Pharmacy Law (MEP) Flashcards
If a veterinary prescriber is prescribing something under the cascade, what is it recommended they also include on the prescription to maximise safety (bar all the appropriate wording)
<p>Any safety warnings/ advice that should be included on the label</p>
e.g. take with food
How many CPDs must pharmacists record per year?
4
What is a GSL medicine?
Sold in a registered pharmacy or retail outlet that can close to the publicHold 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!
GSL sale can only commence once the RP has signed in.
Unless they have been absent for over 2 hours- then you can’t unless another pharmacist becomes the RP.
Can P medicines be sold in the absence of the RP? What if a second pharmacist becomes RP?
NO- not in absence of RP, unless a second pharmacist is present.NB: P medicines should not be available for self-selection!
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 is the only activity that can be done if the RP is absent for over 2 hours and there is no second pharmacist?
Taking in prescriptions- the pharmacy would be closed in this situation but could take prescriptions at door.
What two drugs used in Cold and Flu must you NOT sell together at the same time?
Products containing Pseudoephedrine and Ephedrine
Who can suspicions of possible misuse of OTC products be reported to?
Local GPhC inspector
Local Controlled Drugs liaison
police officer
Accountable officer
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?What about Ulipristal Acetate?
Levornorgesterol is licensed for use in over 16 years. Can be given to under 16’s only if a locally commissioned PGD is in place.
Ella One can be used in any girl of child-bearing age- so can be used in under 16’s!!
Bear in mind- children under 13 are legally too young to consent to any sexual activity. Any younger requesting this should be reported to social services.
Children under 16 also not legal although it may be consensual- i.e. with a boy also under 16.
Can pharmacists provide an advanced supply of EHC?
Yes e.g. for holiday abroad
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.
EHC: If the patient vomits within how many hours of Levonelle/ Ella One should they take another dose?
3 hours of taking Levonorgesterel
3 hours of taking Ella One (Ulipristal acetate)
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?
EHC- levonorgestrel and Ulipristal- both not recommended in severe liver dysfunction. Try and find out how severe the liver disorder is- refer.
What medication can Levonorgestrel increase the toxicity of?
Ciclosporin (immunosuppressant used after transplants)
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 time until next feed (avoid nursing for atleast 8hrs - spc).
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 they be okay?
No- it does not provide protection against pregnancy for the rest of the cycle- they will need to use contraceptive measures if they want to have sex again such as start the pill or condoms.
What is the max number of paracetamol non effervescent and aspirin non effervescent you can buy OTC?
100 of each but remember they 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 POM
RPS recommends the sale of just one pack of 32 at any one time.
NB: Extra warning label needed: “Can cause addiction. For three days use only”. Users can get an ‘overuse headache if they use it for longer.
Why are many cough and cold remedies now no longer used in children under 6 years?
No evidence they are effective - more risk than benefit
Sometimes the ingredients can be linked to SEs including allergies, 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 these may still be used in hayfever These medications should only be used second line in children 6-12 years, for a maximum of 5 days
A 2 year old child presents to the pharmacy with their mother saying that they have a raised temperature. What do you do?
Take their temperature- use a digital thermometer under their armpit (always under armpit in child under 5 years) for around 15 seconds. If the reading >37.5 degrees then it is likely to be a fever.
What to offer: Paracetamol or ibuprofen. Do not use these at the same time in children under 5 years (however if one doesn’t seem to be helping, it’s OK to try the other one before the next dose is due)
Dose in this child:Paracetamol- 2 years old- 180mg (7.5ml) every 4-6 hours. Ibuprofen- 100mg (5ml) TDS
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.
For 1+ years: Simple cough mixtures- eg. glycerol or simple linctus
Can podiatrists and physiotherapists independent prescribers prescribe POMs? What about CDs?
POMs- 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 are valid for 6 months for thisThis is the later of either the date the prescription was signed or the date indicated by the prescriber.For PRIVATE Rxs: the appropriate date will always be the date on which the Rx was signed
When must age be stated on a prescription?
If the patient is under 12 years old
Is it okay to issue carbon copies of prescriptions to patients?
Yes as long as they’re signed in ink
What units need to be written in full on prescriptions?
Micrograms Nanograms Units (i.e for insulin)
What length of time to dispense requirements apply to EPS prescriptions?
Same things- must be dispensed 6 months from appropriate date, 28 days for CDs
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?
