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?
State indication and that the medicine can cause addiction or overuse headache if used continuously for > 3 days. The PIL must also contain info 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
- Ibuprofen if child does not respond to paracetamol, however both not rec 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?
- NHS prescription; the appropriate date is the LATER of date prescription signed or a date indicated by practitioner as the date before which it should not be dispensed.
- Private prescriptions; 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?
PGD = written direction that allows supply and/or administration of a specified medicine(s), by named authorised HCPs, 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?
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 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
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 CD 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
If a drug misuser wants a representative to collect a CD on their behalf, what are pharmacists advised to do?
Obtain a letter
from the drug misuser that authorises and names the representative. (This includes those detained
in police custody who should supply a letter of authorisation to a police custody officer to present to the pharmacist)
A separate letter should be obtained each time and the record of supply should be included about the representative in the CD register
If a CD script is meant to be supervised but a representative with a consent letter from the patient turns up to the pharmacy, what should you do?
You should contact the prescriber before the medicine is supplied to
the representative – since supervision will not be possible. It is legally acceptable to confirm verbally with the prescriber that they are happy with this arrangement since supervision, while important, is not a legal requirement under the 2001 Regulations.
It would not be necessary to contact
the prescriber if the person has been detained in police custody and the representative collecting the dose is a police custody officer
Does phenobarbital require safe custody?
No
Does tramadol require safe custody?
No
What drugs need to be kept under safe custody?
Schedule 1
Schedule 2
Schedule 3
There are some exemptions e.g. tramadol
Does safe custody apply to returned CDs from patients?
Yes until destroyed
What controlled drug schedules need to be denatured before disposal?
Schedules 1, 2, 3 and 4 (part 1)
What is the difference between destroying CDs that are pharmacy stock, and that are returned POMs?
Pharmacy stock needs a witness by authorised person for CD2 whereas returned POMs do not - however it is preferable for denaturing to be witnessed by another staff member
For patient returned CDs, should a record be made when destroying them?
A record should not be made in the Controlled Drugs register but records of patient- returned Schedule 2 Controlled Drugs and their subsequent destruction should be recorded in a separate record for this purpose
Do you need an authorised witness when destroying CD stock?
Yes if schedule 2
Good practice for schedule 3
Do you need to make a record when destroying CD stock?
Yes in the CD register for CD2 drugs
In community pharmacy, only CD2s are entered into the register. How does this advice differ in prisons?
It is recommended to maintain a robust audit trail of Schedule 3 and 4 drugs
True or false:
An accountable officer has the power to authorise other persons to witness the destruction of Controlled Drugs.
True
Can an accountable officer be an authorised witness person?
No
What is the advice regarding capsules and tablets before adding them to a CD denaturing kit?
Grind or crush them
What is the advice regarding CD liquids, ampoules and vials when denaturing them?
If the ampoules contain powder, what should you do?
Pour into CD denaturing kit
Add water to the powder to dissolve it and then pour into CD denaturing kit
What is the advice regarding CD patches when destroying them?
Remove the backing and fold the patch over on itself. Place into a waste disposal bin or a CD denaturing kit
What is the advice regarding CD aerosols when destroying them?
Expel into water and dispose of the resulting liquid into CD denaturing kit
Pharmacists are required to keep a register for CD 2 drugs. What additional drug needs to have a record?
(Hint- schedule 4 part 1)
Sativex (cannabis-based medicine)
How long should a CD register be kept for?
2 years from date of last entry
Can you have an electronic CD register?
Yes
How often should CD stock be checked?
At least once a week (could be less frequent based on risk assessment)
If a product says “Use by 6/2019” what does this mean?
The product should not be used after 31st May 2019
If a product has an expiry date of 6/2019, when should the product be used?
Should not be used after 30th June 2019
When would there be exceptions to not dispensing a medicine in child-resistant packaging?
Patient request e.g. if they have difficulty opening it
Original pack is not child resistant and it is not possible to change it
Can a child collect a prescription on someone else’s behalf?
