Law & MEP Flashcards
Define GSL medicine.
~ Sold in registered pharmacy or retail outlet that can close to the public
~ Hold an EU/UK Marketing Authorisation or Traditional Herbal registration or GSL homeopathic product.
Can GSL medicines be sold in the absence of the responsible pharmacist?
Yes, providing they have signed in as RP on the pharmacy Record. Unless they have been absent for over 2 hours- then you can’t unless another pharmacist becomes the RP.
If they have not (i.e. they are late) then GSL sale can only commence once the RP has signed in.
Can P medicines be sold in the absence of the RP?
NO- not in absence of RP, unless a second pharmacist is present.
What cannot take place when the Responsible pharmacist is absent for under 2 hours?
Sale of P Medicines
Handing out prescriptions and bagged meds
Handing prescriptions to delivery driver
These CAN all take place if a second Pharmacist is present.
What two active ingredients used in cold and flu remedies must NOT be sold at the same time?
Pseudoephedrine
Ephedrine
What are the two licensed EHC drugs that can be obtained from a pharmacy?
Levonorgestrel 1500 mcg (Levonelle One Step)
Ulipristal Acetate 30mg (Ella One)
How many days after unprotected sex is Levonorgestrel licensed for?
What about Ulipristal Acetate?
Levonorgestrel= 3 days (72 hours)
Ulipristal acetate= 5 days (120 hours)
What age is Levonorgestrel licensed for?
Levornorgesterel is licensed for use in over 16 years. Can be given to under 16’s only if a locally commissioned PGD is in place.
What age is Ulipristal Acetate licensed for?
Ella One can be used in any girl of child-bearing age- so can be used in under 16’s
At what age must you report sexual activity of a patient requesting EHC?
Children under 13 legally too young to consent to any sexual activity.
Any younger requesting reported to social services.
Children under 16 also not legal although its may be consensual i.e. with male also under 16.
Can pharmacists legally provide an advanced supply of EHC?
Yes
If you decided to supply a child under 16 with EHC, can patient information be disclosed without consent?
No- still need to obtain consent in order to disclose information. Info can be shared if safeguarding an issue- judge on a case by case basis.
If the patient vomits within how many hours of Levonelle/ Ella One should they take another dose?
2 hours of taking Levonorgesterel
3 hours of taking Ella One (Ulipristal)
At what point in the menstrual cycle should EHC be taken? Can it be taken more than once per cycle?
Can be taken at any point.
SPC for Levonelle states It is not advisable to take more than 1 per cycle as it can disrupt the cycle.
NB: RPS guidance says that women can take more than one if appropriate but should be advised about cycle disruption.
A patient, who you are aware has alcoholic liver cirrhosis, asks for EHC. What do you do?
Refer.
Neither EHC are recommended in severe liver dysfunction
What medication can Levonorgestrel increase the toxicity of?
Ciclosporin
Can EHC be used in breast feeding women?
Levonorgestrel appears in small amounts in breast milk- should not be harmful, but take tablet after a feed to allow maximal team until next feed.
Ulipristal acetate is present in breast milk for 1 week after administration. Advise mother not to BF in this time but express and discard the milk to maintain lactation.
Which EHC drug can reduce the efficacy of COC and POP pills?
Ulipristal acetate.
Patients should use barrier methods until next period as their normal contraceptive cover will be reduced.
A patient has received EHC, and asks if they have unprotected sex again before their next period, will the be okay?
No - it does not provide protection against pregnancy for rest of cycle- they will need to use contraceptive measures if they want to have sex again such as start pill or condoms.
What is the max number of paracetamol non effervescent and aspirin non effervescent you can buy OTC?
100 of each.
Come in packs of 16 and 32 so you would not be able to sell this amount anyway
What is OTC codeine/ dihydrocodeine products indicated for?
