MEP Flashcards
Documents to submit for the revalidation process
4 x CPD (at least 2 planned)
1 x peer discussion
1 x reflective
Pseudoephedrine + Ephedrine limits
when without a Rx,
Pseudoephedrine ≤720mg or
Ephedrine ≤180mg
not at the same time
Emergency contraception choices, time limits, age limits
- Copper intrauterine device
- Ulipristal 30mg - 120 hours (5 days)
- Levonorgestrel 1500mcg - 72 hours (3 days), >16 years old
- Under 16 years old is a sexual offence, but maybe mutual enough to make a decision. It is illegal for those under 13 years for sexual activities => Social service
Paracetamol & aspirin OTC limits (no. of non/effervescent tablet/cap) normal pack size
No more than 100 non effervescent tab/cap
(normal pack size 16 or 32 dose unit)
no limits for effervescent formulations (tab/powder/granules/liquid) => use judgement
Codeine & dihydrocodeine OTC - indication, pack size limit, the PIL & package labelling requirement, duration limit
Indication: short-term acute moderate pain that is not relieved by paracetamol/ibuprofen/aspirin alone
Pack size: no more than 32 unit dose (above this number is POM)
Warning on the package: “can cause addiction. For three days only”
PIL much contain information of warning signs of addition
Good practice: no more than 1 pack when selling
Rx requirements
- Patient’s name
- Patient’s address
- Age if under 12
- Date of Rx
- Prescriber’s signature
- Prescriber’s particulars (type of practitioner)
- Prescriber’s address
Repeats Rx - meaning, contraception repeats, which class of drugs can be repeated, time limit to dispense repeats Rx
“repeat” without number = total dispense 2 times; contraception can be repeated 5 times ( dispense 6 times in total)
“repeat X” = repeat X times+1
CD 2/3 = NOT REPEATABLE
CD 4/5 = repeatable
CD 4 : 1st dispensing must be within 28 days, following has no time limit
CD 5/POM : 1st dispensing must be within 6 months, following has no time limit
Validity of owning (time limit) - CD2/3/4, POM&CD5, P&GSL
CD2/3/4: 28 days after the appropriate dates (supply of owing can exceed 7 days from when the Rx is written only if follow the Pregnancy Prevention Programme to ensure Pt is not pregnant)
POM&CD5, P&GSL: 6 months from the appropriate dates
Appropriate dates = date when the Rx is signed/ indicated start date
Record keeping for private Rx (POM requirements, repeats, years to keep in the pharmacy)
what to do if it’s a CD 2/3
Exemption from record keeping
Regular med keep POM register for 2 years from the date of sales/ last supply of repeat Rx; CD2/3 send to NHS agency
POM:
1. Supply date
2. Rx date
3. Medicine: Name, formulation, strength, quantity
4. Rx’er detail: name & address
5. Pt’s details: name & address
Oral contraception does not need record keeping
CD2 does not require record keeping as it already made a CD register entry
Is faxed Rx valid
No
EEA counties (31 counties + Non EEA 1)
Switzerland
EEA:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland
Rx requirement for EEA Rx’er
What med is not allowed to EEA Rx
- Pt: Full name, DoB
- Px’er’s details: Full name, qualification, direct contact details (incl. email + (international prefix)tel./fax, work address (incl. country)
- Medicine: Name (brand if required), formulation, strength, quantity, dosage details
- Rx’er signature
- Date of issue (up to 6 months; 28 days if CD4) appropriate date is when the Rx is signed
CD1/2/3 and med without a UK MA cannot be supplied
Emergency request from an EEA Pt/EEA Rx’er (what to do)
Request from EEA Pt - normal supply process
Request from EEA Rx’er - normal supply process, but Rx need to be received within 72 hours
Military Rx form name for regular med/CD, which form cannot be dispensed in a community pharmacy, charges?
FMed 296; pink FP10PCD for CD2/3; written CD2/3 on MOD FMed296 is not permitted to dispense in community pharmacy as most are computer generated.
