POM to P

Question 1

What are P medicines?

Answer 1

Sold in a pharmacy without a prescription Under the supervision of a pharmacist

Question 2

What are GSL medicines?

Answer 2

Can be sold in general retail outlets without supervision of a pharmacist

Question 3

List 3 requirements for reclassification from POM to P

Answer 3

1. Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription
2. Unlikely to present a danger to human health if used without the supervision of a doctor
3. Difficult to use incorrectly

Question 4

List 3 requirements for reclassification from P to GSL

Answer 4

1. Ministers must be satisfied that the medicine can be sold or supplied by someone other than a pharmacist and without their supervision
2. Need for special precaution is small
3. Wider sale would be of convenience to the purchaser

Question 5

Why could a P medicine be reclassified to a POM?

Answer 5

When new risks are identified Likely to present a danger to human health, even when used correctly, if used without the supervision of a doctor

Question 6

List 2 examples of recently reclassified drugs from P to POM

Answer 6

1. Diclofenac
2. Domperidone
   Due to new evidence indicating a small increased risk of serious cardiac effects

Question 7

What are new medicines usually classified as?

Answer 7

POM

Question 8

What causes a product to be reclassified?

Answer 8

A request from the company which holds a marketing authorisation for it

Question 9

Which agency evaluates applications to reclassify medicines?

Answer 9

MHRA Medicines and Healthcare Products Regulatory Agency

Question 10

How does the MHRA reclassify a medicine?

Answer 10

Advice from a suitable expert committee
Public consultation
The reclassification application is to a specific marketing authorisation - other products with the same active ingredient will need to make separate applications

Question 11

What are the 2 options of EHC (emergency hormonal contraception)

Answer 11

1. Levonorgestrel 1500mcg tablet (= Levonelle)

2. Ulipristal acetate 30mg tablet (= ellaOne)

Question 12

How do EHCs work?

Answer 12

Inhibit or delay ovulation so that fertilisation cannot take place

Question 13

What are the different age ranges that Levonelle and ellaOne are licensed for?

Answer 13

Levonelle = women over 16 
ellaOne = women of childbearing age including adolescents

Question 14

What are the different time frames that Levonelle and ellaOne must be taken in to be effective?

Answer 14

Levonelle = up to 72 hours after unprotected sex 
ellaOne = up to 120 hours after unprotected sex

Question 15

What is the mechanism of action of Levonelle?

Answer 15

Unclear but thought to delay ovulation by 5-7 days and arrests the development of the ovarian follicle

Question 16

What is the mechanism of action of ellaOne?

Answer 16

Progesterone receptor modulator
Inhibits or delays ovulation
Alters the endometrial epithelium (lining of the uterus)
Can reduce fibroid size

Question 17

Explain the EHC pill discussion guideline (6)

Answer 17

Consider the female’s age
Check when unprotected sex or contraceptive failure happened
Check if she is taking any medications (inc. OTC and herbal)
Check if she has any medical conditions or other factors to consider (pregnancy, allergies, breastfeeding)
If both EHC options are appropriate, ensure she understands all the information to make her choice between them
Counsel female on chosen product and future contraceptive options

Question 18

What are the 3 counselling points for EHC?

Answer 18

If she vomits or has diarrhoea within 3 hours of taking it then she must take another dose
Cycle may be disrupted with use of EHC, advise they do a pregnancy test if period is more than 1 week late
Inform that EHC will not protect against future sexual intercourse

Question 19

What are the possible side effects of EHC?

Answer 19

Headache
Nausea
Abdominal pain
Painful periods

Question 20

What advice can you give the patient to ensure they do not need EHC again?

Answer 20

Explain future contraceptive options

Talk about risk of STIs if barrier contraception is not used Use of lubricants with condoms to stop splitting

Question 21

List 4 referral criteria for women wanting EHC

Answer 21

Pregnant women
If unprotected sex occurred more than 120 hours ago (5 days)
Severe hepatic dysfunction ellaOne is not recommended for women with severe asthma treated by oral corticosteroids

Question 22

What is Tamsulosin used to treat?

Answer 22

Prostate enlargement a.k.a. benign prostatic hyperplasia (BPH)

Question 23

Name 2 factors that are known to contribute towards prostate enlargement

Answer 23

1. Aging

2. Long term exposure to testosterone, particularly dihydrotestosterone

Question 24

What is the mechanism of action of Tamsulosin?

Answer 24

Alpha-1 adrenoceptor antagonist (alpha-1 blocker) Relaxes smooth muscle in benign prostatic hyperplasia

Question 25

What is hyperplasia?

Answer 25

The enlargement of an organ or tissue due to an increase in the reproduction rate of its cells Often an initial stage of cancer

Question 26

List 4 symptoms of lower urinary tract infections (LUTs)

Answer 26

1. Urinary hesitancy 2. Weak stream 3. Frequent urination 4. Urgency

Question 27

List 3 ways that patients may describe a UTI

Answer 27

1. Bladder never feels completely empty 2. Weeing more often 3. Needing to wait before starting to wee

Question 28

What is the brand name of Tamsulosin?

Answer 28

``` Flomax relief (OTC) Single 400mcg slow release capsule after the same meal each day ```

Question 29

List 3 pieces of non-pharmacological advice for Flomax Relief

Answer 29

1. Avoid drinking any liquids for 1-2 hours before going to bed (help to improve symptoms of nocturia) 2. Stop/limit drinking alcohol or caffeine (can irritate bladder and make symptoms worse) 3. Increasing amount of fruit and fibre eaten to avoid constipation - can put pressure on bladder

Question 30

List 3 possible side effects of Flomax/Tamsulosin

Answer 30

Dizziness Drowsiness Blurred vision

Question 31

What is Sumatriptan (Imigran) used to treat?

Answer 31

Treatment of migraine, not prevention No aura experienced by patient 18-65 years old Stable and well-established pattern of symptoms

Question 32

What is the mechanism of action of Sumatriptan

Answer 32

Belongs to a group of medicines called triptans 5HT1 receptor agonist Acts on the 5HT1 receptors in the brain to stabilise the blood vessels which are involved in migraine attacks

Question 33

What are migraines?

Answer 33

A condition resulting from spasm and subsequent over-dilation of certain arteries in the brain Causes recurrent throbbing headache that characteristically affects one side of the head Associated with other symptoms that distinguish it from normal headache - nausea, vomiting, changes in vision and hearing

Question 34

List 3 counselling points for Sumatriptan/Imigran

Answer 34

Advise to take tablet as soon as possible after onset of migraine If symptoms return after initial relief, a 2nd dose can be taken after 2 hours Excessive use of triptans may lead to chronic daily headache or exacerbation of headache

Question 35

List 3 benefits of Sumatriptan/Imigran being an OTC medication

Answer 35

Triptans need to be taken as early as possible in a migraine attack: Infrequent attacks so may be unlikely to always have supplies No need to waste time visiting Dr The impact of migraine (missed work, altered mood, reduced quality of life) may be reduced