Logistics and (cost-)effectiveness of pharmacogenetic (PGx)-testing may be optimized when delivered through a pre-emptive panel-based approach, within a clinical decision support system (CDSS). Here, clinical recommendations are automatically deployed by the CDSS when a drug-gene interaction (DGI) is encountered. However, this requires record of PGx-panel results in the electronic medical record (EMR). Several studies indicate promising clinical utility of panel-based PGx-testing in polypharmacy and psychiatry, but is undetermined in primary care. Therefore, we aim to quantify both the feasibility and the real-world impact of this approach in primary care. Within a prospective pilot study, community pharmacists were provided the opportunity to request a panel of eight pharmacogenes to guide drug dispensing within a CDSS for 200 primary care patients. In this side-study, this cohort was cross-sectionally followed-up after a mean of 2.5-years. PGx-panel results were successfully recorded in 96% and 68% of pharmacist and general practitioner (GP) EMRs, respectively. This enabled 97% of patients to (re)use PGx-panel results for at least one, and 33% for up to four newly initiated prescriptions with possible DGIs. A total of 24.2% of these prescriptions had actionable DGIs, requiring pharmacotherapy adjustment. Healthcare utilization seemed not to vary among those who did and did not encounter a DGI. Pre-emptive panel-based PGx-testing is feasible and real-world impact is substantial in primary care.
Despite the nationwide availability of pharmacogenomic (PGx) guidelines in electronic medication surveillance systems in The Netherlands, PGx guided prescribing is still uncommon in primary care. We set out to investigate the adoption of pharmacist initiated PGx testing in primary care. Community pharmacists were offered a free PGx test covering 40 variants in 8 genes to test patients receiving an incident prescription (IRx) of a selection of 10 drugs. Results of the PGx test along with predicted phenotypes and a therapeutic recommendation based on the Dutch Pharmacogenetics Working Group (DPWG) guidelines were transferred to the pharmacist and physician. Adoption was defined as the percentage of eligible patients that received genotyping. From November 2014-July 2016, 200 patients were included with an adoption of 18.0%. Of the included patients 57.5% received an IRx for atorvastatin, 14.5% started with simvastatin and 28.0% received an IRx for amitriptyline, (es)citalopram, nortriptyline, or venlafaxine. 90% of the patients carried at least one actionable PGx test result in the selected PGx-panel. In 31.0% of the incident prescriptions a combination between a drug with a known genedrug interaction and an actionable genotype was present and a therapeutic recommendation was provided. The provided recommendations were accepted by the clinicians in 88.7% of the patients. Pharmacist initiated implementation of PGx in primary care is feasible, and the frequency of actionable gene-drug interactions for the selected drugs is high.
The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.
Drug response shows significant interpatient variability and evidence that genetics influences outcome of drug therapy has been known for more than five decades. However, the translation of this knowledge to clinical practice remains slow. Using examples from clinical practice six considerations about the implementation of pharmacogenetics (PGx) into routine care are discussed: the need for PGx biomarkers; the sources of genetic variability in drug response; the amount of variability explained by PGx; whether PGx test results are actionable; the level of evidence needed for implementation of PGx and the sources of information regarding interpretation of PGx data.
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