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Law And Ethics > Prescription Only Medicines > Flashcards

Prescription Only Medicines Flashcards

1
Q

What can GSL + P’s be collectively described as ?

A
  • OTC
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2
Q

How long is a prescription valid for ?

A
  • valid for up to 6 months
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3
Q

What are the general prescription requirements ?

A
  • signature by prescriber
  • address of prescriber
  • date prescribed
  • type of prescribed indicated e.g doctor
  • name of patient
  • address of patient
  • age if under 12
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4
Q

What is an owing in pharmacy practice ?

A
  • when the pharmacy does not have enough stock of the prescribed medicine
  • they can issue what they have and provide an owing slip for the remainder
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5
Q

Within what timeframe must POM (Prescription-Only Medicines) and CD Schedule 5 medicines be supplied ?

A
  • 6 month from appropriate date
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6
Q

Within what timeframe must owed CDs in Schedules 2, 3, and 4 be supplied?

A
  • within 28 days from the appropriate date.
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7
Q

Within what timeframe must owed P and GSL medicines be supplied?

A
  • 6 months from appropriate date
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8
Q

What are repeatable prescriptions?

A
  • private prescriptions that can be dispensed more than once, e.g., “repeat x 5.”
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9
Q

How many times can a prescription be repeated if no number is stated?

A
  • It can be repeated once, meaning it is dispensed twice in total.
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10
Q

What is the timeframe for the first dispensing of a POM private prescription?

A
  • the first dispensing must occur within 6 months of the appropriate date, but there is no legal time limit for subsequent repeats.
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11
Q

What is the timeframe for the first dispensing of a Schedule 4 private prescription?

A
  • the first dispensing must occur within 28 days of the appropriate date but there is no legal time limit for subsequent repeats (use professional judgment).
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12
Q

What schedule of control drugs are non-repeatable ?

A
  • schedule 2 and 3 drugs are non-repeatable
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13
Q

How long must private prescriptions for a POM be retained?

A
  • for two years from the date of sale or supply, or for repeatable prescriptions, from the date of the last sale or supply.
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14
Q

What must be done with private prescriptions for Schedule 2 and 3 Controlled Drugs?

A
  • they must be submitted to the relevant NHS agency.
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15
Q

How long must the POM register be retained?

A
  • for two years from the date of the last entry in the register.
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16
Q

What details must be recorded in the POM register?

A
  1. Supply date: The date the medicine was sold or supplied.
  2. Prescription date: The date on the prescription.
  3. Medicine details: Name, quantity, formulation, and strength (if not apparent from the name).
  4. Prescriber details: Name and address of the practitioner.
  5. Patient details: Name and address of the patient.
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17
Q

When should record-keeping in the POM register be completed?

A
  • On the day of supply or sale, or the next day following.
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18
Q

When should record-keeping in the POM register be completed?

A
  • on the day of supply or sale, or the next day following
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19
Q

What additional record must be made for Schedule 2 medicines?

A
  • a separate entry must be made in the Controlled Drug (CD) register.
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20
Q

How are prescriptions dispensed under the eRD service?

A
  • prescriptions are made available for dispensing at specified intervals.
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21
Q

What is the purpose of the Electronic Repeat Dispensing (eRD) service?

A
  • to increase efficiency by allowing a prescriber to authorise a batch of prescriptions for up to 12 months with one signature.
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22
Q

What information must the prescriber add to the repeat prescription?

A
  1. The intended time interval between issues.
  2. The number of times the repeatable prescription can be issued
23
Q

What information must the prescriber add to the repeat prescription?

A
  1. The intended time interval between issues.
  2. The number of times the repeatable prescription can be issued
24
Q

Where is the prescription stored after it is generated in the system?

A
  • it is sent to the NHS Spine, where it can be downloaded by a nominated dispenser
25
Q

What is the repeat authorisation token in the eRD service?

A

• It is the master copy of the prescription.
• It includes patient/prescriber details, items, number of issues, intervals, and the end date.

26
Q

Who typically holds the repeat authorisation token?

A
  • either the patient or the dispenser.
27
Q

What are the two key components of a Repeat Dispensing batch?

A
  • Repeat Authorisation (RA): Indicates the number of repeats allowed.
  • Repeat Dispensing (RD) form: Prescriptions that are dispensed against, with a digital signature.
28
Q

When must the first dispensing from a Repeat Dispensing batch occur?

A
  • within 6 months of the batch being issued
29
Q

What checks must be made before each supply under the Repeat Dispensing Service?

A
  • Confirm the patient is taking and using the medicine correctly.
  • Ensure the appliance/formulation is still appropriate.
  • Check for any side effects or need for a review.
  • Confirm there are no changes to therapy or the patient’s health.
30
Q

Can dentists legally prescribe any POM ?

