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Standardisation in healthcare for ensuring patient safety

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Patient safety takes a centre stage in healthcare and draws attention of regulators and policy makers worldwide. In a study undertaken by Harvard University, it was found that nearly 50 thousand deaths occurred in India, annually, due to medical errors.

Patient safety relates to five basic rights which include, identifying the right patient, administering the right drug with the right dosage, at the right time and through the right route.

Need for accurate drug identification:

A report published by the Institute of Medicine (IOM), ‘To Err is Human‘, states that around 44,000 to 98,000 deaths occur annually due to medical errors, out of which about 7000 deaths per year can be traced to medication errors. The report recommends bar coding of medications to help in accurate drug identification.

Incidence of fake/spurious drugs:

As study conducted in 2014 by one of India’s trade bodies suggests that around 25 per cent of India’s drugs are fake, counterfeit or substandard. Another report released in April’19 by the office of the United States Trade Representative states that 20 per cent of pharma products in India are counterfeit.

To address the menace of drug counterfeits, a strong track and trace system across supply chain trading partners can help. This requires pharmaceutical companies to incorporate barcodes at different product packaging levels and link them using global identification standards. Implication would ensure that all trading partners would scan and record supplies on receipt and onward despatch in the supply chain, helping maintain full traceability from source to sale / dispensation.

Correct patient identification:

An increase in patient volume, gaps in communication between multiple providers, and interoperability and data sharing capabilities among health IT systems contributes to wrong-patient errors, as per a report published by ECRI Institute’s Patient Safety Organisation.** Around 9 per cent of errors have been attributed to wrong patient identification which lead to harm or even death.

This is where e-health record identification comes in. It is important to note that accurate, timely and accessible healthcare data plays a pivotal role in the planning, development and maintenance of health care services.

Improved access to health data across borders is bound to improve the quality and continuity of care offered to citizens. It will also lead to reduced healthcare costs with eliminating things like duplication of medical tests and procedures. The European Commission has adopted a recommendation on a European Electronic Health Record exchange format. The recommendation supports the digital transformation of health and care in the EU by seeking to unlock the flow of health data across borders.

Role of GS1 standards:

Globally, pharma companies are using open and technology-independent standards on drugs at different packaging levels that permit easy identification and monitoring of supplies during movement in healthcare supply-chains.

Automatic identification system (barcode) has a very wide range of applications, including point-of-care scanning to match product data to patient data, verification of patient identity, identifying implants uniquely, recording implant serial numbers in central registries, tracking and tracing of individual instruments for stock control and supplies management, and tracking assets throughout a network of facilities.

Globally there are stringent regulations covering pharmaceuticals which include, the US Drug Quality and Security Act (DQSA), EU Falsified Medicines Directive, National Health Policy in Argentina, National Health Surveillance Agency (ANVISA) in Brazil, Korea Food and Drug Administration (KFDA) and (Ministry of Health & Welfare Notification, 2011 – 58), The Saudi Arabia Food and Drug Authority.

In India, GS1 standards using barcodes have been mandated by the Directorate General of Foreign Trade (DGFT) for pharmaceuticals for exports since 2011.
In India, there exists a need to adopt global best practices and standards to enhance patient safety, upscale its healthcare systems and deliver affordable healthcare.




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