Safety Continues to Elude Drug Development and Manufacturing

August 12, 2011

By Shelley Jazowski

In a recent post, I commented on the safety of generic medications specific to product labeling. Safety concerns are not singular to generics, but pervade the drug development, manufacturing and marketing components of the overall prescription drug industry. Below, I outline three primary concerns and comment on their proposed solutions.

Issue: Lack of Oversight of Internationally Produced Products

This first issue is a direct result from the increased globalization of the drug development industry. Due to the economic impacts, pharmaceutical manufacturers collaborate with global partners to produce pharmaceutical ingredients or products, and this trend shows no sign of slowing. TheFood and Drug Administration (FDA) estimates that 40 percent of finished drugs and 80 percent of active ingredient and bulk chemicals are imported from overseas. With this influx of internationally manufactured products comes the threat of substandard and/or adulterated materials, similar to the tainted Heparin, produced in and shipped from China, which was responsible for dozens of deaths.

Solution: Accountability for the Entire Supply Chain and Standardized Regulations

The solution to the lack of oversight involved in the manufacture and trade of pharmaceutical products does not rest with one party, but must be equally addressed by the federal government, domestic pharmaceutical companies and regulatory agencies. Not only should Congress impose national standards on drug wholesalers, but lawmakers should also require the private sector to both track and verify the authenticity of pharmaceuticals. To that end, pharmaceutical manufacturers should create systems that ensure quality and safety, thus making them responsible for the entire supply chain, including improved testing, transparency and auditing. The solution would not be complete without increased inspections from the FDA and/or approved third parties. Only then would Americans be guaranteed safer and higher quality medicines.

Issue: Counterfeit Medications

In some cases, the cause of one safety issues spurs another. Increased globalization leads to the threat of contaminated medicines, but also increases the likelihood of an influx of counterfeit drugs. Counterfeit medications can infiltrate the market, thus causing physical harm to patients.

Solution: Varied Color and Shape of Brand-Name and Generic Drugs

Similar to the how the cause of one safety issue can set off a chain reaction of subsequent harmful events, so too can proposed solutions. One such solution is the shape and color of medications. When a generic enters the market it has a different shape and color than its brand-name counterpart. The same holds true for drugs whose price has been negotiated and internationally traded according to the World Trade Organization (WTO) regulations. The varied colors and shapes of generics are meant to deter counterfeit medications from entering the market and being traded domestically and abroad. Although the number of counterfeit medications maybe decreased, the variations in pills often prevent the elderly, who are on a number of prescriptions, from adhering to medication guidelines. Thus, is this solution properly addressing the issue at hand? Is the tradeoff of decreased counterfeit activity worth the risk of compromising the health and safety of the elderly?

Issue: Missing Medication Guides

As described above, safety concerns are paramount in the drug development arena, but have increasingly crept into marketing and pharmacies. According to an investigation conducted by Consumer Reports, pharmacies often do not include federally mandated medication guides with filled prescriptions and when the safety information is provided, it is often varied and conflicting. A major driver behind the inconsistency is the lack of a nationwide standard, similar to the Drug Facts labels on over-the-counter medications. Instead, rules are developed and set by each individual state’s pharmacy board.

Solution: Patient Responsibility

Although legislation or regulations have yet to be introduced, one can hope that the results of this investigation will propel lawmakers to devise recommendations that will not only standardize medication guides and language, but also ensure that federally mandated medication guides are included for designated medications. Until lawmakers turn their attention to this safety issue, the responsibility will remain with the consumer. An informed patient is the key component to realizing adherence and guaranteeing safety, but is too much responsibility being placed on the consumer? The pharmacy should be accountable for following regulations and distributing proper safety information.