Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PM2D Spring Amy L > POM to P: Reclassification of Medicines > Flashcards

POM to P: Reclassification of Medicines Flashcards

1
Q

What are POMs?

A

Prescription-only medicines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are P medicines?

A
  • Sold in a pharmacy without a prescription
  • Under the supervision of a pharmacist
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What are GSL medicines?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

List 3 requirements for reclassification from POM to P

A
  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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

List 3 requirements for reclassification from P to GSL

A
  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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Why could a P medicine be reclassified to a POM?

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

List 2 examples of recently reclassified drugs from P to POM

A
  1. Diclofenac
  2. Domperidone

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What are new medicines usually classified as?

A

POM

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What causes a product to be reclassified?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Which agency evaluates applications to reclassify medicines?

A

MHRA

Medicines and Healthcare Products Regulatory Agency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

How does the MHRA reclassify a medicine?

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

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

A
  1. Levonorgestrel 1500mcg tablet (= Levonelle)
  2. Ulipristal acetate 30mg tablet (= ellaOne)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

How do EHCs work?

A

Inhibit or delay ovulation so that fertilisation cannot take place

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

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

A
  • Levonelle = women over 16
  • ellaOne = women of childbearing age including adolescents
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is the mechanism of action of Levonelle?

A

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

17
Q

What is the mechanism of action of ellaOne?

A
  • Progesterone receptor modulator
  • Inhibits or delays ovulation
  • Alters the endometrial epithelium
  • Can reduce fibroid size
18
Q

Explain the EHC pill discussion guideline

A
  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
19
Q

What are the 3 counselling points for EHC?

A
  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
20
Q

What are the possible side effects of EHC?

A
  1. Headache
  2. Nausea
  3. Abdominal pain
  4. Painful periods
21
Q

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

A
  • Explain future contraceptive options
  • Talk about risk of STIs if barrier contraception is not used
  • Use of lubricants with condoms to stop splitting
22
Q

List 4 referral criteria for women wanting EHC

A
  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
23
Q

What is Tamsulosin used to treat?

A

Prostate enlargement

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

24
Q

Name 2 factors that are known to contribute towards prostate enlargement

A
  1. Aging
  2. Long term exposure to testosterone, particularly dihydrotestosterone
25
Q

What is the mechanism of action of Tamsulosin?

A
  • Alpha-1 adrenoceptor antagonist (alpha-1 blocker)
  • Relaxes smooth muscle in benign prostatic hyperplasia
26
Q

What is hyperplasia?

A
  • The enlargement of an organ or tissue due to an increase in the reproduction rate of its cells
  • Often an initial stage of cancer
27
Q

List 4 symptoms of lower urinary tract infections (LUTs)

A
  1. Urinary hesitancy
  2. Weak stream
  3. Frequent urination
  4. Urgency
28
Q

List 3 ways that patients may describe a UTI

A
  1. Bladder never feels completely empty
  2. Weeing more often
  3. Needing to wait before starting to wee
29
Q

What is the brand name of Tamsulosin?

A
  • Flomax relief (OTC)
  • Single 400mcg slow release capsule after the same meal each day
30
Q

List 3 pieces of non-pharmacological advice for Flomax Relief

A
  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
31
Q

List 3 possible side effects of Flomax/Tamsulosin

A
  1. Dizziness
  2. Drowsiness
  3. Blurred vision
32
Q

What is Sumatriptan (Imigran) used to treat?

A
  • Treatment of migraine, not prevention
  • No aura experienced by patient
  • 18-65 years old
  • Stable and well-established pattern of symptoms
33
Q

What is the mechanism of action of Sumatriptan

A
  • 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
34
Q

What are migraines?

A
  • 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
35
Q

List 3 counselling points for Sumatriptan/Imigran

A
  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
36
Q

List 3 benefits of Sumatriptan/Imigran being an OTC medication

A

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

PM2D Spring Amy L (9 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions