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2018 U.S. Pharmaceutical Shortage-Could This Lead to Medical Malpractice?

Posted in Medical Malpractice on June 21, 2018

Puerto Rico is a main supplier of many U.S. pharmaceutical drugs – formulations that help relieve discomfort and treat Americans in emergency departments and hospitals every day. In the wake of Hurricane Maria, however, many of the facilities used to make these pharmaceutical drugs have been knocked out of service.

This is creating drug shortages at many of America’s hospitals. The American Hospital Association reports that the issue continues to get worse, with many hospitals running out of essential drugs to relieve pain and other uncomfortable symptoms. Could this problem lead to more incidents involving medical malpractice? Learn more about how the drug shortage is affecting the country.

The Scope of the Problem

Nearly 10 months after Hurricane Maria made landfall, Puerto Rico is still reeling from the aftermath – and now, the U.S. healthcare system is also feeling the after-effects.

Shortage of IVs

One of the biggest issues stems from the halt of production of IV bags holding saline solution, which helps dilute medication. Puerto Rico is one of the largest producers of these bags, many facilities of which still remain closed in the wake of the disaster.

Medication Shortages

IV bags aren’t the only problem, however. According to the U.S. Food and Drug Administration (FDA), the organization is monitoring a list of 90 medications and other medical product shortages that directly tie back to the disaster in Puerto Rico. After systemic efforts to bring products back to the market, the FDA recently narrowed its list to 10 medication shortages. The FDA does not disclose the names of the drugs being monitored for shortages, but Puerto Rico is a top producer for drugs relating to arthritis, blood thinners, and more.

Existing Issues

On the other hand, it’s important to understand that the medication shortage did not simply appear after Hurricane Maria; rather, it’s part of a larger, systemic problem. For example, before Hurricane Maria, a saline problem already existed because of quality assurance issues at another main distribution plant in California.

In general, medication shortages can be difficult to track because pharmaceutical companies keep the details of their operations under wraps. How and where a company makes a formulation constitutes a trade secret, and companies are not required to disclose any details regarding their medications or supply.

Working on a Solution

Currently, the FDA is working with both medical supply companies and pharmaceutical companies to help restore drug operations in Puerto Rico and find other places for plants. The most recent estimates indicate that power has been restored to about 90% of the island and many facilities are resuming production. However, it has a long way to go before completely resuming operations and getting medication supplies back up to their normal levels.

Can This Lead to More Medical Malpractice Claims?

Another important question that remains is whether this could lead to more medical malpractice claims nationwide. There’s no simple answer, but it’s certainly possible. When hospitals run out of familiar drugs, they must seek alternatives elsewhere, using formulations that might be unfamiliar. This could increase the risk for medication errors, as patients may receive too little or too much of a drug that serves as substitute. Further, a lack of saline solution could lead to improper dilution of drugs and other issues.

While the drug shortage may increase the risk of medical errors in this capacity, it’s unlikely that a hospital could be held accountable for not having enough drugs in stock. This represents a systemic problem that affects healthcare facilities nationwide, so it’s unlikely that failing to have a medication that’s already in short supply will constitute a breach of care. If a pharmaceutical company negligently produces medications or rushes them back to the marketplace without appropriate checks, however, that could be a different story.