WELCOMEYOU ALL

PHARMACOVIGILANCE The Need of The

Hour!Way towards a safe medical practice…………. PRESENTED BY

NILESH.S.JAWALKAR (M.PHARM IInd Semister ) SKB COLLEGE OF PHARMACY NEW

KAMPTEE , NAGPUR 2012-2013

CONTENTINTRODUCTIONAIM AND OBJECTIVEADVERSE EFFECTIMPORTANCEPARTENERS IN PHARMACOVIGILANCEPHARMACOVIGILANCE IN DRUG REGULATIONPHARMACOVIGILANCE IN CLINICAL

PRACTICETHE RaPIDCONCLUSION AND CONSIDARATION FOR

FUTURE.REFERANCES

INTRODUCTIONPharmacovigilance (PV) is the pharmacological

science relating to the detection , assessment ,understanding and prevention of adverse effects, particularly long term and short term side effect of medicines.

All medicines (pharmaceutical and vaccines) have side effect some are known many are still unknown even this medicine has been in clinical use. The important to monitor both known and unknown side effects of medicines in order to determine any new information in relation to their safety profile .

• Pharmacovigilance looks at all available information to assess the safety profile of a drug

• Pharmacovigilance should also take the benefit of the drug in account

• Spontaneous reporting depends on the health professional – YOU.

ADR Suspicion

1 2 3

How Pharmacovigilance works

4ADR Reporting

ADRAnalysis

Sharingof Findings

Aim And Objectives of Pharmacovigilance

Aim:-To identifying new information about

hazards as associated with medicinesObjective:- Improve patient care and safetyImprove public health and safetyEncourage safe, rational and appropriate use

of drugsPromote understanding, education and

clinical training in pharmacovigilance

Adverse drug reactionwhich is noxious ,unintended and which

occurs A response at doses normally used in humans for Prophylaxis, Diagnosis or Therapy of disease , or for modification of physiological function…..(WHO 1972)

Type A(Augmented) Type B(Bizarre)

Pharmacologically predictable Yes No

Dose dependent Yes No

Frequency Common Rarer

Incidence High Low

Mortality Low High

Treatment Adjust Dose Stop the Drug

Adverse Drug Reactions Classifications

Adverse drug reaction(ADR)a)Serious adverse reaction.

b) Unexpected adverse reaction.

DataAnalysis

Response

Side effect Any unintended effect of a pharmaceutical

product occurring at normal dosage which is related to the pharmacological properties of the drug. e.g. antihistamines producing sedation , anticholinergics producing dryness ..

1 approved

5 enter trials5,000

compounds evaluated

Success Rate

Verify effectiveness,

monitor adverse

reactions from long-term use

Evaluate effectiveness, look for side

effects

Determine safety

and dosage

Assess safety and

biological activity

Purpose 

Review process / Approval

1000 to 3000 patient

volunteers

100 to 300 patient

volunteers

20 to 80 healthy

volunteers

Laboratory and animal

studies

Test Populatio

n

Additional Post

marketing testing

required by FDA

12 Total

2.53213.5Years

Phase IV FDA

File NDA at

FDA

Phase IIIPhase IIPhase I

File IND at FDA

Preclinical Testing

 

Clinical Trials

Phases of Product Development It takes 12 years on average for an experimental drug to travel from lab to medicine

chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.

Pharmacovigilance And IndiaIndia is is a hub of Global Clinical trials & a destination for Drug Discovery & Development. However, whether patients in India receive safe drugs or not is still very muchin question

Rapid induction of NCEs and high tech Pharma products in the market throw up the Challenges of monitoring Adverse Drug Reactions (ADRs) over large multiethnic population base...

Who Should Report Safety Data

PhysiciansPharmacistsPharmaceutical companies qualified persons

– (Pharmacovigilance/Regulatory manager)Investigational products (clinical trials)Post-approval reporting – Individual Case

Safety Report (ICSR), Periodic Safety Update Report (PSUR)

In many countries patients are encouraged (but not obligated) to report side effects

What to Report

It is important to report serious unexpected ADRs.

Most cases of unexpected ADRs are associated with medicines newly introduced on the market.

All suspected adverse reactions.Every single problem related to the use of a drug.ADRs associated with radiology contrast media,

vaccines, diagnostics, drugs used in traditional medicine, herbal remedies, cosmetics, medical devices and equipment.

