POM to P: Reclassification of Medicines Flashcards Preview

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Flashcards in POM to P: Reclassification of Medicines Deck (36)
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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

  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


List 3 requirements for reclassification from P to GSL

  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


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

  1. Diclofenac
  2. Domperidone

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


What are new medicines usually classified as?



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?


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)

  1. 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
  • Can reduce fibroid size


Explain the EHC pill discussion guideline

  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


What are the 3 counselling points for EHC?

  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


What are the possible side effects of EHC?

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

  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


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

  1. 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)

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


List 3 ways that patients may describe a UTI

  1. Bladder never feels completely empty
  2. Weeing more often
  3. 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

  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