1. Detection & monitoring of ADR

2. Detection & monitoring of ADR
Pre-marketing Studies
Post-Marketing Surveillance

3. Pre-marketing studies
Studies done before Approval of Drug
Animal Models are starting point of assessment (Before Human Studies start)
Animal Studies provide good assessment of risk , toxicities
Specific test on Carcinogenicity, teratogenicity, mutagenicity to provide specific info
However there is still uncertainty in Animal – Human Prediction

4. Clinical studies (Pre-marketing studies)
< 4000 patients exposed to drug at Approval
Power to detect only ADR which have frequency > 1 %

5. Clinical studies (Pre-marketing studies)
Phase 3 has restrictions on type of patients, This is done to maximize chances of demonstrating effect of drug

6. Clinical studies (Pre-marketing studies)

7. Clinical studies (Pre-marketing studies)

8. Clinical studies (Pre-marketing studies)

9. Post-marketing surveillance
Clinical Studies before approval inadequate to identify all Drug-related risk
Need for strong system to detect ADR post approval
Most Sensitive, Powerful, Cost effective is = Spontaneous Reporting of ADR
Duty of every Healthcare professional to report all ADR
Strong Pharmacovigilance programs needed

10. Post-marketing surveillance
Result of Pharmacovigilance program is detection of signals previously not known
How to verify the link between Adverse event and Drug ?
Two Methods (Epidemiology) commonly used
COHORT STUDIES
CASE-CONTROL STUDIES

11. STUDIES What are Cohort Studies ??
Group of patients (Cohort) are Monitored for Adverse Reactions
Incidence of Adverse Reactions compared to CONTROL group (NO Drug)
What are Case Control Studies ??
Study group of patients that have been affected by Drug
Link that Adverse event to Drug
Useful for rare reactions

12. Adr detection at hospitals
Heath care staff at Hospitals should be VIGILANT in detecting ADR
All adverse events should be carefully examined, evaluated for Drug relation (Differential Diagnosis)
Patient chart review during Wards
Patients that are HIGH risks should be monitored closely
Patients with Renal or Hepatic Impairment
Patients taking drug with ADR potential
Patients with history of Allergic reactions
Patients taking multiple drugs

13. Assessing causality
Causality : What is the extent of relationship between Adverse event and DRUG

14. Assessing causality
If ADR is suspected then ALL relevant data is collected
What drugs patient is taking, Demographics ?
What is adverse reaction, when started, is it still continuing ?
Is the reaction being treated ?
Once the data is obtained, then it is used to correlated / categorized the relationship with DRUG

15. Assessing causality Different approaches to asses causality
Opinion of individual experts
Opinion of Panel of experts
Formal Algorithm

16. Use of algorithms
Collected Data on Adverse Event is critically assessed
One of the several Algorithm used
Several Algorithms available
Naranjo
WHO
European ABO system
French imputation method

17. WHO algorithm

18. Naranjo Algorithm Definite > 9 Probable : 5 – 8 Possible : 1 – 4
Unlikely : < = 0

19. Assessing causality Many Factors while assessing causality
Time relationship between administration of Drug & suspected reaction
Exclusion of other causes
Effect of stopping drug (de-challenge)
Effect of restarting drug (Re-Challenge)
What's the serum concentration of drug

20. Assessing causality
Once DRUG causality is established, this has several applications
Patient Management
Signal Generation
Drug Regulation
Scientific publication
Data exchange

21. Under reporting of ADR
Major deficiency of spontaneous reporting programs
< 5 % ADR are reported to Pvig centers
Many Factors affect HOW the ADR reporting happens
Reporting high for new drugs
Serious, Type B get reported more
Promotional claims of Drug sponsor,
General publicity of ADR within the society

22. Under reporting of ADR Why do Physicians do not report ADR ??
Lack of time
Lack of knowledge
Drug-reaction association uncertain
Fear of litigation
Underlying belief that all medicines are safe

23. Under reporting of ADR What can be done to improve reporting of ADR ??
Improve process, making reporting easier
Provide feedback to clinicians (journal article, newsletter, AE bulletins)
Collaborate with Drugs-therapeutics committee, professional association
Involving other health care personnel (Pharmacist, dentist, nurses, patient)

24. Communicating ADR What can be done to improve communication of ADR ??
Most of ADR info is databases, not readily communicated to doctors
Doctors informed via
Basic training
Continuous education programs
Specially designated Drug Information centers
Package inserts, patient counselling
Mass media campaigns (Important in countries with high rate of self medication)

25. Role of pharmacist in managing ADR
Valuable asset to healthcare team
Monitoring HIGH risk patients
Monitoring patients on DRUGS known to cause ADR
Asses/Document patient allergic status
Asses DDI
Education of other healthcare professionals/Patients
Disseminating information from ADR reports to relevant stakeholders

28. THANK YOU -PHARMA STREET