Introduction to Pharmacovigilance

Done By CID PV Team

QPPV :- Dr. Rania Kamel

Deputy :- Dr. Nahla Raafat

Outlines of the presentation

Smooth orientation

to pharmacovi

gilance

Why do we need

pharmacovigilance?

WHO programme

for drug monitoring

Pharmacovigilance in

Egypt

Important terminologie

s in pharmacovi

gilance

Yellow Card &

Blue CardWorkshop

Smooth orientation to Pharmacovigilance concept.

Medicine Safety

To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine

Molière

Risk/Benefit Balance of medications

Medicines are safe! (X)

Approved medicines are safe! (X)

No medicine is safe! (X)

No medicine is without risk (√)

Risk/Benefit Balance of medications

Acceptable

Unacceptable

What is Pharmacovigilance?

WHO definition ofpharmacovigilance

Pharmacovigilance is

the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem

Pharmacovigilance

prevention of adverse

effects

Assessment &Understand

ing

Detection

Learning from History

Thalidomide Disaster: •Tranquilizer launched - 1957

• First reports of birth defects - 1959

• 13 reports of birth defects - 1961

•Withdrawn shortly afterward

•10000 infants affected by Phocomelia.

• No teratogenicity detected in testis during clinical trials and prior to launch.

Why do we need Pharmacovigilance?

Reason 1:

Humanitarian concern

Insufficient evidence of safety from clinical trials, Animal experiments & Phase 1 – 3 studies prior to marketing authorization

Limitations of clinical trials

•Small number of patients studied

•Restricted populations (age, sex, ethnicity)

•Narrow indications

•Short duration of drug exposure

Reason 2:

Medicines are supposed to save lives

Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005

• ADRs were 4th-6th commonest cause of death in the US in 1994 Lazarou et al, 1998

USA

• It has been suggested that ADRs may cause 5700 deaths per year in UK. Pirmohamed et al, 2004

UK

Reason 3:

ADRs are expensive !!• Cost of drug related morbidity

and mortality exceeded $177.4 billion in 2000 (Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc).

• ADR related cost to the country exceeds the cost of the medications themselves.

Reason 4: Promoting rational use of medicines and adherence

Reason 5: Ensuring public confidence

Reason 6: Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical

Pharmacovigilance is needed in every country

because of differences in:• Drug production • Distribution and use ( e.g.

indications, dose, availability)• Genetics, diet, traditions of the

people (e.g. use of herbal remedies, etc.)

• Pharmaceutical quality and composition (active/inactive ingredients )

Who program for international drug monitoring

Who program for international drug monitoring

• Started 1968

• Located in Uppsala, Sweden

• Collaborating centre for maintaining global ADR database - Vigibase

Roles of WHO Collaborating Centre

• Identify early warning signals of serious adverse reactions to medicines

• Evaluate the hazard

• Undertake research into the mechanisms of action to aid the development of safer and more effective medicines

Pharmacovigilance in Egypt

What is EPVC (Egyptian Pharmacovigilance centre )

In accordance with the legislation, EPVC has established a pharmacovigilance system for the collection and evaluation of information relevant to the risk-benefit balance of medicinal products, Medical devices & Biocides.

(cosmetics, Vet. Products & Herbal products )

Implemented levels of regulatory actions in Egypt based on EPVC decisions

• Asking for specific data from MAH• Modify the package insert• Black box warning in the insert • Boxed warning on the outer pack • Contraindication • Distribute “Dear Dr Letter”• Preventing importation of specific batches • Recall of certain batches from the market• Suspension of the marketing authorization• Withdrawal of the marketing authorization

Important Terminologies in Pharmacovigilance

Side Effect (SE) Vs Adverse Drug Reaction (ADR) Vs Adverse Event (AE)

SEResponse to a drug which is unintended and which occurs at

doses normally used in man for prophylaxis, diagnosis or therapy of disease.

AEAny untoward medical occurrence in a patient or clinical

investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this

treatment.

ADRResponse to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect.

Adverse Drug Reaction (ADR) Vs Adverse Event (AE)

Medication Errors (ME)

They could occur during prescribing, transcribing, dispensing, administering a drug. Examples of medication errors include, misreading or miswriting a prescription.

Medication errors are more common than adverse events, but result in harm less than 1% of the time. About 25% of adverse events are due to medication errors.

Not all medication errors lead to adverse outcomes.

Adverse Drug Reactions (ADR) vs Adverse Events (AE) vs Medication Errors (ME)

Seriousness of Adverse drug reactions

Serious ADR• Life-Threatening• Hospitalization (initial or prolonged)• Disability• Death• Congenital Anomaly• Medically important event or reaction• Cause Cancer

OTHER WISE ADR IS NON-SERIOUS

Serious reports should be submitted in expedited manner i.e. as soon as

possible & no later than 15 calendar

daysThus they best submitted

Online Email or Fax

We are almost there

A VALID REPORT CONSISTS OF:-

• Identifiable patient

• Identifiable drug (pharmaceutical product)

• Identifiable reaction

• Identifiable reporter

Who should report? • Healthcare Professionals

• Marketing authorization holder (MAH)

• Patients & their relatives

• Nurses

• Pharmacists

Reports Journey

Reporter QPPV Data entry RA

Workshop

Q1:- Define Pharmacovigilance:

Pharmacovigilance is

the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem

Q2:-Why do we need Pharmacovigilance ?

• Humanitarian concern

• Medicines are supposed to save lives

• ADRs are expensive !!

• Promoting rational use of medicines and adherence

• Ensuring public confidence

• Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical

Q3:- What are limitations to Clinical trials:

1. Small number of patients studied

2. Restricted populations (age, sex, ethnicity)

3. Narrow indications

4. Short duration of drug exposure

Q4:- Define ADRs :

Response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect

Q5:- Mention four examples for serious ADR:

1. Life-Threatening

2. Death

3. Congenital Anomaly

4. Disability

Q6:- Mention four criteria for a valid report:

1.Identfiable patient

2.Identfiable Drug

3.Identfiable reaction

4.Identfiable reporter

Q7:- Who should report ?

1. Healthcare professional

2. Marketing Authorization Holder

3. Nurses

4. Pharmacist

5. Patient

Contact informationDr. Rania Kamel

Rania.Kamel@hotmail.com

Dr. Nahla Raafat

nahlaraafat@gmail.com