MEP42 2 Flashcards
Do emergency supplies need to be entered into the POM register?
If it is a the request of a patient, what information should be documented?
Yes
If a patient request, should include information and nature of emergency - why the patient needs the POM and why a prescription cannot be obtained
For emergency supplies, what is the max quantity that can be supplied for:
- CD 4 and 5s
- Any other POMs
What are the exceptions to this?
- 5 day supply max
- 30 day supply max
Exceptions include insulin, creams, inhaler where a pack cannot be broken down. The smallest pack available should be given.
How much of an oral contraceptive should you give in an emergency supply?
If an oral contraceptive, a full treatment cycle should be provided
How much of a liquid antibiotic should you give in an emergency supply?
If an antibiotic in liquid form, smallest quantity that will provide full course should be supplied
In addition to standard labelling requirements, what else needs to be included on the dispensing label in an emergency supply?
The words “Emergency supply”
Is it possible to do an emergency supply during GP opening hours?
Yes, need to use professional judgement to see if the patient cannot get a prescription that day
What are the 7 exemptions of supplying a medicine without a prescriptions?
- Patient group directions
- Emergency supply (by prescriber or patient)
- Pandemic exemptions
- Optometrist or podiatrist signed orders for patients
- Supply of salbutamol inhalers to schools
- Supply of adrenaline autoinjectors to schools
- Supply of naloxone by individuals providing recognised drug treatment services
Can schools stock hold salbutamol inhalers and epi pens?
Yes
Who can provide a signed order for salbutamol inhalers and epi pens for a school?
Principal/head teacher
What is needed on a signed order for salbutamol inhalers and epi pens for a school?
(i) the name of the school for which the medicinal product is required
(ii) the purpose for which that product is required
(iii) the total quantity required (there is no limit but should relate to school size, number of kids with asthma)
Ideally, appropriately headed paper should be used; however, this is not a legislative requirement. You need to ensure it is not for profit as well.
How long does a record of salbutamol and epi pen supply for a school need to be kept for?
Signed record needs to be retained for 2 years or an entry in the POM register. You need to include the purpose of supply in this record
What programme is in place for females on isotretinoin and how long should the patient be under this programme for?
Is this compulsory?
Pregnancy prevention programme. During treatment and for at least one month after stopping
Patient should be under PPP unless the prescriber agrees that there
are compelling reasons that indicate there is no risk of pregnancy.
How long are isotretinoin prescriptions under the pregnancy prevention programme valid for?
7 days
What is the max quantity that can be supplied for an isotretinoin prescription under the pregnancy prevention programme?
30 days max
Can you issue repeat prescriptions of oral isotretinoin?
No
Can you issue faxed prescriptions for oral isotretinoin?
No
Can you issue an emergency supply for isotretinoin?
Should only be accepted if this is an emergency supply at the request of a PPP specialist prescriber together with confirmation that pregnancy status has been established as negative within the preceding seven days.
If there is an unplanned pregnancy and patient is on sodium valproate what should you advise the patient?
Do not stop your treatment and arrange to see prescriber ASAP
Why is a biosimilar medicine not a generic medicine?
Due to the complexity of structure and greater size of biologics as well as their inherent heterogeneity resulting from their production methods, it is not possible to make an identical copy of the originator biologic.
All biosimilars need to be prescribed by brand as per MHRA advice
What sort of license is required to prescribe cocaine, dipipanone or diamorphine?
Who can prescribe these?
Home Office License
Doctors
Pharmacist/nurse independent prescribers may for organic disease/injury, not for addiction
When a POM is supplied from a registered pharmacy to healthcare professionals, what needs to be kept and how long for?
Signed order/invoice for 2 years
Alternatively, a register in the POM register
What is a POM-V?
Prescription-only medicines that can only
be prescribed by a veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with a written prescription
What is a POM-VPS?
Prescription-only medicines that can be prescribed and supplied by a veterinary surgeon, a pharmacist or a suitably qualified person on an oral or written prescription. A written prescription is only required
if the supplier is not the prescriber
What is a NFA-VPS?
A category of medicine for non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person.
A written prescription is not required
e.g. Frontlin
What is an AVM-GSL?
An authorised veterinary medicine that is available on general sale e.g. Dentastix
What are exempt medicines under schedule 6 of the veterinary medicines regulations – exemptions for small pet animals? (SAEs)
An unlicensed veterinary medicine that does not require a marketing authorisation because it meets criteria laid out in Schedule 6 of the Veterinary Medicines Regulations - Exemptions for small pet animals
What is an unauthorised veterinary medicine?
