Legislation 3 - HMR - Classification of MPs Flashcards
what should the sale of MPs ideally be restricted to pharmacies to ensure? (3)
- safe use
- appropriate use
- availability use
what does no definitive list of ingredients would cause them to be classed as? (3)
- POM
- P
- GSL
what classes does the HMR 2012 Part 1 (pg17) divides MPs into? (3)
- GSL
- P
- POM
what are GSL? (2)
- general sale list
- MPs which can with reasonable safety by sold or supplied other than under the supervision of a pharmacist
what conditions apply with GSL? (3)
- premises able to exclude the public
- products manufactured elsewhere and sold in unopened containers
- business must be carried out in accordance with prescribed conditions
what are classes of MP that are not usually GSL? (9)
- eye preparations
- products for parenteral administration
- anthelmintics
- enemas
- irrigations
- aspirin/aloxiprin containing products for children
- vit A > 7500iu
- vit D - MDD > 400iu
- paracetamol/aspirin/aloxiprin
what are pack sizes like of certain GSL products when sold from non pharmacy businesses?
- limits are imposed
- if sold outside these limits, classified as P or POM
what are examples of limited retail pack sizes? (7)
- Effervescent Aspirin ≯ 325mg Tabs - 30 tabs
- Aspirin enteric coated tabs ≯75mg - 28 tablets
- Paracetamol tabs/caps – 16 tablets
- Aspirin Tabs/caps – 16 tablets
- Ibuprofen Tabs/Caps – 16 tablets
- Paracetamol liquid – 160ml (>12 years old)
- Paracetamol liquid – 5ml unit dose and max of 20 doses (less than 12 years old))
When is a MP classified as a P? (4)
- in GSL but … sold at larger quantities, higher conc, higher dose than GSL
- POM but exempt on … dose, conc, route of admin, use
- not in GSL or POM list
- made in pharm, ingredients are not POM
when can a person sell/supply/offer for, a MP not in GSL? (4)
- person lawfully conducting retail pharmacy business
- premises that are a registered pharm
- acts under supervision of pharmacist
- responsible pharmacist taken control of premises
what does supervision mean?
pharmacist must be aware of what is going on and must be in position to intervene transaction
where can you obtain GSL from? (2)
- registered pharmacy
- non pharmacy outlet under specified conditions
where can you obtain P from?
registered pharmacy under supervision of a pharmacist
what are GPhC standards for pharmacy - professional accountability for your practice? (2)
- 1st standard - provide patient centred care
- 5th standard - use professional judgement
what are the protocols for sales of medicines? (3)
- all pharmacies have written protocol specifying procedure to be followed when med is supplied and when advice on treatment requested
- med counter staff must have an approved course of training
- GPhC issues guidance for safety and efficacy (june 2018)
what are exemptions from prescription control? (6)
- the maximum single dose (MD)
- the maximum daily dose (MDD)
- the strength of the product (MS)
- its pharmaceutical form
- its packaging, or
- such other circumstances specified
what are exemption from POM of ephedrine and pseudoephedrine? (2)
unlawful to supply without a prescription
- product/combo of products with >720mg pe or 180mg ep in a single transaction
- product with ep together with product with pe
when are POM CDs Ps? (4)
- specified pharmaceutical form
- show dose not exceeding mac
- not for vet use
- not exceeding specified strength of base
what strengths of base should not be exceeded? (6)
- Codeine 1.5%
- Dihydrocodeine 1.5%
- Ethylmorphine 0.2%
- Morphine 0.02% liquid 0.04% solid
- Medicinal Opium 0.02% liquid 0.04% solid
- Pholcodine 1.5%
when are new MPs POMs?
for 5 years after first licensing unless there is existing evidence of safety
when are POMs changed to Ps? (5)
- when MP is safe to be supplied without prescription
- not likely to present danger if used without supervision
- not used incorrectly
- not containing substances that require investigation
- not prescribed for parenteral admin
when are Ps changed to GSL?
when MP is safe to be supplied without supervision
when are GSLs changed to Ps?
when MP is no longer safe to be supplied without supervision
when are Ps changed to POMs?
if new risks are identified which require the involvement of a prescriber (domperidone< diclofenac)
what are examples of POMs to P change examples? (7)
- ibuprofen
- hydrocortisone preparations
- aciclovir
- levonorgestrel
- azithromycin
- chloramphenicol eye drops
- clobetasone (eumovate)
what are restrictions for codeine and dihydrocodeine?
from dec 2009
- max pack size 32 doses
- can cause addiction - use for 3 days only
- PIL info on warning signs of addiction
what are the restriction of cold and cough medicines for children? (3)
- meds containing certain: antitussives, expectorants, nasal decongestants, antihistamines
- should not be used for children
- no change in legal classification (changes warning labelling and duration of treatment)
what is the patient group direction (PGD)? (2)
- written direction about supply/admin of to person, signed by doctor/dentist and pharmacist
- no prescription involved
(pg130 of HMR 2012)
what are PGDs used for?
assist a doctor/dentist in the provision of NHS primary medical/dental services
what are details required for valid PGD? (4)
- clinical condition (condition/situation, inclusion/exclusion, cautions)
- description of treatment (name, dose, advice, records)
- characteristics of pharmacist/HCP (qualifications/training)
- management of PGD
who is permitted to supply/administer drugs under PGD? (5)
- pharmacists
- registered nurse
- registered midwives
- state registered chiropodists
- radiographers
what are the circumstances under which PGDs are permissible? (3)
- supply of meds authorised by HCP on behalf of NHS body
- NHS body authorising PGD for supply of POM by PLCRPB
- to assist a doctor/dentist providing NHS
what are the types of records in the pharmacy? (3)
- signed orders
- NHS prescriptions
- private prescriptions
what are signed orders like? (2)
- record in POM book unless a wholesale transaction
- POM book for good practice
what are NHS prescriptions like? (2)
- GSL, P, POM - no records legally required
- CD(Sch2) - CD register entry legally required
what are private prescriptions like? (3)
- GSL and P - POM Book entry for good practice
- POM - record in POM book legally required
- CD(Sch2) - CD register entry legally required
what is the fate of an FP10 (NHS) prescription? (2)
- retain until end of month, sort and send to NHS business services authority
- daily via EPS
what is the fate of private prescriptions?
- GSL/P - endorse and return to patient
- POM - retain for 2 yrs unless repeatable, then return until final supply
- FP10PCD - send to PPD, retain photocopy for 2 yrs
