By Karen L. Kier
Pharmacist on behalf of the ONU Healthwise Team
The Queen of Soul, Aretha Franklin, released the song Chain of Fools in 1967. This song from her Lady Soul album hit number one on the Billboard Hot Rhythm & Blues chart and was number two on the top 100. Aretha was awarded a Grammy for this song as the Best Female R&B Vocal Performance. The song is about realizing someone has been unfaithful in a long-term relationship and being one of the fools in the chain. In the song, she predicts the chain will break.
What does a chain of fools have to do with medications?
Our drug supply chain has had some significant issues and has resulted in drug shortages and tainted drugs entering the U.S. medication supply. The FDA and other government agencies do not always have the authority or power to control some of these issues.
In order to protect the public and to ensure patient access to safe and effective medications necessitates that every link in the supply chain be secure. This means from the time a drug leaves the manufacturer until it arrives at the pharmacy, physician’s office, or hospital, it is tracked.
In 2013, the Drug Supply Chain Security Act (DSCSA) became a federal law intended to give the FDA more regulatory tools to detect and remove dangerous drugs from the supply chain. Dangerous meaning counterfeit, stolen, contaminated, or potentially harmful. The FDA over the last ten years continues to implement more safeguards for the drug distribution system.
The FDA has partnered with both public and private organizations with a program called the Partnership for DSCSA Governance. This collaborative group is dedicated to developing and sustaining effective technology to trace and verify prescription drugs in the US.
On November 27, 2023, the White House announced the formation of a new Supply Chain Disruption Task Force to address medication shortages. The White House released findings related to supply chain vulnerabilities and focused on the US dependency on imported drugs for key medications including many generic drugs. The report noted about 87% of generic drug manufacturers are located outside of the US. This leaves the country at risk for drug shortages.
The American Society of Health-System Pharmacists (ASHP) is a professional organization representing over 60,000 pharmacy personnel in the United States. The organization monitors and reports on drug shortages. The organization educates lawmakers and the White House on supply chain issues and drug shortages. Recently, Michael Ganio, ASHP’s senior director of pharmacy practice and quality, testified before Congress about drug shortages and potential policy solutions.
The public may not be aware of critical drug shortages which impact patient care. Why?
The large percentage of drug shortages actually occur within hospitals. In August 2023, a survey of hospitals reported 1 out of every 3 were severely affected by shortages, while 2 out of 3 had been moderately impacted. Almost 100% of the hospitals indicated they had to either skip, delay, or prescribe less drugs to take care of patients.
Cancer treatments were significantly affected in 2023 due to drug shortages. Physicians, pharmacists, and nurses had to make decisions about who would get certain cancer agents and who would not. These can be difficult decisions.
Not only are drug shortages an issue: fake or counterfeit drugs are also entering the supply chain.
A May 2023 article in Pharmaceutical Medicine discussed the increasing global trend of counterfeit drugs. The World Health Organization estimates about 10.5% of the drugs circulating globally are fake. The United States is not immune to this issue. Interestingly, most counterfeit drugs enter the U.S. via online pharmacies. These website pharmacies seem reputable, but they can be hard to distinguish.
The Drug Enforcement Agency (DEA) targets rogue online pharmacies with illegal websites through their Operation Cyber Chase program. The FDA warns of unsafe online pharmacies who use fake storefronts to mimic a licensed pharmacy. These sites often make you think their medicines come from countries with high safety standards such as the US and Canada. The FDA program to educate about rogue online pharmacies is called BeSafeRx and more information can be found at the FDA website.
Did you know you can search each state’s Board of Pharmacy website to check if your pharmacy is licensed and official? These are public records!
Tracking and monitoring the drug supply chain is a critical piece of making sure the medications we take are safe! Complete the chain, chain, chain by talking to your pharmacist.
ONU Healthwise Pharmacy
419-772-3784
