Comparing patient reported and medical record data of adverse drug reactions to anti-seizure drugs.

BACKGROUND: Anti-seizure drugs (ASDs) can potentially cause serious adverse drug reactions (ADRs). Patient self-reporting can increase the rate of ADR detection, but studies examining patient self-reporting of ADRs caused by ASDs are lacking. AIM: To determine the characteristics of ADRs reported by patients receiving ASDs, assess laboratory data and medical record confirmation of patient-reported ADRs, and explore factors associated with laboratory data and medical record confirmation. METHOD: A self-reporting questionnaire was distributed to patients prescribed ASDs at outpatient clinics. Patients assessed the causality of suspected ADRs using Causality Assessment Tool. Naranjo's algorithm was used by researchers for causality assessment. Medical records were used to gather information on ADR symptoms, ASD medication, and abnormal laboratory data. RESULTS: From 478 distributed questionnaires, 93.1% completed the questionnaire and 67.4% of respondents reported at least one ADR. The most common ADRs were drowsiness (50.7%), dizziness (9.7%), and ataxia (4.3%). For causality, suspected ADRs were classified as possible in 52.3% of cases and probable in 46.3% of cases by patients, and possible in 64.7% of cases and probable in 25.7% of cases by researchers. Only 12.7% of patients had laboratory data and/or medical record confirmation of suspected ADRs. The psychiatry clinic was less likely to confirm suspected ADRs compared to the epilepsy clinic (OR = 0.412, p = 0.022). CONCLUSION: Confirmation of patient-reported ADRs with either laboratory data or medical records was uncommon. Recording patient-reported ADRs in patients' medical history and monitoring laboratory tests related to patient-reported symptoms should be promoted to increase the safety of ASD treatment.

Accuracy in patient-reported adverse drug reactions and their recognition: a mixed-methods study.

BACKGROUND: The causality assessment tool can be utilized to assist patients in identifying adverse drug reactions (ADRs). AIM: To evaluate the accuracy of the causality assessment tool for patients identifying ADRs compared to assessments made by pharmacists, and to explore how patients recall and recognize symptoms as ADRs. METHOD: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with patients who had experienced ADRs in the past year at a tertiary care hospital in Thailand. RESULTS: Out of 769 questionnaires, 716 were returned and 622 of these were both valid and had at least one ADR (86.8%). Classification of patient-reported symptoms using the causality assessment tool found 12 (1.9%) highly-probable ADRs, 399 (64.1%) probable ADRs, 207 (33.3%) possible ADRs, and 4 (0.6%) that were not classified as ADRs. There was fair agreement between patient-assessed and pharmacist-assessed causality classifications using the Naranjo algorithm (K = 0.268) and the World Health Organization Uppsala Monitoring Centre (WHO-UMC) criteria (K = 0.373). The timing relationship between the occurrence of symptoms and administration of a suspected drug was the most frequently mentioned reason that patients gave for recalling and recognizing suspected ADRs. CONCLUSION: Promoting the causality assessment tool for use by patients in collaboration with healthcare professionals is likely to enhance patients' ability to correctly identify ADRs and ultimately contribute to increased medication safety.

A nationwide survey of methods and barriers to adverse drug reaction monitoring and reporting among hospital pharmacists in Thailand.

