Confidence turns into pride only when you are in denial of your mistakes. Criss Jami

Modern medicines can have adverse effects, and these need to be tracked and monitored, so that we do not see a repeat of the dreaded thalidomide tragedy, which caused thousands of children to be born with birth defects. A study published in 2012 found that out of every 1000 prescriptions, approximately 80 are likely to result in adverse drug events (ADEs) in the general hospitals and clinics in New Delhi.

About Pharmacovigilance

Pharmacovigilance is the pharmacological practice used to detect, assess, understand and prevent adverse effects of medicines. The National Pharmacovigilance Program established in January 2005 is based in the Central Drugs Standard Control Organization, New Delhi. At present, there are 19 monitoring centers across the country, with AIIMS as the nodal centre for monitoring adverse drug reactions in the country.

Recently, the Indian Pharmacopoeia Commission (IPC) in association with the Indian Medical Association (IMA) launched Continuing Medical Education (CME) programs on pharmacovigilance for doctors. The CMEs underline the need for doctors to take responsibility for monitoring and reporting drug side effects.

Learning from the US FDA

The US FDA (Food and Drug Administration) is a world leader in taking action to improve drug safety. Since 80 percent of active ingredients in US medicines come from overseas sources, the Food and Drug Administration Safety and Innovation Act, or FDASIA empowers the FDA to inspect pharmaceutical factories all over the world.

They now even have the clout to shut down factories in India which don’t meet their safety standards! This is the extent to which the FDA goes to in order to protect the global drug supply chain , and making sure that US patients have access to safe drugs . Some countries in the EU have made it compulsory that all AEs (Adverse Events) in the initial post-marketing period are reported.

The FDA MedWatch program at https://www.fda.gov/Safety/MedWatch/ also provides a gateway for clinically important safety information. It sends regular safety alerts and encourages patients and doctors to report problems with drugs. Medication safety studies can be expanded beyond reporting only adverse drug reactions to encompass a broader range of patient injuries , so that the surveillance system becomes more robust in reducing errors. US-headquartered, ISMP (https:/www.ismp.org/) is known and respected worldwide as the premier resource for disseminating accurate medication safety information. It has compiled a huge database of system-based causes of medication errors, based largely on review of thousands of reports in its national Medication Error Reporting Program (MERP). ISMP uses this knowledge base to spread global awareness about practical, proven, error- free strategies of patient care.

For example, the ISMP Medication Safety Self-Assessment® for Community/Ambulatory Pharmacy is one of the online tools designed to heighten awareness about safe pharmacy systems. We need to make a concerted effort to get the key stakeholders to work together to reduce errors related to drug names, packages, and labeling.

Clinical trials– keeping subjects safe by protecting the poor and illiterate

Clinical trials are scientific research experiments conducted on human volunteers in order to find new ways to treat diseases. Medical science has grown by leaps and bounds on the back of such biomedical research. When done properly, such studies are very useful in improving our medical knowledge base. Pharmaceutical companies carry these out routinely, to establish the safety and superiority of the new molecules their R&D department discovers.

However, clinical trials can be risky business. The fact that it is a trial means that we do not know if the intervention will help the patient. The truth is that it may also harm them, and the only way of finding out is by doing the trial. However, this exposes the trial participants to increased risk. Now, if the subjects provide informed consent to participate as human guinea pigs in the trial, that’s fine.

However, the problem is that not all clinical trials are conducted ethically. This is especially true in India, which is fast becoming an attractive destination for carrying out clinical trials, primarily because we have a huge and diverse pool of poor patients on whom these trials can be conducted fairly inexpensively.

To a certain degree, the threat that the clinical trials’ industry poses to patient safety stems from the fact that these are largely conducted by contract research organizations (CROs) which are hired by the pharmaceutical companies. These CROs are commercial enterprises that may cloak their financial motivations under the garb of doing benevolent medical research to advance science.

The bad ones indulge in unethical practices, such as providing lucrative financial incentives to healthcare workers, for the recruitment of poor illiterate “volunteers” , who are then arm-twisted into signing “informed-but-not-understood-consent” forms. The Supreme Court expressed reservations about the unethical way in which most clinical trials are being conducted in the country, and has directed the Ministry of Health to formulate proper guidelines on this, to protect patients’ interests.

While it is important that clinical trials need to be allowed in India, these have to be fair and transparent. Although every hospital is supposed to have its own ethical committee to oversee research carried out in that hospital, in our country most are defunct bodies. The National Human Rights Commission (NHRC) guidelines propose that a research group must provide participants with printed literature, explaining in simple, non-technical language:

* The purpose of the study

* Details of the procedure

* Risks involved

* Financial or other interests of the researcher

* Commitment to treat (completely and free-of-cost), any complication that may arise during the course of the trial

The research subject too has to certify in writing that she has understood the document and is volunteering to participate in the research, without the promise of any monetary inducement that is not permitted under the Indian law.

The desired outcome of clinical research is clear- to facilitate the conduct of responsible research in such a way that no one is harmed. Prevention of harm - the protection of human subjects, is a critical element of an effective and trustworthy research system. Without trust, the supply of volunteers for clinical trials will dry up, and progress in biomedical research will grind to a halt.