1. Pharmacovigilance & Adverse Drug Reactions Dr. Habab Khalid Elkheir
Introduction to
Pharmacovigilance & Adverse Drug Reactions
Reporting systems
Dr. Habab Khalid Elkheir
B.Pharm., M.Pharm., PhD
ISOP
ISPE
IUATLD
SSCP
1/1/2019
Habab khalid Elkheir

2. Objectives of the workshop
Learning objectives By the end of this training course 1. The participants should be able to: a. Define PV and related terms b. Fill the ADR form 2. The participants should be acquainted with: i. different methods of ADR reporting ii. The minimum requirements of an ADR report
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3. Content of this session
Definition of pharmacovigilance (PV)
Major aims of PV
Related definition to PV
Why PV?
Global magnitude of Averse drug reactions
Importance of PV to health care providers & patients
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4. What is Pharmacovigilance
And I guess we have to be thankful for that as it provides many of us in the industry with a job and a means to pay the mortgage
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5. Medicine Safety Molière To undergo treatment
you have to be very healthy, because apart from your sickness
you have to stand the medicine.
Molière
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6. Vigilance Vigilare = to watch Alert Watchfulness
Forbearance Of Sleep; Wakefulness
Watchfulness In Respect Of Danger;
Care; Caution; Circumspection
Process Of Paying Close And Continuous Attention
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7. Definition of pharmacovigilance (PV)
The science and activities concerned with the Detection Assessment Understanding Prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs).
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8. Pharmacovigilance Major Aims
early detection of unknown safety problems
detection of increases in frequency
identification of risk factors
quantifying risks
preventing patients from being affected unnecessarily
Rational and Safe use of Medicines (WHO)
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9. Related Definitions
Drug: A pharmaceutical product, used in or on the human body for the prevention, mitigation, diagnosis and/or treatment of disease, or for the modification of physiological function. This definition includes prescribed medicines, over-the-counter medicines, vaccines, herbal medicines, traditional medicines and biologicals including blood and blood- related products e.g. sera, plasma etc.
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10. Related Definitions
Adverse Drug Reaction (ADR) A response to a medicine used in humans or animals, which is noxious and unintended, including lack of efficacy, which occurs at any dosage and can also result from overdose, misuse or abuse of a medicine
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11. Related Definitions
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12. 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.
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13. A Serious Adverse Event (Experience) or Reaction
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires patient hospitalization, or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, causes a congenital anomaly or birth defect, and requires an intervention to prevent permanent impairment or damage.
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14. A side effect
Any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug.
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15. Signal
A reported information on a possible causal relationship between an adverse event and a drug; the relationship being unknown or incompletely documented previously.
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16. Why Pharmacovigilance ?
1- New Products Information Collected During The Premarketing Phase Are INCOMPLETE ! With Regard To ADR .
2- Animal Tests Are Insufficient In Predicting Human Safety .
3- In Clinical Trials Patients Are Selected And Limited In Number.
The Condition Of Use Differ From Those In Clinical Practice And Duration Of Trial Is Limited .
4. Information About Rare But Serious ADRS , Chronic Toxicity , Use In Special Groups ( Children , Elderly Or Pregnant Women ) DI Is Often Incomplete Or Not Available
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17. Limitations Of Pre-approval Clinical Trials
Size (Maximum 3,000-5,000 Subjects)
Sometimes Larger For Vaccine
Narrow Population
Often Does Not Include Special Groups
(e.g., Children, Elderly)
Narrow Indications Not Covering Actual Evolving Uses In Practice
Short Duration (1-3 Years)
Latent Effects Not Directly Measured
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18. Limitations of Pre-marketing Trials-1
Carefully selected subjects may not reflect real-life patients in whom drug will be used
Study subjects may receive better care than real-life patients
Short duration of treatment
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19. Limitations of Pre-marketing trials-2
Study size
Studies with 3000 patients cannot reliably detect adverse events with an incidence of < 1 per 1000, even if severe
Studies with 500 patients cannot reliably detect adverse events with an incidence of < 1 per 166, even if severe
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20. Consequences of Limitations of Pre-marketing Trials
About 20% of drugs get new “black box” warnings after marketing
About 4% of drugs are ultimately withdrawn for safety reasons
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21. Pharmacovigilance Is Needed In Every Country
Differences Between Countries (Even Regions Within The Same Country)
In ADR Occurrence & Drug-related Problems Due To :
1- Differences In Drug Production
2- Differences In Drug Distribution & Use (Choice, Indications Or Dose.)
3- In Genetics, Diets & Traditions Of People
4- In The Composition, Excipients Or Quality Of Locally Produced Drug.
5- Traditional Local Remedies May Pose Special Toxicology Problems.
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22. WHO Global PV Programme Why??
World Health Assembly Resolution 16.36
INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use.
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24. On September 30, 2004, Merck and Co
On September 30, 2004, Merck and Co. voluntary withdrew rofecoxib (Vioxx) due to increased risk of CV events
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B J Clin Pharm 2007

25. The magnitude of ADR problems globally
Meta-analysis of studies in hospitals:
USA:
ADRs are the 4th – 6th leading cause of death.
Overall incidence of serious ADRs was 6.7%
Fatal ADRs accounted for 0.32%.
Hospital admissions due to ADRs (1970 – 1975) were between % with a median of 5.8%.
2000, drug related morbidity / mortality costed billion $
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26. The magnitude of ADR problems globally cont..
Meta-analysis of studies in hospitals:
England:
ADRs accounted for 6.5% of hospital admissions
fatality 0.15%
Cost the National Health Services (NHS) £466 million/year
70% of ADRs were considered avoidable
These startling figures do not represent the whole picture
They excluded ADRs caused by other drug related problems such as overdose, drug abuse, misuse
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27. Size or Severity of the ADR Problem in Sudan
Unfortunately, due to inadequate research in this area in Sudan, there is a lack of information on the extent of burden due to ADRs in terms of morbidity, mortality and financial drain on the health system. It can only be presumed that it is worse than what is reported in developed countries due to widespread irrational use of medicines
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28. Benefits of ADR reports to patients and healthcare professionals
ADR reporting would benefit healthcare practitioners and patients by:
Improving the quality of care offered to patients
Reducing drug related problems leading to better treatment outcomes
Enhancing patients ‘confidence in practitioners
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29. Benefits of ADR reports to patients and healthcare professionals
Contributing to global knowledge on drug safety issues
Providing access to feedback information on drug related problems reported within the country and internationally
Providing satisfaction for the fulfillment of a moral and professional obligation
Guaranteeing patient safety
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30. The Big Three
More than 300 products in the pipeline for neglected diseases, HIV AIDS, TB and malaria
At least half of them will be launched in the coming years in those very settings where there is little or no capacity for post approval monitoring
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Developer Analysis, BVGH, 2012

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32. Thanks for your Attention
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