Pharmacovigilance core indicators practices in some health facilities in Osun state, Nigeria

https://doi.org/10.51412/psnnjp.2023.19

Authors

Keywords:

Pharmacovigilance, WHO core indicators, Adverse Drug Reactions

Abstract

Background: World Health Organization pharmacovigilance core indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Following the limited information on adverse reactions reporting in some institutions, the study assessed the status of pharmacovigilance in tertiary and secondary hospital facilities in Osun State, Nigeria with a view towards improving the pharmacovigilance system. Methods: A cross-sectional descriptive survey was conducted in the two tertiary hospitals and eight state hospitals in Osun State. The data was assessed using modified WHO core pharmacovigilance indicators

Results: Characteristics of the health facilities included the number of hospital beds; Tertiary 920(70.67%), Secondary 346(29.33%); Hospital workers, Doctors 1044(41.45%), Nurses 1395(55.38%), Pharmacists 80(3.18%) and Number of Out-patients 300915(95.49%)/ In-patients 14199(4.51%).All facilities had a pharmacovigilance focal person responsible for pharmacovigilance activities. None of the facilities had a financial provision for pharmacovigilance activities. All the centers had standard adverse drug reactions reporting form. On Core Processing Indicators (CPI) the absolute value of ADR reports received in ten hospitals in the previous year ranged from 0 to 17. The total reports in the local database ranged from 2 to 76. There were no adequate data to assess other parameters in the center. On Core Outcome/Impact Indicators (CO/II), the number of medicine-related hospital admissions per 1000 admissions ranged from 0.45 to 2.02 and there were no documentations from medical records/registers in the various hospitals of medicine related deaths. Information on other pertinent data was inadequate in making computation of other outcome indicators in the health facilities.

Conclusion: Pharmacovigilance activities were observed to be lacking in most of the health facilities. Factors such as poor funding, lack of documentation were prominent. It is therefore recommended that concerted effort should be made to strengthen the practice in all units of healthcare delivery.

References

Va r g e s s o n N ( 2 0 1 5 ) . T h a l i d o m i d e - inducedteratogenesis: History and mechanisms. Birth Defects Research Part C: Embrayo Today. 105(2): 140-156.

WHO (1969). Annual report of the DirectorGeneral to the World Health Assembly and to the United Nations. World Health Organization. https://apps.who.int/iris/handle/10665/8582 0

NAFDAC (2013). NAFDAC recall and safety alert available http://www.nfdac.gov.ng/safety alerts Assessed on 8th Oct. 2019.

NAFDAC Public Alert no: 0017/2019.Aleron Genotoxic Impurity : N-Nitrosodimethyamine (NNDMA) in Zantac and other ranitidine containing p r o d u c t s . A v a i l a b l e a t http://www.nafdac.gov.ng/index. Assessed on th 7 October 2019

W H O ( 2 0 1 9 ) . T h e i m p o r t a n c e o f pharmacovigilance-safety monitoring of medicinal products. WHO Geneva 2002. Available at http://apps.who.int/medicinedoc/pdf/s4893c .pdf.Accessed on 12thAugust 2019.

WHO (2015). World Health Organization Pharmacovigilance indicators: A practical manual for the assessment of pharmacovigilance Systems. WHO Geneva: 2015 (NLM Classification: 771).

Maigetter K, Pollock A.M, Kadam A, Ward K ,Weiss M.G (2015). Pharmacovigilance in India, Uganda and South Africa with reference to WHO's minimum requirements. International Journal of Health Policy Management 4: 295-305.

National Bureau of Statistics (NBS 2019). National Population Commission (NPC), Federal Government of Nigeria. Pp 1-122.

Olowofela,A, Fourrier RA, Isah AO (2016). Pharmacovigilance in Nigeria: An Overview. Pharmaceutical medicine. 30(2) : 87-94

Opadeyi, AO, Fourrier-Reglat A and Isah AO (2018). Assessment of the State of Pharmacovigilance in the South-South of Nigeria using WHO Pharmacovigilance indicators. BMC Pharmacology and Toxicology.19:27

Olsson S, Shanthi NP, and Dodoo A (2015). Pharmacovigilance in resource limited countries. Expert review of clinical pharmacology. 8(4)-449- 460.Available athttps://www.landfonline.com

WHO (2010).World Health Organization and Global Fund. Minimum requirements for a functional p h a r m a c o v i g i l a n c e s y s t e m . G e n e v a ; (http://www.who.int/medicines/areas/quality_ safety/safety_efficiency/PV_minimumrequirements_ 2012_2_en.pdf, accessed on 23rd September, 2019.

Hazell L, Shakir SA (2019). Under reporting of Adverse Drug Reactions; a systematic review. Drug S a f e t y . 2 0 0 6 ; 2 9 : 3 8 5 - 3 9 6 . A v a i l a b l e athttps://doi.org/10.1186/S40360_0180217- 2

WHO (2006). Safety of medicines in public health programme. Pharmacovigilance an essential tool. Geneva. WHO. 2006.

NAFDAC (2004). National Pharmacovigilance Centre (NPC) NAFDAC, Safety of Medicines in Nigeria: a Guide for detecting and reporting ADR. NAFDAC-NPC-NIG. Lagos, Nigeria (NPC) N A F D A C : A v a i l a b l e a t https://www.nytimes.com.Assessed on 7th October 2019. News Letter 2018 ;29:3

Chinenye JU, Michael OU (2012). Health workers and Hospital patients' knowledge of PV in Sokoto State, North West, Nigeria. Nigerian Journal of Pharmaceutical Science. 11: 31-40.

Oregba A. Ogunleye O, Olayemi S (2011). The k n o w l e d g e , p e r c e p t i o n a n d p r a c t i c e o f Pharmacovigilance among community

pharmacists in L a g o s s t a t e , S o u t h W e s t , N i g e r i a . Pharmacoepidemiology and Drug safety. 20: 30-35.

Ogundele S, Dawodu C, Ogunleye O (2012).ADR reporting among health workers at Nigeria tertiary hospital: A comparative cross sectional survey of health professionals. Global Register Journal Medical Science. 2: 32-7.8

Pinpalkhute S, Jaiswal K, Sontakke S, Bajait C, Gaikwad A (2012). Evaluation of awareness about PV and ADR monitoring in resident doctors of a tertiary care teaching hospital.Indian Journal of Medical Science, 2012;66(3-4): 55-61.

Qadrie ZL, Shakil R, Wafai ZA and Humaira A (2017). Pharmacovigilance: Process of Detection, Assessment, Understanding Prevention ofAdverse Effects:AReview. World Journal of Pharmaceutical Science. 3: (5):78-95.

Tadvi NA, Shareef, SM, Naidu CD.M, Karuna SP, Rao VY (2015). “Profile of ADR in a rural tertiary care hospital”. Journal of Basic and Clinical Research. 2 (1): 15-20.

Downloads

Published

2023-10-08

How to Cite

Oladayo, G. O., Aghahowa, S. E., Aghahowa, M. E., Aikorogie, P. I., & Awogbemi, J. K. (2023). Pharmacovigilance core indicators practices in some health facilities in Osun state, Nigeria: https://doi.org/10.51412/psnnjp.2023.19. The Nigerian Journal of Pharmacy, 57(2), 592–601. Retrieved from https://psnnjp.org/index.php/home/article/view/478