With hundreds of thousands of prescription drugs on the market, the pharmaceutical sector faces an increasingly complex and risky challenge. Rapid growth in the number of available medications may be contributing to increased uncertainties. That is where the new ISO IDMP (IDentification of Medicinal Products) series comes in.
Up until now, there was no means of identifying medical substances on a global basis. This led to numerous challenges when adverse reactions to medicinal products were reported in one country and had to be interpreted by others. Greater co-ordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions was needed to improve current decision-making processes.
ISO IDMP is a collection of five ISO standards, which together form the basis for a system of unique, global identification of medicinal products. It is designed to enable cross-border healthcare delivery, particularly the exchange of electronic prescriptions and safe dispensation of prescribed medicinal products. IDMP will impact many key areas within a pharmaceutical company, from registration with an authority, research and development, to manufacturing, distribution and product safety.
Lisa Spellman, Director of Global Standards for the American Health Information Management Association (AHIMA) and Secretary of technical committee ISO/TC 215 on health informatics, believes the advent of IDMP is a globally significant event that will change the world. “One might have thought that IDMP already existed, but it did not. Now, thanks to ISO experts, IDMP will provide a structure and methodology to generate global product documentation that can be used by regulators and clinicians worldwide.”
ISO IDMP aims to harmonize the way the pharmaceutical industry and all stakeholders refer to medicinal products – including the substances used in the manufacturing process. It applies throughout the medicine’s life cycle, from clinical trials through marketing and, eventually, discontinuation. It will not only support drug adverse event monitoring but clinical processes such as electronic prescriptions.
Dr Herman Diederik, one of the foremost experts on the subject, explains: “Implementation of the ISO IDMP standards will enable scientists around the world to collaborate by delivering high-value substance descriptions. It will become a reference document for scientists and IT experts alike, a kind of unique sum of intelligence and IT architecture.”
According to ISO, the standards will “specify definitions in terms for all data elements required to uniquely, and with certainty, identify medical products for human use”.
The five standards in the IDMP series include:
- Substances – ISO 11238
- Pharmaceutical dose forms, units of presentation, routes of administration, and packaging – ISO 11239
- Units of measurement – ISO 11240
- Regulated medicinal product information – ISO 11615
- Regulated pharmaceutical product information – ISO 11616
The ISO IDMP standards are being adopted globally by health authority agencies and organizations such as the World Health Organization. The initiative has enjoyed cross-border support, with the regulatory authorities of US, Canada and Switzerland all publically committing to adoption at some point in the future and Japan, Australia, Russia and Iran all expressing at least some level of interest. The European Medicines Agency (EMA) has already mandated compliance by 1 July 2016.