OBJECTIVES: To explore the methods of adverse drug reaction identification and monitoring used by hospital pharmacists in all regions of Thailand, to explore barriers to and pharmacists' attitudes towards adverse drug reaction monitoring and reporting, and to assess the factors related to these aspects. METHODS: Pharmacists in 480 hospitals in Thailand were selected by stratified sampling. Self-administered questionnaires were sent by post and pharmacists returned completed questionnaires via QR code. KEY FINDINGS: In total, pharmacists at 286 hospitals returned the questionnaire (response rate = 59.6%). The most common adverse drug reaction (ADR) monitoring methods were the spontaneous reporting system (SRS), which was used by 100% of respondents, followed by high alert drug lists (73.1%) and routine adverse drug reaction monitoring (64.0%). The most frequently used methods of adverse drug reaction prevention were providing drug allergy card and recording allergy history in database. The major barrier to adverse drug reaction monitoring and reporting among respondents was uncertainty about whether the suspected drug caused the reaction (49.3%). Pharmacists had a good attitude towards adverse drug reaction monitoring and reporting (60.5%). Longer work experience (≥10 years) was negatively related with good attitudes towards adverse drug reaction monitoring and reporting (OR = 0.535, P = 0.040), whereas higher education level was positively related (OR = 2.201, P = 0.025). CONCLUSIONS: Spontaneous reporting system is the main method used for adverse drug reaction monitoring and reporting among hospital pharmacists in Thailand. Pharmacists had good attitudes towards adverse drug reaction monitoring and reporting, however, barriers remain.

Evaluation of Medicine Information Leaflets for Omeprazole, Safety Knowledge, and Perceptions of Taking the Medication in Thailand.

Purpose: This study aimed to compare package inserts and patient information leaflets for omeprazole in terms of the quality of and satisfaction with the written medicine information, medication safety knowledge, and perceived benefits and risks. Patients and methods: A cross-sectional, comparative study was conducted at a university hospital in Thailand. Outpatients visiting the pharmacy departments prescribed omeprazole were randomly selected to receive either a package insert or a patient information leaflet. Medication safety knowledge was measured using a set of eight questions. The quality of the written medicine information was measured by the Consumer Information Rating Form. Perceived benefits and risks of the medication were rated using a visual analog scale. Linear regression was used to determine factors associated with perceived benefits and risks. Results: Of the 645 patients, 293 agreed to answer the questionnaire. 157 and 136 patients were given patient information leaflets and package inserts, respectively. Most respondents were female (65.6%), over half had a degree (56.2%). Patients reading the patient information leaflets had slightly higher overall safety knowledge scores than those reading the package inserts (5.88 ± 2.25 vs 5.25 ± 1.84, p=0.01). Using the Consumer Information Rating Form, the patient information leaflets were given significantly higher scores compared to the package inserts for comprehensibility (19.34±3.92 vs 17.32±3.52, p<0.001) and design quality (29.25 ± 5.00 vs 23.81 ± 5.16, p<0.001). After reading the leaflets, patients receiving the patient information leaflets had significantly higher satisfaction with the information provided (p=0.003). In contrast, those receiving the package inserts rated the risks of omeprazole higher (p=0.007). Conclusion: Demonstrable differences were found from the patient perspective between a package insert and a patient information leaflet for the same medicine, mostly in favour of patient information leaflets. Medicine safety knowledge after reading PI and PIL was similar. However, receiving package inserts provided higher perceived risks from taking the medicine.

Severity and Management of Adverse Drug Reactions Reported by Patients and Healthcare Professionals: A Cross-Sectional Survey.

Adverse drug reaction (ADR) severity levels are mainly rated by healthcare professionals (HCPs), but patient ratings are limited. This study aimed to compare patient-rated and pharmacist-rated ADR severity levels and determined methods employed for ADR management and prevention by patients and HCPs. A cross-sectional survey was conducted in outpatients visiting two hospitals. Patients were asked about ADR experiences using a self-administered questionnaire, and additional information was retrieved from the medical records. In total, 617 out of 5594 patients had experienced ADRs (11.0%), but 419 patients were valid (68.0%). Patients commonly reported that their ADR severity level was moderate (39.4%), whereas pharmacists rated the ADRs as mild (52.5%). There was little agreement between patient-rated and pharmacist-rated ADR severity levels (κ = 0.144; p < 0.001). The major method of ADR management by physicians was drug withdrawal (84.7%), while for patients, it was physician consultation (67.5%). The main methods for ADR prevention by patients and HCPs were carrying an allergy card (37.2%) and recording drug allergy history (51.1%), respectively. A higher level of ADR bothersomeness was associated with higher ADR severity levels (p < 0.001). Patients and HCPs rated ADR severity and used ADR management and prevention methods differently. However, patient rating of ADR severity is a potential signal for severe ADR detection of HCPs.

