Law - Semester 1 Flashcards
How does legislation ensure public protection in Pharmacy practice?
- Restrictions to prevent drug crime, self medication and addiction
- Controlled manufacture, distribution and supply ensuring purity, potency and efficacy
What three pieces of legislation control use of medicines?
- Medicines Act
- Misuse of Drugs Act
- Poisons Act
What does the Health Act control?
Practice of pharmacist rather control of medicines
Define pharmacovigilance
Drug safety through detection, assessment, monitoring and prevention of side effects
How are medicinal products defined under the HMR?
- Shows properties for the treatment/prevention of disease
- Administered for medical diagnosis
- Administered with the aim of altering physiological function through pharmacological, metabolical or immunological action
How are authorised medicinal products defined under the HMR?
- Medicines with a marketing authorisation
- Homeopathics with a certificate of registration
- Herbal remedies with a traditional herbal registration
How are relevant medicinal products defined under the HMR?
Medicine with a marketing authorisation
What is the definition of a medicinal purpose under the HMR?
- For treatment or prevention of disease
- For diagnosis of a disease
- Prevents/interferes with normal physiological function
- Contraception
- Anaesthesia
Define administer as set out by the HMR
Given to a human being orally or parenterally
What should be taken into account when using professional judgement?
- Law
- Professional code of conduct
- Ethical standards
What is the difference between the UK and GB?
GB - England, Wales, Scotland
UK - GB + Northern Ireland
Define criminal law
Usually between the individual and the state, where the action is harmful to society
Can result in jail sentence
Define civil law
Usually between two individuals
Generally resolved in compensation being paid to the victim
How are dispensing errors convicted?
Criminal law
Describe the setup of UK legislation
- Primary legislation: General principles (usually acts)
- Secondary legislation: Provides more detail relating to an act
- Statutory instruments: Form of secondary legislation relating to an act
- Schedules: Contain detail separate to an act or SI
What is case law?
Judge makes a decision based on similarities to a previous case in court
Usually when there is no clear outcome set out by law
What are the components of EU law? Describe them
- Treaties
- Regulations: Direct, binding effects on member states
- Directives: Objectives set out but action is for state to decide
- Decisions: Binding to those it is aimed at
Which bodies can implement EU law?
- European commission
- EU council
- European parliament
- European court of justice
Where are pharmacists considered registered healthcare professionals?
Throughout the members of the EU
When are medicines classified as POM?
- Can cause damage to health if taken unsupervised
- May be commonly misused
- New active substances
- Parenterally administered drugs
Who are considered as appropriate practitioners?
- Doctors
- Dentists
- Supplementary prescribers
- Nurse and pharmacist independent prescribers
What are supplementary prescribers?
Prescribe according to patient-specific care plan set out by a doctor or dentist with patient agreement
What should be included in a clinical management plan?
- Patient name
- Conditions treated by SP
- Dates of start/review
- Details of medicinal product
- Patient circumstances
- What to do in the event of an ADR
- When to contact IP
Prescriptions from which EEA health professionals are valid in the UK?
Doctors Dentists Midwives Nurses Pharmacists
What cannot be prescribed by EEA health professionals?
Schedule 1-3 CDs
What are the legal requirements for a prescription to dispense it?
- Prescribers name, address, particulars and signature
- Patient’s name and address
- Patient age if <12years
- Date within the past 6 months
How long are CD2, 3 and 4 prescriptions valid for?
28 days
What are the time requirements on private repeat prescriptions?
Initial dispense within 6 months (28 days for CD4), no time limit for remaining
How many times can medications be dispensed if repeats are unspecified?
- Twice for normal POMs
- Six times for oral contraceptive
What are the prescription requirements for an EEA/Swiss prescription?
- Prescriber name, address, particulars and signature
- Patient name and address
- Details of the prescribed medicine
- Date of issue
Can UK pharmacists dispense an EEA prescription in a foreign language?
Yes, if they can clearly understand the actions to take and it meets the legal requirements
What medicines can dentists prescribe?
Can prescribe from entire BNF BUT should stay within their competency
If FP10D prescription, should be from dental practitioners formulary
Are faxed prescriptions legally valid?
When may they be used?
No, not in indelible ink or signed
May be used for a template in emergency supply
How are forged prescriptions identified?
- Is the medicine commonly misused and does the prescription seem appropriate?
- If the prescriber is known, is it their usual style of prescribing?
- Does the patient behaviour seem normal?
