ISO Renews Standards For Safer Medication
EU endorsed a phased implementation commencing July 2016
- Date: 24 Mar 2016
- Topic: Bioethics, legal and economic issues
The International Organisation for Standardisation (ISO) is updating and expanding its key Identification of Medicinal Products (IDMP) standards to help stem the global toll of death and injury caused by medication errors. The European Commission, the European Union Network Data Board, and the EU ISO IDMP Task Force have endorsed a phased implementation commencing July 2016.
With regards to the implementation of the renewed standards, the EU-funded openMedicine project will provide recommendations for cross-border ePrescriptions.
European data and statistics made available by the World Health Organization (WHO), gathered mostly from EU member states, consistently show that medical errors and healthcare-related adverse events occur in 8% to 12% of hospitalisations. The UK Department of Health has estimated that about 850 000 adverse events take place each year, representing roughly 10% of hospital admissions. Health authorities in Denmark, France and Spain have published incidence studies with similar results. Also, some 23% of EU citizens claim to have been directly affected by a medical error, and 11% claim to have been prescribed the wrong medication. The probability of patients being harmed while receiving hospital care is even higher in developing countries.
Some of the problems are caused by medications that have similar names and look much the same, but have completely different pharmaceutical properties. The situation today is exacerbated by the fact that clinicians have access to an armamentarium of over 10 000 prescription drugs, presenting an increasingly complex and risky challenge to those who prescribe and deliver medications.
While many errors do not cause harm, thousands of patients die unnecessarily each year in the EU alone from mistakes in drug selection or dosage. However, figures provided by WHO suggest that 50% to 70% of harm caused by medical errors can be prevented through comprehensive systematic approaches to patient safety. “Statistics show that strategies to reduce the rate of adverse events in the EU alone would lead to the prevention of more than 750 000 harm-inflicting medical errors per year, leading to over 3.2 million fewer days of hospitalization, 260 000 fewer incidents of permanent disability, and 95 000 fewer deaths per year.”
Beyond the tragic human cost of such errors, the economic benefits of improving patient safety are compelling. A 2014 WHO report cites studies showing that additional hospitalisation, litigation costs, infections acquired in hospitals, lost income, disability and medical expenses have set some countries back between USD 6 billion to USD 29 billion per year.
Leading the way
In view of these distressing statistics, it is not surprising that there has been a global demand for internationally harmonised specifications for the identification of medicinal products (IDMP). In response, ISO is leading a major collaborative effort involving medical experts from 32 participating and 27 observing countries, to address this urgent need by developing a set of five international IDMP standards.
First published in 2012 and now being updated and expanded to include helpful implementation guides, they facilitate the exchange of medicinal product information between regulators, worldwide data sources and pharmaceutical companies, aid the development, registration and life-cycle management of medicinal products, and provide the basis for the unambiguous identification of those products across regions. The outcome is to improve the robustness of pharmacovigilance – the process of monitoring the use of drugs after they have entered the market – and regulatory activities globally.
Complementing this effort, and in accordance with ISO 11615, technical specification ISO/TS 16791 has been published in the meantime to address issues such as “the right medication for the right patient”. It provides guidance on how to implement bar codes to secure the medication process.
Adoption of the ISO IDMP standards is gathering pace, with their use being increasingly required by governments around the world. There is general agreement among stakeholders that IDMP will become the required reference information model for all medicinal data submissions worldwide.
The European Medicines Agency (EMA) is in the process of implementing ISO IDMP standards and the European Commission, the European Union (EU) Network Data Board, and the EU ISO IDMP Task Force have endorsed a phased implementation commencing July 2016. Commission Implementing Regulation (EU) No 520/2012 obliges member states, marketing-authorisation holders and the EMA to make use of terminologies defined in ISO IDMP standards from that date. Pharmaceutical companies will be required to submit data on medicines to the EMA in accordance with those formats and terminologies.
“The impending EU imperative has been a major driver for completion of the standards in a timely fashion,” says Michael Glickman, President, Computer Network Architects, Inc., and Chair of ISO technical committee ISO/TC 215, Health informatics. “Also, an initial regional Implementation Guide ʻbundledʼ with the core ISO IDMP standards has allowed us to address the EUʼs specific requirements while remaining consistent with the core needs.”
Although Europe is ahead in regulating and mandating a central product dictionary based on ISO IDMP standards, the US Food and Drug Administration (FDA) is looking at options to update its current standards to be in line with ISO IDMP product definitions. Japanese authorities have also indicated the intention to adopt IDMP standards.
Safety is paramount
“New medicines and therapies bring incredible value to the public, but ensuring patient safety is paramount, particularly for global regulators charged with protecting public health. As the EMA moves to require IDMP for registering medical products, this will improve transparency of medical product information and detection of adverse drug reactions throughout the drug development (and product marketing) life cycle. The aim? To improve patient safety through global data standardization, via ISO IDMP standards,” says Bron Kisler, Co-Founder & Vice-President, CDISC (Clinical Data Interchange Standards Consortium).
In the USA, 80% of active pharmaceutical ingredients and 40% of finished dosage drugs are imported. This illustrates the importance of a harmonised approach to global identification with respect to pharmacovigilance, compliance, and information exchange for assessing the quality, purity, potency, safety and efficacy of medicinal products worldwide, comments Vada Perkins of the US FDA, who is also ISO IDMP Project Leader. “The ISO IDMP standards provide a solid foundation for exchanging pharmaceutical information to support regulatory and clinical activities, and enable a much more efficient and effective regulatory review.”