Evaluation of patient comprehension and quality of consumer medicine information

Background: Consumer medicine information (CMI) is voluntarily produced by pharmaceutical manufacturers in Thailand, but quality assessment of Thai- CMI is not routinely performed. Objective: This study aimed to evaluate the content and design quality of CMI available in Thailand and assess patient understanding of the medicine information provided. Methods: A cross-sectional study that consisted of two phases. Phase 1 was expert assessment of CMI using 15-item content checklists. Phase 2 was patient assessment of CMI by user-testing and the Consumer Information Rating Form. Participants (n=130) were outpatients aged 18 years or older with an educational level of less than grade 12. Self-administered questionnaires were distributed to patients at two university-affiliated hospitals in Thailand. Results: A total of 60 CMI produced by 13 Thai pharmaceutical manufacturers were included in the study. Most of the CMI contained essential information about the medicines, but lacked information about serious adverse effects, maximum dose, warnings, and use in specific patient groups. Of 13 CMI selected for user-testing, none met the passing criteria with only 40.8% – 70.0% of answers found in the correct position and answered correctly. The mean values of patients’ rating the CMI were between 2.5 (SD=0.8) and 3.7 (SD=0.5) for utility on a 4-point scale, and 2.3 (SD=0.7) to 4.0 (SD=0.8) for comprehensibility and 2.0 (SD=1.2) to 4.9 (SD=0.3) for design quality on a 5-point scale. Eight CMI were rated as poor (less than 3.0) for font size. Conclusion: More safety information about medications should be included in Thai CMI and the design quality must be improved. CMI needs to be evaluated before distribution to consumers. (AU)

Exploring Healthcare Professionals' Practices and Attitudes towards Monitoring and Reporting of Severe Adverse Drug Reactions.

Healthcare professionals (HCPs) play a key role in the monitoring of severe adverse drug reactions (ADRs). The present study aims to explore practices and barriers of HCPs in severe ADR monitoring and reporting, to evaluate their attitudes towards the monitoring and to assess the related factors. Self-administered questionnaires produced in hard copy and Google form were sent to 510 HCPs by stratified random sampling. Of the 350 HCPs that responded (68.6%), 44.9% had ever monitored ADRs. The most common practices were the observation of abnormal symptoms for ADR identification (88.5%), discontinuation of the suspected drug for ADR management (88.5%) and advice on recurrent drug allergy for ADR prevention (88.5%). Most HCPs (93.0%) obtained further patient history to identify severe ADRs. The uncertainty of the causal relationship was a major barrier to ADR reporting (60.0%). Pharmacists were more involved with practices in ADR monitoring and reporting (OR 20.405; p < 0.001), whereas longer work experience (>20 years) was negatively related to the practices (OR 0.271; p = 0.024). Over one-third (37.6%) of HCPs had a positive attitude towards severe ADR monitoring. In conclusion, the practices in severe ADR monitoring varied among different professions. However, the barriers to the reporting of ADRs still exist; hence, improving knowledge and cooperation among HCPs should be promoted.

Thai Patients' Drug Safety Knowledge and Perceptions Relating to Different Forms of Written Medicine Information: A Comparative Study.

