WorksheetsPharmacy Practice Unit 1, ADR and Community Pharmacy
Total questions: 20
Worksheet time: 20mins
Excessive pharmacological effects (Type A) are:
Rare and unpredictable
Dose dependent and predictable
Due to genetic factors
Only from drug withdrawal
Secondary pharmacological effects refer to:
Effects beyond target organ due to known pharmacology
Genetic idiosyncratic responses
Withdrawal reactions
Allergic (hypersensitivity) reactions
Idiosyncratic drug reactions (Type B) are:
Dose dependent
Predictable
Unpredictable and not concentration dependent
Withdrawal effects
Allergic drug reactions involve:
Phase I metabolism variation
Nonimmune response
Immune mediated (often IgE) hypersensitivity
Additive pharmacologic effects
Genetically determined toxicity includes:
Typical dose effects
Drug withdrawal syndrome
Abnormal metabolism based on inherited CYP variants or enzyme deficiencies
Additive drug interactions
Toxicity following sudden drug withdrawal (Type E):
Dosedependent toxicity
Chronic exposure effects
Withdrawal syndrome after abrupt stoppage
Late-onset carcinogenicity
Beneficial drug interactions are characterized by:
Increased toxicity
Reduced therapeutic effect
Enhanced therapeutic efficacy
Unpredictable adverse effects
Pharmacokinetic drug interactions often result from:
Immune hypersensitivity
Shared metabolic pathways (e.g. CYP inhibition/induction, Pgp changes)
Withdrawal phenomena
Genetic abnormalities
A primary method for detecting drug interactions in real world use is:
Randomized controlled trials only
Spontaneous case reports (SRS)
Animal testing
Premarketing nonclinical studies
Record linkage studies involve:
Reporting by physicians only
Linking healthcare databases to detect ADR associations
Laboratory allergy testing
Genetic testing only
An individual case safety report (ICSR) must include:
Drug dose only
Patient's genetic profile
Patient, reporter, suspect drug, and event
Cohort study results
A standard management step when ADR is suspected is to:
Ignore and continue therapy
Adjust dosage or discontinue suspect drug and monitor resolution
Increase dose for resolution
Switch to a stronger drug
Spontaneous ADR reporting systems are limited by:
Over-reporting of minor events
Under reporting, especially of mild or known reactions
No statistical methods for analysis
Incompatibility with WHO standards
What is the minimum qualification required on site in a community (retail or wholesale) pharmacy in India?
Matriculation and experience
Diploma in Pharmacy or B. harm and registration under the Pharmacy Council
Any graduate degree
No formal qualification required
According to good storage practices, which principle applies when organizing the shelves?
Last In First Out (LIFO)
Random placement to save space
Alphabetical by brand name only
FIFO and FEFO rotation (Store drugs using First In First Out and First Expire First Out principles)
Which license form is required to sell Schedule X drugs in retail pharmacies?
Form 19
Form 20
Form 21
Form 20F
Extemporaneously prepared powders and capsules should have labeling instructions such as:
No label needed
‘
Store in dry place’
Expiry term listed as indefinite
No caution for external use
Community pharmacists must be registered under which Act?
Pharmacy Act, 1950
Pharmacy Act, 1948
Drugs Act, 1940
Food & Drug Act, 1970
Which document is required when applying for a new retail drug store license?
Diploma attestation, registration, affidavit, and layout map
Only diploma certificate
Financial statements only
Employee appointment letters
Schedule N compliance is relevant for:
Banks in India
Hospitals
in India
Modern drug stores in India
Traditional herbal shops in India
