Flashcards in POM to P and Emergency Contraception Deck (22)
What is the main criteria for POM to P? (has to no longer fufil?)
1. Likely to present a direct or indirect danger to human life- even when used correct when used without supervision of doctor
2. Frequency and to a very wide extend when used incorrectly- results in direct or indirect danger to human life
3. Contains substances, preparations of substances of which the activity requires- or side effects require, further investigation
4. Prescribed by doctor for parenteral administration
What is the main criteria for P to GSL, satisfied that?
1. Can with reasonable safety be sold or supplied other wise (than by or under supervision of pharmacist)
2. Reasonable safety- may be usefully defined as where the health and risk of misuse and the need for special precautions in handling are small
What is the main criteria for P to POM?
1. Less often medicines can be upgraded from P to POM if new risks are identified
2. P medicine no longer meets the requirements to supply with legal status P (Example: may cause harm to human health even when used correctly, used without supervision of any doctor)
How do you get a reclassification procedure of a product to occur?
1. A company must make a request and hold marketing authorisation for it to the MHRA
2. Request can be made by any interested party
What are the two products of Emergency Hormonal Contraception (morning after pill)?
1. Levonelle- Levonorgestrel 1500mcg tablet
2. ellaONE- Ulipristal acetate 30mg tablet
What is the brief mechanism of action of emergency contraception?
1. Inhibiting or delaying ovulation (release of ovum) so fertilisation cannot take place
2. Prevents the egg from being fertilised and implantation of planted egg
What is the dose of an emergency hormonal contraception?
ONE tablet taken orally as soon as possible within licensed time frame
Give the properties of ellaONE? (audience, duration, specific MoA)
1. Licensed for woman of child bearing age including adolescents
2. Can be used up to 120 hours after unprotected sex
3. Progestogen receptor modulator (inhibits or delays ovulation- alters endometrial epithelium and reduce fibroid size)
Give the properties of Levonelle (audience, duration, specific MoA)
1. Licensed for women more than 16 years (unless supplied via PGD)
2. Can be used 72 hours after unprotected sex
3. Unclear mode of action, delays ovulation by 5 to 7 days (arrests development of ovarian follicle)
What is the EHC pill discussion guideline?
Consider females age
Check when unprotected sex or contraceptive failure happened
Check if she is taking any medications: OTC and herbal
Check if she has any medical conditions or other factors- pregnancy, allergies, breast feeding
Ensure she understands all information to make her choice
Counsel female on chosen product and future contraceptive
Why do we need to consider the females age?
1. Levo is only for 16 year olds and above
2. Do not supply if they do not understand what you're talking about
Why is it necessary to ask if you had unprotected sex within the last 120 hours?
1. Past 120 hours- refer to doctor
2. They could be taking the pill:
if they forget the pill, take it as soon as possible- missing one pill doesn't mean you must take EHC
Why is it necessary to ask if they are currently taking ant medicines, including herbal remedies?
1. Liver enzyme inducers (CYP3A4 inducers)
2. Plasma concentration of drug drops from interactions with many drugs: phenobarbital, primidone
Why is it necessary to ask if they have any medical conditions or other factors to consider?
1. Could they already be pregnant- used EHC before, period is light
2. Suffering from severe hepatic impairment or galactose intolerance - have to refer patient
3. Severe asthma (ella one not recommended)
4. Allergies, breast feeding (Ella One)
What is the main advice you can provide patients on taking the pill? (dose, menstrual cycle, side effects)
1. Dose: 1 tablet immediately
2. Vomit or have severe diarrhoea within 3 hours- take another dose
3. Cycle can be disrupted by EHC- ensure they do pregnancy test if period is more than 1 week late or bleeding differs from normal
4. Side effects: Headache, nausea, abdominal pain and painful periods
5. Inform EHC will not protect against future intercourse
What other advice can you give to patients about EHC?
1. Holistic application- customer leaves with confidence and respect intact
2. Future contraception options
4. Use of lubricants and condoms
5. Implants and coils
When should you refer the patient if they come for EHC?
1. Unprotected sexual intercourse or failed contraceptive- 120 hours ago
2. Pregnant woman
3. Taking medication like carbamazepine, St Johns wort etc
4. Problems affect absorption of oral contraceptive (vomiting, severe diarrhoea)
5. Severe hepatic dysfunction
6. Previous allergy or reaction to either EHC
7. Ella one is not recommended for women with severe asthma treated by corticosteriods
Should you give an advance supply of EHC to a woman?
1. Not given routinely- only when women rely solely on barrier method or travelling abroad
2. Assess if clinically appropriate
3. Customer is competent and intend to use it properly
What is Tamsulosin?
1. Used for treatment of prostate enlargement - benign prosttic hyperplasia
2. Alpha 1 antagonist
3. Relaxes smooth muscle in prostatic hyperplasia
What are the symptoms of lower urinary tract symptoms?
1. Urinary hesitancy
2. Weak stream
3. Frequent Urination
What is Flomax relief indicated for? And what must be done to screen customers?
1. Treatment of functional symptoms of benign prostatic hyperplasia (BPH) male aged 45 to 75
2. Pharmacy questtionare is done to rule out conditions that would need GP referral