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Sean Milmo is a freelance writer based in Essex, UK.
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
The European Union is aiming to play a big role in the creation of a global uniform system for medicines identification by establishing across Europe a project under which pharmaceutical data would be captured once and then used to underpin a product’s whole lifecycle. The pioneering scheme would be based on a five-year-old package of data standards on the Identification of Medicinal Products (IDMP) drawn up by the Geneva-based International Organization for Standardization (ISO). However, a growing proportion of the European pharmaceutical industry have been losing enthusiasm for the project because of its complexity, which has been causing numerous problems with its implementation.
The industry’s perspective
“The leading multinational pharma companies are taking IDMP seriously and are taking steps to be ready when it legally has to be implemented,” said Paul Attridge, senior director R&D Europe of the Veeva Vault data management platform of San Francisco-based Veeva Systems Inc. “But a lot of medium-sized and smaller companies are holding back,” he told Pharmaceutical Technology Europe.
The European Commission, the EU’s Brussels-based executive, and the European Medicines Agency (EMA), the EU’s central medicines authority, which at present is headquartered in London, are having to step up their efforts to persuade doubting pharmaceutical companies of the benefits of the scheme. Medium and smaller pharma companies have become even more sceptical in the wake of postponements of key stages in the introduction of IDMP in the EU. Much of the blame for these disruptions has been put on failures by ISO to meet timelines for the publication of implementation guides for IDMP standards.
Companies are reluctant to spend money now on making their data systems IDMP-compliant when EMA may have to yet again put back the mandatory enforcements of the standards. In 2016, EMA postponed the full implementation of IDMP by two years.
A big worry among companies, however, is the impact of Brexit on the operations of the agency because of the need for it to move its headquarters out of the United Kingdom following the country’s vote in favour of leaving the EU in a referendum held in June 2016. The UK’s departure from the Union is not due to take place until the spring of 2019, while the relocation of EMA to one of the EU’s remaining 27 member-states may be deferred beyond that date. There are still fears that during preparations for its exit, work in the agency on IDMP will be slowed down, particularly if specialist staff start to leave.
“Companies are not investing in IDMP themselves because of the constant delays in its implementation and now concerns about the impact of Brexit,” Christine Hirt, managing consultant at Extedo GmbH, regulatory information management specialists at Ottobrunn, Germany, told Pharmaceutical Technology Europe. Another factor is a distrust of standards, particularly among the smaller companies. Such distrust tends to become stronger the more complex the standards are and the more effort and preparation are required to comply with them.
The scope of IDMP standards
A major reason for IDMP’s complexity is the breadth and depth of the scope of its five standards with an emphasis on a high degree of “granularity” or detailed information on the main stages of a product’s lifecycle. The standard on substances (ISO 11238) covers both active and non-active substances, their general characteristics, and also specific details on manufacturing, purity, and grade (1). The one (ISO 11239) focusing mainly on dose forms includes units of presentation, routes of administration, and packaging (2). It identifies, for example, injection solution, injection suspension, and infusion solution. Another standard (ISO 11240) relates to the usage of units of measurement with requirements for reference code systems and vocabularies for units (3).
IDMP distinguishes between products as medicines and pharmaceuticals by having two separate standards for each. The one (ISO 11616) on pharmaceuticals brings together identifiers such as active substance, strength of units, and administrable dose forms (4). The standard (ISO 11615) on medicinal products focuses mainly on regulation information during the entire lifecycle-such as that on development, authorization, post-marketing, and approval renewal or withdrawal from the market (5).
The first versions of the standards were published by ISO in 2012 to serve the needs of pharmacovigilance schemes, in particular the necessity that authorized drugs found to have previously unknown side effects can be accurately identified with their manufacturing details such as production sites and batch numbers. The primary purpose of IDMP was to create a basis for healthcare providers and professionals to be alerted across Europe immediately after the reporting of an adverse reaction to a drug. Over time, it would also allow data banks on these reactions to be built up for in-depth analysis so that actions can be taken to prevent side effects. However, it soon became clear that IDMP also had the potential to be applied to many more areas of pharmaceuticals and healthcare than pharmacovigilance.
An EMA list of other applications for IDMP include batch recalls, in addition to those triggered by pharmacovigilance, inspections including those related to good manufacturing practice (GMP), drug shortages, regulatory activities such as approval of variations like process changes, e-prescriptions, and initiatives under the EU’s Falsified Medicines Directive (FMD), such as the identification of individual product packs.
A drawback of IDMP’s broad scope is that it makes the necessity for continuous correction of glitches and deficiencies more likely. This problem became clear at an early stage when ISO specialists discovered defects when working on implementation guides for the standards. When EU experts started looking closely at the standards, they found important omissions, such as proper coverage of differences in packaging and pack sizes. All these flaws-some minor and others major-were a primary reason for delays in the implementation stages.
For EMA, the key application of IDMP will be the obligation for pharmaceutical companies under article 57 (6) of its amended 2004 medicines authorization legislation to submit information to the agency on authorized medicines and keep this information up-to-date. Currently, article 57 data are based on an EMA format, Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), that ultimately will be replaced and considerably expanded by IDMP. It is an example of a process under which large amounts of data are captured at one source and then reused for several other applications, such as pharmacovigilance and variations approvals.
For EMA, IDMP is viewed as a master data management system with master data being defined as any information that is considered to play a key role in the core operation of a business. IDMP will be realized through the agency’s SPOR master data programme covering the four domains of substances, products, organizations, and referentials (SPOR). Data on substances will be on the ingredients making up the medicinal product while data on products will cover their marketing and medicinal information.
Organization data will be about organizations that develop, own, and manufacture the products, which, with pharmaceutical manufacturers, will be their company names, their addresses, plants, distribution centres, and their regulatory agencies. Referentials data list terms and controlled vocabularies (CVs) used to describe attributes of products such as dosage forms, country codes, package codes, and weight codes.
Each SPOR domain is being operated through management services projects that will be key enablers in a phased implementation of IDMP, especially in the maintenance of timelines. By mid-2017, the referentials and organizations management services (RMS and OMS) should start the process for testing their data systems with external users who will then have the chance to correct deficiencies. This will provide a basis for the later testing of the products and substances management services (PMS and SMS). The whole of SPOR should go live for testing as an integrated system by mid-2018, leading to IDMP becoming mandatory for pharmaceutical and other companies a year later.
EMA’s IDMP operation should extend beyond just the agency being a repository for vast quantities of data. It also must provide the means for the analysis of data, especially data relating to adverse drug reactions.
“The analytics capability is crucial to the whole realization of the IDMP scheme because without it, EMA will not be able to work out where else adverse reactions may take place and where they may be able to take preventive action,” explained Attridge. “Otherwise pharmaceutical companies will not be very happy about establishing IDMP-compliant systems at quite high costs when the agency is not able to make proper use of it.”
“For companies, IDMP can be a transformational programme, which will provide them with their own master data management system to break down information siloes and ensure that important information is accessible,” he continued. Ultimately, the success of IDMP in Europe and elsewhere will depend not only on its improvement of regulatory efficiencies but also of the IT operations of pharmaceutical companies.
Article DetailsPharmaceutical Technology Europe
Vol. 29, No. 5
Citation: When referring to this article, please cite it as S. Milmo, “The Complexity of IDMP,” Pharmaceutical Technology Europe 29 (5) 2017.