LAW Flashcards
What does the Pharmacy Act 1852 establish?
Framework of the pharmaceutical society
Established the power to hold examinations and issue certificates, making ‘pharmaceutical chemist’ a protected title.
What are the three legal classes of medicines as per the Medicines Act 1968?
- POM – Prescription Only Medication
- P – Pharmacy Only Medication
- GSL – General Sales List
What is required for all products to be legally sold?
A ‘Marketing Authorisation’ issued by the MHRA
Ensures quality and safety of medicines.
What does legal classification of medicines relate to?
The PRODUCT and not the active substance
The same drug substance may be classified differently based on the product.
Fill in the blank: Paracetamol can be classified as GSL, P, or POM depending on _______.
[pack size]
What tighter controls were introduced for Codeine and Dihydrocodeine in September 2009?
Aim to minimize overuse and addiction
These medications are POM for products with over 32 dose units.
What is unlawful under the Human Medicines Regulations 2012 regarding Pseudoephedrine and Ephedrine?
Supply of more than 720mg of Pseudoephedrine or 180mg of Ephedrine at one time without a prescription.
True or False: The Responsible Pharmacist (RP) can be absent from the pharmacy for a maximum of 2 hours in a 24-hour period.
True
What is the statutory duty of the Responsible Pharmacist (RP)?
Ensure safe and effective running of the pharmacy.
What major change did the Human Medicines Regulations 2012 introduce regarding pharmacy practice?
Enabled the use of professional judgement when labelling medicines.
What is the implication of the Health Act 1999?
Modernised and strengthened regulation of healthcare professionals.
What must be displayed by the Responsible Pharmacist in the pharmacy?
A notice with their name, registration number, and a statement confirming they are in charge.
What are the potential changes that can be made to medication labels under the Human Medicines Regulations 2012?
- Change directions
- Change name or common name of medicine
- Change precautions on label
Fill in the blank: Generic substitution for a branded product would be considered _______.
[NHS fraud]
What are the legal requirements for a prescription to be valid?
Specific information must be present as summarized in the MEP section 3.3.
What does the term ‘PO’ refer to in pharmacy law?
Pharmacy Only, not a separate legal classification but indicates some GSL ingredients licensed for sale through pharmacies.
What is the purpose of formularies in prescribing?
Lists of preparations that can be prescribed by specific types of prescribers.
What is the consequence of prescribing restrictions for independent and supplementary prescribers?
Prescribing is restricted to areas of clinical competence and included within an agreed clinical management plan.
What does the ‘FP10’ prescription form signify?
Used by GP/Hospital Doctors, Independent Prescribers, and Supplementary Prescribers.
What is the main responsibility of a pharmacist regarding Emergency Hormonal Contraception?
Assess clinical suitability and approve sales.
What healthcare professionals can sell, supply, and/or administer certain medicines under specific exemptions made under the HMR?
- Midwives
- Orthoptists
- Optometrists
- Paramedics
- Podiatrists/Chiropodists
What is the maximum number of dose units for Codeine before it is classified as POM?
32 dose units.
What is the legal classification of Levonorgestrel 1500 microgram tablets?
Licensed as a P medicine.
What distinguishes between the two preparations of Levonelle?
Different dosages and their implications in terms of supply.
What is the majority method of prescribing in practice?
Electronic tokens sent via EPS
EPS stands for Electronic Prescription Service, which streamlines the prescribing process.
What are the key legal requirements for a prescription to be valid?
Must include the following information:
* Signed in ink (if handwritten)
* Dated
* Written/generated in indelible ink
* Address of practitioner
* Particulars indicating type of prescriber
* Name and address of patient
* Age (if under 12 years)
* Additional requirements for CDs in schedule 2 and 3
CDs refer to Controlled Drugs.
What information is legally required on a medicine label?
Must include:
* Name of the patient
* Name and address of the supplying pharmacy
* Date of dispensing
* Name of the medicine
* Directions for use
* Precautions related to the use of the medicine
C&A labels refer to caution and advisory labels.
What additional label recommendations does the Royal Pharmaceutical Society suggest?
Should include:
* ‘Keep out of the sight and reach of children’
* ‘Use this medicine only on your skin’
These recommendations enhance safety for patients.
What changes did the amendments to the Poisons Act 1972 introduce?
Changes include:
* Classification and regulation of poisons and chemicals
* Requirement to report suspicious transactions, significant stock loss, and theft to the police
* Valid licence requirement for public to purchase dangerous poisons or chemicals
Licences must be checked for validity and matching requests.
What must pharmacists do when a licence is required for purchasing poisons?
Pharmacy teams must:
* Check the licence is valid
* Ensure it is unaltered
* Confirm it matches the request
This ensures compliance with legal requirements.
What are the three key regulations related to chemicals mentioned?
- REACH (Registration, Evaluation, Authorisation and restriction of chemicals)
- CLP (Classification, Labelling and packaging of chemicals)
- COSHH (Control of Substances Hazardous to Health)
These regulations help ensure safety and compliance in handling chemicals.
What are Controlled Drugs (CDs)?
Substances controlled by the Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001
CDs are scheduled based on the risk and potential harm from abuse.
What do drug schedules determine?
Schedules determine:
* Degree of control
* Storage requirements
* Record keeping requirements
These vary depending on the substance’s classification.
What is the significance of the MEP section 3.3.1?
Summarizes the legal prescription requirements
MEP stands for Medicines, Ethics, and Practice.
What are the two parts of the Pharmacy guide from RPS regarding poisons?
- Part 1 – Regulated explosive pre-cursors
- Part 2 – Regulated non-medicinal poisons
These guides provide essential information on regulated substances.
Fill in the blank: Controlled drugs are scheduled according to their _______.
[risk and potential harm from abuse]
True or False: The schedules of controlled drugs are the same as the classes used to classify substances in law.
False
Schedules and classes are different classifications.
