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.

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.

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)

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.