Causes and Management of Drug Shortages in Hospitals

Main Article Content

Wipanee Uraisakul

Abstract

Drug shortage is one of the key factors affecting the efficacy and safety of drug and quality of life among patients. The problem is caused by a number of factors, such as supply and demand balance, production, import, transportation and business factors. The application of risk assessment to establish guidelines in hospitals can reduce the impact on patients. Such guidelines include problem-reporting, formation of a team to assess drug shortages, verification of drug shortages, assessing the patient's need for medication, evaluation of alternative medicines for treatment, analysis of impacts on the hospital’s drug system, preparation of an action plan, communication of information and implementation of plans and evaluations.  Although many countries have paid attention to the problem and implemented measures to reduce the impact of the drug shortage, this problem still exists and continuously affecting patients. Therefore, taking proactive actions and establishing an action plan in the hospital so that personnel can respond immediately when the shortage arises will help prevent and minimize the impact on patients.

Article Details

Section
Research Articles

References

Shukar S, Zahoor F, Hayat K, Saeed A, Gillani AH, Omer S, et al. Drug shortage: causes, impact, and mitigation strategies. Front Pharmacol 2021; 12: 693426. doi: 10.3389/fphar.2021.69342.

Mazer-Amirshahi M, Pourmand A, Singer S, Pines JM, van den Anker J. Critical drug shortages: implications for emergency medicine. Acad Emerg Med 2014; 21: 704-11. doi: 10.1111/acem.12389.

Phuong JM, Penm J, Chaar B, Oldfield LD, Moles R. The impacts of medication shortages on patient outcomes: a scoping review. PLoS One 2019; 14: e0215837. doi: 10.1371/journal.pone.0215837.

Ventola CL. The drug shortage crisis in the United States. P&T 2011; 36: 740-57. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3278171/

Miljkovic N, Godman B, Kovacevic M, Polidori P, Tzimis L, Hoppe-Tichy T, et al. Prospective risk assessment of medicine shortages in Europe and Israel: findings and implications. Front Pharmacol 2020; 11: 357. doi: 10.3389/fphar.2020.00357.

National Drug Information. List of drug shortages in situation of COVID-19 pandemic [online]. 2022 [cited Oct 25, 2022]. Available from: ndi.fda.moph.go.th/ndi _news_detail/index/301

Cameron EE, Bushell MA. Analysis of drug shortages across two countries during pre-pandemic and pandemic times. Res Social Adm Pharm 2021; 17: 1570-73.

Schwartzberg E, Ainbinder D, Vishkauzan A, Gamzu R. Drug shortages in Israel: regulatory perspectives challenges and solutions. Isr J Health Policy Res 2017; 6: 17. doi: 10.1186/s13584-017-0140-9.

Poulsen JH, Clemmensen MH, Nørgaard LS, Dieckmann P. Prospective risk assessments of patient safety events related to drug shortages in hospitals: three actor-level perspectives. Explor Res Clin Soc Pharm 2021; 3: 100055. doi: 10.1016/j.rcso p.2021.100055.

Socal MP, Sharfstein JM, Greene JA. The pandemic and the supply chain: gaps in pharmaceutical production and distribution. Am J Public Health 2021; 111: 635–39. doi:10.2105/AJPH.2020.306138.

Al Zoubi S, Gharaibeh L, Jaber HM, Al-Zoubi Z. Household drug stockpiling and panic buying of drugs during the COVID-19 pandemic: a study from Jordan. Front Pharmacol 2021; 12: 813405. doi: 10.3389/fphar.2021.813405.

Kostev K, Lauterbacha S. Panic buying or good adherence? Increased pharmacy purchases of drugs from wholesalers in the last week prior to Covid-19 lockdown. J Psychiatr Res 2020; 130: 19–21. doi: 10.1016/j.jpsychires.2020.07.005.

