Injectable diabetes medications including semaglutide, namely Wegovy and Ozempic, have been in shortage since 2022, limiting patient access to the drug across the nation. Many other drugs have appeared on FDA’s shortage list in the past few years, including ADHD medications, chemotherapy treatments, and even antibiotics. However, the semaglutide shortage has been featured prominently in the media due to the extreme demand of this product for weight loss.
Why Do Drugs Go into Shortage?
Unfortunately, there is no easy answer to why drug shortages happen, and there are usually many factors complicating access to a particular medication. Supply chain problems can factor into medication shortages, as well as geopolitical issues limiting manufacturers’ ability to obtain certain products that are made outside the US. FDA also cites manufacturing quality issues as a major reason for drug shortages, as well as drug discontinuations.
Regarding injectable medications, FDA says, “With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage.”
ASHP notes the cause of the Ozempic and Wegovy shortages as “increased demand”.
How Drug Shortages Affect Pharmacies
Drug shortages can create tension in pharmacy environments where staff are already under pressure. Patients become understandably upset when they cannot access their medication, or their medication becomes more expensive. From the pharmacist’s perspective, they end up spending work hours searching for drugs that are not available and trying to find solutions for patients. They also may need to create partial refills (for example, providing patients with a 30-day refill instead of a 90-day refill) and spend time notifying the patient’s health care providers about the prescription change or lack of access to the medication. More than likely, an individual patient at a pharmacy experiencing a drug shortage is not the only affected patient – the pharmacist will need to go through this same process with many patients.
Simultaneously, compounding pharmacies have been overwhelmed with the production of semaglutide injections that are compounded copies of Ozempic and Wegovy. When a drug appears on FDA’s shortage list, it is not seen as “commercially available,” allowing compounding pharmacies to create that drug to keep up with patient need. This is only allowed by the Federal Food, Drug, and Cosmetic Act if the compounding pharmacy is using the exact ingredient contained in the commercially available drug. In the case of Ozempic and Wegovy, the base form of semaglutide must be used.
How Drug Shortages Can Put Patients at Risk
When drugs are limited and difficult to obtain, bad actors can take advantage of patients. Because Ozempic and Wegovy are commercially popular, illegal online sales of the products have increased dramatically. There are many illegal online pharmacies advertising the sale of semaglutide injections without requiring a prescription. Some criminal organizations set up non-delivery schemes (ie, sales of drugs that are never received). In other words, they are just stealing consumers’ money.
Some criminal organizations are selling fake products that can lead to adverse medical effects. Fake Ozempic has been found in the US and in Europe. In one instance, insulin was found as opposed to semaglutide, causing hospitalizations of patients experiencing seizures and dangerously low blood sugar. Whenever purchasing medications online, consumers should use NABP’s Safe Site Search Tool to make sure they are buying from a legitimate source.
If you or one of your patients suspects they have taken or purchased fraudulent or substandard drugs, they should report it to the state board of pharmacy, FDA Office of Criminal Investigation (OCI), and the state attorney general.