• 1.

    Hoban CL, Byard RW & Musgrave IF 2019. Analysis of spontaneous adverse drug reactions to echinacea, valerian, black cohosh and ginkgo in Australia from 2000 to 2015. J Integr Med 17: 338343.

    • Search Google Scholar
    • Export Citation
  • 2.

    Frazier SK, Higgins J, Bugajski A, Jones AR & Brown MR 2017. Adverse reactions to transfusion of blood products and best practices for prevention. Crit Care Nurs Clin North Am 29: 271290.

    • Search Google Scholar
    • Export Citation
  • 3.

    Patton K & Borshoff DC 2018. Adverse drug reactions. Anaesthesia 1: 7684.

  • 4.

    World Health Organization , Quality Assurance and Safety of Medicines Team , 2002. Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions: Why Health Professionals Need to Take Action. Geneva, Switzerland: WHO.

  • 5.

    Vargesson N 2015. Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Res C Embryo Today 105: 140156.

  • 6.

    Elshafie S, Zaghloul I & Roberti AM 2018. Pharmacovigilance in developing countries (part I): importance and challenges. Int J Clin Pharm 40: 758763.

    • Search Google Scholar
    • Export Citation
  • 7.

    Zhang C, Li PP, Wang LX, Xie YM & Li L 2020. ADR/AE early warning analysis of Shujin Jianyao Pills based on spontaneous reporting system. Zhongguo Zhongyao Zazhi 45: 35333538.

    • Search Google Scholar
    • Export Citation
  • 8.

    Le TT, Nguyen TTH, Nguyen C, Tran NH, Tran LA, Nguyen TB, Nguyen N & Nguyen HA 2020. Factors associated with spontaneous adverse drug reaction reporting among healthcare professionals in Vietnam. J Clin Pharm Ther 45: 122127.

    • Search Google Scholar
    • Export Citation
  • 9.

    Alsaleh FM, Lemay J, Al Dhafeeri RR, AlAjmi S, Abahussain EA & Bayoud T 2017. Adverse drug reaction reporting among physicians working in private and government hospitals in Kuwait. Saudi Pharm J 25: 11841193.

    • Search Google Scholar
    • Export Citation
  • 10.

    Shchory MP, Goldstein LH, Arcavi L, Shihmanter R, Berkovitch M & Levy A 2020. The effect of an intervention program on the knowledge and attitudes among medical staff regarding adverse drug reaction reporting. Pharmacoepidemiol Drug Saf 29: 12461253.

    • Search Google Scholar
    • Export Citation
  • 11.

    Shanko H & Abdela J 2018. Knowledge, attitudes, and practices of health care professionals toward adverse drug reaction reporting in Hiwot Fana Specialized University Hospital, Harar, eastern Ethiopia: a cross-sectional study. Hosp Pharm 53: 177187.

    • Search Google Scholar
    • Export Citation
  • 12.

    Shroukh WA, Shakhatreh FM, Yasein NA & Sharkas GF 2018. A survey on the knowledge, attitudes and practices of physicians towards pharmacovigilance in Jordanian health centres. Int Health 10: 363370.

    • Search Google Scholar
    • Export Citation
  • 13.

    Rana S., 2017. 6th Census Findings: 207 Million and Counting. The Express Tribune. Available at: https://tribune.com.pk/story/1490674/57-increase-pakistans-population-19-years-shows-new-census/. Accessed March 23, 2021.

    • Search Google Scholar
    • Export Citation
  • 14.

    Hussain R & Hassali MA 2019. Current status and future prospects of pharmacovigilance in Pakistan. J Pharm Policy Pract 12: 19178.

  • 15.

    Hussain R, Hassali MA, Hashmi F & Farooqui M 2018. A qualitative exploration of knowledge, attitudes and practices of hospital pharmacists towards adverse drug reaction reporting system in Lahore, Pakistan. J Pharm Policy Pract 11: 18143.

    • Search Google Scholar
    • Export Citation
  • 16.

    Lozano Fernández R, Vera Sánchez E, Lozano Estevan MDC, Madurga Sanz M & Serna Núñez A 2020. Knowledge and attitude about pharmacovigilance practices of pharmacy professionals of community pharmacy and hospital pharmacy in Spain. Rev Esp Salud Publica 94: e202007068.

    • Search Google Scholar
    • Export Citation
  • 17.

    Mukattash TL, Alwadi MW, Abu-Farha RK, Jarab AS, Al-Zubiedi SA & Alwedyan T 2018. Knowledge, attitudes, and practices of pharmacovigilance and ADRs spontaneous reporting among pediatricians and pediatric residents in Jordan. Curr Clin Pharmacol 13: 4554.

    • Search Google Scholar
    • Export Citation
  • 18.

    Riordan DO, Kinane M, Walsh KA, Shiely F, Eustace J & Bermingham M 2020. Stakeholders’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study. Eur J Clin Pharmacol 76: 13631372.

    • Search Google Scholar
    • Export Citation
  • 19.

    Awodele O, Akinyede A, Adeyemi OA & Awodele DF 2011. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. Int J Risk Saf Med 23: 217226.

    • Search Google Scholar
    • Export Citation
  • 20.

    Paveliu MS, Bengea-Luculescu S, Toma M & Paveliu SF 2013. Perception on adverse drug reaction reporting by physicians working in southern Romania. Maedica (Buchar) 8: 1725.

    • Search Google Scholar
    • Export Citation
  • 21.

    Iffat W, Shakeel S, Rahim N, Anjum F, Nesar S & Ghayas S 2014. Pakistani physicians’ knowledge and attitude towards reporting adverse drug reactions. Afr J Pharm Pharmacol 8: 379385.

