Ad Hoc Data Sources

AD HOC DATA SOURCES
WHAT IS AD HOC ??
 Ad hoc is a Latin phrase meaning "for this". It generally signifies a solution

designed for a specific problem or task.
 Common examples are organizations, committees, and commissions created

at the national or international level for a specific task.
 The data sources available for pharmacoepidemiological studies as Ad hoc

sources are those that are collected during post marketing surveillance
studies
 Ad hoc is concerned mainly with one specific purpose i.e providing data
regarding drug safety in long term use or about the drug aspects in a large
population which is seen in post marketing studies compared to pre
marketing studies.
LIMITATIONS OF PRE MARKETING CLINICAL TRIALS
 Size of patient population studied
 Narrow population-often not providing for special groups (geriatric,

pediatric , pregnancy)
 Narrow indication studies
 Short duration (not suitable for chronic diseases)
OBJECTIVES OF POST MARKETING SURVEILLANCE STUDIES :
 Rare adverse effects
 Long term effects
 Effectiveness of the drug for the original indication
 Other benificial effects of drugs can be studied

DIFFERENT AD HOC DATA SOURCES
 SPONTANEOUS REPORTING
 PRESCRIPTION- EVENT MONITORING
 GLOBAL DRUG SURVEILLANCE : The WHO program for international

drug monitoring
 CASE-CONTROL SURVEILLANCE
Global Drug Surveillance: WHO Programme for International Drug

Monitoring
 Drug safety (Pharmacovigilance)
 The science and activities relating to the detection, assessment,

understanding and prevention of adverse effects or any other drug-related
problems.
 It provides a forum for WHO member states to collaborate in the monitoring

of drug safety. Within the Programme, individual case reports of suspected
adverse drug reactions are collected and stored in a common database.
 In each of the countries participating in the Programme, the government has

designated a National Centre for Pharmacovigilance.
 Started in1968.
 In INDIA (1998)
 WHO Headquarters, Geneva
 The Uppsala Monitoring Centre, in Uppsala, Sweden.
 In each country participating in the WHO program there is a national centre,

appointed by the government, responsible for collecting spontaneously
reported suspicions of ADRs , originating from health professionals.
 National centers transform their case reports into specific WHO format and
submit them to the UMC on a regular basis.
Func
tions of the WHO Programme for International Drug Monitoring include:
 Identification and analysis of new adverse reaction signals from the case

report information submitted to the National Centres, and sent from them to
the WHO ICSR database. A data-mining approach (BCPNN) is used at the
UMC to support the clinical analysis made by a panel of signal reviewers
 Provision of the WHO database as a reference source for signal

strengthening and ad hoc investigations.
 Information exchange between WHO and National Centres, mainly

through 'Vigimed', an e-mail information exchange system
 Provision of training and consultancy support to National Centres and

countries establishing Pharmacovigilance systems
 Publication of periodical newsletters, (WHO Pharmaceuticals Newsletter

and Uppsala Reports), guidelines and books in the Pharmacovigilance and
risk management area
 Supply of tools for management of clinical information including adverse
drug reaction case reports. The main products are the WHO Drug Dictionary
and the WHO Adverse Reaction Terminology
 Computer software for case report management designed to suit the needs

of National Centres (VigiFlow)
 Annual meetings for representatives of National Centres at which

scientific and organizational matters are discussed
 Methodological research for the development of Pharmacovigilance as a

science.
advantages-
 1. not influenced by prior knowledge & investigators bias
 2. It is objective, transparent and reproducible
Limitations-
 1. selected mechanism is purely quantitative
 2. No medical or pharmacological considerations.

