Abstract
Background
The present study aimed to evaluate the knowledge, attitude and practices (KAP) about pharmacovigilance (PV) practices among health care professionals, that is, pharmacists and nursing staff before and after educational intervention in a tertiary care hospital.
Methods
This was an observational and questionnaire-based pre- and post-test educational interventional study involving pharmacists and nursing staff. A 15-point prevalidated questionnaire on KAP about PV was distributed to pharmacists and nursing staff before and after educational intervention. Ethical clearance was obtained before the start of the study.
Results
A total of 120 pharmacists and 60 nursing staff participated in pre- and post-KAP questionnaire study. The KAP of PV when compared before (pre-KAP) and after (post-KAP) the educational intervention, the correct response rates were found to be statistically significant (P < 0.001). Encouraging feedback was received from the participants.
Conclusion
This study proves that KAP of PV and adverse drug reaction reporting in routine practice can be improved by imparting knowledge about PV and hands-on training on adverse drug reaction reporting among pharmacists and nursing staff who are the backbone of health care system.
Keywords: Pharmacovigilance, Adverse drug reaction, Health care professional, Questionnaire
Introduction
The main purpose of pharmacovigilance (PV) is to reduce the risk of drug-related harm to the patient. All drugs are capable of producing adverse effects, and it is implied that when drug is given, a risk is taken.1,2 Adverse drug reactions (ADRs) are common causes of morbidity as well as mortality all over the world.3 PV activity in India is coordinated by the Indian Pharmacopoeia Commission (IPC). The IPC develops and maintains the PV database consisting of all observed suspected ADRs to medicines and acts as a World Health Organization Collaborating Centre for PV in public health programmes and regulatory services.4
Health care professionals play an important role in reporting and monitoring of adverse reactions. In India, underreporting is a matter of concern for PV programme of India (PvPI). To improve ADR reporting, multiple interventions are needed.5 Medication safety is the combined responsibility of physician, nurses, pharmacists and other health care workers. Knowledge, attitude and practice (KAP) studies are one of the best tools to assess ADR reporting among health care professionals towards PV. An educational intervention, which sensitises on PV and ADR form filling, is the need of the hour to create awareness about ADR and its reporting among health care professionals, especially, nursing staff and pharmacists.6 Studies from different settings indicate inadequate knowledge and perception about PV and its relevance among health care professionals, which is responsible for the high degree of underreporting.7, 8, 9 Data regarding KAP studies among pharmacists and nursing staff on PV are scanty in literature. Hence, a questionnaire-based comparison study was planned to evaluate KAP about PV practices among pharmacists and nursing staffs before and after educational intervention, that is, sensitisation workshop on PV.
Material and methods
Study setting
This study was conducted at a tertiary care hospital. Institutional Ethics Committee approval as well as participants informed consent was obtained. The study period was from 5 November to 15 November 2021. All guidelines as per the Declaration of Helsinki and good clinical practice guidelines were followed.
Study design
It was an observational, cross-sectional, questionnaire-based survey. A total of 120 pharmacists and 60 nursing staff posted in various departments participated actively in the study. Consent was obtained from the participants. Pharmacists and nursing staff who were not willing to participate and who were not available in the allotted time were excluded from the study. An educational intervention, that is, sensitisation workshop about PV and ADR reporting, was conducted for pharmacists and nursing staff. Before the educational intervention, a pretest was conducted, and the session was followed by a posttest.
Study tool
There were a total of 15 questions in the questionnaire to assess the knowledge (n = 11) on ADR, attitude (n = 2) towards PV and their practice (n = 2) on reporting ADR. The KAP questionnaires were designed and validated by the faculty of department of pharmacology who was trained in the field of PV. The questionnaire evaluated pharmacists and nursing staff in their KAP skills in PV and ADR reporting. Pretest was conducted with the questionnaires before the sensitisation workshop. The sensitisation workshop started with a presentation of 60 min, which included ADR definition with types, PV introduction, its necessity, benefits of ADR reporting, ADR reporting procedure like who can report, what/where/whom/how to report and filling the ADR form version 4 of PvPI.10 The presentation was followed by hands-on training on filling up the ADR form as per the case history provided. At the end of the session, the posttest was conducted with the same questionnaire and was collected after 10 min. The pretest and posttest were analysed using statistical methods.