Treat as private Rx, up to the Pt wants to claim back the cost (provide receipt)
Labelling of medicine requirements (original package), where to stick the label
- Pt’s name
- Pharmacy’s name & address
- Date of dispensing
- Name of medicine
- Directions of use
- Precautions
Good practice:
- Keep out of reach and sight of children
- Use this medicine only on your skin where applicable
Stick to the inner container if possible
Labelling of broken down medicine from bulk
- Name of medicine
- Quantitative particulars of the medicine (ingredient)
- Quantity in the container
- Handling and storage if appropriate
- Expiry date
- Batch number (LOT number/BN)
Adrenaline: administration route, which regulation allows administration of adrenaline in life emergency situation
i.m. route
Regulation 238 of Human Medicines Regulations 2012
Situations/ under which “Directions” of when medicines can be supplied without a Rx
- PGD (patient group direction) => POM labelling should be the same as dispensing a POM against a Rx
- PSD (patient specific directions)
- Emergency supplies
- optometrist/podiatrist signed patient orders
- Salbutamol/ Adrenaline autoinjectors to school
- Naloxone if individuals providing recognised drug treatment services
Which professional can request emergency supply of medication
Doctor
Dentist
SP
community nurse
EEA/Swiss professional
IP of: pharmacist, nurse, physio, podiatrist, therapeutic radiographer, optometrist, paramedic
Emergency supply, request by Rx’er:
Nature requirements, the dosage of the med, Rx time limit to reach pharmacy, which med can/can’t be supplied (request by which professions), record keeping requirements, labelling
Requirement: ensure it’s an emergency situation that Rx can’t be reached to the pharmacy
Rx need to be provided within 72 hours
Supply med according to Rx’er instruction
NO CD1/2/3 by UK/Swiss/EEA Rx’er
The exception is phenobarbital (phenobarbitone/phenobarbitone sodium) for epilepsy by UK (Doc/dentist/nurse/pharmacist IP or SP)
Record keeping POM:
POM:
1. Supply date.
2. Rx date - add back when receiving the Rx
3. Medicine: Name, formulation, strength, quantity.
4. Rx’er detail: name & address.
5. Pt’s details: name & address.
6. Date of receiving the Rx
Labelling requirement: as usual
Emergency supply, request by Pt:
which regulation requires the Pharmacist to interview Pt, what to consider, requirements, dose, which med cannot be supplied, length of treatment, record keeping, labelling
Regulation 225 of Human Medicine Regulation 2012 requires the pharmacist to interview pt. If not possible, use professional judgement
Ensure Pt is in immediate need, impossible to obtain Rx even if surgery is open
The POM must be prescribed previously by a UK/Swiss/EEA Rx’er.
The pharmacist must be satisfied with the dose given to the pt (according to PMR/repeat slip etc)
NOT CD1/2/3 or ammonium bromide, calcium bromide, calcium bromidolactobianoate, embutramide, fencamfamin HCL, fluanisone, hexobarbitone, hexobarbitone sodium, hydrobromic acid, meclofenoxate HCL, methohexitone Na, pemoline, piracetam, potassium bromide, strychnine HCL, Tacrine HCL, thiopentone Na
**except for phenobarbital, can be given
Length of treatment:
CD4/5/phenobarbital => 5 days
POM => 30 days/smallest pack size if it’s insulin/ointment/cream/inhaler for asthma or full cycle if it’s oral contraception or smallest quantity for a full course of antibiotic liquid form.
Record keeping
1. Supply date.
2. -
3. Medicine: Name, formulation, strength, quantity.
4. -
5. Pt’s details: name & address.
6. Nature of emergency
Labelling:
1. Pt’s name.
2. Pharmacy’s name & address.
3. Date of dispensing.
4. Name of medicine.
5. Directions of use.
6. Precautions.
7. “Emergency supply”
What should the pharmacist do if he refuses the emergency supply request from the pt?
refer to Dr/ NHS111/ NHS walk in/ A&E
NHS111 can arrange emergency supply of regular medicine
Which items can be supplied to the school? Documentations required, the maximum number to supply; record keeping, which type of school
Salbutamol inhaler + autonormic adrenaline injector
School: Primary, secondary (maintained school, independent school, pupil referral unit, maintained nersery school
Signed order:
1. Name of school
2. Product details (incl. spacer if relevant)
3. Strength (if relevant)
4. Purpose for the supply
5. Total quantity
6. Signature of the principal/head teacher
#idealy use headed paper
#have different brands of salbutamol/adrenaline, try to avoid confusion
The maximum number to supply: no limit
Signed order record keeping: 2 years from the date of supply/entry from the POM register
Good practice for making a POM register
1. Date of supply
2. Name, quantity, formulation, strength
3. Name/address of business or profession of the person
4. Purpose
Advices give to primary school when supplying salbutamol/adrenaline
Directions of use, age group for different type of spacers
Storage and disposal advises
Internal record keeping, regular expiry date check, when to replace
What is Naloxone for and what’s special about it. Fall under which legislation
It is an antagonist of opioid/opiate anatagonist which can completely/partially reverse the CNS depression, esp respiratory depression. ie. can treat opioid overdose.
