA-approval safety data: Why they are vital and how they can be made accessible, actionable and predictable. Download your complimentary copy now.
Executive Vice President