NHS Rx’s are NOT repeatable. This is because Repeatable prescriptions are a different concept to prescribing for regular items made under the NHS repeat dispensing scheme. This is where patients tick what they want each time, and the Electronic repeat dispensing service is used where a prescriber issues a batch of repeat Rx’s electronically that can be used until the patients next review.
Are Rx’s for Sch 2, 3, 4 and 5 CDs repeatable?Are private prescriptions repeatable?
Rx’s for Schedules 2 and 3 CDs are NOT repeatable.Rx’s for Schedule 4 and 5 are.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.
For repeatable Schedule 5 CD Rx’s, the first dispensing date must be within _____.For schedule 4 CDs it must be within ____. Schedule 2 and 3 are not repeatable.
Schedule 5- 6 monthsSchedule 4- 28 daysFollowing this there is no legal time limit for remaining dispensing- clinical judgement.
You have OWINGS on a Rx for P meds and GSL meds. How long do you have to dispense these owed items?
6 months6 months for POMS + Sch 5 CDs28 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?
NAME?
Prescriptions for What are exempt from having to be written in the POM register?
For oral contraceptivesFor 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 validNot written in indelible inkRisk not receiving an original prescriptionDo it as an emergency supply instead- then it is on their back to get the original prescription to you
Can you dispense from prescriptions from an EEA (EU) country and Switzerland (Not part of EU)?
Yes- only for schedule 4& 5 CDs and POMs, must have a UK Marketing Authorisation!Rx has to include prescriber details- full name, qualifications, direct contact details (email address and phone), address- including countryThey are allowed to be in a foreign languageIf confirmation of registration status of the prescriber is not possible- may still be able to make a safe legal supply
Can emergency supplies be made for EEA/ Swiss prescribers?
Emergency supplies from these prescribers are also allowedPrescription still needs to be received in 72 hours from EEA prescriberNB: 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 (also called phenobarbitone) for EPILEPSY by as UK-registered Doctor(NOT EEA)
Can an emergency supply be made to a patients relative?
No- must 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 POMs?
CD’s: 5 daysSo things like Zopiclone can only be given for max 5 days.POMs: 30 days
Who can Isotretinoin (for severe acne) therapy be initiated by?
Directly by or under the supervision of a consultant dermatologist, and under the conditions of the Pregnancy Prevention Programme.This programme protects women at risk of becoming pregnant during therapy, as isotretinoin is a retinoid and will cause severe malformations in a foetus and there is also risk of spontaneous abortion.
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 you dispense repeat prescriptions of isotretinoin? What about faxes? What about emergency supplies?
No repeatsNo faxesEmergency supply only if at request of a pregnancy prevention programmes practitioner and confirmation of pregnancy status has been established as negative within the previous 7 days.
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.
Can pharmacist independent Prescribers prescribe Cocaine, dipipanone or diamorphine for treating addiction?
NoNurse independent prescribers, pharmacist independent prescribers and supplementary prescribers cannot prescribe these at all for addiction, but can for organic disease/ injury.Can prescribe CDs, but must only prescribe drugs for medical conditions within their competence.
Which two professions independent prescribers can only prescribed ‘Off-label’ medicines as opposed to unlicensed?
PhysiotherapistsPodiatristsOptometrists Cannot Rx unlicensed, all other IP’s can apart from Community practitioner nurses and EEA doctors.
Can EEA/ Swiss HCP’s and UK Community practitioner nurses prescribe unlicensed or Off-label medicines?
NoThe product must hold a UK Marketing Authorisation
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?
NoPharmacies can supply other healthcare professionals in the UK who need to hold small quantities for drugs for treatment/ onward supply of their patients.
You are working a Lloyds pharmacy and realise you do not have any spiriva inhalers left. Mrs P is due to come in an hours time to pick up her prescription and you know she is going away tomorrow. Can you ring up Boots down the road and request a spiriva inhaler to meet this patients needs, do you need a Wholesalers Dealers License to do so?
Community + Hospital pharmacies can obtain small quantities of a medicine from other pharmacies to meet patients needs.A Wholesalers dealers license is not needed for this, as it is considered as ‘Provision of healthcare services’, not seen as commercial dealing.
Pharmacies can give other pharmacies medicines and also give HCP’s small quantities of medicines without the need for a Wholesalers dealers license, as it is seen as providing a healthcare service and not commercial dealing. This is as long as 4 criteria are met, what are these?
NAME?
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 supplyGood practice to also make an entry in the POM register
Use by?Expires?
Use by: End of previous monthExipires: End of current month
A patient returns some unwanted medicines to your pharmacy. Some of it is blister strips in their outer packaging, some of it is bottles of liquids. How should these be disposed?
