Pharmacopeia

Question 1

What is the compendia? What can it be divided into?

Answer 1

books that contain the standards for the drugs and other related substances

official - pharmacopoeia
non-official - Martindale

Question 2

What are substandard drugs?

Answer 2

drugs that are produced by legitimate manufacturers and fail to meet the pharmacopoeia specifications used for its formulation

Question 3

What are counterfeit drugs?

Answer 3

a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source

Question 4

What makes a drug counterfeit?

Answer 4

no active ingredient

correct ingredient but from an illegitmate manufacturer

a different active ingredient than on the label

insufficient active ingredients

fake packaging

fraudulent labelling

Question 5

How can the production of counterfeit drugs be inhibited?

Answer 5

anti-counterfeit features
- at least one marker should be incorporated in every finished pack, and where appropriate more than one feature should be used

secure operations

• raw materials and components must be sourced from audited and secure suppliers
• all waste components, tooling and equipment must be securely disposed of
• intermediates and finished products must be stored and transported under secure conditions

procedures
- must be documented for the handling and investigation of suspect packs, consistent with Corporate Policy

appropriate measures
- should be implemented to prevent repeat occurrences of counterfeiting

Question 6

What are the requirements for anti-counterfeit features?

Answer 6

must be kept secret
may not be difficult to copy if compromise
can be used in combination
can be relatively easy to incorporate
can be changed or added to
can be VERY cost-effective

example - hologram

Question 7

What are the consequences of counterfeit drugs?

Answer 7

ineffective drug therapy
- prolonged illness

treatment failure

side effects, allergic reactions, drug interactions and toxicity

increased drug resistance

death.

Question 8

What should a record be kept for? What should a record include? How long should it be kept for?

Answer 8

a record should be kept for

• special manufactures
• extemporaneous preparations

must include

• formula
• ingredients
• quantities used
• source of ingredients
• batch number
• expiry date

record must be kept for 5 years

Question 9

What are the requirements for preparations for internal use?

Answer 9

expiry of the diluted preparation is 14 days unless otherwise stated

always label “Store in a Cool Dry Place”

Question 10

What are the requirements for preparations for external use?

Answer 10

expiry = 14 days unless otherwise stated

always label “Store in a Cool Dry Place”

Question 11

What are the requirements for dilutions?

Answer 11

it is important to avoid bacterial contamination and application of heat

dilutions should always be freshly prepared
- made not more than 24 hours before being issued for use