CASE-CONTROL SURVEILLANCE
There is no assurance that medications are safe at the time they are released to the
market, because premarketing trials for safety and efficacy are
 too small to detect any but common adverse effects and
 too brief to detect effects that occur after long latent intervals or durations of
use.
 Postmarketing surveillance serves not only to document unintended adverse

effects of medications, but also to document beneficial effects unrelated to
the indications for use.
Need for CCS
 Current surveillance systems focus on prescription drugs
 More drugs now are being converted to non-prescription (OTC) medication:

 Ibuprofen, naproxen, cimetidine
 Large increase in their use due to this conversion
 Initially only for acute/ self-limiting diseases
 Drugs for hypercholesterolemia, osteoporosis, HTN also under consideration
 Increase in use of dietary supplements and herbal supplements
History of CCS
 Began in 1976 in US under FDA
 Mainly focussing on monitoring of malignant and non-malignant illnesses
 To detect potential carcinogens
CCS includes monitoring
 of non-prescription drugs and dietary supplements
 as well as prescription drugs.
Method
 Cases and controls are identified
 Cancer patients admitted to the hospital setting are interviewed
 Patients with recently diagnosed malignant and non-malignant conditions

are enrolled (cases and controls respectively)
 Trained interviewers
 Patients between ages of 21 to 79
 Accrual is done based on diagnosis and the priority of the interviewers
 Written informed consent is obtained before interviews are conducted.

 The interview setting—a hospital or clinic room—is similar for cases and
controls.
 The interviewers are unaware if the patient is a “case” or “control” because

many diseases and hypotheses are assessed, and cases in one analysis may
be controls in another.
Among the most common nonmalignant diagnoses are
 traumatic injury (e.g., fractured arm),
 benign neoplasms,
 acute infections (e.g., appendicitis),
 orthopedic disorders(e.g., disc disorder),
 gallbladder disease, and hernias.

Data Collected includes
1. Drug information
 Specific mediaction categories
 Analgesics, cholesterol lowering, OCP’s
 Herbal or dietary supplements etc.
 Drug name, timing, duration, brand name
2. Information on factors other than drugs
 Patient demographics:
 Age, height, weight changes over a period of time, racial/ethnic

group.
 Habits
 Medical history
 Family history and use of medical care
 Reproductive and gynecologic factors for women
3. Information on hospital record
 A copy of the discharge summary is obtained for every patient enrolled in

the study and the pathology report for all patients with cancer.
4. Biologic samples (buccal cell samples)
 A biologic component was added in 1998: participants provide cheek cell

samples from which DNA is extracted and stored.
 All participants provide written informed consent separately for the
interview and for the buccal cell sample.
Data analysis
 Statistical power
 Is excellent for detection of association of public health importance
 Drug/Genotype analysis
 Assessment of association of a drug as an etiologic factor being

modified by a certain genotype is also assessed
 Discovery of unsuspected associations
 Associations derived from animal studies can be further confirmed
 Data analysis
 Hypothesis testing:
 Proper cases and controls have to be selected for a valid result
 Drug use aspects:
 Drug use at least 1 yr prior is inspected (cancer)
 Particular drug category is selected based on the hypothesis
 Dosing, frequency and duration provide useful measure in intensity of

exposure
 Control of confounding factors:
 ODD’s Ratio
 Effect modification
 Assessed by examining exposure-disease associations in sub-groups

and statistical modelling
 E.g. Estrogen supplements in relation to breast cancer (more in thin
women)
Strengths and weakness
Strengths
 Assessment of non-prescription medication and dietary supplements along

with prescription medication
 Discovery of unsuspected association
 Assessment of chronic drug usage
 Control of confounding
 Accurate data outcome
 High statistical power
 Biological component
Weaknesses
 Potential for bias
 Selection
 Recall bias
APPLICATIONS
 CCS has the capacity to assess the risk of illnesses in relation to use of
prescription drugs, non-prescription drugs, and dietary supplements
 documents increased risk, decreased risk, and absence of risk.
 generates important new hypotheses, probably the most important of which

are the positive association of alcohol with breast cancer and the inverse
association of nonsteroidal anti-inflammatory drugs with large bowel cancer.
 CCS has also made contributions to assessment of the health effects of non-
drug factors, such as the tar and nicotine content of cigarettes, menthol
cigarette smoking, alcohol and coffee consumption, and vasectomy.
The drugs and drug classes assessed include
 ACE inhibitors, acetaminophen, antidepressants, antihistamines, aspirin and