Blister strips can be removed from their outer packaging (but do not pop out tablets from blister) and ensure and patient info is confidentially disposed of. Liquids- do not empty the contents into the waste container- just put the whole bottle in- could be hazardous otherwise.
What do members of the public require if they wish to purchase dangerous poisons or chemicals (that could be used in explosives) from a pharmacy?
Valid license issued by the home office
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?
noBut legal and good practice guidelines should still be followed
What is the dose of adrenaline that should be given intramuscularly in anaphylaxis?
Adrenaline is given intramuscularly in a 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)The dose is repeated if necessary at 5-minute intervals according to blood pressure, 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.
There are new laws around drugs and driving that affect patients taking prescribed medicines. What are these prescribed drugs that can be tested for in drivers?
The Benzo’s:ClonazepamDiazepamLorazepamOxazepamTemazepamFlunitrazepam (not licensed in UK)(Note: Nitrazepam not listed)Also:MethadoneMorphineAmphetamine
A patient has been pulled over and a saliva screen performed for drugs. Their level of Diazepam has come back above the set limit. If this patient is taking their medicine as prescribed by their GP, they have their prescription with them to prove this, can they be prosecuted?
If their driving was NOT impaired then NO, they have something called a ‘Medical defence’ that can be raised.If driving was impaired- i.e. the patient was sleepy, dizzy, unable to concentrate, slowed thinking, then they CAN be prosecuted. Therefore they need to be capable of knowing when their driving ability is impaired.
A driver has been pulled over and a drug saliva test performed. The level of Morphine in their system comes back high. The patient claims they have been prescribed this drug and thats why they have it in their system at this level. How can this be proved?
By showing an FP10 for morphine, or by speaking to their prescriber to confirm the advice given to the patient on how to take this.This is used as the basis for the patients ‘Statutory medical defence’. This new legislation allows protection for patients who may test positive for certain drugs as a result of taking it as prescribed.
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?
No- not acceptable as an administration instruction, should state ‘with food’
When must the words ‘Prescribed under the cascade’ be used on veterinary prescriptions?
The cascade allows the supply of medicines not licensed in animals. It is ILLEGAL to supply a human medication for an animal if this wording is not present.E.g:-A medicine authorised in the UK for human use but being used in an animal -A vet medicine not authorised in the 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’sNB: 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 to both(Differs to human prescriptions: for private Rxs for Sch 2 and 3 CD’s a standardised form is needed- FP10PCD)
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 orignal 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 For humans this is max 30 days
If a vet prescribes a product and writes ‘prescribed under the cascade’ on the Rx, but there is an alternative licensed vet medicine that could be used, what happens?
The cascade requires the Licensed veterinary product to be supplied, not the medicine only licensed for human use, this is because licensed veterinary products should be given where available, even if it is for use in a different species.
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. N/A of owner, N/A 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
If there is an Rx:
Name and address of prescriber
Copy of Rx
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.
A woman comes to your counter with a pack of ranitidine tablets. You ask “are these for yourself?” and she says no “they’re actually for my dog”. Can you sell them?
It is unlawful to sell unlicensed veterinary medicines/ human medicines, including GSL and P medicines, unless this takes place under the cascade. This applies even if the Vet has told to owner to purchased an OTC human medicine. It is on your back.
For what veterinary medicines must the pharmacist be physically present when handing them out? (Unless the individual handing it out is judged to be competent enough)
POM-V (Rx’d by the veterinary surgeon) POM-VPS (Rx’d by a registered qualified person) NFA-VPS (supplied by a registered QP- do not need a prescription)
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.
No therapeutic use- e.g. LSD, ecstasy
However a pharmacist may be required to possess these if they’re taken off a patient on a ward, allowed to if:
1) For purpose of destruction
2) For handing over to Police
Protect patients confidentiality - only disclose if they had enough to be a drug dealer, or if the patient is refusing to give authority for destruction.
Name some Schedule 3 CD’s?
Buprenorphine
Temazepam
Midazolam
Phenobarbital
Name some Schedule 4 CD’s?Hint: Part I CD Benz POMPart II CD Anab POM
CD Benz POM: diazepam, clonazepam, nitrazepam, clobazam Also non bento hypnotics e.g. Zopiclone Also SATIVEX- cannabinoid oromucosal mouth sprayCD Anab POM: Anabolic (e.g testosterone)/ androngenic steroids, plus clenbuterol
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 sprayBut 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
Examples: Co-codamol, codeine linctus BP, codeine phosphate tablets, co-dydramol, pholcodine, DHC (dihydrocodeine) Continus ®, Oramorph ® oral solution 10mg in 5ml
What can pharmacist independent prescribers do with Schedule 2, 3, 4 and 5 CD’s?
