The Pharmacist - Semester 1 Flashcards
List three ways in which UK legislation protects the public in regards to medicines use
- Restrictions for drug crime, self medication and addiction
- Manufacture, distribution and supply are controlled to ensure drug purity, potency and efficacy
- Suppliers must adhere to a professional code of conduct
List three legislations relating to medicines
Medicines Act
Misuse of Drugs Act
Poisons Act
Define Pharmacovigilance
Drug safety through detection, assessment, monitoring and prevention of side effects
What is a medicinal product?
- A substance that shows properties of treating/preventing disease
- A substance that is administered for medical diagnosis or to alter physiological function
What is an authorised medicinal product?
- A medicine with a marketing authorisation
- Homeopathics with a certificate of registration
- Herbal remedies with traditional herbal registration
What is a relevant medicinal product?
A medicine with a marketing authorisation
What is a medicinal purpose?
- Treatment, prevention or diagnosis of disease
- Alteration of normal physiological function
- Contraception and anaesthesia
Define ‘administer’
Give to a human being either orally or parenterally (non-oral route)
What should be considered when using professional judgement?
- Professional code of conduct
- Ethical standards
What is the difference between Great Britain and the United Kingdom?
- GB = Wales, England, Scotland
- UK = GB + Northern Ireland
What is the difference between criminal and civil law?
- Criminal law refers to a situation where an individuals actions are harmful to society and can result in a jail sentence
- Civil law refers to a dispute between two individuals and is usually settled with a compensatory payout
What is a dispensing error convicted as?
Criminal offence
What does UK law consist of?
Primary legislation (acts) and secondary legislation
How is an act altered?
- Production of a new act or addition of secondary legislation
What are statutory instruments?
Secondary legislation providing detail relating to an act
What are schedules?
They contain detail that is separate to that contained in an act or secondary legislation
What is case/judicial law?
A situation where there is no clear law, so the judge makes a decision based on a previous, similar case
What does EU law consist of?
- Treaties
- Regulations - Direct, binding effects on member states
- Directives - Objectives set out but actions are for individual state to decide
- Decisions - Binding to the states it is aimed at
Who can implement EU law?
- European Commission
- EU Council
- European Parliament
- European Court of Justice
Can Pharmacists practise anywhere in the EU if registered?
Yes, they are recognised healthcare professionals with freedom of movement through the EU
Define a Prescription Only Medicine
- Can only be sold/supplied in accordance with a prescription from a relevant medical professional
What is usually classified as a Prescription Only Medicine?
- A medicine that can cause damage to health if used without supervision
- A medicine that is commonly misused with a detrimental effect to health
- Any new active substances
- A medicine that is not administered orally
Who is considered an appropriate practitioner to prescribe a POM?
- Doctors and Dentists
- Supplementary Prescribers (in accordance with a clinical management plan)
- Independent Prescribers (nurses and pharmacists)
Can other practitioners prescribe?
If independent prescribers, YES, but with restrictions
What are the Nurse/Dentist Prescribers Formularies?
They set out which drugs can be prescribed by a nurse IP or dentist on the NHS
If the prescribe outside of this, the medicine can be dispensed but the Pharmacy will not be reimbursed
What is supplementary prescribing?
A prescribing partnership in which a patient-specific clinical management plan is developed WITH THE PATIENT
What should a clinical management plan contain?
- Patient name
- Conditions that can be treated by supplementary prescriber
- Dates of commencement/review
- Details of relevant medicinal product
- Patient allergies/any difficulties
- What to do in the event of an ADR
- When supplementary prescriber should contact independent prescriber (doctor/dentist)
Same record should be used by IP and SP throughout treatment course
Who would be considered an EEA health professional and what restrictions do they have?
- EEA/Swiss Doctors, Dentists, Nurses, Midwives and Pharmacists
- Prescriptions are valid in the UK but Schedule 1-3 CDs cannot be prescribed
- Registration details should be checked
What are the UK legal prescription requirements?
- Name and address of patient and prescriber
- Particulars of prescriber
- Prescriber signature
- Date of prescription
- Patient age (if less than 12 years)
What are the time limits for dispensing a prescription?
- Within 6 months of appropriate date (POMs)
- Within 28 days of appropriate date (Schedule 2, 3, 4 CDs)
What are the dispensing conditions for repeatable private prescriptions?