    • Search Google Scholar
    • Export Citation
  • 22.

    Khan SA, Goyal C, Chandel N & Rafi M 2013. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: an observational study. J Nat Sci Biol Med 4: 191196.

    • Search Google Scholar
    • Export Citation
  • 23.

    Thomas TM, Udaykumar P & Scandashree K 2013. Knowledge, attitude and practice of adverse drug reaction reporting among doctors in a tertiary health care centre in South India. Int J Pharmacol Clin Sci 2: 8288.

    • Search Google Scholar
    • Export Citation
  • 24.

    Nisa ZU, Zafar A & Sher F 2018. 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 26: 453461.

    • Search Google Scholar
    • Export Citation
  • 25.

    Shamim S, Sharib SM, Malhi SM, Muntaha SU, Raza H, Ata S, Farooq AS & Hussain M 2016. Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists. Springerplus 5: 16–3337.

    • Search Google Scholar
    • Export Citation
  • 26.

    Kassa Alemu B & Biru TT 2019. Health care professionals’ knowledge, attitude, and practice towards adverse drug reaction reporting and associated factors at selected public hospitals in northeast Ethiopia: a cross-sectional study. BioMed Res Int 53: 177187.

    • Search Google Scholar
    • Export Citation
  • 27.

    Sanghavi DR, Dhande PP & Pandit VA 2013. Perception of pharmacovigilance among doctors in a tertiary care hospital: influence of an interventional lecture. Int J Risk Saf Med 25: 197204.

    • Search Google Scholar
    • Export Citation
  • 28.

    Ghazala Z, Kalshetty P & Vardhamane S 2019. Knowledge, attitude and practices towards pharmacovigilance among health care professionals in a teaching and general hospital of South India. IJBCP 8: 7.

    • Search Google Scholar
    • Export Citation
  • 29.

    Agarwal R, Daher AM & Mohd Ismail N 2013. Knowledge, practices and attitudes towards adverse drug reaction reporting by private practitioners from Klang Valley in Malaysia. Malays J Med Sci 20: 5261.

    • Search Google Scholar
    • Export Citation
  • 30.

    Khan SA, Goyal C, Chandel N & Rafi M 2013. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: an observational study. J Nat Sci Biol Med 4: 191.

    • Search Google Scholar
    • Export Citation
  • 31.

    Figueiras A, Tato F, Fontaiñas J, Takkouche B, Gestal-Otero JJ, 2001. Physicians’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract 7: 347–354.

  • 32.

    Ahmad A, Patel I, Balkrishnan R, Mohanta G & Manna P 2013. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: a pilot study. Perspect Clin Res 4: 20410.

    • Search Google Scholar
    • Export Citation
  • 33.

    Desai CK, Iyer G, Panchal J, Shah S & Dikshit RK 2011. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res 2: 129136.

    • Search Google Scholar
    • Export Citation
 
 

 

 

 

 

 

 

An Exploration of Knowledge, Attitude, and Practices of Physicians toward Pharmacovigilance at Tertiary Care Hospitals in Khyber-Pakhtunkhwa Province, Pakistan

View More View Less
  • 1 Department of Pharmacy, COMSATS University Islamabad-Abbottabad Campus, Abbottabad, Khyber Pakhtunkhwa, Pakistan;
  • | 2 Department of Pharmacy, COMSATS University Islamabad-Lahore Campus, Lahore 54000, Pakistan;
  • | 3 Department of Clinical Pharmacy, College of Pharmacy, Al-Ain University, Abu Dhabi, United Arab Emirates;
  • | 4 Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman P.O. Box 346, United Arab Emirates;
  • | 5 Medical and Bio-Allied Health Sciences Research Centre, Ajman University, Ajman P.O. Box 346, United Arab Emirates;
  • | 6 Department of Pharmacy, University of Peshawar, Peshawar, Khyber Pakhtunkhwa, Pakistan;
  • | 7 College of Pharmacy, South-Central University for Nationalities, Wuhan 430074, China;
  • | 8 Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, Pakistan;
  • | 9 Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi’an Jiaotong University, Xi’an, China

ABSTRACT.

Drug safety assures the effectiveness, safety, and security of drugs, vaccines, and other biologicals to protect public health. Medication-related errors coupled with unjudicial medication practices often cause a catastrophic impact on the healthcare system globally. The present study aimed to assess the knowledge, attitude, and practice of physicians toward pharmacovigilance and barriers to adverse drug reaction (ADR) reporting at tertiary care hospitals in Khyber-Pakhtunkhwa (KP) province, Pakistan. A descriptive cross-sectional study was conducted among registered doctors working in seven tertiary care hospitals from seven administrative divisions of KP province of Pakistan from July 2019 to March 2020. During the study period, 358 physicians who fulfilled the inclusion criteria and agreed to participate completed and returned the validated structured questionnaires. Descriptive and inferential statistics were applied for data analysis. The majority of physicians had poor knowledge (81.3%) regarding pharmacovigilance along with poor reporting practices (94.9%), although (96.5%) had a positive attitude toward ADR reporting. A significant barrier identified was the unavailability of reporting forms (95.9%), whereas mandatory ADR reporting (96.2%) was the major factor to encourage ADR reporting. Physicians aged ≥ 41 and experience ≥ 11 years had significantly more knowledge than other categories (P < 0.001). Significant association (P < 0.001) of physicians’ knowledge and practice were found where 77.2% of the participants having poor knowledge reported poor practices. Physicians’ understanding of pharmacovigilance was suboptimal, although they have a positive attitude toward ADR reporting. Thus, there is a need for continuous education and training programs to support pharmacovigilance activities that could improve physicians’ understanding.

