CORNERING THE TECHNOLOGY

FUTURA ADVERSE EVENT REPORTING SYSTEM - A NOVEL CONCEPT FOR PHARMACOVIGILANCE PROGRAM

Mammen Paul, Pharm.D Intern, Alshifa College of Pharmacy

Genesis of Pharmacovigilance:

Pharmacovigilance is defined by the WHO as ‘the science and activities related to the detection, assessment, understanding and prevention of ADRs or any other drug-related problems’. During the 1940’s and 1950’s there was flooding of new medicines with cures claimed for many diseases.But during these times there were no proper evaluation techniques for ensuring the drug safety on a long term base or after post marketing.The thalidomide tragedy that occurred during the early 1960’s was a wakeup call for the authorities for initiating a surveillance on drug related adverse effects of marketed products.  Thalidomide when given to the pregnant mothers lead to the birth of congenitally deformed infants. This urgent need for action was recognized and guidelines for post marketing surveillance on drug safety and efficacy was initiated.In this epoch of globalization, a global need for surveillance was imperative and henceforth the Uppsala Monitoring Centre was built. The ADR obtained from various countries are updated to UMC database and signals are generated based on the data obtained. This method of global surveillance is very effective, but in the long term, every country should develop its own national Pharmacovigilance system, which contributes to a global database such as that held by the Uppsala Monitoring Centre.

In clinical settings a major problem encountered by the healthcare professionals is the ADRs associated with medications. Adverse drug reactions are a response to a drug, which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modifications of physiological function. No healthcare professionals can be held responsible for these reactions. ADRs may or may not occur in individuals, which is imputable to the genetic diversity of the patients.But these responses can be anticipated and managed properly from the past experiences and literatures available.For the proper prevention and management of these ADRs there should be a proper arrangement for reporting ADRs and also their retrieval. A major problem with ADR Reporting is the communication gap between healthcare professionals of different strata.Time consumption for documentation, reporting and monitoring is rather a difficult task for healthcare professional in the midstof their busy schedule. These problems associated with ADR Reporting and Management can easily be managed by the computer technology available now.

Advent of computer technology:

In hospitals, the information regarding the patients are stored manually on physical media such as paper based files, films, etc.There are many disadvantages associated with this manual system. One such disadvantage isa large storage space required for storing these physical media. Another is the cost involved in these physical media.  These troubles are resolved with the advent of computer engineering, where large data could be salted away in small places with better management in a cost effective nature.Computer databases like oracle, SQL server, MySQL, etc., are preferred over manual management of documents for effective data management in a timely fashion.Other problems like misplacing, time taken for transferring of documents is also reduced.Databases are convenient storage systems which, along with an application programusing graphic user interfaces can aid in faster retrieval of data both economically and efficiently.There are many programming languages, like Java, C#, C++, .net and so on, which are used in the coding of these applications. 

Software for ADR Reporting and Monitoring:

In developing countries changes in policy are being devisedfor increasing the accessibility to medicines. This has led to the flow of innumerable number of medicines into the market, which is in favor of the general population. But this stream also has its defects, i.e., there is likewise an increase in adverse drug reactions that are connected with these drugs. There is a strict lack of Pharmacovigilance programs that look into the matter of medication safety and efficacy in developing countries. Even though Pharmacovigilance is implemented in some developing countries, there are many lacunas which have led to ineffective ADR Reporting and Management. ADRs are reported through paper based forms in most of the developing countries. This paper based reports are difficult to document and maintain and most often not communicated either with the national pharmacovigilance center or other healthcare professionals. Patients areuneducated and negligentof the Adverse Drug Reactions associated with drugs, hence their participation is very minimal when compared to the developed countries.

This software developed can be used by healthcare professionals for reporting and retrieving an Adverse Drug Reaction using their unique username and password. The disadvantages that are faced with the paper based system in hospitals are evaded with this software. This software on ADR Reporting and Monitoring is developed so that proper database of these reactions can be maintained, retrieved and communicated between healthcare professionals when required. The software is embedded with a multitude of features and currently in use at Department of Pharmacy Practice at KIMS AL SHIFA HOSPITAL, Perinthalmanna. Once implemented, this can be used by the health care professionals in the hospital to communicate the ADRs seen in patients effectively. Another major benefit of this software is that reports can be generated so that proper management of the ADR and action plans on ADR management can be generated. Better coordination between healthcare professionals in ADR Reporting and its management is another promise of this software. 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. ADR forms can be generated with this software which can be communicated with Pharmacovigilance peripheral centers.Students in the Pharmacy Practice Department are also given due consideration with a clerkship report feature, which auto generates the clerkship report for their academic purposes. So as a whole the software will provide mutual benefits to the patients as well as the hospital authorities, taking the patient care to a whole new level.

A major proportion of the Indian population depends on clinics for minor ailments and so the ADRs in these populations are not usually reported. This software can also be implemented in clinics and pharmacies with very minimal infrastructure. The software doesn’t need any technical expertise for its operation and 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 the Pharmacovigilance program.This innovative concept is accepted for presentation at India'sonly international conference on the impact of Information Technology in healthcare - 'Transforming Healthcare with Information Technology 2015'. This is the 6^th instalment of the international seminar which brings together speakers from different countries addressing over 750 delegates about the latest happenings in the field of Healthcare IT in their respective countries. This conference is being held along with the 5th International Patient Safety Congress.

Innovations in the healthcare industry are usually far from the dreams of rural population. Rural populations are not benefited with the technological innovations taking place in health care industry due to the immense demand for infrastructure, cost involved and the complicated techniques for operation. But this software proves these concepts wrong, with its economic feasibility, user friendly design, abundance of features and minimal infrastructural requirements. Hence, this software can be utilized in rural small towns as well as in cities by healthcare professionals for carrying out Pharmacovigilance.The problem our country faces in Pharmacovigilance is the lack of a proper system for reporting and monitoring the adverse drug reactions. India can become a role model to other developing countries with the inclusion of such innovative software into its pharmacovigilance program for proper ADR reporting and monitoring. The introduction of software like this into the Pharmacovigilance programs can alsobeeffective in the management of ADRs. This can help advance Pharmacovigilance practice in the country, thereby promoting patient safety and better therapeutic outcome. As mentioned earlier in the long run, every country should have its own database that contributes to the global surveillance program. To conclude, a novel software like this can become the back bone of India’s Pharmacovigilance Program in creating a national database which then can contribute to the global surveillance program.