Establishing Pharmacovigilance Center in Hospital
- The human safety data extrapolated from animal studies are often deviant in many aspects and not conclusively predictive. Although surface clinical trials reveal a fair percentage of ADRs, but they may not always give the fuller picture due to relatively fewer number of patients from a specified geographic location on trial, limited duration of 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 pharmaceutical manufacturing protocols.
- This issue needs more attention in India as herbal remedies are widely used which 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, homeopathy, 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.
- Pharmacovigilance 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 center is dictated by the political governance and its healthcare priorities, including willingness to do, law enactment, its enforcement, funding, organization, staffing, training, and development.
- For national coordination of PV, governmental support and sustained monitoring is a must. A center can be started in a hospital or at any department, preferably in pharmacology, medicine, clinical pharmacy or clinical toxicology. Initially it may be started in one hospital locally and then extended to other hospitals to cover the entire region which could communicate closely with a zonal center.
- All zonal centers in turn can report to the national nodal center which would collate the data gathered from the entire country and channel it to the Uppsala Monitoring Center (UMC), Sweden, within specified time line, for global referencing and use. If a center is handling data of an entire country right from the beginning, foolproof channels of effective communication should be ensured with clinicians.
- The center should have at least one clinical pharmacologist, clinical pharmacist or a physician to start working
PLANNING THE BASICS
A blueprint should be drawn up to establish and get a PV system to work. Care needs to be taken to establish the following:
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 center
Producing printed handouts as well as conducting meetings or workshops in hospitals and academia to acquaint health care 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 suitable place for accommodating them as well as the center, 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 centers 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 categorizing the data and summarizing 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 center, medical journals, health bulletins and other professional healthcare publications
To encourage healthcare professionals to contact institutions working on a global scale in PV e.g. Uppsala Monitoring Centre (UMC) WHO department of Essential Medicines and Medicines Policy, Geneva, and net groups like International Network for the Rational Use of Drugs (INRUD), E-drug, and Network for Rational Use of Medicines (NetRUM)
THE MANPOWER AND THE MACHINERY
- To begin with, a PV center can kick start with a part time expert who can be a physician or clinical pharmacist with some secretarial support. Gradually, as the data traffic increases, a full time professional should be appointed to maintain the center and secretarial support expanded. The increase in the quantum of work, staff resource requirements are calculated by flatly assuming the time of assessment of a single case as one hour. For the smooth functioning of a PV center, professionals with expertise in pharmacology, clinical medicine, epidemiology, toxicology prove to be fruitful.
- Additionally, the center requires a permanent secretariat to handle phone calls, database, and documentation of literature and coordination of activities like interfacing with related departments to maintain secretarial continuity for successful functioning of the center.
- An advisory committee serves to get funding and support for the center, monitoring, and evaluation, keeping a tab in 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.
- There are a few basic technological requirements for a PV center – uninterrupted electric supply, intercom, multi connection telephone, computer, printer, FAX, internet, photocopier, which should be made available and care should be taken that these remain working at all times. Adequate back up facilities should be present so that work is not paralyzed in case of sudden breakdowns.
A CRF should contain minimum following information:
Patient: Age, gender, medical history in brief, ethnic origin (in some countries)
ADE monitoring: Detailed description (nature, localization, severity, characteristics), reports of investigations and tests, date of appearance, course, outcome
Suspected medicines: Name (brand, formulation, ingredient, concentration, manufacturer), dose, route of administration, date of initiation of therapy/date of withdrawal of therapy, indications for use, and rechallenge in case of non serious ADEs
Other medicines: All other medicines used by the patient (including self medication) including their name, dose, route, date of initiation and withdrawal
Risk factors: e.g. impaired renal function, past exposure to suspected medicines, history of allergy, and social drug use
Reporter: Name and address of the reporter (confidential and to be used for data completion, verification, and follow up)
BRINGING A REPORTING CULTURE
Reporting of ADR is a continuous process and important to cultivate and sustain the attention and interest of healthcare workers so that it gets incorporated as a routine procedure in healthcare. The following measures may be adopted to give a fillip to reporting:
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 center staff in scientific meetings, undergraduate and postgraduate education
Collaborating with other PV committees
Collaborating with professional associations
Utilizing PV data for development of clinical pharmacy and clinical pharmacology
- Money is required to fuel the PV center and it should have an officially approved guaranteed source, which is immune to political governance and economic fluctuations, to direct a steady flow of funds so that the progress of work is not hindered.
- The requisite financial support required for a particular PV center is estimated based on how big a population the center is schemed to cater and the anticipated rate at which it is going to generate reports.
- Additional monetary support may be sought from health insurance companies, academia, philanthropic organizations, and government departments with an interest in medicine safety.
- It is good to start a program in high spirits, but what is more important is to continue with the tempo to sustain it. The sustainability of PV program in India can be well recognized by the fact that during one calendar year, not even a single ADR report was sent to UMC from a country of 1 billion, and India rates below 1% in PV as compared to the overall world average of 5%.
- It could be remedied by training our technical manpower in the latest developments in PV, identifying, and supporting centers of excellence across the country which can impart quality training in PV to the health care professionals.
- Efficient communication both in sharing our own findings with the global database and reaching feedbacks and analyzed reports to the prescribers well in advance should be ensured.