MEP Flashcards
What is a POM-V medicine?
POM that can be prescribed by a vet, and supplied by a vet or pharmacist with a written prescription
POM-VPS
POM that can be prescribed and supplied by a vet, pharmacist or suitably qualified person with an oral or written prescription.
A written prescription is only required if the supplier is not the prescriber.
NFA-VPS
A category of medicines for non-food animals - a written prescriptions is not required.
AVM-GSL
An authorised veterinary medicine that is available on general sale.
Exempt medicines under schedule 6 of the veterinary medicines regulations - exemptions for small pet animals (SAES)
Unlicensed veterinary medicine that does not require a marketing authorisation because is meets criteria laid out in section 6 of the VMR - exemptions for small per animals.
Unauthorised veterinary medicines
Unlicensed medicines that does not have a marketing authorisation and is not eligible for exemptions through the SAES. Can only be prescribed by a vet under the cascade - this included any human medicine used for animals.
What information must be on a prescription for POM-V, POM-VPA and medicines supplied under the veterinary cascade?
- Name, address, telephone number, qualification and signature of prescriber.
- If CDs have been prescribed, the Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber.
- Name and address of the owner
- Identification and species of the animal (and address if different from the owners)
- Date - valid for 6 months or 28 days if CD (or shorter if indicated by the prescriber). Repeat prescriptions must be repeated within this time too.
- Name, quantity, dose and instructions of medicines. ‘As directed’ is NOT acceptable.
- Warnings and relevant withdrawal period (e.g. time that must elapse between when an animal receives a medicine and when it can be used for food)
- ‘Prescribed under the cascade’.
- If CD’s have been prescribed: ‘this item has been prescribed for an animal or herd under the care of the veterinarian.’ Usual CD requirements also apply.
- Number of time the prescription can be repeated if repeatable.
Are standardised forms required for veterinary prescriptions?
No, not for CDs either.
How long should veterinary prescriptions retained?
5 years
Do you submit veterinary prescriptions to the relevant NHS agency?
No
As good practice - what is the maximum days of a CD that should be supplied on a veterinary prescription?
28 - unless longterm e.g. epilepsy meds in dogs
Can medicines be supplied under veterinary cascade if a licensed animal medicine is available?
No
What is the veterinary cascade?
- Supply a licensed veterinary medicines.
IF THIS IS NOT POSSIBLE
- An exicisting licensed veterinary medicine for another species or condition can be used
IF THIS IS NOT POSSIBLE
- A licensed human medicine or EU-licensed veterinary medicine can be prescribed
ONLY WHEN ALL THE ABOVE NOT POSSIBLE
- Extempt or special can be considered
Can an animal owner purchase OTC human meds if advised by a vet?
No - supply of all unauthorised veterinary medicines must take place under the cascade.
What must pharmacists who supply NFA-VPS and POM-VPS do?
- Advise how to use the product safety
- Advise on any applicable warnings and contraindications on the packaging or label
- Be satisfied that the recipient intends to use the medicine correctly and is competent to do so
- Prescribe or supply the minimum quantity required for treatment.
Does a pharmacist need to be physically present for the supply of POM-V, POM-VPS and NFA-VPS?
Yes - unless the transaction has been individually authorised in advance and the person handing out the medicine is judged to be competent.
What is required on the label / packaging of a veterinary medicine?
- Name of the prescriber
- Name and address of animal owner
- Name and address of the pharmacy
- Identification and species of the animal
- Date of supply
- Expiry date of the product
- Name or description of product or its active ingredients and quantity
- Directions
- Special storage instructions
- Warnings
- Applicable withdrawal period
- ‘For animal treatment only.’
- ‘Keep out of reach of children’.
RPS recommended KOOSAROC instead.
Is a label required for a veterinary medicine is not prescribed under the cascade?
No - however RPS advises to generate a label, particularly for individual animals (pets).s
Records of receipt and supply should be kept for which veterinary medicine categories?
POM-V and POM-VPS
What should the records for POM-V and POM-VPS medicines contain?
- Name of medicine
- Date of receipt or supply
- Batch number
- Quantity
- Name and address of supplier or recipient
- If there is a written prescription, name and address of the prescriber. Keep a copy of the prescription.
What POM-V / POM-VPS records should be kept?
Pharmacists can either keep the documents that show the required information, or can record in private prescription book.
Records can be kept electronically
Kept for 5 years
Pharmacies must undertake an annual audit
Can you wholesale veterinary medicines?
Only the manufacturer or a holder of a wholesale dealer’s authorisation (WDA) may supply authorised retailers with veterinary medicines.
An authorised retailer may supply to another authorised retailer to relieve a temporary shortage, without a WDA. .
What criteria do pharmacies need to meet to supply medicines to other HCP / pharmacies with a WDA?
- Takes place on an occasional basis
- The quantity of medicines supplied is small
- The supply is made ono a not for profit basis
- The supply is not for onward wholesale distribution
What do you need to trade medicines?
