FPP legilisation Flashcards
What are the legal requirements for A PRESCRIPTION?
Signature of Prescriber, Address of Prescriber, Date ( prescription is valid for up to 6 months), Particulars of prescriber, Patient Name, Patient Address, Age of Patient (if under 12 years)
What is different about a prescriber from EEA country or Switzerland?
Can only write prescriptions for sch 4 and 5 drugs
Is a faxed prescription a legally valid prescription?
Fax of a prescription does not fall into a legally valid prescription because its not written in inedible ink and has not been signed in ink by a practioner.
What are the label requirements and what is good practice?
Name of patient, Name and address of supplying pharmacy, date of dispence, name of medicine, strength and quantity, direction,
Good practice
Label is on tube bottle not on packaging
keep out of reach and sight of children
Use medicine only on your skin where appr
In prison - prison number should be on label.
Which prescriptions are repeatable?
private prescriptions can be repeated, if number is not stated it can be repeated once dispensed twice, unless prescription is for an oral contraceptive in which it can be repeated 5 times (dispensed 6 times).
Schedule 2 and 3 CDs are not repeatable however schedule 4 and 5 are repeatable. First dispensing of schedule 5 CD must be made within 6 months. If it’s a schedule 4 CD drug the first dispensing must be made within 28 days of app date making sure there is no time limit for repeats.
What records should keep for private script and where?
Private prescription for a POM must be retained for 2 years from the date of sale or supply. Private prescriptions for schedule 2 and schedule 3 CDs must be submitted to the relevant NHS agency. POM prescriptions should be put in POM register needs supply date, prescription date, medicine details, prescriber details and patient details. Prescriptions for oral contraceptives are exempt of record keeping as are prescriptions for schedule 2 CDs where a separate CD record has to be made.
How could a patient obtain an emergency supply?
Patient can obtain an emergency supply by being registered with Scottish GP, had the medication before in last 6 months, item is not excluded from being supplied under the PGP or NHS.
Who can request an emergency supply?
GP, Prescriber, healthcare practitioner, (anywhere in Britain)
Are the rules different if the request is by a prescriber?
Prescriber is unavailable - cant supply
What medicines cannot be supplied by emergency supply and are there any differences using the Patient Group Direction (PGD) in Scotland for urgent provision of medicines?
Part B of schedules in PGD - ACBS products - controlled drugs, injections except EpiPen, self-administered inj daltaparin.
Can you refuse an emergency supply?
Yes, provision is not urgent, clinical condition has changed. no agreement to share clinical info.
Do records need to be kept for an emergency supply?
Yes needs to be passed on to prescriber + if on CMS with another pharm advise them on supply.
Do the labelling requirements for an emergency supply differ to those of standard labelling?
No - state emergency supply
What are the requirements for urgent provision of medicines using the PGD in Scotland?
Registration of scottish GP, medicine which is not on section B, medicine prescribed before in scotland
What steps should be followed when using the PGD for urgent provision of medicines in Scotland?
Consultation - pharmacist produces UCF for item - labelled, dispensed - creating signed on back by prescriber of UCF record - Pharmacist checks - UCF passed on to prescriber + pharmacy is informed.
How do you endorse a broken bulk?
Pack size e.g. prescribed 56 tabs but box id pack of 100. PUT 100 in 4 boxes to left of prescription and underneath BB + date claimed with no dashes. E+P
What is a PSD?
A Patient Specific Direction (PSD) is 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 dm+d?
The NHS Dictionary of Medicines and Devices (dm+d) is the standard for transferring medicine and medical device information between clinical systems. It is also required for all EPS prescribing. This information covers some common issues when using EPS.
What is ephedrine and what is it used for?
Ephedrine - counteract orthostatic hypotension. It is an anaesthesia hypotension drug and helps to prevent low blood pressure during anaesthesia. Orthostatic hypotension is a form of low blood pressure typically when you stand up too fast. It is also used in asthma medicines as a bronchodilator by acting on blood vessels in the lungs
What is pseudoephedrine and what is it used for?
Pseudoephedrine is used to decongest the nasal passages. Binds with noradrenaline. Used in Sudafed
Max amount of pseudoephedrine and ephedrine you can buy?
Pseudoephedrine - 720mg
ephedrine - 180mg
Cant sell both products at same time
What are the different classes of drugs?
Class A most harmful
Class B
Class C least harmful
What does the ACMD do?
The advisory Council on Misuse of drugs
Independant expert body which advices government on drug-related issues in uk
established under Misuse of drugs act 1971
reviews current drug misuse situation and advises government ministers on action to be taken inc classification of drugs
Why are certain drugs controlled under the Misuse of Drugs act?
Main purpose is to prevent the misuse of controlled drugs - this is done by putting a complete ban on possession, supply, manufacture, import and export of controlled drugs except by regulations or by license from the government.
What are the schedules of drugs and how are they allocated?
schedule 1 - MOST RESTRICTIVE CONTROL - are drugs which have no therapeutic value and therefore cannot be lawfully possessed or prescribed. These include LSD (lysergic acid diethylamide), MDMA (ecstasy). Schedule 1 drugs may be used for research but a home office license is required.
