Across the globe, drug shortages are a problem impacting most countries and healthcare organizations, from health care providers to the hospital pharmaceutical distributor. It is also an issue that has been growing in recent years, affecting all therapeutic classes. Drug shortages pose a challenge for health care providers and pharmacies and have an impact on patient outcomes, representing an ongoing public health crisis. While the number and characteristics of shortages vary by geographic location and healthcare setting, wholesalers and health care providers can work together to help mitigate the impact of drug shortages on the quality and efficiency of patient care. Understanding the problem is the first step.
What drives drug shortages?
Identifying the causes of drug shortages is difficult as many factors are involved. The most common known issues for drug shortages fall in three main categories:
- Manufacturing problems. Manufacturing difficulties are often responsible for drug shortages. Difficulties can include loss of production or compliance personnel, outmoded equipment, or a shift of a company’s resources from manufacturing to other areas, such as research and development.
- Supply/demand issues. Demand for a drug can exceed expectations or production capacity, contributing to a drug shortage. This can occur in response to the spread of a disease, the approval of a new indication for an existing drug, changes in therapeutic guidelines, or other unforeseeable factors.
- Raw materials problems. Many manufacturers import raw materials from other countries. Armed conflicts, political upheaval, and trade disputes can disrupt the import of raw materials needed for production. Other problems of availability include animal diseases, contamination or degradation during transport, and climate or environmental conditions. Issues related to the availability of raw and bulk materials can affect multiple drug manufacturers when a primary supplier delays or discontinues production.
Additionally, business decisions, regulatory issues, and many other disturbances within the supply chain contribute to drug shortages.
How is the issue being addressed?
Governments and state health authorities are adopting initiatives to help reduce drug shortages over the long term as well as better forecast shortages. These efforts are often supplemented by independent actions at pharmacies, healthcare organizations, and lower-level local health authorities. Independent actions may include bottom-up initiatives and organizational frameworks such as establishing working groups, guidelines, codes of conduct, good practices, and management plans.
How can healthcare organizations better manage drug shortages?
Healthcare organizations can adopt several strategies to proactively tackle the issue of drug shortages locally. Consider the following practices:
- Develop a plan. Many disruptions in the drug supply chain occur rapidly and with limited advance notice. In these instances, it is important to have a management plan in place to ensure responsiveness. After identifying a drug shortage and its characteristics, a plan should include an operational assessment to evaluate the healthcare organization’s ability to endure the shortage; a therapeutic assessment to determine the potential effect on patients; and preparation and implementation phases that detail the formal process for maintaining patient care and controlling costs.
- Collaborate with wholesalers. Wholesalers, including the hospital pharmaceutical distributor, are a crucial link between drug manufacturers and health care providers in terms of the flow of information. Driving increased communication with distributors to get accurate information regarding product availability is a key element in managing disruptions. Typically, wholesalers have systems in place to convey critical information regarding supply. Healthcare organizations should become familiar with these processes. After obtaining the right information, providers can deliver timely communication to put a drug shortage plan in motion.
Drug shortages are a complex, global problem affecting most countries and healthcare organizations. Health care providers should consider readily available resources, including distribution partners, to help cope with drug supply chain problems. Maintaining a strong line of communication with wholesalers, such as the hospital pharmaceutical distributor, and adopting independent, bottom-up initiatives and collaborative management plans can ensure patients continue to receive necessary care amid shortages.