Statistical analysis
The data obtained were entered in Microsoft excel spreadsheet and evaluated. The paired t-test was used to evaluate the pretest and posttest scores of pharmacists and nursing staff. All results attained were entered in Microsoft excel, and the statistical calculations were executed using GraphPad Instat. The P-value less than 0.05 was considered to be statistically significant.
Results
The demographic details of the participants with baseline characteristics are summarised in Table 1. All 15 questions were answered by pharmacists and nursing staff in pre- and post-test.
Table 1.
Baseline characteristics of study population (n = 180).
| S. No | Characteristics | Frequency (number) |
|---|---|---|
| 1 | Gender | |
| Male | 60 | |
| Female | 120 | |
| 2 | Age distribution in years | |
| 20–29 | 158 | |
| 30–39 | 22 | |
| 3 | Healthcare professional (education) | |
| Pharmacists (diploma pharmacy) | 120 | |
| Nursing staff (BSc Nursing) | 80 |
Knowledge analysis before and after educational intervention
Question 1 of Table 2 framed to obtain awareness on ADR monitoring centre under PvPI. In both pharmacist and nursing staff, statistically significant (P < 0.0001) differences in responses were evident in pre-KAP and post-KAP after educational session. Question 2 assessed regarding the year in which PvPI was established. In pharmacists, the score increased significantly to 93.3% from 20.8% after educational session (P < 0.0001). Similarly, in nursing staff, statistically significant results were noted (P < 0.0001). Question 3 was framed on reporting of drug-related issues to PvPI. In pharmacists, the percentage of correct response increased from 44.1% to 92.5% (P < 0.0001), whereas in nursing staff, none gave correct response in pretest group and in posttest, the response was 96.6% (P < 0.0001). Question 4 was regarding type A pharmacological class of ADR. According to the data, 8.33% of pharmacists chose the right answers in the pretest, which increased to 90% in posttest (P < 0.0001). In nursing staff, 41.6% chose the right answers in the pretest, which increased to 98.3% in posttest (P < 0.0001). Question 5 assessed location of IPC, the coordinating centre of PvPI. The number of correct responses increased significantly (P < 0.0001) after the intervention in both the groups. Question 6 was regarding the reporting timeline of serious ADR to Adverse Drug Reaction Monitoring Centre (AMC). Only 8.3% and 3.3% of pharmacists and of nursing staff chose the correct answer in pretest, respectively. After educational session, correct responses in pharmacist (96.6%) and nursing (90%) increased significantly (P < 0.0001).
Table 2.
Knowledge analysis before and after educational intervention.
