PATIENT COMPLIANCE - PharmXpert Academy

Regulatory & Market PlaceInjections and Infusions on Own ResponsibilityInjections and Infusions by Physician’s DelegationGraphs: overview on which HCP is allowed to administer injections onown responsibility and by delegation 8However, if we look at injections by “delegation” ofa physician, nurses in all countries are able to do this – inDenmark even pharmacists. Nevertheless, what has to beconsidered is the fact that the “delegation” in the differentcountries is differently defined. In Germany, for example, thephysician has to be within earshot, but this is not applicableto a patient at home.For infusions, the same applies as for injections. Onlyphysicians can administer them on their own responsibilitywhile infusions by delegation can be carried out by nurses(taking into account the “within earshot” rule in Germanyand regulations in the other countries).The situation is different for information provided topatients about indication and therapy. This is possible inall four countries by not only physicians, but also nursesand pharmacists at the patient’s home and via the medicaldialogue centre, and forms one of the core foundations ofhealth management services. In Germany, the regulationdefines that it is possible if it is supportive of the physician’stherapy or to fulfill the manufacturer’s safety duties.Informing Patients about Indication and TherapyAnother core factor is the support of patients in the safeapplication of the drug, which is possible to do on ownresponsibility by physicians and nurses and with pharmacists(except Belgium).Support of Patients in the Safe Application of the Drug 9Set-up of Pan-European Health Management ServicesHaving analysed the four countries in terms of four differentlegal challenges to overcome when setting up a patientcentricprogramme, it can be concluded that it is basicallypossible for pharmaceutical companies and third partyproviders to carry out the health management servicesdescribed in the European countries discussed.In general, it seems to be advisable to go with a third-partyprovider, since resources, structures and processes might bemissing and also time-consuming to set up within the strictpatient data protection laws in the European countries. It willmake it easier for the pharmaceutical industry to pass thischallenge to a third-party provider. Moreover, there may bescepticism towards a pharmaceutical company interactingdirectly with a patient, even if for supporting reasons.In Spain, pharmaceutical companies can’t access any patientinformation regarding the diagnosis and/or treatmentdefined by the physician. So, a third-party model is not anoption, it’s a must to implement such patient programmes.The legal differences are not so severe that it is impossibleto carry out one or other of the services discussed. It is justintricacies that have to be taken care of, and other factorsthat might play a role in the set-up of a patient-centricprogramme need to be carefully managed.Pharmaceutical headquarters could, after having taken onboard the legal analysis, issue minimum requests with regardto the patient-centric programme. This might concern thecontent of the programme, the process of the programmeand possible cooperation partners, the recruitment ofadequate HCPs, IT systems, and the KPIs that are importantfor the set up and smooth running of the project.It is recommended that then the countries evaluatethe minimum requirements with the legal and healthcaremarket situation in the country as regards their feasibility,www.JforPC.comJournal For Patient Compliance Strategies to enhance Adherence and Health Outcomes 17