- Signature - Unlikely to be signed as ‘Dr’
- Can it be compared with old Rxs
What are the requirements for electronic prescriptions?
Signature should be unique and allow ID of prescriber
Changes should be detected
Creation and alteration is solely by prescriber
Why are electronic prescriptions used?
More efficient and convenient
Can be sent to a pharmacy of the patient’s choice
What is a patient specific direction?
- Allows medication supply to a specific patient in hospitals without a prescription
- Written by prescriber, supplied by appropriate practitioner
- Good practice to have in writing
What are the fates of NHS, Private and CD prescriptions and wholesale deals?
- NHS to NHSBSA
- Private - POM record made (except oral contraceptives)
- CD - CD record (CD2)
- Wholesale - Keep order for 2 years or make POM entry
What are the time requirements for records?
Made on day of or day after supply
Kept for 2 years
What are the legal requirements for a POM register?
Dates: Prescription issue and supply
Name and address of patient and prescriber
Details of POM supplied
What are the legal requirements for a dispensing label?
- Name of patient
- Name and address of pharmacy
- Name of medicine and directions for use
- Dispensing date
- Cautionary/advisory labels
- ‘Keep out of sight and reach of children’
What can a pharmacist change on a prescription?
Dose or duration if using professional judgement to optimise use
What are P medicines?
Medicines with a MA stating they should only be available from a pharmacy
When can P medicines be DISPENSED?
In a pharmacy with a pharmacist present
Who can SELL a P medicine?
Any member of pharmacy team as long as pharmacist is present and able to advise
Give some examples of P medicines
Anthelmintics (parasitic worm infections)
Parenteral medicines
Enemas
Irrigation for wounds, bladder, vagina and rectum
Aloxiprin (U16)
Aspirin (U16)
In what circumstances may the same medicine be in multiple classes?
Different quantities, strengths or formulations
Conditions of MA
Give 3 examples of Schedule 1 Part 1 POM exemptions and their conditions
- Budesonide: Nasal administration SPECIFIED for seasonal allergic rhinitis. MDD = 200mcg per nostril, max pack size 10mg. For >12years
- Econazole: External use for vaginal candidiasis
- Chloroquine phosphate: Licensed and labelled for malaria prophylaxis
What exemptions must CDs satisfy to be classified as P medicines?
- Only contain ONE CD2 substance
- At a specified max dose
- Supplied in specified form and packaging
Which CDs to P exemptions apply to?
Codeine Dihydrocodeine Ethylmorphine Morphine Pholcodine (+ salts) Medicinal opium
What are counter prescribed medicines and what can be given?
Pharmacist can supply against customer request using professional judgment
NOT POMs, P medicines, GSL (considered as P in this situation)
What are the conditions for the sale of pseudoephedrine and ephedrine?
- Not sold together
- No more than 720mg pseudoephedrine
- No more than 180mg ephedrine
- Sold using professional judgement
Can EHC be given as a P medicine? How much?
Yes - A single dose
What are the conditions for the sale of codeine or dihydrocodeine?
- Max 3 days use (32 tablets)
- Possibility of addiction must be stated on packaging and PIL
- Codeine linctus only given to over 18s
What are GSL medicines?
Medicines with a MA allowing the sale of medicine without a pharmacist present (with reasonable safety)
What does the legal status of a medicine refer to?
Specific product in that amount and strength, so same active ingredient may be in a number of classes
Give 4 examples of POM medicines classified as GSL medicines and the conditions for this
- Liquid paraffin preparations (except nasal preparations and oral laxatives)
- Quinine: POM medicine but 100mg MD is P and 35mg MD is GSL
- Cetirizine Hydrochloride: POM medicine but MDD 10mg P medicine. IF packaging specifies indication, appropriate age, max strength and MDD as 10mg, classified as GSL. Max 30 tabs or 70ml liquid
- Beconase: Indication changes class - If specified for hay fever GSL but generic nasal spray is POM
Where are GSL medicines sold?
Retail stores
Retail pharmacies
Automatic machines
What is the responsibility of the pharmacist in the sale of GSLs?
- Staff training
- SOPs
What are the conditions for retail stores to sell GSL medicines?
- Must be able to lock premises to exclude public
- Medicines must be assembled elsewhere
- Packaging must not be opened
Which practitioners can give GSL medicines to a patient?
Doctors
Dentists
Midwives
IF patient under their care
Who can supply GSL medicines under the direction of a prescriber?
Hospitals and health centres