Medicines are essential for the prevention and treatment of diseases and the most widely used medical therapy. Medication-related processes are a crucial part of healthcare delivery. Safer and more effective use of medicines is only possible with high professional standards and multidisciplinary, guideline-based collaboration between doctors, pharmacists, and nurses, as well as the active involvement of patients and their families. This policy brief focuses on the digital enablers of this collaboration. It highlights the tools for consistent and comprehensive digital management of all medication-related information, such as prescriptions, dispensations, dosage instructions, drug-drug interactions, as well as documented patient’s side effects, intolerances, and allergies. Digitally supported medication processes can be a powerful tool to prevent medication errors. In addition, improved access to medication information helps patients adhere to their prescribed treatments, which improves overall health outcomes.
The challenge of collecting and consolidating information on medication use
Medications carry risks. Evidence suggests that one in 30 patients in healthcare settings experiences medication-related harm. More than a quarter of these harms are serious or life-threatening. It is therefore essential that all stakeholders in the delivery of healthcare have access to accurate information about a patient’s medication. Digital Medication Management addresses this issue by making medication-related information easily accessible to patients and their trusted healthcare professionals at any time. This makes a significant contribution to patients’ health, well-being and safety.
For a proper overview of the medicines a patient is taking, it is necessary to have information on both prescribed and dispensed medicines. Dispensed medicines should be further complemented by information on over-the-counter (OTC) medicines, i.e. medicines purchased without a prescription in pharmacies (or supermarkets and drugstores, as is possible in countries such as the UK and the US).
In addition, a lack of standardisation in the documentation of medicines prescribed by doctors makes it even more difficult to obtain a standardised overview of a patient’s medicines.
Consolidating disparate information systems (e.g. from GPs, specialists or hospitals) and creating a single view of each patient’s medicines remains a major challenge in most countries around the world. This increases the risk of doctors overlooking side effects and intolerances in the interaction of multiple medications.
ePrescription represents the first step in transitioning to digitally enabled medication treatment. However, as a single, isolated service, it only addresses the long-standing problems associated with illegible medication orders and system-wide inefficient transactions. To move patient safety to a next level, nationwide services that provide medication tracking information to all stakeholders in the ePrescribing/eDispensing process are necessary. Such ePrescribing services can be described as the ‘hidden champions of digital health’ given their potential for improving patient health and safety.
An essential element in the medication information chain are the dispensing reports. These reports provide an insight into the medicines that have been picked up by the patient and allow for estimations of actual medication use to be observed in conjunction with the prescribing information. The so called Medication List, also known as the Medication History or Medication Record, collates data from electronic prescription orders and dispensing messages and makes it available in regional or national databases, accessible to all stakeholders in the medication treatment process. The medication records can be automatically generated and updated in near real time from the relevant data sources for each part of the medication process.
The information in the respective databases can be enhanced by recording additional information on acute drug reactions and other individual side effects, drug dosage and other parameters related to drug decision support,
such as glomerular clearance (renal function).
Patients, their families, nurses, doctors and pharmacists can view the current medication regimen at any time. In addition, personal medication records, i.e., current and relevant past medications, are part of the European Patient Summary, which is aligned with the International Patient Summary (IPS) standard.
Medication reconciliation and curated medication plans
It is imperative that physicians, pharmacists and nurses have full access to comprehensive medication-related information. This enables them to make informed therapeutic decisions and to optimise drug dispensation and application. The key procedure for optimising medication plans is a medication reconciliation. This defines the professional process of ensuring that a patient’s medication plan (schedule) is accurate and up-to-date across all care settings, reducing the risk of medication errors.
The medication reconciliation process is based on the comprehensive (and sometimes annotated) medication history information. This information is then used to create a curated digital medication plan (schedule). It is recommended that this curated digital medication plan is integrated into the electronic health record. Physicians and pharmacists, as well as fully interprofessional teams, should routinely perform medication reconciliation exercises. Preferably, this would be mandated by all national or regional health systems.
In Germany, a formalised medication plan is a legally defined document that primarily lists all medications and related dosage instructions. It contains also other important medication-related information such as known allergies/intolerances and e.g. signs of impaired renal function. The German medication plan currently exists as a standardised printout. An extended, digital version called “Elektronischer Medikationsplan” (eMP) is saved on the patient’s electronic health card. It will be integrated in the near future into the next generation of Germany’s national EHR application, Elektronische Patientenakte (ePA). This new medication plan service will be widely available from mid-2025.