| S. No | KAP questions knowledge | Pharmacists (n = 120) |
Nursing staff (n = 60) |
||||
|---|---|---|---|---|---|---|---|
| Pretest score, n (%) | Posttest score, n (%) | P-value | Pretest score, n (%) | Posttest score, n (%) | P-value | ||
| 1 | Are you aware regarding ADR reporting to Pharmacovigilance Centre/ADR monitoring centre (AMC)? A. Yesa B. No |
6 (5) | 120 (100) | 0.0001 | 2 (3.3) | 60 (100) | 0.0001 |
| 2 | Pharmacovigilance Programme of India (PvPI) was established in India in the year: A. 2015 B. 2010a C. 2008 D. 2012 | 25 (20.8) | 112 (93.3) | 0.0001 | 8 (13.3) | 58 (96.6) | 0.0001 |
| 3 | What are the following drug-related issues to be reported to PvPI? A. Adverse Reactions B. Drug interactions C. Medication errors D. Alla |
41 (34.1) | 111 (92.5) | 0.0001 | 0 | 58 (96.6) | 0.0001 |
| 4 | Type A pharmacological class of ADR stands for______________ A. Bizzare B. Augmenteda C. Delayed D. Continuous drug use |
10 (8.33) | 108 (90) | 0.0001 | 25 (41.6) | 59 (98.3) | 0.0001 |
| 5 | PvPI coordinated by the Indian Pharmacopeia Commission, is situated at A. Calcutta B. Mumbai C. Ghaziabada D. Jaipur | 25 (20.83) | 120 (100) | 0.0001 | 25 (41.6) | 60 (100) | 0.0001 |
| 6 | A serious adverse event in India should be reported to the AMC within? A. One day B. Seven calendar day C. Fourteen calendar daya D. Fifteen calendar day |
10 (8.3) | 116 (96.6) | 0.0001 | 2 (3.3) | 54 (90) | 0.0001 |
| 7 | ADRs are_____________ A. Only side effects B. Noxious and unintended response of drug at normal therapeutic dosea C. 1st leading cause of death D. Pharmacogenomic effect |
80 (66.6) | 118 (98.3) | 0.0001 | 15 (25) | 60 (100) | 0.0001 |
| 8 | Rare ADRs can be identified in the following phase of a clinical trial? A. Phase-1 B. Phase-2 C. Phase-3 D. Phase-4a |
30 (25) | 96 (80) | 0.0001 | 4 (6.6) | 54 (90) | 0.0001 |
| 9 | Indian Pharmacovigilance system is regulated by_____________ A. USFDA B. CDSCOa C. IPC D. DRDO |
22 (18.3) | 111 (92.5) | 0.0001 | 17 (28.3) | 52 (86.6) | 0.0001 |
| 10 | Serious adverse event in Pharmacovigilance is? A. Results in death B. Is life threatening C.Requires in patient hospitalization or prolongation of existing hospitalization D. Results in persistent or significant disability/incapacity E. Is a congenital anomaly/birth defect F. Alla |
10 (8.3) | 120 (100) | 0.0001 | 52 (86.6) | 60 (100) | 0.0038 |
| 11 | Is there any Pharmacovigilance Committee in this Institute? A. Don't know B. Yesa C. No D. Not yet formed |
45 (37.5) | 120 (100) | 0.0001 | 52 (86.6) | 60 (100) | 0.0038 |
Correct response.
Question 7 was based on the definition of ADR. A total of 66.6% of pharmacists correctly chose in pretest, and after session, correct responses significantly increased to 98.3% (P < 0.0001). While in nursing staff, 25% chose the correct response in pretest, and after session, all chose the correct responses (P < 0.0001). Question 8 assessed the knowledge regarding the detection of rare ADRs in phase 4 clinical trial. In both pharmacist and nursing staff, statistically significant (P < 0.0001) differences in responses were evident in pretest and posttest after educational session. Question 9 was regarding the knowledge of regulatory body of Indian PV system. In pharmacist group, correct responses significantly increased from 18.3% to 92.5% (P < 0.0001), and in nursing group, correct responses significantly increased from 28.3% to 86.6% (P < 0.0001) after intervention. Question 10 assessed knowledge regarding serious adverse event. In pharmacists, 8.3% opted for the right answer, which increased significantly to 100% after intervention. In nursing group, 86.6% were already aware of serious adverse event, and in posttest, all nursing staff chose the correct response (P < 0.0038). Question 11 was framed to assess the awareness regarding existence of PV committee in this Institute. In pharmacist group, responses as ‘yes’ were significantly increased from 37.5% to 100% (P < 0.0001), and in the nursing group, 86.6% were already aware of the existence of PV committee in this institute and in posttest, all nursing staff chose correct response (P < 0.0038).
