Physicians’ Understanding and Practices of Pharmacovigilance: Qualitative Experience from a Lower Middle-Income Country
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethical Approval
2.2. Study Design
2.3. Study Sampling and Sampling
2.4. Data Collection
2.5. Analysis
2.6. Reporting
3. Results
3.1. Demographic Details of the Participants
3.2. Thematic Analysis of the Content
3.2.1. Theme 1: Familiarity with Medication Safety and ADR Concept
Subtheme 1: Knowledge about the Definition
“Medication safety is the use of a drug causing no harm to the patients.”(Phy-7)
“It means if a drug is given to the patient, there should not be any harm, I give medicines to treat the patient. For me, safety is more important than the drug.”(Phy-10)
“It is any reaction of the body to the drug which is harmful to the body that is what I can simply define.”(Phy-6)
“An ADR is a reaction which is unwanted after taking the medication.”(Phy-11)
Subtheme 2: Perceptions towards Types of ADR Need to be Reported
“Drug allergies or drug causing arrhythmias, cardiopulmonary arrest or any drug causing life threatening conditions, it should be reported. For minor reactions, we don’t bother.(Phy-5)
I think every sort of ADR should be reported either its minor or major.”(Phy-7)
3.2.2. Theme 2: Knowledge about Pharmacovigilance Activities
Subtheme 1: Knowledge about ADR Reporting
“We have guidance and basic knowledge about ADR reporting. There is a form, it’s available in pharmacy, in case of any ADR, we fill the form and send it through the proper channel to AMS (Assistant Medical Superintendent) and then it is sent back to pharmacy for the medicine evaluation.”(Phy-5)
“No guidance, as there is no protocol, there is no proper reporting system in tertiary care hospital of Lahore.”(Phy-7)
Subtheme 2: Knowledge about ADR Reporting Center
“No, I am not aware about this body.”(Phy-3)
“I am not aware because I never heard about any system of adverse drug reaction reporting maybe the system is not in practice, I haven’t seen anyone around me reporting.”(Phy-6)
“Yes, I am aware about the system, but I am not in touch. I really don’t know the name but there is some drug regulatory authority.”(Phy-10)
3.2.3. Theme 3: Practices Related to ADR Reporting
“We usually inform the pharma companies and also we discuss with the other colleagues as well, but we do not report in a particular documented way.”(Phy-3)
“We verbally report to each other but do not document this as such.”(Phy-6)
“Yes, we note it down but do not report.”(Phy-8)
3.2.4. Theme 4: Barriers to ADR Reporting
Subtheme 1: Impact of Workload
“Our health system is a barrier, and workload are another barrier. Basically these 2 barriers will fit everywhere in the system.”(Phy-4)
“Time is one of the factors, if I am sitting in outdoor patient department, I have to see 100 patients in a day and have 4 hours to see them then what will you expect from a person, so they cannot report.”(Phy-7)
Subtheme 2: Lack of a Reporting System
“First of all, no proper system is there to whom we can report. There is nothing which is bounding or stopping me from reporting it’s just that there is no so system that is why we do not report.”(Phy-6)
“I think lack of system, as we don’t have any reporting system and we are not taught to do it.(Phy-10)
Sub-theme 3: Lack of Education
“Barriers are not there, personally speaking about my opinion. Merely ignorance is there. We are not being educated at this level. Being a physician or a surgeon, we are conducting our jobs. But we are not educated properly that when, how and where to report?”(Phy-3)
“The system in which I have studied and worked, I have no idea about ADR reporting and even about the yellow card. It is a lack of education and my training.”(Phy-4)
Sub-theme 4: Legal Liability
“Legal liability is another barrier, nowadays people are aware of all these things and they know what is happening and they seek the legal actions also against the companies and sometime against the practitioners.”(Phy-1)
“We do not report, because in a public hospital if I report anything, it is going to be a risk at my professional carrier. We verbally report to each other but do not document this as such.”(Phy-5)
Sub-theme 5: Peer Pressure
“No, we have not been told about the protocol because, if some kind of drug reaction had occurred and if we face any kind of difficult thing, we just have to report our seniors. We have not been told about reporting.”(Phy-9)
3.2.5. Theme 5: Acknowledgement of Pharmacist’s Role
“Clinical pharmacist is needed in the wards because he can really take care of the event because they have studied in detail about the pharmaceutical aspects of drugs, but we did not.”(Phy-5)
“Every hospital should have pharmacist to tell the staff about the safety of the drug and the brand of the drug. If some adverse effects occur pharmacist should be knowing those things and should be a bridge between the company and physician, the safety of the drug will be improved.”(Phy-10)
3.2.6. Theme 6: System Change Needs
“Like if the government has introduced CME (Continuing Medical Education) concept for doctors, the same way they should have some drug reactions like learning thing as a condition for the renewal of the registration. It would be a great step in improving the adverse reaction reporting by doctors.”(Phy-4)
“Well, need is there to develop a system where we can report ADRs and can get the feedback directly and promptly. The system should be linked throughout the country for the maximum coverage. Hence, this will make us to come up with some solid data on adverse drug reaction at national level.”(Phy-3)
4. Discussion
Strengths and Limitations
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Appendix A
Part I
- What comes into your mind, when you hear the word “Medication Safety”.
