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The prevalence of harms in healthcare related to drug treatment is often quantified using terms developed for pharmacovigilance and pharmaceutical care. In this overview, we guide through the definitions and the settings for which they were developed, with the underlying intention to facilitate the interpretation of hitherto available research intended to contribute information regarding the magnitude of the problem in healthcare and to provide guidance for future research. To start, the regulatory/academic definitions of an adverse drug reaction (ADR) and a drug-related problem (DRP) are considerably broader than a literal interpretation would suggest. ADRs are defined for the pharmacovigilance setting, and for drug safety reasons the opposite of the benefit of the doubt rules; if it cannot be excluded that the medication has caused or contributed to an event, it will be a suspected ADR. DRPs represent the pharmaceutical care setting where every aspect is included that could potentially be problematic; a manifested problem is not required. When quantifying the prevalence of harms related to drug treatment in the healthcare setting, however, it may not be considered reasonable to count every circumstance that could possibly be an ADR or everything that could potentially be problematic. Therefore, definitions developed for the pharmacovigilance and the pharmaceutical care settings are not fully applicable to estimate the magnitude of drug treatment problems in healthcare. Proposed guidance for the future includes cautious interpretation of research results, as well as a conscious choice of definitions according to purpose and tempered reporting in research., Funding Agencies|University of Gothenburg

Background: Despite efforts to improve undergraduate clinical pharmacology & therapeutics (CPT) education, prescribing errors are still made regularly. To improve CPT education and daily prescribing, it is crucial to understand how therapeutic reasoning works. Therefore, the aim of this study was to gain insight into the therapeutic reasoning process. Methods: A narrative literature review has been performed for literature on cognitive psychology and diagnostic and therapeutic reasoning. Results: Based on these insights, The European Model of Therapeutic Reasoning has been developed, building upon earlier models and insights from cognitive psychology. In this model, it can be assumed that when a diagnosis is made, a primary, automatic response as to what to prescribe arises based on pattern recognition via therapy scripts (type 1 thinking). At some point, this response may be evaluated by the reflective mind (using metacognition). If it is found to be incorrect or incomplete, an alternative response must be formulated through a slower, more analytical and deliberative process, known as type 2 thinking. Metacognition monitors the reasoning process and helps a person to form new therapy scripts after they have chosen an effective therapy. Experienced physicians have more and richer therapy scripts, mostly based on experience and enabling conditions, instead of textbook knowledge, and therefore their type 1 response is more often correct. Conclusion: Because of the important role of metacognition in therapeutic reasoning, more attention should be paid to metacognition in CPT education. Both trainees and teachers should be aware of the possibility to monitor and influence these cognitive processes. Further research is required to investigate the applicability of these insights and the adaptability of educational approaches to therapeutic reasoning.

Purpose To analyse the reliability and validity of the Swedish indicator 'Drugs that should be avoided in older people'.Methods From a previous study that included consecutive primary care patients >= 65 years of age, all patients >= 75 years of age were analysed. Two physicians independently screened their medication lists and medical records, applying the Swedish indicator which includes potentially inappropriate medications (PIMs): long-acting benzodiazepines, drugs with anticholinergic action, tramadol, propiomazine, codeine, and glibenclamide. The clinical relevance of identified PIMs was independently assessed. Thereafter, the physicians determined in consensus whether some medical action related to the drug treatment was medically justified and prioritised before the next regular visit. If so, the drug treatment was considered inadequate, and if not, adequate.Results A total of 1,146 drugs were assessed in 149 patients (75-99 years, 62% female, 0-20 drugs per patient). In 29 (19%) patients, at least one physician identified >= 1 PIM according to the indicator at issue; 24 (16%) patients were concordantly identified with >= 1 such PIM (kappa: 0.89). Of 26 PIMs concordantly identified, the physicians concordantly assessed four as clinically relevant and 12 as not clinically relevant (kappa: 0.17). After the consensus discussion, six (4%) patients had >= 1 PIM according to the studied indicator that merited action. Using the area under the receiver operating characteristic (ROC) curve, the indicator did not outperform chance in identifying inadequate drug treatment: 0.56 (95% confidence interval: 0.46 to 0.66).Conclusion The Swedish indicator has strong reliability regarding PIM detection but does not validly reflect the adequacy of drug treatment., Funding Agencies|The Swedish Research Council

Aim To investigate methodological aspects potentially related to the diverging scientific literature on the prevalence of drug-related hospitalisations, focusing on causality assessments. Methods Original studies contributing data to a recent meta-analysis were reviewed. Methodological aspects, in particular those related to causality assessments, were extracted and compiled. Results Thirteen studies provided data on the prevalence of drug-related admissions. Seven studies focused on adverse drug reactions (prevalences 1.3-10%), and six studies used the broader concept of drug-related problems (prevalences 4.5-41%). In 10 out of 13 studies, causality between the drug and the specified problem was assessed. One study required a probable causal relationship; the remaining studies merely required a possible causal relationship. Five studies assessed the association between the problem assumed to be related to drug therapy and the admission, at one end requiring the former to be demonstrated as the underlying cause and, at the other, merely requiring a temporal relationship between drug intake and admission. Three out of eight studies involving multiple assessors for all/some cases reported the inter-rater agreement, ranging from none to almost perfect. Physicians were involved in the assessments in five studies, reporting prevalences of 3.2% to 4.5%, while studies without such medical input reported prevalences of 8.8% to 41%. Conclusions This review illustrates that methodological issues contribute to the diverse literature on drug-related admissions. We provide suggestions for harmonisation of research, including explicitly assessing the drug-problem-admission relationships from a medical perspective, focusing on problems where the drug treatment is the probable culprit., Funding Agencies|Swedish Network for Pharmacoepidemiology; Swedish government [ALFGBG-716941]; county councils (the ALF-agreement) [ALFGBG-716941]; Swedish Research CouncilSwedish Research CouncilEuropean Commission [2013-02639]

IMPORTANCE Potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) are used in research to reflect the quality of drug treatment in older people and have been suggested for inclusion in core outcome sets for evaluation of interventions for improved prescribing. Their validation so far, however, is primarily restricted to expert opinion-based processes. OBJECTIVE To evaluate the performance of 3 explicit PIM/PPO criteria sets as diagnostic tools to identify inadequate drug treatment in older patients. DESIGN, SETTING, AND PARTICIPANTS This diagnostic study analyzed patients aged 65 years or older consecutively included from 2 primary health care centers from October to November 2017. Data were analyzed from February to August 2022. EXPOSURES The PIMs/PPOs were concordantly identified by 2 specialist physicians (2018-2019) retrospectively after a planned physician visit, using 3 European PIM/PPO criteria sets and without knowledge of this diagnostic study. MAIN OUTCOMES AND MEASURES Area under the receiver operating characteristic (ROC) curve, reflecting the ability of PIM/PPO criteria sets to identify the reference standard of inadequate drug treatment, determined by 2 specialist physicians in consensus. Inadequate drug treatment implied that additional action related to the medication could be medically justified before the next regular visit. RESULTS A total of 302 patients were analyzed (median age, 74 [IQR, 69-81] years; 178 women [59%]; median number of drugs in the medication list, 6 [IQR, 3-9]); 98 patients (32%) had inadequate drug treatment. A total of 0 to 8 PIMs/PPOs per patient were identified using the Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) criteria, 0 to 6 with the European EU(7)-PIM list, and 0 to 12 with the Swedish set of indicators of prescribing quality. The areas under the ROC curve for the 3 sets to identify the reference standard for inadequate dru