Narumol Jarernsiripornkul

Adverse drug reaction monitoring: comparing doctor and patient reporting for new drugs†

To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post‐discharge and to compare both to formal reporting in Thailand.

Patient self-reporting of potential adverse drug reactions to non-steroidal anti-inflammatory drugs in Thailand.

Objectives To validate and pilot in Thailand a questionnaire to enable patients to identify and report symptoms perceived as potential ADRs from NSAIDs. To determine the questionnaire’s usefulness in enabling Thai out-patients to report potential ADRs. To determine the frequency with which symptoms patients reported were recorded by health professionals and the frequency of ADRs to these drugs reported to the APRM Centre. To assess whether patients reported symptoms from non COX-selective inhibitors and COX-2 selective NSAIDs with different frequencies. Setting Out-patient departments (OPD) of a University teaching hospital in North-East Thailand. Method A questionnaire which incorporated an extensive symptoms checklist, developed and validated in English, was translated, piloted and validated in Thai. This was distributed to patients receiving one of five NSAIDs. Causality assessment of the symptoms reported was undertaken by a pharmacist, using data on concomitant medicines and disease states from OPD records. Outcome measures Frequency and type of symptoms reported by patients, recording of these in OPD records, reports sent to APRM Centre. Results Piloting found that patients were able to understand the questionnaire, but were unaware of drug names. A response rate of 42% was obtained: 694 usable questionnaires were returned out of 1,654 distributed. Overall 73% of respondents reported at least one symptom perceived to be an ADR. Sixty percent of symptoms reported were classed as probably or possibly an ADR. Fewer symptoms per patient were reported by those taking COX-2 selective inhibitors (3.5) than those taking non-selective NSAIDs (5.5), although there were no differences in the frequency of GI symptoms reported between these two sub-classes, which may relate to other factors, such as age, previous GI problems and prescription of protective ulcer-healing therapy. Only 5% of symptoms were recorded in OPD records and reporting of ADRs to these drugs to the APRM Centre of the Thai FDA during the study was very limited. Conclusion Thai out-patients were willing and able to complete questionnaires regarding potential ADRs. The questionnaire could form part of routine out-patient monitoring, aiding identification of ADRs, and may help to increase ADR reporting in Thailand.

Experiences of and attitudes towards receiving information about non-steroidal anti-inflammatory drugs: a cross-sectional survey of patients in Thailand

ABSTRACT Objective: To determine sources of information about NSAIDs used by out-patients, factors related to receipt of information and patient attitudes towards receiving safety information. Research design and methods: Cross-sectional survey, using self-completed questionnaires distributed directly to 500 outpatients prescribed any NSAIDs from an orthopaedic clinic in Thailand, over a 4-month period. Results: There were 548 patients approached and 474 completed questionnaires returned (94.8%). The most frequent aspects of medicines information that were provided related to administration (97.2%), mostly provided by pharmacists, and indication (85.8%), mostly provided by physicians. Information on identifying, monitoring and managing adverse effects was received by fewer than 50% of patients. Safety information was received significantly more frequently by younger patients (P<0.01), those using non-selective COX-2 inhibitors (P<0.001), intermittent NSAIDs (P<0.05) and fewer concomitant medicines (P<0.05). Only 14.1% patients used additional information sources. Attitudes towards receiving medicines safety information were positive. Most patients agreed they should know about ADRs (98.1%) and receive information leaflets with first prescription (96.8%). Conclusions: Patients received medicines information mostly from healthcare professionals, but safety information was limited. Type of NSAIDs, regularity of NSAID use and age affected receipt of safety information about NSAIDs. Provision of more medicine information is needed, particularly written documents.