Short term (3 days max) treatment of acute - moderate pain not relieved by paracetamol, ibuprofen or aspirin alone.NOT for cold, flu sore throat etc.
What is the largest pack size of codeine/ dihydrocodeine products available OTC?
32
Anything bigger requires an MA as a POMRPS recommends the sale of just one pack of 32 at any one time.
Why are many cough and cold remedies now no longer used in children under 6 years?
Limited evidence of efficacy. Ingredients linked to SEs including allergic reactions, sleep disturbances and hallucinations.
Medicines containing what 4 types of cough and cold remedy ingredients have been deemed unsuitable for children under 6 years?
Antitussives (eg dextromethorphan, pholcodine)
Expectorants (eg Guaifenesin)
Nasal decongestants (pseudoephidrine, phenyephidrine, oxymetazoline)
Antihistamines- but still used in hayfever
THESE should ONLY be used 2nd line in children 6-12 years, for maximum of 5 days
What is first line treatment for nasal congestion in children?
Saline nasal drops
Vapour rubs
Decongestants- e.g. Karvol decongestant drops
What is first line treatment for a cough in a child?
Warm, clear fluids, honey and lemon if child is OVER 1 year old.
Simple cough mixtures- eg. glycerol or simple linctus
Can podiatrists and physiotherapists independent prescribers prescribe POMs? What about CDs?
Yes if in their area of expertise
They can only prescribe the following CDs for oral administration: Diazepam Dihydrocodeine Lorazepam Temazepam
Physiotherapist IPs can also prescribe: Oxycodone (oral)
Morphine (oral or injection)
Fentanyl (transdermal)
What is the ‘appropriate date’ on a prescription?
Rx’s = valid for 6 months
This is later of either date prescription was signed or date indicated by prescriber.
For PRIVATE Rxs: appropriate date always be date on which Rx signed
When must age be stated on a prescription?
If the patient is under 12 years old
What units need to be written in full on prescriptions?
Micrograms
Nanograms
Units (i.e for insulin)
What does ‘repeatable prescription’ mean?
It means the prescriber has added an instruction onto the main prescription for the item to be repeated.
It is NOT referring to the prescription counterpart that patients tick in the pharmacy to indicate to their prescriber what they need on their Rx next time.
Are NHS prescriptions repeatable?
NOT repeatable.
Are Rx’s for Sch 2, 3, 4 and 5 CDs repeatable?
Rx’s for Schedules 2 and 3 CDs are NOT repeatable.
Rx’s for Schedule 4 and 5 are.
Are private prescriptions repeatable?
Private prescriptions can be repeated, indicated by prescriber, e.g. ‘Repeat x 3’ means the Rx can be dispensed 4 times in total.
If the number of repeats is not stated on an Rx- i.e. it just says ‘Repeat’, they can only be repeated once. What is the exception to this rule?
Prescriptions for an oral contraceptive. This can be dispensed 6 times if the number of repeats is not specified, within 6 months of appropriate date.
You have OWINGS on a Rx for P meds and GSL meds. How long do you have to dispense these owed items?
6 months
6 months for POMS + Sch 5 CDs
28 days for Sch 2,3,4 CDs
How long should private Rxs be kept?
How long should the POM book be kept?
2 years- for repeatable Rx this should be 2 years from last dispensing date.
Keep POM book for 2 years from last entry.
What needs to be entered in the POM register?
Date Name, strength and form of medicine Quantity supplied Name and address of patient Nature of the emergency
Prescriptions for what are exempt from having to be written in the POM register?
For oral contraceptives
For schedule 2 CDs- as these will be recorded in the CD register
Are details of the medicinal product (Name, strength, quantity, dose) legal requirements for POM prescriptions?
No
But they are obviously needed for supply
Can you dispense against a faxed prescription?
No- not legally valid
Not written in indelible ink
Risk not receiving an original prescription
Do it as an emergency supply instead
Can emergency supplies be made for EEA/ Swiss prescribers?
