Establishing Pharmacovigilance Center in Hospital

THE NEED

• 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.

GETTING STARTED

• 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:

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.

DATA ACQUISITION

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

Contract Research Organizations | How to Choose & Find CRO | Concern before selection of CRO | Pharmacovigilance Notes

Contract Research Organizations | How to Choose & Find CRO | Concern before selection of CRO | Pharmacovigilance Notes