Purpose: The aim of the study was to evaluate the medication safety knowledge, quality of the written medicine information (WMI), and perceptions of taking the medicines in patients receiving package inserts (PIs) in comparison with patient information leaflets (PILs). Methods: A cross-sectional, comparative study was conducted from December 2020 to May 2021 at two university hospitals in Thailand. Outpatients who visited the pharmacy departments and were prescribed one of the three medicines: atorvastatin, celecoxib, or metformin were randomly selected by a permuted block randomization. The medication safety knowledge was measured using a set of validated and closed questions. The quality of the WMI was measured by the Consumer Information Rating Form (CIRF). Satisfaction with information and perceptions of the benefits and risks of medications were rated by the participants using a visual analog scale (0 to 10). Results: Of the 1150 invited patients, 750 completed the questionnaires (65.2%). A higher proportion of respondents with high level of medication safety knowledge was found in those reading the PILs than the PIs (44.5% and 20.8%, respectively). The type of leaflet received was a significant predictor of the high knowledge level (p < 0.001). The mean CIRF scores were significantly higher among those reading the PILs than the PIs (p < 0.001). Patients reading the PILs were also more satisfied with the information and had more positive perceptions of the benefits from taking medicines and intention to adhere than those reading the PIs. Patients' perceptions of risks after reading both leaflets were moderate (median score = 5.0), with the PIL group having slightly more concern about risks than the PI group. Conclusion: The PILs showed superior effectiveness to the PIs in enhancing knowledge about medication safety, providing greater satisfaction with the information, and positive perceptions of benefit and intention to comply with the medications. PILs should be provided more frequently to patients receiving medicines than PIs.

Evaluation of patient comprehension and quality of consumer medicine information.

Background: Consumer medicine information (CMI) is voluntarily produced by pharmaceutical manufacturers in Thailand, but quality assessment of Thai-CMI is not routinely performed. Objective: This study aimed to evaluate the content and design quality of CMI available in Thailand and assess patient understanding of the medicine information provided. Methods: A cross-sectional study that consisted of two phases. Phase 1 was expert assessment of CMI using 15-item content checklists. Phase 2 was patient assessment of CMI by user-testing and the Consumer Information Rating Form. Participants (n=130) were outpatients aged 18 years or older with an educational level of less than grade 12. Self-administered questionnaires were distributed to patients at two university-affiliated hospitals in Thailand. Results: A total of 60 CMI produced by 13 Thai pharmaceutical manufacturers were included in the study. Most of the CMI contained essential information about the medicines, but lacked information about serious adverse effects, maximum dose, warnings, and use in specific patient groups. Of 13 CMI selected for user-testing, none met the passing criteria with only 40.8% - 70.0% of answers found in the correct position and answered correctly. The mean values of patients' rating the CMI were between 2.5 (SD=0.8) and 3.7 (SD=0.5) for utility on a 4-point scale, and 2.3 (SD=0.7) to 4.0 (SD=0.8) for comprehensibility and 2.0 (SD=1.2) to 4.9 (SD=0.3) for design quality on a 5-point scale. Eight CMI were rated as poor (less than 3.0) for font size. Conclusion: More safety information about medications should be included in Thai CMI and the design quality must be improved. CMI needs to be evaluated before distribution to consumers.

Evaluation of Patient's Knowledge of Atorvastatin Information in Patient Information Leaflets: A Pre-Post Intervention Study in Thailand.

