Prof (Dr) Vandana Arora Sethi, Group Director, Lloyd Group of Institutions, talks about the rise in reporting on adverse drug reactions, and how institutionalising PV centres in the medical and pharmacy colleges of India can help the government and the healthcare industry overcome, or better tackle, this problem
Adverse drug reactions’ reporting is on the rise due to pharmacotherapy, hence pharmacovigilance (PV) is the key topic of discussion in healthcare circles. There has been a national directive to institutionalise a PV centre in every medical college of India and the thought of having the same is ripe for pharmacy colleges. There is an urgent and crucial need to inform, educate, and enlighten the readers about the constitution and dynamics of a PV centre.
Efforts have to be accelerated to contain the damage before it looms large on the country and there is a pressing demand to better define the relationship between the pharmaceutical industry, healthcare professionals and medicine regulatory authorities so that deleterious effects of medicines in their routine use could be avoided and if at all this occurs, it should be effectively tackled.
PV is a central idea that will enable the country to examine drug safety data and arrive at tailor-made regulatory decisions for its population. For any drug, it is firstly desired by the users that the same should be absolutely safe and without any risk. PV envisions this at its core and scrutinises the drugs for their ADRs and sets a mechanism for noting drug effects to uphold the safety of people on priority.
Establishing a robust PV system in any country requires meticulous planning, continuing zeal, proactive approach and motivation of the concerned staff. PV has to ensure that future generations will not condemn the present one for its indifference and callousness to the gravity of the situation and no adverse effects should go unnoticed or unreported.
Roots of PV in history
In India, PV was conceived in 1986, which resulted in the proposal of 12 regional centres. Activities were insignificant for about a decade. Initially, three centres were assigned the task of ADR monitoring of marketed medicines — All India Institute of Medical Sciences (AIIMS) New Delhi, King Edward Memorial (KEM) Hospital Mumbai, JLN Hospital Aligarh Muslim University. These centres were to report to Drug Regulatory Authority of India. This too did not yield much. Finally, in 2005, the National Pharmacovigilance Program (NPP) was launched by the WHO and funded by the World Bank, with 24 PV centres at present under this programme.
India has woken up a bit late to its importance and is lagging in the implementation of the necessary systems and manpower to get it rolling. To address this concern, the Central Drug Standard Control Organization (CDSCO) launched the National Pharmacovigilance Program (NPP) in January 2005. To give it a further impetus, the Drug Controller General of India (DCG(I)) has announced the CDSCO’s ‘VISION 2020,’ which proposes to create a PV centre in every medical college in the country which is an ambitious task keeping in view the fact that it is still at low ebb in many government medical colleges and the condition may be worse in the private institutes. It is likely that the proposal may have to face many bottlenecks to pay some dividends.
Need for PV
PV is defined as per the World Health Organization (WHO) as “Science and activities relating to detection, evaluation, understanding, and prevention of adverse drug reactions or any other drug-related problems.” The scope of the definition has now been widened to include ethnopharmacological products and complimentary blood products, biological, medical devices and vaccines.
The human safety data that is extrapolated from only animal studies are often deviant in many aspects and not conclusively predictive. The surface clinical trials reveal a fair percentage of adverse drug reactions, but they may not always give the fuller picture due to various factors like the relatively fewer number of patients from a specified geographic location on trial, limited duration of the trial, differences in the conditions of use from clinical practice. Gross variations in the effects of medicines exist among populations of different countries and also various regions of the same country which may be attributed to the differences in prescribing practices and diseases, genetics, food habits, and pharma manufacturing protocols. This issue needs more attention in India as there is haziness on regulations for herbal remedies, which are widely used and may pose problems when used singly or in combination. India, now being a signatory to the World Trade Organization (WTO) and a hub of clinical trials, is fast becoming a market for new molecules whose safety data are not available from other countries. Therefore, it needs to exercise earnest efforts to remedy its lapses in this vital sector of healthcare and generate its own dependable data from long term use of medicines. In addition to these, clinical trials may not always pick up rare adverse reactions. Also with the prevailing heterogeneity in clinical practices in India – allopathy, ayurvedic, homoeopathy, unani, siddha and in view of the complex interplay among these various systems of medicine, the need for an efficient monitoring system is further underscored.
Advantage pharmacy colleges
Expert manpower and facilities
To begin with, a PV centre can kick start with a part-time expert who can be a physician/clinical pharmacist with some secretarial support. Gradually, as the data traffic increases, a full time professional can be appointed to maintain the support. For the smooth functioning of a PV centre, professionals with expertise in pharmacology, clinical medicine, epidemiology, toxicology prove to be most useful.
Additionally, there could be a secretariat to handle phone calls, database, and documentation of literature and coordination of activities like interfacing with related or successful functioning of the centre.