- Do you counsel patients on medication safety? If yes which particular aspect of it, under what conditions do you counsel them and why? (condition mean disease state)
- Any recent counselling being offered to patients, any examples (prompt for conversation, symptoms, recommendations/advice given)
Part II
- Do you know, what is Adverse Drug Reaction? How would you define it?
- What would you do if you were approached by a patient with a severe ADR (any recent incidence, what was your strategy to deal with the patient)?
- What type of adverse drug reactions you consider should be reported?
- In your current practice, how many ADR cases you have seen? (Did you report/ record them by yourself or heard it from some other colleague)
- In your organization, who is responsible for ADR reporting?
- Do you have any guidance on reporting or how to and when to report any ADR? And report to whom and Where?
- Have you ever sent an adverse drug reaction report to your national reporting agency, when that happened and what is the reason behind?
- Have you ever sent an adverse drug reaction report to the responsible pharmaceutical company, when that happened and why did you send it?
- What are the factors that you think can impact and may encourage physician to report ADRs (why a physician should report an ADR)?
- In your opinion, what are the possible factors that contribute as the barriers to ADR reporting?
- Do you think your job in any way makes it easy/difficult to report ADR.
- What type of medicine information resources (journal, news, formulary{BNF}) you prefer while reporting ADR?
- Do you receive and routinely review publications to become aware of medications with error potential?
Part III
- Are you aware about the existence of the regulatory body that regulates ADR reporting in Pakistan? Reasons? if you are not aware? (education/training)
- In your opinion, do you think that there is a need to change the system about medicine safety and ADR reporting? What benefit would it have?
Part IV
- Do you think that your role has changed and how it can contribute towards medication safety?
- What could be the possible suggestions to improve ADR reporting in hospital setting in future?
Conclusion/Suggestions
References
- WHO. The Importance of Pharmacovigilance—Safety Monitoring of Medicinal Products. Available online: https://apps.who.int/medicinedocs/en/d/Js4893e/ (accessed on 31 January 2020).
- Wu, W.K.; Pantaleo, N. Evaluation of outpatient adverse drug reactions leading to hospitalization. Am. J. Health Syst. Pharm. 2003, 60, 253–259. [Google Scholar] [CrossRef] [PubMed]
- Kongkaew, C.; Noyce, P.R.; Ashcroft, D.M. Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies. Ann. Pharm. 2008, 42, 1017–1025. [Google Scholar] [CrossRef] [PubMed]
- WHO. Manual of the International Statistical Classification of Diseases, Injuries, and Causes of Death; World Health Organization: Geneva, Switzerland, 1975; Volume 2, pp. 34–40. [Google Scholar]
- Lexchin, J. Is there still a role for spontaneous reporting of adverse drug reactions? CMAJ 2006, 174, 191–192. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Yadav, S. Status of adverse drug reaction monitoring and pharmacovigilance in selected countries. Indian J. Pharm. 2008, 40 (Suppl. 1), S4–S9. [Google Scholar]
- Oshikoya, K.A.; Awobusuyi, J.O. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin. Pharmacol. 2009, 9, 14. [Google Scholar] [CrossRef] [Green Version]
- Stoynova, V.; Getov, I.N.; Naseva, E.K.; Lebanova, H.V.; Grigorov, E.E. Physicians’ knowledge and attitude towards adverse event reporting system and result to intervention—Randomized nested trial among Bulgarian physicians. Med. Glas. 2013, 10, 365–372. [Google Scholar]
- Adhikari, A.; Indu, R.; Ray, M.; Bhattacharya, S.; Biswas, R.; Das, A.K. Knowledge, attitude and perception of physicians towards adverse drug reaction (ADR) reporting: A pharmacovigilance study. Int. J. Adv. Med. 2017, 4, 1685–1689. [Google Scholar] [CrossRef] [Green Version]
- Belton, K.J.; Lewis, S.C.; Payne, S.; Rawlins, M.; Wood, S. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br. J. Clin. Pharmacol. 1995, 39, 223–226. [Google Scholar] [CrossRef]
- 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, 945–950. [Google Scholar] [CrossRef]