A best practice example for a digital medication plan is the Belgian App called Mes medicaments (in French language) or Mijn Geneesmiddelen (in Dutch). Patients using this sophisticated App on their smart phones benefit from all of the above described functionalities as illustrated in the figure below (for more information see INAMI).
Digitally-enabled medication treatment as inter-disciplinary process
Digital medication management services represent a valuable tool for optimising medication treatment. This is a multidisciplinary task that primarily involves physicians and pharmacists. While both professions are authorised to update patients’ medication regimens as a result of medication reconciliation processes, the extent to which pharmacists can make necessary medication changes varies according to national legislation. In the Netherlands and the United Kingdom, for example, there appear to be few or no restrictions on pharmacists. In Germany, pharmacists are allowed to make adjustments that do not change the active ingredients of prescribed medicines. However, if such a change is necessary, they must contact the prescribing doctor.
The development of digital medication services requires close cooperation between national medicines agencies and national digital health agencies. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM), fulfils the role of the national drug authority and is responsible for maintaining the AMIce drug information system. Therefore, BfArM will play a key role in the development of the emerging framework for safe and patient-focused electronic prescribing and dispensing.
In Denmark, for example, the Danish Medicines Agency provides the drug reference database whereas the Digital Health Agency is responsible for the technical implementation and maintenance of the IT infrastructure and services, the eHealth portal Sundhed.dk It provides e.g. the patient “health journal” with latest information recorded regarding treatments, prescribed and dispensed medicines, allergies, laboratory results, referrals, hospital visits and more.
Integration of digital medication services into national electronic health record (EHR) infrastructures
The Danish example shows the benefits from integrating digital medication services into the national electronic health record (EHR) systems. This way, the necessary information can be easily shared by patients, doctors, pharmacists and all other stakeholders and made available for all ePrescribing processes. This provides a significant and immediate benefit to users and encourages also wider adoption of digital solutions in healthcare.
The need for National, European and Global Drug Reference Databases
While drug authorisation and pharmacovigilance are managed jointly by Member States and European institutions, national and European drug dictionaries and databases evolve together, in collaboration, towards pan-European ePrescribing and digital medication services.
Both national and European drug dictionaries and databases should be used in the further development of digital medicines services. Current efforts in European standardisation play a central role, such as the development of the SPOR database, the master data management for substances, products, organisations and referential). This cornerstone in European harmonisation for an international register of medicines is being established at the European Medicines Agency (EMA) with the involvement of national authorities for medicines and medical devices.
The importance of drug information systems and standardised identification of medicines is further and particularly evident in the context of the European electronic cross-border ePrescription and eDispensation services in MyHealth@EU. A valid prescription in one of the participating European Member States does not guarantee that the intended medicine will be dispensed in a pharmacy in another country, as not all medicines are available in all countries. In addition, the names of active ingredients and medicines, as well as pack sizes, may differ. For example, in the initial period of cross-border operation between Finland and Estonia, only about one-third of all ePrescriptions submitted were actually dispensed. This suggests that pharmacies encountered difficulties in clearly identifying medicines, including substances, composition, dosage forms, manufacturing processes, and packaging. A key contribution to enhancing the MyHealth@EU services was made by the EU funded project UNICOM. It aimed to support the univocal identification of medicinal products anywhere in Europe and globall, through accelerating and scaling up the implementation of the suite of standards of the International Organization for Standardization for the Identification of Medicinal Products (ISO IDMP). The project promoted improvements in describing medicines, encompassing aspects such as complex packaging, diverse representations of dose forms and strengths, and the identification of prescribed and dispensed medicinal products through distinct identifiers. The final white paper called for creating an interoperable and increasingly integrated medicinal product data ecosystem in the EU.
Outlook
- ePrescribing/eDispensing is only a first step in the transition to digitally supported medication management and needs to be complemented by full medication lists/records based on dispensing records.
- To enable effective decision support and improve patient safety, prescription and dispensing information should be enhanced with additional information on patient’s intolerances, adverse drug reactions and other relevant parameters such as renal function measures.
- Patients, their families, nurses, doctors and pharmacists should be able to view the current medication schedule of the patient at any time.
- Both national and European drug dictionaries and databases should be used in the further development of advanced digital medication management services and should be integrated with national, regional, European EHR infrastructures / systems.
DISCLAIMER
Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of DG CONNECT, European Commission. Neither the European Union nor the granting authority can be held responsible for them.