Gestión de riesgos en la cadena de suministro farmacéutica: revisión de estrategias para prevenir desabastecimientos
DOI:
https://doi.org/10.53591/0vyf3f21Palabras clave:
gestión de riesgos; cadena de suministro farmacéutica; desabastecimiento de medicamentos; resiliencia logística; abastecimiento farmacéutico.Resumen
Los desabastecimientos de medicamentos constituyen un desafío creciente para los sistemas de salud debido a la complejidad y vulnerabilidad de la cadena de suministro farmacéutica. El objetivo de esta revisión fue identificar y analizar la evidencia científica reciente sobre los principales riesgos que afectan la disponibilidad de medicamentos y las estrategias implementadas para prevenir desabastecimientos. Se realizó una revisión sistemática de literatura publicada entre 2020 y 2025. La pregunta se estructuró mediante PCC: cadenas de suministro farmacéuticas en sistemas de salud (P), riesgos y estrategias de mitigación/resiliencia (C) y disponibilidad y continuidad del suministro de medicamentos (C). La estrategia contempló PubMed, Scopus, Web of Science, ScienceDirect y Google Scholar como fuente complementaria. La evidencia seleccionada mostró cinco grupos recurrentes de riesgo: manufactura y calidad, concentración de proveedores y producción, logística e inventarios, demanda y comportamiento del mercado, y factores regulatorios/geopolíticos. Se concluye que la gestión integral de riesgos es esencial para garantizar la continuidad del acceso a medicamentos esenciales. Las estrategias con mayor convergencia fueron diversificación de fuentes, inventarios de seguridad diferenciados por criticidad, mecanismos de alerta temprana, visibilidad digital, coordinación entre actores, producción geográficamente diversificada y planes formales de mitigación.
Referencias
Acosta, A., Vanegas, E. P., Rovira, J., Godman, B., & Bochenek, T. (2019). Medicine shortages: Gaps between countries and global perspectives. Frontiers in Pharmacology, 10. doi:https://doi.org/10.3389/fphar.2019.00763
Adewumi, G., Dada, S. A., Azai, J. S., & Oware. (2024). A systematic review of strategies for enhancing pharmaceutical supply chain resilience in the U.S. International Medical Science Research Journal, 4(11), 961-972. doi:https://doi.org/10.51594/imsrj.v4i11.1711
AlRuthia, Y., Almutiri, N. M., Almutairi, R. M., Almohammed, O., Alhamdan, H., El-Haddad, S. A., & Asiri, Y. A. (2023). Local causes of essential medicines shortages from the perspective of supply chain professionals in Sau-di Arabia. Saudi Pharmaceutical Journal, 31(6), 948-954. https://doi.org/10.1016/j.jsps.2023.04.019
Aromataris, E., & Munn, Z. (2024). JBI Manual for Evidence Synthesis. Joanna Briggs Institute. Obtenido de JBI Manual for Evidence Synthesis. Joanna Briggs Institute.: https://doi.org/10.46658/JBIMES-20-01
ASPE. (2024). Department of Health and Human Services. Obtenido de Policy considerations to prevent drug shortages and mitigate supply chain vulnerabilities in the United States. U.S.: https://aspe.hhs.gov/reports/preventing-shortages-supply-chain-vulnerabilities
Atif, M., Sehar, A., Malik, I., Mushtaq, I., Ahmad, N., & Babar, Z.-U.-D. (2021). What impact does medicines shortages have on patients? A qualitative study exploring patients' experience and views of healthcare professionals. Journal of Pharmaceutical Policy and Practice, 14, 63
Badejo, O. (2024). Enhancing pharmaceutical supply chain resilience: A multi-objective study with disruption management. Computers & Chemical Engineering. Obtenido de https://www.sciencedirect.com/science/article/pii/S009813542400187X?via%3Dihub
Bade, C., Olsacher, A., Boehme, P., Truebel, H., Fehring, L., et al. (2023). Reasons for supply side driven drug shortages: A mixed-methods study on first-level, higher-level, and root causes from the perspective of marketing authorization holders. Research in Social and Administrative Pharmacy, 19(8), 1218-1227. https://doi.org/10.1016/j.sapharm.2023.05.007
Broughel, J. (2022). Allowing compounding pharmacies to address drug shortages. Journal of Law and the Bioscienc-es, 9(1).
Bapatla, A. K., Mohanty, S. P., & Kougianos, E. (2022). PharmaChain: A Blockchain to Ensure Counterfeit Free Pharmaceutical Supply Chain. arXiv. Obtenido de https://arxiv.org/abs/2202.02592
Bilal, A. I., Bititci, U. S., & Fenta, T. G. (2024). Effective Supply Chain Strategies in Addressing Demand and Supply Uncertainty: A Case Study of Ethiopian Pharmaceutical Supply Services. Pharmacy, 12(5), 132. doi:https://doi.org/10.3390/pharmacy12050132
Booth, A., Sutton, A., & Papaioannou, D. (2022). Systematic approaches to a successful literature review. Sage Publications.