An unlicensed medicine that does not have
a marketing authorisation and is not eligible
for exemption through the SAES. It can only be prescribed by a veterinary surgeon under the Cascade (see Diagram 10). This includes any human medicine used for animals
What 8 pieces of information must be present for a veterinary prescription to be valid?
1 Name, address, telephone number, qualification and signature of the prescriber. Where Schedule 2 or 3 Controlled Drugs have been prescribed, the Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber must also be included.
2 Name and address of the owner.
3 Identification and species of the animal and its
address (if different from the owner’s address).
4 Date. prescriptions are valid for six months
or shorter if indicated by the prescriber
(the Veterinary Medicines Directorate
has confirmed in the case of repeatable prescriptions all supplies must be made within 6 months or shorter if indicated by prescriber). Prescriptions for Schedule 2, 3 and 4 Controlled Drugs are valid for 28 days.
5 Name, quantity, dose and administration instructions of the required medicine
NB: The Veterinary Medicines Directorate advises that ‘as directed’ is not an acceptable administration instruction.
6 Any necessary warnings and if relevant the withdrawal period (i.e. the time that must elapse between when an animal receives a medicine and when it can be used for food).
7 Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary Cascade (e.g. ‘prescribed under the Cascade’ or other wording to the same effect).
8 Where Schedule 2 or 3 Controlled Drugs have been prescribed, a declaration that ‘the item has been prescribed for an animal or herd under the care of the veterinarian’ – usual Controlled Drugs prescription requirements apply
Is there a standardised form for vet prescriptions?
No
How long should vet prescriptions be retained for?
5 years
Entry into POM register required
They do not need to be submitted to an NHS agency, but pharmacies that supply veterinary medicines must undertake an annual audit
What information about the prescriber must be present on a vet prescription for a CD 2 and 3 drug?
Registration number
What is the veterinary cascade?
Allows the supply of medicines that are not licensed for animals (e.g. if there is no licensed alternative)
It is unlawful to supply a human medicine (including GSL and P) against a veterinary prescription unless it is prescribed by a veterinary surgeon and specifically states that it is ‘for administration under the Cascade’, or other wording to this effect.
Need a written prescription (verbal request will not suffice)
Does a pharmacist have to be physically present during the sale of a POM-V/POM-VPS/NFA-VPS medicine?
Yes unless the transaction has been individually authorised in advance
When a medicine is being dispensed under the veterinary cascade, what should be on the label?
- Name of the prescribing veterinary surgeon
- Name and address of the animal owner
- Name and address of the pharmacy
- Identification and species of the animal
- Date of supply
- Expiry date of the product
- The name or description of the product or its active ingredients and content quantity
- Dosage and administration instructions
- If appropriate, special storage instructions
- Any necessary warnings for the user (e.g. relating to administration, disposal, target species, etc)
- Any applicable withdrawal period (i.e. The time between when an animal receives a medicine and when it can safely be used for food)
- The words: ‘For animal treatment only’
- The words: ‘Keep out of reach of children’.
What do accountable officers do?
Responsibility for supervising and managing the use of Controlled Drugs in their organisation or setting.
What are the two sub-classes of CD 4s?
Part 1- mostly benzos
Part 2- anabolic and androgenic steroids
With regards to CDs, what classes require a license to import and export?
1 , 2, 3
4 (unless for self-administration)
5 - no
With regards to CDs, what classes require invoices to be retained for 2 years?
2- No (has CD register)
3- Yes
4- No
5- Yes
When the MEP states repeatable prescriptions, what is it referring to?
Where the prescriber adds an instruction on the main prescription for the prescribed item to be repeated,e.g. repeat x 3. This does not refer to the prescription counterpart which is sometimes used as a patient repeat request to the prescriber.
Can a prescriber on an NHS prescription indicate “repeat x times”?
No- usually used on private prescriptions
Who supplies the licenses to possess and supply controlled drugs?
Home Office
What are the two exemptions of pharmacists possessing Schedule 1 drugs?
- For the purpose of destruction (if the patient does not agree, contact police)
- For the purpose of handing over to a police officer
The patient’s confidentiality should be maintained unless the quantity is so large it cannot just be for personal use
What is the advice if a patient on controlled drugs and is travelling?
