Patient-Reported Medication Symptoms in Primary Care

Weingart, Saul N.; Gandhi, Tejal K.; Seger, Andrew C.; Seger, Diane L.; Borus, Joshua; Burdick, Elisabeth; Leape, Lucian L.; Bates, David W.

doi:10.1001/archinte.165.2.234

Cited by 117 publications

(108 citation statements)

References 22 publications

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“…[19] Given that 36% of our respondents cited a health professional as a method of identifying a suspected ADR, it is unsurprising that 57% of all those who had this experience claimed they had discussed their experience. Previous work has shown that in response to reporting of symptoms suspected by patients to be ADRs, the most common action of primary care physicians was to discontinue the offending medicine or to change therapy, [4] as was found here. However other work has suggested that physicians may sometimes be dismissive [11,12] and we also found a small number of patients who experienced this type of response.…”

Section: Comparison To the Literaturesupporting

confidence: 59%

“…Two large prospective studies in Liverpool hospitals have shown that 6.5% out of 18,820 admissions to medical units were caused by adverse drug reactions (ADRs), that 2.3% of patients admitted with ADRs die [1] and that 14.7% of 3,695 medical or surgical in-patients experienced an ADR during their stay. [2] In primary care, studies which have relied on patients' reports of ADRs, either to postal questionnaires or telephone surveys suggest annual prevalence estimates of the order of 25-29% in the USA [3,4] and 30% in the UK. [5] Higher estimates were found in a Dutch study involving only anti-epileptic drugs.…”

Section: Conclusion Introductionmentioning

confidence: 99%

“…[3,4] One potential reason for this may be that health professionals sometimes express dismissive attitudes about patients' judgements concerning symptoms they have experienced. [10][11][12] It is important to explore further and in a wider, more representative population how patients use information about medicines, such as the patient information leaflet (PIL) or information provided by health professionals, to help them assess symptoms they suspect are ADRs and their experiences of discussing their views with health professionals.…”

Section: Conclusion Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Patients’ Use of Information about Medicine Side Effects in Relation to Experiences of Suspected Adverse Drug Reactions: A Cross-Sectional Survey in Medical In-Patients

Krska

Morecroft

2013

Drug Saf

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Section: Comparison To the Literaturesupporting

confidence: 59%

Section: Conclusion Introductionmentioning

confidence: 99%

Section: Conclusion Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Patients’ Use of Information about Medicine Side Effects in Relation to Experiences of Suspected Adverse Drug Reactions: A Cross-Sectional Survey in Medical In-Patients

Krska

Morecroft

2013

Drug Saf

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“…Patient self-reports of adverse drug events (ADEs) are an important additional source of information on the safety of drugs because they differ from healthcare professional reports [2][3][4][5][6][7]. Healthcare professionals often underestimate symptomatic ADEs experienced by patients [7,8].…”

Section: Introductionmentioning

confidence: 99%

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

et al. 2013

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Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to develop and test a generic questionnaire to identify ADEs and quantify their nature and causality as reported by patients. Methods We created a draft list of common ADEs in layterms, which were classified in body categories and mapped to the Medical Dictionary for Regulatory Activities (MedDRA Ò ) terminology. Questions about the nature and causality were derived from existing questionnaires and causality scales. Content validity was tested through cognitive debriefing, revising the questionnaire in an iterative process. Feasibility and reliability were assessed using a Web-based version of the questionnaire. Patients received the questionnaire twice. Feasibility was assessed by the reported time needed for completion and ease of use. Reliability was calculated using Cohen's kappa and proportion of positive agreement (PPA) on: (1) any ADE at patient level; (2) similar ADEs at MedDRA Ò System Organ Class level; and (3) the same ADE at ADE-specific level.Results In the development phase, 28 patients with type 2 diabetes or asthma/chronic obstructive pulmonary disease (COPD) participated. Questions and answer options were rephrased, layout was improved, and changes were made in the classification of ADEs. The final questionnaire consisted of 252 ADEs organized in 16 body categories, and included 14 questions per reported ADE. A total of 135 patients using a median of five different drugs completed the Web-based questionnaire twice. The median completion time was 15 min for patients not reporting any ADE, and 30 min for patients reporting at least one ADE. Three quarters of the patients found the questionnaire easy to use. Test-retest reliability was acceptable at patient level (j = 0.50, PPA 0.64) and at MedDRA Ò System Organ Class level (j = 0.52, PPA 0.54), but was low at ADEspecific level (j = 0.38, PPA 0.38). Conclusion We developed a generic patient-reported ADE questionnaire and confirmed its content validity. The questionnaire was feasible and reliable for reporting any ADE and similar ADEs at MedDRA Ò System Organ Class level. Additional work is, however, needed to reliably quantify specific ADEs reported by patients.

