Causes of Drug Shortages in the United States

Manesh R. Patel, MD: Welcome to this Peers & Perspectives® presentation titled, “Implications of Potential Heparin Shortage.” I’m Dr Manesh Patel. I’m a professor of medicine and [the] chief of the Divisions of Cardiology and Clinical Pharmacology at the Duke University School of Medicine in Durham, North Carolina.

Heparin is the anticoagulant of choice when a rapid anticoagulant is indicated. About 60% of the crude heparin used to manufacture heparin in the US originates in China, derived from porcine mucosa. The recent heparin shortage represents a significant threat to public health and is a major challenge for US healthcare systems. It is vital that clinicians rapidly address the current shortage and select evidence-based alternatives while maintaining focus on efficacy and safety.

To discuss these challenges, I’m joined by Sarah Spinler. [She] is a professor and the chair of pharmacy practice at the School of Pharmacy and Pharmaceutical Sciences at Binghamton University in Binghamton, New York. Welcome, Sarah.

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: Thanks.

Manesh R. Patel, MD: Thanks for being here. Let’s get started. How does the shortage happen, and what are the factors that lead to a shortage?

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: The typical drugs that go under shortage are the older generic, sterile parenteral agents, just like heparin. One of the more common reasons [is] issues with good manufacturing practices in plants where they’re manufactured. Another common reason is that the actual ingredients are under shortage. There may be delays in shipping, in getting the drug to the market or to the distributors. There could be other reasons, such as a discontinuation altogether of [the] manufacturer. That [has] caught practitioners short a few times [when] a company just announces that they’re not making a product anymore and there [are] very few manufacturers of that product.

Manesh R. Patel, MD: Yeah, I’ve seen that in practice. Patients come in and say, “My blood pressure medicine, all of a sudden it’s on shortage. What are we going to do?” And you have to respond quickly.

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: Right.

Manesh R. Patel, MD: I guess I would say, are there things that the FDA requires companies to tell us about drug shortages? Are they required to tell us when 1 [is] coming, or is this always going to be sort of a surprise sometimes?

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: The FDA does maintain a website, [so] you can look up which medications are under shortage. But manufacturers are required to report [only] when they discontinue the product, [as] we’ve mentioned before. The 1 that would be, lead to the most urgent, severe need potentially. If they’re going to stop manufacturing altogether. If for some reason there is a delay in the shipping or they have an issue at the plant, they really focus more on getting them back up to speed and working with them to establish their good manufacturing practices again, so the shortage can be resolved. It’s not necessarily that they report those in all instances, but certainly if they discontinue it all together.

Manesh R. Patel, MD: The FDA has a website where, if I was wanting to, I could go look up possible shortages.

Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: Right. The American Society of Health-System Pharmacists [ASHP] also maintains a very helpful website that practitioners use all the time. Actually, the FDA and the ASHP are in communications with each other to make sure that all shortages are reported. The communities could report a shortage if they wanted to, and certainly practitioners can report a shortage if they would like to.

Transcript edited for clarity.