POM to P 1

Question 1

outline the criteria for the reclassification of a POM-to-P

Answer 1

1) Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription.
2) That is it is a medicine which no longer fulfils any of the following criteria:
- likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor
- 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 the activity requires, or the side effects require, further investigation
- normally prescribed by a doctor for parenteral administration

Question 2

Outline the criteria for the reclassification of a P-to-GSL

Answer 2

Ministers must be satisfied that :

1) can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist’ (Medicines Act 1968, section 51).
2) ‘Reasonable safety’ may be usefully defined as “Where the hazard to health and the risk of misuse and the need for special precautions in handling are small, and where wider sale would be a convenience to the purchaser”

Question 3

Less often medicines can be upgraded from P to POM if new risks are identified . Outline the criteria for the reclassification of a P-to-POM.
- give examples

Answer 3

1) When a P medicine product no longer meet the requirements for supply with legal status ‘P’ for example being likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor
2) Recent examples; Diclofenac and Domperidone

Question 4

what authorisation do new medicines normally have?

- if P medicines which have been safely used for several years what might happen to their classification?

Answer 4

1) New medicines are usually authorised for use as POMs
2) P medicines which have been safely used for several years may be reclassified as GSL
3) Reclassification of a product follows a request from the company which holds a marketing authorisation for it
- Requests can be made by any interested party
4) Less often medicines can be upgraded from P to POM if new risks are identified
5) GSL medicines could be reclassified as P if new information showed that it was no longer safe to supply it without a pharmacist checking that it was suitable for the patient

Question 5

who evaluates Applications to reclassify medicines? outline the Reclassification procedure

Answer 5

1) Applications to reclassify medicines are evaluated by the MHRA
- Advice from a suitable expert committee
- Where it is considered that the proposed reclassification may safely be made, public consultation, via the MHRA website can take place
- Responses to the consultation are evaluated by the MHRA and advice is sought from the CHM if a new safety issue is raised during consultation
2) Successful reclassification proposals lead to a change of legal status being conferred on the product.
3) 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 6

list some Recent POM to P changes

Answer 6

1) Tamsulosin hydrochloride 400mcg capsules
2) Tranexamic acid 500mg tablets
3) Rabeprazole 10mg tablets
4) Esomeprazole 20mg tablets
5) Ulipristal acetate tablet (ellaOne)

Question 7

list some recent P to POM changes

Answer 7

1) Diclofenac 12.5mg/25mg tablets - Voltarol®
2) Domperidone 10mg tablets - Motilium®
- Both drugs we reclassified due to new evidence indicating a small increased risk of serious cardiac effects with their use

Question 8

what is EHC and how does it work? name two brands and the doses

Answer 8

1) 2 options:
- Levonorgestrel 1500mcg tablet (Levonelle©)
- Ulipristal acetate 30mg tablet (ellaOne©)
2) EHC’s work by inhibiting or delaying ovulation (the release of an ovum), so that fertilisation cannot take place
3) Dose: ONE tablet taken orally as soon as possible within the licensed time frame

Question 9

compare and contrast ellaOne and levonelle

Answer 9

1) license:
- ella : Licensed for woman of childbearing age including adolescents
- levo: Licensed for women ≥ 16 years (unless supplied through PGD*)
2) how long after sex:
- ella: Can be used up to 120 hours after unprotected sex
- levo- Can be used up to 72 hours after unprotected sex
3) mechanism of action:
- ella: Progestogen receptor modulator; inhibits or delays ovulation, alters the endometrial epithelium, and can reduce fibroid size
levo: Unclear mode of action but is thought to delay ovulation by 5 -7 days and arrests the development of the ovarian follicle
4) risk of unplanned pregnancy:
- ella: 0-24 hours, 9 in 1000, 0-72 hours, 14 in 1000, 0-120 hours, 13 in 1000
- levo: 0-24 hours, 23 in 1000, 0-72 hours, 22 in 1000
5) price: ella: £35.00, levo: £27

Question 10

outline the EHC Pill Discussion Guidelines

Answer 10

1) Consider the female’s age
2) Check when unprotected sex or contraceptive failure happened
3) Check if she is taking any medications; including OTC or herbal preparations
4) Check if she has any medical conditions or other factors to consider e.g. pregnancy, allergies, breastfeeding
5) If both options are appropriate ensure she understands all the information to make her choice
6) Counsel female on chosen product and future contraceptive options

Question 11

before the consultation what should you ask?