What about a CD2 drug?
Yes but need to use professional judgement regarding maturity of child, reason for collection, understanding counselling points
Should get identification for CD2 drugs but a child may not have this. Use professional judgement
Children under what age are legally too young to consent to any sexual activity?
Under 13 years
In terms of driving, when can a statutory medical defence be raised?
When the driver has been taking a prescribed drug on the list of specified drugs (e.g. morphine, diazepam) but driving is not impaired
If driving is impaired, it can lead to an offence
What is the Pharmacy record and what do you record in it?
Legal document to show who is the responsible pharmacist at any one time (include GPhC number, date and time)
Also includes absence details
How long must you keep the Pharmacy record for (records responsible pharmacist info)?
5 years
How long can the responsible pharmacist be absent for?
Max of 2 hours in 24 hour period
If there is more than one responsible pharmacist in 24 hours, what can the total hours absent be?
2 hours
What are the required arrangements if the responsible pharmacist is absent?
They must remain contactable
If they cannot, then they must arrange for another pharmacist to be contactable and available for advice
Needs to record absence in Pharmacy record
Can a pharmacy receive patient returned medicines if there is no RP and what is the exception?
Yes apart from CDs
How do you dispose of used methadone bottles?
Once a methadone bottle is emptied rinse bottles and add liquid to a denaturing kit and treat as pharmaceutical waste.
Empty container is then disposed of into the recycling or general waste
How would you destroy solid dosage form CDs?
- Grind / crush the solid dose formulation before adding to the CD denaturing kit to ensure that whole tablets / capsules are not retrievable.
- The resulting mixture may then be poured onto an appropriate amount of suitable product and added to an appropriate waste disposal bin.
- If a CD denaturing kit is not available - mix it with warm soapy water
How would you destroy liquid dosage form CDs?
Pour into a CD denaturing kit e.g. DOOP kit
If this is not available, pour into a suitable product then add to an appropriate waste disposal bin
How would you destroy ampoules and vials if they contain CDs?
i) Liquid containing vials
ii) Powder containing vials
i) For liquid containing ampoules, open the ampoule and empty the contents into a CD denaturing kit
Dispose of ampoules into sharps bin
ii) For powder containing ampoules, open the ampoule and add water to dissolve the powder inside. The resulting mixture can be poured into the CD denaturing kit and the ampoule disposed of as sharps pharmaceutical waste
How would you destroy patches that are CDs?
Remove the backing and fold the patch over on itself. Place into a waste disposal bin or a CD denaturing kit
How would you destroy aerosol products containing CDs?
Expel into water and dispose of the resulting liquid in accordance with the guidance on destroying liquid formulations
For MDA (methadone) scripts, what is the maximum number of days you can prescribe on one script?
14 days
If a patient came into the pharmacy with a prescription for:
Levothyroxine 25 mcg
Levothyroxine 50 mcg
How many charges would this be?
1 charge as same drug and formulation
If a patient came into the pharmacy with a prescription for:
Amoxicillin 500mg caps
Amoxicillin 250/5mL solution
How many charges would this be?
2 charges as different formulations
True or false:
The duty of confidentiality still applies after the person has died
True
In what situations would you not need the person’s consent to share their information?
• Disclosure is required by law, or
• Disclosure can be justified in the
public interest
• To do so is impracticable, would put the pharmacy professional or others (including the person receiving treatment or care) at risk of serious harm, or would prejudice the purpose of the disclosure, for example to prevent a crime
However, only disclose the necessary information required
Make a record about the details of the disclosure
When gaining consent from a patient about disclosing confidential information, what 4 things should you ensure the patient understands?
- What information will be disclosed
- Why it will be disclosed
- Who it will disclosed to
- Consequences of disclosing and not disclosing information
What organisation can provide advice regarding guidance on data protection legislation?
ICO - Information Commissioner’s Office
What are the two types of consent?
