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Current Drug Safety


ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Research Article

Adverse Drug Reaction Monitoring and Reporting Among Physicians and Pharmacists in Pakistan: A Cross-sectional Study

Author(s): Zaka Un Nisa, Ayesha Zafar, Fatima Zafar, Sally Pezaro* and Farooq Sher

Volume 15, Issue 2, 2020

Page: [137 - 146] Pages: 10

DOI: 10.2174/1574886315666200427120322

Price: $65


Background: The success of a reporting system of adverse drug reaction (ADR) depends on the knowledge, attitudes, and practices of the health care professionals. However, due to a lack of knowledge and poor contribution by healthcare workers, ADR remains underreported. To improve safety, proper identification and ADR reporting is necessary.

Objective: This study was carried out to determine knowledge, attitude, and practices of ADR among physicians and pharmacists working in Pakistan and the factors which encourage and discourage effective reporting.

Methods: A cross-sectional study was conducted using a pretested questionnaire. Questionnaires were distributed among 333 physicians and 34 pharmacists with a 95.5% response rate. The Statistical Package for Social Science (SPSS) was used for data analysis.

Results: Pharmacists have more knowledge regarding ADR compared to physicians (47.1% vs. 13.8%, p < 0.001). Pharmacists also have a positive attitude compared to physicians (97.1% vs. 76.3%, p < 0.001). No significant difference was noticed in ADR practice by physicians and pharmacists (12.3% vs. 11.8, p = 0.92). The seriousness of ADR was the main factor that encouraged nearly all pharmacists to report, whereas among physician’s, seriousness and the unusualness of reaction, the new drug involvement, and confidence in diagnosis were the factors which encouraged them to report ADR.

Conclusion: Overall, pharmacists had more knowledge and a positive attitude regarding ADR reporting compared to physicians, but practices of ADR reporting remained the same among both. Therefore, it is suggested that educational interventions, along with training programs, should be developed.

Keywords: Adverse drug reactions, public health, pharmacovigilance, health care systems, hospitals, ADR reporting.