- Wholesale dealers license (WDA)
- Good distribution practice (GDP) standards
- Have a suitably experienced ‘responsible person’ named on a license
- Medicines can only be supplied to other wholesale dealers, pharmacists or persons authorised to supply medicines to the public.
These restrictions do not apply to the exchange
of stock between pharmacies that are part of the same legal entity, although where a legal entity holds a WDA(H) as one (or more) of its pharmacies is involved in the commercial trade of medicines, the supplying pharmacy must also be named on the WDA(H) if the stock supplied is for the purposes of wholesale.
What license do you need to wholesale deal controlled drugs?
WDA
Home Office CD license (Sch 2-5).
Who can be supplied with medicinal products?
Doctors Dentists Registered pharmacies Hospitals, clinics and independant medical agencies Midwives Chiropodists / podiatrists Optometrists Paramedics Owner or master of a ship First aid organisations Certified first aiders Working for the national lifeboat organisations Occupational health schemes Drugs treatments services NHS Trusts
What are the record keeping requirements for signed orders?
When a POM is supplied, an entry need to be made in the POM register OR the signed order/invoice needs to be retained for 2 years from the date of supply. Good practice to always enter in register.
What must be included in an entry in the POM register for a signed order?
- Date the POM was supplied
- Name, quantity and, where it is not apparent, formulation and strength of the POM
- Name and address, trade, business or profession of the person to whom the medicine was supplied
- Purpose for which it was sold or supplied
What is the falsified medicines directive (FMD)?
- New secutiry features on individual packs - anti-tampering device.
- Electronic scanning authentication process to be undertaken at the point of dispensing/supply
Aim to ensure medicines in the UK are safe, and reduces the risk fake medicines entering the supply chain.
Applies to POMs for human use and NHS/private supplies.
What is a PGD?
Patient group direction.
Allows the supply and/or administration of medicines, by named, authorised healthcare professionals, to a well-defined group of patients requiring treatment for a specific condition.
Can pharmacists supply / administer diamorphine or morphine under a PGD for the immediate, necessary treatment of a sick or injured person?
Yes
Can you supply an emergency supply for veterinary medicines?
No
For emergency supply at the request of a prescriber, who does ‘relevant prescriber’ include?
Doctor Dentist Supplementary prescriber Nurse / pharmacist / podiatrist / therapeutic radiographer / optometrist / paramedic independant prescriber Community practitioner nurse EEA or Swiss HCP
HCP from outside the EEU or Switzerland are NOT recognised as ‘relevant prescribers’.
What are the conditions for an emergency supply at the request of a prescriber?
Relevant prescriber
Emergency
Prescription within 72 hours
Directions
Not for CDs - except phenobarbital for epilepsy
Record kept (in day of supply or following day)
Usual labelling requirements
What needs to be recorded in the POM register for an emergency supply at the request of a prescriber?
- Date supplied
- Name and quantity of medicine
- Name and address of prescriber
- Name and address of patient
- Date on the prescription (can be added retrospectively)
- Date which the prescription is received.
What are the conditions for an emergency supply at the request of a patient?
Interview Immediate need Previous treatment Dose - satisfied you know Not for CDs 2 and 3 - except phenobarbital for epilepsy Length of treatment - 5 days for CD 4/5/phenobarb, or 30 days for other POMs (or smallest pack size when cannot be broken down or full course of abx. Records kept in POM register 'Emergency supply' on label
What records must be kept for emergency supplies at the request of the patient?
- Date supplied
- Name and quantity of medicine
- Name and address of patient
- Nature of emergency.
What is the maximum number of days CD you can supply for an emergency supply at the request of a patient?
5
What is the maximum number of days of a POM you can supply at the request of a patient?
30
What can you not give on an emergency supply ?
Sch 1, 2 and 3 (except phenobarbital)
Ammonium bromide Calcium bromide Potassium bromide Sodium bromide Calcium bromidolactobionate Embutramide Fencamdamin hydrochlodire Fluanisone Fexobarbitone Hydrobromic acid Meclofenoxate Methohexitone Permoline Piracetam Prolintane Styrchnine Tacrine Thiopentone
Unlicensed medicines
What exemptions apply to emergency supplies during a pandemic?
No interview required with patient
Medicines can be collected from designated collection points - does not have to be a pharmacy and requires no supervision of a pharmacist.
Optometrist or podiatrist signed order - what are the rules?
POMs can be supplied in accordance with a signed patient order.
The medicine must be one which can be legally sold or supplied by the optometrist (rather than one they can only administer).
Optometrists who have undertaken additional training and are accredited by the GOC can issue signed orders for an extended range of medicines.
Prescriptions requirements do not apply
Entry into POR required
Labelling requirements apply
Who can provide a signed order for salbutamol inhalers for a school?
Written order signed by principal or head teacher
What information should be on a signed order for salbutamol for a school?
- Name of school
- Purpose of product
- Total quantity of product
- Signed by head teacher
Ideally but not required: appropriately headed paper
How many inhalers can a school obtain?
Small quantities - dependant on many factors
What records need to be kept when salbutamol is supplied to schools?