Explicit/express
Implied
Pharmacists should use their professional judgement to decide what kind of consent to get
True or false:
People with capacity can withdraw their consent at any time
True
For a patient to have capacity and to be able to make an informed decision, what 4 things must they be able to do?
- Understand information provided
- Remember information provided
- Use & weigh up the info provided
- Communicate their decision to the pharmacy professional (by any means).
True or false:
If a person lacks capacity to make a certain decision, it is assumed they do not have capacity to make any decisions
False
Pharmacy professionals must not assume that because a person lacks capacity on one occasion, or in relation to one type of service, that they lack capacity to make all decisions
What is the target number of MURs each year in community pharmacy?
400
How many CPD entries do you have to do a year to revalidate?
4
2 must be planned learning activities
What do you have to submit each year to revalidate as a pharmacist from end of 2019 onwards?
4 CPD records (2 must be planned learning activities), a peer discussion record and a reflective account record.
in 2018, was 4 CPDs
What is the recommended number of days to be prescribed for a CD script on a vet prescription vs a human prescription?
Good practice to prescribe 28 days worth of treatment vet prescriptions for all CDs- unless in situations of long term treatment e.g. epilepsy
For human prescriptions- recommended max of 30 days for CD 2,3,4 (over this amount must be justified by the prescriber)
What are the 4 steps of the veterinary cascade when choosing a medicine to dispense?
- Supply LICENSED VET MEDICINE»_space;
- An EXISTING LICENSED VET MEDICINE FOR ANOTHER SPECIES / DIFFERENT CONDITION»_space;
- A LICENSED HUMAN MEDICINE OR AN EU-LICENSED VET MEDICINE»_space;
- EXTEMPORANEOUS OR SPECIALLY MANUFACTURED MEDICINES
If a veterinary surgeon has told the animal owner to purchase a human medicine for their pet, would you be able to do sell this?
No- it has to be prescribed under the veterinary cascade
What must be present on a midwife supply order for CDs?
- Name of the midwife
- Occupation of the midwife
- Name of the patient
- Purpose of CD required
- Total quantity of the drug
- Signature of an appropriate medical officer – a doctor authorised (in writing) by the local supervising authority or the person appointed by the supervising authority to exercise supervision over midwives within the area
What are the MHRA checkpoints for accuracy checking a prescription?
Right medicine Right patient Right dose Right route Right time
A mother approaches you and asks for a spacer for her five year old son because his has broken. What would be the most appropriate course of action?
Sell the mother a spacer
A spacer is a medical device not a medicine. Therefore there are no restrictions on the sale of the spacer.
How long should the responsible pharmacist record be kept for?
5 years
How long should the CD register be kept for?
2 years
How long should you keep a signed order?
2 years
How long should you keep private prescriptions?
2 years
If the responsible pharmacist absence exceeds 2 hours, can the pharmacy still be open?
No- after the 2 hours in 24 hours, the pharmacy must close if the pharmacist needs to be absent
You are stuck in traffic on the bus on the way to work and will be late. Your pharmacy has an electronic responsible pharmacist register that allows you to log in remotely.
Are you allowed to do this so the pharmacy can open?
Yes if you feel confident in doing so
Is the quantity on a prescription a legal requirement for non CD scripts?
No
A patient brings in a script during GP opening hours to community pharmacy
What should you do if a non-CD script does not have a quantity on it?
Contact the prescriber for guidance and add a ‘PC’ endorsement to the prescription
A patient brings in a script (GP is closed) to community pharmacy
What should you do if a non-CD script does not have a quantity on it?
If cannot contact prescriber, supply enough for 5 days of treatment only and endorse “PNC”
What is the maximum interval your responsible pharmacist should leave for reviewing pharmacy procedures?
2 years
Can CD2 drugs be repeated on a prescription?
No
Can CD3 drugs be repeated on a prescription?
No
Can CD4 drugs be repeated on a prescription?
Yes
How long should the following be retained:
An invoice for a Schedule 3 CD taking account of tax.