Graphical Abstract
Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med 2005; 165(12): 1363-9.
[] [PMID: 15983284]
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009; 9(1): 14.
[] [PMID: 19671176]
Wu WK, Pantaleo N. Evaluation of outpatient adverse drug reactions leading to hospitalization. Am J Health Syst Pharm 2003; 60(3): 253-9.
[] [PMID: 12613234]
Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital--their severity and cost involved. Pharmacoepidemiol Drug Saf 2003; 12(8): 687-92.
[] [PMID: 14762985]
Khan SA, Rao PG, Rodrigues GS, Rajan S, Heda A. From thalidomide to rofecoxib: Can we afford to wait and watch? Int J Risk Saf Med 2006; 18(4): 219-30.
White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics 1999; 15(5): 445-58.
[] [PMID: 10537962]
Chyka PA. How many deaths occur annually from adverse drug reactions in the United States? Am J Med 2000; 109(2): 122-30.
[] [PMID: 10967153]
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998; 279(15): 1200-5.
[] [PMID: 9555760]
Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45(3): 301-8.
[] [PMID: 9517375]
Pattanaik S, Dhamija P, Malhotra S, Sharma N, Pandhi P. Evaluation of cost of treatment of drug-related events in a tertiary care public sector hospital in Northern India: A prospective study. Br J Clin Pharmacol 2009; 67(3): 363-9.
[] [PMID: 19523017]
Thiyagu R, Mallayasamy SR, Rajesh V, et al. Development of indicators for identifying adverse drug events in an Indian tertiary care teaching hospital. Drug Healthc Patient Saf 2010; 2: 95-100.
[] [PMID: 21701622]
Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2008; 65(2): 210-6.
[] [PMID: 17662089]
Gholami K, Shalviri G. Factors associated with preventability, predictability, and severity of adverse drug reactions. Ann Pharmacother 1999; 33(2): 236-40.
[] [PMID: 10084421]
Ghaffar A, Kazi BM, Salman M. Health care systems in transition III. Pakistan, Part I. An overview of the health care system in Pakistan. J Public Health Med 2000; 22(1): 38-42.
[] [PMID: 10774902]
WHO. Report of the Health System Review Mission–Pakistan. United Kingdom: World Health Organization, United Nations Children Fund, Department for International Development, The World Bank 2007; pp. 19-28.
Su C, Ji H, Su Y. Hospital pharmacists’ knowledge and opinions regarding adverse drug reaction reporting in Northern China. Pharmacoepidemiol Drug Saf 2010; 19(3): 217-22.
[] [PMID: 20033911]
WHO National Drug Policy- Pakistan. 2003.
Raza A, Jamal H. Assessment of knowledge, attitudes and practice among the medical and pharmacy students towards pharmacovigilance and adverse drug reactions in Abbottabad, Pakistan. J Pharmacovigil 2015; 3: 1-5.
Mahmood KT, Amin F, Tahir M, Haq IU. Pharmacovigilance: A need for best patient care in Pakistan: A review. J Pharm Sci Res 2011; 3(11): 1566-84.
Rizvi N, Nishtar S. Pakistan’s health policy: Appropriateness and relevance to women’s health needs. Health Policy 2008; 88(2-3): 269-81.
[] [PMID: 18479774]
Yadav S. Status of adverse drug reaction monitoring and pharmacovigilance in selected countries. Indian J Pharmacol 2008; 40(Suppl. 1): S4-9.
[PMID: 21369413]
Smith CC, Bennett PM, Pearce HM, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 1996; 42(4): 423-9.
[] [PMID: 8904613]
Moride Y, Haramburu F, Requejo AA, Bégaud B. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol 1997; 43(2): 177-81.
[] [PMID: 9131950]
van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004; 13(7): 457-64.
[] [PMID: 15269929]
Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspect Clin Res 2015; 6(1): 45-52.
[] [PMID: 25657902]
Palaian S, Ibrahim MI, Mishra P. Health professionals’ knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada) 2011; 9(4): 228-35.
[] [PMID: 24198861]
Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Javadi M. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting. Iran J Nurs Midwifery Res 2012; 17(1): 21-5.
[PMID: 23492864]
Bakhsh TMA, Al-Ghamdi MS, Bawazir SA, Raddadi R, Qureshi NA. Physicians sociodemographics and knowledge, awareness, attitude and practice towards reporting adverse drug reactions: An association study in Jeddah city, Saudi Arabia. Br J Pharm Res 2016; 12(3): 1-15.
Sharrad AK. Pharmacists’knowledge, attitude and practice about adverse drug reaction in basra/iraq. Int J Pharm Sci Res 2017; 8(5): 2309.
Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran. Pharm World Sci 2009; 31(2): 183-7.
[] [PMID: 19116770]
Hasford J, Goettler M, Munter K-H, Müller-Oerlinghausen B. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55(9): 945-50.
[] [PMID: 12393084]
Toklu HZ, Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci 2008; 30(5): 556-62.
[] [PMID: 18350373]
Nazir S. Adverse drug reaction reporting system at different hospitals of Lahore-An evaluation and patient outcome analysis. Value Health 2014; 17(3): A166.
Anwar M, Haq NU. Assessment of knowledge, attitude and practice of healthcare professional (Pharmacist) regarding adverse drug reaction reporting and pharmacovigilance in public hospitals in Quetta, Pakistan. Saudi Pharm J 2018; 26(4): 453-61.
Iffat W, Shakeel S, Rahim N, Anjum F, Nesar S, Ghayas S. Pakistani physicians knowledge and attitude towards reporting adverse drug reactions. Afr J Pharm Pharmacol 2014; 8(14): 379-85. 10.5897/AJPP2013.3930
