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
Who can supply naloxone without a prescription, PGD, or PSD?
- Individuals employed or engaged in lawful, recognized drug treatment centers.
26
What are examples of programs that can supply naloxone?
- 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
What is naloxone?
- opioid/opiate antagonist that can partially or completely reverse central nervous system and respiratory depression caused by opiod overdose
28
Who can administer certain POMs for emergency care under exemptions?
- Paramedics, for the emergency care of sick or injured persons (e.g., benzylpenicillin or morphine).
29
Can paramedics keep stocks of POMs?
- Yes, paramedics can keep stocks of POMs as part of their practice.
30
Who are other professionals with exemptions for POM use?
Orthoptists and optometrists
31
Are there specific legal requirements for the content of a signed order?
- No, but it is advisable to include details needed for the POM register as a minimum.
32
What must be recorded when a POM is supplied from a registered pharmacy to an HCP or organization?
- Record the supply in the POM register. - Retain the signed order or invoice for 2 years (good practice to do both).
33
What information must be included in the POM register?
- 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
What must anyone trading medicines, other than to a patient have ?
– 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
what are exemptions to not having a WDA ?
- 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
What does an SSP allow a pharmacist to do?
- 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
What are the conditions for exemption under an SSP?
- 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.