Human Medicines Regulation 2015
it remains as a POM. However, it can be used without a Rx if it’s for life emergency situation
What is Pregnancy Prevention Programme for? which medication need PPP
For preventing women from getting pregnant from these drug which can cause foetal malformation.
Oral Retinoids (acitretin, alitretinoin, isotretinoin) , Valporate, Thalidomide, Lenalidomide, Pomalidomide
What does oral retinoid include? indication, ADR, what does PPP include, how frequently does the Pt need follow-up, who can Rx, Requirement prior Rx, Rx validity, Quantity requirement. Emergency supply requirement
- acitretin, alitretinoin, isotretinoin
- For treating severe skin conditions
- can cause high frequency and severe life-threatening birth defeat
- PPP include education, therapy management, pregnancy testing, contraceptions
Professions that can Rx retinoid:
Dermatologist
GP in dermatology
Specialist dermatology nurse
Follow-up on a monthly basis
Rx only valid for 7 days. Need to have a pregnancy test before writing Rx.
Maximum quantity is 30 days
Emergency supply(tel) can only be made by PPP specialist Rx’er tgt to confirm pregnancy status. Do not accept repeat Rx, free samples distribution, faxed Rx.
Valporate indication, what does pharmacist need to discuss with the Pt
For epilepsy, biopolar disorder
- confirm Pt has regular meeding with the Dr
- Understand he risk
- Arrange appointment if finds out pregnant
- Provide Valporate Pt card everytime when dispensing
- Provide PIL each time
- Ensure dispensing label does not cover warning label
- Report any suspected symptoms via Yellow Card
- Ensure annual review
Can Swiss/EEA Rx’er Rx CD1/2/3
No.
CD1 can only Rx by Home Office license
CD2/3 can only Rx by Rx’er which the address is in the UK
Who can Rx CD1
Who can RX CD2/3
CD1 can only Rx by Home Office license
CD2/3 can only Rx by Rx’er which the address is in the UK
What is required if want to Rx cocaine/diamorphine/dipipanone for treating addition
Home Office License
Dr:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
These restrictions are similar to which type of Rx’er
Can Rx CD2-5?
Yes, if want to treat addition, need Home Office license to Rx cocaine/diamorphine/dipipanone
Can Rx unlicensed+/or off-label med?
Yes
Can authorised emergency supply for which can be Rx?
Yes - incl. Phenobarbital for epilepsy, but NOT CD1/2/3
**All CD1/2/3 can’t be Rx by any type of Rx’er exp phenobarbital
Need to register with GMC and hold a license to practise
Same as a dentist, apart from the information
Dentist:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
Can Rx CD2-5?
Yes, if want to treat addition, need Home Office license to Rx cocain, diamorphine, dipipanone
Can Rx unlicensed+/or off-label med?
Yes
Can authorised emergency supply for which can be Rx?
Yes - incl. phenobarbital for epilepsy, but NOT CD 1/2/3
**All CD1/2/3 can’t be Rx by any type of Rx’er exp phenobarbital (excl. paramedic IP)
Other information
Dentist should restrict to Rx for dental conditions, but can Rx anything within their expertise
Same restrictions as GP
Vet surgeon:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
Can Rx CD2-5?
Yes, CD2/3 does not need to be on standardized form, but it must have the RCVS registration number of the Rx’er
Can Rx unlicensed+/or off-label med?
Yes. for medicines that tare not licensed for animal, it needs to be Rx under the cascade
Can authorised emergency supply for which can be Rx?
No (Emergency supply only apply to human)
Other information
for treating animals only
Nurse/midwife IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Can Rx CD2-5?
Yes, except cocain/diamorphine/dipipanone for treating addition
Can Rx unlicensed+/or off-label med?
Yes for unlicensed med
No for nurses in Scottland coz restrictions in the formulary
Can authorised emergency supply for which can be Rx?
