By: Emily Kapustin and Keiran Pace
Drug shortages can impact anyone suffering from a health issue, whether it be a headache or a life-threatening illness. Regardless of the health problem, the causes and impacts of drug shortages are multifaceted and complex. Some common causes of drug shortages include manufacturing delays, regulatory challenges, recovering from the COVID-19 supply chain issues, and difficulties in dealing with higher demand during peak seasons. Drug shortages occur naturally and inevitably.The extent to which drug shortages can impact an individual varies. They can either be a minor inconvenience or a complete barrier to treatment. Given that drug shortages are imminent, it is important to develop more efficient and highly organized systems involved in drug manufacturing and delivery to minimize shortages and their impacts. Simultaneously, it is equally important to focus on strategies to navigate drug shortages so we are prepared when they do arise.
Since more commonly used brand-name drugs are often sold under generic names, such as Advil and Tylenol, they typically have substitutes that individuals can use in the case of a shortage. However, in the case of less common drugs that are not as broad spectrum, they do not usually have easily accessible substitutes. One such example is intravenous immune globulin (IVIG) which is a lifesaving drug for those with compromised immune systems. The lack of this drug directly puts the patient’s life at risk, especially if their illness is severe since IVIG works faster than alternatives.4 One of the leading causes of drug shortages is manufacturing as well as supply and demand issues. The supply chain is a complicated mechanism with numerous components involved. The pandemic further disrupted the global healthcare and pharmaceutical supply chain due to recurring lockdowns. These lockdowns either slowed down or temporarily stopped the flow of drugs to their target destination. Even simple drugs such as Advil (ibuprofen) and Tylenol (acetaminophen) experienced significant shortages because of unprecedented demand throughout Canada.
Figure 1 describes the process of getting a product onto a retail store shelf which has many steps. Based on this graphic, it is clear how disruption in one step can have a significantly disruptive effect on the steps that come after. Meanwhile, figure 2 focuses on the common reasons for drug shortages, with manufacturing issues being the most common. As a result of drug shortages, the whole healthcare system suffers, from patients to healthcare providers. A study published in 2021 found that lots of health service providers expressed dissatisfaction because of the shortages as well as a loss of credibility with their patients. Furthermore, drug shortages lead to financial losses for both the hospital as well as the drug manufacturer which triggers a negative feedback loop for all parties involved. On a patient level, studies have shown that shortages also lead to more patient mortality, such as death because a patient was unable to receive the appropriate medication in time.8 These shortages do not only apply to “traditional” drugs such as the ones that come in pill form, but also vaccines which are necessary for an individual's health. For example, during the COVID-19 pandemic, Canada experienced a series of vaccine shortages because of supply issues.9 This was especially impactful since individuals who wanted immunity against the disease as well as those who were immunocompromised, could not get access to it. It is vital that mitigation strategies are developed to mediate current shortages while working to prevent future shortages.
While drug shortages are extremely detrimental, they prompt governments and corporations to find ways to prevent future shortages. Ultimately, ensuring that the healthcare system operates smoothly while also ensuring a stable flow of drugs in order to keep patients healthy and satisfied. The FDA proposed the idea of developing strategic plans, a plan on what to do in case a specific drug experiences a shortage, such as focusing on their mitigation response regarding drug shortages and its root causes. Another form of mitigation the FDA employs is permitting drugs with minor defects (such as labeling defects or particulate matter that can be filtered out prior to administration) to enter the market in case of a shortage. Developing prevention strategies to combat this public health issue focus on having multiple suppliers for drugs as well as developing more robust drug shortage reporting systems. These measurements are of utmost importance so that action can be taken to prevent wide-scale shortages.
Drug shortages are inevitable, and their causes are numerous. Internal issues such as manufacturing issues combined with external factors like high demand and world events such as COVID are all factors that contribute to delays and shortages. These shortages affect everyone in the healthcare system, especially affecting those who rely on these drugs for their treatment. By continuously developing prevention strategies, we can begin working towards a system that is well-prepared for any shortage-related issue that can arise, benefiting everyone, and making sure that patients can receive the treatment they need when they need it and with the appropriate drugs.
Reference List:
1. Shukar S, Zahoor F, Hayat K, et al. Drug Shortage: Causes, Impact, and Mitigation Strategies. Frontiers in Pharmacology. 2021;12. doi:https://doi.org/10.3389/fphar.2021.693426
2. Atif M, Sehar A, Malik I, Mushtaq I, Ahmad N, Babar ZUD. What impact does medicines shortages have on patients? A qualitative study exploring patients’ experience and views of healthcare professionals. BMC Health Services Research. 2021;21(1). doi:https://doi.org/10.1186/s12913-021-06812-7
3. Alkire M. Industry Voices—Industry reaction to shortages of lifesaving drugs underscores urgency. Fierce Healthcare. https://www.fiercehealthcare.com/hospitals-health-systems/industry-voices-industry-reaction-to-shortages-lifesaving-drugs#:~:text=One%20shortage%20drug%2C%20intravenous%20immune. Published October 30, 2019.
4. Shehata N. UpToDate. Uptodate.com. Published February 13, 2023. https://www.uptodate.com/contents/intravenous-immune-globulin-ivig-beyond-the-basics
5. ASHP. Drug Shortages Statistics - ASHP. www.ashp.org. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics?loginreturnUrl=SSOCheckOnly
6. Harapko S. How COVID-19 impacted supply chains and what comes next. www.ey.com. Published February 18, 2021. https://www.ey.com/en_ca/supply-chain/how-covid-19-impacted-supply-chains-and-what-comes-next
7. Health Canada. Infant and children’s acetaminophen and ibuprofen shortage. www.canada.ca. Published October 26, 2022. https://www.canada.ca/en/health-canada/services/drugs-medical-devices/safe-use-medication-for-children/infant-childrens-acetaminophen-ibuprofen-shortage.html#a1
8. Phuong JM, Penm J, Chaar B, Oldfield LD, Moles R. The impacts of medication shortages on patient outcomes: A scoping review. van Rein N, ed. PLOS ONE. 2019;14(5):e0215837. doi:https://doi.org/10.1371/journal.pone.0215837
9. BBC News. Why Canada is falling behind in Covid vaccinations. BBC News. Published February 12, 2021. Accessed February 27, 2023. https://www.bbc.com/news/world-us-canada-56035306
10. Food and Drug Administration. Strategic Plan for Preventing and Mitigating Drug Shortages Food and Drug Administration.; 2013. https://www.fda.gov/files/drugs/published/Strategic-Plan-for-Preventing-and-Mitigating-Drug-Shortages.pdf
11. Mazer-Amirshahi M, Pourmand A, Singer S, Pines JM, van den Anker J. Critical Drug Shortages: Implications for Emergency Medicine. Schneider S, ed. Academic Emergency Medicine. 2014;21(6):704-711. doi:https://doi.org/10.1111/acem.12389
Images
1. World Transport Association. The difference between Logistics and Supply Chain Management (SCM). www.wtagroup.com. https://www.wtagroup.com/shipping-resources/the-difference-between-logistics-and-supply-chain-management-scm
2. Pickell L. Drug Shortages: Enduring Effects, Continued Challenges of the 2011 Crisis. ASCO Connection. Published October 23, 2017. https://connection.asco.org/magazine/features/drug-shortages-enduring-effects-continued-challenges-2011-crisis
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