Answer 11

1) age- ask for id especially for levonelle
2) is it for you? boyfriend might come in
3) cost its not free , if you have a PGD you can sell it for free -walk in centre free
4) do you want someone to accompany them in the consultation?
5) Have you had unprotected sex within the last 120 hours (5 days)? greater than 5 days refer.
- missed pills? take as soon as possible
6) currently taking any other medicines?-
- Liver enzyme inducers (CYP3A4 inducers) sj johns
7) Do you have any medical conditions or other factors to consider: severe hepatic impairment or galactose intolerance? Severe asthma? allergies? breastfeeding?

Question 12

outline the advice given to patients before taking the Pill

Answer 12

1) Dose: 1 tablet immediately
2) If they vomit or have severe diarrhoea within 3 hours of taking the tablet they must take another dose
3) Cycle may be disrupted with use of EHC, ensure you advise they do a pregnancy test if period is > week late or bleeding differs to normal
4) Side effects; headache, nausea, abdominal pain, and painful periods
5) Inform EHC will not protect against future sexual intercourse.

Question 13

what other non pharmacological advice would you give to patients who have come in requesting the pill?

Answer 13

1) Future contraception options
2) STI’s
3) Use of lubricants with condoms

Question 14

discuss the supply of EHC to To Females of Child-bearing Age

Answer 14

1) Must assess female’s understanding and competency to consent
2) Be aware of important issues such as non-consensual intercourse, child protection, vulnerable adults, consent and confidentiality
3) Sexual activity with children under the age of 16 is also an offence but may be consensual. 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 15

outline the referral criteria for EHC

Answer 15

1) If unprotected sexual intercourse or failure of a contraceptive method was more than 120 hours ago
Pregnant woman
2) If taking any of the following medicines: carbamazepine, griseofulvin, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, ritonavir, oxcarbazepine, fosphenytoin, St.John’s wort, & ciclosporin.
3) Problems that may affect absorption of the oral emergency contraception (e.g. vomiting, severe diarrhoea, Crohn’s disease)
4) Severe hepatic dysfunction Previous allergy or reaction to either EHC
5) ellaOne is not recommended for women with severe asthma treated by oral corticosteroids

Question 16

discuss the Refusal To Supply EHC because of religious or Moral Beliefs

Answer 16

You must make sure that if your religious or moral beliefs prevent you from providing a service, you tell the relevant people or authorities and refer patients and the public to other providers

Question 17

discuss the provision of an advanced supply of EHC

Answer 17

1) Should not be given routinely but may be considered if necessary i.e. when women relying solely on a barrier method or travelling abroad
2) Assess if clinically appropriate, and the customer using it is competent and that they intend to use it properly
4) Non-judgemental

Question 18

Your healthcare advisor refers a customer to you who has requested Levonelle®. On questioning, you discover that she has missed one tablet of Marvelon from the middle of the pack. How do you proceed?

Answer 18

1) If a woman misses 2 or more pills (especially from the first 7 in a packet), she may not be protected. She should take an active pill as soon as she remembers and then resume normal pill-taking. In addition, she must either abstain from sex or use an additional method of contraception such as a condom for the next 7 days. If these 7 days run beyond the end of the packet, the next packet should be started at once, omitting the pill-free interval (or, in the case of everyday (ED) pills, omitting the 7 inactive tablets).
2) A missed pill for a woman taking Qlaira® or Zoely® is one that is 12 hours or more late.
3) Emergency contraception is recommended if 2 or more combined oral contraceptive tablets are missed from the first 7 tablets in a packet and unprotected intercourse has occurred since finishing the last packet.