Yes, incl. phenobarbital for epilepsy.
NO CD1/2/3
**All CD1/2/3 can’t be Rx by any type of Rx’er exp phenobarbital
Optometrist IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
Can Rx CD2-5?
NO
Can Rx unlicensed+/or off-label med?
Yes to only “off-label” med (licensed med but outside its approved use
**This part is the same as optometrist IP, paramedic IP, physio IP, podiatrist IP, therapeutic radiographer, EEA/Swiss
Can authorised emergency supply for which can be Rx?
Yes
Other information
Can only Rx for eye/around eye conditions/tissues. can also Rx parenteral preparation
Paramedic IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Can Rx CD2-5?
No
Can Rx unlicensed+/or off-label med?
Only “off-label”
**This part is the same as optometrist IP, paramedic IP, physio IP, podiatrist IP, therapeutic radiographer, EEA/Swiss
Can authorised emergency supply for which can be Rx?
Yes, but not CD1/2/3 incl. phenobarbital
Pharmacist IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Can Rx CD2-5?
Yes, but not cocaine,diamorphine/dipipanone for treating addition
Can Rx unlicensed+/or off-label med?
Yes
Can authorised emergency supply for which can be Rx?
Yes (incl. phenobarbital), NOT CD1/2/3
Physiotherapy IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Can Rx CD2-5?
Certain CD:
- Oral: diazepam, dihydrocodeine, lorazepam, morphine, oxycodone, teemazepam
- Inj: morphine
- Transdermal: fentanyl
Can Rx unlicensed+/or off-label med?
Only “ off-label med”
Can authorised emergency supply for which can be Rx? Yes but no to CD1/2/3 incl. phenobarbital
Podiatrist/chiropodist IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Can Rx CD2-5?
Certain CD:
- Oral: diazepam, dihydrocodeine, lorazepam, temazepam
Can Rx unlicensed+/or off-label med?
Only “off-label” med
Can authorised emergency supply for which can be Rx? Yes but no to CD1/2/3 incl. phenobarbital
Radiographer IP:
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Can Rx CD2-5?
No
Can Rx unlicensed+/or off-label med?
Only “off-label” med
Can authorised emergency supply for which can be Rx?
Yes but no CD1/2/3 incl. phenobarbital
SP of dietician, midwife, optometrist, paramedic, pharmacist, physiotherapist, podiatrist, chiropodist, radiographer
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
Can Rx CD2-5?
Yes, but not cocaine, diamorphine, dipipanone for treating addition
Can Rx unlicensed+/or off-label med?
Yes
Can authorised emergency supply for which can be Rx?
Yes incl. phenobarbital for epilepsy. NO CD1/2/3
Other information
Rx restriction to within agreed written clinical management
Community practitioner nurse prescriber
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
Can Rx CD2-5?
No
Can Rx unlicensed+/or off-label med?
No, only Nystatin for off-label use in neonates
Can authorised emergency supply for which can be Rx?
Yes
Other information
Only Rx dressings and nurse prescriber formulary
EEA/Swiss Rx’er
Can Rx CD2-5?
Can Rx unlicensed+/or off-label med?
Can authorised emergency supply for which can be Rx?
Other information
Can Rx CD2-5?
CD 4/5 only
Can Rx unlicensed+/or off-label med?
only “off-label”
Can authorised emergency supply for which can be Rx?
Yes
Other information
Can only Rx med with UK MA
What to do if want to wholesale, need to comply with which practice and information need to be on the license.
Is it specific to human and vet?
What are the exemptions that don’t require WDA
- Need a Wholesaling Distribution Authorisation (WDA) which needs to comply with Good Distribution Practice (GDP), with a “Responsible Person” on the licenses to ensure medicines are procured, stored and distributed appropriately.
- WDA is specific to human OR vet => WDA(V)
- if supply stock to other pharmacy, not for wholesale purpose/small quantity/ transaction takes place on a occasional basis/not for a profit basis/ not for onward wholesale distribution, no need WDA
Which license for wholesaling CD is required?
