POM to P

Question 1

What controls the sale and supply of meds?

Answer 1

Medicines Act 1968

Question 2

what marketing authorisation might products be available in?

Answer 2

• POM
• P
• GSL

Question 3

The Criteria for POM to P

Answer 3

• ministers must be satisfied that it would be safe to allow the med to be supplied without a prescription
• it is a medicine which no longer fulfils any of these criteria:
• likely to present a direct or indirect danger to human health, even when used correctly, if used without medical supervision
• frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health
• contains substances or preparations of substances of which activity requires, or the side effects require, further investigation
• normally prescribed by a doctor for parenteral admin

Question 4

Criteria for P to POM

Answer 4

• less often meds can be upgraded from P to POM if new risks are identified
• When a p med product no longer meet the requirements for supply with legal P status, for example, like to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of doctor
• example: diclofenac

Question 5

Criteria for P to GSL

Answer 5

before this occurs, minister must be satisfied that

• ‘can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist’
• ‘reasonable safety’ may be usefully defined as “where the hazard to health and the risk of misuse or the need for special precautions in handling are small, and where wider sale would be a convenience to the purchaser”

Question 6

Reclassification procedure

Answer 6

• new meds are usually authorised for use as POMS
• P meds which have been safely used for several years may be reclassified as GSL
• reclassification of a product follows a request from the company which holds the MA for it, request can also be made by an interested party
• GSL meds could be reclassified to P if new info showed that it was no longer safe to supply it without a pharmacist checking that it was suitable for the patinet
• Applications to reclassify meds are evaluated by MHRA
• advice from a suitable expert committee
• where it is considered that the proposed classification may safely be made, stakeholder groups, public consultation, via the MHRA website can take place
• responses to the consultation are evaluated by the MHRA and advice is sought from CHM if a new safety issue is raised during consultation
• successful reclassification proposals lead to a change of legal status conferred on the product
• the reclassification application is to a specific marketing authorisation and all other products with the same active substance will need to make a separate application to follow suit

Question 7

Consent

Answer 7

• legal age of sex in England is 16
• although not legal, children between ages of 13-15 are able to consent to sexual intercourse
• 13 legally considered unable to consent to sexual activity, this is considered non-consensual and must be reported to the safeguarding lead
• the law is not intended to prosecute mutually agreed sexual activity between young people of a similar age, unless it involves abuse or exploitation

Question 8

Tamsulosin supply criteria

Answer 8

• male 45-75
• symptoms of BPH present for a minimum of three months
• 2 week supply of tamsulosin, if there has been an improvement in urinary sx within initial 2 weeks, further 4 week can be made
• after 6 weeks, further supply can be made only where patient confirms that doc has carried out a clinical assessment and agreed further supplies are appropriate

Question 9

Supply Criteria for migraine

Answer 9

• establish pattern of migraine, 5 or more within the year
• migraine has to be diagnosed by pharmacist or doctor
• other treatment ineffective

Question 10

Sildenafil

Answer 10

-pharmacy supply indicated for patients 18 and above suffering from ED