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Law And Ethics > Exemptions on retail > Flashcards

Exemptions on retail Flashcards

1
Q

What is a typical route for the sale, supply, and administration of medicines in a registered pharmacy ?

A
  • GSL (General Sales List), P (Pharmacy), and POMs (Prescription Only Medicines)
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2
Q

What are the exemptions to restrictions on sale, supply + administration of medicines ?

A
  • Patient Specific Directions (PSDs)
  • Patient Group Directions (PGDs)
  • Optometrist or podiatrist signed patient
    order
  • School supplies- salbutamol/ adrenaline
  • Naloxone for drug treatment services
  • Emergency Supply (see PL&E7B)
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3
Q

Where can GSL (General Sales List) medicines be sold or supplied without the supervision of a pharmacist?

A
  • can be sold or supplied in places like supermarkets and vending machines without pharmacist supervision.
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4
Q

What is a Patient Specific Direction (PSD)?

A
  • Written instruction from a doctor, dentist, or non-medical prescriber for a medicine to be supplied or administered to a named patient, following an individual assessment.
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5
Q

Can organisations limit who is authorised to supply or administer medicines under a PSD?

A
  • Yes, organisations can choose to limit who is authorised to supply and/or administer medicines under a PSD.
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6
Q

What is an example of where a PSD might be used?

A
  • a hospital ward inpatient chart or a discharge medicines list
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7
Q

Is there a list of criteria for PSD’s ?

A
  • No list of criteria but must be enough information for person to safety administer.
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8
Q

Can a PSD for administration be given verbally or by telephone?

A
  • Yes, a PSD for administration can be given verbally or by telephone, though a written PSD is generally preferred, as per Specialist Pharmacy Service advice.
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9
Q

Should there be a separation of roles when it comes to prescribing and administering medicines under a PSD?

A
  • Yes, there should be a separation of prescribing and supply/administration roles wherever possible.
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10
Q

What is a Patient Group Direction (PGD)?

A
  • PGD is a written direction that allows specified medicines to be supplied and/or administered by authorised health professionals to a well-defined group of patients requiring treatment for a specific condition.
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11
Q

What recent change allows registered pharmacy technicians to be involved in PGDs?

A
  • Registered pharmacy technicians are now allowed to supply and administer medicines under a PGD in the course of their professional practice.
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12
Q

When is a PGD used in relation to patient care?

A
  • PGDs are reserved for situations where they benefit patient care without compromising patient safety
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13
Q

What are some examples of situations where a PGD might be used?

A
  • Baby immunisation clinic/ seasonal vaccinations (planned)
    – Oral contraception (unplanned via walk-in centre/ pharmacy)
    – Pharmacy First- supply of nitrofurantoin for uncomplicated UTI
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14
Q

Can Pharmacy (P) or General Sales List (GSL) medicines be administered without a PGD or PSD?

A
  • Yes, P or GSL medicines can be administered without a PGD or PSD, and pre-packed GSL medicines can be supplied without a PGD.
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15
Q

When is a PGD or PSD required for the supply of a Pharmacy (P) medicine?

A
  • A PGD or PSD is required for the supply of a P medicine unless an exemption applies, or the supply is made under a pharmacist’s supervision or by a registered midwife.
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16
Q

How should PGD’s be labelled ?

A
  • as if supplied against a prescription
17
Q

Can optometrists and podiatrists write prescriptions for POMs?

A
  • Only if they are qualified as independent or supplementary prescribers.
18
Q

Can pharmacists supply POMs based on a signed patient order from an optometrist or podiatrist?

A
  • Yes, but the medicine must be one legally sold or supplied by the optometrist or podiatrist, not just administered by them
19
Q

Do signed patient orders need usual prescription requirements?

A
  • No, they do not require the usual prescription format.
20
Q

What labeling requirements apply to medicines dispensed under signed patient orders?

A
  • Label as a dispensed medicinal product, include a Patient Information Leaflet (PIL), and record the supply in the POM register.
21
Q

Which medicines can be supplied to schools via a signed order?

A
  • Adrenaline autoinjectors and/or salbutamol inhalers.
22
Q

Who administers these medicines in schools?

A
  • Trained personnel, during emergencies, to pupils who have been prescribed the medication and with parental consent.
23
Q

What information must be included on a signed order for schools?

A
  • School name.
  • Product details.
  • Strength of the medicine.
  • Purpose of the medicine.
  • Total quantity (small, occasional basis).
  • Signature of the principal or head teacher.
  • Ideally on letter-headed paper.
24
Q

How long must the signed order (SO) be retained?

A
  • Retain the SO for 2 years from the date of supply OR make an entry in the POM register (best practice is to do both).
25
Q

Who can supply naloxone without a prescription, PGD, or PSD?

A
  • Individuals employed or engaged in lawful, recognized drug treatment centers.
26
Q

What are examples of programs that can supply naloxone?

A
  • Commissioned needle and syringe
    programs
    – A pharmacy may be commissioned
    to participate in a local take home
    naloxone scheme.
    – Service can continue to be provided
    by appropriately trained staff in the
    absence of the RP
27
Q

What is naloxone?

A
  • opioid/opiate antagonist that can partially or completely reverse central nervous system and respiratory depression caused by opiod overdose
28
Q

Who can administer certain POMs for emergency care under exemptions?

A
  • Paramedics, for the emergency care of sick or injured persons (e.g., benzylpenicillin or morphine).
29
Q

Can paramedics keep stocks of POMs?

A
  • Yes, paramedics can keep stocks of POMs as part of their practice.
30
Q

Who are other professionals with exemptions for POM use?

A

Orthoptists and optometrists

31
Q

Are there specific legal requirements for the content of a signed order?

A
  • No, but it is advisable to include details needed for the POM register as a minimum.
32
Q

What must be recorded when a POM is supplied from a registered pharmacy to an HCP or organization?

A
  • Record the supply in the POM register.
  • Retain the signed order or invoice for 2 years (good practice to do both).
33
Q

What information must be included in the POM register?

A
  • Date the POM was supplied.
  • Name, quantity, formulation, and strength (if not apparent) of the POM.
  • Name and address, trade, business, or profession of the recipient.
  • Purpose for which the medicine was sold or supplied.
34
Q

What must anyone trading medicines, other than to a patient have ?

A

– Hold a wholesale licence (AKA: wholesale distribution
authorisation (WDA))
– Comply with GDP standards and pass inspections
– Have suitable RP to ensure suitable procurement,
storage and distribution of medicines

35
Q

what are exemptions to not having a WDA ?

A
  • Pharmacies supplying stock to another pharmacy withinsame legal entity are not required to have a WDA
  • but must be small quantities on an ocassional basis
36
Q

What does an SSP allow a pharmacist to do?

A
  • Substitute a medicine when there is a serious shortage, including:
  • A different strength, quantity, or form of the prescribed POM
  • A different POM, such as a generic version of the prescribed drug
  • eg. Fluoxetine 10mg tablets Out of stock- supply 10mg capsules instead
37
Q

What are the conditions for exemption under an SSP?

A
  • The SSP must be followed.
  • The supervising pharmacist must use professional judgment to ensure the substitution is appropriate.
  • The patient must agree to the switch for the dispensing month.

Law And Ethics (11 decks)

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