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  • Title: Hospital pharmacists' activities and attitudes regarding the Thai safety monitoring program for new drugs.
    Author: Jarernsiripornkul N, Krska J, Pongmanachai M, Nasritha N.
    Journal: Pharmacoepidemiol Drug Saf; 2009 Sep; 18(9):837-41. PubMed ID: 19548223.
    Abstract:
    PURPOSE: To determine the knowledge, attitudes and practices of Thai hospital pharmacists concerning the safety monitoring programme and reporting of adverse drug reactions to the Thai Food and Drug Administration. METHODS: Postal questionnaires distributed to 414 Thai hospitals, including all larger hospitals and a proportion of small community hospitals, for completion by the pharmacist responsible for ADR reporting to the Thai FDA. RESULTS: The response rate was 63.0% (n = 262) with most respondents (190; 72.8%) being directly responsible for ADR reporting. Most hospitals (251; 96.5%) designated at least one pharmacist as responsible for ADR reporting, but only 164 (62.8%) respondents were aware of the SMP. Only 15 respondents out of the 56 working in hospitals using new drugs had established reporting via the SMP. Uncertainty in ascribing causality, lack of co-operation between health professionals and lack of staff were identified as barriers to reporting. Most respondents agreed that enhanced co-operation and improvements needed in hospital systems were required. Less than half agreed that the reporting system was simple and the majority agreed that changes were required to the SMP reporting mechanisms. CONCLUSIONS: Thai hospital pharmacists have positive attitudes towards reporting of ADRs, but not all are aware of the SMP for new drugs. Few hospitals use new drugs and even less are involved in active reporting of suspected ADRs via the SMP. To increase reporting rates, potential difficulties with the organization of reporting via the SMP and the potential role of hospital pharmacists in ADR identification should be investigated further.
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