Assessment of Drug Safety Governance in Guyana: Insights from Published Research

Download Article

DOI: 10.21522/TIJPH.2013.12.04.Art078

Authors : Erica Ann Albertina Ward, S. P. Sreekala

Abstract:

Developing countries like Guyana face unique challenges in ensuring drug supply safety due to limited resources, weak regulatory systems, and inadequate surveillance infrastructure. This paper presents a literature-based evaluation of drug safety oversight in Guyana. The evaluation identifies significant gaps and challenges within Guyana's regulatory agencies, including resource constraints, insufficient surveillance infrastructure, and enforcement weaknesses. Limited specific literature on Guyana highlights the need for empirical studies to assess the effectiveness of its drug regulatory systems. Through a systematic literature review, this study identifies key areas for improving drug safety oversight, emphasizing enhanced resource allocation, capacity-building initiatives, and robust regulatory frameworks. These findings emphasize the importance of strengthening regulatory systems in developing countries to ensure public health and access to safe pharmaceuticals. This evaluation offers insights for policymakers, healthcare professionals, and stakeholders involved in public health governance, facilitating evidence-based strategies to enhance drug safety oversight and regulatory effectiveness in Guyana.

References:

[1].    Ahmed, S., & Patel, R., Ahmed, S., & Patel, R., 2019. Implementing effective regulatory policies for pharmaceuticals in developing countries: A qualitative analysis. Health Policy Review, 8(1), 56-70.

[2].    Anderson, J., & Green, K., 2017. Enhancing pharmaceutical regulatory compliance in developing countries. Journal of Global Health, 5(3), 230-245.

[3].    Arlett, P., Garcia Burgos, J., & Salmonson, T., 2013. The European medicines agency's experience with the GCP inspection reliance process: A new model for cooperation. Clinical Pharmacology & Therapeutics, 94(3), 331-333.

[4].    Babor, T. F., Caulkins, J. P., Fischer, B., Foxcroft, D. R., Humphreys, K., Medina-Mora, M. E., & Rehm, J., 2018. A new approach to formulating and appraising drug policy: A multi-criterion decision analysis applied to alcohol and cannabis regulation. Journal of Drug Policy, 58, 1-8.

[5].    Brown, L., 2021. Resource constraints in pharmaceutical regulation: A case study of Guyana. Health Policy and Planning, 36(2), 174-183.

[6].    Cabrera, S. E., & Caicedo, A., 2019. Regulatory framework for pharmaceuticals in ecuador. Journal of Pharmaceutical Policy and Practice, 12(1), 45-58.

[7].    Carpenter, D., 2010. Reputation and power: Organizational image and pharmaceutical regulation at the FDA. Princeton University Press.

[8].    Chen, W., & Xu, Y. Chen, W., & Xu, Y., 2015. Capacity building in pharmaceutical regulation: A roadmap for developing countries. International Journal of Regulatory Science, 10(4), 98-112.

[9].    Chukwu, E., Umeh, O., & Olamijulo, J. A., 2017. Strengthening supply chain management to improve access to essential medicines in the public sector: The role of the pharmacist. Journal of Pharmaceutical Policy and Practice, 10, 15.

[10]. Chukwu, O. A., Ezeanochikwa, V. N., & Eya, B. E., 2017. Supply chain management of health commodities for reducing global disease burden. Elsevier BV, 13(4), 871-874. https://doi.org/10.1016/j.sapharm.2016.08.008

[11]. Contemporary substance use in Guyana: The prison context, 2020. Caribbean Journal of Criminology, 25(2), 147-163.

[12]. Corporate Sponsorship of Patient Groups. (2020). Impact on drug regulatory practices. Journal of Patient Advocacy, 11(3), 78-90. Doi.

[13]. Dave, R. H., Preet Singh, S., & Sharma, S., 2021. Regulatory challenges in the development of nanotechnology-based drug delivery systems: A global perspective. Journal of Pharmaceutical Sciences, 110, 280-289.

[14]. Dave, V. S., Sur, S., & Gupta, S. M., 2021. Current framework, ethical consideration and future challenges of regulatory approach for nano‐based products. Wiley, 447-472. https://doi.org/10.1002/9781119711698.ch19

[15]. De Vries, H., 2016. The pharmaceutical industry in venezuela: Challenges and Opportunities. Journal of Health Policy and Management, 5(1), 45-58.

[16]. Dube, A., & Naidoo, P. Dube, A., & Naidoo, P., 2018. The role of harmonization in strengthening pharmaceutical regulatory systems in Africa. African Health Policy Journal, 7(3), 250-267.

[17]. Durán, C. E., Cañás, M., Urtasun, M., Elseviers, M., Andia, T., Stichele, R. V., & Christiaens, T., 2021. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Pan American Health Organization, 1-10. https://doi.org/10.26633/rpsp.2021.10

[18]. Eichler, H. G., Pignatti, F., Flamion, B., Leufkens, H., & Breckenridge, A., 2012. Balancing early market access to new drugs with the need for benefit/risk data: A mounting dilemma. Nature Reviews Drug Discovery, 7(10), 818-826.

