Unlicensed Medicine

Question 1

What are unlicensed medicine?

Answer 1

Meds without uk MA as issues by MHRA

Question 2

What is MA

Answer 2

-guarantee of quality, safety and efficacy of med when used in accordance with summary of product characteristics

Question 3

Requirements of professional bodies

Answer 3

-all expect licensed meds to be used, there may be circumstances where this is not possible eg. meds for tropical disease may not be marketed in countries where the disease is not endemic

Question 4

HMR 2012 provides an exemption for the need of MA for a med product which is supplies:

Answer 4

• in response to an unsolicited order
• manufactures and assembled in accordance with the specification of a doctor, dentists, pharmacist independent prescriber, supplementary independent prescriber
• for use by a patient who’s treatment that person is directly responsible in order to fulfil the special needs of the patient;. and meets the conditions specific in regulations

Question 5

What does unlicensed actually mean?

Answer 5

using a licensed med product outside what it is written for in the summary product of characteristics

• age
• dose
• condition

Question 6

MHRA guidance Note 14, how to interpret HMR 2012

Answer 6

use of unlicensed medication is only justified if there is no licensed medication which fully meets the patients clinical needs- not cost, convenience or operational

• all in supply chain aware of med status
• records of supply to be kept for 5 years

Question 7

Responsibility when supplying unlicensed med

Answer 7

• responsibility of product lies with prescriber and pharmacist
• need to be sure to give best quality product to patient, where puts patient at least risk, and us as well
• Expectation that unlicensed med is supplied by exception and with full knowledge of all in supply chain, prescriber to patine t

Question 8

Hierarchy of risk – based on product origin

Answer 8

• UK licensed medicine
• 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 9

UK Licensed meds Steps assessment

Answer 9

• Quality
• Safety
• Efficacy

Question 10

Off label use of UK licensed med

Answer 10

Quality: tested- confidence

• Safety: tested for SPC condition, confidence depending on condition/patient. info for patient may not be quite right
• Efficacy: tested for SPC conditions-confidence-depending on patient/condition

Question 11

Imported and licensed in country of origin

Answer 11

• obtained via import agencies: need WDA (H)
• standards equivalent to UK eg. Europe, Canada
• Standard not equivalent to UK? what are they missing?

Question 12

UK manufactured products made in licensed facilities

Answer 12

-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 analysis
-may vary between manufacturers
Safety and Efficacy: not formally tested, usually no SPC or equivalent info for patients

Question 13

Certificate of analysis

Answer 13

• there is variation, relevant to product

- What is being tested and why, use BP as guide

Question 14

Certificate of conformity

Answer 14

Usually only states complies with specification- only useful if u know the specification

Question 15

Extemp dispensed

Answer 15

-med made in pharmacy under supervision of pharmacist
-no end product testing
Quality is professional responsibility
-Safety and efficacy not formally tested no info

Question 16

imported product not licensed in country of origin ; food supplement/cosmetic

Answer 16

• need to establish quality

- safety and efficacy not formally tested