Dr.Sharad H. Gajuryal

MHA Trainee,

AIIMS

Pharmacovigilance: Pillar for Patient Safety

Introduction

Pharmacovigilance = Greek words

Pharmacon= “Drug”Vigilare =“To keep alert "

According to WHO it is the science relating to detection, assessment, understanding and prevention of adverse drug reaction or any drugs related problem.

ADR???

Adverse drug reaction

A response to a drug that is noxious and unintended which occurs at a dose normally used in man for prophylaxis, diagnosis or therapy of disease.

Adverse Event Vs

Adverse Reaction

Pharmacovigilance is not only confined to Modern medicine but also includes Herbal medicines, blood products and vaccines too.

Aim of PharmacovigilanceTo improve patient care and safety in relation to use of

medicationTo improve public health and safety in relation to use of

medicineContribute to assessment of benefit, harm, effectivemess and

risk of medicines ,encouraging their safe and rational use.Promote understanding, Educational and clinical Training in

Pharmacovigilance.

Guides regulators on whether the drug should be Guides regulators on whether the drug should be continue in market, continue in market,

be restricted in usages, orbe restricted in usages, or in worst possible in worst possible

scenario,withdrawn from the marketscenario,withdrawn from the market

DRUGS RECENTLY BANNED IN INDIA?Pioglitazone-can cause heart failure and increases risk of

bladder cancer.

Dienxit- Deanxit  is a harmful combination

Analgin-causing a sharp fall in white blood cells, a potentially fatal condition, called agranulocytosis

Others-Sibutramin, Gatifloxacin,Nimuslide

History and Evolution1937 –Sulphanilamide +Diethylglycol Disaster

Death of 105 individuals

Diethyleneglycol was incriminated

Drug and Cosmetic Act, 1938 under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing them for sale.

1959-1961 –Thalidomide Disaster (Max. Seen in Germany)

Linked to a congenital abnormality phocomelia

In 1962, It was discontinued.

The Kefauver-Harris amendment was approved, under which scientific evidences

of efficacy and safety of drugs required before drug test/trail in humans.

Thalidomide effect

WHO's Programme for International Drug Monitoring was started in 1968 as a means of pooling existing data on adverse drug reactions .

At the end of 2010, 134 countries were part of the WHO Pharmacovigilance Programme.

This Program is coordinated by WHO together with its collaborating centre in Uppsala, Sweden.

The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports

Till Date -149 countries

Process in Pharmacovigilance

Collect and Record Adverse Event/ Adverse Drug Reaction

Causality Assesment and analysis of ADRCollate and Code in DatabaseCompute Risk benefit and Suggest regulatory actionCommunicate for safe use of drugs among stakeholders.

Pharmacovigilance in INDIA

150 Adverse Monitoring Center & NCC (Indian Pharmacopoeia commission)

Patient Safety and Performance Improvement Program @JPNATC

PS & PIP-

Pharmacovigilance at JPNATCObjectives:

To Monitor Adverse Drug Reaction seen in JPNATC Patients

To Create awareness among HCP about the importance of ADR Reporting

To monitor Benefit risk profile of Medicines

To Support National Pharmacovigilance Center for formulation of safety related regulatory decision for Medicine.

Pharmacovigilance at JPNATCInitiated along with Patient Safety Program at JPNATC

Feb 10th : Meeting conducted at Pharmacology department Main Hospital AIIMS. The following Stake holders were present at the meeting.

1. HOD,Pharmacology Department,2. Add. MS JPNATC,3. Faculty Incharge IT.4. HOD,Microbiology5. Residents Hospital Administration

Minutes of Meeting

To Initiate Pharmacovigilance program in JPNATC .

1 Phd Student and two Research Assistant to be appointed for Pharmacovigilance program.

Adverse Drug Reaction form to be digitalized in coordination with faculty I/C IT and to be incorporated in E-Hospital

Appropriate Training session to be designed to enhance knowledge of ADR reporting among Health care professionals of JPNATC.

Orientation classes to Health care professional for guidance to Report ADR

13th March,2015 : Orientation class regarding pharmacovigilance was given to Nursing Staffs .

KAP SurveyTotal 25 Participants (Nurses , DNS, ANS ,Grade I and

Grade II)

20 set of question

Designation Frequency (n=25) Percentage

ANS 10 25%

DNS 3 12%

Grade I 8 32%

Grade II 7 28%

Result

KNOWELDGE & AWARENESS12 Questions

Pre-Test Mean Result =5.4

Post-Test Mean Result=9.5

ConclusionPharmacovigilance program is a helpful tool for protecting

consumers (Patients) from harmful effects of medicines.ADR Should be considered as professional obligationEvery HCP should be aware of existing pharmacovigilance

mechanism in their country .It’s the efficient way to boost the confidence for safety.

Dying from a disease is sometime unavoidable, Dying from a medicine is unacceptable !-Lepakhin V. Geneva