An advisory committee serves to get funding and support for the centre, monitoring and evaluation, keeping a tab on the quality of the procedures relating to data collection and mining, data interpretation and publication information. The advisory committee may be represented by the disciplines of clinical medicine, pharmacology, toxicology, epidemiology, phytotherapy, pathology, drug regulation and quality assurance.
The pharmacy college could easily fulfil the few basic technological requirements for a PV centre — uninterrupted electric supply, intercom, multi-connection telephone, computer, printer, FAX, Internet, photocopier. Adequate backup facilities are also present so that work is not paralysed in case of sudden breakdowns.
The centre should have access to up-to-date and comprehensive literature database, which can be made available in the college’s library. This is because one of the primary responsibilities of a centre is to make high quality credible and latest medicine information available to healthcare professionals.
Newsletters, medicine bulletins, columns from reputed medical or pharma journals may be chosen as routes of effective propagation of the latest developments in medical research and therapy to the healthcare professionals.
The ADR case reports obtained are evaluated by the centre staff, employing the collective know-how of clinical medicine, pharmacology, toxicology, and epidemiology.
Data is best managed electronically by computer, wherein, data is entered in a hierarchical format according to the product name, medicine name or therapeutic category. The computer centre facility can serve this purpose.
The pharmacy faculty and experts can assist PV centre keep a close eye on the new medicines launched in the market and follow them up to look for newer ADEs, issue warnings, unmask newer indications or changes or to advocate withdrawal of medicines in extreme cases.
The pharmacy college can provide the required technical support and know-how for the reporting system. Reports of suspected ADRs are taken in case report forms (CRF) which in PV is defined as a notification relating to a patient with an ADE suspected to be induced by a medicine.
Healthcare professionals e.g. practising physicians, pharmacists, nurses, dentists, and midwives are reliable sources of information. Pharmacists at colleges and nurses can illuminate on concomitant medication and a history of medicine usage. It is imperative for pharma companies to report any ADRs of their products to regulatory authorities.
The college can provide
- Easy and free availability of prepaid reporting forms and other modes of reporting
- Duly acknowledging the receipt of ADR reports telephonically or through personal communication
- Providing journal articles, ADR bulletins, newsletters to reporters
- Actively involving the PV centre staff in scientific meetings, undergraduate and postgraduate education
- Collaborating with professional associations
The academia may provide the requisite financial support required for a particular PV centre and additional monetary support may be sought from health insurance companies, philanthropic organisations, and government departments with an interest in medicine safety.
India rates below 1 per cent reporting in PV as compared to the overall world average of
5 per cent. It could be remedied by training our technical manpower in the latest developments in PV, identifying, and supporting centres of excellence across the country which can impart quality training in PV to the healthcare professionals. And there could be no better manpower than pharmacy graduate and undergraduate students and faculty. Efficient communication both in sharing our own findings with the global database and reaching feedbacks and analysed reports to the prescribers well in advance should be ensured.
Planning for the study
The following requisites can be set up in the PV centre at Pharmacy College:
Getting in conversation with health authorities and local, regional, national bodies and groups engaged in clinical medicine, pharmacology, toxicology, epidemiology, briefing them about the importance of the project and its applicability in modern therapeutics.
Designing a template for ADR reporting and making available ADR reporting forms at all times, to hospital departments and general practitioners, on which they can furnish relevant information to the data bank of the centre.
Producing printed handouts as well as conducting meetings or workshops in hospitals and academia to acquaint healthcare professionals about the definitions, goals, scope, and methodology of the PV system to create awareness about its relevance in present times.
Hiring the right qualified and interested staff, getting a suitable place for accommodating them as well as the centre, making arrangements for telephones, computers, printers, word processors, database management, bibliography support services and Internet.
Ensuring proper education and frequent updating of the staff belonging to the PV centres by training them in data collection, filtration, mining, verification, interpretation and coding of ADRs, medicines coding, causality assessment, signal detection, risk management, and action in case of serious/fatal adverse drug events (ADE). Data mining is a relatively nascent interdisciplinary area which involves finding correlations and patterns among many fields in large databases with the aim of categorising the data and summarising identified relationships.
Creating a safely stored, classified database which is retrievable and guarded by required degrees of confidentiality.
To inculcate and promote the habit of reporting ADRs to the higher centre, medical journals, health bulletins and other professional healthcare publications PV is all about drug regulation and rests on sound collaborative ties, coordination, communications, and public relations. The most suitable location for setting up a PV centre is dictated by the political governance and its healthcare priorities, including a willingness to do, law enactment, its enforcement, funding, organisation, staffing, training, and development. For national coordination of PV, governmental support and sustained monitoring is a must. A centre can be started in a college,a hospital or at any department, preferably in pharmacology, medicine, clinical pharmacy or clinical toxicology. The requisite of one hospital locally is a must in that case.
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