Yes
Prescription still needs to be received in 72 hours from EEA prescriber
NB: Schedule 1,2,3 CDs cannot be supplied- INCLUDING phenobarbital
Can community nurse practitioners, optometrist, pharmacist independent, physiotherapist, podiatrist, EEA/ Swiss doctors request emergency supplies?
Yes
How long have prescribers got to get a written prescription to the pharmacy if they request an emergency supply?
72 hours
Emergency supplies cannot be made for CDs Schedule 1, 2, 3. With the exception of what?
Phenobarbital
For EPILEPSY by as UK-registered Doctor (NOT EEA)
Can an emergency supply be made to a patients relative?
Should be able to interview the patient themselves.
However at times this may not be possible- e.g. a young child or patient being cared for. In this case use professional judgement
Medicinal products containing ammonium bromide, calcium bromide, fluanisone, hexobarbitone, pemoline… and many more cannot be what?
Cannot be given as an emergency supply
Maximum quantity for an Emergency supply for CD’s (Phenobarbital, Schedule 4’s and 5’s) is?
What about for POM?
CD: 5 days
POM: 30 days
How long are prescriptions for Isotretinoin valid for under the pregnancy prevention programme? What is the maximum quantity that can be supplied?
R valid for 7 days
i.e. have to dispense it within 7 days of date due to pregnancy test window. Rx’s presented after this 7 days are considered expired.
Maximum of 30 days supply. If not under the Pregnancy prevention programme, more than 30 days may be supplied.
Can registered UK doctors prescribe Cocaine, dipipanone or diamorphine for treating addiction?
Only if they have a Home Office License
If not they can only prescribe these drugs for treating organic disease or injury.
Which two professions independent prescribers can only prescribed ‘Off-label’ medicines as opposed to unlicensed?
Physiotherapists
Podiatrists
Optometrists Cannot Rx unlicensed, all other IP’s can apart from Community practitioner nurses and EEA doctors.
If a pharmacist is supplying an oncall doctor a small quantity of certain medicines for his doctors bag, do they require a Wholesale Dealers License?
No
If a pharmacy wants to engage in commercial trading it requires a wholesalers dealers license. What if the pharmacy wants to exchange stock between itself and another pharmacy…. what if the other pharmacy intends to use the stock to wholesale deal/ commercial trade?
If the other pharmacy is part of the same legal entity, i.e. it does not intend to wholesale deal/ commercially trade the stock, a WSDL is not needed.
If it does intend to do these, the supplying pharmacy must also be named on the wholesale dealers license.
How long do signed order/ invoices, used when pharmacy supplies a POM to a HCP, need to be kept for?
2 years from date of supply
Good practice to also make an entry in the POM register
What are the definitions of
Use by?
Expiry date?
Use by: End of previous month
Exipires: End of current month
When medicines are dispensed from an ‘In-house’ pharmacy for administration or supply to patients within a prison, does the pharmacy need to be registered with the GPhC?
No
But legal and good practice guidelines should still be followed
What is the dose of adrenaline that should be given intramuscularly in anaphylaxis?
Adrenaline given IM in dose of 500 micrograms (0.5 mL adrenaline injection 1 in 1000)
A dose of 300 micrograms (0.3 mL adrenaline injection 1 in 1000) may be appropriate for immediate self-administration)
~ dose repeated if necessary at 5-minute intervals according to B[, pulse, and respiratory function.
Whats the issue with using Adrenaline in patients on beta blockers?
Severe anaphylaxis in patients taking beta-blockers may not respond to adrenaline—consider bronchodilator therapy, e.g. IV salbutamol, adrenaline can cause severe hypertension and bradycardia in those taking non-cardioselective beta-blockers.
What are the symptoms of anaphylaxis?
Rapid development of airway and/or hypotension.
Skin and mucosal changes may be present, e.g. urticaria (hives like rash) and angio-oedema of the face.