PURPOSE: This study aimed to evaluate the effect of using atorvastatin PIL on patients' medication knowledge, perceptions of the PIL usefulness, their anxiety about the medication, and factors related to these aspects. PATIENTS AND METHODS: A pre-post intervention study was conducted in outpatients at a university hospital. Patients prescribed atorvastatin were enrolled using systematic random sampling. Participants were asked to complete Self-Administered Questionnaire to assess atorvastatin knowledge at baseline. An atorvastatin-PIL produced by the manufacturer was introduced to the participants as the intervention. One month after receiving the PIL, the participants were re-assessed. Ten questions were developed to assess atorvastatin knowledge and visual analog scale (VAS) was used to assess perceived benefits of using the PIL and patient anxiety about the medication. Multiple linear regression was used to assess the related factors. RESULTS: Of 450 questionnaires distributed, 370 were returned. Atorvastatin knowledge significantly increased with mean score of 5.06±1.92 at baseline to 8.34±1.79 at 1-month after intervention. Reading all sections of the PIL (p=0.017) and working for civil service (p=0.006) were associated with higher knowledge scores at baseline and after intervention. Low educational level was associated with lower knowledge scores at baseline (p=0.002), but experience of allergy (p=0.042) was associated with higher knowledge scores after the intervention. Patients had high level of perceived usefulness from the PIL (average scores=8.87±1.83) and low level of anxiety (average scores=3.69±3.06). Reading all sections of the PIL (p=0.007) and taking more than 5 medications (p=0.012) were related to perceived usefulness of the PIL. Females (p<0.001) and herbal supplement users (p=0.048) were related to anxiety about the medication. CONCLUSION: PILs could improve medication knowledge in patients. Patients' perceptions of benefits of PILs were high and anxiety about medication was low. Use of PILs should be encouraged to improve patients' knowledge and appropriate use of medications.

Development and psychometric validation for evaluating written medicine information in Thailand: The Consumer Information Rating Form.

OBJECTIVE: To translate and validate the consumer information rating form (CIRF) for use in Thai populations. DESIGN: The development of the CIRF was carried out in two phases: translation process and cognitive interview, and psychometric testing. SETTING: A university hospital and a tertiary hospital in northeast Thailand. PARTICIPANTS: 150 outpatients from medicine department: 30 for phase 1 and 120 patients for phase 2 study. METHODS: The CIRF was translated with cultural adaptation into Thai using cognitive interview technique in a sample of outpatients. A larger sample of outpatients then completed the CIRF in relation to either a package insert (PI) or a patient information leaflet (PIL) for one of three medicines: atorvastatin, celecoxib and metformin. Construct validity was assessed using principal component analysis (PCA) and internal consistency using Cronbach's α coefficient. Known group validity was assessed by comparing mean consumers' ratings for PIs and PILs. RESULTS: Thirty participants engaged in the cognitive interview and 120 participants completed the CIRF. The PCA found the 17 items of the CIRF were extracted into three factors: comprehensibility, utility and design quality scales, mirroring the original. Cronbach's α for the overall scale (0.904) indicated good internal consistency. Known-group validity demonstrated significant differences in consumers' rating between PIs and PILs for almost all items (p<0.001). CONCLUSION: Thai version of CIRF had acceptable validity and reliability for Thai consumers' ratings of written medicine information. The CIRF could be of practical use in the process of developing medicine information to ensure consumers' comprehension and their usefulness.

Patients' Experiences and Perspectives of Receiving Written Medicine Information About Medicines: A Qualitative Study.

PURPOSE: Written medicine information informs patients about the benefits and risks of medicines and supports their safe and effective use. In Thailand, patient information leaflets (PILs) are not obligatory and therefore not routinely supplied. This study aimed to explore the experiences and information needs of patients, their views on PILs and the likely impact of PILs on their knowledge, perceptions and behaviors towards medicines. These factors are important to establish the value of PILs. METHODS: Semi-structured interviews with outpatients who received simvastatin or atorvastatin were conducted exploring their experiences of receiving medicine information, their views on the utility of and need for PILs, the impact of PILs on their behaviors, and recommendations for how PILs could be improved. All interviews were audio-recorded, transcribed verbatim, and analyzed using a framework approach. RESULTS: Thirty interviews were conducted from which four themes emerged: experience of receiving medicine information, views of package inserts and PILs, impact of PILs on knowledge, perceptions and behaviors, and patients' need for medicine information. Most participants received verbal information from healthcare professionals, as well as written information. Verbal information was perceived as being particularly useful to inform about changes to medicine regimens or the long-term adverse effects of medicines. Patients perceived that the PILs had influenced their knowledge about medicines, and also their behaviors including safety awareness, adherence, and engagement with healthcare professionals. Participants suggested that the information in electronic format could provide an additional resource. Some changes to improve the content and general format of the PIL were identified. CONCLUSION: PILs are perceived as useful by patients and met their information needs, although they were viewed as an adjunct to verbal advice provided by healthcare professionals. PILs influenced patients' medicine taking behaviors and encouraged sharing of information with their physicians.