To wholesale CD2-5, WDA(H) and a Home Office CD licence is required by the pharmacy
Classes of vet medicine and definition
NFA-VPS
non-food animal; supplied by surgeon/pharmacist/suitable qualified person; No Rx; these med not accessible by the public
POM-V
Rx by Vet; supplied by Vet/pharmacist; need written Rx
POM-VPS
Rx by Vet; supplied by vet/pharmacist/suitable person; need written Rx if not the Rx’er
AVM-GSL
authorised vet med for general sale
SAES (Exempt med under the schedule 6 of the vet med regulation) (Exemptions for small pet animals)
Unlicensed vet med which doesn’t required a MA as the regulation exempt them
Unauthorised veterinary medicines
Unlicensed med without a MA and not eligible through SAES. Can only Rx by vet “UNDER THE CASCADE”; include human medicine
Rx requirement for POM-V & POM-VPS & under the cascade
POM-V & POM-VPS & under the cascade
1. Owner’s name and address
2. Identification of the species and address if not live tgt
3. Medicine: name, dose, quantity, administration instruction **“As Directed” is not allowed
4. **IF CD2/3, NEED TO STATE “THE ITEM HAS BEEN PRESCRIBED FOR AN ANIMAL OR HERD UNDER THE CARE OF THE VERTERINATIAN” and FOLLOW CD Rx requirement
5. Necessary warning/withdrawal period
6. “Rx under the cascade” if required
7. Repeat number if prn
8. Rx date (Valid for 6 months, can be shorter if indicated by the Rx’er; repeatable Rx need to made within 6 months; CD valid for 28 days)
9. Rx’er Name, address, tel., qualification, signature CD 2/3 need RCVS registration number
How long does a Vet Rx be kept in the pharmacy
5 years
Does Vet CD Rx need to be on a standardised form
No, and no need to send it to an NHS agency
The maximum quantity of CD Rx to vet &human
Vet: all CD: 28 days
Human CD2/3/4: 30 days
Rx’er need to include which information when Rx CD for vet & human
Vet CD Rx: CD2/3 => RVCS registration number
Human PRIVATE CD2/3 Rx: Prescriber identification number
What is the vet cascade process
Vet cascade steps
1. Supply Vet med with GB/UK-wideMA for specific species & condition
2. Vet med with Northern Ireland(NI) MA for specific species and condition
3. GB/NI/UK-wide vet med for other species/different conditions
4. GB/NI/UK-wide for human med OR vet med authorised out the UK
5. extemporaneous/special manufactured med
Labelling of the vet med under the cascade
Labelling of the vet med under the cascade
1. Owner: Name and address
2. Animal: Identification and species
3. Vet surgeon’s Name
4. Pharmacy: Name and address
5. Animal: Identification and species
6. Product: Name/descripton/ingredient and content quantity, Dosage & administration instructions, special storage details, Expiry date,
7. Any necessary warning for users
8. Any Withdrawal period
9. “For Animal Treatment only”
10. “Keep out of reach of children”
Record Keeping for POM-V, POM-VPS, method of keeping the record, how many years to keep, any annual audit?
Record Keeping for POM-V, POM-VPS
1. Date of receipt/supply
2. Recipient’s name and address
3. if it’s a written Rx, the name and address of the prescriber & keep a copy of the Rx
4. Medicine: name and quantity, batch number,
- Method: a) keep all documents, b) make a record in private Rx book, c)electronically
Must keep for 5 years
Pharmacy that supply POM-V/POM-VPS must carry out annual audit
What does an accountable officers do
Accountable officer is respnible for supervising and manage the use of CD in the organisation/settings
Classification of CD: definition and which med does it include
Sch 1 (CD LIC POM)
: most has no therapeutic use
: require a license to possess, production, supply
: hallucinogenic drug (LSD), ecstasy-type substances, raw opium
Sch 2 (CD POM)
: opiate (diamorphine, morphine, methadone, oxycodone, pethidine); majoyrstimulant (amphetamines)
Quinalbarbitone, ketamine
Sch 3 (CD no register POM)
: minor stimulant and others (buprenorphine, temazepam, tramdol, midazolam, phenobarbital, gabapentin, pregabaline
Sch 4 (CD BENZ POM/CD ANAB POM)
: Part 1: CD BENZ POM: most benzodiazepine (diazepam), non-benzodiazepine hypnotic (zopliclone), Sativex (a cannabinoid oromucosal mouth spray)
: Part 2: CD ANAB POM: anabolic and androgenic steroids, together with clenbuterol (adrenoceptor stimulant), growth hormone
Sch 5. (CD INV POM/CD INV P)
: codeine, pholcodine, morphine