Elek P, Bíró A, Fadgyas‐Freyler P. Income gradient of pharmaceutical panic buying at the outbreak of the COVID‐19 pandemic. Health Econ 2021; 30: 2312-20. doi: 10.1002/hec.4378.

Musazzi UM, Giorgio DD, Minghetti P. New regula- tory strategies to manage medicines shortages in Europe. Int J Pharm 2020; 579: 119171. doi: 10.101 6 /j.ijpharm.2020.119171.

Dill S, Ahn J. Drug shortages in developed countries reasons, therapeutic consequences, and handling. Eur J Clin Pharmacol 2014; 70: 1405-12. doi: 10.100 7/s00228-014-1747-1.

Wechsler J. Drug shortages reveal GMP concerns [online]. 2002 [cited Oct 27, 2022]. Available from: www.pharmtech.com/view/drug-shortages-reveal-gmp-concerns

Chatterjee P. Indian pharma threatened by COVID-19 shutdowns in China. Lancet 2020; 395: 675. doi: 10.1016/S0140-6736(20)30459-1.

Ayati N, Saiyarsarai P, Nikfar S. Short and long term impacts of COVID-19 on the pharmaceutical sector. DARU J Pharm Sci 2020; 28: 799–805. doi: 10.1007/s40199-020-00358-5.

Pharmaceutical Inspection Convention Pharmaceu tical Inspection Co-operation Scheme. Guide to good manufacturing practice for medicinal products part I [online]. 2022 [cited Oct 17, 2022]. Available from: picscheme.org/en/publications?tri=gmp#zone

Gray A, Manasse Jr HR. Shortages of medicines: a complex global challenge. Bull World Health Organ 2012; 90: 158–158A. doi: 10.2471/BLT.11.101303.

Chokwiwat W, editors. Thai drug system 2020. Vol 1.Bangkok: Health Systems Research Institute; 2021.

Arnum PV. Global API market: crunching the num bers [online]. 2022 [cited Oct 27, 2022]. Available from: www.dcatvci.org/features/global-api-market-cr unching-the-numbers/

Alruthia YS, Alwhaibi M, Alotaibi MF, Asiri SA, Alghamdi BM, Almuaythir GS, et al. Drug shortages in Saudi Arabia: root causes and recommendations. Saudi Pharm J 2018; 26: 947-51. doi: 10.1016/j.jsp s.2018.05.002.

Awad H, Al-Zu'Bi ZMF, Abdallah AB. A quantitative analysis of the causes of drug shortages in Jordan: A supply chain perspective. Int Bus Res. 2016; 9: 53-63. doi:10.5539/ibr.v9n6p53.

Center for Drug Evaluation and Research. Risk management plans to mitigate the potential for drug shortages [online]. 2022 [cited Nov 2, 2022]. Available from: www.fda.gov/regulatory-information/ search-fda-guidance-documents/risk-management-plans-mitigate-potential-drug-shortages

European Medicines Agency. ICH guideline Q9 on quality risk management [online]. 2015 [cited Nov 10, 2022] Available from: www.ema.europa.eu/en/ documents/scientific-guideline/international-conferen ce-harmonisation-technical-requirements-registratio n-pharmaceuticals-human-use_en-3.pdf

Pascarella G, Rossi M, Montella E, Capasso A, Feo GD, Nardone A, et al. Risk analysis in healthcare organizations: methodological framework and critical variables. Risk Manag Healthc Policy 2021; 14: 2897 -911. doi: 10.2147/RMHP.S309098.

VHA National Center for Patient Safety. Healthcare failure mode and effect analysis (HFMEA) [online]. 2021 [cited Nov 12, 2022]. Available from: www.pa tient safety.va.gov/professionals/onthejob/hfmea.asp

Fox ER, McLaughlin MM. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm 2018; 75: 1742-50. doi:10.2146/ajhp180441.

Chen E, Goold S, Harrison S, Ali I, Makki I, Kent SS, et al. Drug shortage management: A qualitative assessment of a collaborative approach. PLoS One. 2021; 16: e0243870.