- Hazell, L.; Shakir, S. Underreporting of adverse drug reactions: A systematic review. Drug Saf. 2006, 29, 385–396. [Google Scholar] [CrossRef]
- Belton, K.; Group, E.P.R. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur. J. Clin. Pharmacol. 1997, 52, 423–427. [Google Scholar] [CrossRef] [PubMed]
- Wilson, R.M.; Michel, P.; Olsen, S.; Gibberd, R.; Vincent, C.; El-Assady, R.; Rasslan, O.; Qsous, S.; Macharia, W.; Sahel, A. Patient safety in developing countries: Retrospective estimation of scale and nature of harm to patients in hospital. BMJ 2012, 344, e832. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- UMC. Members of the WHO Programme for International Drug Monitoring. Available online: https://www.who-umc.org/global-pharmacovigilance/members/who-programme-members/ (accessed on 15 December 2019).
- Denzin, N.K.; Lincoln, Y.S. The Sage Handbook of Qualitative Research; Sage: Newbury Park, CA, USA, 2011. [Google Scholar]
- Pope, C.; Mays, N. Qualitative research: Reaching the parts other methods cannot reach: An introduction to qualitative methods in health and health services research. BMJ 1995, 311, 42–45. [Google Scholar] [CrossRef]
- Howlett, B. Healthcare research methods. In Evidence-Based Practice for Health Professionals; Jones and Bartlett Learning: Burlington, MA, USA, 2013; Volume 2013, pp. 31–51. [Google Scholar]
- Aspers, P.; Corte, U. What is qualitative in qualitative research. Qual. Sociol. 2019, 42, 139–160. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Yilmaz, K. Comparison of quantitative and qualitative research traditions: Epistemological, theoretical, and methodological differences. Eur. J. Educ. 2013, 48, 311–325. [Google Scholar] [CrossRef]
- Punch, K.F. Introduction to Social Research: Quantitative and Qualitative Approaches; Sage: Newbury Park, CA, USA, 2013. [Google Scholar]
- Hussain, R.; Hassali, M.A.; Hashmi, F.; Farooqui, M. A qualitative exploration of knowledge, attitudes and practices of hospital pharmacists towards adverse drug reaction reporting system in Lahore, Pakistan. J. Pharm. Policy Pract. 2018, 11, 16. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Cresswell, J.; Plano Clark, V. Designing and Conducting Mixed Method Research, 2nd ed.; Sage: Thousand Oaks, CA, USA, 2011. [Google Scholar]
- Flotta, D.; Rizza, P.; Bianco, A.; Pileggi, C.; Pavia, M. Patient safety and medical errors: Knowledge, attitudes and behavior among Italian hospital physicians. Int. J. Qual. Health C 2012, 24, 258–265. [Google Scholar] [CrossRef] [Green Version]
- 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, 379–385. [Google Scholar]
- Abdel-Latif, M.M.; Abdel-Wahab, B.A. 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, 154–161. [Google Scholar] [CrossRef] [Green Version]
- Fadare, J.O.; Enwere, O.O.; 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. [Google Scholar] [CrossRef] [Green Version]
- Creswell, J.W.; Poth, C.N. Qualitative Inquiry and Research Design: Choosing among Five Approaches; Sage Publications: Thousand Oaks, CA, USA, 2016. [Google Scholar]
- Braun, V.; Clarke, V. Using thematic analysis in psychology. Qual. Res. Psychol. 2006, 3, 77–101. [Google Scholar] [CrossRef] [Green Version]
- Tong, A.; Sainsbury, P.; Craig, J. Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. Int. J. Qual. Health C 2007, 19, 349–357. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Backstrom, M.; Mjorndal, T.; Dahlqvist, R.; Nordkvist-Olsson, T. Attitudes to reporting adverse drug reactions in northern Sweden. Eur. J. Clin. Pharmacol. 2000, 56, 729–732. [Google Scholar] [CrossRef] [PubMed]
- Atif, M.; Ahmad, M.; Saleem, Q.; Curley, L.; Zaman, M. Pharmaceutical policy in Pakistan. In Pharmaceutical Policy in Countries with Developing Healthcare Systems; Babar, Z.U.D., Ed.; Springer International: Berlin, Germany, 2017; pp. 25–44. [Google Scholar]
- Aziz, Z.; Siang, T.C.; Badarudin, N.S. Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia. Pharmacoepidemiol. Drug Saf. 2007, 16, 223–228. [Google Scholar] [CrossRef]
- Okezie, E.O.; Olufunmilayo, F.I. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiol. Drug Saf. 2008, 17, 517–522. [Google Scholar] [CrossRef] [PubMed]
- WHO. Patient Safety Education and Training. Available online: https://www.who.int/patientsafety/education/en/ (accessed on 1 January 2020).