Experiences and Views of Medicine Information Among the General Public in Thailand.

PURPOSE: Written and electronic medicine information are important for improving patient knowledge and safe use of medicines. Written medicine information in Thailand is mostly in the form of printed package inserts (PIs), designed for health professionals, with few medicines having patient information leaflets (PILs). The aim of this study was to determine practices, needs and expectations of Thai general public about written and electronic medicine information and attitudes towards PILs. PATIENTS AND METHODS: Cross-sectional survey, using self-completed questionnaires, was distributed directly to members of the general public in a large city, during January to March 2019. It explored experiences of using information, expectations, needs and attitudes, the latter measured using a 10-item scale. Differences between sub-groups were assessed, applying the Bonferroni correction to determine statistical significance. RESULTS: Of the total 851 questionnaires distributed, 550 were returned (64.2%). The majority of respondents (88%) had received PIs, but only a quarter (26.2%) had received PILs. Most respondents (78.5%) had seen medicine information in online form. High educational level and income increased the likelihood of receiving PILs and electronic information. The majority of respondents (88.5%) perceived PILs as useful, but 70% considered they would still need information about medicines from health professionals. Indication, drug name and precautions were the most frequently read information in PIs and perceived as needed in PILs. Three-quarters of respondents would read electronic information if it were available, with more who had received a PIL having previously searched for such information compared to those who had not. All respondents had positive overall attitudes towards PILs. CONCLUSION: Experiences of receiving PILs and electronic medicine information in Thailand are relatively limited. However, the general public considered PILs as a useful source of medicine information. Electronic medicine information was desired and should be developed to be an additional source of information for consumers.

Survey of healthcare professionals' practices, expectations, and attitudes towards provision of patient information leaflets in Thailand.

Background Patient information leaflets are an important source of medicine information for patients. In Thailand, there is a lack of studies exploring activities of healthcare professionals and their attitudes towards provision of patient information leaflets. Objectives This study aimed to survey healthcare professionals' practices on provision of medicine information, expectations of, attitudes towards provision of patient information leaflets and factors influencing these. Setting Two university hospitals in Thailand. Methods A self-completion questionnaire was distributed to chiefs of departments for further distribution to staff. A stratified sample of physicians and nurses was invited, while all pharmacists were invited to ensure sufficient numbers for comparison. Main outcome measure Healthcare professionals' practices on provision of medicine information, expectations of, attitudes towards provision of patient information leaflets. Results Of the total 981 healthcare professionals invited, 493 responded (50.3% response rate). The number of respondents aware of patient information leaflets was 270 (57.6%). Of these, only 44.4% had ever given patient information leaflets to patients. Pharmacists provided patient information leaflets more frequently than other healthcare professionals. The expectation for patient information leaflets to be available was high; mean score 7.9 ± 2.31 of possible 10. Most respondents had positive attitudes towards providing patient information leaflets to patients (58.2%). Respondents who were aware of patient information leaflets availability were more likely to have a positive attitude (OR 0.543, p = 0.002). Level of education, time spent in direct care and being aware of patient information leaflets were factors associated with healthcare professionals' attitudes. Conclusion Limited number of healthcare professionals had provided patient information leaflets to patients but most had positive attitudes regarding the usefulness of patient information leaflets for patients. Increased availability and use of patient information leaflets should be promoted.

Practices of healthcare professionals in communicating with nonsteroidal anti-inflammatory drug users in Thailand: a qualitative study.

