By Colleen Becker
When the coronavirus pandemic began and Americans were asked to stay at home, millions of people—especially those living with chronic illness—had to quickly figure out how to get extended refills of their needed medicines. Rushes such as these were just the tip of the drug shortage iceberg as the new era of COVID-19 emerged.
Fissures that existed in the pharmaceutical supply chain prior to the pandemic became more prominent as the crisis ensued. Both COVID-19 and non-COVID-19 treatments ran short early in the emergency. Hard-to-find drugs include those used for sedating hospitalized patients on ventilators.
The generic drug hydroxychloroquine, a medicine used to treat Lupus, rheumatoid arthritis and other diseases, was initially thought to be a treatment for COVID-19, but studies so far have debunked this theory. Today the clamor for this drug has waned, but people who required this medicine before the pandemic still have difficulty acquiring it.
Shortages are not a new phenomenon and Americans have had to navigate this circumstance before. Puerto Rico is a hub for pharmaceutical manufacturing and, according to the U.S. Bureau of Labor Statistics, was the top exporter of pharmaceutical products in 2019 for the U.S. totaling over $16.4 billion. In fact, many of the most well-known drug makers have plants in Puerto Rico. In the aftermath of Hurricane Maria, many drugs—like solutions used to dilute other medicines in intravenous (IV) bags—suddenly became hard to find.
The federal Food & Drug Administration (FDA) was able to tap companies overseas to fill in the gaps after hurricane Maria, whereas the COVID-19 crisis poses risks to the supply chain on a global scale. Many of the raw materials from which medicines are made come from other countries, including India and China. Though companies in both countries currently report being back online and operational, the manufacture and exportation of these products were significantly scaled back early on.
Even prior to the virus, shortages were not uncommon and, at the request of 135 members of Congress, the FDA was tasked in June 2018 with the oversight of the newly established Drug Shortage Task Force. The task force identified three causes for drug shortages in its March 2020 report:
- A lack of incentives for manufacturers to create less expensive drugs.
- A lack of incentives for systems that focus on continuous improvement and early detection of supply chain issues.
- Operational and regulatory challenges in the market, making it difficult to recover from a disruption.
To ease shortages at the state level, pharmacy boards in many states have issued waivers allowing pharmacists to use mobile pharmacies. Boards have also suspended regulations laws to permit pharmacies to receive drugs from wholesalers in other states. Some boards have even restricted access to hydroxychloroquine to ensure it is received by patients who truly need it.
With so much attention on solutions at the federal and executive levels, it leaves a legislator to wonder, what can a state lawmaker do? Although states do not have authority over large employer insurance plans, they may regulate plans sold on the individual market. Policymakers have a long history of passing laws to allow early prescription drug refills or relax certain utilization management processes, such as prior authorization, which is required of some drugs before being approved.
One example of this type of legislation passed in response to the pandemic, South Carolina law allows a pharmacist to dispense an emergency refill up to a 14-day supply of any medication as long as it is not a controlled substance.
Often, shortages translate into higher prices; the good news is that this does not seem to be the case so far. At present, it appears the U.S. drug supply chain has been tested but not compromised. But researchers at 46Brooklyn say it is still too early to tell. The effect that COVID-19 will have on drug prices may not be realized for another six months or more.
Before the pandemic, states had already put into motion policies, such as transparency laws, that will help lawmakers better understand the effect this crisis will have on drug prices. The data collected is likely to be a window into how states can better prepare against such disruptions and a treasure trove of information for future researchers to examine.
Colleen Becker is a senior policy specialist with NCSL’s Health Program.