POM to P Flashcards
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)
2. 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 (lining of the uterus)
Can reduce fibroid size
Explain the EHC pill discussion guideline (6)
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
2. 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
