Unapproved medicines

Question 1

Why are so many drugs unapproved for paediatric patients?

Answer 1

Lack of suitable medicines eg. formulation issues

Parents are not willing to hand over their newborns for clinical trials!

Question 2

What are some other terms for “unapproved” medicines?

Answer 2

• Unregistered
• Unlicensed
• Off-label use

Question 3

What criteria are medicines registered with?

Answer 3

• Specific indications
• Dosage form
• Dosing frequency
• Use
• Populations groups

If anything changes (eg. source of ingredients), Medsafe must be informed

Question 4

MA25

Answer 4

Exemptions for practitioners & others

Question 5

MA25 - Exemptions for practitioners & others

Answer 5

Authorised prescribers may manufacture/pack/label medicines to a particular patient of that authorised prescriber

Authorised prescribers may procure the sale/supply of any medicines for patients under their care

–> these include unapproved products

Question 6

MA29

Answer 6

Exemption for medicines required by medical practitioner

Question 7

MA29 - Exemption for medicines required by medical practitioner

Answer 7

Other sections cannot prevent supply by any person to any medical practitioner, on the medical practitioner’s request, of
any medicine required by that medical practitioner for the treatment of a particular patient currently
under that medical practitioner’s care

Sale/supply must be reported to Director-General in writing; disclose practitioner, patient, medicine, place & time of sale

–> pharmacists can only dispense unapproved meds if prescription is supplied by medical practitioner

Question 8

MA26

Answer 8

Exemptions for pharmacists

Question 9

MA26 - Exemptions for pharmacists

Answer 9

• Pharmacist may manufacture/pack/label/sell/supply any medicine if pursuant to a prescription
• Pharmacist can only compound if for specific patient

Question 10

What is the risk of using unapproved medicines?

Answer 10

• No evaluation of safety/efficacy/quality of medicine
• No assurance that product has been manufactured to the same standard as approved medicines

–> requires informed consent (from parent of paediatric patients)

Question 11

HIPC principle 3 - what to tell an individual

Answer 11

Patients should be advised of the forwarding of information under section 29

Question 12

Care of Children Act 2004

Answer 12

Consent given by 16+yo carries same weighting as if the patient was adult

BUT children under 16yo not automatically prohibited from giving consent –> as long as they are competent to make informed choices & validly consent

Question 13

HDC right 7 - informed consent

Answer 13

Customers are presumed to be competent unless there is reasonable indication to suggest otherwise