OBJECTIVE: This study aimed to explore practices among healthcare professionals in nonsteroidal anti-inflammatory drug (NSAID) information provision. METHODS: In-depth interviews were conducted with orthopaedic physicians (OPs), hospital and community pharmacists (CPs) in northeastern Thailand. Ten hospitals and 20 pharmacies in five provinces were purposively selected. Interviews followed a topic guideline, were audio-recorded, transcribed verbatim and analysed using a framework approach. KEY FINDINGS: Fifty-one participants were involved: 13 OPs, 20 hospital pharmacists and 18 CPs. Four main themes emerged: general information, safety information, differences between new and regular NSAID users and non-selective and selective NSAID users. Pharmacists mostly provided information on administration and indication. While all three groups informed of adverse effects, this was selective, related to factors including trading, time available, patients' age and perceived ability to understand. Gastrointestinal adverse effect information was most commonly provided, with other side effects, drug interactions and need to monitor for adverse effects rarely mentioned. Variation was reported in provision of safety information depending on whether patients were using selective or non-selective NSAIDs, and new or long-term users. CONCLUSIONS: The content and frequency of NSAID information provision varied between health professionals. Greater awareness of NSAID risks is essential; therefore, strategies to improve information provision to Thai patients are desirable.

Development and evaluation of user-tested Thai patient information leaflets for non-steroidal anti-inflammatory drugs: Effect on patients' knowledge.

INTRODUCTION: Thai patients do not routinely receive patient information leaflets (PILs) with medicines, so awareness of safety issues is low. This study aimed: i) to develop Thai PILs for NSAIDs and subject these to user-testing, and ii) to assess the potential value of PILs from the patient perspective and effect on patient knowledge. METHODS: Four PILs for NSAIDs were developed and subjected to multiple rounds of user-testing by the general public. Self-administered questionnaires were distributed to orthopaedic out-patients prescribed one of these NSAIDs, assessing knowledge before and after providing a PIL. The follow-up questionnaire also sought use of and views on the PILs using a visual analogue scale (VAS). RESULTS: 1,240 baseline questionnaires were completed; only 13.5% of patients had good knowledge. 688 patients returned follow-up questionnaires (55.5%), of whom75% had good knowledge. In patients completing both questionnaires, mean knowledge score increased from 6.22±1.40 to 8.42±1.41 (p<0.001). Patients with high educational levels had high baseline scores (OR = 2.728) and showed greatest improvement in knowledge (OR = 5.628). 90% (625) of follow-up respondents indicated they read all information in the PILs. All also agreed that these PILs should distributed to all patients taking NSAIDs. The median VAS score for usefulness was 9.3 (IQR 8.6-10.0). CONCLUSIONS: User-testing of PILs was feasible in a Thai population and enabled the development of acceptable and desirable PILs. PILs could improve patients' knowledge about their medicine, particularly among those with higher educational level. User-tested PILS could meet the need for more written medicine information.

Survey of outpatients' use and needs of patient medicine information leaflets in Thailand.

Background Patient information leaflets are important sources of medicine information. Regulations of patient information leaflet provision varies among country. Little is known regarding patients' behavior and expectation on use of patient information leaflets. Objectives To explore patients' use of either package inserts or patient information leaflets and to survey patients' expectations and needs on use of patient information leaflets and their associated factors. Setting Two university hospitals in Thailand. Methods Cross-sectional study using self-administered questionnaires distributed to outpatients over a 3-month period. Participants were selected through systematic random sampling. Logistic regression was used for data analysis. Main outcome measure Patient use of medicine information. Visual Analogue Scale scores for patient needs and their expectation of knowledge gains from using patient information leaflets. Results The response rate was 77.0%. Most respondents had received package inserts (91.3%) with 59.4% reporting that they sometimes read them. While most respondents had not previously known about patient information leaflets (75.9%), 97.3% reported that patient information leaflets would be useful. Respondents scored their needs and expected knowledge gains after reading patient information leaflets as 9.68 ± 0.97 and 9.64 ± 0.99, respectively. Previous experience with package inserts was associated with increased patient need scores (p = 0.002) and higher expected knowledge gains from use of patient information leaflets (p = 0.037). In addition, patients who had not previously known about patient information leaflets had higher expectations of knowledge gains (p = 0.016). Conclusion Overall, patients showed good behavior on reading package inserts. Although many patients were not previously aware of patient information leaflets, they realized the importance. Hence, patient information leaflets should be developed and provided to Thai patients.

