Pharm 5

Question 1

What is the difference between using a drug on-label and off-label?

Answer 1

• On label = using a drug formulated and registered for a specific species and purpose. Must use it exactly as dose, route, frequency and duration suggests and for the specific purpose. Another other is “off label”
• Off-label = if you have violated an instruction and/or any recommendation that is provided on the packet

Question 2

What is the patent period for a new/pioneer drug?

Answer 2

10 years = patent period for a new or pioneer drug

Question 3

What is a registered copy-cat drug?

Answer 3

After the pioneer/patent period has passed a company creates a drug that is of bio-equivalence.

Question 4

Do compounded drugs need to be registered?

Answer 4

No

Question 5

What is meant by the term drug compounding?

Answer 5

Drug compounding = manipulation of drug prepared by a pharmacist or veterinarian under the instruction of a doctor, dentist or veterinary surgeon to meet specific needs of an individual patient

Question 6

Who is able to request for a drug to be compounded?

Answer 6

vet, dentist, doctor

Question 7

Who is allowed to do the drug compounding?

Answer 7

vet or pharmacist

Question 8

What are the advantages of drug compounding?

Answer 8

• Basically, no regulatory requirements – so you are able to get exactly what you want. Need to be particularly careful with transdermal medication as proof they work is not required
• Often flavored to make more palatable
• Sometimes cheaper

Question 9

What are the disadvantages of drug compounding?

Answer 9

• Owner consent required – legally problematic
• Efficacy unproven – compounding pharmacies do not have to prove the drug works
• Safety is unproven
• Little quality control
• Expiry dates are not always accurate

Question 10

What are some questions that should be asked of a compounding pharmacy?

Answer 10

• What training does the pharmacist have in the formulation of compounded drugs
• What quality assurance programs are in place?
• Are facilities sterile and complying with the Australian standards?
• What are the Standard Operating procedures?
• Does pharmacist have access to appropriate texts/reference books that they can refer to

Question 11

What is an important consideration in informed patient/owner consent?

Answer 11

• Patient needs to have informed consent the “whatever you say doc” is not acceptable
• Need to make sure they know that a registered and non-registered product and which one they are getting
• In some cases, getting them to sign may be the best method – protect yourself in litigation