Prescribe them
Administer them
Direct their administration (to e.g. a nurse)
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 supplyA covering letter from their prescriber is advised
Is the requisition of controlled drugs on a standardised CD requisition form a legal requirement?
Yes! In the community (FP10CDF)New from Nov 2015- requisitions in the community must be on a standardised form now!! Keep a copy of these for 2 years.Hospitals use a controlled drugs requisition book- each ward has its own and carbon copies made, similar system in prisons. Only needed for Schedule 2 and 3 CD’s (Sch 4 and 5 don’t need requisitions)
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).
A Doctor calls you to tell you he has faxed across a requisition form for some Oxycodone MR tablets for his doctors bag, and will be picking them up tomorrow. What do you do?
If it is an emergency, this would be okay but ONLY if the original requisition is supplied in 24 hours otherwise it would be their offence!!If not an emergency: Tell him he will have to provide the original requisition form or the supply cannot be made.Supplies against faxed or photocopied requisitions are not acceptable.
Does a requisition in writing need to be provided if a pharmacy is requesting CD’s from another registered pharmacy?
Not legallyBut good practice for an audit trail! It IS a legal requirement for other recipients however, such as: doctors, hospitals, care homes
Someone comes into your pharmacy claiming that they are the messenger for someone that has sent a requisition form for CD’s, they are here to collect the supply. What do you do?
Ask them if they have a letter of authorisation from the requester, this empowers them to receive the CD on behalf of the purchaser. This letter should be retained for 2 years, along with a copy of the original requisition 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 formSend the original to the NHS BSARetain a COPY of the form for 2 years
When do you NOT need to send a CD requisition form (FP10CDF) off to the relevant NHS agency?
Only for community pharmaciesThis does not need to be done when supplied by:Hospitals/ care homes Pharmaceutical companies/ wholesalersPrisons (when supplied to prison wings)Midwife supply ordersVet requisitions- Animals not covered under NHS!!
What THREE Controlled drugs may a midwife request on a midwife supply order?
DIAMORPHINEMORPHINEPETHIDINE
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 normal FP10 prescription, are the name of drug, strength, formulation, quantity legal requirements?
No!!Prescription still legal without these on it, but need this information to actually give the drug and cannot write any of these in yourself!
On a CD prescription, is the name of the drug a legal requirement?
No!the dose, formulation, quantity etc are though….. but name would be needed to dispense medication!
Can a CD prescription be signed by another prescriber than the one whose name is on the prescription?
Yes- the prescription can be signed by another prescriber other than the named prescriber and still be legally valid.The name of the prescriber on the prescription isn’t actually a legal requirement just the signature and prescribers address..Therefore the address still needs to be applicable to the prescriber who signed it- i.e. work at same practice.
Can electronic signatures ever be used on CD prescriptions?
Yes for 2,3,4,5 CD’s- where EPS (electronic prescribing service) is used.
Is the “appropriate date” the earlier or later one on a CD prescription out of the signature date and any other appropriate date?
The later one
Some examples of inappropriate wording of the dosage on CD prescriptions…
Titration doseAs 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 millilitres- and best to write this out in full.Words and figures
What is the maximum quantity of controlled drugs that should be supplied? Is this a legal restriction?
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- could even put NFA
Is abbreviations like ‘tabs’ and ‘caps’ acceptable on a CD prescription?
Yes
Whats the deal with 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.
What happens if a patient misses their dose of methadone on an instalment prescription? They have unsupervised consumption. The prescriber wants to make sure the patient is supplied with their remaining doses.
The prescription must have special wording that indicates that if collection is missed, the remainder of the instalment, minus the days missed can be collected.This is providing that no more than THREE days have been missed.
What happens if you have an instalment prescription, and you realise the pharmacy is closed tomorrow and the day after for bank holiday?
The prescription needs to state “Instalments due on days when the pharmacy is closed should be dispensed on the day immediately prior to closure”UNLESS the prescriber has already taken the bank holiday into account when choosing the instalment dates!NB: Its not the end of the world if this specific wording isn’t on it, but does not provide the same protection, so should try get prescriber to include this approved Home Office wording.
What are the legal requirements on a CD prescription (Schedules 2,3)?
