On January 1, 2024, the pharmaceutical company GlaxoSmithKline (GSK) discontinued production of the Flovent (fluticasone) inhaler (1). Arguably the most popular inhaler on the market, Flovent has been the standard treatment for many long-term respiratory conditions for decades, despite its 50% price increase between 2014 and 2023 (2). Likely in response to changes in Medicaid drug price regulations designed to ease prescription cost increases on consumers, GSK opted to discontinue this widely used and effective product (1, 2). Although the company has manufactured a generic form of fluticasone since 2022 and shortages are not anticipated, the anticipated consequences of the disappearance of Flovent highlight the harmful effects of medical treatments being discontinued (3).
In the pharmaceutical industry, roughly 10 treatments are withdrawn for harmful effects or, as in Flovent’s case, discontinued by manufacturers every year (4). Treatments may be discontinued for a myriad of reasons, including cost avoidance, market oversaturation (“polypharmacy”) reduction, manufacturing problems, and company objective changes (5). Discontinuation is ostensibly overseen by the Food and Drug Administration (FDA), but loose regulations and lack of penalties often results in significant communication problems between pharmaceutical companies, physicians, and patients (5). As a result, discontinuing treatments may cause delays in notification and sudden withdrawal. Patients who must abruptly stop a medication may face exacerbation of symptoms, deterioration of health, or even adverse outcomes (6, 7). Discontinuation can disrupt established care plans, lead to complications, cause rebound effects, and potentially put patients at risk, especially in patients with chronic conditions such as cardiovascular disease or mental health disorders (7, 8).
The main complications for patients and providers include communication, difficulty accessing an appropriate replacement, and financial burden. First, manufacturers are not required to alert healthcare institutions, providers, or pharmacies, which results in the lack of provider-patient communication. Because many pharmacies can continue to fill the prescription, many patients remain unaware of the discontinuation until their pharmacy no longer carries it, causing abrupt withdrawal (9). Second, the task of finding a suitable replacement for the discontinued medication may be difficult. For example, Flovent has been in the market since the 1990s, and no generics of this medication existed until 2022 (8, 10). Third, replacing a discontinued treatment often causes financial problems associated with insurance, causing problems ranging from inconvenient to dire (10, 11). In some cases, insurers will not cover replacements, resulting in excessive financial burden, while in others, they may require prior authorization, which may delay access of a medically necessary treatment.
Clear, transparent communication between healthcare providers, pharmaceutical companies, and patients is crucial to reduce harmful effects when treatments are discontinued. Although companies do not always abide by this regulation, the FDA requires that manufacturers notify them of a discontinuation 6 months in advance (5). Therefore, physicians should keep up to date with discontinuations of treatments they prescribe via their associated pharmacists and start searching for replacements before discontinuation takes effect (12, 13). Providing patients with information about the reasons for discontinuation, alternative treatment options, and potential impacts on their health empowers them to make informed decisions and participate actively in their care. In many cases, providers must advocate for their patients by requesting that insurers cover replacements, as exemplified by the American Academy of Pediatrics’ letter to insurers in response to the Flovent discontinuation (3, 10). Providers, pharmacists, pharmaceutical companies, and patient advocacy groups must work together to ensure a smooth, safe transition for patients.
References
1: Lupkin, S. 2023. “A popular asthma inhaler is leaving pharmacy shelves. Here’s what you need to know.” NPR Shots. URL: https://www.npr.org/sections/health-shots/2023/12/30/1222224197/a-popular-asthma-inhaler-is-leaving-pharmacy-shelves-heres-what-you-need-to-know.
2: Walrath-Holdridge, M. 2023. “Flovent asthma inhalers pulled from shelves and replaced with generic Jan. 1.” USA Today. URL: https://www.usatoday.com/story/news/health/2024/01/02/flovent-inhaler-discontinued-generic-replacements-available/72057813007/.
3: Meadows, J. 2024. “PBMs — how influential are they?” American College of Allergy, Asthma and Immunology Advocacy Resources. URL: https://college.acaai.org/pbms-how-influential-are-they/.
4: Siramshetty, V., Nickel, J., Omieczynski, C., Gohlke, B., Drwal, M. and Preissner, R. 2016. WITHDRAWN — a resource for withdrawn and discontinued drugs. Nucleic Acids Research, vol. 44. DOI: 10.1093/nar/gkv1192.
5: Ventola, C. 2011. The drug shortage crisis in the United States. Pharmacy and Therapeutics, vol. 36. URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278171/.
6: Stout, R., Braciszewski, J., Subbaraman, M., Kranzler, H., O’Malley, S. and Falk, D. 2015. What happens when people discontinue taking medications? Lessons from COMBINE. Addiction, vol. 109. DOI: 10.1111/add.12700.
7: Thio, S., Nam, J., van Driel, M., Dirven, T. and Blom, J. 2018. Effects of discontinuation of chronic medication in primary care: a systematic review of deprescribing trials. British Journal of General Practice, vol. 68. DOI: 10.3399/bjgp18X699041.
8: Rapaport, L. 2024. “Discontinued Flovent asthma inhaler leaves people scrambling, doctors say.” Everyday Health News. URL: https://www.everydayhealth.com/asthma/discontinued-flovent-asthma-inhaler-leaves-people-scrambling/.
9: Mankey, C. and Varkey, P. 2014. “Discontinued medications: are they really discontinued?” Patient Safety Network Case Studies. URL: https://psnet.ahrq.gov/web-mm/discontinued-medications-are-they-really-discontinued.
10: Jenco, M. 2023. “Experts call on insurers to prioritize corticosteroid medicines appropriate for children.” American Academy of Pediatrics News. URL: https://publications.aap.org/aapnews/news/27474/Experts-call-on-insurers-to-prioritize.
11: Neighmond, P. 2020. “When insurance won’t cover drugs, Americans make ‘tough choices’ about their health.” NPR Shots. URL: https://www.npr.org/sections/health-shots/2020/01/27/799019013/when-insurance-wont-cover-drugs-americans-make-tough-choices-about-their-health.
12: Beck, K., Chen, B. and Gordon, B. 2017. Physician approaches to drug shortages: results of a national survey of pediatric hematologists/oncologists. World Journal of Clinical Oncology, vol. 8. DOI: 10.5306/wjco.v8.i4.336.
13: Paulsen, E. 2019. “Tips to prepare for and respond to medication shortages.” Duke Health Practice Management. URL: https://physicians.dukehealth.org/articles/tips-prepare-and-respond-medication-shortages.