- First dispense within 6 months, no time limit for repeat dispensing (unless schedule 4 CD - 28days)
- If number of repeats is unspecified only dispense twice for POMs and six times for contraceptives
What are the EEA/Switzerland legal prescription requirements?
- Patient details
- Prescriber details (including address and contact details)
- Prescriber signature
- Medicine details
- Date of issue
If Pharmacist can still understand prescription if written in another language, still legal to dispense
What medicines can Dentists prescribe?
Any POM but should prescribe within professional competence
Can medicines be supplied from a faxed prescription?
NO, not legally valid due to non-indelible ink/no signature
BUT if emergency supply at prescriber’s request, can be used to show there is a true prescription present
How are forged prescriptions generally identified?
- Commonly misused medicine?
- Do dosage and amounts seem correct?
- If prescriber is known does the prescription fit with their usual style of writing (if not should check)
- Patient behaviour
- Contact prescriber (not with details on prescription)
What are electronic prescriptions?
- They are created, signed and sent electronically
- Electronic signature should be unique to allow prescriber ID - only the prescriber can alter it (changes can be detected)
- More efficient and easier for patient
What are patient specific directions?
- Generally used in hospitals to supply medication without a prescription
- Written by prescriber and specific to an individual
- Supply made by appropriate practitioner according to drug chart and patient notes
- Directions do not have to be in writing but good practice
When should POM records be made and how long should they be kept for?
- All private POM prescriptions (except contraceptives)
- Made on day of supply or day after
- Kept for 2 years (from last dispensing if a repeatable prescription)
What should happen with an NHS POM prescription?
Sent to NHSBSA for funding
When should wholesale deals be recorded?
If signed order/invoice isn’t kept for 2 years
What are the legal requirements for a POM record?
- Dates for supply and prescription issue
- Details of POM supplied
- Name and address of patient and prescriber
What should be included on the label for a dispensed medicine?
- Name of patient
- Name and address of pharmacy
- Name and directions for medicine given
- ‘Keep Out of the Reach of Children’
- Cautionary/advisory labels
- Dispensing date
When can a Pharmacist alter directions for use?
- To optimise medicines use if details seem inappropriate
- Pharmacist can use professional judgement
What are Pharmacy Only medicines?
- Only dispensed in a registered pharmacy with pharmacist present
- Marketing authorisation is GSL but manufacturer has restricted sale to pharmacies
How may the class of a medicine be altered?
- Different strengths and pack sizes of a medicine may move it into different classes
- Marketing authorisation specifications can alter the class of a medicine
What classifies a medicine as POM?
- Part 1 of Schedule 1 in HMR
- Certain conditions can cause exemptions
When can CDs be sold as a P medicine?
If all the following exemptions are satisfied:
- Only one schedule 2 substance is present at a specified max strength
- Supplied in a specific form/packaging
- Is one of codeine, dihydrocodeine, ethylmorphine, morphine, pholcodeine (+salts) and medicinal opium
What are counter prescribed medicines?
A medicine which is supplied to a patient at their request by a pharmacist using their professional judgement
POMs cannot be given but a GSL given in this situation would be considered a P medicine
What are the restrictions for the sale of pseudoephedrine and ephedrine?
- Not sold together
- No more than 720mg of pseudoephedrine or 180mg of ephedrine (substance misuse)
- Sold through professional judgement
When can EHC be given as a P medicine?
When provided as a single dose
What are the restrictions for the sale of codeine and dihydrocodeine?
- Only 3 days use provided
- 32 tablet maximum as a P medicine
- Possibility of addiction stated on PIL and packaging
- Codeine linctus only for over 18s
What are GSL medicines?
Marketing authorisation allows general sale without a pharmacist present
Generally relates to an individual product rather than an active ingredient (hence one medicine being in multiple classes)
Where can GSL medicines be sold?
- Retail stores
- Retail pharmacies
- Automatic machines
Give four examples of GSL medicines
- Liquid paraffin preparations (except nasal and oral laxatives)
- Quinine (35mg dose)
- Cetrizine Hydrochloride (10mg MDD, indication stated on packaging)
- Beconase Nasal Spray (when specified for hay fever)
What are the conditions for sale of medicines in a retail store?