INTRODUCTION

The hazards related to medicine use have always been a point of discussion in the scientific community. In contrast, there is enough evidence suggesting the common occurrence of adverse drug reactions (ADR) leading to patient morbidity, mortality, and implicating a financial burden on healthcare systems around the world.13 The WHO defines an ADR as “any drug effect, which is a noxious, unintended and undesired effect and occurs at normal therapeutic doses.”4

The need to establish a mechanism to evaluate ADRs was felt to ensure medicine safety and monitoring because of the thalidomide disaster in the early 1960s that resulted in many babies born with malformed limbs.5 As a result, in 1971, WHO, along with its associated members, established an early detection ADR and monitoring program at its headquarter in Geneva, which was shifted to Uppsala, Sweden, in 1978.

The evaluation mechanism is termed pharmacovigilance (PV), which is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.” Pharmacovigilance aims at identifying possible harm related to medicine use and communicating it to healthcare professionals to minimize the hazards and improve patient safety.4 A total of 134 member countries are linked with UMC Sweden, and 96% of developed countries have a national PV system compared with low and middle-income countries (LMICs) with only 27%, mainly because of the lack of infrastructure and resources.6

Spontaneous ADR reporting is an effective way of generating ADR signals, and physicians play a crucial role in spontaneous ADR reporting.7,8 Physicians observe ADRs in their daily practice, yet the percentage of ADRs reported is significantly low.9 Previous studies have documented numerous factors, including physicians’ knowledge and attitude, that could cause underreporting of ADRs by physicians and contribute to the public health catastrophe.1012

Pakistan is a populous country ranked sixth with a population of approximately 207.8 million.13 In Pakistan, PV is regulated by the Drug Regulatory Authority of Pakistan (DRAP), which has set up a National Pharmacovigilance Center in 2017, followed by provincial PV centers in 2018. Pakistan turned into a full member of UMC in 2018. However, its PV system is still in its early stages.14 Unfortunately, the data regarding ADR statistics from Pakistan is not available at the WHO drug monitoring center (UMC), and there is little or scarce data regarding communication between national PV centers and physicians.15 As reported in previous studies, sufficient knowledge about PV among healthcare professionals is vital for the PV center’s optimal working.1618 Nevertheless, no study has been undertaken on physicians about PV from Khyber-Pakhtunkhwa (KP) province of Pakistan. More than 17% of the total population of Pakistan live in KP. There are 5,136 doctors excluding dentists practicing in various hospitals of KP. This study intended to investigate the knowledge, attitudes, and practices regarding ADR reporting among physicians working in tertiary care hospitals of KP province, Pakistan.

METHODS

Study design and sampling strategy.

A questionnaire-based, descriptive cross-sectional study was conducted among registered doctors working at tertiary care government hospitals in the KP province of Pakistan from July 2019 to March 2020. KP has seven administrative divisions, so one tertiary care hospital from each division was included to minimize bias. The sample size was determined based on the number of registered doctors working in KP at 5,136 in 2019. Raosoft sample size online calculator was used, keeping 95% CI, 5% margin of error, and 50% response rate. The minimum sample size required was 358, which was distributed proportionally in each district.

Questionnaire.

The questionnaire was constructed by an extensive review of the literature.3,11,17,19 The questionnaire’s content validity was assessed by review from two experts in the discipline of social and administrative pharmacy. Clinical sensibility testing was carried out by a panel of physicians who assessed the questions in terms of their understanding and clarity. The questionnaire was then simplified according to suggestions keeping important constructs.

The initial part of the questionnaire included demographic information (age, gender, specialty of physicians, and overall work experience). Modified Blooms cutoff point was used to categorize the overall knowledge, attitude, and practice of participants. The questionnaire was based on three primary domains and two secondary domains as follows

  1. a.Knowledge about pharmacovigilance had 12 statements, and responses were noted as yes, no, and don’t know with a total score of 12 (1 point for each correct response and 0 for incorrect or do not know response). It was categorized as either good (score 10–12), moderate (score 6–9) or poor (score < 6) knowledge.
  2. b.Attitude toward pharmacovigilance was assessed on eight questions and a total of 40 points. A 5-point Likert scale was used to grade responses related to attitude, with 1 point for strongly disagree to 5 points for Strongly agree. Overall attitude as categorized as either positive (score 32–40), neutral (score 24–31), and negative (score < 24). Responses were then merged into two nominal categories, “Agree” and “Disagree,” for descriptive analysis.
  3. c.Subsequently, the practice was assessed by five questions having a total of 5 points, whereas practice level was classified as poor (1–2 score), fair (3 scores), and good level (4–5 scores).
  4. d.Barriers to ADR reporting were recorded by eight questions, and factors encouraging to report ADRs were recorded by five questions.

A pilot testing with 40 participants was conducted to measure the internal consistency, which was acceptable (Cronbach’s alpha = 0.766).

Ethical approval and informed consent.

Ethical approval was obtained from the COMSATS University Islamabad (CUI) Abbottabad research and ethics committee (No. PHM.E.th/CF-M10/17-0043). Verbal consent was obtained from the participants before participants were handed the questionnaires to fill and then returned.

Data analysis.

Questionnaires were checked whether complete, sorted, and edited and entered in Statistical Package for the Social Sciences (SPSS) V 21 for analysis. Data were cleaned and summarized using percentages and frequencies and described as means and standard deviation. A P value of 0.05 was considered significant with an independent t-test and analysis of variance (ANOVA) used for cross-group comparison. A χ2 test was performed to determine the association between the variables.

RESULTS

Demographics.

In the current study, 358 questionnaires were distributed, and a response rate of 88.2% was achieved, as 316 questionnaires were correctly filled and returned. Among the respondent’s majority were male (53.5%), with participants between 20 and 30 years representing the largest group (61.7%). The information about demographics is displayed in Table 1.