6 years
Although the law relating to CDs requires the invoices to be retained for 2 years (as per the BNF advice), the law relating to tax requires the invoices to be kept for 6 years (as per SPS advice).
What is the first date you could supply the following prescription?
An NHS prescription for amoxicillin capsules 250 mg signed 1 May 2019, with the words “supply on 10 May” in the body of the prescription
10th May
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.
What is the first date you could supply the following prescription?
A private prescription for amoxicillin capsules 250 mg signed 1 May 2019, with the words “supply on 10 May” in the body of the prescription.
1st May
For private prescriptions, the appropriate date will always be the date on which it was signed.
A prescription which is hand written by a German doctor registered in Germany as he stands in your pharmacy for amoxicillin. Can you dispense this?
Do NOT dispense the prescription, the prescriber is not allowed to prescribe whilst in the UK
EEA and Swiss prescribers can only prescribe whilst in the country they are registered in. They can not prescribe in the UK unless also registered with the GMC.
You receive an NHS prescription for a Schedule 2 controlled drug. The prescription is signed on 6 March 2019. The prescriber has written in the body of the prescription “Supply on 10 April”.
What is the last date you can dispense this prescription?
28 days from 10th April
The appropriate date of a NHS CD prescription is either the signature date or the date indicated by the prescriber as a date before which the medicine should not be supplied, whichever is the later. The 28 day validity of a CD prescription runs from the appropriate date.
Out of the 4 CPDs you have to do to revalidate, how many of them should be planned learning?
2
Does midazolam require safe custody?
No
Does temazepam require safe custody requirements?
Yes
Does buprenorphine require safe custody requirements?
Yes
What are the two types of conflict of interest?
Actual and potential
What gender is finasteride contraindicated in?
Women
True or false:
A no culture blame is encouraged in Pharmacy
False
A “right or just culture” is needed - based on fairness, transparency, learning from mistakes
Who do you report safety incidents to?
NRLS - National reporting and learning system
OTC is a collective term for what categories of medicines?
P and GSL
On prescriptions, if it states “repeat x times”, when must the first dispensing be done?
What about controlled drugs?
Within 6 months (following this no time limit)
CD2 and 3 are not repeatable
CD4 within 28 days (following this no time limit)
Supplementary prescribers can prescribe what?
Items under a clinical management plan
In partnership with an independent prescriber - doctor or dentist
Can optometrist independent prescribers prescribe CDs?
No
Can optometrist independent prescribers authorise emergency supplies?
Yes
Can EEA prescriptions have unlicensed meds?
No
And can only prescribe medicines that have a MA in the UK
On vet prescriptions, is “as directed” suitable directions?
No
What must it state on CD2 and 3 vet prescriptions?
“The item has been prescribed for an animal or herd under the care of a vet”
Are vet prescriptions repeatable?
Yes
Do CD2 and 3 vet prescriptions need to be written on a standardised form?
No
Do CD2 and 3 vet prescriptions need to be submitted to the relevant NHS agency?
No - but prescription should be retained for 5 years
True or false:
Pharmacies that supply POM-V and POM-VPS must undertake an annual audit
True
Approved CD requisition forms must be used for CD2 and 3 drugs except if the request is from what two places?
Hospice
Prison
Does a controlled drug requisition need to have the patient’s name on?
How does this differ from a midwife supply order for CD (morphine, pethidine, diamorphine)?
No
Midwife supply order needs to have the patient name
On CD scripts, is it recommended that multiple strengths of the same medicine are prescribed separately?
Yes
Do “in house” pharmacy prisons need to be registered with the GPhC?
No
What logo is compulsory if selling medicines online via internet pharmacy?
What logo is voluntary?
EU internet logo is compulsory - apply to the MHRA for it
GPhC logo is voluntary
Can an emergency supply be made at the request of an EEA patient?
Yes
A Scottish lady asking for a emergency dutasteride for her husband who has taken his last tablet this morning.
What should you do?
Need to speak to the patient
Emergency supply at the request of a patient requires interviewing the patient
What are the 8 essential services in community pharmacy?