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“…Elderly patients may be unable to recognise the symptoms of conditions that increase the risk of falls, such as hypotension or dizziness; or they may not report them to their healthcare givers, increasing the risk of experiencing falls, if the medication regimen is not adjusted (248). Safety issues of medications with repeat prescribing, including antihypertensive medications, have also been warranted (249).…”

Section: Discussionmentioning

confidence: 99%

Inappropriate prescribing, non-adherence to long-term medications and related morbidities : Pharmacoepidemiological aspects

Hedna

2015

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Aim:The aim of this thesis is to estimate and analyse the burden of potentially inappropriate prescriptions (PIPs) in the elderly and non-adherence to long-term medications among adults across care settings, and to investigate how IUM is associated to DRMs. Methods:A meta-analysis summarised the previous evidence on the percentage of adverse drug reactions (ADRs) associated to IUM across healthcare settings (Study I). From a cohort in the general population, using medical records and register data, the prevalence of PIPs in the elderly and its association with ADRs were estimated retrospectively (Study II). From the same cohort, the factors associated with refill non-adherence to antihypertensive therapy, considering the use of multiple medications, and the association between non-adherence and sub-therapeutic effects (STEs) were investigated (Study III). A survey assessed the refill behaviour to antihypertensive, lipid lowering and oral antidiabetic medications (undersupply, adequate supply and oversupply), and its association with perceived ADRs and STEs (Study IV).Results: IUM was the cause 52% and 45% of ADRs occurring in adult outpatients and inpatients respectively. Across healthcare settings, 46% of the elderly refilled PIPs over a 6-month period;PIPs were considered the cause of 30% of all ADRs; and the elderly who were prescribed PIPs had increased odds to experience ADRs (OR 2.47, 95% CI 1.65-3.69). In total, 35% was nonadherent to the full multidrug therapy and 13% was non-adherent to any medication (complete vi non-adherence). Sociodemographic factors (working age and lower income) were associated with non-adherence to any medication, while clinical factors (use of specialised care, use of multiple medications, and being a new user) with non-adherence to the full multidrug therapy. STEs were associated with non-adherence to any medication a month prior to a healthcare visit (OR 3.27, 95% CI 1.27-8.49), but not with long-term measures of non-adherence. Among survey respondents, 22% of the medications were oversupplied and 12% were undersupplied. Inadequate refill behaviour was not associated with reporting ADRs or STEs (p<0.05). Conclusions:A large proportion of ADRs occurring in hospital is caused by IUM, but more knowledge is needed in other settings. PIPs are common in the elderly general population and associated with ADRs. Therefore decreasing PIPs could contribute towards ADR prevention.Considering the use of multiple medications may help to better understand the factors associated with non-adherence to a multidrug therapy for tailoring the interventions to patient needs.Monitoring the adherence prior to a healthcare visit may facilitate interpreting STEs. Yet, the absence of an association between long-term measures of refill non-adherence with clinical and perceived DRMs suggest the need to enhance the knowledge of this association in clinical practice.In summary, this thesis shows a significant potential for improvements of medication use and outcomes.Key words: Drug-related morbidity, medica...

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Patient-Reported Medication Symptoms in Primary Care

Abstract: Primary care physicians may be able to reduce the duration and/or the severity of many ADEs by eliciting and addressing patients' medication symptoms.

Cited by 117 publications

References 22 publications

Patients’ Use of Information about Medicine Side Effects in Relation to Experiences of Suspected Adverse Drug Reactions: A Cross-Sectional Survey in Medical In-Patients

Patients’ Use of Information about Medicine Side Effects in Relation to Experiences of Suspected Adverse Drug Reactions: A Cross-Sectional Survey in Medical In-Patients

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

Inappropriate prescribing, non-adherence to long-term medications and related morbidities : Pharmacoepidemiological aspects

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