Table 1

Demographic characteristics

Demographic dataResponse n (%)
Gender
 Male169 (53.5)
 Female147 (46.5)
Age groups
 20–30195 (61.7)
 31–4094 (29.7)
 ≥ 4127 (8.5)
Specialty
 House officer163 (51.6)
 Medical officer124 (39.2)
 Consultant29 (9.2)
Experience (years)
 ≤ 1107 (33.9)
 2–5136 (43)
 6–1054 (17.1)
 ≥ 1119 (6)

A mean knowledge score of 3.8 ± 1.9 was obtained, followed by a mean attitude score of 36.7 ± 2.9 and a mean practice score of 1.2 ± 0.8. Among the respondents, 18.7% had moderate knowledge, whereas 81.3% had a poor knowledge level. The majority of respondents (96.5%) had a positive attitude, whereas 3.5% had a neutral attitude. 94.9% of respondents had poor practice, whereas 5.1% had fair practice level (Table 2).

Table 2

Description of KAP scores and level

QuestionMean ± SD
Knowledge score3.79 ± 1.94
Attitude score36.73 ± 2.9
Practice score1.17 ± 0.8
Response n (%)
Knowledge level
 Moderate knowledge59 (18.7)
 Poor knowledge257 (81.3)
Attitude level
 Positive attitude305 (96.5)
 Neutral attitude11 (3.5)
Practice level
 Fair level16 (5.1)
 Poor level300 (94.9)

KAP = knowledge, attitude, and practice.

Knowledge of participants.

Table 3 describes the correct responses to knowledge questions indicating that only 19.9% of respondents knew about the term PV, whereas 74.7% were able to identify the term ADR correctly. Approximately 23.1% and 50.9% of respondents were able to identify types of ADRs and relate side effects, drug interactions, and allergic reactions as types of ADRs, respectively. Moreover, only 11.1% were able to identify the international ADR reporting and monitoring center, whereas only 8.5% knew about the WHO online database for reporting ADRs. Few participants knew that a national or regional ADR reporting center exists in Pakistan (22.5%), whereas a very small proportion of respondents knew that an ADR reporting form exists in Pakistan (5.4%). Over half of the participants (63%) knew that any serious event should be reported to the Ministry of Health/Drug regulatory authority. Among the participants, 49.1% identified that companies used postmarketing surveillance to monitor existing medicines’ ADRs. Almost half of the participants (47.5%) showed agreement that all healthcare professionals, including doctors, pharmacists, and nurses, were responsible for reporting an ADR. The majority of respondents (90.8%) did not know how to report an ADR.

Table 3

Correct response of knowledge regarding pharmacovigilance

QuestionResponse n (%)
Define pharmacovigilance63 (19.9)
WHO has defined an ADR “as any noxious, unintended and undesired effects of a drug that occur at doses used for prevention, diagnosis or therapy.”236 (74.7)
The types of ADR are Type A, B, C, D, E, and F.73 (23.1)
Side effects, drug interactions, and allergic reactions are counted as ADR.161 (50.9)
Where is the International Center for Adverse Drug Reaction Monitoring located?35 (11.1)
Which one of the following is the WHO online database for reporting ADRs?27 (8.5)
Does a national or regional/district ADR center linked to the DRAP exist in Pakistan?71 (22.5)
What procedures do companies adapt to monitor ADRs once launched into markets?155 (49.1)
If a serious adverse drug event is observed, where should it be reported in Pakistan?199 (63)
The healthcare professionals are primarily responsible for reporting an ADR in the hospital?150 (47.5)
Are there any ADRs reporting forms that exist in Pakistan?17 (5.4)
Do you know how to report an ADR?29 (9.2)

ADR = adverse drug reaction; DRAP = Drug Regulatory Authority of Pakistan.

Attitude of participants.

The attitude of the participants is described in Table 4. The majority of respondents agreed that ADR reporting was necessary (99.7%), contributes to patient safety (97.8%), should be compulsory (98.7%), and was their professional obligation (87.7%). Moreover, there was an agreement among 95.3% and 94% of respondents that all ADRs for newly marketed drugs and of herbal/nonallopathic drugs should be reported, respectively. Further, the majority of respondents (95.6%) agreed that it was necessary to be confirmed that an ADR was related to a specific drug before reporting. In contrast, there should be an ADR monitoring center in every hospital (97.8%).

Table 4

Attitude of physicians toward pharmacovigilance

QuestionsResponse: n (%)
AgreeDisagree
ADR reporting is necessary315 (99.7)1 (0.3)
ADR reporting should be made compulsory312 (98.7)4 (1.3)
ADR reporting is a professional obligation for you277 (87.7)39 (12.3)
ADR reporting contributes to patient safety309 (97.8)7 (2.2)
All ADRs for newly marketed drugs should be reported301 (95.3)15 (4.7)
ADR of herbal and nonallopathic drugs should also be reported297 (94)19 (6)
It is necessary to be confirmed that an ADR is related to a specific drug before reporting302 (95.6)14 (4.4)
ADR monitoring center should be in every hospital309 (97.8)7 (2.2)

ADR = adverse drug reaction.

Practices of participants.

Most respondents (80.4%) had experienced an ADR in their patients during their professional practice, whereas only 28.2% had reported any ADR in the last 5 years. Moreover, 94% of respondents said that there is no regulatory body in their hospital to regulate ADR reporting, whereas 97.5% of respondents had never seen an ADR reporting form in their hospital. The majority of respondents (98.7%) had never been trained to report an ADR (Table 5).

