{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:45:07Z","timestamp":1787028307538,"version":"build-2736575974"},"reference-count":59,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2020,3,25]],"date-time":"2020-03-25T00:00:00Z","timestamp":1585094400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJERPH"],"abstract":"<jats:p>Developed countries have established pharmacovigilance systems to monitor the safety of medicines. However, in the developing world, drug monitoring and reporting are facing enormous challenges. The current study was designed to explore the challenges related to the understanding and practices of physicians in reporting adverse drug reactions in Lahore, Pakistan. Through the purposive sampling technique, 13 physicians were interviewed. All interviews were audio-recorded, transcribed verbatim, and analyzed for a thematic content analysis. The thematic content analysis yielded six major themes: (1) Familiarity with medication safety and adverse drug reaction (ADR) concept, (2) Knowledge about pharmacovigilance activities, (3) Practices related to ADR reporting, (4) Barriers impeding ADR reporting, (5) Acknowledgement of the pharmacist\u2019s role, and (6) System change needs. The majority of the physicians were unaware of the ADR reporting system; however, they were ready to accept practice changes if provided with the required skills and training. A lack of knowledge, time, and interest, a fear of legal liability, poor training, inadequate physicians\u2019 and other healthcare professionals\u2019 communication, and most importantly lack of a proper reporting system were reported as barriers. The findings based on emerging themes can be used to establish an effective pharmacovigilance system in Pakistan. Overall, physicians reported a positive attitude towards practice changes, provided the concerned authorities support and take interest in this poorly acknowledged but most needed component of the healthcare system.<\/jats:p>","DOI":"10.3390\/ijerph17072209","type":"journal-article","created":{"date-parts":[[2020,3,25]],"date-time":"2020-03-25T13:10:47Z","timestamp":1585141847000},"page":"2209","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Physicians\u2019 Understanding and Practices of Pharmacovigilance: Qualitative Experience from a Lower Middle-Income Country"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8183-0855","authenticated-orcid":false,"given":"Rabia","family":"Hussain","sequence":"first","affiliation":[{"name":"Department of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang 11800, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed Azmi","family":"Hassali","sequence":"additional","affiliation":[{"name":"Department of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang 11800, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6502-8464","authenticated-orcid":false,"given":"Anees","family":"ur Rehman","sequence":"additional","affiliation":[{"name":"Department of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang 11800, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaya","family":"Muneswarao","sequence":"additional","affiliation":[{"name":"Department of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang 11800, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Furqan","family":"Hashmi","sequence":"additional","affiliation":[{"name":"University College of Pharmacy, University of the Punjab, Lahore 54000, Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2020,3,25]]},"reference":[{"key":"ref_1","unstructured":"WHO (2020, January 31). The Importance of Pharmacovigilance\u2014Safety Monitoring of Medicinal Products. Available online: https:\/\/apps.who.int\/medicinedocs\/en\/d\/Js4893e\/."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1093\/ajhp\/60.3.253","article-title":"Evaluation of outpatient adverse drug reactions leading to hospitalization","volume":"60","author":"Wu","year":"2003","journal-title":"Am. J. Health Syst. Pharm."},{"key":"ref_3","first-page":"1017","article-title":"Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies","volume":"42","author":"Kongkaew","year":"2008","journal-title":"Ann. Pharm."},{"key":"ref_4","unstructured":"WHO (1975). Manual of the International Statistical Classification of Diseases, Injuries, and Causes of Death, World Health Organization."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1503\/cmaj.050971","article-title":"Is there still a role for spontaneous reporting of adverse drug reactions?","volume":"174","author":"Lexchin","year":"2006","journal-title":"CMAJ"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"S4","DOI":"10.4103\/0253-7613.40235","article-title":"Status of adverse drug reaction monitoring and pharmacovigilance in selected countries","volume":"40","author":"Yadav","year":"2008","journal-title":"Indian J. Pharm."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Oshikoya, K.A., and Awobusuyi, J.O. (2009). Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin. Pharmacol., 9.","DOI":"10.1186\/1472-6904-9-14"},{"key":"ref_8","first-page":"365","article-title":"Physicians\u2019 knowledge and attitude towards adverse event reporting system and result to intervention\u2014Randomized nested trial among Bulgarian physicians","volume":"10","author":"Stoynova","year":"2013","journal-title":"Med. Glas."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1685","DOI":"10.18203\/2349-3933.ijam20175191","article-title":"Knowledge, attitude and perception of physicians towards adverse drug reaction (ADR) reporting: A pharmacovigilance study","volume":"4","author":"Adhikari","year":"2017","journal-title":"Int. J. Adv. Med."