Attitude analysis before and after educational intervention
Question 12 of Table 3 asked them whether reporting an ADR is necessary. In pharmacists, the pretest and the posttest responses as ‘yes’ were 90% and 100% (P < 0.0007), respectively. While in nursing group, the pretest and the posttest responses as “yes” were 96.6% and 100%, respectively. Question 13 was regarding the overall thinking about PV. Overall, 73.3% of pharmacists and 93.3% of nursing staff thought that PV improves public health before intervention. This perception increased to 96.6% and 100% after session, respectively.
Table 3.
Attitude analysis before and after educational intervention.
| S No | KAP questions attitude | Pharmacists (n = 120) |
Nursing staff (n = 60) |
||||
|---|---|---|---|---|---|---|---|
| Pretest score, n (%) | Posttest score, n (%) | P-value | Pretest score, n (%) | Posttest score, n (%) | P-value | ||
| 1 | Do you think reporting of adverse drug reaction (ADR) is necessary? A. May be B. Can't say C. Yesa D. No |
108 (90) | 120 (100) | 0.0007 | 58 (96.6) | 60 (100) | 0.159 |
| 2 | What do you think about Pharmacovigilance? A. Increase economic burden on healthcare system B. Improve public healtha C. Neglects patient safety D. Discourage effective drug use |
88 (73.3) | 116 (96.6) | 0.0001 | 56 (93.3) | 60 (100) | 0.0445 |
Correct response.
Practice analysis before and after educational intervention
Question 14 of Table 4 was regarding the training of ADR reporting, including filling of ADR form. Only 3.3% of pharmacists were trained in ADR reporting, whereas none of the nursing staff was trained. Question 15 asked them the factor that prevents them from reporting ADR. A total of 13.3% of pharmacists claimed that they were unable to decide whether ADR occurred, and this percentage was 58.3 in nursing group. Lack of time to report ADR was chosen by 20.8% of pharmacists, whereas 40% of nursing staff chose lack of time to report ADR. In addition, 7.5% of pharmacists chose no remuneration for reporting ADR. Reporting single ADR may not affect database was chosen by 58.3% of pharmacists, which decreased to 6.6% after educational session (P < 0.0001). While in nursing staff, only single nursing staff chose this option in pretest who disagreed after session.
Table 4.
Practice analysis before and after educational intervention.
| S No | KAP questions practice | Pharmacists (n = 120) |
Nursing staff (n = 60) |
||||
|---|---|---|---|---|---|---|---|
| Pretest score, n (%) | Posttest score, n (%) | P-value | Pretest score, n (%) | Posttest score, n (%) | P-value | ||
| 1 | Are you trained for ADR reporting including filling of ADR form? A. Yes B. No |
4 (3.3) | 120 (100) | 0.0001 | 0 | 60 (100) | 0.0001 |
| 2 | Which of the following factor prevent you from reporting ADRs? | ||||||
| A. Unable to decide whether ADR occurred or not | 16 (13.3) | 10 (8.3) | 0.0137 | 35 (58.3) | 04 (6.6) | 0.0001 | |
| B. Lack of time to report ADR | 25 (20.8) | 38 (31.6) | 0.0002 | 24 (40) | 39 (65) | 0.0001 | |
| C. No remuneration | 09 (7.5) | 64 (53.3) | 0.0001 | 0 | 17 (28.3) | 0.0001 | |
| D. Reporting a single case may not affect ADR database | 70 (58.3) | 08 (6.6) | 0.0001 | 01 (1.6) | 0 | 0.3214 | |
Discussion
In this study, we targeted educational session on PV for nursing and pharmacists, as they are backbone of healthcare system. In both groups, knowledge regarding regulatory bodies on ADR reporting was lacking. After educational intervention, posttest score significantly increased in both groups. This signifies that educational session is vital for the success of the PV programme. The study conducted by Gupta et al11 included assessment of KAP for doctors, nursing and pharmacists. However, educational intervention was not included in this study. This study concluded that knowledge and attitude towards PV are gradually improving among healthcare professionals, but the actual practice of ADR reporting is still deficient among them. Knowledge on criteria for serious ADR in nursing pretest group (86.6%) was found to be more compared with pharmacist pretest group (8.3%). This could be explained by the fact that nurses are dealing with clinical cases daily compared with pharmacists. Overall, we found significant increase in scores of knowledge regarding the definition and types of ADR, serious ADR including reporting duration. This emphasises the role of continuous educational session for healthcare workers.