- Olsson, S.; Pal, S.N.; Dodoo, A. Pharmacovigilance in resource-limited countries. Expert Rev. Clin. Pharmacol. 2015, 8, 449–460. [Google Scholar] [CrossRef] [PubMed]
- Toklu, H.Z.; Mensah, E. Why do we need pharmacists in pharmacovigilance systems? Online J. Public Health Inform. 2016, 8, e193. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Aljadhey, H.; Mahmoud, M.A.; Alshammari, T.M.; Al-Dhaeefi, M.; Le Louet, H.; Perez-Gutthann, S.; Pitts, P.J. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia. Saudi Med. J. 2015, 36, 1097. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- PMC. Pakistan Medical Commission. Available online: https://pmc.gov.pk/ (accessed on 13 February 2020).
- Amrain, M.; Becic, F. Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance. J. Health Sci. 2014, 4, 120–125. [Google Scholar] [CrossRef] [Green Version]
- Almandil, N.B. Healthcare professionals’ awareness and knowledge of adverse drug reactions and pharmacovigilance. Saudi Med. J. 2016, 37, 1359. [Google Scholar] [CrossRef] [Green Version]
- Nisa, Z.U.; 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, 453–461. [Google Scholar] [CrossRef] [PubMed]
- Bello, S.O. Knowledge and attitudes of physicians relating to reporting of adverse drug reactions in Sokoto, northwestern Nigeria. Ann. Afr. Med. 2011, 10, 13–18. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Flemons, W.W.; Mcrae, G. Reporting, learning and the culture of safety. Healthc Q. 2012, 15, 12–17. [Google Scholar] [CrossRef] [PubMed]
- DRAP. Pakistan National Pharmacovigilance Guidelines (Draft), 1st ed.; Drug Regulatory Authority of Pakistan: Islamabad, Pakistan, 2019; p. 95. [Google Scholar]
- Mikkola, L.; Suutala, E.; Parviainen, H. Social support in the workplace for physicians in specialization training. Med. Educ. Online 2018, 23, 1435114. [Google Scholar] [CrossRef] [Green Version]
- Ajzen, I. Models of human social behavior and their application to health psychology. Psychol. Health 1998, 13, 735–739. [Google Scholar] [CrossRef]
- Ajzen, I. The theory of planned behavior. Organ. Behav. Hum. Decis. Process. 1991, 50, 179–211. [Google Scholar] [CrossRef]
- Millstein, S.G. Utility of the theories of reasoned action and planned behavior for predicting physician behavior: A prospective analysis. Health Psychol. 1996, 15, 398. [Google Scholar] [CrossRef]
- Murshid, M.A.; Mohaidin, Z.; Nee, G.Y. Influence of pharmacists expertise on physicians prescription decisions. Trop. J. Pharm. Res. 2016, 15, 1549–1557. [Google Scholar] [CrossRef] [Green Version]
- Dupotey Varela, N.M.; Oliveira, D.R.D.; Sedeño Argilagos, C.; Oliveros Castro, K.; Mosqueda Pérez, E.; Hidalgo Clavel, Y.; Sánchez Bisset, N. What is the role of the pharmacist? Physicians’ and nurses’ perspectives in community and hospital settings of Santiago de Cuba. Braz. J. Pharm. Sci. 2011, 47, 709–718. [Google Scholar] [CrossRef] [Green Version]
- Grootheest, V. Attitudinal survey of voluntary reporting of adverse drug reactions. Br. J. Clin. Pharmacol. 1999, 48, 623–627. [Google Scholar]
- Ahmad, A.; Patel, I.; Balkrishnan, R.; Mohanta, G.; Manna, P. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study. Perspect. Clin. Res. 2013, 4, 204. [Google Scholar] [CrossRef] [PubMed]
- Generali, J.A. Adverse Drug Event Reporting: Awareness is not Enough; SAGE Publications: Los Angeles, CA, USA, 2014. [Google Scholar]
