Accuracy in patient identification, timely reporting of critical test results and display caution during high-alert medications are thrust areas for drug regulatory authorities to consider in a bid to improve drug safety parameters, said Dr BR Jagashetty, drugs controller, government of Karnataka.

India which has enforced the required regulations for the pharma industry now needs to ensure that its healthcare providers adhere to protocols to improve medication safety, said Dr Jagashetty while addressing the Regulatory Perspective On Patient Safety at an international seminar recently.

There is need to reduce the risk of patient harm by adopting the universal protocol for preventing wrong site, wrong procedure and wrong person surgery, he added.

Medical errors continue to be at the forefront of any treatment and surgery. We should take the required care to provide the best in patient care and safety. There is need to look for best practices, expert advice and strategies to build and sustain a culture of safety in healthcare space, he said.

Diseases such as dengue, hepatitis, tuberculosis, malaria and pneumonia continue to plague India due to increased resistance to drugs. In 2011, India developed a totally drug-resistant form of tuberculosis. Diarrhoeal diseases attributed to inadequate sanitation and safe drinking water lead to early childhood mortality.  Yet the brighter side is that India reported to be polio free for the first time which was achieved with its government initiated Pulse Polio Programme in 1995-96.

“Patient safety onus is also on the drug manufacturer. Penalty to the manufacturer for non disclosure of information on patients safety have been observed during clinical trials carried out here in India, said Dr Jagashetty adding that where the safety of the drugs is well established, provision for limited or controlled usage as Fixed Dosage Combinations (FDCs) may be considered. This gives the opportunity to innovate therapeutic FDCs.

As the current R&D is unable to come up with new chemical entities (NCEs) to fulfill all the regulator’s safety and efficacy requirements, review of the prevalent regulations during 1940 – 1970s which encouraged drug discovery compared to the decline in during 1990 – 2010. New application of existing drugs or those drugs which are no more in current use helps revisit and review abandoned molecules.

The reality is that there will be strategic solutions like sufficient manpower, well-equipped infrastructure, adequate budget allocation, inter & intra departmental interactions for file tracking, effective monitoring of district level officers’ performance with regards to collection and compilation of reports. All these could help to enhance the drug regulators efforts to increase thrust on inspections of medication safety parameters. Efficient training, strict monitoring of clinical studies with legislation for indiscriminate prescriptions and irrational use of anti-biotic could also address the regulatory perspective on  patient safety, concluded Dr Jagashetty.