A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study: the study protocol for a randomised controlled trial.

BACKGROUND: Older patients with type 2 diabetes mellitus (T2D) have an increased risk of hypoglycaemic episodes when using sulphonylureas or insulin. In the Netherlands, guidelines exist for reducing glucose-lowering medication in older patients. However, evidence is lacking that a medication reduction in older patients can be safely pursued. Here, we will examine if promoting the deprescribing of insulin/sulphonylureas with a deprescribing programme (DPP) in general practice affects T2D-complications in older overtreated patients. METHODS: We will perform a 1:1 cluster randomised controlled trial in 86 general practices in the Netherlands. The DPP will consist of education sessions with general practitioners and practice nurses about reducing glucose-lowering medication in older patients (≥ 70 years). Topics of the sessions include the necessity of deprescribing, tools to initiate deprescribing and strategies to discuss deprescribing with patients (shared decision making). The DPP further includes a support programme with practice visits. The study will employ a selection tool to identify possibly overtreated older patients from the electronic medical records of the general practitioner. Eligibility for enrolment in the study will be based on HbA1c targets indicated by the Dutch guidelines, which depend on age, diabetes duration, presence of frailty, and life expectancy. The control group will provide usual care. We aim to include 406 patients. The follow-up period will be 2 years. For the primary outcome, the effect of the DPP on T2D-complications will be assessed by counting the cumulative incidence of events related to under- and overtreatment in T2D as registered in the electronic medical records. We shall perform an intention-to-treat analysis and an analysis including only patients for whom deprescribing was initiated. The implementation of the DPP in general practice will be evaluated quantitatively and qualitatively using the Extended Normalisation Process Theory (ENPT) and the Reach, Efficacy - Adoption, Implementation and Maintenance (RE-AIM) model. Other secondary outcomes include quality of life, cognitive functioning, events related to overtreatment or undertreatment, biomarkers of health, amount of blood glucose-lowering medication prescriptions, and cost-effectiveness. DISCUSSION: This study will provide insight into the safety and feasibility of a programme aimed at deprescribing sulphonylureas/insulin in older people with T2D who are treated in general practice. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN50008265 , registered 09 March, 2023.

Medication Appropriateness for Older Nursing Home Patients With a Limited Life Expectancy: From STOPP/START Version 2 to the ReNeWAL Criteria.

OBJECTIVES: To adapt the 2015 Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) criteria to older nursing home patients with a limited life expectancy of 1.5 to 2 years. DESIGN: A modified Delphi consensus study. SETTING AND PARTICIPANTS: The study was established in The Netherlands and conducted online. The international panel consisted of 23 experts with experience in medicine for older people. METHODS: The expert panel was presented with the 2015 STOPP/START criteria using an online survey program (Survey Monkey). The panelists were asked for their opinion on the appropriateness of the STOPP and START criteria, and adaptations to these criteria for older nursing home patients with a limited life expectancy on 4-point Likert scales. Consensus was defined as ≥70% of the panelists answering (very) inappropriate or (very) appropriate, and (completely) disagree or (completely) agree. RESULTS: Twenty-one panelists completed all 3 Delphi rounds. The final list of "Represcribing for Nursing home residents With A Limited life expectancy (ReNeWAL)" criteria comprises 132 criteria: 98 criteria to stop (70 original STOPP criteria and 28 adapted) and 34 criteria to start (16 original START criteria and 18 adapted) for older nursing home patients with a limited life expectancy. Considerations that panelists mentioned for adapting criteria were mainly prevention and treatment of discomfort. CONCLUSION AND IMPLICATIONS: It is clear that represcribing for older nursing home patients is highly complex and requires the consideration of various elements. The ReNeWAL criteria may be useful in enhancing represcribing for older nursing home patients with a limited life expectancy.

[A prescription for yourself or acquaintances, a good idea?] / Een recept voor jezelf of een bekende, een goed idee?

Many doctors regularly write a prescription for themselves or for family members or friends. In this article, we discuss the legal and ethical considerations surrounding these prescriptions. We also discuss the role of the pharmacist who receives the prescription. Although there is no legal obstacle, codes of conduct and guidelines state that prescribing to acquaintances or yourself is undesirable, especially because it is often not possible to maintain sufficient professional distance, necessary to provide proper treatment. If the GP or other care providers have no knowledge of the prescription and no medical file is kept, undesirable situations may arise for the patient. A prescription for yourself or acquaintances can be made occasionally and under special circumstances (acute situation, no serious problem, short-term), but then requires a quick transfer of treatment to regular practitioners.

Impact of Drug Recalls on Patients in The Netherlands: A 5-Year Retrospective Data Analysis.

Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive overview the extent of conducted recalls and their impact on patients remains unknown. To address this, we developed a comprehensive overview of drug recalls affecting patients. We compiled this overview based on the drug recall registrations from the Jeroen Bosch Hospital (JBZ), the University Medical Center Utrecht (UMCU), and the Royal Dutch Pharmacists Association (KNMP). A retrospective data analysis was conducted to identify drug recalls that affected patients. Specifically, we defined these as drug recalls that required patients to actively switch their drug to a different batch or brand of the same drug or to switch to a drug within the same or a different class of drugs. To quantify the impact, we used real-world drug dispensing data. Between January 1, 2017, and December 31, 2021, we identified 48 drug recalls that necessitated patients to make active changes to their medications an estimated 855,000 times. Most of the affected patients (292,000) were required to switch to a different brand of the same drug, whereas in 95,000 cases patients had to switch to a drug from another drug class. Our study suggests that a significant number of patients are affected by drug recalls. Future efforts are needed to elucidate patients' experiences and preferences regarding drug recalls, which could provide valuable insights to aid decision-making by relevant (national) authorities concerning drug recalls.