Personal license not required by the Home Office if they are carrying less than 3 months worth
It is advised they carry a covering letter signed by prescriber including travel plans, name, quantity, dose
They should also check they are complying with the countries’ regulations that they are going to
What are the requisition requirements for CD 2 and 3 drugs and what places are exempt from this?
Need to use approved forms
Requisitions should be in writing (not faxed/photocopied) before delivery
Hospices and prisons are exempt from this requirement
If the request is within a hospital setting for a ward/department within the same legal entity, an approved form is not required
What are the legal requirements for a controlled drug requisition?
1. Signature of the recipient 2 Name of the recipient 3 Address of the recipient 4 Profession or occupation 5 Total quantity of drug 6 Purpose of the requisition
CD requisitions:
In an emergency, can a doctor/dentist be supplied with a CD 2 or 3 drug without a CD requisition?
What must be supplied and within what time frame?
Yes but the requisition needs to be supplied within 24 hours (failure to do so is an offence on behalf of doctor/dentist)
What is an FP10CDF form?
Requisition form for CD 2 and 3 for private supplies
What is an FP10GP10A form?
Requisition form for CD 2 and 3 for NHS supplies
- When you receive a CD 2 or 3 requisition, what should you legally do?
- What are the exceptions to this?
- Mark the requisition indelibly with name and address of supplier e.g. name of pharmacy
Send the original requisition to the relevant NHS agency
Good practice- retain a copy for 2 years
- Exceptions- if the supply is made by a person dispensing at a hospital, care home, hospice, prison
- By pharmaceutical manufacturers or wholesalers
- Veterinary requisitions
A midwife may use a midwife supply order to obtain what 3 controlled drugs?
- Diamorphine
- Morphine
- Pethidine
Can advanced electronic signatures be accepted for CD 2 and 3 drugs?
Yes where the electronic prescribing service (EPS) is used
Does the strength of a medicine always need to be on a prescription?
If there is more than one strength available, yes
What does the quantity on a CD 2 and 3 prescription need to be written as?
Words and figures
What does the DOH recommend that the maximum prescribed quantity of Schedule 2, 3 and 4 drugs on one prescription (in terms of days)?
Is this a legal restriction?
30 days
Not a legal restriction but prescribers should be able to justify the quantity requested
If a patient is homeless, what should you put in the address section on a prescription?
No fixed abode
When a controlled drug prescription is written by a dentist, what phrase must be present?
“For dental treatment only”
When a controlled drug is supplied, it is a requirement to mark the prescription with what?
Date and time of supply
True or false:
Sugar free products have a greater potential for abuse, so the RPS advises that these are only supplied when specifically prescribed
True
Page 97 of MEP
Would the instructions “as directed” be acceptable on a controlled drug prescription?
No
“One as directed” would be acceptable however
If a woman of child bearing age is on valproate, do they have to be on the pregnancy prevention programme?
Yes- Government warning came in April 2018 stating they should not be prescribed it unless on PPP
True or False:
For instalment prescriptions, there is approved wording set out by the Home Office
True
1 Please dispense instalments due on pharmacy
closed days on a prior suitable day.
2 If an instalment’s collection day has been
missed, please still dispense the amount due for
any remaining day(s) of that instalment.
3 Consult the prescriber if three or more
consecutive days of a prescription have been
missed.
4 Supervise consumption on collection days.
5 Dispense daily doses in separate containers
For CD 2 and 3 prescription, if either the words or figures (but not both) of the quantity has been omitted, can a pharmacist amend this?
Yes- should mark the prescription to show amendment has been made
If there is a minor typographical error/spelling mistake on a CD 2/3 prescription, can a pharmacist amend this?
Yes- should mark the prescription to show amendment has been made
For CD 2/3 prescriptions, can a pharmacist amend a date, dose, form or strength?
No
True or false:
Private CD 2/3 prescriptions must be written on standardised forms
True
If a hospital is dispensing a private CD 2/3 prescription within the same legal entity, is a standardised form required?
No
What must you have on a private CD prescription to identify the prescriber and what is it?
A prescriber identification number must be
included on standardised private prescriptions.
This number is not the prescriber’s professional registration number (i.e. the GMC number).
It is a number issued by the relevant NHS agency and the prescriber can obtain it from their local primary care organisation
Do vet CD prescriptions need to be written on a standardised private CD form?
No
If a healthcare professional is picking up a CD2 on behalf of a patient, what is required?
Name of HCP
Address of HCP
Identity required - if they do not have identity, it is up to discretion of pharmacist