- Dispensing medicines and appliances
- Repeat dispensing
- Clinical governance
- Disposal of unwanted medicines
- Signposting
- Support for self care
- Funding for essential services
- Public health
What is the recommended number of clinical governance audits a community pharmacy has to do a year?
What do they have to be and how are they chosen?
2 audits a year
At least one Pharmacy based and one other audit
1 audit the pharmacy chooses, the other one is chosen by NHS England
Where do you submit incident forms to?
NRLS
How often should SOPs be reviewed in community pharmacy?
Every 2 years
True or false:
A Pharmacy should have a clinical governance lead
True
How often should you have a self-assessment of clinical governance compliance in community pharmacy?
Annually
Patient satisfaction survey comes under what essential service for community pharmacy?
Clinical governance
What is the time limit to make a complaint in community pharmacy?
12 months
What is the time limit to respond to a complaint in community pharmacy?
6 months
True or false:
Community pharmacies do not require to make a complaints report
False
Annual report of complaints needed
How often should community pharmacies do a complaints report?
Annually
After a GPhC inspection, what is the time limit to respond to confirm accuracy of report?
5 days
After a GPhC inspection, what is the time limit to resolve any outstanding issues in the action plan?
The inspector will already have identified whether the improvement action in relation to each standard, must be completed within 10, 20 or 60 working days.
Patient groups of what ages will get free prescriptions?
> 60 years
<16 years
16-18 and in full time education
OR <20 AND you are dependent on someone receiving income support
How long after having a baby are female patients eligible for free prescription charges?
Up to 12 months after having the baby
The medical exemption certificate covers what conditions?
- Permanent fistula e.g. colostomy
- Hypoadrenalism
- Hypothyroidism
- DB (not diet controlled)
- DB insipidus
- Hypoparathyroidism
- Myasthenia gravis
- Epilepsy
- Continuing physical disability where you need permanent help e.g. carer
- Cancer patients receiving therapy
How many public health campaigns a year are recommended by PHE for community pharmacy?
6
What are the 7 advanced services in community pharmacy?
- MURs
- Flu vaccinations
- Funding for advanced services
- Stoma appliance customisation
- Appliance use reviews
- New Medicines Service
- NUMSAS
What does NUMSAS stand for?
NHS urgent medicines supply advanced service
How long do you need to keep a record of an MUR for?
2 years
Is written consent needed for MUR?
Yes
What are the room consultation requirements for MURs?
What other things are advisable?
Compulsory room consultation req
- The pt and pharmacist can sit down together (so 2 chairs)
- They can talk at normal speaking volumes without being overheard by staff or customers
- The area is clearly signed as a private consultation area.
Also advisable:
- Consultation area to include a table or workbench.
- Space for a computer terminal in the consultation area.
- If the pharmacy is commissioned to provide diagnostic testing services in the future, it may need hand washing facilities in the consultation area.
How long do you need to keep a record of an appliance use review?
12 months
Who can carry out a appliance use review?
Specialist nurse of pharmacist
What are the requirements for NUMSAS to take place both in the pharmacy and requirements of the patient?
- Have to have a consultation room
- Referred by NHS 111
- Patient needs to be under NHS care and paperwork to identify patient’s GP
What % of MURs need to be under the target group?
70% minimum
What are the 4 target groups for MURs?
- Taking 1 high risk med - diuretics, anticoagulation (inc LMWH), NSAIDs, antiplatelets
- Taking TWO or more respiratory meds
- Taking FOUR or more:
- Cardiovascular drugs
- Diabetes drugs
- Thyroid drugs
(Cardiovascular risk patients) - Discharged from hospital and had medicine changes
Ideally within 4 weeks, max within 8 weeks
What is the max number of weeks after being discharged with new medicines should a patient have an MUR?
Within 8 weeks max
Ideally within 4 weeks
What is classed as high risk meds under the MUR target group?
