Pharmacoepidemiology

Question 1

Define epidemiology and pharmacoepidemiology

Answer 1

Pharmacoepidemiology- study of therapeutic effects, risk, and use of drugs in populations.
- Merge clinical pharmacology (drug exposure and individual effects) and epidemiology (risk factors for disease in populations)

Question 2

Describe the role of pharmacoepidemiology in QUM

Answer 2

Can use RCTs in clinical phase to check safety and efficacy and post-approval phase to determine effectiveness

limitations: short duration, small sample size, narrow population (excludes young women, children, elderly), and limited comparison groups (placebo)

Assess risk, patterns of drug utilisation, cost-effectiveness, efficacy.

Question 3

Describe host-agent-environmental model of public health

Answer 3

Host= recipient of causative agent of disease

Agent= cause of disease, risk factors.

Environment= condition affecting survival and transmission of causative agent

Question 4

define incidence and prevalence

Answer 4

Incidence- measure of new cases of a disease over a period of time. consider new cases.

Cumulative incidence- number of new cases within a specified time period divided by size of population initially at risk

Prevalence- number of people with a disease at one time. new and old cases. measures burden of disease.

Question 5

define DDD and average PDD

Answer 5

Define daily dose
- Assumed average maintenance dose for indication. Measure drug over/under usage.
- DDD’s per 1000 people per day. Hospital= DDDs per 100 bed
DDD= total amount of drug / amount of drug in a DDD

Prescribed daily dose
- Validate DDDs. Average dose prescribed obtained from a sample of scripts.

Question 6

Role of pharmacoepidemiology in drug regulation

Answer 6

Early communication for an ongoing safety review.
e.g. TGA is still evaluating drug safety data and is yet to reach a conclusion.

Public health advisories - provide safety information recommendations to avoid or minimise harm from a medicine

Letters to healthcare professionals- e.g. hydroxychloroquine in covid-19

medical affairs

Question 7

Define endemic

Answer 7

Disease is present in community at all times but in low-frequency. e.g. chicken pox in young school children

Question 8

Define epidemic

Answer 8

sudden outbreak in region or group.
e.g. AIDs in IV drug users

Question 9

Define pandemic

Answer 9

epidemic becomes widespread and affects whole region, continent, or global spread.
e.g. global outbreak of covid-19

Question 10

Types of pharmacoepidemiological studies

Answer 10

Pharmacovigilance
Clinical trials
Observational studies- case report, case series, cross sectional, case control, cohort studies.