Table 5

Description of practice of pharmacovigilance

QuestionsResponse: n (%)
YesNo
Have you ever experienced adverse drug reactions in your patients during your professional practice?254 (80.4)62 (19.6)
Have you ever reported any ADR among your patients in the last 5 years?89 (28.2)227 (71.8)
Is there any regulatory body that regulates ADR reporting in your hospital?19 (6)297 (94)
Have you ever seen the ADR reporting form in your hospital?8 (2.5)308 (97.5)
Have you ever been trained on how to report ADRs?4 (1.3)312 (98.7)

ADR = adverse drug reaction.

Barriers to reporting ADRs.

Figures 1 and 2 show the barriers to reporting ADRs and factors to encourage ADR reporting, respectively. The most frequently cited barriers were unavailability of reporting forms (95.9%), absence of a professional environment to discuss ADR (81.6%), lack of training (79.1%), and not knowing how to report an ADR (67.4%). Participants also recognized the lack of motivation (44.6%) and fear of legal liability (23.1%) as reporting barriers. The most common factors to encourage ADR reporting were obligatory reporting (96.2%), encouragement from hospital administration to report (94.9%), and provision of ADR management guidelines and training (94.3%).

Figure 1.
Figure 1.

Description of barriers to reporting adverse drug reactions (ADRs). This figure appears in color at www.ajtmh.org.

Citation: The American Journal of Tropical Medicine and Hygiene 105, 6; 10.4269/ajtmh.21-0336

Figure 2.
Figure 2.

Description of factors that encourage adverse drug reaction (ADR) reporting. This figure appears in color at www.ajtmh.org.

Citation: The American Journal of Tropical Medicine and Hygiene 105, 6; 10.4269/ajtmh.21-0336

Table 6 displays the differences in knowledge, attitude, and practice (KAP) scores and sociodemographic characteristics. There was a statistically significant difference in mean knowledge and practice scores between age groups, the physician’s specialty, and years of experience. Post hoc analysis revealed that this difference was more significant between 20–30 and 41 ≥ age categories, house officer and consultants for both knowledge and practice scores, whereas it was larger between 2–5 and ≥ 11 years of experience for knowledge and ≤ 1 year and ≥ 11 years of experience for practice scores respectively. Mean attitude scores showed no significance.

Table 6

Association between mean scores and demographics

VariableSubgroupMean score ± SD*
KnowledgeAttitudePractices
Age20–303.6 ± 1.936.8 ± 2.91.1 ± 0.7
31–403.9 ± 1.836.7 ± 31.2 ± 0.8
≥ 415.6 ± 2.436.4 ± 3.71.7 ± 0.9
P value< 0.001*0.837< 0.001*
GenderMale4 ± 2.136.7 ± 2.91.1 ± 0.8
Female3.6 ± 1.936.8 ± 31.2 ± 0.8
P value0.200.650.59
SpecialityHouse officer3.4 ± 1.936.9 ± 2.70.98 ± 0.7
Medical officer3.9 ± 1.736.5 ± 3.31.3 ± 0.8
Consultant5.6 ± 2.436.4 ± 3.21.6 ± 0.9
P value< 0.001*0.40< 0.001*
Experience

(Years)
≤ 13.9 ± 1.936.5 ± 2.80.9 ± 0.7
2–53.5 ± 1.936.9 ± 2.91.0 ± 0.7
6–103.7 ± 1.936.4 ± 3.51.6 ± 0.9
≥ 115.5 ± 2.637.3 ± 2.71.8 ± 0.9
P value< 0.001*0.442< 0.001*

P < 0.05 is significant.

Analysis of variance (ANOVA).

Independent t-test.

There was no association found between knowledge and attitudes and attitude and practices. However, a significant association (P < 0.001) of physician knowledge and practices toward PV was found, where 77.2% of the participants who had poor knowledge were more likely to have poor practices, as shown in Table 7.

Table 7

Association of knowledge and practices

ItemPracticeP value*
Fair (%)Poor (%)
Knowledge level, n (%)Moderate knowledge3 (0.9)56 (17.7)< 0.001†
Poor knowledge13 (4.1)244 (77.2)

Chi-square

DISCUSSION

Our study’s overall findings suggested that physicians lack knowledge and adequate PV practices, although they had a positive attitude toward ADR reporting. Physicians’ knowledge was significantly associated with their age, speciality, and years of experience (P < 0.001). Aside from that, this study has shown that knowledge and practice were not associated with attitude. This indicates that although one may have a good mindset, they may not have sufficient knowledge and good practice toward PV. Lack of knowledge might be because PV is a new concept to physicians. Its awareness is a crucial component for a medical practitioner, and failure to do so may result in patient harm and increased cost of therapy.

The study results showed inadequate physicians’ knowledge regarding the term PV, with only a few physicians understanding its meaning. However, the majority were able to define ADRs. These results were consistent with the findings from different studies from Romania (22.6%) and Pakistan (31.5%).20,21 In contrast to these findings, studies from India (69.1%) and Nigeria (82.9%) revealed adequate knowledge of the term PV by the physicians.19,22 On the contrary, most physicians were able to identify the term ADR correctly (74.7%), as observed in other studies.12,20 Physicians were also unable to identify types of ADRs (23.1%). This may be because the term PV is a new one among physicians in Pakistan; hence their knowledge regarding PV is inadequate.

Our study indicated that despite knowing to report a serious ADR to the Ministry of Health (63%), maximum physicians had poor knowledge regarding the location of international (11.1%) and national centers (22.5%) for ADR reporting and monitoring. Additionally, maximum participants (91.5%) were unaware of the WHO online database for reporting ADRs. These results were in line with findings of studies conducted in India23 and Pakistan.24 Despite knowing where to report a serious ADR, physicians were not aware of the international, national, and regional centers and databases for reporting ADRs. Nevertheless, this has also been demonstrated in previous studies.25,26 This illustrates that a crucial element of PV activity is missing by our physicians, compromising patient safety.