What are these prescribed drugs that can be tested for in drivers?
BZDs
Clonazepam, Diazepam, Lorazepam, Oxazepam, Temazepam, Flunitrazepam (not licensed in UK)
(Note: Nitrazepam not listed)
Also: Methadone, Morphine, Amphetamine
What 5 things relating to the Veterinary prescriber must be present on the prescription for it to be valid?
Name Address Telephone number Qualification Signature If the Rx is for a Schedule 2 or 3 CD: Royal college of Veterinary Surgeons Qualification number is needed
How long are veterinary prescriptions valid for?
What if its a CD?
6 months
Schedule 2, 3, 4 CD
Rx’s valid for 28 days
Schedule 5 CD
Rx’s for 6 months
(This is the same as human Rx’s)
Can veterinary prescribers use ‘As directed’ on their prescriptions?
Not acceptable as an administration instruction, should state ‘with food’
When must the words ‘Prescribed under the cascade’ be used on veterinary prescriptions?
cascade allows supply of medicines not licensed in animals
~ ILLEGAL to supply human medication for animal if this wording not present. E.g. medicine authorised in UK for human use but being used in animal.
A vet medicine not authorised in UK but in another European country for use in any animal species and in accordance with an import certificate issued by the VMD
When is ‘prescribed for an animal or herd under the care of the veterinarian’ required on a vet prescription?
For Schedule 2 or 3 CD’s
NB: Usual CD prescription requirements apply here- words and figures for quantity,
Are standardised forms required for veterinary prescriptions? What about if its a CD?
No.
How long should veterinary prescriptions be retained for? What about records (e.g. POM book entries) and documents for Vet supplies in general?
Keep all of them for 5 years
They do not get submitted to an NHS agency
Are original private prescriptions for Schedule 2 and 3 CDs retained in the pharmacy? If so, for how long?
No- they must be sent of to the relevant NHS agency.
NB: these Rx’s will be on standardised FP10PCD forms
How many days supply is considered good practice for Veterinary CD Prescriptions?
28 days
When must the expiry date appear on a label for veterinary prescriptions?
When the medicine is supplied under the cascade- i.e. human medicine for animal use.
Also need other details on label e.g. name of owner, name pharmacy, Name of VET, Name/species of animal
What is the difference between POM-V and POM-VPS?
POM-V: Can only be prescribed by a VETERINARY SURGEON.
The animal must be clinically assessed before these are prescribed.
POM-VPS: Can be prescribed by a Registered qualified person- e.g. Veterinarian, Pharmacist.
A clinical assessment of the animal is not needed in this situation, however sufficient info must be provided e.g. how the animal is kept. Minimum quantity should be prescribed.
What is a NFA-VPS Vet medicinal product?
Can be SUPPLIED by a Registered Qualified Person e.g. a Vet, a pharmacist, and DO NOT need a prescription- i.e. the vet can give this directly to the animal without needing to write and Rx for it. Minimum quantity should be supplied.
What is a AVM-GSL Vet medicinal product?
Products with no legal restrictions- same as OTC products.
Receipts and supplies of POM-V and POM-VPS medicines must be recorded in the POM book. What must be included in POM book entries for these?
Name of medicine Date of receipt/ supply BATCH Number Quantity Name and address of supplier/ recipient
How often must pharmacies supplying POM-V and POM-VPS medicines undertake an audit?
Annually
What is the Small Animal Exemption Schemes (SAES)?
Allows certain medicines to be placed on the market without a Marketing Authorisation, for use exclusively in certain animals, such as aquarium fish and caged birds.
Schedule 1 controlled drugs are called “CD Lic POM”, what does this mean?
You need a Home Office license to produce, possess or supply these.
What schedule of CD’s is Sativex? What does good practice with this drug involve?
