PHARMACOVIGILANCE AN OVERVIEW

PHARMACOVIGILANCE AN OVERVIEW

Dr. M. Kannan¹, Dr. P. Sathiyarajeswaran², Dr. S.Natarajan³

Introduction:

Medicines cannot be claimed as absolutely safe for all people, in all places & at all times.Adverse drug reactions are one of he major cause of death in a hospital. Clinical Research without ensuring patient safety is unethical. Various studies suggest that irrational use of traditional medicines and procedures may lead to negative or dangerous effects.

The drugs were studied in ancient days according to their Properties, Uses, Dose, Drug Reactions / Side Effects, their Management, Compatibilities & Incompatibilities; Interactions etc.The Pharmacovigilance system is prevalent from ancient days. Validation with suitable documentation is the need of the hour. Adverse Drug Reactions are the integral part of drug Pharmacology.

Traditional Medicine is presumed to be Natural, Safe even in Long term usage..Pharmacovigilance includes drug and Therapeutic procedures (Varmam & Thokkanam, Karanool, Detoxification procedures in Siddha).

What is Pharmacovigilance?

Pharmakon (Greek) = drug Vigilare(Latin) = to keep watch; awake, alert; watchfulness in respect of care,danger, caution, circumspection; process of paying close and continuous attention.

Pharmacovigilance is defined as the science and activities concerned with thedetection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). Pharmacovigilance system is in infant stage in India The ultimate goal of this activity is to improve the safe and rational use of medicines, thereby improving patient care and public health.

Aim:

a. Early detection of Unknown Adverse reactions & Interactions

b. Detection of increases in frequency of Adverse reaction

c. Identification of risk factors and possible mechanisms underlying Adverse reaction

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1 & 2 Research Officer, 3 Senior Research Fellow Siddha Central Research Institute (CCRS), Arumbakkam, Chennai - 60006

d. Estimation of quantitative aspects of benefits / Risk analysis and dissemination of information needed to improve drug prescribing regulation

e. Preventing patients from being affected unnecessarily

Why is Pharmacovigilance important?

A medicine is released into the market after rigorous procedures pertaining to standardisation and safety of the product. Once marketed the medicines are used by patients who have multiple morbidities, and may using several drugs which have different characters do’s and don’ts which may influence the efficacy and safety of a medicine. Different brands of medicines may differ in the SOP’S .The adverse drug reactions and poisonings associated with traditional and herbal remedies are to be monitored in every country. The information we receive on the adverse effects of drugs in one country may not be relevant or applicable to citizens of other countries. In some cases, adverse effects to certain drugs may occur only in certain races .In order to prevent unnecessary suffering by patients and to decrease the economic burden sustained by the patient due to the inappropriate or unsafe use of medicines, it is essential that a monitoring system for the safety of medicine supported by doctors, pharmacists, nurses and other health professionals in thecountry.NPC is improving drug safety through adverse drug reactions ,monitoring adverse reactions should be reported on a dailybasis.Differences in drug use, genetics, diet, tradition of people and excipients etc.

Who should report Adverse Drug Reactions?

All health care workers, including doctors, pharmacists, nurses and other health care professionals are requested to report all suspected adverse reactions to drugs (including vaccines, X-ray contrast media, traditional and herbal remedies),especially when the reaction is unusual, potentially serious or clinically significant. It is vital to report an adverse drug reaction to the nearest and appropriate Pharmacovigilance centre even if you do not have all the facts or are uncertain about the medicine and the ADR reported.

Will reporting have any negative consequences on the health worker or the Patient?

This adverse drug reaction report does not constitute an admission that you or any other health professional contributed to the event in any way. The outcome of the report, together with any important or relevant information relating to the reaction you have reported, will be sent back to you as appropriate. The details of your report will be stored in a confidential database. The names of the reporter or any other health professionals named on a report and the patient will be removed before any details about a specific adverse drug reaction are used or communicated to others. The information obtained from your report will not be used for commercial purposes. The information is only meant to improve our understanding of the medicines we use in the country.

How to avoid ADR’s?

• Medicines of good quality (GMP) and safety .
• Doctors, pharmacists, nurses got good basic education in pharmacotherapy (Good Academic Knowledge & Experience).
• Doctors prescribe sensibly (GPP) Populations knew rational use of medicines.
• Appropriate nosology
• Selection of Adjuvant / Vehicle
• Pathiyam
• Food & drug interaction awareness
• Drug & Drug interaction awareness and Seasonal awareness

What to report?

All adverse reactions / interactions suspected to have been caused by ASU drugs alone or along with any other drugs, any untoward medical occurrence that at any dose Results in death, requires hospitalization or Prolongation of existing hospitalization, Results in persistent significant disability or incapacity.

Where to report?

The reporting on prescribed format will be done to any of the Pharmacovigilance centres. (Visit www.crisiddha.tn.nic.in)

What happens to the ADR’s submitted?

The information in the form shall be handled in confidentiality. Peripheral Pharmacovigilance centres shall forward the form to the respective Regional Pharmacovigilance centres that will carry out the causality analysis. This information shall be forwarded to National Pharmacovigilance Resource centre. The data will be statistically analysed and forwarded to the Dept. of AYUSH, Govt. of India.

Adverse event:

Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment

Adverse Drug reaction (ADR):

A reaction 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 modification of physiological function

Signals:

Signals are Reported information on a possible causal relationship between an adverse event and drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.

Spontaneous Reporting:

It is a System where case reports of adverse drug events are voluntarily submitted from health professionals and pharmaceutical manufacturers to the national regulatory authority.

Vigibase:

Vigi base is WHO international ADR database.

Vigiflow:

Vigiflow (formerly called Vigibase online) is sophisticated case report management system created by the UMC (UPPSALA Monitoring Committee, Sweden)

Vigi search:

This is custom search service offered by the UMC to third –party inquirers for several types of standard presentations are available.

Vigi med:

E-mail conferencing facility exclusive to member countries of the WHO programme for International Drug Monitoring.