Several studies in different countries have described that almost 70–90% of physicians consider themselves the most qualified professional to report an ADR, whereas giving less importance to other healthcare professionals.19,21,27 However, our study suggested contradicting results in which almost 50% of the participants accepted that doctors, pharmacists, and nurses are equally responsible and capable of reporting ADRs. There is another study in India with similar results.28 This suggests the possibility of the growing acceptance of physicians toward the role of other healthcare professionals.

Our study also reported that maximum physicians (90.8%) did not know how to report an ADR or whether an ADR reporting form exists in Pakistan (94.6%). This is well supported by several studies conducted in India and Romania, where more than 60–90% of physicians were not familiar with the procedure to report an ADR in their countries.29 These findings indicate an overall lack of knowledge by the physicians toward PV.

The study showed that physicians aged ≥ 41 years had a moderate level of knowledge, followed by physicians between 20 and 30. It also showed that consultants had more knowledge followed by house officers rather than medical officers, whereas physicians with more than 11 years of experience had greater knowledge as compared with physicians with less experience. This might be probably because experienced physicians hold a higher knowledge level and experience and can better understand and identify ADRs compared with young doctors. However, young doctors are keener on learning new terms.

In our study, we found that maximum physicians (96.1%) showed an overall positive level of attitude toward PV and ADR reporting. Physicians responded positively that ADR reporting should be made compulsory (98.7%) and account for their professional obligations (87.7%). These are in conjunction with findings from many studies conducted in several countries where a strong agreement of 60–90% was seen among the physicians on the need to report ADR and was accounted as their professional duty to report.11,27

Several studies measuring physicians’ attitude regarding ADR reporting concluded that 80–95% of the agreement was seen among physicians that ADR reporting contributed toward patient safety, and the benefit was passed on to the patients.28 Our study also found that 97.8% of physicians agreed that ADR reporting contributes to patient safety.

Our study reported that 95.3% of physicians believed that all ADRs for newly marketed drugs should be reported. Physicians’ opinions on reporting of ADRs for newly marketed drugs varied in several studies. Some studies from India23 and Pakistan21 suggested that over 85–98% of physicians agreed that ADRs of newly marketed medicines should be reported, whereas a study from Romania20 and India30 reported that 70–90% of physicians were of a view that serious ADRs of medicines are well known before they are marketed. This difference of opinion may affect the determinant to report an ADR by the physicians.

In a few studies, physicians have emphasized upon reporting an ADR only if it is confirmed to be related to a specific drug23 and establishment of ADR monitoring centers in every hospital.22 Similar findings were observed in our study where 95.6% of physicians agreed to report only confirmed ADRs related to specific medications, and 97.8% wanted ADR to be established in each hospital. This reflects the positive attitude of physicians toward PV activities.

Our survey data indicated overall poor practice (94.9%) of physicians reporting ADRs. The majority of physicians (80.4%) responded that they had encountered ADRs in their patients in their professional practice. Similar results were observed from several studies where 70–90% of physicians did encounter ADRs.22,23 Contrasting findings were seen in a study from Nigeria,19 where 64.9% of physicians reported that they did not come across an ADR in their practice. Although the majority responded to have encountered an ADR but when it came to ADR reporting, our study showed that only 28.2% of physicians admitted to reporting any ADR to some authority which was consistent with reporting rates as 5.3% from Malaysia,29 15% from Romania,31 5.6% from Nigeria,19 and 25% from India.23 This reflects upon an overall trend of poor reporting practices.

Our study revealed that 90.8% of physicians had never been trained on reporting ADRs, similar to different studies where 80–100% of physicians agreed on not receiving adequate ADR reporting training.19,27 Furthermore, only 6% of physicians responded to whether there was any regulatory body in their hospital to regulate ADRs, whereas only 2.5% had ever seen any ADR reporting form. These findings were also in conjunction with other studies where 80–90% of physicians had not seen reporting forms and were not aware of their hospitals’ ADR regulations.28 Furthermore, better outcomes can be obtained in terms of PV activities with physicians’ prior exposure to proper training.32 Thus, lack of training is a strong determinant toward an overall lack of knowledge and poor reporting practices by the physicians.

While evaluating the barriers to reporting ADRs, our study revealed that the most common barrier faced by physicians to report ADR was the unavailability of reporting forms (95.9%). This was followed by unavailability of a professional environment to discuss an ADR (81.6%), lack of training (79.1%), not knowing how to report an ADR (67.4%), not being confident to identify an ADR (56.5%), and lack of motivation (44.5%). These are consistent with findings from several studies.29 However, because of the difference in healthcare systems and varied cultural, geographical, and medical practices, the order in which barriers are reported differs from our study.

Our study found that major factors that would encourage physicians to report ADRs were if they were compulsory (96.2%); a simplified reporting method in place (95.6%); encouragement from hospital administration (94.9%); regular guidelines, and training on ADR reporting (94.3%) and feedback from relevant authorities (91.8%). These suggestions agreed upon by physicians corresponded with observations in other studies from Nigeria19 and India,33 which suggested that regular training programs and facilitated reporting system should be in place, as well as encouraging feedback would help to improve ADR reporting practices.

The basic PV knowledge should be incorporated in medical education curricula as part of its public health and institutional module prior to students going on to their clinical training. During clinical training and house officer experience, PV knowledge and reporting skills should be reinforced, with an item on PV included in their periodic evaluations.