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.

Evaluation of community pharmacists' roles in screening and communication of risks about non-steroidal anti-inflammatory drugs in Thailand.

AimThis study aimed to explore community pharmacists' roles on screening for risk factors, providing safety information-related non-steroidal anti-inflammatory drugs (NSAIDs) to patients. BACKGROUND: NSAIDs are widely dispensed without a prescription from pharmacies in Thailand, while they are frequently reported as causing adverse events. METHODS: Self-administered questionnaires were distributed to all accredited pharmacies in Thailand, inviting the main pharmacist in each pharmacy to participate in this study.FindingsOut of 406 questionnaires distributed, 159 were returned (39.2%). Almost all pharmacists claimed to engage in NSAID dispensing practice, but not all of them provided relevant good practice, such as, screening for risk factors (56.3-95.5%), communication on adverse drug reactions (ADRs) (36.9-63.2%) and ADR management (58.9-79.7%), history of gastrointestinal (GI) problems was frequently mentioned for screening, but many pharmacists did not screen for history of NSAID use (24.7-35.5%), older age (45.2-48.9%), concomitant drug (63.7%), and problems of cardiovascular (24.1%), renal (34.9-43.3%), and liver systems (60.3-61.0%). Male pharmacists were significantly less likely to inform users of non-selective NSAIDs about ADRs [odds ratio (OR) 0.44], while provision of information about selective NSAID ADRs was higher among pharmacy owners (OR 2.28), pharmacies with more pharmacists (OR 3.18), and lower in pharmacies with assistants (OR 0.41). Screening for risk factors, and risk communication about NSAIDs were not generally conducted in Thai accredited community pharmacists, nor were NSAID complications fully communicated. Promoting of community pharmacists' roles in NSAID dispensing should give priority to improving, especially in high-risk patients for taking NSAIDs.

Physicians' communication of risks from non-steroidal anti-inflammatory drugs and attitude towards providing adverse drug reaction information to patients.

RATIONALE, AIMS, AND OBJECTIVES: Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for orthopaedic conditions, therefore this study aimed to explore orthopaedic physicians' perceptions of their role in NSAID-risk communication, their attitudes towards the necessity of informing patients about adverse drug reactions (ADR), and factors associated with these. METHODS: Self-administered questionnaires were mailed to all 206 orthopaedic physicians working at hospitals in Northeastern Thailand. Attitudes were assessed using 17 statements and total scores classed as poor, moderate and good attitude. RESULTS: Sixty-six questionnaires were returned (32.04%). The responses showed that 75% of physicians claimed to communicate NSAID ADR information, more frequently about gastrointestinal (GI) complications, than about renal and cardiovascular (CVS) complications. ADR management (36%) and monitoring (30%) were not frequently communicated. The time spent with patients was associated with provision of ADR and monitoring advice. Renal function was the risk factor of greatest concern for prescribing any NSAID, followed by history of GI complications, and allergy for non-selective NSAIDs, and history of CVS diseases and age for selective COX-2 NSAIDs. Most physicians (41) had moderate attitude towards providing information and 24 good attitude. Fewer physicians working in tertiary hospitals than general and community hospital physicians considered that time limitations prevented counseling and that patient information leaflets offered easily accessible information. Additionally, more physicians who did not inform patients about ADRs agreed that ADR communication can lead to anxiety and discontinuing treatment. CONCLUSION: The study indicates that, although orthopaedic physicians had positive attitudes towards providing ADR information to patients, improvement is needed in communicating NSAID risk information.