Withdrawn Drugs From the Market

Drug Year ReasonLumiracoxib 2008 HepatotoxicityAprotinin 2008 Kidney and cardiovascular toxicityTegaserod 2007 Cardiovascular ischemic eventsXimelagatran 2006 HepatotoxicityValdecoxib 2005 Dermatology adverse eventsPemoline 2005 HepatotoxicityRofecoxib 2004 Thrombotic cardiovascular eventsLevomethadyl 2003 Fatal ArrhytmiaRapacuronium 2001 Risk of fatal bronchospasmCerivastatin 2001 RhabdomyolosisTrovafloxacin 2001 HepatotoxicityAmineptine 2000 Hepatotoxicity, dermatological side effects, abuse potentialCisapride 2000 Cardiac arrhythmiasTroglitazone 2000 Hepatotoxicity

Four common drug banned in other countries but not in India

IMPORTANCE OF PHARMACOVIGILANCE Complete safety data (especially for unexpected

and serious adverse events) can only be captured through pharmacovigilance

It cannot be captured through clinical trials which are conducted in an “artificial environment.” In clinical trials

patients are not taking any other medications do not have concomitant diseases are taking the drug short-term (during the duration of the

trials only) and are not part of vulnerable groups (e.g., children, pregnant

women, elderly, etc.)

PATNERS IN PHARMACOVIGILANCE

The WHO Quality Assurance and Safety : Medicines team

The Uppsala Monitoring Centre (UMC) The National Pharmacovigilance Centers Hospitals And Academia Health Professionals Patients Other Partners

System of Safety Data Gathering

PharmaceuticalCompanies

Patients National RegulatoryAuthority

International SafetyDatabases

HealthcareProfessionals

Clinical Trials

Pre-ApprovalPost-Approval

PHARMACOVIGILANCE IN DRUG REGULATION

Clinical Trial Regulationi) Collection of ADRii)monitoring clinical dataiii)reporting of clinical data

Post Marketing safety Monitoring

THE RaPID The RaPID is a PV program it conduct public

health program.It provide support to focal point.Focus on RaPID HIV, T.B, Malaria and other

program. It is important to encourage and ensure

reporting of ADR.It consist of various department for working

various type of diseases

I964 :U. K. starts "Yellow Card" system..

The Yellow Card Scheme is the main ADR reporting scheme in the UK and was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. It receives more than 20,000 reports of possible side effects each year.

What should be our contribution……

True challenge lies in….In recognising at the earliest possible stage,

the adverse effects that a drug may induce , so that the risk (unfavourable results) never becomes disproportionate to benefit (Favourable results)

At the level of Clinicians …..My Doctor is a good doctor, He made me no iller than

I was…….Willem Hussem (The Netherlands)1900 -1974

Translation: Peter Raven There are no really safe biologically active drugs .

There are only safe physicians…. Harold A. kaminetzsky1963

1.Active reporting of ADVERSE DRUG REACTIONS as forms are available freely e.g. Nimusulide

European Medicine Evaluation Agency Bans NIMESULIDE

Avoid Prescription errors

Articles highlighting the rise in prescription errors

Illegible prescriptions? Who is to blame……

At the level of Pharmacists & Pharmacologists

To train Pharmacists in drug interactions, side effects ,drug dosages

11. Students can start Pharmacy bulletins with help of Respected Principal sir & coordinators…..

( Australian Prescriber, USPDI)

Student involvement. Students can start Pharmacy bulletins with help of Respected Principal sir & coordinators….. ( Australian Prescriber, USPDI)

Aims of Drug Alerts…. The information resources should be

designed to assist the health provider in their clinical choice of drugs, in an effort to reduce the incidence and severity of adverse effects & medication errors .

Student involved in making Drug alerts

Presenting Drug Alerts

Drug Alert Leaflets FDA pulls antiparkinsonism drug of

Pergolide from market

EMEA bans Nimesulide

Petitions to remove Cox2 inhibitors

Cisapride under strict scrutiny

Phenylpropanolamine risk of Hemorragic stroke

Animation of Pharmacovigilance: Students have presented & posted on Google images

conclusion

Think less about drug safety: more about patient safety

Use and react to concerns

Think less about regulating (incl. withdrawal) and automating data input: more about useful information output

Think more about impact and consequences of decisions and non-decisions

It is expected that 50 – 75 % of medical errors are preventable.