NSAIDs
Anticoagulants (inc LMWH)
Diuretics
Antiplatelets
Do you need patient consent to do an appliance use review?
Yes
What is the timeline for the new medicines service?
Review patient
Then 2 weeks later
Then 2 weeks after this
What 4 groups are eligible for the new medicines service?
New medicine for:
1) Hypertension
2) Asthma/COPD
3) Antiplatelet/anticoagulation
4) Type 2 diabetes
Are patients that have newly prescribed medicine for Type 1 diabetes eligible for new medicines service?
No, only Type 2
Due to the falsified medicines directive, market authorisation holders are required to place what safety features on prescription medicines?
Unique 2D identifier- barcode that can be scanned to determine its authenticity
Anti-tamper device
Due to the falsified medicines directive, what are pharmacy contractors required to do?
Check the anti-tampering device to ensure its intact prior to dispensing
Change the status of the pack in the verification system from “active” to “inactive-supplied” via scanning the barcode
What does the FMD aim to do?
To combat the increasing risk that falsified medicines reach patients
What is a class 1 medicines recall?
Requires immediate recall, because the product
poses a serious or life threatening risk to health
What is a class 2 medicines recall?
Specifies a recall within 48 hours, because the
defect could harm the patient but is not life threatening.
What is a class 3 medicines recall?
Requires action to be taken within 5 days because
the defect is unlikely to harm patients and is being carried out for reasons other than patient safety
What is a class 4 medicines recall?
Alerts advise caution to be exercised when using
the product, but indicate that the product poses no threat to patient safety.
Most medicines recalls fall into what classes according to the MHRA?
2 and 3
What is a licensed medicine?
A medicine that has a UK marketing authorisation, at that strength, that is being used for a condition it’s MA covers
What is the definition of an off-label medicine?
The medicine has a UK MA but it is being used for a different indication. This will be stated under the ‘unlicensed use’ heading in the monograph: states “Not licensed for use in…” This does not mean it’s a unlicensed product, just means it’s being used for a condition out of its licensing
What is the definition of an unlicensed medicine?
A product that does not hold a MA license for use in the UK. These medicines will not appear in the BNF, they will only be made up in specials manufacturing units/ imported from other countries
Be careful: the product itself may be listed but the specific strength you’re after is not: this would still be a special/ unlicensed
A 59-year-old man presents his prescription for oxycodone hydrochloride 40 mg m/r tablets. What is the maximum recommended duration of supply on a single prescription for this medicine? A. 7 days B. 28 days C. 30 days D. 3 months E. 6 months
c
A 59-year-old man presents his prescription. How long is this prescription valid for? 1. Lormetazepam 500mcg tablets. 2. Oxycodone Hcl 40 mg MR tablets A. 7 days B. 28 days C. 30 days D. 3 months E. 6 months
b
Prescriptions for Schedule 2, 3 and 4 CDs are only valid for 28 days from the appropriate date (i.e. date of signing unless the prescriber indicates a date before which the CD should not be dispensed).
Lormetazepam is BZD
A known Specialist Doctor registered in the UK, calls you with a emergency supply of methadone request for a 32 yo male patient as his prescription has not been received, delayed in the post. Will you supply and which of the options is the most appropriate?
A You do not supply and explain to the doctor that you can not supply this medication in an emergency.
B You do not supply as you do not feel competent to do so and explain this to the doctor.
C Yes, you will make the supply as you have all the prescription details from the doctor and will receive the prescription soon.
D Yes, you will make the supply once you have checked the doctor is on the appropriate addiction services prescriber register
E Yes, you will make the supply as the doctor has provided you will all the details and confirms a prescription will be hand delivered the next day.
Emergency supply
It’s NOT for a Schedule 1, 2 or 3 CD (except phenobarbital (phenobarbitone or phenobarbitone sodium) for the treatment of epilepsy.
A
Which of the following would not be classed as eligible for NHS Flu vaccine ? A. Class III obesity B. T2DB C. COPD D. Epilepsy
Epilepsy