[The conversation with the patient is essential for good pharmacotherapeutic care]. / Het gesprek met de patiënt is essentieel voor goede farmacotherapeutische zorg.

Frail elderly with polypharmacy are at greater risk of preventable medication-related health damage. To improve medication safety, the healthcare field prepared, in consultation with the Dutch Health Care Inspectorate, a number of guidelines and standards containing conditions for safe prescribing. According to these standards the active involvement of patients by health care professionals is essential for good pharmacotherapeutic care. However, two studies with patients show that there is still room for improvement. According to patients, they can be (even) better informed about changes in their medication. Also the caregivers could communicate more clearly who is the central contact point and who is ultimately responsible for the medication. Patients are not sufficiently informed on this. Furthermore, there is uncertainty about how and why medication reviews are performed. More explanation to patients about this is desirable. In addition, patients experience that keeping their medication list up to date and transferring medication data between health care providers could be improved. Finally, a group of patients welcomes the opportunity to co-decide on changes in their medication. In order to prescribe safely, it is crucial that caregivers actively involve patients in pharmacotherapeutic care and really enter into conversation with them about their medication.

A baseline assessment by healthcare professionals of Dutch pharmacotherapeutic care for the elderly with polypharmacy.

Background: Polypharmacy is common in the elderly population and is associated with an increased risk of adverse drug events. To diminish this risk, the guideline 'Polypharmacy in the Elderly' has been developed in 2012. This study examines, to what extent Dutch pharmacotherapeutic practice amongst elderly with polypharmacy mirrors the best practice described in this guideline and which barriers threaten it. Methods: An observational study was conducted in 2013/14 using a questionnaire distributed amongst Dutch healthcare professionals and elderly patients with polypharmacy. Healthcare professionals were asked about their current practice and the presence of five significant barriers, selected through a literature review and from expert opinion. These barriers are: inadequate transfer of patient records; insufficient documentation of prescribed drugs; a lack of collaboration between professionals; a failure to take a full control of the medication and insufficient involvement of the patient. The patients were asked about their experience with pharmacotherapeutic care. Results: No more than 26% of the healthcare professionals indicated that they use the guideline. The five barriers threatening the pharmacotherapeutic care were found to be present. Forty-three percent of the patients mentioned that their medication was assessed last year. Conclusion: The guideline is not used frequently by the healthcare professionals, but there is a will to improve the care by following this guideline. However, the presence of the five barriers hampers its implementation. Good management of those barriers is necessary in order to improve the collaboration between primary and secondary care and to enhance the documentation of prescribed drugs.

[Pharmacotherapeutic care for vulnerable groups with polypharmacy has to get better]. / Farmacotherapeutische zorg voor kwetsbare groepen met polyfarmacie moet beter.

Pharmacotherapeutic care of the elderly and psychiatric patients is complex and risky, because polypharmacy, the chronic use of five or more medications by a patient, is highly prevalent in these groups. Polypharmacy is a risk factor for medication related hospital admissions. The Dutch Health Care Inspectorate (IGZ) adopted 'improving care for the elderly' and 'improving medication safety' as spearheads. In order to provide input to IGZ enforcement policy, RIVM investigated the risks of polypharmacy as well as the measures that might limit these risks. This study shows that over- and undertreatment frequently occur. This may be caused by the fact that a physician sometimes does not know which medicines for a patient were prescribed, changed or stopped by other physicians. It was also found that psychiatric patients often experience side effects or interactions that are specific to psychiatric medicines, sometimes in combination with somatic medication. Various guidelines to improve medication safety are available, but several bottlenecks hamper the implementation, for example in the area of collaboration, direction and transfer of information on medication. But also ICT is insufficiently facilitating and physicians have too little knowledge of polypharmacy in the frail populations. The health care sector is taking various initiatives to remove bottlenecks. IGZ will from 2015 in all health care domains focus on four guidelines that describe the conditions for sensibly prescribing medication to frail people with polypharmacy.

Practical feasibility of outcomes research in oncology: lessons learned in assessing drug use and cost-effectiveness in The Netherlands.

