MEP42 Flashcards
What are the 4 principles of medicine optimisation?
- Aim to understand the patient’s experience
- Evidence-based choice of medicines
- Ensure medicines use is as safe as possible
- Make medicines optimisation part of routine practice
What are the 9 GPhC standards?
- Provide person-centred care
- Work in partnership with others
- Communicate effectively
- Maintain, develop and use their professional knowledge and skills
- Use professional judgement
- Behave in a professional manner
- Respect and maintain the person’s confidentiality and privacy
- Speak up when they have concerns or when things go wrong
- Demonstrate leadership
What does the Human Medicines Regulation 2012 cover?
Legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the Medicines Act 1968.
However, important to note that the Medicines Act 1968 has not been replaced fully and some parts are still active
What does the Programme Board for Rebalancing Medicines Legislation and Pharmacy Regulation do?
Reviews relevant pharmacy legislation and regulation to ensure it provides safety for users of pharmacy services.
What is the name of the regulation that covers prescribing and supply of medicines for animals?
Veterinary Medicines Regulations
What is PO medicine?
Licensed as a GSL medicine however the manufacturer wishes to restrict sales/supplies through pharmacies only e.g. 30 sachet packets of Fybogel.
Within a pharmacy, when can a GSL medicine be sold?
When a pharmacist has assumed the role of RP. However, the pharmacist may be physically absent for a limited period of time whilst RP.
What is the max amount (in mg) of pseudoephedrine and ephedrine you can sell over the counter at any one time?
720mg pseudoephedrine and 180mg of ephedrine
Can you sell a product containing pseudoephedrine at the same time as selling a product with ephedrine over the counter?
No
What other products would be concerning if a patient were to buy as well as requesting ephedrine containing products?
Lithium batteries and chemicals such as acetone
If you suspect a customer is misusing ephedrine products to make meth, who can you report this to?
Local GPhC inspector, local controlled drugs liaison police officer or accountable officer
What 2 medicinal products are licensed as EHC?
Levonorgestrel 1500 micrograms
Ulipristal acetate 30mg
EHC:
What age group is levonorgestrel licensed for and within what time frame of unprotected sex?
> 16 years
Within 72 hours
EHC:
What age group is ulipristal licensed for and within what time frame of unprotected sex?
Supply is not contraindicated < 16 years however pharmacist may wish to consider additional factors e.g. consent, Gillick competency
Within 120 hours (5 days)
Can you give an advance supply of EHC?
Yes - need to make sure the patient is competent, intend to use the medicine appropriately and that it is clinical appropriate to give it to the patient
Children under what age are legally too young to consent to any sexual activity?
Under 13 years
If someone wanted EHC however the sale would be inappropriate e.g. outside the marketing authorisation, who could you refer them to?
GP, family planning clinics, GUM clinics
What is the legal restriction on selling paracetamol?
No more than 100 non-effervescent tablets
There is no legal limit on quantity of effervescent tablets, powders, liquids or granules however professional judgement should be used.
What is the legal restriction on selling aspirin?
No more than 100 non-effervescent tablets
There is no legal limit on quantity of effervescent tablets or, powders however professional judgement should be used.
What are the indications for solid dose OTC codeine and dihydrocodeine?
Short term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone.
All other indications such as flu, cough, sore throats and minor pain have been removed
What is the maximum pack size of codeine and dihydrocodeine OTC?
32 (any more is a POM)
This includes effervescent formulations
What warning label must be on the front of codeine and dihydrocodeine packs?
“Can cause addition. For 3 days use only”
What info must the PIL and packaging of codeine and dihydrocodeine contain?
They need to state the indication and that the medicine can cause addiction or overuse headache if used continuously
for more than three days. The PIL must also contain
information about the warning signs of addiction.
What medicines OTC are deemed unsuitable for children under 6 years?
What are the recommendations for this in the 6-12 years age group?
- Antitussives:
Dextromethorphan, pholcodine - Expectorants:
Guaifenesin, ipecacuanha - Nasal decongestants:
Ephedrine, oxymetazoline, phenylephrine,
pseudoephedrine, xylometazoline - Antihistamines:
Brompheniramine,
diphenhydramine, doxylamine, promethazine,
triprolidine.
For 6-12 years:
These medicines should be used as 2nd line and should not be used for more than 5 days
What is 1st line treatment for children with coughs and colds?
