POM to P Flashcards
Reclassification from POM- P
MHRA must be satisfied that it would be safe to allow the medicine to
be supplied without a prescription.
• It is a medicine which no longer fulfils any of these criteria:
o it is likely to present a direct or indirect danger to human health,
even when used correctly, if used without medical supervision
o it is frequently and to a very wide extent used incorrectly, and as a
result is likely to present a direct or indirect danger to human health
o it contains substances or preparations of substances of which the
activity requires, or the side effects require, further investigation
o it is normally prescribed by a doctor for parenteral administration
(that is, by injection)
Reclassification:
The criteria for P-to-GSL
MHRA must be satisfied that it:
• ‘can with reasonable safety be sold or supplied otherwise than by or under
the supervision of a pharmacist’ (Medicines Act 1968, section 51).
what does reasonable safety mean?
• ‘Reasonable safety’ may be usefully defined as “Where the hazard to
health and the risk of misuse or the need for special precautions in handling
are small, and where wider sale would be a convenience to the purchaser”
Reclassification P- POM
Less often medicines can be upgraded from P to POM if new risks are
identified
o When a P medicine no longer meets the requirements for supply with
legal status ‘P’ for example being likely to present a direct or indirect
danger to human health, even when used correctly, if used without
the supervision of a doctor
• P medicines which have been safely used for several years may be
reclassified as GSL
Applications to reclassify medicines are evaluated by the MHRA
what are recent POM- P changes
2009 – tamsulosin hydrochloride 400mcg capsules
2010 – tranexamic acid 500mg tablets
2013 – esomeprazole 20mg tablets (P to GSL in 2015)
2015 – ulipristal acetate tablet (ellaOne®)
2021 – desogestrel
(progesterone-only pill POP, mini-pill)
2017
Maloff Protect® - atovaquone 250mg with proguanil hydrochloride 100mg
• Viagra Connect ® - erectile dysfunction in men aged 18 years and over.
• Dovonex ® Psoriasis 50 microgram/g Ointment in adults aged 18 years
and over.
• Otrivine ® Extra Dual Relief Nasal Spray in adults 18 years and over
• Nasonex ® Allergy Control 0.05% Nasal Spray in adults 18 years and over,
for a period of not more than 3 months.
p-POM changes
2014 – diclofenac 12.5mg/25mg tablets - Voltarol®
• 2014 – domperidone 10mg tablets - Motilium®
• Both drugs were reclassified due to new evidence indicating a small
increased risk of serious cardiac effects with their use
emergency hormonal contraception - the morning after pill
ellaOne
Women of childbearing age including adolescents
Up to 120 hours after unprotected sex
MoA: Progestogen receptor modulator; inhibits or delays ovulation, alters the endometrial epithelium, and can reduce fibroid size
levonelle
Women ≥ 16 years (unless supplied through PGD)
Up to 72 hours after unprotected sex
MoA: Unclear mode of action but is thought to delay ovulation by 5 -7 days and arrests the development of the ovarian follicle
what is the emergency hormonal contraception - the morning after pill discussion guideline?
- consider the females age
-check when the unprotected sex was or contraceptive failure
-Check if she is taking any medications; including OTC or herbal
preparations
-Check if she has any medical conditions or other factors to consider e.g.
pregnancy, allergies, breastfeeding
-If both options are appropriate ensure she understands all the
information to make her choice
-Counsel female on chosen product and future contraceptive options
advice on taking EHC
Dose: 1 tablet immediately
• Vomit or severe diarrhoea within 3 hours, another pill must be taken.
• Cycle may be disrupted with use of EHC, ensure you advise they do a
pregnancy test if period is > week late or bleeding differs to normal
- Side effects: headache, nausea, abdominal pain, and painful periods
- Inform EHC will not offer protection for future sexual intercourse
Other advice
Future contraception options
• Sexually transmitted infections (STIs)
• Use of lubricants with condoms
when should you refer
If unprotected sex or contraception failure was more than 120 hours ago (5days)
• Pregnant woman
• If taking any of the following medicines:
carbamazepine, griseofulvin, phenobarbital,
phenytoin, primidone, rifabutin, rifampicin, ritonavir,
oxcarbazepine, fosphenytoin, St.John’s wort, &
ciclosporin.