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1111\/j.1365-2125.1995.tb04440.x","article-title":"Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom","volume":"39","author":"Belton","year":"1995","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"945","DOI":"10.1016\/S0895-4356(02)00450-X","article-title":"Physicians\u2019 knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions","volume":"55","author":"Hasford","year":"2002","journal-title":"J. Clin. Epidemiol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"385","DOI":"10.2165\/00002018-200629050-00003","article-title":"Underreporting of adverse drug reactions: A systematic review","volume":"29","author":"Hazell","year":"2006","journal-title":"Drug Saf."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1007\/s002280050314","article-title":"Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union","volume":"52","author":"Belton","year":"1997","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"e832","DOI":"10.1136\/bmj.e832","article-title":"Patient safety in developing countries: Retrospective estimation of scale and nature of harm to patients in hospital","volume":"344","author":"Wilson","year":"2012","journal-title":"BMJ"},{"key":"ref_15","unstructured":"UMC (2019, December 15). Members of the WHO Programme for International Drug Monitoring. Available online: https:\/\/www.who-umc.org\/global-pharmacovigilance\/members\/who-programme-members\/."},{"key":"ref_16","unstructured":"Denzin, N.K., and Lincoln, Y.S. (2011). The Sage Handbook of Qualitative Research, Sage."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1136\/bmj.311.6996.42","article-title":"Qualitative research: Reaching the parts other methods cannot reach: An introduction to qualitative methods in health and health services research","volume":"311","author":"Pope","year":"1995","journal-title":"BMJ"},{"key":"ref_18","first-page":"31","article-title":"Healthcare research methods","volume":"Volume 2013","author":"Howlett","year":"2013","journal-title":"Evidence-Based Practice for Health Professionals"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1007\/s11133-019-9413-7","article-title":"What is qualitative in qualitative research","volume":"42","author":"Aspers","year":"2019","journal-title":"Qual. Sociol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1111\/ejed.12014","article-title":"Comparison of quantitative and qualitative research traditions: Epistemological, theoretical, and methodological differences","volume":"48","author":"Yilmaz","year":"2013","journal-title":"Eur. J. Educ."},{"key":"ref_21","unstructured":"Punch, K.F. (2013). Introduction to Social Research: Quantitative and Qualitative Approaches, Sage."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1186\/s40545-018-0143-0","article-title":"A qualitative exploration of knowledge, attitudes and practices of hospital pharmacists towards adverse drug reaction reporting system in Lahore, Pakistan","volume":"11","author":"Hussain","year":"2018","journal-title":"J. Pharm. Policy Pract."},{"key":"ref_23","unstructured":"Cresswell, J., and Plano Clark, V. (2011). Designing and Conducting Mixed Method Research, Sage. [2nd ed.]."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1093\/intqhc\/mzs014","article-title":"Patient safety and medical errors: Knowledge, attitudes and behavior among Italian hospital physicians","volume":"24","author":"Flotta","year":"2012","journal-title":"Int. J. Qual. Health C"},{"key":"ref_25","first-page":"379","article-title":"Pakistani physicians knowledge and attitude towards reporting adverse drug reactions","volume":"8","author":"Iffat","year":"2014","journal-title":"Afr. J. Pharm. Pharmacol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1016\/j.jsps.2014.07.005","article-title":"Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia","volume":"23","year":"2015","journal-title":"Saudi Pharm. J."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Fadare, J.O., Enwere, O.O., Afolabi, A., Chedi, B., and Musa, A. (2011). Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Trop. J. Pharm. Res., 10.","DOI":"10.4314\/tjpr.v10i3.4"},{"key":"ref_28","unstructured":"Creswell, J.W., and Poth, C.N. (2016). Qualitative Inquiry and Research Design: Choosing among Five Approaches, Sage Publications."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"Braun","year":"2006","journal-title":"Qual. Res. Psychol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","article-title":"Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups","volume":"19","author":"Tong","year":"2007","journal-title":"Int. J. Qual. Health C"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"729","DOI":"10.1007\/s002280000202","article-title":"Attitudes to reporting adverse drug reactions in northern Sweden","volume":"56","author":"Backstrom","year":"2000","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"Babar, Z.U.D. (2017). Pharmaceutical policy in Pakistan. Pharmaceutical Policy in Countries with Developing Healthcare Systems, Springer International.","DOI":"10.1007\/978-3-319-51673-8"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1002\/pds.1313","article-title":"Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia","volume":"16","author":"Aziz","year":"2007","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1002\/pds.1597","article-title":"Adverse drug reactions reporting by physicians in Ibadan, Nigeria","volume":"17","author":"Okezie","year":"2008","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_35","unstructured":"WHO (2020, January 01). Patient Safety Education and Training. Available online: https:\/\/www.who.int\/patientsafety\/education\/en\/."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1586\/17512433.2015.1053391","article-title":"Pharmacovigilance in resource-limited countries","volume":"8","author":"Olsson","year":"2015","journal-title":"Expert Rev. Clin. Pharmacol."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"e193","DOI":"10.5210\/ojphi.v8i2.6802","article-title":"Why do we need pharmacists in pharmacovigilance systems?","volume":"8","author":"Toklu","year":"2016","journal-title":"Online J. Public Health Inform."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"1097","DOI":"10.15537\/smj.2015.9.12125","article-title":"A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia","volume":"36","author":"Aljadhey","year":"2015","journal-title":"Saudi Med. J."