Pharmaceutical Trends

According to a recent survey of pediatric hospital pharmacies, one-third of children admitted to pediatric hospitals receive drugs that have been reformulated by the hospital pharmacies using extemporaneous recipes.1 This is because many of the needed drugs are available only in pill form.

The Advent of ePRO

The use of patient reported outcomes (PROs) in clinical drug trials has grown in popularity as pharmaceutical manufacturers recognize the value of direct patient feedback for conditions and symptoms that cannot be physically measured by researchers, such as pain, mental health and overall quality of life.   

Challenges

This decade had brought increased pressures on the pharmaceutical industry from practically every angle. Pharmaceutical manufacturers continue to seek out new blockbuster drugs but it’s getting harder and harder to find them.

Background
In 1987, the U.S. Food and Drug Administration (FDA) passed the Prescription Drug Marketing Act (PDMA) to secure the pharmaceutical supply chain from counterfeit, misbranded, adulterated or diverted prescription drugs. The PDMA required drug wholesalers to provide documentation or a “pedigree” on the chain of custody of drug products, including identification of each prior sale, purchase or trade of a drug, along with the associated dates and parties involved. Over the past 22 years, the implementation of the PDMA has been delayed time and time again, most recently due to an injunction filed in the Northeast claiming the PDMA is discriminatory against smaller wholesalers.