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PHARMACY > LAW > Flashcards

LAW Flashcards

1
Q

What does the Pharmacy Act 1852 establish?

A

Framework of the pharmaceutical society

Established the power to hold examinations and issue certificates, making ‘pharmaceutical chemist’ a protected title.

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2
Q

What are the three legal classes of medicines as per the Medicines Act 1968?

A
  • POM – Prescription Only Medication
  • P – Pharmacy Only Medication
  • GSL – General Sales List
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3
Q

What is required for all products to be legally sold?

A

A ‘Marketing Authorisation’ issued by the MHRA

Ensures quality and safety of medicines.

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4
Q

What does legal classification of medicines relate to?

A

The PRODUCT and not the active substance

The same drug substance may be classified differently based on the product.

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5
Q

Fill in the blank: Paracetamol can be classified as GSL, P, or POM depending on _______.

A

[pack size]

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6
Q

What tighter controls were introduced for Codeine and Dihydrocodeine in September 2009?

A

Aim to minimize overuse and addiction

These medications are POM for products with over 32 dose units.

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7
Q

What is unlawful under the Human Medicines Regulations 2012 regarding Pseudoephedrine and Ephedrine?

A

Supply of more than 720mg of Pseudoephedrine or 180mg of Ephedrine at one time without a prescription.

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8
Q

True or False: The Responsible Pharmacist (RP) can be absent from the pharmacy for a maximum of 2 hours in a 24-hour period.

A

True

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9
Q

What is the statutory duty of the Responsible Pharmacist (RP)?

A

Ensure safe and effective running of the pharmacy.

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10
Q

What major change did the Human Medicines Regulations 2012 introduce regarding pharmacy practice?

A

Enabled the use of professional judgement when labelling medicines.

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11
Q

What is the implication of the Health Act 1999?

A

Modernised and strengthened regulation of healthcare professionals.

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12
Q

What must be displayed by the Responsible Pharmacist in the pharmacy?

A

A notice with their name, registration number, and a statement confirming they are in charge.

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13
Q

What are the potential changes that can be made to medication labels under the Human Medicines Regulations 2012?

A
  • Change directions
  • Change name or common name of medicine
  • Change precautions on label
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14
Q

Fill in the blank: Generic substitution for a branded product would be considered _______.

A

[NHS fraud]

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15
Q

What are the legal requirements for a prescription to be valid?

A

Specific information must be present as summarized in the MEP section 3.3.

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16
Q

What does the term ‘PO’ refer to in pharmacy law?

A

Pharmacy Only, not a separate legal classification but indicates some GSL ingredients licensed for sale through pharmacies.

17
Q

What is the purpose of formularies in prescribing?

A

Lists of preparations that can be prescribed by specific types of prescribers.

18
Q

What is the consequence of prescribing restrictions for independent and supplementary prescribers?

A

Prescribing is restricted to areas of clinical competence and included within an agreed clinical management plan.

19
Q

What does the ‘FP10’ prescription form signify?

A

Used by GP/Hospital Doctors, Independent Prescribers, and Supplementary Prescribers.

20
Q

What is the main responsibility of a pharmacist regarding Emergency Hormonal Contraception?

A

Assess clinical suitability and approve sales.

21
Q

What healthcare professionals can sell, supply, and/or administer certain medicines under specific exemptions made under the HMR?

A
  • Midwives
  • Orthoptists
  • Optometrists
  • Paramedics
  • Podiatrists/Chiropodists
22
Q

What is the maximum number of dose units for Codeine before it is classified as POM?

A

32 dose units.

23
Q

What is the legal classification of Levonorgestrel 1500 microgram tablets?

A

Licensed as a P medicine.

24
Q

What distinguishes between the two preparations of Levonelle?

A

Different dosages and their implications in terms of supply.

25
Q

What is the majority method of prescribing in practice?

A

Electronic tokens sent via EPS

EPS stands for Electronic Prescription Service, which streamlines the prescribing process.

26
Q

What are the key legal requirements for a prescription to be valid?

A

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.

27
Q

What information is legally required on a medicine label?

A

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.

28
Q

What additional label recommendations does the Royal Pharmaceutical Society suggest?

A

Should include:
* ‘Keep out of the sight and reach of children’
* ‘Use this medicine only on your skin’

These recommendations enhance safety for patients.

29
Q

What changes did the amendments to the Poisons Act 1972 introduce?

A

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.

30
Q

What must pharmacists do when a licence is required for purchasing poisons?

A

Pharmacy teams must:
* Check the licence is valid
* Ensure it is unaltered
* Confirm it matches the request

This ensures compliance with legal requirements.

31
Q

What are the three key regulations related to chemicals mentioned?

A
  • 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.

32
Q

What are Controlled Drugs (CDs)?

A

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.

33
Q

What do drug schedules determine?

A

Schedules determine:
* Degree of control
* Storage requirements
* Record keeping requirements

These vary depending on the substance’s classification.

34
Q

What is the significance of the MEP section 3.3.1?

A

Summarizes the legal prescription requirements

MEP stands for Medicines, Ethics, and Practice.

35
Q

What are the two parts of the Pharmacy guide from RPS regarding poisons?

A
  • Part 1 – Regulated explosive pre-cursors
  • Part 2 – Regulated non-medicinal poisons

These guides provide essential information on regulated substances.

36
Q

Fill in the blank: Controlled drugs are scheduled according to their _______.

A

[risk and potential harm from abuse]

37
Q

True or False: The schedules of controlled drugs are the same as the classes used to classify substances in law.

A

False

Schedules and classes are different classifications.

PHARMACY (4 decks)

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