POM to P: Reclassification of Medicines

Question 1

What are POMs?

Answer 1

Prescription-only medicines

Question 2

What are P medicines?

Answer 2

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

Question 3

What are GSL medicines?

Answer 3

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

Question 4

List 3 requirements for reclassification from POM to P

Answer 4

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 5

List 3 requirements for reclassification from P to GSL

Answer 5

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 6

Why could a P medicine be reclassified to a POM?

Answer 6

• 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 7

List 2 examples of recently reclassified drugs from P to POM

Answer 7

1. Diclofenac
2. Domperidone

Due to new evidence indicating a small increased risk of serious cardiac effects

Question 8

What are new medicines usually classified as?

Answer 8

POM

Question 9

What causes a product to be reclassified?

Answer 9

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

Question 10

Which agency evaluates applications to reclassify medicines?

Answer 10

MHRA

Medicines and Healthcare Products Regulatory Agency

Question 11

How does the MHRA reclassify a medicine?

Answer 11

• 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 12

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

Answer 12

1. Levonorgestrel 1500mcg tablet (= Levonelle)
2. Ulipristal acetate 30mg tablet (= ellaOne)

Question 13

How do EHCs work?

Answer 13

Inhibit or delay ovulation so that fertilisation cannot take place

Question 14

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

Answer 14

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

Question 15

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

Answer 15

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

Question 16

What is the mechanism of action of Levonelle?

Answer 16

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

Question 17

What is the mechanism of action of ellaOne?

Answer 17

• Progesterone receptor modulator
• Inhibits or delays ovulation
• Alters the endometrial epithelium
• Can reduce fibroid size

Question 18

Explain the EHC pill discussion guideline

Answer 18

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

Question 19

What are the 3 counselling points for EHC?

Answer 19

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

Question 20

What are the possible side effects of EHC?

Answer 20

1. Headache
2. Nausea
3. Abdominal pain
4. Painful periods

Question 21

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

Answer 21

• Explain future contraceptive options
• Talk about risk of STIs if barrier contraception is not used
• Use of lubricants with condoms to stop splitting

Question 22

List 4 referral criteria for women wanting EHC

Answer 22

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

Question 23

What is Tamsulosin used to treat?

Answer 23

Prostate enlargement

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

Question 24

Name 2 factors that are known to contribute towards prostate enlargement

Answer 24

1. Aging
2. Long term exposure to testosterone, particularly dihydrotestosterone

Question 25

What is the **mechanism of action of Tamsulosin**?

Answer 25

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

Question 26

What is **hyperplasia**?

Answer 26

* 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 27

List **4 symptoms** of **lower urinary tract** infections (LUTs)

Answer 27

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

Question 28

List **3 ways** that patients may **describe a UTI**

Answer 28

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

Question 29

What is the **brand name** of **Tamsulosin**?

Answer 29

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

Question 30

List **3 pieces** of **non-pharmacological advice** for **Flomax Relief**

Answer 30

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 31

List **3 possible side effects** of **Flomax/Tamsulosin**

Answer 31

1. **Dizziness** 2. **Drowsiness** 3. **Blurred vision**

Question 32

What is **Sumatriptan (Imigran) used to treat**?

Answer 32

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

Question 33

What is the **mechanism of action of Sumatriptan**

Answer 33

* 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 34

What are **migraines**?

Answer 34

* 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 35

List **3 counselling points** for **Sumatriptan/Imigran**

Answer 35

1. Advise to take tablet **as soon as possible** after onset of migraine 2. If symptoms return after initial relief, a **2nd dose can be taken after 2 hours** 3. **Excessive use** of triptans may lead to **chronic daily headache or exacerbation of headache**

Question 36

List **3 benefits** of **Sumatriptan/Imigran** being an **OTC medication**

Answer 36

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**