Drug Safety: Failure to Communicate - Pharmaceutical Executive

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Drug Safety: Failure to Communicate
The new drug safety system won't be fixed until companies learn new approaches for teaching patients about their drugs


Pharmaceutical Executive


Many companies already have huge files of patient names that they gained from databases and mailing lists they purchased or compiled through Internet visitors and redeemers of coupons. They will seek new methods of involving these patients in relationship-building exercises. This will be important, particularly when the safety messages are complicated and evolving. Look for greater use of patients recruited to be "experts" who tell their friends about medicines. If the regulatory challenges can be met (assuring compliance with FDA regulations), such face-to-face communications can be a whole new way to influence people with a condition to see their doctors.

Public relations efforts and events will continue. However, there will be more backlashes, particularly when it comes to obtaining transparent sources of information. The hidden influence of pharma companies in celebrity discussions of drugs, the use of PR firms to draft consumer articles without reference to drug-company funding, and the use of video–press release B-roll—again without reference to source—will continue to come under fire. While OIG has mostly focused its efforts on professional marketing, source-unattributed PR efforts appear vulnerable to investigations and negative publicity as true sources of information are found out and disclosed in the press.

Patient Risk Communication Comes Out of the Closet

Historically, drug risks have been relegated to informed-consent sheets, package inserts, and fair balance disclosures. While disclosed, the information is often ignored. In the new Culture of Drug Safety, patients will become more in tune with the fact that every drug also has risks. They will expect to receive such information, and they will pay attention to its message.

There will always be various patient segments that differ in how they respond to risk information. Some people will seek to avoid drug risks by ignoring the information, some will delegate all worry to their prescriber, and some will cope by denial. However, the segment of patients that will actively participate in healthcare decision making is growing. The more patients know about drug risks the less they will fear them. They will feel more in control of their own health. Our challenge is to make risk information available in a form that will permit active participation possible. The new Culture of Drug Safety will envelop drug adoption and use. Whether we flourish or flounder in this new culture will be a matter of our adaptability.

This is the last in a three-part series on the new Culture of Drug Safety. Please send comments to
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