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 outpatients 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) offollow-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

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, hospital and community pharmacists in northeastern Thailand. Ten hospitals and twenty pharmacies in five provinces were purposively selected. Interviews followed a topic guideline, were audio-recorded, transcribed verbatim and analyzed using a framework approach. Key findings; Fifty-one participants were involved: 13 orthopedic physicians, 20 hospital pharmacists and 18 community pharmacists. 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

Evaluation of community pharmacists’ roles in screening and communication of risks about non-steroidal anti-inflammatory drugs in patients

Aim: This study aimed to explore community pharmacists’ roles on screening for risk factors, providing safety information related NSAIDs to patients Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely dispensed without 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. Findings: Out 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 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 (CV) (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 (Odd 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

Development and preliminary validation of an instrument to enable laypersons to assess suspected side effects from medicines

Purpose Research into causality assessment tools enabling patients to assess suspected adverse drug reactions (ADRs) is limited. Supporting patients with tools could improve their confidence in discussions with health professionals and encourage reporting of suspected ADRs to regulators. This study describes development and preliminary validation of an instrument: Side Effect Patient ASsessment Tool (SE‐PAST). Methods SE‐PAST was developed from survey and interview data involving patients experiencing suspected ADRs. It included 10 statements enabling causality assessment, covering timing, additional information sources, and experiences, with four options: yes/no/don't know/not applicable. Scoring and weighting resulted in four categories of causal association: highly probable, probable, possible, unlikely. Validation involved obtaining feedback from 31 individuals experiencing an ADR. Further validation involved online distribution through patient support groups and comparison of reported symptoms to known ADRs. Results Validators found SE‐PAST easy to read (31), to understand (27), and to complete (29). A total of 294 respondents completed SE‐PAST online, with 98% completing eight or more causality assessment statements. Symptoms were categorised as highly probable (46; 16%), probable (80; 62%), possible (44; 15%), and unlikely (21; 7%). A total of 221 respondents identified one suspected medicine, with 95% of these reporting at least one symptom known to be an ADR. Of 227 providing feedback, 139 (61%) found SE‐PAST useful, 160 (71%) felt motivated to discuss their experience with a health professional, and 136 (60%) were encouraged to report to the regulator. Conclusion SE‐PAST was easily completed and understood by people experiencing suspected ADRs and could be useful in encouraging patient reporting to health professionals and agencies

Knowledge and perceptions of the risks of non-steroidal anti-inflammatory drugs among orthopaedic patients in Thailand

Background There is a high incidence of adverse effects from non-steroidal antiinflammatory drugs (NSAIDs) in Thailand, but patients’ perceptions and knowledge of NSAID risks is unknown. Objective This study aims to assess patients’ perceptions and knowledge of NSAID risks and factors affecting them. Setting University hospital in North-East of Thailand. Method A Cross-sectional study conducted over 4 months, using a self-administered questionnaire. Patients prescribed NSAIDs for at least one month duration from orthopaedic clinic were recruited using systematic random sampling. Main outcome measure Patients’ perceptions on NSAID risks, knowledge on risk factors, and their associated factors. Results A total of 474 questionnaires were assessed. Overall perceptions of risks was low (scoring below five on a 0–10 visual analogue scale), with risks associated with the renal system scoring highest. Perceived risk of gastrointestinal problems differed between patients using non-selective and selective NSAIDs (3.47 ± 2.75 vs 2.06 ± 2.98; P < 0.001). Receiving side effect information from a health professional was associated with higher risk perception. Most patients (80 %) identified high doses, renal disease and gastrointestinal ulcer increased risks of NSAIDs, but fewer than half recognized that use in the elderly, multiple NSAID use, drinking, hypertension and cardiovascular disease also increased risk of adverse events. Having underlying diseases and receiving side effect information were associated with 1.6–2.0 fold increased knowledge of NSAID risks. Conclusion Perceptions and knowledge concerning NSAID risks was generally low in Thai patients, but higher in those who had received side effect information. Risk-related information should be widely provided, especially in high-risk patients

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

Hospital pharmacists’ roles and attitudes in providing information on the safety of non-steroidal anti-inflammatory drugs in Thailand

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for patients to manage pain and inflammation, especially in older adults. Failure to cope with some adverse drug reactions (ADRs) of NSAIDs could lead to more serious symptoms, therefore, providing useful information about medicine is an important step in protecting patients from developing serious ADRs. The pharmacy service should be a frequent source of medicine information for patients, however in Thailand, little is known about pharmacists’ provision of safety information to patients for management and prevention of these ADRs. Objective: Aims of this study were to determine Thai hospital pharmacists’ roles in providing drug safety information and to assess their attitudes towards the importance of giving drug safety education to patients. Setting: All government hospitals in north-eastern Thailand. Methods: This study was a cross-sectional survey. A total of 761 pharmacists in 287 hospitals in north-eastern Thailand were selected by stratified random sampling. Self-administered questionnaires were sent by post, with two reminders. Main outcome measures: Proportion of hospital pharmacists providing ADR information on NSAIDs to patients, factors affecting this provision, and pharmacist attitudes towards drug safety education for patients. Results: The response rate was 54.8 % (N = 417), the majority of respondents worked in community hospitals (57.2 %). A total of 347 pharmacists (83.6 %) had informed patients about ADRs, although less than half had informed patients about ADR monitoring and management (36.6 % and 44.1 % respectively). The proportion of time spent in direct patient contact, type of hospital, and other routine work were associated with the frequency of drug safety information provision. Pharmacists had moderately good attitudinal scores towards drug safety education (62.2 ± 5.4), with significantly higher scores found in those who provided most ADR information to patients (60.3 ± 5.2 vs. 62.6 ± 5.4, P = 0.002). The majority (82.2 %) agreed that patient information leaflets should be provided. Conclusions: Thai hospital pharmacists’ provision of ADR information for NSAIDs may occur less frequently than is desirable. However, their positive attitude towards provision of ADR information suggests that drug safety education by pharmacists should be routinely provided to patients, particularly patients at high risk of NSAID use

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

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