Campbell, M., McKenzie, J. E., Sowden, A., Katikireddi, S. V., Brennan, S. E., Ellis, S., et al. (2020). Synthesis without meta-analysis (SWiM) in systematic reviews: Reporting guideline. BMJ, 368, l6890. https://doi.org/10.1136/bmj.l6890
Dienes, B. B., Qorri, D., & Felföldi, J. (2024). Pharma supply chain resilience: A systematic review. Applied Studies in Agribusiness and Commerce, 18(1). Obtenido de https://doi.org/10.19041/APSTRACT/2024/1/8
European Medicines Agency. (2024). Guidance for industry on implementing shortage mitigation plans. EMA.
European Medicines Agency. (2025). European Shortages Monitoring Platform (ESMP). EMA.
Food and Drug Administration. (2020). Drug shortages: Root causes and potential solutions. U.S. Food and Drug Administration.
Food and Drug Administration. (2024). Drug shortages report to Congress: Calendar year 2024. U.S. Food and Drug Administration.
Food and Drug Administration. (2026). Drug shortages. U.S. Food and Drug Administration.
Gentile, T., Snee, I., Heinrichs, D., Hockstein, M. A., Mazer-Amirshahi, M., & Fox, E. R. (2024). The empty code cart: Drug shortages over time. American Journal of Health-System Pharmacy, 81(17), e543-e547. https://doi.org/10.1093/ajhp/zxae150
Goswami, A., Baveja, A., & Ding, X. e. (2024). An integrated framework for modeling pharmaceutical supply chains with disruptions and risk mitigation. Ann Oper Res. Obtenido de https://link.springer.com/article/10.1007/s10479-024-06381-y
Guo, Y., Liu, F., Song, J.-S., & Wang, S. (2025). Supply chain resilience: A review from the inventory management perspective. Fundamental Research, 5(2), 450-463. doi:https://doi.org/10.1016/j.fmre.2024.08.002
Hong, J., Song, S., Hung Lau, K., & Zhaoa, N. (2026). Enhancing pharmaceutical supply chains: unveiling the power of digital control tower through stress testing. International Journal of Logistics Research and Applications, 29(5), 577–604. doi:https://doi.org/10.1080/13675567.2025.2477178
Iyengar, S., Hedman, L., & Forte, G. e. (2016). Escasez de medicamentos: un comentario sobre las causas y las estrategias de mitigación. BMC Med.
Jaberidoost, M., Nikfar, S., Abdollahiasl, A., & Dinarvand, R. (2013). Pharmaceutical supply chain risks: A systematic review. DARU Journal of Pharmaceutical Sciences, 21(69), 1-7. doi:https://doi.org/10.1186/2008-2231-21-69
JBI. (2024). JBI manual for evidence synthesis. Joanna Briggs Institute.
Jifar, W. W., Geneti, G. B., & Dinssa, S. D. (2022). The impact of COVID-19 on pharmaceutical shortages and supply disruptions for non-communicable diseases among public hospitals of South West, Oromia, Ethiopia. Journal of Multidisciplinary Healthcare, 15, 1933-1943. https://doi.org/10.2147/JMDH.S377319
Lee, Y. H., An, D., Baek, Y., Yoo, K., Hyun, S., Park, S.-K., & Lee, E.-K. (2024). Factors influencing drug shortages and their resolution in South Korean community pharmacies. Risk Management and Healthcare Policy, 17, 2083-2095. https://doi.org/10.2147/RMHP.S473859
Miljković, N., Polidori, P., Leonardi Vinci, D., Kuruc Poje, D., Makridaki, D., Kohl, S., & Süle, A. (2024). Results of EAHP's 2023 shortages survey. European Journal of Hospital Pharmacy. https://pubmed.ncbi.nlm.nih.gov/38307707/
National Academies of Sciences, Engineering, and Medicine. (2022). Building resilience into the nation's medical product supply chains. The National Academies Press. https://doi.org/10.17226/26434
Postma, D. J., Notenboom, K., De Smet, P. A. G. M., Leufkens, H. G. M., & Mantel-Teeuwisse, A. K. (2022). Impact of medicine shortages on patients-a framework and application in the Netherlands. BMC Health Services Research, 22, 1366. https://doi.org/10.1186/s12913-022-08765-x
Postma, D. J., Notenboom, K., De Smet, P. A. G. M., Leufkens, H. G. M., & Mantel-Teeuwisse, A. K. (2023). Medicine shortages: Impact behind numbers. Journal of Pharmaceutical Policy and Practice, 16, 44. https://doi.org/10.1186/s40545-023-00548-x
