Knowledge, Practice and Attitudes Toward Pharmacovigilance and Adverse Drug Reactions Reporting Process Among Health Care Providers in Dammam, Saudi Arabia

Abstract

Background: Pharmacovigilance is the science that plays an essential role in the reduction of ADRs which helps in predicting unwanted effects of drugs in community. Studying adverse drug reaction is an important arm of patient care. It aims at making the safe use of medicines for the treatment or prevention of disease.

Objectives: To assess knowledge, Practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process among Health Care Providers in Dammam, KSA.

Methods: This was a cross-sectional and questionnaire-based study involving health care providers working in different hospitals. 160 questionnaires were distributed to the respondents (25 doctors, 65 nurses, 50 pharmacists and 25 other health care provides). Participants were selected randomly and those not willing to participate were excluded from the study. Chi-square test was used for the calculation of P-Value.

Results: 135 participants responded to the questionnaire, while 160 participants were recruited for the study. The majority (n= 99, 73.33%, p=0.007) had no idea about national pharmacovigilance centers of KSA. The standard SFDA adverse drug reaction form was only known to 38.51 %, p=0.028 and only 38.51 %, p=0.002 were aware about electronic reporting of ADR. Only 34 %, p =0.002 of the respondents had ever reported an adverse drug reactions, 76.29 %, p=0.041 have not attended any training on ADR reporting and 86.66%, p=0.045 participants have no idea about impact of ADR reporting.

Conclusion: The knowledge and attitude to ADR reporting was inadequate, our study has shown that the actual practice of ADR reporting is unsatisfactory. This indicates that there is a need to create an awareness of the importance of ADR reporting through CME/training of ADR reporting among healthcare providers.

Keywords: Adverse Drug Reaction (ADR); Continuous Medical Education (CME); Saudi Food and Drug Administration Authority (SFDA); knowledge; pharmacovigilance; practice..