Schedule 4 Part I (CD Benz POM)
It is a cannabinoid oromucosal mouth spray
But still good practice to write in CD book or keep a log of it going in/out the pharmacy
How long are prescriptions for Schedule 4 CD’s valid for?
What about Schedule 5?
Schedule 4: valid for 28 days
Schedule 5: valid for 6 months
What are the Schedule 5 Controlled drugs?
May be CD INV P or CD INV POM
What schedule CD’s is a license needed for to import or export them?
Schedule 1, 2, 3, 4 (part I)
Also needed for 4 (part II) unless it is imported/ exported by a person for self-administration.No restrictions on schedule 5’s
How does a patient go about taking Controlled drugs abroad on holiday?
A personal license is NOT required if they are carrying less than a 3 month supply
A covering letter from their prescriber is advised
What are the six legal requirements for a requester to write on a controlled drug requisition?
1) Name of recipient
2) Address of recipient
3) Signature of recipient
4) Profession/ occupation of recipient
5) Total quantity of drug
6) Purpose of requisition
These are all indicated on the standardised FP10CDF forms so the requester won’t forget any
When the requisition is received, the pharmacy must add on their name and address (section for this on form).
You have made a supply against a FP10CDF to a doctor for some CD’s for his doctors bag. He has collected it, What do you now do with the requistion form?
Make sure your pharmacy name and address is marked on the form
Send the original to the NHS BSA
Retain a COPY of the form for 2 years
What THREE Controlled drugs may a midwife request on a midwife supply order?
DIAMORPHINE
MORPHINE
PETHIDINE
What special signature is required on midwife supply orders?
Signature of an appropriate medical officer that has been authorised (by local supervising authority) to supervise all midwives in the area
Where a CD prescription is written by a dentist, what extra wording is required on the prescription?
For dental treatment only
Is ‘Keep out of reach and sight of children’ a legal requirement on a label? Are cautionary labels?
Keep out of reach and sight: No, just good practice
Cautionary labels: Yes- legal requirement
Is temazepam exempt from Schedule 2 and 3 CD prescription requirements? (e.g. Quantity in words and figures etc)
No- not exempt from prescription requirements as of June 2015. It is a CD schedule 3, only thing its exempt from is CD register requirements. Must be kept in CD cupboard
On a CD prescription, is the name of the drug a legal requirement?
No
Can a CD prescription be signed by another prescriber than the one whose name is on the prescription?
Yes
Give examples of inappropriate wording of the dosage on CD prescriptions.
Titration dose As directed (One as directed would be ok) PRN (One PRN would be ok)When required (One when required would be ok) Decrease dose by 3.5ml every 4 days- Needs to be instalment prescribing
The strength only needs to be written on a CD prescription if there is more than one strength available. True or False?
True
How should quantities of liquids be expressed on CD prescriptions?
In millitres
What is the maximum quantity of controlled drugs that should be supplied?
30 days maximum
‘No fixed abode’ is written as the patients address on a CD Rx, whilst another states PO Box 4300 as the address. Which one is okay to dispense from?
No fixed abode (NFA)
What are the dangers of sugar free and colour free products?
They have a greater potential for abuse
More likely to be incorporated into illegal produce.
Only supply these if specifically prescribed.
How long are instalment prescriptions valid for? (i.e. Methadone prescriptions)
The first instalment has to be dispensed within 28 days of the appropriate date on the prescription, then the rest can be supplied any time afterInstalment prescriptions on need to be signed once by the collector (but not a legal requirement)
If the prescription is intended to be supplied in instalments (CD schedule 2 and 3), for example methadone, what is a legal requirement on the prescription?
An instalment direction. This is a legal requirement: i.e. supply X amount on //_then Y on //_Special wording can be used to take into account missed doses or if the pharmacy is closed.
Most Schedule 3 (CD No Reg POMs) are exempted from being stored in the CD cabinet. Which two drugs are not exempt from this?
Temazepam
Buprenorphine
What can pharmacists edit themselves on CD prescriptions?