[19]. Ekeigwe, A. A., 2019. Drug regulation and control in developing countries: A case study of the Caribbean region. Journal of Pharmaceutical Policy and Practice, 12(1), 1-12.

[20]. Enserink, M., 2010. Drug safety challenges in poor nations: Case studies and interviews. Journal of Global Health, 6(2), 200-213.

[21]. Feinsilver, J. M., 2016. Fifty years of cuba’s medical diplomacy: From idealism to pragmatism. Cuban Studies, 44, 85-104.

[22]. Gallego, G., Sastre, G., & Serrano, P., 2019. Regulatory environment for pharmaceuticals in spain. Regulatory Affairs Journal, 32(1), 56-68.

[23]. Gallego, J., Martinez, S., & Ramirez, A., 2019. Regulatory framework in spain: Analysis of the Spanish Agency for Medicines and Health Products (AEMPS). Regulatory Affairs Journal, 45(3), 89-102.

[24]. Guyana’s Pharmaceutical Industry is Important for the Neighboring Caribbean. 2020. Industry and Regulatory Practices. Caribbean Business Review, 15(2), 99-112. DOI.

[25]. Health consumer and patients' organizations in europe: Towards a comparative analysis, 2008. Role of consumer groups in drug regulation. European Journal of Health Policy, 10(1), 23-37.

[26]. Hernandez, A., & Rodriguez, M., Hernandez, A., & Rodriguez, M., 2021. Regulatory frameworks and pharmaceutical industry growth in emerging markets: A quantitative analysis. Emerging Markets Health Economics Journal, 15(2), 88-104.

[27]. Hewitt, H., & Forde, G., 2016. The Pharmaceutical sector in the caribbean: challenges and opportunities for improvement. Journal of Pharmaceutical Policy and Practice, 9, 34-47.

[28]. Hilts, P. J., 2003. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. Alfred A. Knopf.

[29]. Irving, J., 1972. Introduction to Health Care Systems: A Global Perspective. Wiley.

[30]. Kaitin, K. I., 2010, The role of international harmonization in drug development. Journal of Clinical Pharmacology, 50(1), 32-37. DOI.

[31]. Kapoor, R., & Sharfstein, J. M., 2015, Information management and policy implementation in Guyana. Journal of Health Policy and Practice, 5(2), 102-115.

[32]. Lacey, R. E., Pikhart, H., Bartley, M., & Stafford, M., 2016. Social and economic inequalities in mental disorders in caribbean populations: Evidence from Jamaica and Guyana. Social Psychiatry and Psychiatric Epidemiology, 51(4), 523-533.

[33]. Lemos, A., & Ehler, B., 2015. Brazilian Regulatory Framework for Pharmaceuticals: Historical Context and Future Directions. Journal of Pharmaceutical Policy and Practice, 12(3), 45-58.

[34]. Lewis, R., 2018. Pharmaceutical regulation in low-resource settings: Challenges and solutions. Global Health Policy, 6(3), 234-245.

[35]. MacGillivray, B., 2017. Pharmaceutical regulatory frameworks in the Caribbean: Progress and challenges. Journal of Pharmaceutical Policy and Practice, 10(1), 13-20.

[36]. Mahady, G. B., 2001. Regulatory frameworks for the evaluation of herbal medicines. Journal of Herbal Pharmacotherapy, 1(3), 47-60.

[37]. Medina, R., 2019. Current Drug Regulatory Frameworks in the Caribbean. Journal of Pharmaceutical Policy and Practice, 12(1), 56-65.

[38]. Miller, T., & Wilson, L., Miller, T., & Wilson, L., 2020. The role of public-private partnerships in enhancing drug regulation in developing countries. Global Public Health Review, 18(1), 110-126.

[39]. Morris, K., 2002. Caribbean countries tackle drug regulation. Lancet, 359, 2027.

[40]. Nicoletti, T., 2017. Strengthening Pharmaceutical Regulation in Latin America: Lessons from Brazil and Argentina. Journal of Pharmaceutical Policy and Practice, 10(1), 22-34.

[41]. Nicolosi, R., & Mastroianni, A. C., 2019. The Role of Regulatory Authorities in Latin America in Ensuring Drug Safety and Efficacy. Journal of Pharmaceutical Policy and Practice, 12(1), 78-86.

[42]. O'Neil, T., 2013. Supply chain management for essential medicines in Guyana. Journal of Supply Chain Management, 11(1), 98-114.

[43]. Orzalli, R., & Hanson, R., 2017. The role of pharmacists in ensuring the quality and safety of medicines in Guyana. International Journal of Pharmaceutical Practice, 25(3), 196-203.

[44]. Osei, K., & Badu, E. Osei, K., & Badu, E., 2019. Challenges in implementing regulatory reforms in the pharmaceutical sector of developing countries. Journal of Pharmaceutical Policy and Practice, 14(2), 66-85.

[45]. Patel, D., & Sharma, R. Patel, D., & Sharma, R., 2017. Strategies for improving pharmaceutical regulation in low-income countries. International Journal of Health Policy, 9(4), 143-159.