Poulsen, J. H., Clemmensen, M. H., Nørgaard, L. S., & Dieckmann, P. (2021). Prospective risk assessments of patient safety events related to drug shortages in hospitals: Three actor-level perspectives. Exploratory Research in Clinical and Social Pharmacy, 3, 100055. https://doi.org/10.1016/j.rcsop.2021.100055
Poulsen, J. H., Dieckmann, P., Clemmensen, M. H., & Nørgaard, L. S. (2022). Drug shortages in hospitals: Actors' perspectives. Research in Social and Administrative Pharmacy, 18(4), 2615-2624. https://doi.org/10.1016/j.sapharm.2021.05.001
Roshani, A., Walker-Davies, P., & Parry, G. (2024). Designing resilient supply chain networks: a systematic literature review of mitigation strategies. Ann Oper Res, 1267–1332. Obtenido de https://link.springer.com/article/10.1007/s10479-024-06228-6
Sabogal De La Pava, M. L., & Tucker, E. L. (2023). Effects of geopolitical strain on global pharmaceutical supply chain design and drug shortages. arXiv. Obtenido de https://doi.org/10.48550/arXiv.2308.07434
Sanket, J. S., & Patel, N. A. (2024). Review on pharmaceutical supply chain resilience: Strategies for managing disruptions and ensuring continuity. World Journal of Current Medical and Pharmaceutical Research, 6(3). Obtenido de https://wjcmpr.org/index.php/journal/article/view/341
Santhireswaran, A., Chaudhry, S., Ho, M., Fuller, K., Gaudette, E., Burry, L., & Tadrous, M. (2025). Impact of supply chain disruptions and drug shortages on drug utilization: A scoping review. Pharmacoepidemiology and Drug Safe-ty, 34(7), e70178. https://doi.org/10.1002/pds.70178
Shukar, S., Zahoor, F., Hayat, K., Saeed, A., Gillani, A. H., Omer, S., Hu, S., Babar, Z.-U.-D., Fang, Y., & Yang, C. (2021). Drug shortage: Causes, impact, and mitigation strategies. Frontiers in Pharmacology, 12, 693426. https://doi.org/10.3389/fphar.2021.693426
Socal, M. P., Sharfstein, J. M., & Greene, J. A. (2021). The pandemic and the supply chain: Gaps in pharmaceutical production and distribution. American Journal of Public Health, 111(4), 635-639. https://doi.org/10.2105/AJPH.2020.306138
Socal, M. P., Crane, M. A., & Anderson, G. F. (2024). Global production of active pharmaceutical ingredients for US generic drugs experiencing shortages. JAMA, 331(20), 1763-1765. https://doi.org/10.1001/jama.2024.5296
Socal, M. P., Acha, J., Yang, C.-Y., Sun, Y., Dada, M., Dai, T., Anderson, G., & Ballreich, J. (2025). Key drivers and mitigation strategies of oncology drug shortages 2023 to 2025. The Cancer Journal, 31(5), e0791. https://doi.org/10.1097/PPO.0000000000000791
Snyder, H. (2019). Literature review as a research methodology: An overview and guidelines. Journal of Business Research, 333–339. doi:https://doi.org/10.1016/j.jbusres.2019.07.039
Tucker, E. L., & Daskin, M. S. (2022). Pharmaceutical supply chain reliability and effects on drug shortages. Computers & Industrial Engineering. Obtenido de https://www.sciencedirect.com/science/article/pii/S036083522200328X?via%3Dihub
WHO. (2024). World Health Organization. Obtenido de Shortages impacting access to glucagon-like peptide 1 receptor agonist products; increasing the potential for falsified versions.: https://www.who.int/news/item/29-01-2024-shortages-impacting-access-to-glucagon-like-peptide-1-receptor-agonist-products--increasing-the-potential-for-falsified-versions?utm_source=chatgpt.com
Wong, W. P., Saw, P. S., Jomthanachai, S., Wang, L. S., Ong, H. F., & Lim, C. P. (2023). Digitalization enhancement in the pharmaceutical supply network using a supply chain risk management approach. Scientific Reports. Obtenido de https://www.nature.com/articles/s41598-023-49606-z
Wright, A., Snowdon, A., Saunders, M., & Trampas, D. (2024). The necessity of healthcare supply chain resilience for crisis preparedness. Healthcare Management Forum, 7(2), 95-100. doi:doi:10.1177/08404704231207386
Yang, Y. T., Socal, M., & Bennett, C. L. (2024). Addressing the drug-shortage crisis in oncology. JAMA Oncology, 10(2), 155-156. https://doi.org/10.1001/jamaoncol.2023.5722
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Derechos de autor 2026 karina Gaibor García
Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial-SinDerivadas 4.0.