• Problems that may affect absorption of the EHC
(e.g. vomiting, severe diarrhoea, Crohn’s disease)
- Severe hepatic dysfunction
- Previous allergy or reaction to EHC
- ellaOne is not recommended for women with severe asthma treated by oral corticosteroids
Refusal - religious beliefs
you tell the relevant people or authorities and refer patients and the public to other providers
Desogestrel (POP - mini pill)
- progesterone-only oral contraceptive pill
- 99% effective when taken correctly
MoA:
- inhibit ovulation
- thin the lining of the uterus -preventing implantation
- increases the thickening of the cervical mucus which prevents the sperm getting in
who and what is lovina licensed for?
-oral contraception
- for women of childbearing age
- including adolescents*,
- who are not pregnant and where pregnancy is ruled out with reasonable
certainty
who and what is hana licensed for?
-oral contraception
- women of childbearing age*,
who are not pregnant and where pregnancy is ruled out with reasonable certainty
what are contradictions of lovina and hana?
- active thrombosis
- liver disease
- undiagnosed vaginal bleeding
- allergy to - lactose, soya, peanuts
Hana - does not contain soya bean oil wheras lovina does
what does of hana and lovina needs to be taken
If it’s new for the patient: Start on day 1 of period. Can start on
days 2-5 but will need to use an additional barrier method (e.g.
condom) for first 7 days.
• Maintenance: Take one tablet orally at the same time daily
(every 24 hours). Take continuously without breaks between
packs.
what are some side effects of lovina and hana
Common
Irregular bleed patterns* • Mood altered • Depressed mood • Libido decreased • Headaches • Nausea • Acne • Breast pain/tenderness* • Amenorrhoea • Weight changes
uncommon Vaginal infection • Contact lens intolerance • Vomiting • Hair loss • Dysmenorrhoea • Ovarian cyst • Fatigue
when should you refer a patient when using lovina/hana
If the person is pregnant
If the person has a contraindication
If the person is on a medicine that causes a clinically relevant interaction in
your professional judgement.
If the person is concerned with their bleed pattern
If the person has a history of thrombosis or breast cancer
If the person has diabetes
If the person has uncontrolled hypertension
Counselling points for lovina and hana
Missed pill:
• If pill is late:
• < 12 hours — protected — take it as soon as you remember and
carry on with the next pill at the right time
• > 12 hours — not protected — take it as soon as you remember
and carry on with the next pill at the right time AND use an
additional barrier method (e.g. condom) for the next 7 days.
Consider emergency contraception if unprotected sexual
intercourse occurred after the missed pill.
Diarrhoea and vomiting:
• If a woman vomits within 3-4 hours of taking desogestrel – follow missed pill rules.
• If vomiting or diarrhoea persists, see relevant product SPC and
educational risk minimisation materials, which can be found
under ‘Further information’.
examples of P classified antimalarials
• Maloff Protect ® (atovaquone 250mg with proguanil
hydrochloride 100mg)
• Avloclor ® (chloroquine 250mg)
• Paludrine ® (proguanil hydrochloride 100mg)
• Paludrine/Avloclor ® Anti-Malarial Travel Pack (proguanil
hydrochloride 100mg/chloroquine 250mg)
POM antimalarials
- Atovaquone with proguanil (Malarone ® or generic)
- Doxycycline
- Mefloquine (Lariam ®)
what are symptoms of malaria
High temperature • Sweats and chills • Headaches • Vomiting • Muscle pains • Diarrhoea • Tiredness
what can malaria be misdiagnosed as
- Influenza (very similar symptoms)
- Viral illness (e.g. viral hepatitis if jaundiced)
- Gastroenteritis (if diarrhoea present)
- Lower respiratory tract infection (cough can be a nonspecific symptom)
what is the ABCD approach
Awareness
• Bite Protection
• Chemoprophylaxis
• Diagnosis early
what is maloff protect
Indication: prevention of Plasmodium falciparum (P.