As for POM’s, plus:- If a preparation - the form- If needed- the strength- total quantity in words and figures- the doseDrug name is not a legal requirement!
Most Schedule 3 (CD No Reg POMs) are exempted from being stored in the CD cabinet. Which two drugs are not exempt from this?
TemazepamBuprenorphine
True or false: CD register entries must be entered on the day of supply?
False- can be entered the following day
What can pharmacists edit themselves on CD prescriptions?
Minor Typo’s.Add quantity in either words or figures if missing. Should not correct anything else- i.e. adding form or MR etc
A private prescription for buprenorphine tablets is presented to you. It is not on a standard FP10PCD form. The prescriber has included his General Medical Council number. You can dispense it. True or False?
FalseALL private CD Rx’s MUST be on the standard FP10PCD form, following the Shipman enquiry.Also the GMC number is NOT the correct number to include: must be the prescriber ID number issued by their relevant NHS agency!Only exception: Vet Rx’s. In hospitals if the private Rx was written by someone in that hospital. If it has come from outside the hospital: must be on FP10PCD.
You receive a prescription on an FP10PCD for Morphine sulphate tablets, Zopiclone and ibuprofen. Is there any issues here?
You are required to send FP10PCD forms off to the relevant NHS agency. This is so they can keep track of CD’s being prescribed. The Zopiclone (sch 4) and ibuprofen need to be entered into the POM book and the prescription for these kept for 2 years. Therefore this would not be possible in this case.Need a separate prescription for the zopiclone and ibuprofen!
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 supervised consumption a legal requirement?
No
Getting the person collecting a CD schedule 2 or 3 to sign the back the Rx is a legal requirement, true or false?
False.It is good practice
Are there any schedule 2 CD’s that don’t have to be kept in the CD cupboard?
Quinalbarbitone (aka Secobarbital)Some liquid preparations
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. IT is good practice to get another member of staff to witness it and to keep a separate record of patient returned CD’s that have been destroyed.
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 2’s (schedule 3’s don’t go in the register anyway!)
All CD’s schedule 2,3 and 4 (part I) should be destroyed by being denatured and rendered irretrievable before being placed in what?
A waste container to be sent for incineration
How should tablets and capsule CD’s be disposed of? What about liquids?
Grind / crush and add to a denaturing kit, ensure not retrievable. Can add to warm soapy water and poor onto cat litter.Liquids can be poured straight into a denaturing kit or cat litter.
How should CD ampoules and vials be disposed of? What about patches? Aerosols?
Ampoules: empty contents into a CD denaturing kit and dispose of glass in sharps bin.Patches: fold patch over on itself and place in waste disposal bin or denaturing kit.Aerosols: squirt contents into water or absorbent material and dispose.
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 book
Is keeping a running balance in the CD register a legal requirement?
No- good practice Be sure to notify the owner, superintendent, GpHC inspector, accountable officer or Controlled Drug liaison officer of any discrepancies.
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. Don’t get confused in the BNF if it states unlicensed use: this does not mean the product itself is unlicensed, just means its being used for an unlicensed indication!
Medicines disposal is an ESSENTIAL service. Pharmacies do not need a license to store waste as long as it is stored in _____. No more than ___ cubic meters of waste is storedThe waste cannot be stored for over __ monthsService is not provided as a waste management service i.e. you don’t receive ___ The waste must not have a flash point of less than ___ (lowest temp that vapours of a fluid will ignite)
stored in secure containers- separate area from your stockno more than 5 cubic metersWaste not stored for over 3 monthsDont receive payment for the serviceFlash point less than 21 degrees
Only schedule 2 and 3 CD’s need to be denatured before disposal. True of False?
False: schedule 4 part I e.g. Zopiclone, diazepam also need to be!!
If you’re the only pharmacist in the pharmacy, you don’t need to sign in as the RP as it could only be you. True or false?
False- need to still sign in the the RP record and put the sign up.
What schedule drug is Tramadol?
Schedule 3(CD No Reg POM)So Rx only valid for 28 daysCD prescription requirements neededRequisitions neededDenaturing neededAddress of prescriber in UK neededSafe custody not needed
T or F:Pharmacist independent prescribers are able to prescribe and Controlled Drugs in Schedule 2 to 5.
TrueApart from diamorphine or cocaine for treatment of addiction (but can for pain/ organic disease)
If a school wants to obtain a salbutamol inhaler for use in the school who must the request come from?
The head teacherHeadteacher does not need to have any other involvement with childs medicines- confidentiality, only school nurser/ carer needs to know
