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Jarernsiripornkul N.,Khon Kaen University | Chaipichit N.,Khon Kaen University | Pratipanawatr T.,Khon Kaen University | Uchaipichat V.,Khon Kaen University | Krska J.,The Universities of Greenwich and Kent at Medway
Pharmacoepidemiology and Drug Safety | Year: 2016

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. © 2016 John Wiley & Sons, Ltd. Source

Saramunee K.,Liverpool John Moores University | Saramunee K.,Mahasarakham University | Krska J.,The Universities of Greenwich and Kent at Medway | Mackridge A.,Liverpool John Moores University | And 3 more authors.
Public Health | Year: 2015

Objectives: To explore the experience of and willingness to use seven pharmacy public health services related to cardiovascular risk among the general public in England. Study design: Mixed-methods study. Methods: A mixed-methods study, involving a cross-sectional survey using multiple distribution methods followed by a focus group discussion (FGD) with a sample of survey respondents. Results: From 3596 approachable individuals, 908 questionnaires were completed (response rate 25.3%). Few respondents (2.1-12.7%) had experienced any of the seven pharmacy public health services. About 40% stated they would be willing to use health check services, fewer (9.3-26.3%) were willing to use advisory services. More females, frequent pharmacy users and those in good health were willing to use services in general (P < 0.05). Smokers, overweight individuals and those with alcohol-related problems were most willing to use specific advisory services supporting their problems (P < 0.05). FGD identified barriers to service use; for example, frequent staff changes, seeing pharmacist as medicines suppliers and concerns about competence for these services. Conclusion: The general public are receptive to pharmacy public health services. Pharmacists must consider barriers if uptake of services is to increase. © 2015 The Royal Society for Public Health. Source

Chaipichit N.,Khon Kaen University | Krska J.,The Universities of Greenwich and Kent at Medway | Pratipanawatr T.,Khon Kaen University | Jarernsiripornkul N.,Khon Kaen University
International Journal of Clinical Pharmacy | Year: 2015

Background Although statins have great benefit on the prevention of cardiovascular diseases with limited adverse effects (AEs), little is known about patients’ contribution of AE reports in clinical practice. Objectives To explore patients’ experiences of statin AEs and related laboratory monitoring in clinical practice. Setting Outpatient clinics of two University hospitals in northeast Thailand. Methods Generic symptom checklist questionnaires for self-reporting AEs were distributed to patients prescribed simvastatin, atorvastatin, or rosuvastatin at outpatient clinics. Clinical information was obtained from medical records. Reported symptoms were assessed for causality considering previously known statin AEs, concomitant diseases and drugs. Main outcome measure Potential statin AEs reported by patients and monitoring of laboratory parameters related to musculoskeletal and liver disorders. Results Of the total 718 valid responses, 76.0 % of patients reported at least one symptom, most of which (69.0 %) were probable/possible statin AEs. Musculoskeletal and liver-related symptoms were reported by 283 (39.4 %) and 134 patients (18.7 %), respectively. Probable/possible AEs were categorized in 56.7 % of their musculoskeletal and gastrointestinal symptoms. Majority of patients had at least one laboratory test on initiation of (64.8 %) and during statin treatment (61.8 %). Patients taking atorvastatin or rosuvastatin, and patients with history of chronic renal diseases were more likely to have creatine kinase (CK) monitored on initiation of and during statin treatment. Additionally, taking drugs which could potentially increase muscle injury (OR 1.929, P < 0.01) and self-reporting of musculoskeletal symptoms (OR 1.805, P < 0.01) were associated with CK monitoring during statin treatment. Reporters of musculoskeletal symptoms also had significantly higher mean CK level than those not reporting any musculoskeletal symptoms (207.35 ± 155.40 vs. 143.95 ± 83.07 U/L, respectively; P = 0.037). Patient reporting of liver AEs was not related to alanine aminotransferase (ALT) level and monitoring, however, prior history of liver disorders was significantly associated with monitoring of ALT on initiation of and during statin treatment (OR 5.745 and OR 23.063, respectively; P < 0.01). Conclusion Many patients experienced at least one possible adverse effects on a statin. The findings suggest that laboratory monitoring is relatively selective in relation to risks and patient-reported adverse symptoms. © 2015, Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie. Source

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