In attitude practice analysis, though the majority of pharmacists and nursing staff were in agreement that ADR reporting is necessary and improves public health, but very few participants were actually trained in filling ADR form. Three main reasons prevented them to report ADRs. The first reason was that they were not able to decide whether ADR occurred or not, and the second reason was lack of time to report ADR and the belief that single ADR reporting is insignificant. Various technical terms related to PV, such as ADR, reporter, reportee, causality, outcome, and so on, were explained, giving nonmedical example, relating to it to burglary. This was found to be very interesting novel and made the session easy to grasp. Bagewadi et al12 and Augustine et al13 assessed the effectiveness of educational intervention on PV among undergraduate medical students and medical interns, respectively. Both these studies concluded that imparting knowledge about PV and ADR reporting promotes drug safety and rational use of medicines in future.
In Fig. 1A, for the pharmacist group, the total pre-KA score (mean ± standard deviation) on knowledge was 27.63 ± 21.62, and for attitude, the score of 98 ± 14.14 was noted. The total post-KA mean score on knowledge was 113.81 ± 7.38, and for attitude, the mean score was increased to 114.5 ± 6.36. The overall increase in correct response rate with statistical significance (P < 0.0001) was observed after educational intervention. In the nursing group (Fig. 1B), the total pre-KA mean score on knowledge was 18.36 ± 1.84, and for attitude, the score of 57 ± 1.54 was noted. The total post-KA mean score on knowledge was 57.72 ± 2.96, and for attitude, the mean score was increased to 60. The overall increase in correct response rate with statistical significance (P < 0.0001) was observed after educational intervention on knowledge domain.
Fig. 1.
(A) Mean KA scores of pharmacists – Overall level of knowledge and attitude among the participants (n = 120). (B) Mean KA scores of nursing staff – Overall level of knowledge and attitude among the participants (n = 60).
Feedback from the participants was encouraging with suggestions, and no negative feedback was received. Some of the feedback points are ‘very interesting and informative session’, very productive session’, ‘best session on ADR reporting to improve patient safety’ and well-explained class with hands-on experience on ADR form filing’. Interesting suggestions included ‘ADR reporting should be included in graduation courses of pharmacy and nursing’ and ‘prescriptions in hospitals should be uniform to avoid medication errors’. All these participants were made aware of the National Medical Commission guidelines on prescription writing for physician.
The result of this study suggests that nurses and pharmacists were strongly influenced by educational session on PV, including hands-on training on ADR reporting, which are in accordance with earlier studies published nationally12,13 and internationally.14,15 Considering the ignorance about PV and lack of training on ADR reporting, the authors suggest that health care workers need to undergo educational hands-on training to tackle the obstacle of underreporting of ADR.
The major limitation of this study is that it was conducted in single hospital with limited number of participants, and there are likely to be variations between different hospitals. In addition, other factors that are associated with questionnaire-based studies, such as accuracy of recall and leading language bias, could also have affected the results of this study. Apart from these, an important limitation of such questionnaire-based study is that although improvement in knowledge and/or attitude is easily seen in short time, change in practice needs long-term follow-up.
Conclusion
In conclusion, comparing the scores in the pretest and posttest is the definite proof that educational intervention is very much helpful in the betterment of KAP of PV among nursing staff and pharmacists. As this study suggests, educational intervention on PV is necessary to increase the awareness and reporting of ADR by nursing staff and pharmacists who are the backbone of health care delivery.