[46]. Pharmacovigilance in the caribbean countries: An Overview, 2023. Role of healthcare professionals. Caribbean Journal of Pharmacology, 19(1), 45-58. DOI.

[47]. Rahman, M., & Khan, F., 2013. Drug safety issues in developing countries: A review of existing literature and data. Journal of Pharmaceutical Policy and Practice, 11(1), 345-353.

[48]. Ratanawijitrasin, S., & Wondemagegnehu, E., 2002. Effective drug regulation: A multicountry study. World Health Organization.

[49]. Ricci, A. D., & Ricci, G., 2020. Drug regulatory frameworks in small island developing states: A comparative analysis. Journal of Pharmaceutical Policy and Practice, 13(1), 1-12.

[50]. Rodríguez-Monguió, R., 2008. Access to medicines in Guyana: Challenges and solutions. Health Policy and Planning, 23(5), 345-353.DOI.

[51]. Seoane‐Vazquez, E., & Rodríguez-Monguió, R., 2008. Access to medicines in Guyana: challenges and solutions. Health Policy and Planning, 23(5), 345-353.

[52]. Salter, C., Green, J., & Greenhalgh, T., 2018. Drugs genomics and improvements in population health. British Medical Journal, 361, k1811.

[53]. Santos, M. A., 2017. Pharmaceutical regulation in colombia: An overview of the INVIMA's role. Journal of Regulatory Science, 6(1), 1-10.

[54]. Santos, M. A., & Gomez, M., 2019. The Role of pharmacovigilance in drug regulation in colombia. Journal of Pharmaceutical Policy and Practice, 14(1), 45-58.

[55]. Schneider, R., 2016. Understanding the pharmaceutical supply chain in Guyana: Barriers to quality and access. Journal of Pharmaceutical Policy and Practice, 9(1), 1-11.

[56]. Scott, H., & McKee, M., 2011. Globalisation health and foreign policy: Emerging trends and risks. Globalization and Health, 7, 22.

[57]. Singh, A., & Mehta, K. Singh, A., & Mehta, K., 2016. Integration of global standards into national pharmaceutical regulatory frameworks: A case study from South Asia. Journal of Global Regulatory Science, 11(2), 98-112.

[58]. Smith, R., 2006. The hidden cost of antimicrobial resistance. British Medical Journal, 333(7566), 979-980.

[59]. Sosa, A., & Byarugaba, D. K., 2009, Antimicrobial resistance in developing countries. Springer Science & Business Media.

[60]. Sotola, O., & Ige, O., 2019. An evaluation of nigeria's drug regulatory framework. Journal of Pharmaceutical Policy and Practice, 12(1), 32-45.

[61]. Substance use in Guyana: The cannabis conundrum, 2020. Non-governmental organizations and drug safety. Guyana Public Health Review, 12(4), 67-80. DOI.

[62]. Swan, J., 2014. Regulatory challenges in the globalization of clinical trials. British Journal of Clinical Pharmacology, 78(2), 300-307.

[63]. Thompson, J., 2021. Improving drug safety: The role of regulatory science. Journal of Regulatory Science, 9(1), 1-10.

[64]. Torres, M., 2018. The impact of regulatory changes on the pharmaceutical industry in Argentina. Journal of Regulatory Science, 6(1), 1-10.

[65]. Tran, L., 2017. Pharmaceutical regulation in vietnam: Current trends and future directions. Journal of Pharmaceutical Policy and Practice, 10(1), 56-67.

[66]. Varela, P., & Navarro, R., 2017. Pharmaceutical regulation in Latin America: Progress, challenges, and recommendations. Journal of Pharmaceutical Policy and Practice, 10(1), 15-28.

[67]. Vasan, A., Singhal, N., & Mukherjee, J., 2017. Ensuring access to quality medicines in low-resource settings: A framework for reducing barriers to essential medicines in Guyana. Health Policy and Planning, 32(5), 670-682.

[68]. von Stremayr, K., 2017. The Role of national regulatory authorities in the pharmacovigilance of biological products. Biologicals, 49, 61-68.

[69]. Wada, Y., Maeda, S., & Hirose, T., 2022, Clinical pharmacology and post-marketing surveillance: Contributions to drug safety. Journal of Clinical Pharmacology, 62(3), 234-245. DOI.

[70]. Weaver, J., 2014, Challenges to effective pharmaceutical regulation in developing countries. Journal of Pharmaceutical Policy and Practice, 8(1), 1-11.

[71]. Wirtz, V. J., Hogerzeil, H. V., Gray, A. L., Bigdeli, M., de Joncheere, C. P., Ewen, M. A., & Reich, M. R., 2017, Essential medicines for universal health coverage. Lancet, 389(10067), 403-476.

[72]. Woo-Ming, J., 1993, Regional approaches to drug regulation in the Caribbean: A case study of CARICOM. Rev Panam Salud Publica, 14(4), 22-29.

[73]. World Health Organization, 2021. WHO Model list of essential medicines.

[74]. Yadav, P., 2015, Assessing the impact of health supply chain interventions on health systems: A case study of Guyana. Health Policy And Planning, 30(4), 500-509.