A series of Identification of Medicinal Products (IDMP) standards are under revision and will bring a host of benefits to patients and the global health care community.
Implementing these standards should simplify the exchange of information between stakeholders and enhance the interoperability of systems in the medical field.
IDMP standards and technical specifications, comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844, support the activities of medicines agencies worldwide. These cover a variety of regulatory activities related to the development, registration and life-cycle management of medicinal products, as well as pharmacovigilance and risk management.
Christian Hay, senior healthcare consultant for the GS1 global office, explains: ‘IDMP standards are essential for the world’s increasingly integrated health care. They provide the precise architecture for the computerisation of information on medicinal products all around the world. When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care. This is, for example, a huge benefit for adverse-event reporting and documenting medication in patient records.’
Beneficial to regulators, industry and patients
To meet the primary objectives of the regulation of medicines and pharmacovigilance, the reliable exchange of medicinal product information in a robust and consistent manner is essential. IDMP standards fully support this, which is why their revision was deemed opportune.
‘The revision has become necessary because of the development of IDMP implementation guides, which take the form of four CEN1 ISO technical specifications. The overall standard has not really changed but rather gained in usability for implementers. By developing implementation guides, it has been possible to shift some detailed information from the standard itself to its corresponding implementation guide,’ Hay comments.
‘By publishing the ISO IDMP standards in 2012, the community has been able to understand a potential fundamental change in each respective data model – which are currently very diverse. Having learned from users’ reactions, the IDMP project leaders have initiated an ambitious standards development programme, which consists of working on implementation guides. Now, one can expect the creation of educational material and a uniform implementation both on the part of the manufacturer and the regulator. In parallel, IDMP provides a basis for existing or new IT solutions, such as prescriptions, medication reports, medicinal product dictionaries for clinical use, and more.’
Using ISO IDMP within regulatory activities brings benefits to regulators, industry and, ultimately, patients. ‘The trend towards global standards continues to increase. I cannot imagine the world without IDMP, whose implementation programme is going to last several years. Without IDMP, the existing information fragmentation by country or region would cause increasing risks to patients globally – not only those who travel, but also those faced with mobile health or because of the globalisation of supply chains,’ Hay concludes.