Patients/ Guardians/ Participants consent
Participants informed consent was obtained.
Ethical clearance
Institute/hospital ethical clearance certificate was obtained.
Source of support
Nil.
Disclosure of competing interest
The authors have none to declare.
Acknowledgements
The authors wish to thank all pharmacists and nursing staff who actively and enthusiastically participated in the survey. Authors also acknowledge Indian Pharmacopoeia Commission, Ghaziabad a National Coordination Centre for Pharmacovigilance Programme of India, Government of India.
References
- 1.Tripathi K.D. 8th ed. Jaypee Brothers Medical; 2018. Essentials of Medical Pharmacology. [Google Scholar]
- 2.Palaian S., Mishra P., Shankar P.R., Dubey A.K., Bista D., Almeida R. Safety monitoring of drugs - where do we stand? Kathmandu Univ Med J. 2006;4(13):119–127. [PubMed] [Google Scholar]
- 3.Holmes O.W. Medical Essays (1843–1892. Houghton Mifflin; Boston: 1911. Currents and counter-currents in medical science; pp. 173–208. [Google Scholar]
- 4.Nimesh S., Chaudhary A., Sharma A., et al. Pharmacovigilance programme of India: a review. Acta Scientific Pharmaceutical Sciences. 2019;3(9):12–17. [Google Scholar]
- 5.Tandon V.R., Mahajan V., Khajuria V., Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol. 2015;47:65–71. doi: 10.4103/0253-7613.150344. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.De Baetselier E., Dilles T., Feyen H., et al. Nurses' responsibilities and tasks in pharmaceutical care: a scoping review. Nursing Open. 2021:1–10. doi: 10.1002/nop2.984. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Hasford J., Goettler M., Munter K.H., et al. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55:945–950. doi: 10.1016/s0895-4356(02)00450-x. [DOI] [PubMed] [Google Scholar]
- 8.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]
- 9.Perlik F., Slanar O., Smid M., Petracek J. Attitude of Czech physicians to adverse drug reaction reporting. Eur J Clin Pharmacol. 2002;58:367–369. doi: 10.1007/s00228-002-0476-z. [DOI] [PubMed] [Google Scholar]
- 10.Indian Pharmacopoeia Commission, Ghaziabad, India. Pharmacovigilance Program of India. Retrieved on 07 Feb 2022. http://www.ipc.gov.in/PvPI/adr.html.
- 11.Gupta S.K., Nayak R.P., Shivaranjani R., et al. A questionnaire study on the knowledge, attitude, and the practice ofpharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspect Clin Res. 2015 Jan-Mar;6(1):45–52. doi: 10.4103/2229-3485.148816. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Bagewadi H.G., Deodurg P.M., Patil B.V., Dass A.P. Knowledge, attitude, perceptions and assessment of effectiveness of educational intervention on Pharmacovigilance among undergraduate medical students at Gulbarga Institute of Medical Sciences, Kalaburagi, India. Int J Basic Clin Pharmacol. 2018;7:103–108. [Google Scholar]
- 13.Augustine A., Rajesh M., Parimala K. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among medical interns in a tertiary care hospital, Kanchipuram. Drug Invention Today. 2019;12(1):77–82. [Google Scholar]
- 14.Suveges L.G., Gesy K.F., Wallace S.M., Blackburn J.L., Appel W.C. Adverse drug reaction reporting part II: evaluation of the Saskatchewan pilot project for a regional reporting program in Canada. Drug Inf J. 1995;29:581–589. [Google Scholar]
- 15.Scolt H.D., Thacher-Renshaw A., Rosenbaum S.E., Waters W.J., Green M., Andrews L.G. Physician reporting of adverse drug reactions: results of the Rhode Island adverse drug reaction reporting project. JAMA. 1990;263:1785–1788. [PubMed] [Google Scholar]