falciparum) malaria in adults aged 18 years and over,
weighing more than 40kg who are travelling to areas where
malaria is widespread for up to 12 weeks
• Dose: ONE tablet daily. Commencing one or two days
before entering malaria endemic zone, continue during
period of stay and for seven days after leaving the area.
what are the side effects of maloff
Most commonly reported side effects • Headache • Diarrhoea • Abdominal Pain • Nausea and Vomiting Severe side effects • Severe allergic or skin reaction
counselling points for maloff
Dosage • Take at the same time each day • With food or a milky drink (to ensure maximum absorption) • Complete the course
• Vomiting
Advise patients to take a repeat dose if they vomit within
one hour of taking their dose
• Diarrhoea
In the event of diarrhoea, normal dosing should be
continued
what does viagra connect do?
Pharmacy supply is indicated for use in adult men over 18
years old with erectile dysfunction (ED)
How does it work?
• Sildenafil is a phosphodiesterase type-5 inhibitor and acts
by increasing blood flow to the penis.
what are the risk factors for erectile dysfunction
Lifestyle
• Obesity, smoking, alcohol, cycling, sedentary lifestyle
- Physical condition
- Hypertension, diabetes mellitus, hypercholesterolemia, cardiovascular disease
- Psychological
- Anxiety, depression
• Side effects of drugs
• Antihypertensives, antidepressants, antipsychotics, recreational
drugs including alcohol; diuretics, fibrates, histamine H2 antagonists,
hormones and hormone-modifying drugs
what are the counselling points for viagra?
One 50mg tablet to be taken one hour before sexual
activity. Maximum dose of 50mg per day
• Viagra Connect may need to be taken a number of times on
different occasions (a maximum of one 50mg tablet per
day), before they can achieve a penile erection satisfactory
for sexual pleasure
- When taken with food the onset of activity may be delayed
- Advice about online purchase of the products .
Advise patient to inform their doctor within six months for a
clinical review of potential underlying conditions and risk
factors associated with ED
- Side effects
- Lifestyle advice
when should you refer a patient using viagra?
If after several attempts on different dosing occasions
patients are unable to achieve a penile erection sufficient for
sexual activity.
• If symptoms worsen after use, refer to a doctor
• Already using a different dose of sildenafil, or a different
treatment for erectile dysfunction
what is Sumatriptan – Imigran Recovery®
Sumatriptan is a 5HT1 receptor agonist, a group of drugs often referred
to as ‘triptans’. It acts on the receptors in the brain to stabilise the blood
vessels which are involved in migraine attacks.
• Triptans are used for the treatment of migraine, not prevention.
• Pharmacy supply of sumatriptan (Imigran®) is indicated for the acute
treatment of migraine attacks with or without aura in adults aged 18-65
years.
what is migranes
Migraine is a condition resulting from spasm and
subsequent over dilation of certain arteries in the brain
• Causing recurrent throbbing headache that
characteristically affects one side of the head
• Migraines are associated with other features that
distinguish it from a normal headache such as nausea,
vomiting and changes in vision and hearing
what are counselling points for viagra
One 50mg tablet should be taken as soon as possible after the
onset of a migraine
• A single dose should relieve symptoms after 30 minutes: if
symptoms do not improve in this time no further doses should be
taken for the same migraine attack
• If symptoms return after initial relief, a 2nd dose can be taken
after 2 hours
• Patients experiencing 4 or more attacks per month or requesting
4 or more packs per month should be referred to their GP
• Excessive use of triptans may lead to chronic daily headache or
exacerbation of headache
when should you refer
drug interactions e.g. tricyclic antidepressants,
SSRIs/SNRIs
• hepatic or renal impairment
• IHD, arrythmias, PVD, hypertension, MI, CVA
• age exclusion
• pregnancy/breastfeeding
why is sumatripan - benefit of OTC supply
• Triptans should be taken as early as possible in a migraine
attack
• Infrequent attacks, may be unlikely to always have supplies
• No need to waste time visiting the doctor
• The impact of migraine, through missed work, distress,
altered mood, and reduced quality of life, may therefore be
reduced
