Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed During Clinical Medication Reviews: A Cross-Sectional Observational Study

Schoenmakers, Tim W. A.; Teichert, Martina; Wensing, Michel; Smet, Peter A. G. M. De

doi:10.1007/s40264-017-0504-7

Cited by 15 publications

(18 citation statements)

References 35 publications

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“…PROMISE was developed as a paper-based instrument to collect patient information in six domains for the patient interview in CMRs and for the follow-up evaluation (Online Resource 1). The main domain comprised 22 common predefined symptoms, with the option of reporting additional symptoms [ 22 ]. Patients were asked to report all symptoms experienced in the previous month (yes/no) and to report any suspicion that these symptoms were associated with the drugs they were using (yes/do not know/no).…”

Section: Methodsmentioning

confidence: 99%

“…In PROMISE, additional information was collected in four other domains based on existing validated instruments: general health perception [ 7 ], a question about self-rated health that can serve as a global measure of health status [ 26 , 27 ]; necessity and concern beliefs, five of the ten items in the Beliefs about Medicines Questionnaire reflecting the current and future necessity and concern beliefs, and the concern beliefs about the knowledge of the medicines [ 28 ]; self-efficacy in understanding and using medicines, one item for both subscales of the eight-item MUSE scale [ 29 ]; medication adherence from the patient’s perspective according to the frequently used Medication Adherence Rating Scale [ 21 , 30 – 32 ]. Finally, patients could propose other issues to be discussed in the interview with the pharmacist [ 22 ].…”

Section: Methodsmentioning

confidence: 99%

“…The pharmacists sent the completed PROMISE and other documents with anonymised information on actual drug use and patient sex and age to the researchers. All dispensed drugs covering the month before completing PROMISE were considered to be in use and were recorded [ 22 ] according to the 2013 version of the Anatomic Therapeutic Chemical classification system of the World Health Organisation [ 34 ].…”

Section: Methodsmentioning

confidence: 99%

“…Specifically, information on a patient’s beliefs and concerns about and the use of his/her drugs could be collected to optimise and individualise drug treatment [ 21 ]. Thus the ‘Patient-Reported Outcome Measure, Inquiry into Side Effects’ (PROMISE) instrument was developed to facilitate the gathering of meaningful information from patients in CMRs to support pharmacists in detecting drug-related symptoms [ 22 ], and to use this information as PROMs in CMRs. In this trial the ability of the instrument to detect changes was assessed.…”

Section: Introductionmentioning

confidence: 99%

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Patient-reported common symptoms as an assessment of interventions in medication reviews: a randomised, controlled trial

Schoenmakers

Wensing

Smet³

et al. 2017

Int J Clin Pharm

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Background A ‘Patient-Reported Outcome Measure, Inquiry into Side Effects’ (PROMISE) instrument was developed for patients to report common symptoms in clinical medication reviews. Objective To determine changes in patient-reported drug-associated symptoms collected by PROMISE before and after community pharmacist-led clinical medication reviews compared with usual care. Setting Community pharmacies in the Netherlands. Methods Patients were randomised into an intervention group (IG) and a control group (CG). PROMISE was used to collect symptoms experienced during the previous month, and any suspected drug-associated symptoms from both groups at baseline and at follow-up after 3 months. IG patients received a one-time clinical medication review, while CG patients received usual care. Main outcome measure Mean number of drug-associated symptoms at follow-up. Results Measurements were completed by 78 IG and 67 CG patients from 15 community pharmacies. Mean numbers of drug-associated symptoms per patient at follow-up were 4.0 in the IG and 5.0 in the CG, with an incident rate ratio between the groups of 0.90 (95% CI 0.62–1.33). Mean numbers of drug-associated symptoms per patient reported at follow-up and persisting since baseline were 2.1 in the IG and 2.6 in the CG, with an incident rate ratio of 0.85 (95% CI 0.43–1.42). The lowest percentages of persisting drug-associated symptoms detected in the IG were ‘palpitations’ and ‘stomach pain, dyspepsia’ while in the CG they were ‘stomach pain, dyspepsia’ and ‘trembling, shivering’. Conclusion PROMISE provided meaningful information on drug-associated symptoms in clinical medication reviews, however the number of drug-associated symptoms was not reduced by performing clinical medication reviews compared with usual care.Electronic supplementary materialThe online version of this article (10.1007/s11096-017-0575-7) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Patient-reported common symptoms as an assessment of interventions in medication reviews: a randomised, controlled trial

Schoenmakers

Wensing

Smet³

et al. 2017

Int J Clin Pharm

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“…Direct questioning by professionals doubles the number of adverse drug events identified [ 111 ]. Primary care pharmacist questioning identified problems in 168/180 patients, for example, xerostomia, sweating, diarrhoea, constipation [ 112 ]. ADR reporting in clinical trials using standard questions and diary cards increased ADR reporting, for example, from 1.5–5.1% to 29–49% [ 113 ].…”

Section: Regulatory Interventions To Modify Prescribing and Outcommentioning

confidence: 99%

Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles

et al. 2018

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The power and influence of healthcare systems comes largely from the ability to prescribe efficacious medicine. However, medicine can sometimes cause harm rather than bring benefits. Systematically checking patients for the adverse effects of medicines, as listed in manufacturers’ literature, would protect patients from iatrogenic harm, but this is rarely undertaken. We argue for the benefits of this approach using the example of the prescription of antipsychotics to older adults. Prescribing antipsychotics to control challenging behaviours associated with dementia is a controversial matter, and regulatory intervention is under discussion. Improved regulatory systems could protect against iatrogenic harm, such as over-sedation, falls, tremor, or drug-induced Parkinsonism. However, measuring the impact and outcomes of regulatory interventions has proved difficult, not least because there are rarely systematic records of all adverse effects of medicines. We indicate how regulatory initiatives to reduce antipsychotic prescribing can be supported by systematic monitoring and documentation of patients’ signs and symptoms of putative adverse drug reactions. Monitoring documentation then provides the rationale and support for professionals’ responses to identified problems. Longitudinal monitoring records would improve understanding of the impact and outcomes of adverse drug reactions (ADRs) on health and wellbeing, and the many costs of ADRs.

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