- Premises must be lockable to exclude public
- Product must be assembled elsewhere
- Packaging must remain unopened
Who can supply patients with GSL medicines?
- Doctors, dentists and midwives
- Hospitals/health centres (under directions from a relevant prescriber)
What are the HMR Schedule 15 requirements for the sale of aloxiprin, aspirin and paracetamol?
Effervescent Tablets - 30 tablets if containing 0-325mg of aspirin - 20 tablets if containing 325mg aspirin with 500mg max total tablet Aspirin Only Tablets - 28 tablets EC 75mg Aspirin Non-Effervescent Tablets (No Aspirin) - 16 tablets Paracetamol Liquids - Powder/Granules 10 sachets - 160ml Liquid Preparations - 12 liquid preparations of 100ml total (5ml/dose) Ibuprofen Liquids - Powder/Granules 12 sachets - 100ml liquid preparation (5ml/dose)
When can POM medicines be reclassified as P medicines?
- Negligible danger to health if used without supervision
- Not commonly misused
- Does not contain any substances under investigation
- Not normally administered by injection
When can P medicines be reclassified as GSL?
- Safe to be sold without pharmacist supervision
- Wider sale more convenient and efficient than risk of damage to health
What are the conditions for dispensing a GSL on prescription?
Pharmacist should be present for legal/clinical check
When can medicines be supplied at a prescriber’s request?
When prescription can’t be provided straight away
What can be supplied at a prescriber’s request?
- All POMs
- No CDs from schedules 1, 2 and 3 (except phenobarbital for epilepsy)
- If EEA/Swiss prescriber no CDs at all
Does a prescription need to be supplied for emergency supply at a prescriber’s request?
YES, within 72 hours of request (responsibility of the prescriber)
Does a record need to be made for emergency supply at a prescriber’s request?
Yes, on day of supply or day after. It should contain:
- Name and address of patient and prescriber
- 3 dates - Supply, prescription written and prescription supplied
- Details of emergency supply and medicine provided
When can medicines be supplied at a patient’s request?
When it is impractical to gain a valid prescription in time BUT the medicine has been prescribed by an appropriate practitioner previously
What can be given as emergency supply at a patient’s request?
- All POMs
- Phenobarbital for epilepsy
Dose should be checked by pharmacist
What is a summary care record?
Contains allergies, ADRs and medication detail relating to a specific patient
- Additional detail added if patient requests it
- Purpose of increased patient safety and increased efficacy of treatment
When can a summary care record be accessed?
If patient consents
How many days emergency supply can be given at a patient’s request?
- 30 days for normal POMs
- 5 days supply for CDs (phenobarbital)
- If a medicine where pack can’t be broken (e.g. inhaler) give smallest size
- Oral contraceptives - give full course
- Liquid antibiotics - give full course
What should be recorded in a POM record if given at a patient’s request?
- Name and address of patient
- Date of supply
- Details of medicine supplied
- Nature of emergency
- Price and ref. no as good practice
What should be done before providing emergency supply at a patient request?
Recommend another way of obtaining prescription (e.g walk in centre, GP)
When can emergency supply be provided without interviewing patient?
- Pandemic diseases
- Pharmacist does not have to be present for supply
In what situation can anyone administer a parenteral POM?
- Life saving situations (e.g. 1 in 1000 adrenaline/snake bite antivenom can be administered)
What is a Patient Group Direction?
Allows supply of a medicine without a prescription to a patient who fits the conditions of the PGD
What can be supplied under a PGD and who can supply it?
- Usually written for a specific POM
- Any health professional that is a named individual in the PGD
What should be included in a PGD?
- Name of business owner
- Start and end dates of PGD
- Description of medicines supplied
- Signature of doctor/dentist, pharmacist and other health professionals who may have to act under the PGD
- Clinical conditions and exclusions
- Description for further referral
- Details for administration of medicine
Which CDs can be included under a PGD?
- All schedule 5 CDs
- Schedule 4 CDs except anabolic steroids
- Midazolam (schedule 3)
- Diamorphine and morphine (schedule 2)
Who requires a wholesale dealers license?
Wholesale dealers who supply medicines to other wholesale dealers or people who can supply medicines to the public
Can pharmacists supply medicines to other public suppliers?