- Drink plenty of fluids
- Paracetamol for fever and pain
- Can use ibuprofen if child does not respond to paracetamol, however paracetamol and ibuprofen is not recommended together under 5 years
- Saline nasal drops, vapour rubs, decongestants or steam inhalation for nasal congestion
- Warm, clear fluids or warm lemon and honey drinks (honey if > 1 year)
- Simple cough mixture e.g. glycerol or simple linctus
What age is honey unsuitable for?
Below 1 year of age
What age group is codeine linctus unsuitable for?
Below 18 years of age
What 7 pieces of info must be present for a standard prescription to be legal?
- Signature of prescriber
- Address of prescriber
- Date
- Particulars of prescriber (type of prescriber)
- Patient name
- Patient address
- Age is below 12
How long is a standard FP10 valid for from the date of prescribing?
6 months
What is the difference between validity of prescriptions in terms of dates between NHS and private prescriptions?
For an NHS prescription, the appropriate date is the LATER of either the date on which the prescription was signed or a date indicated by the appropriate practitioner as the date before which it should not be dispensed. For private prescriptions, the appropriate date will always be the date on which it was signed.
Still 6 months for POM and 28 days for CD for private and NHS
Is it permissible to issue carbon copies of prescriptions?
Yes, as long as it is signed in ink
Can an advanced electronic signature be used to sign a prescription?
Yes
What are instalment prescriptions?
Provided for a single prescription for a controlled drug so it can be dispensed in several instalments
If a repeat number is not stated on a repeat prescription, how many times can it be repeated?
What is an exception to this rule?
Only once
(so dispensed twice in total)
Oral contraceptives can be repeated 5 times (dispensed 6 times in total)
Are controlled drugs repeatable on prescription?
2 and 3 cannot be repeated, however 4 and 5 can be
On repeat prescriptions, is there a time limit?
No- the first dispensing must be made within 6 months of the date like a normal prescription
However after this, there is no legal time limit for the remaining repeats. However, pharmacists should use professional judgement
For repeat prescriptions, can they be dispensed from different pharmacies?
Yes, the patient can retain the prescription and choose to have repeats dispensed from different pharmacies. You can maintain an audit trail mark on the prescription (name and address of pharmacy, date of supply)
Are FP10 forms used in prison?
Is there any exceptions to this?
No, unless in a special circumstance where it has been authorised
However, if a prisoner is about to be released and the usual method of ensuring continuity of supply in the community has not happened e.g. being released unexpectedly, can be given an FP10MDA to take to a community pharmacy
These forms have the prison address and are exempt from paying
What is the time limit on prescription owings for:
- POM
- GSL/P
- CD 2, 3, 4
- 6 months
- 6 months
- 28 days
How long must a record be kept for a POM private prescription?
What should the record include?
2 years from the date of supply
The record should include:
- Supply date
- Prescription date
- Medicine details
- Prescriber details (name and address)
- Patient details (name and address)
What must you do if you dispense a private or NHS CD 2 or 3 medicine?
Is this the same with vet private CD prescriptions?
Private and NHS CD 2 and 3 prescriptions should be submitted to the relevant NHS agency
Do not need to submit vet private CD script however the prescription needs to be retained for 5 years
When recording private prescriptions, when should the record be made into the POM register?
On the day of supply, and if this is not practical, on the next day following
What 2 medicine classes are exempt from record keeping for private prescriptions?
Oral contraceptives and CD2s where a separate controlled drug register has been made
Do you need to have details of the medicine in order for a prescription to be legal?
No, you do not legally need name, strength, form, quantity and dose however these are important to identify what medicine you need to dispense
Is a faxed prescription a legal document?
No as it has not been written in indelible ink and has not been signed in ink
There are various risks associated with faxed prescriptions e.g. sent to multiple pharmacies for multiple supplies, forged prescriptions.
There are other options with a better risk profile
Pharmacists considering supplying medicines against a fax should make an informed decision and consider record making of the decision-making process
What can dentists legally prescribe?
Is there a restriction on NHS Dental prescriptions?
Any POM however the General Dental Council advises that dentists should restrict their prescribing to within their competency
On NHS dental prescriptions, dentists are restricted to the Dental Prescribers’ Formulary
Who can you report to if you suspect a forged prescription?
Police or NHS Counter Fraud Services
Are repeatable prescriptions from a registered EEA/Switzerland prescriber allowed?
YES
Are emergency supplies for patients of registered EEA/Switzerland prescriber allowed?
Are there any exceptions?
Yes
Not for CD2 or 3 (INCLUDING phenobarbital)
But can for CD4 and 5
What are the details required on an EEA/Switzerland prescription?
