On the lines of the Vigiflow software technology introduced by the Indian Pharmacopoeia Commission for reporting adverse drug reactions (ADR), the Pharm D interns and faculties at the Al Shifa College of Pharmacy in Malappuram district in Kerala, with the help of software engineers, have designed and developed a new software for monitoring and reporting adverse events from patients.
The software, which is already in application at the hospital attached to the college, is known as Futura AERS. AERS stands for Adverse Event Reporting System.
The product has been created with a view to support and to ease the efforts of the Pharmacovigilance Programme of India (PvPI), according to the team behind the development of the technology, comprising the aspiring and perspiring pharmacists at the college and the hospital.
The team claims that this software will find a concrete solution to the present challenges and difficulties in detecting and reporting adverse reactions of drugs in humans. The cost-effective and minimal infrastructure requiring product can be made useful by all healthcare professionals even in resource-limited settings like those in rural villages.
“This software can be installed in clinics and pharmacies with very minimal infrastructure. It doesn’t need any technical expertise for its operation. Its user friendly design with dashboard and shortcuts makes it easy to use. This simplicity in function and the economic feasibility makes this software apt for pharmacovigilance activities,” said Dr C Dileep, head of the department of pharmacy practice at the College.
He said this innovative concept was accepted for presentation at the international conference held in Bengaluru in October last, on the theme, ‘Transforming Healthcare with Information Technology 2015'.
Mammen Paul, a Pharm D intern and member of the team, said Futura AERS can be used by healthcare professionals for reporting and retrieving an adverse drug reaction using their unique username and password. The difficulties of paper based systems and manual documentations in hospitals are avoided through this software. The software helps for storing proper database of all adverse events and they can be maintained, retrieved and communicated among healthcare professionals as and when needed.
According to Paul, once this technology is introduced, it can be used by the healthcare professionals in the hospitals to communicate the information on adverse reactions in patients with physicians in other hospitals. Better coordination among healthcare professionals in ADR reporting and its management is another benefit of this product. Once an ADR is reported on a drug in a particular patient, it remains in the database and can be reviewed upon the next admission of the patient.
Dr Linu Mohan, assistant professor at Al Shifa College of Pharmacy said, India can become a role model to other developing countries with the introduction of this innovative software for inclusion into the pharmacovigilance programme of the country. This can help advance pharmacovigilance practices and thereby to promote patient safety and better therapeutic outcome. He said, every country should have its own database to contribute to the global surveillance programme.
While elaborating the facilities provided by the software, Mammen Paul pointed out that all the details that are available in the CDSCO’s sheet for ADR reporting have been included in this software also. Patient initials, age, gender, weight, date of reaction started, date of recovery, reaction description, concomitant medications, relevant laboratory tests, relevant history, seriousness of reaction, suspected medication which includes brand name, generic name, manufacturer of the medicine, batch number, expiry date of the drug, dose used, route used, frequency, therapy starting date, therapy ending date, indication of drug, de-challenge and re-challenge data (stopping and re-starting of drugs) and finally the reporter details are included in Futura AERS.