Thought Leadership

When it comes to pharmaceutical recalls, those at the patient level are often very different from those that only affect hospitals, clinics, and other providers. First, there is the challenge of effectively notifying patients. For prescription drugs, the manufacturer typically notifies pharmacies, who then contact patients. Over-the-counter (OTC) medications usually leave no way of contacting the consumer directly, although there are some exceptions, such as retailer loyalty programs.

Many pharmaceutical recalls are routine. As demonstrated by the most recent Recall Index, they rarely involve the most serious Class I designation. But even when they aren’t high risk, they may be highly sensitive. That’s because pharmaceuticals treat conditions that may not be life-threatening but are critically important – even emotional – to the patients who are prescribed them.

Consignee identification and notification are among the first steps pharmaceutical companies need to take when they experience a recall. They can also be some of the biggest challenges. When physicians, pharmacists, and other healthcare professionals change office locations or transfer to other employers, available data can become outdated. It is important to identify gaps and obtain up-to-date contact information to ensure notifications are being sent to the correct professionals.

The 21st Century Cures Act has cleared a major Senate hurdle and is expected to be signed into law by President Obama. Among other provisions, the bill will fast-track the approval process for certain drugs and medical devices. The $6.

Anyone who has ever had a prescription filled knows these drugs come with a lengthy list of both benefits and risks that could rival many peer-reviewed journals. But of course, that isn’t the only place both types of information must be listed. Any promotion of a drug’s claims must also include a “fair balance” of risk information as well. The requirement has made many forms of online marketing difficult due to lack of space. Now, the Food and Drug Administration (FDA) is