Patient details:
Patient’s full first name(s), surname and date of birth
Prescriber Details:
Prescriber’s full first name(s), surname, professional qualifications, direct contact details including email address and telephone or fax number
(with international prefix), work address
(including the country they work in)
Prescribed medicine(s) details: Name of the medicine (brand name where appropriate), pharmaceutical form, quantity, strength and dosage details
Prescriber signature
Date of issue:
Valid for up to six months from the appropriate date (prescriptions for Schedule 4 Controlled Drugs 28 days). For prescriptions from these countries the appropriate date is the date on which the prescription was signed.
If an EEA/Switzerland prescription is written in a foreign language is it legally acceptable?
Yes, but the pharmacist must have enough information to carry out the safe supply
What medicines cannot be dispensed on an EEA/Switzerland prescription in the UK?
Schedule 1, 2, 3 drugs and those without a marketing authorisation valid in the UK
Is there an online platform to check for all registered EEA/Swiss prescribers?
No, however you can contact EEA competent authorities to check registration details (can get contacts for these via GMC and other registered UK professional bodies)
If it has not been possible to confirm the registration status of an EEA prescriber after taking all reasonable steps, is it possible to make a legal supply?
Yes, but it is recommended that you keep a record of decision making and any steps taken. This includes questioning the patient and using professional judgement
If you give an emergency supply via an EEA/Swiss prescriber, within how many hours does the prescription need to be received?
Within 72 hours
Can you give an emergency supply of controlled drugs via EEA/Swiss prescriber?
Cannot give schedule 1,2, 3 including phenobarbital
However can supply schedule 4 and 5
What is a military prescription also known as?
FMed 296
How does dispensing of military prescriptions work?
Large military medical centres do their own in house dispensing
Smaller centres outsource the dispensing process to designated community pharmacies under a Ministry of Defence contract. These pharmacies will invoice the Ministry and Defence directly
- In the event that a military prescription is presented in a non-contracted pharmacy, how should it be dispensed and how is it paid?
- What about a military personnel that presents with an NHS prescription?
- It should be treated as a private prescription. The pharmacy are not to invoice the MOD directly but should charge the patient. It is then up to the patient if they wish to recover this cost from their military unit.
This should only happen in exceptional circumstances as there are contracted pharmacies to dispense these prescriptions
- Same process as a normal NHS prescription, unless they fall under NHS exemption and do not have to pay for their prescriptions
The person can then try and claim the money back from the military
Can military CD prescriptions be on a standard FMed 296 form?
No, you need designated standardised forms which can be obtained from local primary care organisation/NHS health boards, in the same manner as prescribers wishing to prescribe CDs privately
What 2 aspects of an FMed 296 (miliatry) prescription would flag up concern?
- If it is handwritten, as they are normally computer generated - look out for CDs, codeine, sedatives, and medicines for erectile dysfunction
- British Forces Post Office address stamp present- these are not normally seen in the UK so be wary
What 6 pieces of information are legal requirements on a dispensed label?
What does the RPS also recommend should be on the label?
- Name of patient
- Name and address of supplying pharmacy
- Date of dispensing
- Name of medicine
- Directions for use
- Precautions relating to the use of the medicine
The RPS recommends the following should also appear:
- Keep out of reach and sight of children
- Use this medicine only on your skin (where applicable)
In secure environments (prison) what is strongly recommended that is also on the label to identify the patient?
Prisoner number
The assembly or pre-packing of medicines by a pharmacy to be supplied to a separate legal entity e.g. NHS trust required the appropriate license from who?
MHRA or Manfuacturer’s Specials License
What is covert administration of medicines?
When medicines are administered in a disguised format without the knowledge or consent of the person receiving them, for example, in food or in a drink.
What is a patient specific direction?
An instruction to administer a medicine to a list of individually named patients where each patient on the list has been individually assessed by that prescriber
What is a patient group direction?
A PGD is a written direction that allows the supply and/or administration of a specified medicine
or medicines, by named authorised health professionals, to a well-defined group of patients requiring treatment for a specific condition.
Since 23 April 2012, pharmacists have been empowered by legislation to supply, offer to supply and administer diamorphine or morphine under a PGD for the immediate, necessary treatment of sick or injured persons.
For emergency supply at the request of a prescriber: Within how many hours does a prescriber need to provide a prescription after an emergency supply?
Within 72 hours. The date of receiving the prescription should be documented in POM register
Can controlled drugs be issued as an emergency supply?
Is there any exceptions?
1,2,3 no
4 and 5 yes
Exception is phenobarbital which can be supplied
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?
- 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 if not on the packaging?
- 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