Drug Shortages: A Growing Concern for the Healthcare Industry Worldwide

April 26, 2023 - Drug shortages have become a growing concern for the healthcare industry worldwide as patients are left without essential medications, and healthcare providers struggle to find alternative treatments. The problem has been rising for several years but was exacerbated by the COVID-19 pandemic, which disrupted global supply chains and caused production and distribution delays.

How Many Drugs Are in Short Supply?

As of April 2023, 235 forms of drugs are in short supply, according to the American Society of Health-System Pharmacists (ASHP). The World Health Organization (WHO) has also reported a global shortage of essential medications and has urged countries to take action to prevent and mitigate drug shortages. Shortages of important medicines, such as antibiotics, painkillers, and cancer drugs, can delay treatment or force healthcare providers to prescribe less effective medications, resulting in compromised patient care.

What Causes Drug Shortages?

The FDA published a report in 2019 titled "Drug Shortages: Root Causes and Potential Solutions" that identifies three primary root causes for drug shortages: manufacturing and quality problems, lack of incentives for manufacturers to produce less profitable drugs, and market dynamics, such as consolidations and scarcity of raw materials.

“Among other reasons, drug shortages may occur due to increased drug demand, logistical challenges, or pharmaceutical manufacturer decisions,” said Hazem Abawi, PharmD, MBA, Senior Director of Home Delivery Operations at AllianceRx Walgreens Pharmacy, in an interview with PharmaNewsIntelligence — in which he shed light on the causes of drug shortages and detailed their impacts on patients, healthcare providers, and drug manufacturers.

Global drug shortages highlight the need for better supply chain management and improved regulatory oversight, requiring the pharmaceutical industry and government organizations to devise effective solutions collaboratively. Additionally, other stakeholders must work more closely to ensure continuous access to necessary medications.

How Can Drug Shortages Be Prevented?

According to the FDA, several potential solutions could improve drug shortages and patient outcomes, including improving communication and data sharing among stakeholders, incentivizing manufacturers to produce critical drugs, increasing manufacturing redundancy, and improving the FDA's regulatory process.

“Drug shortages may occur due to increased drug demand, logistical challenges, or pharmaceutical manufacturer decisions, among other things,” explained Abawi. “When faced with a drug shortage, AllianceRx Walgreens Pharmacy first attempts to procure the drug from all available resources. When that is no longer viable, we consult with the patient and the prescriber to substitute the patient’s therapy for a clinically equivalent alternative.”

For example, healthcare providers may offer alternative medications or adjust the dosage of existing medication to minimize the impact on patients' therapy. Abawi also emphasized the importance of working closely with patients and their providers to explore all possible options and ensure the continuity of their treatment.

Additionally, healthcare providers can manage a drug shortage by staying in contact with pharmacies and patient care advocates, staying up to date with current market conditions, and working closely with pharmacies to confirm stock availability.

Regulatory agencies can help prevent drug shortages by expediting the approval process for new manufacturers, increasing oversight of drug manufacturing facilities, and offering incentives for manufacturers to produce drugs in short supply.

Ultimately, a collaborative effort between manufacturers, regulatory agencies, healthcare providers, and other stakeholders is necessary to prevent drug shortages and ensure patients can access the necessary medications.

What Is the Role of the FDA During Drug Shortages?

The FDA plays a vital role in managing national drug shortages by monitoring the drug supply chain and expediting approvals for new manufacturers or alternate suppliers to increase the availability of critical medications. The FDA can also exercise regulatory flexibility by allowing temporary or alternative manufacturing processes, extending expiration dates of drugs in short supply, or waiving certain requirements while ensuring patient safety.

“The FDA works closely with pharmaceutical manufacturers and other stakeholders in the pharmaceutical supply chain to mitigate public health risks presented by drug shortages. The FDA can assist in temporarily easing certain regulatory burdens to help enhance production while still ensuring drugs in the market are safe and effective,” detailed Jonathan McLachlan, PharmD, RPh, CSP, Manager of Professional Practices at AllianceRx Walgreens Pharmacy.

“The FDA is also a key conduit for communicating information to the public regarding drug shortages via its website,” added McLachlan.

By staying informed, communicating openly, and working collaboratively, healthcare providers, drug manufacturers, and regulatory agencies can ensure patients receive the necessary medication and mitigate the disruption caused by drug shortages.

What Can Specialty Pharmacies Do During Drug Shortages?

Specialty pharmacies can use several strategies to manage drug shortages effectively. One approach is establishing a proactive communication system with prescribers, patients, and suppliers to anticipate and mitigate potential supply disruptions. Another strategy is to collaborate with manufacturers and wholesalers to secure alternative products and sources of supply.

“The most effective strategies for specialty pharmacies to manage drug shortages are to work with different wholesalers to procure needed medications and have open communication with those wholesalers who have more information on drug shortages,” described Abawi.

Specialty pharmacies can implement inventory management systems that allow for early identification of potential shortages and prompt ordering of alternative or restocking current products. Finally, specialty pharmacies need to maintain an open line of communication with regulatory agencies to ensure compliance with any regulations related to drug shortages.

“Often, wholesalers can send an alert when a drug shortage is anticipated so pharmacies can act quickly. Specialty pharmacists can keep the patient updated with the latest information so they can be part of the solution, whether going to a local pharmacy, discussing options with their prescriber, or confirming days’ supply on hand. It all comes down to having the healthcare provider, pharmacy, and patient work together to mitigate the results of a drug shortage,” said Abawi.

Abawi emphasized the importance of collaboration among healthcare providers, pharmacies, and patients to mitigate the consequences of drug shortages, with wholesalers sending alerts to pharmacies and specialty pharmacists updating patients. Pharmacists must be well-informed, empathetic, and available to answer patient questions.

“Specialty pharmacists need to be available and ready to answer questions since patients have quicker access to pharmacists than any other healthcare professional,” Abawi added. “Pharmacists need to be equipped with the right information and solutions to drug shortage disruptions — as well as empathy to take care of the patient.”