Yes, in small quantities a wholesale dealers license is not required
- Doctors for home visits
- Other pharmacies on a patient basis
If medicine is supplied with no profit and intent to treat a patient a wholesale dealers license is not required
What can midwives supply to patients in the course of their work?
- All GSL and P medicines
- POMs containing diclofencac, hydrocortisone acetate, miconazole, nystatin and phytomenadione
- Some parenterally administered POMs (e.g. adrenaline and diamorphine)
What can optometrists supply in the course of their work?
- All GSL and P medicines In the case of an emergency: - Eye drops up to 0.5% chloramphenicol - Eye ointments up to 1% chloramphenicol - POMs containing cyclopentolate Hal, fusidic acid, tropicamide
What can a pharmacist supply under a signed order from an optometrist?
- All P medicines
- POMs containing amethocaine HCl, lignocaine HCl, oxybuprocaine HCl and proxymetacaine HCl
When can additional supply optometrists supply POMs?
- Emergencies
- If provided with a valid signed order pharmacist can supply medicine to patient
What can podiatrists supply in the course of their work?
- Any GSL
- P medicines for external use
What do annotations in the Healthcare Professionals Council mean?
Select medicines in the specified class can be supplied
What cannot be supplied to a patient directly even with a signed order?
Local anaesthetics
What can paramedics administer and in what situations?
Certain medicines can be administered to a sick or injured patient if it is required immediately
What are the conditions for supply of inhalers and epi-pens to schools?
- Can be given for use in an emergency
- Supplied against a signed order and record kept in POM register for 2 years
What is the relationship between signed orders and POM records?
- If signed order is not kept POM record needs to be made
- Both is good practice
- If keeping signed order, all details required for POM register should be present
Can healthcare professionals self-prescribe/prescribe for those close to them?
Doctors and dentists technically yes, but not considered good practice
What is the purpose of the Misuse of Drugs Act?
Control of import, export, production, supply and possession of dangerous/harmful drugs
What are the CD classes and how are they generally assigned?
- Classes A, B and C
- Generally grouped on ability to cause harm but only used for prosecution
What are the legalities surrounding Novel Psychoactive Substances?
It is illegal to manufacture, import and supply them but it is not illegal to be in possession
What action should be taken if a doctor or pharmacist is asked for information about the supply of harmful drugs?
Give the information accurately to the best of their ability
What are the schedules of Controlled Drugs? (+ detail)
- Schedule 1 - No therapeutic use so only used for research, possession requires a home office license
+ Pharmacist can possess a small amount if intent is to destroy or pass on to police - Schedule 2 - (CD POM) Stock has to be kept safely in pharmacy and records should be kept for supply. Stock keeping should be present if required by an auditor and unused medicines should be destroyed appropriately
- Schedule 3 - (CD No Register POM) Less likely to be harmful/misused therefore no CD record required. Invoice should however be kept for 2 years. Some require safe storage
- Schedule 4, Part 1 ( Benzodiazepines) and Part 2 (Anabolic Steroids) - Requires no record keeping/invoice, can be given as emergency supply, import and export requires Home Office license
- Schedule 5 - Negligible potential for misuse, invoice kept for 2 years
Who can legally be in possession of Schedule 2, 3 and 4 CDs?
- Patients with a valid prescription
- People with a Home Office License
- Practitioners and Pharmacists
- Those handling it as a part of their job
Where can the CD schedules be found?
BNF
When is it legal to possess a Schedule 4 CD?
If it is contained in a medicinal product
Who can only POSSESS Schedule 2-4 CDs?
- Those administering drug on directions of a practitioner
- Owner of a hospital or care home, if they have a pharmacist in charge of supply (can supply if no pharmacist present)
When can a senior nurse possess and supply a CD?
If the CD was supplied to them by the person in charge of possession and supply
When is a personal license required for CDs?
- When travelling for longer than 3 months
What should be done when travelling with CDs?
- Obtain letter from practitioner stating reason for use and dose
- Check policies of countries visiting
How do practitioners obtain CDs?
Through a requisition order that is written in indelible ink and satisfies the same legal requirements as a prescription
What should be contained on a requisition form (FP10CDF) and which Schedules is it required for?