A
  • Yes, dentists can legally write prescriptions for any POM.
31
Q

What are the restrictions for dentists prescribing on an NHS prescription?

A
  • dentists must prescribe only from the Dental Prescribers Formulary (found in the BNF).
32
Q

Are prescriptions from approved health professionals in EEA or Switzerland legally recognised in the UK?

A
  • Yes, both prescriptions and repeatable prescriptions are legally recognised.
33
Q

Can emergency supplies be provided for patients of EEA or Swiss healthcare professionals?

A
  • Yes, emergency supplies are permitted
34
Q

Are Schedule 2 and 3 Controlled Drugs (CDs) allowed on EEA or Swiss prescriptions?

A
  • No, prescriptions for Schedule 2 and 3 CDs are not allowed.
35
Q

What patient details are required on an EEA or Swiss prescription?

A
  1. Patient’s full first name(s).
  2. Surname.
  3. Date of birth.
36
Q

What prescriber details are required on an EEA or Swiss prescription?

A
  1. Full first name(s) and surname.
  2. Professional qualifications.
  3. Direct contact details (email, telephone, or fax with international prefix).
  4. Work address, including the country they work in.
37
Q

What prescriber details are required on an EEA or Swiss prescription?

A
  1. Full first name(s) and surname.
  2. Professional qualifications.
  3. Direct contact details (email, telephone, or fax with international prefix).
  4. Work address, including the country they work in.
38
Q

What are the signature and date requirements for EEA or Swiss prescriptions?

A
  • the prescriber’s signature must be included.
  • the prescription date must be present. - Prescriptions are valid for 6 months from the signed date (28 days for Schedule 4 CDs).
39
Q

What should pharmacists do if there are concerns about the prescriber’s registration or details?

A
  • exercise professional judgement to confirm the prescriber’s status, prioritising patient safety and support.
40
Q

What must pharmacists consider when supplying medicines to other countries?

A
  • they must ensure compliance with local laws and verify the medicine has the necessary Marketing Authorisation (MA) for the destination country.
41
Q

Legal requirement to have :

A
  • Name of the patient
    – Name and address of the supplying pharmacy
    – Date of dispensing
    – Name of the medicine
    – Directions for use
    – Precautions relating to the use of the medicine.
42
Q

What pharmacy information must legally be included on the label of a dispensed product?

A

name and address of the supplying pharmacy.

43
Q

What details about the medicine and its use must appear on the label of a dispensed product?

A
  1. Name of the medicine.
  2. Directions for use.
  3. Precautions related to its use.
44
Q

What additional information must be included on the label when supplying a broken-down quantity of medicine?

A
  1. Name of the medicine.
  2. Quantity of the medicine in the container.
  3. Quantitative particulars of the medicine (i.e., the ingredients).
  4. Handling and storage requirements (if appropriate).
  5. Expiry date.
  6. Batch reference number (e.g., LOT number or BN).
45
Q

What is the Pregnancy Prevention Programme (PPP), and what are the key responsibilities for pharmacists?

A
  • certain medicines with high risk of foetal malformations and/or increase risk of spontaneous abortion
    – pharmacists: ensure medicines are not dispensed for women or girls who might be pregnant or are
    considering pregnancy
46
Q

How does PPV apply to specific medicines like oral retinoids and valproate?

A
  • there are different PPVs for oral retinoids and valproate due to their specific risks related to pregnancy
47
Q

What is a biosimilar?

A
  • a biologic medicine that is similar to an already licensed biological medicine but may not be identical.
48
Q

What is a biologic ?

A
  • medicine made from natural sources (human animal or microorganism)
  • e.g., vaccine, blood products, somatic
    cells, DNA etc.
49
Q

Who decides whether to switch between brands of biologic medicines?

A
  • the decision to switch between biologic brands is made by the prescriber in consultation with the patient.
50
Q

What is the MHRA’s recommendation regarding biosimilars and biologics?

A
  • the MHRA recommends that biologics should be prescribed by brand and that there should be no automatic switching between brands.
51
Q

What is an Advanced Therapy Medicinal Product (ATMP)?

A
  • an ATMP is a biological medicinal product based on genes, tissues, or cells, which can be:
    1. Gene therapy medicinal product
    2. Somatic cell therapy medicinal product
    3. Tissue engineered product
52
Q

Are ATMPs widely available?

A

Most ATMPs are still in clinical trial phases, but some are available as licensed medicines.

53
Q

What are the 3 special requirements for POMS ?

A
  • PPP
  • Biologics
  • ATMPs

Law And Ethics (11 decks)

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