other NSAIDs, benzodiazepines, beta-blockers, calcium channel blockers,
female hormone supplements, hydralazine etc .
The diseases assessed include
 breast cancer, ovarian cancer, endometrial cancer, choriocarcinoma, prostate

cancer, large bowel cancer and other gastrointestinal cancers, lung cancer,
melanoma, liver cancer, pelvic inflammatory disease, cholecystitis, venous
thromboembolism.
Fazit
 CCS proves to be an important tool in monitoring effects of prescription and

non-prescription medication. This data source provides not only for
hypothesis testing but also its generation in some cases. Hence the scope of
the use of CCS as a data source is broad with a major contribution to study
of health effects.

Ad Hoc Data Sources

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AD HOC DATA SOURCES

 Ad hoc is a Latin phrase meaning "for this". It generally signifies a solution

 Common examples are organizations, committees, and commissions created

 The data sources available for pharmacoepidemiological studies as Ad hoc

LIMITATIONS OF PRE MARKETING CLINICAL TRIALS

 Size of patient population studied

 Narrow population-often not providing for special groups (geriatric,

 Narrow indication studies

 Short duration (not suitable for chronic diseases)

OBJECTIVES OF POST MARKETING SURVEILLANCE STUDIES :

 Rare adverse effects

 Long term effects

 Effectiveness of the drug for the original indication

 Other benificial effects of drugs can be studied

 PRESCRIPTION- EVENT MONITORING

 GLOBAL DRUG SURVEILLANCE : The WHO program for international

Global Drug Surveillance: WHO Programme for International Drug

 Drug safety (Pharmacovigilance)

 The science and activities relating to the detection, assessment,

 It provides a forum for WHO member states to collaborate in the monitoring

 In each of the countries participating in the Programme, the government has

 WHO Headquarters, Geneva

 The Uppsala Monitoring Centre, in Uppsala, Sweden.

 In each country participating in the WHO program there is a national centre,

 Identification and analysis of new adverse reaction signals from the case

 Provision of the WHO database as a reference source for signal

 Information exchange between WHO and National Centres, mainly

 Provision of training and consultancy support to National Centres and

 Publication of periodical newsletters, (WHO Pharmaceuticals Newsletter

 Computer software for case report management designed to suit the needs

 Annual meetings for representatives of National Centres at which

 Methodological research for the development of Pharmacovigilance as a

 1. not influenced by prior knowledge & investigators bias

 2. It is objective, transparent and reproducible

 1. selected mechanism is purely quantitative

 2. No medical or pharmacological considerations.

 too small to detect any but common adverse effects and

 Postmarketing surveillance serves not only to document unintended adverse

Need for CCS

 Current surveillance systems focus on prescription drugs

 More drugs now are being converted to non-prescription (OTC) medication:

 Large increase in their use due to this conversion

 Initially only for acute/ self-limiting diseases

 Drugs for hypercholesterolemia, osteoporosis, HTN also under consideration

 Increase in use of dietary supplements and herbal supplements

 Began in 1976 in US under FDA

 Mainly focussing on monitoring of malignant and non-malignant illnesses

 To detect potential carcinogens

CCS includes monitoring

 of non-prescription drugs and dietary supplements

 as well as prescription drugs.

 Cases and controls are identified

 Cancer patients admitted to the hospital setting are interviewed

 Patients with recently diagnosed malignant and non-malignant conditions

 Patients between ages of 21 to 79

 Accrual is done based on diagnosis and the priority of the interviewers

 Written informed consent is obtained before interviews are conducted.

 The interviewers are unaware if the patient is a “case” or “control” because

Among the most common nonmalignant diagnoses are

 traumatic injury (e.g., fractured arm),

 acute infections (e.g., appendicitis),

 orthopedic disorders(e.g., disc disorder),