OBJECTIVE: To investigate the practical feasibility to develop evidence on drug use and cost-effectiveness in oncology practice. PATIENTS AND METHODS: Feasibility was examined using three Dutch case studies. Each case study investigated the degree of appropriate drug use and its incremental cost-effectiveness. Detailed data were retrospectively collected from hospital records. In total, 391, 316 and 139 patients with stage III colon cancer, metastatic colorectal cancer and multiple myeloma were included in 19, 29 and 42 hospitals, respectively. RESULTS: The methods used in the case studies were feasible to develop evidence on some aspects of drug use including types of treatments used, dosages, dose modifications and healthcare costs. Aspects such as baseline patient characteristics, reasons to start or stop a treatment and treatment effects were less feasible because of missing values. Despite difficulties to correct for confounding by indication, it was possible to estimate incremental cost-effectiveness by synthesising evidence in two of the three case studies. CONCLUSION: It is possible to generate evidence about drug use and cost-effectiveness in oncology practice to facilitate informed decision-making by both payers and physicians. This can improve quality of care and enhance the efficient allocation of resources. However, the optimal approach differs between drugs and their indications. Generating high-quality evidence requires active interdisciplinary collaboration. Patient registries can facilitate data collection but cannot resolve all issues. In most circumstances it is inevitable to use data-synthesis to obtain valid incremental cost-effectiveness estimates, but for some indications it will not be feasible to derive a valid and precise estimate.

Methodological quality of economic evaluations of new pharmaceuticals in The Netherlands.

BACKGROUND: In the Netherlands, decisions about the reimbursement of new pharmaceuticals are based on cost effectiveness, as well as therapeutic value and budget impact. Since 1 January 2005, drug manufacturers are formally required to substantiate the cost effectiveness of drugs that have therapeutic added value in comparison with existing ones through pharmacoeconomic evaluations. Dutch guidelines for pharmacoeconomic research provide methods guidance, ensuring consistency in both the evidence and the decision-making process about drug reimbursement. AIM: This study reviewed the methodological quality of all 21 formally required pharmacoeconomic evaluations of new pharmaceuticals between 1 January 2005 and 1 October 2008, and verified whether these evaluations complied with pharmacoeconomic guidelines. METHODS: Data on the quality of the pharmacoeconomic evaluations were extracted from the pharmacoeconomic reports published by the Dutch Health Care Insurance Board (CVZ). The Board's newsletters provided information on the advice to, and reimbursement decisions made by, the Dutch Minister of Health. All data extraction was carried out by two independent reviewers, and descriptive analyses were conducted. RESULTS: The methodological quality was sound in only 8 of the 21 pharmacoeconomic evaluations. In most cases, the perspective of analysis, the comparator drugs, and the reporting of both total and incremental costs and effects were correct. However, drug indication, form (i.e. cost utility/cost effectiveness) and time horizon of the evaluations were frequently flawed. Moreover, the costs and effects of the pharmaceuticals were not always analysed correctly, and modelling studies were often non-transparent. Twelve drugs were reimbursed, and nine were not. CONCLUSIONS: The compliance with pharmacoeconomic guidelines in economic evaluations of new pharmaceuticals can be improved. This would improve the methodological quality of the pharmacoeconomic evaluations and ensure consistency in the evidence and the decision-making process for drug reimbursement in the Netherlands.

[Cost-effectiveness of new drugs impacts reimbursement decision making but room for improvement]. / Kosteneffectiviteit van nieuwe geneesmiddelen: van belang bij geneesmiddelenvergoeding, maar voor verbetering vatbaar.

OBJECTIVE: For new drugs to be included in appendix 1B of the drug reimbursement system, they must have proven added therapeutic value, an acceptable budget impact, and be cost-effective. To validate the latter, pharmacoeconomic evaluations have become mandatory. These evaluations should adhere to guidelines for pharmacoeconomic research. Our study evaluates: 1) the extent to which the pharmacoeconomic evaluations adherence pharmacoeconomic guidelines; 2) which guidelines are decisive in evaluating the validation of cost-effectiveness of new drugs; and 3) the impact of pharmacoeconomics in the recommendations and final decision making on drug reimbursement. DESIGN: Retrospective, descriptive study. METHOD: We examined all 1B requests for reimbursement submitted to the Dutch Health Care Insurance Board and the Medicinal Products Reimbursement Committee between 1 January 2005 and 30 September 2008, and on which recommendations on drug reimbursement have been published (n = 21). Data on adherence to guidelines, validation of cost-effectiveness, and recommendations and decision making on drug reimbursement were extracted from publicly available sources by two independent evaluators. Quantitatively and qualitatively descriptive analyses were carried out. RESULTS: Since pharmacoeconomic evaluations have become mandatory, these evaluations increasingly adhere to guidelines for pharmacoeconomic research. This was particularly true of the perspective chosen, the relevant treatment comparator and the incremental and total analyses of costs and effects of the drugs under comparison. However, cost-effectiveness of new drugs was often inadequately validated by incorrect indications for drug use, and incorrect forms of evaluation or periods of analysis. In addition, costs and effects were not always correctly analysed, nor and not enough insight was provided into the analysis model used. Partially on the basis of pharmacoeconomics, 12 new drugs are reimbursed and 9 not. CONCLUSION: Cost-effectiveness of new drugs and more valid pharmacoeconomic evaluations appear to play an ever more important role in reimbursement decision making and the pursuit of better and affordable health care.