Our study had several limitations. The data set mainly consisted of relatively young doctors as they were enthusiastic and willingly participated compared with consultants. This study has only targeted participants working in government hospitals, and the perspective of physicians practicing in private hospitals could differ. Furthermore, the limited sample is unable to generalize the findings of this study nevertheless our study is exploratory, and findings could be a valuable input for future researchers and address the actual scenario in our country.

CONCLUSION

The findings from our study have identified and highlighted a crucial problem in Pakistan, that is, the overall lack of knowledge of physicians regarding PV, in addition to poor ADR reporting practices with a significant implication on patient safety. Therefore, there is an urgent need for all stakeholders to address this issue by continuous education and training programs and ensure proper implementation of PV activities in tertiary care hospitals of KP, Pakistan. Furthermore, with the principal aim of PV, interventional studies should be carried out to improve the physician’s overall knowledge and practice.

ACKNOWLEDGMENTS

Foremost, we would like to express gratitude to the physicians from tertiary hospitals in Khyber-Pakhtunkhwa for spending their time participating in the survey. We also sincerely thank Sagar Singh for participating and helping in the data collection of the survey. We are deeply grateful to the participants of the study. The American Society of Tropical Medicine and Hygiene (ASTMH) assisted with publication expenses.

REFERENCES

  • 1.

    Hoban CL, Byard RW & Musgrave IF 2019. Analysis of spontaneous adverse drug reactions to echinacea, valerian, black cohosh and ginkgo in Australia from 2000 to 2015. J Integr Med 17: 338343.

    • Search Google Scholar
    • Export Citation
  • 2.

    Frazier SK, Higgins J, Bugajski A, Jones AR & Brown MR 2017. Adverse reactions to transfusion of blood products and best practices for prevention. Crit Care Nurs Clin North Am 29: 271290.

    • Search Google Scholar
    • Export Citation
  • 3.

    Patton K & Borshoff DC 2018. Adverse drug reactions. Anaesthesia 1: 7684.

  • 4.

    World Health Organization , Quality Assurance and Safety of Medicines Team , 2002. Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions: Why Health Professionals Need to Take Action. Geneva, Switzerland: WHO.

  • 5.

    Vargesson N 2015. Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Res C Embryo Today 105: 140156.

  • 6.

    Elshafie S, Zaghloul I & Roberti AM 2018. Pharmacovigilance in developing countries (part I): importance and challenges. Int J Clin Pharm 40: 758763.

    • Search Google Scholar
    • Export Citation
  • 7.

    Zhang C, Li PP, Wang LX, Xie YM & Li L 2020. ADR/AE early warning analysis of Shujin Jianyao Pills based on spontaneous reporting system. Zhongguo Zhongyao Zazhi 45: 35333538.

    • Search Google Scholar
    • Export Citation
  • 8.

    Le TT, Nguyen TTH, Nguyen C, Tran NH, Tran LA, Nguyen TB, Nguyen N & Nguyen HA 2020. Factors associated with spontaneous adverse drug reaction reporting among healthcare professionals in Vietnam. J Clin Pharm Ther 45: 122127.

    • Search Google Scholar
    • Export Citation
  • 9.

    Alsaleh FM, Lemay J, Al Dhafeeri RR, AlAjmi S, Abahussain EA & Bayoud T 2017. Adverse drug reaction reporting among physicians working in private and government hospitals in Kuwait. Saudi Pharm J 25: 11841193.

    • Search Google Scholar
    • Export Citation
  • 10.

    Shchory MP, Goldstein LH, Arcavi L, Shihmanter R, Berkovitch M & Levy A 2020. The effect of an intervention program on the knowledge and attitudes among medical staff regarding adverse drug reaction reporting. Pharmacoepidemiol Drug Saf 29: 12461253.

    • Search Google Scholar
    • Export Citation
  • 11.

    Shanko H & Abdela J 2018. Knowledge, attitudes, and practices of health care professionals toward adverse drug reaction reporting in Hiwot Fana Specialized University Hospital, Harar, eastern Ethiopia: a cross-sectional study. Hosp Pharm 53: 177187.

    • Search Google Scholar
    • Export Citation
  • 12.

    Shroukh WA, Shakhatreh FM, Yasein NA & Sharkas GF 2018. A survey on the knowledge, attitudes and practices of physicians towards pharmacovigilance in Jordanian health centres. Int Health 10: 363370.

    • Search Google Scholar
    • Export Citation
  • 13.

    Rana S., 2017. 6th Census Findings: 207 Million and Counting. The Express Tribune. Available at: https://tribune.com.pk/story/1490674/57-increase-pakistans-population-19-years-shows-new-census/. Accessed March 23, 2021.

    • Search Google Scholar
    • Export Citation
  • 14.

    Hussain R & Hassali MA 2019. Current status and future prospects of pharmacovigilance in Pakistan. J Pharm Policy Pract 12: 19178.

  • 15.

    Hussain R, Hassali MA, Hashmi F & Farooqui M 2018. A qualitative exploration of knowledge, attitudes and practices of hospital pharmacists towards adverse drug reaction reporting system in Lahore, Pakistan. J Pharm Policy Pract 11: 18143.

    • Search Google Scholar
    • Export Citation
  • 16.

    Lozano Fernández R, Vera Sánchez E, Lozano Estevan MDC, Madurga Sanz M & Serna Núñez A 2020. Knowledge and attitude about pharmacovigilance practices of pharmacy professionals of community pharmacy and hospital pharmacy in Spain. Rev Esp Salud Publica 94: e202007068.

    • Search Google Scholar
    • Export Citation
  • 17.

    Mukattash TL, Alwadi MW, Abu-Farha RK, Jarab AS, Al-Zubiedi SA & Alwedyan T 2018. Knowledge, attitudes, and practices of pharmacovigilance and ADRs spontaneous reporting among pediatricians and pediatric residents in Jordan. Curr Clin Pharmacol 13: 4554.

