Why we are seeing drug shortages and the impact on patients and professionals
For at least the past couple of years, the American public has been affected by a prescription drug shortage. Despite action and the commissioning of FDA initiatives and task forces, by the end of 2018, the University of Utah Drug Information Service reported almost 250 national drug shortages.
The cost of more expensive substitutes was estimated at nearly a quarter-billion ($250 million. Injectables were particularly hard to come by, but the shortage wasn’t limited to any particular area of healthcare. Antimicrobials, chemotherapy products, and cardiovascular medications were among those impacted by the shortage.
For healthcare professionals, this means no matter your work setting, there’s a good chance the shortage has impacted you—or will in the near future. It could be the young child in need of a flu shot, the patient fighting cancer who needs one last medication to round out his ‘cocktail’ of drugs, or the elderly patient in need of certain heart medication.
Here’s a closer look at the causes, and hopeful solution to this shortage.
Generally speaking, drug shortages start at the most natural of locations, the manufacturing facility. Like any line of business, it can be employee turnover, management issues, problems with the location itself—any of these issues can cause a slowdown in production and ultimately lead to a shortage.
For example, Pfizer’s been seeing unwanted headlines regarding trouble at their McPherson, Kansas manufacturing plant acquired in their 2015 deal for Hospira. About two years ago, a letter of warning from the Food and Drug Administration (FDA) went public, referring to the company’s manufacturing process for sterile, injectable drugs as “out of control” and claiming the process was putting patients at risk.
The FDA added that several products were contaminated with multiple foreign particulates, specifically the injectable antibiotic vancomycin, which had been compromised by cardboard pieces.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacturer of drugs is inadequate,” the FDA said.
That spring, Pfizer began sending a letter to companies warning of the impending drug shortage—largely owed to the issues at the McPherson facility.
While it’s hard to say exactly how the bad publicity affected the company or the plant, by the end of 2018 it was reported in several outlets that Pfizer was desperately trying to fill some 350 open positions at the same facility. Kansas’ relatively sparse population and low unemployment rate contributed to the challenge, with the company holding job fairs in Wichita and Salina—towns at least 40 miles from McPherson.
At that time, Pfizer indicated that things would be looking up sometime around the midpoint of this year, but just last week Pfizer CEO Albert Bourla adjusted that timeline, saying the company will be continuing to work through the issues for the balance of this year. “We expect these issues to be significantly improved by the end of 2019, and we continue to expect this business to be a solid growth contributor in the future,” he said.
Either way, this example illustrates just one source of a potential drug shortage. The Associated Press reports that the McPherson plant is designed to produce 125 million units of injectable medicine annually, much of which is used in hospitals and emergency rooms.
On the provider’s side, it can result in different issues. Imagine a scenario where the patient has an allergy to all the available medicines on a given day. Some practitioners are reduced to difficult conversations about allergies—are you truly allergic, or just sensitive to this medicine? The choice can be as simple as tolerating some miserable side effects, or no effective way to deal with a patient’s pain at a given time.
Manufacturing issues are one problem, but when a natural disaster strikes like Hurricane Maria, which ravaged Puerto Rico in September 2017, it creates a twofold issue with no designated timeline for resolving. Assuredly, there are patients in need of medicine in the storm-affected nation, but more importantly, Puerto Rico is one of the United States’ leading producers of saline solution. That production was shut down for an extended period, and also caused a bottleneck in the supply of critical amino acids used to feed patients, including premature babies.
“It’s devastating for pediatrics and babies because hospitals were telling us they were down to just a few days’ supply and they were really getting extremely concerned,” Captain Valerie Jensen, Associate Director of the Drug Shortages Program in the FDA’s Center for Drug Evaluation and Research, told NBC News at the time.
The website RxEConsult published a list of three ways that hospitals can stay on top of drug shortages and prepare themselves for any shortcomings in the future:
Keep informed of drug supply trends: Pharmacists and other members of the pharmacy team should actively seek out information related to drug supply or availability. Pharmacies should track their order history and identify products which are on backorder, available in limited quantities, temporarily unavailable, or discontinued.
Identify alternative treatment options: Pharmacists should collaborate with physicians and other healthcare practitioners in identifying alternative treatment options for impacted drugs. Providers must act rapidly to find safe comparable treatments to avoid disruptions in patient care.
Notify the FDA of any disruptions in supply: The FDA’s Drug Shortage Program was designed to ensure that medications (prescription and over-the-counter) remain available to the public when needed. The FDA coordinates with the manufacturers to prevent and resolve drug supply issues.
Also, you can’t simply rely on manufacturers to take the initiative to inform you of any issues or production slowdowns. They’re supposed to, but as we saw in the Pfizer scenario, the news isn’t exactly welcome or accepted gracefully. In fact, certain privately held companies aren’t even legally required to provide such information.
SOURCES: FiercePharma, NBC News