Minor typos
Add quantity in either words or figures if missing.
Should not correct anything else- i.e. adding form or MR etc
Can a representative pick up for a drug misuser?
Yes if they have a letter from the drug misuser, a separate letter each time they pick up, and that the pharmacist sees the drug misuser at least once a week.
If the medication is supervised consumption- contact doctor- legally acceptable to confirm with Dr they are happy with this over the phone.
This is because supervised consumption is not a legal requirement. If it was a police officer collecting as the person is in custody then don’t need to contact doctor- as consumption will be supervised by a HCP.
Is destruction required for a patient- returned controlled drug? If so, does this need to be witnessed by an authorised witness?
Destruction is required- if schedule 1,2,3,4 Part I. Use a denaturing kit.Patient returns destruction does NOT need to be witnessed by an authorised witness.
Is destruction required for expired controlled drugs? If so, does this need to be witnessed by an authorised witness (e.g. police officer)? What records should be made?
Yes destruction required if schedule 1,2,3,4 Part I. This does need to be witness by an authorised witness for SCHEDULE 2’s, and its good practice to get another member of staff to witness for schedule 3’s. This applied to any destruction of pharmacy stock (expired, unwanted). Make an entry in the CD register so that the balance can be amended for schedule 2s
How long does a CD register need to be kept? Can the register be electronic?
2 years from the last entry date Yes can be electronic as an alternative to paper book2 years from the last entry date
Yes can be electronic as an alternative to paper book
What is the difference between unlicensed and off-label?
Unlicensed= does not hold a UK marketing authorisation, so will not be listed in the BNF, has to be manufactured as a special. Off-label= has a UK marketing authorisation (i.e is licensed) but is being used for a different condition to the one it has a licensed indication for- i.e. being used for an unlicensed indication.
Which CD schedules do invoices need to be retained for? And how long for?
Schedule 3 and schedule 5 Schedule 2 you are going to be writing in the CD book any stock received so no need for these.
How long must the RP log be retained?
5 years from last entry
What does the ‘withdrawal period’ on a vet Rx indicate?
The length of time after administering the drug before the animal can be used for food
In general, considering record keeping either involves 2 years or 5 years, what is the general rule (not just for vet stuff- for EVERYTHING)?
2 years for things to do with CDs and private Rx’s:
- CD register (from date of last entry) (legal)
- Requisitions (send off but keep copy) order records etc (legal)
- Invoices for schedule 3 and 5 CDs (legal)
- POM book- 2 yrs last entry, private prescriptions (legal)
- MUR/ NMS records (legal)
5 years for:
- Vet prescriptions- POM-V and POM-VPS (legal)
- Responsible Pharmacist record (from date of last entry) (legal)
- Extemporaneous dispensing records (legal- community, 13 yrs reference hospital)
What are the extra requirements on a Vet label when compared to a human label?
For animal treatment only
Pet details and Owner details
Expiry date if not on box
Warnings for owner re administration etc
Are standardised forms needed when a vet prescribes a CD? What needs to be written on the prescription?
No
“prescribed for the treatment of an animal under my care”
How long should veterinary prescriptions be retained for?
5 years
What specific thing relating to the Vet needs to be present on Rx’s for schedule 2 and 3 CDs?
Royal College of Veterinary Surgeons reg number
(for human CD’s: need a specific prescribed identification number on the standardised form so that prescribing of CDs can be tracked).
Which should be first line?
- Prescribing a licensed human medicine for an animal
- Prescribing a licensed Vet medicine for another species or in a different condition
1) Prescribing a licensed Vet medicine for another species or in a different condition (basically Off-label)
2) Prescribing a licensed human medicine for an animal
Growth hormones are contained in what sch?
Sch 4 part II
NICE recommends keeping records of the destruction of a patient’s own returned controlled drugs for a minimum of what?
7 years
Invoices for CDs 6 years