    • Search Google Scholar
    • Export Citation
  • 18.

    Riordan DO, Kinane M, Walsh KA, Shiely F, Eustace J & Bermingham M 2020. Stakeholders’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study. Eur J Clin Pharmacol 76: 13631372.

    • Search Google Scholar
    • Export Citation
  • 19.

    Awodele O, Akinyede A, Adeyemi OA & Awodele DF 2011. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. Int J Risk Saf Med 23: 217226.

    • Search Google Scholar
    • Export Citation
  • 20.

    Paveliu MS, Bengea-Luculescu S, Toma M & Paveliu SF 2013. Perception on adverse drug reaction reporting by physicians working in southern Romania. Maedica (Buchar) 8: 1725.

    • Search Google Scholar
    • Export Citation
  • 21.

    Iffat W, Shakeel S, Rahim N, Anjum F, Nesar S & Ghayas S 2014. Pakistani physicians’ knowledge and attitude towards reporting adverse drug reactions. Afr J Pharm Pharmacol 8: 379385.

    • Search Google Scholar
    • Export Citation
  • 22.

    Khan SA, Goyal C, Chandel N & Rafi M 2013. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: an observational study. J Nat Sci Biol Med 4: 191196.

    • Search Google Scholar
    • Export Citation
  • 23.

    Thomas TM, Udaykumar P & Scandashree K 2013. Knowledge, attitude and practice of adverse drug reaction reporting among doctors in a tertiary health care centre in South India. Int J Pharmacol Clin Sci 2: 8288.

    • Search Google Scholar
    • Export Citation
  • 24.

    Nisa ZU, Zafar A & Sher F 2018. 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 26: 453461.

    • Search Google Scholar
    • Export Citation
  • 25.

    Shamim S, Sharib SM, Malhi SM, Muntaha SU, Raza H, Ata S, Farooq AS & Hussain M 2016. Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists. Springerplus 5: 16–3337.

    • Search Google Scholar
    • Export Citation
  • 26.

    Kassa Alemu B & Biru TT 2019. Health care professionals’ knowledge, attitude, and practice towards adverse drug reaction reporting and associated factors at selected public hospitals in northeast Ethiopia: a cross-sectional study. BioMed Res Int 53: 177187.

    • Search Google Scholar
    • Export Citation
  • 27.

    Sanghavi DR, Dhande PP & Pandit VA 2013. Perception of pharmacovigilance among doctors in a tertiary care hospital: influence of an interventional lecture. Int J Risk Saf Med 25: 197204.

    • Search Google Scholar
    • Export Citation
  • 28.

    Ghazala Z, Kalshetty P & Vardhamane S 2019. Knowledge, attitude and practices towards pharmacovigilance among health care professionals in a teaching and general hospital of South India. IJBCP 8: 7.

    • Search Google Scholar
    • Export Citation
  • 29.

    Agarwal R, Daher AM & Mohd Ismail N 2013. Knowledge, practices and attitudes towards adverse drug reaction reporting by private practitioners from Klang Valley in Malaysia. Malays J Med Sci 20: 5261.

    • Search Google Scholar
    • Export Citation
  • 30.

    Khan SA, Goyal C, Chandel N & Rafi M 2013. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: an observational study. J Nat Sci Biol Med 4: 191.

    • Search Google Scholar
    • Export Citation
  • 31.

    Figueiras A, Tato F, Fontaiñas J, Takkouche B, Gestal-Otero JJ, 2001. Physicians’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract 7: 347–354.

  • 32.

    Ahmad A, Patel I, Balkrishnan R, Mohanta G & Manna P 2013. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: a pilot study. Perspect Clin Res 4: 20410.

    • Search Google Scholar
    • Export Citation
  • 33.

    Desai CK, Iyer G, Panchal J, Shah S & Dikshit RK 2011. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res 2: 129136.

    • Search Google Scholar
    • Export Citation

Author Notes

Address correspondence to Shujaat Ali Khan, Department of Pharmacy, COMSATS University 22060, Islamabad-Abbottabad Campus, Khyber Pakhtunkhwa, Pakistan, E-mail: drshujatalikhan@cuiatd.edu.pk or Khezar Hayat, Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore 54000, Pakistan, E-mail: Khezar.hayat@uvas.edu.pk.

These authors contributed equally to this work.

Authors’ addresses: addresses: Muhammad Junaid Hassan Sharif, Ghulam Murtaza, Abdul Mannan, Xianju Huang, and Shujaat Ali Khan, Department of Pharmacy, COMSATS University Islamabad-Abbottabad Campus, Abbottabad, Khyber Pakhtunkhwa, Pakistan, E-mails: junaidhassan@cuiatd.edu.pk, gmdogar356@gmail.com, amannan@cuiatd.edu.pk, xianju@mail.scuec.edu.cn, and drshujatalikhan@cuiatd.edu.pk. Zelal Kharaba, Department of Clinical Sciences, College of Pharmacy and Health Science, Ajman University, Ajman, United Arab Emirates, E-mail: zelal.kharaba@aau.ac.ae. Nihal Abdalla Ibrahim and Manal Buabeid, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates, E-mails: n.ibrahim@ajman.ac.ae and m.buabeid@ajman.ac.ae. Mohammad Ismail, Department of Pharmacy, University of Peshawar, Abbottabad, Khyber Pakhtunkhwa, Pakistan, E-mail: ismailrph@uop.edu.pk. Khezar Hayat, Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, Pakistan, and Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi’an Jiaotong University, Xi’an, China, E-mail: khezar.hayat@uvas.edu.pk.

Save