- Schedules 2 and 3
- Part A should be completed by supplier (their details)
- Part B should indicate the details of the CD requested and the reason for use
- Part C should have the name and address of the Practitioner as well as the signature and date of order
Do pharmacies require a requisition form?
No but it is good practice to complete one
Who can collect requested CD stock?
- Purchaser
- Someone on behalf of purchaser IF they have written authorisation (which should be kept for 2 years)
Can emergency supply of schedule 2 and 3 drugs be requested by an independent prescriber?
Yes, by a doctor or dentist. Written requisition should be provided within 24 hours
When are requisitions not sent to NHSBSA and how long should they be kept for?
Requisitions from:
- Hospitals
- Care Homes
- Prison Pharmacies
- Manufacturer
- Wholesaler
- Midwife Supply Orders
- Vet Requisitions
Kept for 5 years (vet) or 2 years (hospital/care home)
What should a midwife supply order contain?
- Midwife name and occupation
- CD details and purpose
- Patient details
- Signature of appropriate medical officer
How long should records be kept for relating to a midwife supply order?
- Retain supply order for 2 years
- Make CD record and keep for 2 years if CD is schedule 2
Can CDs be given on repeatable prescriptions?
- Schedule 2 and 3 cannot
- Instalment prescriptions used instead (14 days treatment)
What is the time limit for dispensing an instalment prescription?
28 days of signature OR a specified date on the instalment prescription
What should be included on an instalment prescription for treatment of addiction?
- Dose
- Amount given per instalment
- Interval between supplies
All instructions should be complied with unless prescription has approved wording by Home Office
When can instalments be dispensed on a day different to that specified?
If the pharmacy is closed on the day in question (e.g. bank holiday/weekend)
What are the requirements for a prescription to treat addiction of cocaine, diamorphine and dipipanone?
- Prescription written by a doctor
- Has to be authorised by secretary of state
Should Schedule 2 and 3 prescriptions be signed when collected? (Legally)
Not legal requirement but good practice
Who can collect a schedule 2 CD?
- Patient
- Patient representative
- Healthcare professional acting within their role
Pharmacist must know and should collect details of person collecting (must collect HCP details)
What should be done if a representative is collecting a schedule 2 CD?
- May ask for form of ID
- Representative should have a letter from patient to confirm collection
- If dose should be supervised, contact prescriber to check whether to dispense
- Record representative details in CD register
Which CDs can NIPs/PIPs prescribe?
All schedule 2-5 except cocaine, dipipanone and diamorphine
What is the role of NIPs and PIPs in drug misuse?
Can supply paraphernalia and advice for safe injecting/use
What are the legal requirements for a CD prescription?
- Prescriber signature and address
- Date of prescription/specified date of start
- Specific dose, formulation and strength
- Quantity in numbers and words
- Instalment wording
- Patient name and address
In what circumstances may a wrong prescription still be dispensed?
- Minor spelling mistakes
- Number OR words of quantity missing (but not both)
Mistakes should be marked with Pharmacist’s initials
When do hospital bed charts have to meet the requirements for a CD prescription?
If CD is intended for supply but not if it is being administered
Which CDs should be kept under safe custody?
All schedule 1, most of schedule 2 and some schedule 3
How should out of date/patient returned stock be kept?
Separate from new stock and labelled ‘waiting to destroy’
How should CD drug content be marked?
- Amount of drug in product
- If preparation, dosage unit as well as total number in preparation or percentage of the total preparation
What should be recorded in a CD register?
- Receipt or supply of schedule 1 or 2 CDs
- Supply of Sativex Spray due to presence of cannabis derivatives
What should be included in a CD record of receipt?
- Date of receipt
- Name and address of the person giving it
- Quantity received
What should be included in a CD record of supply?
- Date of supply
- Name and address of recipient
- Details of authority to possess
- Quantity supplied
- Details of person collecting
- Whether proof of ID was obtained
How should a CD register be set up?
- Classes of drugs separated
- Different formulations/strengths of a drug on different pages
- Class, strength and form at the top of each page
- Chronological order with records being completed on day of/day after supply or receipt
How can corrections be made to a CD register entry?
Marginal notes or footnotes
Where should CD record be kept?
In the premises they are relevant to
- Either hard copy or computerised
- Computerised copies should have adequate controls
When should destruction of stock be witnessed?
If CD record needs to be made, destruction should be witnessed