Signed order kept for 2 years OR entry in POR.
POR entry must include:
- Date supplied
- Name, quantity, form and strength
- Name and address, trade, business or profession of the person whom the medicine was supplied to
- Purpose for which it was sold / supplied
What other information could the pharmacy be asked to provide when supplying salbutamol to schools?
- How to use the inhaler
- Advise on the most appropriate spacer device for different age groups
Where can you obtain information on a school, including details of the head teacher?
No centralised database
Possible sources:
- Ofsted reports
- Schools website
- Department for education’s register or educational establishments
What other information could pharmacists be asked for when supplying epipens to schools?
- Administration instructions
- General advice e.g. storage, disposal, expired stock
- Advise schools on the important of keeping a record of spare AAIs held and their expiry dates, to ensure they are replaced appropriately.
What brand adrenaline should you supply to schools?
DoH advises schools stock a single brand to avoid confusion - but discretion of brand depends on the school.
What drug can be supplied in lawful drug treatment services from a wholesaler to the patient, without a prescription, PGD or PSD?
Naloxone
Nasal naloxone
What is a lawful drug treatment service?
Persons engaged in the provision of drug treatment services, provided by, on behalf of, or under arrangements made by:
- An NHS body
- A local authority
- PHE
- Public health agency
This extends to commissioned services providing needle and syringe programmes.
Who can administer naloxone for the purpose of saving a life?
Anyone
Does a pharmacist need to be present to supply naloxone in a local take home scheme?
No - can be provided by appropriately trained staff.
What should you consider before supplying a self-prescribed prescription?
- Considered poor practice
- Professional judgement of prescriber may be impaired
- May not be possible for prescriber to conduct a proper clinical assessment
- GMC advises doctors should avoid prescribing for themselves or close family/friends
- Nurses and pharmacists should not prescribe for themselves
- If there a local policy advising?
- Potential for abuse
- CDs may prompt referral to local CD accountable officer
What is the risk of using oral retinoids in pregnancy?
e.g. isotretinon, alitretinoin, acitretin.
High risk of causing severe foetal malformations and increase the risk of spontaneous abortion.
Suppling oral retinoids - what special distribution control are in place for females at risk of pregnancy?
Prescription is only valid for 7 days
Maximum 30 days supply - can only supply more than 30 days if confirm with the prescriber that the patient is not pregnant.
Do not accept repeat prescriptions
What should pharmacists do when supplying sodium valproate?
- Consultation with patient: are then on PPP and aware of risks?
- Advise patients planning pregnancy to schedule an appointment with the prescriber to review treatment.
- If unplanned pregnancy, advise NOT to stop taking medicine and arrange urgent appointment with prescriber
- Report any adverse effects via yellow card scheme.
What is a biologic?
Medicine made from natural sources, which may be human, animal or microorganism.
Examples: vaccines, blood products, DNA, human cells etc.
What is a biosimilar?
Biological medicine similar to an already licensed biologic medicine in terms of: quality, safety and efficacy.
Can only be marketed after the patent protecting the originator product have expired.
Why is a biosimilar not a generic?
Due to complex structure and greater size, inherent heterogeneity resulting from production methods.
Not possible to characterise a biologic to the same extent as a small molecule drug.
Should you switch between biologics/biosimilars?
Decision must be made by the prescriber.
Should biosimilars be prescribed by brand name?
Yes - recommended by MHRA
What additional details should be recorded when reporting a suspected ADR to a biological medicine?
Brand name
Batch number
Where can you check the registration of vets?
Royal college of veterinary surgeons
Where can you check the registration of paramedics, chiropodists, podiatrists, physiotherapists, optometrists, dieticians, orthoptists and radiographers?
Health and Care
Professions Council
What should you do when you become aware of a dispensing error?
- Take steps to let the patient know promptly
- Make things right (may involve contacting the prescriber)
- Offer an apology
- Let colleagues involved in the error know
When can the defence to the section 64 ‘dispensing error’ offence be used?
When the dispensing error has been:
- Dispensed in a registered pharmacy
- Dispensed by of under the supervision of a registered pharmacist
- Supplied against a prescription, PGD or direction from a prescribed
- Promptly notified to the patient
What does ‘use by’ and ‘use before mean’?
Should be used before month stated.
What does expiry date mean?
Product should not be used after end of the month stated.
Where should waste medicines be stored?
Secure waste containers in designated area, preferable away from medicines fit for use
Should you de-blister tablets when disposing?
No. Blister strips can be removed from inert outer packaging, but tabs and caps not de-blistered.
How should liquid medicines be disposed of?
The whole bottle (including empty bottles containing residue) should be placed in the pharmaceutical waste container.
What does the responsible pharmacist need to do?
Secure the safe and effective running of the pharmacy
Display a notice
Complete the pharmacy record
Establish, maintain and review pharmacy procedures
What does the RP notice need to include?
Name
GPHC number
The fact that the responsible pharmacist is in charge of the pharmacy at the time
How may the pharmacy record be kept?
In writing
Electronically
Both