Schedule 2 +3 - These drugs can be prescribed and possessed legally by pharmacists and doctors. If you have a prescription you can lawfully possess the drug. It is an offence contrary to 1971 Act to Possess any drug belonging to schedule 2 and 3 without a prescription or lawful authority. Schedule 2 drugs - methadone, diamorphine - heroin, cannabis (since nov 2018) Schedule 3 drugs - Subutex and most of the barbiturate family (CNS depressants) Barbiturate drugs are commonly used for sleep aids, epilepsy treatment and anaesthetics Difference between schedule 2 and 3 is schedule 2 has different storage and record keeping to schedule 3 drugs ( 2001 Regulations) Schedule 4 drugs - Split into 2 (i) and (ii) (2001 Regulations updated in 2012) Schedule 4(i) drugs controls most of the benzodiazepines , they can only be lawfully possessed under prescription otherwise its an offence under 1971 act. Schedule 4(ii) drugs can be possessed but only for personal use. e.g steroids Schedule 5 - Drugs that are considered to have therapeutic value and are commonly available under the counter medicines. Legally possessed without a prescription.
Who many write CD prescriptions for CD? Are there any restrictions?
Doctors ( schedule 2-3),
Dentist ( schedule 2-3),
veterinary surgeon (schedule 2-3) must include RCVs registration number of prescriber,
Nurse/ midwife IDP (not cocaine, diamorphine, or dipipanone for treating addiction) ,
pharmacist IDP (not cocaine, diamorphine or dipipanone for treating addiction),
physiotherapist IDP ( ONLY for oral - diazepam, dihydrocodeine, lorazepam, morphine, oxycodone and temazepam, injection - morphine, transdermal - fentanyl),
Podiatrist IDP oral ( ONLY diazepam, dihydrocodeine, lorazepam and temazepam),
EEA or Swiss health professionals, (schedule 4 and 5 CD’s only).
What are the prescription requirements for a CD drug?
- Controlled Drug Prescription (schedule 2 + 3)
- Signature of Prescriber
- Date - only valid for 28 days after the ‘appropriate date’ ( signature date or date stated on prescription) - for schedule 4 CD’s and any balances
- Name of CD
- Form - stated tabs or caps and if its m/r, s/r
- Strength - only needs to be written if there is more than one strength, prescription requests more than one strength of a drug it is prescribed separately.
- Dose ( does not need to be in words and figures
- Total Quantity - (needs to be in words and figures)
- Quantity Prescribed - For schedule 2, 3 and 4 drugs the maximum quantity is a 30 day supply
- Patient Name
- Patient Address
- Dental wording where appropriate - CD is written by a dentist - ‘for dental treatment only’
- Instalment wording where appropriate
What are the restrictions for the amount of CD drug to be supplied?
For CD drugs only 30 day supply can be made - 720mg of pseudoephedrine can be sold over counter and 120mg of ephedrine. Can’t buy 2 or one of each
What are the specific CD prescription requirements for instalments?
A valid instalment direction is required. Schedule 2 or 3 CD -
- Amount of medicine to be supplied per instalment (addition of the dose)
- Interval between each time medicine can be supplied. MUST HAVE A DOSE AND AN INSTALMENT AMOUNT SPECIFIED SEPERATLY. First instalment must be dispensed within 28 days of appropriate date - prescription must be marked with the date of each supply.
What are technical errors?
Technical errors - schedule 2 or 3 CD prescriptions contain a minor typographical error or spelling mistake e.g. either has words or figures (but not both) of the total quantity a pharmacist can amend the prescription indelibly so that it becomes compliant with legalisation. Pharmacists cannot amend missing date, incorrect dose, form or strength.
Where should controlled drugs be stored?
Controlled drugs must be stored in a CD cabinet with CD keys. The safe needs a license to make sure safe is able to store CDs.
What are the record keeping requirements for CDs?
Record Keeping - when collecting cd need ID unless known by the pharmacist. Health care professionals 1. name of the healthcare professional
2. address of healthcare professional also id. Good practice for schedule 2 and 3 drugs patient signs back of prescription.
Someone is collecting of CD need to know the relationship of the patient e.g husband and need ID.
Every time a CD goes out it needs to be recorded in CD log book.
What is the Information Commissioners Office?
The Information Commissioner’s Office is the UK’s independent authority set up
to uphold information rights in the public interest, promoting openness by public
bodies and data privacy for individuals.
Those responsible for storing and processing personal information must register
every year with the Information Commissioner’s Office:
Name and address and category of organisation, nature of the work you do and type of data
you hold, name of data controller, details of procedures for ensuing security of data etc
What is personal data?
Personal data: any information relating to an identified or identifiable natural person (“data
subject”).
Who is a data controller?
The Data Controller is the main decision maker and exercises overall control over the
purposes and means of the processing of personal data i.e. decides how and why to collect
and use the data.
This will usually be an organisation, but can be an individual (eg a sole trader). If you are an
employee acting on behalf of your employer, the employer would be the controller. The
controller must make sure that the processing of that data complies with data protection law.
What is processing?
Processing is the collection, recording, organisation, structuring, storage, retrieval,
consultation, use and disclosure of data.