Alsaleh FM, Alzaid SW, Abahussain EA, Bayoud T, Lemay J. Knowledge, attitude and practices of pharmacovigilance and adverse drug reaction reporting among pharmacists working in secondary and tertiary governmental hospitals in Kuwait. Saudi Pharm J 2017; 25(6): 830-7.
[PMID: 28951666]
John LJ, Arifulla M, Cheriathu JJ, Sreedharan J. Reporting of adverse drug reactions: An exploratory study among nurses in a teaching hospital, Ajman, United Arab Emirates. Daru 2012; 20(1): 44.
[] [PMID: 23351252]
Mahmoud MA, Alsowaida Y, Alshammari T, et al. Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia. Saudi Pharm J 2014; 22(5): 411-8.
[] [PMID: 25473329]
Nichols V, Thériault-Dubé I, Touzin J, et al. Risk perception and reasons for noncompliance in pharmacovigilance: A qualitative study conducted in Canada. Drug Saf 2009; 32(7): 579-90.
[] [PMID: 19530744]
Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007; 16(2): 223-8.
[] [PMID: 16947117]
Fadare JO, Enwere OO, Afolabi A, Chedi B, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Trop J Pharm Res 2011; 10(3): 235-42.
Graille V, Lapeyre-Mestre M, Montastruc JL. Drug vigilance: Opinion survey among residents of a university hospital. Therapie 1994; 49(5): 451-4.
[PMID: 7855763]
Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res 1997; 35(2): 85-8.
[] [PMID: 9175573]
Khan T. Challenges to pharmacy and pharmacy practice in Pakistan. Australas Med J 2011; 4(4): 230.
Abdel-Latif MM, Abdel-Wahab BA. Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia. Saudi Pharm J 2015; 23(2): 154-61.
[] [PMID: 25972735]
Azhar S, Hassali MA, Ibrahim MIM, Ahmad M, Masood I, Shafie AA. The role of pharmacists in developing countries: The current scenario in Pakistan. Hum Resour Health 2009; 7(1): 54.
[] [PMID: 19594916]
Owusu-Daaku F, Smith F, Shah R. Addressing the workforce crisis: The professional aspirations of pharmacy students in Ghana. Pharm World Sci 2008; 30(5): 577-83.
[] [PMID: 18369737]
Ahsan N. Pharmacy education and Pharmacy Council of Pakistan. Pakistan Drug Update 2005; 7(8): 4-5.
Jose J, Jimmy B, Al-Ghailani ASH, Al Majali MA. A cross sectional pilot study on assessing the knowledge, attitude and behavior of community pharmacists to adverse drug reaction related aspects in the Sultanate of Oman. Saudi Pharm J 2014; 22(2): 163-9.
[] [PMID: 24648829]
Suyagh M, Farah D, Abu Farha R. Pharmacist’s knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Saudi Pharm J 2015; 23(2): 147-53.
[] [PMID: 25972734]
Li Q, Zhang S-M, Chen H-T, et al. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J (Engl) 2004; 117(6): 856-61.
[PMID: 15198887]
Okezie EO, Olufunmilayo F. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiol Drug Saf 2008; 17(5): 517-22.
[] [PMID: 18404621]
Lee KK, Chan TY, Raymond K, Critchley JA. Pharmacists’ attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother 1994; 28(12): 1400-3.
[] [PMID: 7696734]
Generali JA, Danish MA, Rosenbaum SE. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists. Ann Pharmacother 1995; 29(4): 365-9.
[] [PMID: 7633012]
Granas AG, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007; 16(4): 429-34.
[] [PMID: 16953518]
Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51(1): 81-6.
[] [PMID: 11167664]
Bakhsh TMA, Saeed Al-Ghamdi M, Bawazir SA, Omer TY, Qureshi NA. Assessment of hospital physicians’ knowledge. Saudi Arabia: Awareness, attitude and practice of reporting adverse drug reactions in Jeddah, Saudi Arabia. J Adv Med Med Res 2016; 16(1): 1-16.
Bawazir SA. Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting. Saudi Pharm J 2006; 14(1): 75-83.
Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48(4): 623-7.
[] [PMID: 10583035]
Tribune T. Doctors in Pakistan give less time to patients. Asian J Pharm Clin Res 2017; 5(3): 210-4.
Kamtane RA, Jayawardhani V. Knowledge, attitude and perception of physicians towards adverse drug reaction (ADR) reporting: A pharmacoepidemiological study. Asian J Pharm Clin Res 2012; 5(3): 210-4.
Nisa ZU, Zafar A, Sher F. Assessment of knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan. Saudi Pharm J 2018; 26(4): 453-61.
Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Influence of pharmacists’ attitudes on adverse drug reaction reporting: A case-control study in Portugal. Drug Saf 2006; 29(4): 331-40.
[ ] [PMID: 16569082]
Qassim S, Metwaly Z, Shamsain M, Al Hariri Y. Reporting adverse drug reactions: Evaluation of knowledge, attitude and practice among community pharmacists in UAE. IOSR J Pharm 2014; 22(30): 31-40.
Figueiras A, Herdeiro MT, Polónia J, Gestal-Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: A cluster-randomized controlled trial. JAMA 2006; 296(9): 1086-93.
[] [PMID: 16954488]
Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA 1990; 263(13): 1785-8.
[] [PMID: 2313850]
Abubakar AR, Simbak NB, Haque M. A systematic review of knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among doctors. J Appl Pharm Sci 2014; 4(11): 117-27.
Adhikary J, Bhandare B, Adarsh E, Satyanarayana V. A study to assess knowledge, attitude and practice of adverse drug reaction reporting among physicians in a tertiary care hospital. J Evolution Med Dental Sci 2013; 2(9): 1027-34.

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