- Farha, R.A.; Hammour, K.A.; Rizik, M.; Aljanabi, R.; Alsakran, L. Effect of educational intervention on healthcare providers knowledge and perception towards pharmacovigilance: A tertiary teaching hospital experience. Saudi Pharm. J. 2018, 26, 611–616. [Google Scholar] [CrossRef] [PubMed]
- Hussain, R.; Hassali, M.A.; Rana, S.M. Evaluation of an educational intervention on physicians’ knowledge about adverse drug reaction reporting system. J. Public Health 2019. [Google Scholar] [CrossRef]
- Babar, Z.U.D.; Ibrahim, M.I.M.; Hassali, M.A.A. Pharmaceutical industry, innovation and challenges for public health: Case studies from Malaysia and Pakistan. J. Pharm. Health Ser. Res. 2011, 2, 193–204. [Google Scholar] [CrossRef]
- Inácio, P.; Cavaco, A.; Airaksinen, M. The value of patient reporting to the pharmacovigilance system: A systematic review. Br. J. Clin. Pharmacol. 2017, 83, 227–246. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Vilhelmsson, A. Consumer narratives in ADR reporting: An important aspect of public health? Experiences from reports to a Swedish consumer organization. Front. Public Health 2015, 3, 211. [Google Scholar] [CrossRef] [PubMed] [Green Version]
No. | Summary of the Interview Topic Guides |
---|---|
1 | Knowledge and perceptions about Medication safety |
2 | Knowledge, attitudes and practices about Adverse Drug Reaction (ADR) reporting |
3 | Knowledge about Adverse Drug Reaction reporting system |
4 | Future directions |
Phase of Analysis | Tasks Completed | Research Team Member Involved |
---|---|---|
Phase 1: Data familiarization | Transcription, reading and re-reading of interview transcripts. | RH |
Phase 2: Initial codes generation | Initial, open coding of entire data set | RH and MAH |
Phase 3: Search for themes | Categorization of codes into potential themes | RH and MAH |
Phase 4: Review of themes | Confirming themes—ensuring the internal homogeneity and external heterogeneity of themes. | RH, discussed with MAH and FH. |
Phase 5: Defining and naming themes | Further refinement of themes | RH, confirmed with MAH and FH |
Phase 6: Report finalization | Production of the manuscript, selection of illustrative quotes | RH, reviewed by and discussed with MAH. |
Characteristics | Frequency |
---|---|
Gender | |
Male | 8 |
Females | 5 |
Age (Years) | |
20–30 | 3 |
31–40 | 5 |
>41 | 5 |
Education | |
Graduation | 4 |
Specialization | 9 |
Experience (Years) | |
1–5 | 4 |
5–10 | 4 |
>10 | 5 |
ADR reporting | |
Yes | 8 |
No | 5 |
© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
Hussain, R.; Hassali, M.A.; ur Rehman, A.; Muneswarao, J.; Hashmi, F. Physicians’ Understanding and Practices of Pharmacovigilance: Qualitative Experience from a Lower Middle-Income Country. Int. J. Environ. Res. Public Health 2020, 17, 2209. https://doi.org/10.3390/ijerph17072209
Hussain R, Hassali MA, ur Rehman A, Muneswarao J, Hashmi F. Physicians’ Understanding and Practices of Pharmacovigilance: Qualitative Experience from a Lower Middle-Income Country. International Journal of Environmental Research and Public Health. 2020; 17(7):2209. https://doi.org/10.3390/ijerph17072209
Chicago/Turabian StyleHussain, Rabia, Mohamed Azmi Hassali, Anees ur Rehman, Jaya Muneswarao, and Furqan Hashmi. 2020. "Physicians’ Understanding and Practices of Pharmacovigilance: Qualitative Experience from a Lower Middle-Income Country" International Journal of Environmental Research and Public Health 17, no. 7: 2209. https://doi.org/10.3390/ijerph17072209