},{"key":"ref_39","unstructured":"PMC (2020, February 13). Pakistan Medical Commission, Available online: https:\/\/pmc.gov.pk\/."},{"key":"ref_40","first-page":"120","article-title":"Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance","volume":"4","author":"Amrain","year":"2014","journal-title":"J. Health Sci."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"1359","DOI":"10.15537\/smj.2016.12.17059","article-title":"Healthcare professionals\u2019 awareness and knowledge of adverse drug reactions and pharmacovigilance","volume":"37","author":"Almandil","year":"2016","journal-title":"Saudi Med. J."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1016\/j.jsps.2018.02.014","article-title":"Assessment of knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan","volume":"26","author":"Nisa","year":"2018","journal-title":"Saudi Pharm. J."},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"13","DOI":"10.4103\/1596-3519.76563","article-title":"Knowledge and attitudes of physicians relating to reporting of adverse drug reactions in Sokoto, northwestern Nigeria","volume":"10","author":"Bello","year":"2011","journal-title":"Ann. Afr. Med."},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"12","DOI":"10.12927\/hcq.2012.22847","article-title":"Reporting, learning and the culture of safety","volume":"15","author":"Flemons","year":"2012","journal-title":"Healthc Q."},{"key":"ref_45","unstructured":"DRAP (2019). Pakistan National Pharmacovigilance Guidelines (Draft), Drug Regulatory Authority of Pakistan. [1st ed.]."},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"1435114","DOI":"10.1080\/10872981.2018.1435114","article-title":"Social support in the workplace for physicians in specialization training","volume":"23","author":"Mikkola","year":"2018","journal-title":"Med. Educ. Online"},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1080\/08870449808407426","article-title":"Models of human social behavior and their application to health psychology","volume":"13","author":"Ajzen","year":"1998","journal-title":"Psychol. Health"},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1016\/0749-5978(91)90020-T","article-title":"The theory of planned behavior","volume":"50","author":"Ajzen","year":"1991","journal-title":"Organ. Behav. Hum. Decis. Process."},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1037\/0278-6133.15.5.398","article-title":"Utility of the theories of reasoned action and planned behavior for predicting physician behavior: A prospective analysis","volume":"15","author":"Millstein","year":"1996","journal-title":"Health Psychol."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"1549","DOI":"10.4314\/tjpr.v15i7.27","article-title":"Influence of pharmacists expertise on physicians prescription decisions","volume":"15","author":"Murshid","year":"2016","journal-title":"Trop. J. Pharm. Res."},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"709","DOI":"10.1590\/S1984-82502011000400007","article-title":"What is the role of the pharmacist? Physicians\u2019 and nurses\u2019 perspectives in community and hospital settings of Santiago de Cuba","volume":"47","author":"Oliveira","year":"2011","journal-title":"Braz. J. Pharm. Sci."},{"key":"ref_52","doi-asserted-by":"crossref","first-page":"623","DOI":"10.1046\/j.1365-2125.1999.00060.x","article-title":"Attitudinal survey of voluntary reporting of adverse drug reactions","volume":"48","author":"Grootheest","year":"1999","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"204","DOI":"10.4103\/2229-3485.120168","article-title":"An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study","volume":"4","author":"Ahmad","year":"2013","journal-title":"Perspect. Clin. Res."},{"key":"ref_54","doi-asserted-by":"crossref","unstructured":"Generali, J.A. (2014). Adverse Drug Event Reporting: Awareness is not Enough, SAGE Publications.","DOI":"10.1310\/hpj4902-110"},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1016\/j.jsps.2018.03.002","article-title":"Effect of educational intervention on healthcare providers knowledge and perception towards pharmacovigilance: A tertiary teaching hospital experience","volume":"26","author":"Farha","year":"2018","journal-title":"Saudi Pharm. J."},{"key":"ref_56","doi-asserted-by":"crossref","unstructured":"Hussain, R., Hassali, M.A., and Rana, S.M. (2019). Evaluation of an educational intervention on physicians\u2019 knowledge about adverse drug reaction reporting system. J. Public Health.","DOI":"10.1007\/s10389-019-01116-x"},{"key":"ref_57","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1111\/j.1759-8893.2011.00058.x","article-title":"Pharmaceutical industry, innovation and challenges for public health: Case studies from Malaysia and Pakistan","volume":"2","author":"Babar","year":"2011","journal-title":"J. Pharm. Health Ser. Res."},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1111\/bcp.13098","article-title":"The value of patient reporting to the pharmacovigilance system: A systematic review","volume":"83","author":"Cavaco","year":"2017","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"211","DOI":"10.3389\/fpubh.2015.00211","article-title":"Consumer narratives in ADR reporting: An important aspect of public health? Experiences from reports to a Swedish consumer organization","volume":"3","author":"Vilhelmsson","year":"2015","journal-title":"Front. Public Health"}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/17\/7\/2209\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T09:11:34Z","timestamp":1760173894000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/17\/7\/2209"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,25]]},"references-count":59,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2020,4]]}},"alternative-id":["ijerph17072209"],"URL":"https:\/\/doi.org\/10.3390\/ijerph17072209","relation":{},"ISSN":["1660-4601"],"issn-type":[{"value":"1660-4601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,3,25]]}}}