POM to P: Reclassification of Medicines Flashcards
What are POMs?
Prescription-only medicines
What are P medicines?
- Sold in a pharmacy without a prescription
- Under the supervision of a pharmacist
What are GSL medicines?
Can be sold in general retail outlets without supervision of a pharmacist
List 3 requirements for reclassification from POM to P
- Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription
- Unlikely to present a danger to human health if used without the supervision of a doctor
- Difficult to use incorrectly
List 3 requirements for reclassification from P to GSL
- Ministers must be satisfied that the medicine can be sold or supplied by someone other than a pharmacist and without their supervision
- Need for special precaution is small
- Wider sale would be of convenience to the purchaser
Why could a P medicine be reclassified to a POM?
- 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
List 2 examples of recently reclassified drugs from P to POM
- Diclofenac
- Domperidone
Due to new evidence indicating a small increased risk of serious cardiac effects
What are new medicines usually classified as?
POM
What causes a product to be reclassified?
A request from the company which holds a marketing authorisation for it
Which agency evaluates applications to reclassify medicines?
MHRA
Medicines and Healthcare Products Regulatory Agency
How does the MHRA reclassify a medicine?
- 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
What are the 2 options of EHC (emergency hormonal contraception)
- Levonorgestrel 1500mcg tablet (= Levonelle)
- Ulipristal acetate 30mg tablet (= ellaOne)
How do EHCs work?
Inhibit or delay ovulation so that fertilisation cannot take place
What are the different age ranges that Levonelle and ellaOne are licensed for?
- Levonelle = women over 16
- ellaOne = women of childbearing age including adolescents
What are the different time frames that Levonelle and ellaOne must be taken in to be effective?
Levonelle = up to 72 hours after unprotected sex ellaOne = up to 120 hours after unprotected sex
What is the mechanism of action of Levonelle?
Unclear but thought to delay ovulation by 5-7 days and arrests the development of the ovarian follicle
What is the mechanism of action of ellaOne?
- Progesterone receptor modulator
- Inhibits or delays ovulation
- Alters the endometrial epithelium
- Can reduce fibroid size
Explain the EHC pill discussion guideline
- 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
What are the 3 counselling points for EHC?
- 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
What are the possible side effects of EHC?
- Headache
- Nausea
- Abdominal pain
- Painful periods
What advice can you give the patient to ensure they do not need EHC again?
- Explain future contraceptive options
- Talk about risk of STIs if barrier contraception is not used
- Use of lubricants with condoms to stop splitting
List 4 referral criteria for women wanting EHC
- 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
What is Tamsulosin used to treat?
Prostate enlargement
a.k.a. benign prostatic hyperplasia (BPH)
Name 2 factors that are known to contribute towards prostate enlargement
- Aging
- Long term exposure to testosterone, particularly dihydrotestosterone
What is the mechanism of action of Tamsulosin?
- Alpha-1 adrenoceptor antagonist (alpha-1 blocker)
- Relaxes smooth muscle in benign prostatic hyperplasia
What is hyperplasia?
- The enlargement of an organ or tissue due to an increase in the reproduction rate of its cells
- Often an initial stage of cancer
List 4 symptoms of lower urinary tract infections (LUTs)
- Urinary hesitancy
- Weak stream
- Frequent urination
- Urgency
List 3 ways that patients may describe a UTI
- Bladder never feels completely empty
- Weeing more often
- Needing to wait before starting to wee
What is the brand name of Tamsulosin?
- Flomax relief (OTC)
- Single 400mcg slow release capsule after the same meal each day
List 3 pieces of non-pharmacological advice for Flomax Relief
- Avoid drinking any liquids for 1-2 hours before going to bed (help to improve symptoms of nocturia)
- Stop/limit drinking alcohol or caffeine (can irritate bladder and make symptoms worse)
- Increasing amount of fruit and fibre eaten to avoid constipation - can put pressure on bladder
List 3 possible side effects of Flomax/Tamsulosin
- Dizziness
- Drowsiness
- Blurred vision
What is Sumatriptan (Imigran) used to treat?
- Treatment of migraine, not prevention
- No aura experienced by patient
- 18-65 years old
- Stable and well-established pattern of symptoms
What is the mechanism of action of Sumatriptan
- 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
What are migraines?
- 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
List 3 counselling points for Sumatriptan/Imigran
- 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
List 3 benefits of Sumatriptan/Imigran being an OTC medication
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
