unlicensed medication

Question 1

what is unlicensed medicines?

Answer 1

Those medicinal products without a UK Marketing Authorisation as issued by MHRA – Licensed products may be identified by PL followed by number

Question 2

what is marketing authorisation?

Answer 2

a guarantee of the quality, safety and efficacy of a medicine when used in accordance with the Summary of Product Characteristics.

Question 3

what kind of circumstances mean that unlicesened medication can be given out

Answer 3

There may be circumstances where this is not possible e.g. Medicines for tropical diseases may not be marketed in countries where the disease is not endemic.

Question 4

what is unlicensed used referred to as?

Answer 4

Unlicensed Use – often referred to as ‘off-label’

Using a Licensed Medicinal Product outside what is written in the Summary of Product Characteristics.
Age
Dose
Condition

Question 5

how are unlicensed medicines justified? - law

Answer 5

MHRA Guidance Note 14
How to interpret Human Medicines Regulations 2012

• Use of Unlicensed Medicine only justified when there is no licensed medicine which fully meets patient’s clinical needs– not cost, convenience or operational.
• All in supply chain aware of medicine status
• Records of supply to be kept for 5 years

Question 6

how long should unlicenced medicine supply records be kept for?

Answer 6

5 years

Question 7

who has the responsibilities when supplying an unlicensed medication?

Answer 7

Responsibility for the product lies with the prescriber and with the pharmacist

Need to be sure giving best quality product to the patient-where patient is put at least risk – also minimising risk to ourselves.

Expectation that Unlicensed Medicine is supplied by exception and with full knowledge of all in supply chain – Prescriber to patient

Question 8

what are the considerations for supplying unlicensed medication

Answer 8

• Clinical need established
  - Intolerant to excipient
  - Unable to swallow solid dose formulation
• Product quality
  - Product origin
  - Documentation available

Question 9

in terms of supplying- you use hierarchy of risk which based on what?

Answer 9

Hierarchy of risk – based on product origin

UK licensed medicine - gold standard

try to find information :

Off label use of UK licensed medicine
Imported product licensed in country of origin
UK manufactured product made in MHRA licensed facilities
Extemporaneously dispensed medicine
Imported product not licensed in country of origin
Food supplement/cosmetics

Question 10

uk licensed medication has to undergo what?- how does this relate to unlicensed medication

Answer 10

Undergone rigorous assessment for
Quality –Premises/Raw Materials/Personnel/Process/End product testing
Safety
Efficacy

Off-label use of UK licensed medicine
Quality – tested - confidence
Safety- tested for SPC conditions- confidence depending on condition/patient. Information for patient may not be ‘quite right’
Efficacy – tested for SPC conditions - confidence depending on condition/patient

Question 11

what licence do you need for Imported product licensed in country of origin

Answer 11

Obtained via import agencies -need wholesale dealers licence-register on MHRA website

Standards equivalent to UK – MHRA list e.g. Europe, USA, Canada, Australia, New Zealand, Japan, Israel, Switzerland-quality, safety and efficacy established – is the information in English? are translations available? are they right/make sense?

Standards not equivalent to UK – what do we need to find out-compliance with GMP – clinical trial data?

Question 12

how can you identify UK manufactured product made in licensed facilities

Answer 12

identified by MS followed by number- register on MHRA website

Quality
Premises suitable -checked by MHRA –licensed for product type.
Audits may be available.
Product formula and method of production can be confirmed.
Final product testing may be done and confirmed by means of certificate of analysis
May vary between manufacturers

Safety and Efficacy – not formally tested – usually no SPC or equivalent/information for patients

Question 13

what are extemporaneously dispensed medicine?

Answer 13

Extemporaneously dispensed medicine
Medicines made in a pharmacy under the supervision of a pharmacist.
No end product testing.
Quality –professional responsibility

Safety and Efficacy not formally tested no information

Question 14

unlicensed medicines: Imported product not licensed in country of origin
what needs to be checked?

Answer 14

Need to establish quality- Is it GMP compliant?
What testing is done?

Safety and Efficacy not formally tested

Question 15

unlicensed medicine: Food supplement/cosmetic

what needs to be checked

Answer 15

Need to establish quality as a medicine – Is it GMP compliant?
What testing is done?

Safety and efficacy not formally tested

Question 16

to check patients safety with unlicensed products what needs to be considered

Answer 16

Patient safety first
Communication – ask the right questions never assume

Constant change- new products developed, more information gained for existing products.

Maintenance of supply- bioavailability

May choose to purchase for patient safety – need to assess risks and benefits of all options e.g. infusion bags containing potassium

Timeliness of supply

Question 17

what are the requirements for medical devices?

Answer 17

In order to be registered as a Medical Device then the

primary action must be a physical one and

any pharmacological action is a secondary effect.

Please take note of how/when devices are used.

Question 18

what can go wrong with unlicensed medicines?

Answer 18

there can be things wrong with the certificate
or even the product and if they match.

therefore assess the risks