Patient Safety – a fundamental tenet of healthcare delivery

Patient Safety is the cornerstone of the global healthcare industry.? The focus of special attention by WHO, Patient Safety is defined as ‘a framework of organized activities that creates cultures, processes, procedures, behaviours, technologies and environments in health care, that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make error less likely and reduce its impact when it does occur’.

For India, the world's largest provider of generic medicines by volume, having a 20% share of total global pharmaceutical exports, it is a top priority.

As the third-largest pharmaceutical producer globally, Indian companies supply a substantial portion of the world's affordable medicines. Our contributions are particularly significant, accounting for approximately 40% of the U.S. prescription, 25% of the EU and around 20% of contribution to the world. The world looks to India for quality drugs that will ensure the safety of patients.

This being so, ensuring that millions of patients around the globe receive safe and high-quality products is a complex issue that requires collaboration between a wide cross-section of people, starting with the patients themselves and their caregivers, and moving on to physicians, nurses, pharmacists and diagnostic service providers; pharmaceutical companies; researchers; medical device manufacturers; vendors of ingredients and services and several others. All the links in this chain must believe in patient safety above everything else!

Bottlenecks on the path to quality

Within India’s boundaries, patient safety is challenged by issues such as poor access to quality care. The disparities in healthcare infrastructure between rural and urban areas is a major factor that compounds the issue, because inadequate medical supplies, poorly stocked pharmacies and shortage of qualified physicians are a grim reality. Another serious problem is the prevalence of substandard and spurious drugs, or drugs being sold after their expiry date, and their impact on patient safety. Although the government has a zero-tolerance policy towards such drugs, these products find their way into the market endangering the lives of millions. When it is accompanied by low patient awareness, it poses a huge challenge.

Enforcing global standards and excelling at it

To counter the bottlenecks, companies have enforced global standards of drug manufacturing, including conducting rigorous clinical trials to evaluate the efficacy and safety of new drugs before they are approved for market. Risk assessment and risk management plans are implemented to identify and mitigate potential risks associated with any particular drug. Pharmacovigilance systems are established by leading drug manufacturers, to monitor drugs that are in the market. Pharma companies collaborate with the Central Drugs Standard Control Organization (CDSCO) and other regulatory authorities to improve drug safety regulations and practices and support stronger enforcement of safety standards at the national level.

Following global best practices to ensure patient safety

It has been mandated that patients and their caregivers must be provided with clearly articulated instructions about the medication – the chemicals and other ingredients used. Directions for consumption and side effects, if any, must also be communicated. The medicines themselves must have their date of manufacture and expiry printed clearly. Patients must be made aware of the dangers of not checking all these details before purchasing a drug from a chemist.

In addition, quality assurance must play a crucial role in ensuring the safety of medications. Adherence to Good Manufacturing Practices (GMP) guarantees consistent quality in drug production and helps prevent counterfeit or substandard products from entering the market. To maintain quality standards India’s principles of GMP have been recently updated to include a world-class pharmaceutical quality system (PQS), quality risk management (QRM), and other modern practices. Manufacturers must ensure their products meet quality standards, comply with regulations, and are safe for patients.

The Central Drugs Standard Control Organization (CDSCO) ensures that Indian-made drugs meet international benchmarks, bolstering the country's reputation as a reliable source of high-quality medications.

Transformative technologies that strengthen our focus on quality

The world over, digital technologies, big data, and AI are revolutionizing the pharmaceutical industry by enhancing drug manufacturing and delivery. A global player, India is no exception. Big data analytics enable real-time monitoring of manufacturing processes, identifying potential quality issues early on. AI-powered algorithms optimize supply chains, ensuring timely and efficient delivery of drugs to patients. Additionally, these technologies facilitate the development of personalized medicine, tailoring treatments to individual patients based on their genetic makeup and other factors. This not only improves treatment outcomes but also reduces the risk of adverse reactions.

Cultivating a culture of safety

Encouraging healthcare professionals and organizations to report adverse events is vital for identifying areas of improvement in patient safety protocols. A culture of reporting and learning from mistakes promotes transparency, accountability, and continuous improvement.

Known as The Pharmacy of the World, the Indian pharma industry has many patient safety success stories to tell. Pulse Polio and COVID-19 are just two of these. There is still much for the industry to achieve. As one of the world's fastest-growing economies, the time has come for India to embrace a comprehensive and sustainable approach by focusing on improving investment, infrastructure, access, affordability, and R&D to ensure even better standards of patient safety.

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