Public confidence in ADR identification and their views on ADRreporting: mixed methods study

PurposeThe value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public’s awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected adverse drug reactions (ADRs), information sources they use and their views towards direct ADR reporting.MethodsMixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public recruited in primary care centres, pharmacies and public places during October 2013 to February 2015. All questionnaire respondents reporting an ADR were invited to participate in phase 2. Written informed consent was made before the start of the interview.ResultsThere were 414 (17.2%) of 2400 questionnaire respondents who had experienced an ADR, almost half (46%) of whom used their own experience to identify ADRs. Having a degree, having a severe ADR and consulting a physician increased respondent confidence in the association between medicine and suspected ADR. The majority (27) of the 30 interviewees indicated general agreement with patient reporting to regulatory authorities. Four main themes emerged covering reasons for reporting ADRs including expectations of health authorities, healthcare professionals and manufacturers, and helping other people. Awareness of direct reporting was low with a desire for a range of reporting methods.ConclusionResults indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required.

Experiences relating to adverse drug reactions in the community: a cross-sectional survey among patients and the general public in Thailand

ABSTRACT Objective: To determine the frequency and characteristics of adverse drug reactions (ADRs), experiences of receiving and desire for information about medicines, and attitudes toward ADR knowledge and reporting among the community-dwelling Thai population. Methods: A cross-sectional self-administered survey conducted during October 2013 to December 2014 by convenience sampling. The study was conducted in three settings in the second-largest city, North-eastern Thailand: primary care units, community pharmacies and public areas. Results: Of 2400 respondents, 414 (17.3%) reported experiencing an ADR; two-thirds of which involved mild symptoms (66.7%) and 55.6% occurred within the last year. Self-reported ADR knowledge was low (4.1 ± 2.5 on a scale of 0 to 10). Pharmacists and physicians were the most common sources of information about medicines, but only 28.5% had received information about ADRs. Over 40% wanted information about ADRs and drug interactions, with healthcare professionals and information leaflets being desirable sources. The majority of individuals had positive views towards both receiving information and reporting their ADR experiences. Conclusions: To enable the Thai public to report their experiences of ADRs more effectively, they require more medicines information. Information leaflets should be more widely available, while healthcare professionals should provide more detailed information of ADRs.

Initial development and testing of an instrument for patient self‐assessment of adverse drug reactions

To develop and conduct preliminary testing of a causality assessment tool for patients, for potential use in encouraging both discussions with clinicians about suspected adverse drug reactions (ADRs) and reporting to authorities.

Hospital pharmacists' activities and attitudes regarding the Thai safety monitoring program for new drugs.

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.

Confidence and accuracy in identification of adverse drug reactions reported by outpatients

Background Patient reporting of adverse drug reactions (ADRs) could supplement the existing reporting system and contribute to early detection of ADRs. The confidence in ADR identification and their attribution of ADRs were limited to outpatients. Objective To determine the type and frequency of ADRs reported by outpatients, to evaluate confidence and accuracy in ADR identification as well as contributing factors. Setting University hospital in northeastern Thailand Method Cross-sectional study using questionnaires distributed to 500 outpatients who claimed to have experienced an ADR. Confidence in identifying ADRs was measured by visual analogue score (VAS), while accuracy of reported ADRs was determined using Naranjo algorithm and WHO criteria. Main outcome measure Number and type of ADRs, confidence rating and accuracy category. Results In total, 390 outpatients completed the questionnaire (response rate = 78.0%). Rash (19.0%), nausea/vomiting (7.4%), and dizziness (5.8%) were the top three reported ADRs. Sixty-one percent of respondents rated their level of confidence in identifying ADRs as high (VAS 9.2 ± 0.95), which was associated with having underlying diseases (OR 1.93), low number of reported symptoms (OR 0.38) and severe ADRs (OR 1.33). Causality assessment was classified as true ADRs in 90.0% and 88.9% of cases, using Naranjo algorithm and WHO criteria, respectively. Respondents with low number of reported symptoms (OR 0.27) and high level of confidence had greater accuracy in ADR identification (OR 1.11). Conclusion The outpatients reported a high proportion of potential ADRs with high confidence and accuracy. Patient reporting of ADRs has potential to support the pharmacovigilance system.