Problem faced by Europe with Various names of Medicines
Medication errors and adverse drug events can occur in nearly half of all surgical procedures, according to a new study published in the October 2015 issue of Anesthesiology[i]. Although focused on 277 operations involving 3671 medication administrations at the Massachusetts General Hospital, Boston, USA, the disturbing statistic highlights the frequency of drug-related incidents, many caused by mistakes in labelling, incorrect dosage and documentation errors that are occurring on a global scale.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 hospitalizations. The UK Department of Health has estimated that about 850000 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. 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.
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.
In view of these distressing statistics, it is not surprising that there has been a global demand for internationally harmonized 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.
What is IDMP
The Identification of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. The EU is the first to implement these standards. USA, Japan are expected to provide their deadlines in the near future.
The European Medicines Agency (EMA) has set the compliance deadline to 1 July 2016, but final guidance is not yet published. With non-compliance of up to 5% of revenue, not having a good solution for initial and on-going IDMP compliance is a risk no pharmaceutical company can afford to take.
IDMP is defined by five standards created by the International
Organization for Standardization (ISO): ISO 11615, ISO 11616, ISO 11238,
ISO 11239, ISO 11240. ISO 11615 and 11616 define and differentiate
"medicinal products" and "pharmaceutical products" which have "MPID" and
"PhPID" numbers. ISO 11238 defines substances. ISO 11239 and 11240
define controlled vocabularies for pharmaceutical dose forms, units of
presentation, and routes of administration, packaging, and units of
measurement.Solution Approach
For any IDMP solution it consists below two main components:- An application and gateway to exchange information between pharmaceutical sponsor and authorities
- A data hub to integrate, cleanse and IDMP-standardize data from multiple data sources, and verify data according to specified CVs.
Implementing IDMP involves regulatory affairs, safety, clinical development, and others:The product data will usually have to be sourced from many departments, transformed and cleaned, collated in a company product repository, and have any data gaps filled via data entry
The central repository will have to be maintained using change control
The repository data will be sent to regional/worldwide IDMP dictionary maintenance orgs
Safety and clinical applications will consume the regional/worldwide IDMP dictionaries
Implementation
Some companies in the life science industry have not yet adopted master data management (MDM). Many pharmaceutical companies have initiatives to evaluate MDM, and many companies perceive IDMP to be a first step on an MDM journey.
MDM as a technology is specifically designed to automate how master
data is consolidated, resolved and managed in order to create trusted
data. It is a mature and proven technology with advanced features for
complex data models, automation of data record consolidation, attribute
resolution, process flow and complete data lineage tracking.Data Quality technology is an excellent complement to MDM, increasing processing efficiency and data accuracy. Submission can be achieved either through a RIMS system, or data exchange technology such as B2B Exchange, which is specifically designed to manage the interchange of data between two organizations.
The key differentiators for the MDM approach is it enables use of the IDMP data set in other areas of the business to extend the solution’s value beyond the single area of IDMP compliance. MDM supported by data governance process will improve your organizations’ overall product data quality, which is becoming increasingly important for competitive advantage. The phased approach to MDM provides a real opportunity to strengthen data governance processes as part of the IDMP compliance program.
Due to the complexity and very limited timeline for IDMP, organizations may want to focus on implementing IDMP first and then use it as a basis for expanding and adopting MDM. For those organizations that have already implemented and fully adopted MDM, assessments should be made as to the degree to which their MDM solution can support their IDMP business requirements, and at what total cost of ownership.
Advantage
Through IDMP implementation 360° understanding of the investigational and authorized medicinal products delivered to patients in specific markets will allow health authorities, such as the European Medicines Agency (EMA), to take preventive and corrective actions that ensure patient safety.Full disclosure means for Patients that they can get answers to questions such as:
- Where did you manufacture my drug?
- Where did you package my drug?
- Which qualified sources have you used?
- Where was the packaging printed?
- Which controls have you executed?
- Which formulation has been used?
- Did you have the approval to ship this product?
- What is the expiration date?
Full Disclosure means for Life Sciences Companies that they need to find a new way of managing the massive and consistent data set owned by multiple departments within their organization, with hundreds of fields defined in the data model.
Challenges
As the IDMP is for Europe as of now the basic challenge is language diversity. So Built-in UI to enable manual data entry including verification for handling unstructured data is mandatory. Also the source can be Document/PDF from which data needed to be extracted and then structuring them is real challenge because 60% of IDMP-related data is in documents across Europe. Documents are in national languages. So pulling the data from documents and language element is key here---------------
Information gathered from discussions attended and also from Internet
[i] http://anesthesiology.pubs.asahq.org/journal.aspx
