Drug shortages occur when the demand for medication exceeds the supply. They can have far-reaching repercussions, especially for those with life-threatening conditions. Having timely access to medications can be a matter of life or death for these patients.
Drug shortages can affect global regions relying on imports to manage endemic diseases. For example, a lack of antimalarial drugs in a malaria-prone region can increase cases and endanger more lives. 503B partnerships can help address this problem by bolstering compounded medication supply.
This partnership is a collaboration in the pharmaceutical industry, derived from Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act in the US. 503B partnerships are helping hospital in addressing challenges by working with outsourcing facilities to secure a stable supply of essential medications.
Beyond the implications for individual health, drug shortages can put a strain on healthcare systems. For instance, hospitals must prioritize crisis management, diverting resources from other critical healthcare initiatives. Hence, higher costs of alternative options can increase healthcare expenses, affecting patients and taxpayers.
This article examines the effects of drug shortages on public health by discussing the reasons behind these shortages and the resulting consequences.
Causes of Drug Shortages
Drug production is complex, and delays anywhere in the process might lead to stockouts. For example, a manufacturing facility may encounter technical issues or difficulties sourcing raw materials, which can cause delays.
An example of a shortage occurred in 2017 when there was a lack of intravenous saline bags in the US. Delays in production and higher demand during the flu season caused this shortage. As a result, patient care in hospitals throughout the country was affected.
Drug shortages can occur due to several factors:
1: Regulatory Difficulties
Ensuring drug safety and efficacy requires health authorities to impose stringent regulations. However, these regulations can sometimes unintentionally contribute to drug shortages. For example, complex and lengthy approval processes for new drugs can affect production. In addition, changes in manufacturing sites can slow operations, resulting in temporary shortages.
2: Supply Chain Disruptions
The pharmaceutical supply chain is extensive, with numerous stakeholders. Disruption at any stage can cause shortages. Natural disasters like earthquakes or hurricanes are excellent examples of disruption. They can cause damage to manufacturing facilities or transportation routes. This situation was evident in Puerto Rico during the devastating Hurricane Maria in 2017.
3: Increased Demand
An unexpected increase in demand for a specific drug could overwhelm the supply chain. It can occur during disease outbreaks or when a new drug is approved to treat an incurable condition. During the 2009 H1N1 flu pandemic, there were shortages of antiviral drugs like oseltamivir in some places because of the high demand.
4: Economic Factors
The cost of manufacturing specific drugs, including raw materials and manufacturing expenses, can impact drug manufacturers’ decisions. If the manufacturing costs outweigh the financial benefits, manufacturers may discontinue the drug or divert their resources to more profitable medications.
5: Pharmaceutical Industry Consolidation
In the pharmaceutical industry, mergers and acquisitions can reduce competition and limit the number of manufacturers producing a specific drug. Consolidation can reduce redundancy, but it can also create supply chain vulnerabilities.
A notable example is the EpiPen shortage. It was caused by production issues at Mylan, the manufacturer, who faced limited competition in the market for epinephrine auto-injectors.
Consequences On Health
Patients suffering from chronic illnesses, like diabetes or hypertension, require constant access to medications. Drug shortages can cause treatment delays, increasing the risk of disease complications and hospitalization. For example, insulin shortages can lead to poorly controlled blood sugar levels and serious health consequences for patients with diabetes.
The consequences of drug shortages can be severe and widespread. Here are some of them:
1: Medication Mistakes
Without preferred medication, healthcare providers may use different drugs or dosages. However, this approach can cause medication errors, adverse reactions, and therapeutic ineffectiveness.
For example, a shortage of intravenous opioids could force healthcare providers to administer less familiar pain medications, potentially leading to overdose or inadequate pain relief.
2: Increased Healthcare Costs
Drug shortages can cause prices to rise as demand exceeds supply. As a result, insurance companies and patients carry the burden of price increases, causing financial strain. For example, during the COVID-19 pandemic, demand for medications such as hydroxychloroquine skyrocketed, significantly increasing prices.
3: Prioritization And Rationing
During severe shortages, healthcare providers may prioritize certain patient populations, potentially depriving others of essential medications. When healthcare workers must make challenging choices about how to use limited resources, social problems can arise.
For example, oncologists may prioritize cancer patients based on the availability of chemotherapy drugs during a shortage.
4: Less Effective Treatment Options
When a patient’s chosen drug is no longer available, they may have to take a less effective one. However, it can lead to less-than-ideal treatment results. This scenario may affect patients with drug-resistant illnesses or medical disorders that require specialized treatments.
Drug shortages can have life-threatening consequences in extreme cases. For example, a lack of epinephrine auto-injectors during anaphylactic reactions can be fatal for people with severe allergies.
Conclusion
Numerous factors contribute to drug shortages, ranging from manufacturing difficulties and regulatory issues to supply chain disruptions and economic factors. On the other hand, the consequences on health include medication errors, higher healthcare expenses, and poor health outcomes.
Effectively addressing drug shortages is crucial. Hence, pharmaceutical companies, regulatory agencies, healthcare providers, and other stakeholders must work together. This collaboration is necessary to enhance the resilience of the supply chain. It can also give people access to the medicines they need for health and well-being.