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

PURPOSE: The 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. METHODS: Mixed 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. RESULTS: There 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. CONCLUSION: Results indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required.

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

PURPOSE: 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. METHODS: Ten causality statements, developed from qualitative studies involving patients, with a scoring system allowing categorization, were embedded in a questionnaire which also included a symptom checklist and additional details about one suspected ADR and medicine, selected for causality assessment. Patients with experiences of suspected ADRs were involved in cognitive interviews (15), piloting (20) and psychometric testing (120). Test-retest reliability, construct validity and criterion-related validity were evaluated, through repeated causality assessment, comparison with a visual analogue scale assessing certainty of causality and comparison with causality assessment using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, respectively. The study involved outpatients at a university hospital in northeast Thailand. RESULTS: Ninety-eight patients completed causality assessment twice: both causality scores (Spearman rs = 0.715; p < 0.001) and causality classification [percentage of positive agreement (PPA) = 68.4; κ = 0.419; p < 0.001] showed satisfactory reliability. Causality scores were positively correlated with certainty of causality (Spearman rs = 0.556; p < 0.01). There was moderate agreement against WHO-UMC criteria [PPA = 70.4; κ = 0.440; p < 0.001]. Of the 91 completing an evaluation, 88% agreed that the tool should be used routinely, 78% agreed that it gave them useful results and 80% agreed that it was easy to use. CONCLUSIONS: This novel instrument has satisfactory psychometric properties and was acceptable to Thai patients, but it requires further testing. It has potential for use in supporting patients with suspected ADRs to discuss these with health professionals, and perhaps to report directly.

A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions.

PURPOSE: To explore how Thai patients assess symptoms as adverse drug reactions (ADRs). METHODS: Out-patients at two hospitals in Thailand previously reporting suspected ADRs to statins were purposively selected to cover factors relevant to the accuracy of ADR reports. Semi-structured interviews explored the mechanisms participants used to work out whether their symptoms were related to their statin. All interviews were audio-recorded, transcribed and independently thematically analyzed by two researchers. RESULTS: One hundred interviews were suitable for analysis; 52 were male, age range was 36 to 77 years (mean ± S.D.: 59.83 ± 9.14) and most (92) were taking other medicines in addition to statins. Patient assessment of symptoms as ADRs fell into two major themes: medicine-related factors and external factors. Timing relationships were mentioned most frequently (74), followed by information received (55), seeing similar symptoms in others (7) and diagnosis through blood tests (4). Use of multiple medicines, consideration of the medicine versus diseases, symptoms occurring with more than one medicine or relieved through treatment reduced confidence in ADR attribution. Many participants proposed alternative explanations for symptoms, including old age. Lack of information and knowledge were obstacles to the assessment process. CONCLUSIONS: Patients assessed possible ADRs most often by considering timing relationships. While they also used medicine information, Thai patients received inadequate information to help them assess their symptoms. Patients expressed uncertainty and difficulties in deciding attribution when concomitant medicines and diseases were involved. The findings could support the development of a patient-friendly systematic tool for identifying and assessing possible ADRs.

Patients' Identification, Management and Prevention of Adverse Drug Reactions: A Cross-Sectional Survey of Patients with Severe Adverse Drug Reactions.

Background: Few studies have been conducted on how patients identify, manage, and prevent severe adverse drug reactions (ADRs). This study aimed to explore the reasoning that patients use to identify symptoms of severe ADRs and the methods they employ to manage and prevent them. Methods: A cross-sectional survey using structured telephone interviews was administered to patients with a self-assessed severe ADR and to patients with serious skin ADRs from a hospital medical record database (in-patient and out-patient) from 1 September 2016 to 1 September 2019. Patients identified via the medical records were asked to assess their ADR for severity, and only patients that rated their ADR as severe were followed up with a telephone interview. Structured telephone interviews were conducted with respondents by a research pharmacist and audio-recorded. Results: A total of 722 patients with a severe ADR were identified, with 300 completing the interview (41.6%). The most frequently cited reasons for classifying ADRs as severe was worsening ADR symptoms (58.3%), severe ADR symptoms (44.4%), and ADR symptoms interfering with their life (36.4%). Only severe ADR symptoms were significantly different between the questionnaire and the medical records database groups (p = 0.007). The most frequent method of ADR management was discontinuation of drug by physicians (88.3%). About 79.0% of patients stated that they increased their carefulness when using other drugs after experiencing ADRs. The main method patients used to prevent ADRs was informing healthcare professionals (HCPs) about their drug allergy history (65.7%). Conclusions: Worsening ADR symptoms were often used to identify severe ADRs. However, HCPs were mainly responsible for the management and prevention of severe ADRs. Increasing awareness of ADRs by HCPs, and providing additional drug information, may improve patient safety.

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.

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.

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.

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 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.

Patient reporting of suspected adverse drug reactions to antiepileptic drugs: factors affecting attribution accuracy.

This study was aimed to assess the frequency and number of suspected ADRs reported by patients taking antiepileptic drugs (AEDs) and to explore the factors that may affect patients' symptom attribution accuracy. A validated questionnaire containing an extensively checklist of symptoms was distributed to outpatients prescribed one or more AEDs. Data on concomitant drugs and diseases were obtained from outpatient records. All symptoms identified were assessed for causality. Of 1388 questionnaires distributed to 1214 patients, 830 completed questionnaires were returned (59.8%) from 727 patients. In total, 7815 symptoms were identified on 757 questionnaires (91.2%). Symptom severity ratings were positively related to the number of symptoms reported (p=0.003). Causality assessment found that 71.9% of the symptoms were 'true' ADRs and 28.1% were 'false' ADRs. Attribution accuracy was primarily influenced by the number of symptoms identified and indication for AED therapy, fewer symptoms and use for non-epilepsy indications being associated with greater attribution accuracy.

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.

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'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.

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.

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.

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.

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.

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.

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.