He points out that IDMP benefits the regulated industry, independent of compliance to any regulatory mandate. “Master data management and data governance is important to the industry for a variety of reasons (R&D, analytics, M&A activity, etc.), and IDMP directly supports this. So there is a solid value proposition to be made to the pharmaceutical industry, independent of a regulatory mandate.”
Globally significant event
Lisa Spellman, Director of Global Standards for the American Health Information Management Association (AHIMA) and Secretary of ISO/TC 215, 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, IDMP will provide a simple structure and methodology to generate global product documentation that can be used worldwide through the entire supply chain.”
“IDMP is already changing the world because, as adoption and use of these standards grow, they will help eliminate death and injury caused by medication interactions or allergies, and greatly improve pharmacovigilance and drug monitoring – the process of tracking the outcomes of medication. Even in todayʼs high-tech world, it is not a simple matter to track and document adverse medication events – now at last we have IDMP, and that will make an increasing difference over time.”
Christian Hay, Senior Consultant Healthcare, GS1 Global Office, and Convenor of ISO/TC 215 working group WG 6, the ISO IDMP working group specialising in the pharmacy and medicines business, sees IDMP as a major step for enhanced patient safety across the world, and the building block for adverse event reporting and clinical documentation about administered medication. “Stakeholders have joined forces to deliver a global approach for the description of product characteristics. It is a fascinating project – and standardization is just the beginning.”
Introduction of the updated “bundle” of ISO IDMP standards will mark a key milestone in progress towards a much safer system of identification of medicinal products. “Completion of the revised ISO IDMP standards and finalization of the corresponding technical specifications and technical report (ISO/TR 14872) are our main priority. We anticipate that this will be completed by the end of 2016/early 2017,” confirms Vada Perkins.
Some interested parties might question why development of the IDMP series of standards was taken through ISO as opposed to regulatory/standardisation channels established by the healthcare, medicinal and pharmaceutical products sectors, particularly since IDMP originally evolved from a forum conducted by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Initially, the ICH formed an Expert Working Group (M5) to develop ICH requirements for the standardisation of medicinal product identifiers and related terminology, Vada Perkins explains. In particular, it identified a need to harmonise product information that would facilitate the electronic exchange of Individual Case Safety Reports (ICSRs) within and across ICH regions using the ICH E2B format in post-marketing pharmacovigilance. This led to a key decision to develop electronic specifications in collaboration with ISO and HL7, a not-for-profit organisation that provides standards for the exchange of electronic health information, to enable wider interoperability across regulatory and healthcare communities.
Lisa Spellman adds that IDMP standardisation became the responsibility of ISO “because the organization is the largest developer of consensus-based International Standards and has the broadest global reach. The list of IDMP stakeholders is long and includes a breadth of pharmaceutical and policy stakeholders who want these standards to reach the largest possible global audience. And also because the stamp of ISO on a standard carries important weight and trust.”
Challenges to IDMP
Nevertheless, the path to developing a robust, practical and effective set of ISO standards has not been without its setbacks. According to Christian Hay, IDMP is an extremely complex domain with a limited number of experts that have the overarching understanding and knowledge required. “However, I see development of the standards as an opportunity to broaden the number of experts,” he asserts. “Another challenge is certainly that there is a political pressure to deliver and implement in a short timeline. Nevertheless, in the midst of all this very intense and technical work, our team of experts never forget there are patients – and concern for their care, their safety, their pain must be front of mind.”
WG 6 also struggled in meeting regional practices. “The IDMP standards are unique as a series of five different standards with four corresponding technical specifications and one technical report. Regions have their own approaches and processes for medicinal product identification in their areas, which may involve different criteria. Coming to common agreement in core principles/defining elements to uniquely identify a medicinal product without compromising current practices in a region can have its challenges,” says Vada Perkins. Fortunately, the standards do provide very concrete requirements for uniquely identifying a medicinal product at a very granular level (through the substances and manufacturing processes) while still allowing the necessary flexibility for medicines regulatory agencies and other stakeholders to operate according to regional requirements.
Dr. Jean-François Forget, Chief Medical Officer for Vidal France, a digital Drug Information System (DIS) provider, says that one of the challenges to IDMP implementation will be to support not only the EMAʼs pharmacovigilance database (Article 57), but also the computer-generated e-prescription interoperability needs in primary or secondary care. “If we are able to address both, it will create a unique reference repository to describe all the drugs that are on the market in Europe, to be used by actors in public health and by healthcare providers. It will have a positive impact on the global health system, on pharmacovigilance, and on the safety and quality of prescription and delivery, which for sure will contribute to a better world.”
Once global implementation of ISO IDMP standards is achieved by all international stakeholders, it will be time to revise them for adverse event reporting. That will also be the right time to work intensively on the use of IDMP in the clinical space, says Christian Hay, looking ahead to an IDMP future.
Currently, the standards are only applicable to human medicinal products, but discussions are taking place among the ISO IDMP community to extend the application of the standards to veterinary medicines and foods. “The applicability of the ISO standards to all regulated products within a given jurisdiction would be the ultimate goal; the identification of medicinal products could accommodate other regulated products as there are common elements throughout each regulated domain. A change from IDMP to IDP (identification of products) could be a possibility in the not-so-distant future,” Vada Perkins concludes.