non-prescription supply of medicine Flashcards

1
Q

How can you supply medicines without a prescription?

A
Emergency supply (request of patients/prescriber)
Community Pharmacist Consultation Service (CPCS)

Pandemic exemptions (to public)

Wholesale dealing (restricted list of people – not directly to patients)

Patient Group Directions (PGDs) (to patients)

Signed orders (restricted list of people – not directly to patients)

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2
Q

define what is the wholesale dealing of medicines

A

Selling or supplying, or procuring or holding or exporting medicines to a person who receives it for purposes of:

  • selling or supplying the product (to anyone other than a member of public);
    or
    administering it or causing it to be administered to one or more human beings,
    in the course of a business carried on by that person

A person making sales by way of wholesale dealing must possess a wholesale dealer’s licence (WDA(H))

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3
Q

To explain the conditions on sales by way of wholesale dealing

A
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4
Q

what was the pandemic exemption?

A
  • you do not need to interview the patient
  • allow the supply of medicines against a protocol from designated collection point do not have to be a registered pharmacy
  • do not need to take place under the supervision of a pharmacist
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5
Q

what is the three types of vaccination sites

A
  1. vaccination centre (large scale)
  2. hospital hubs (part of NHS trust )
  3. Local vaccination services - pharmacy

The provider must ensure that appropriate and formal authorisation for vaccine administration is in place such as a Patient Group Direction, protocol or written instruction, and that the staff groups who are supplied with, prepare, and administer the COVID-19 vaccine are those defined as eligible to do so

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6
Q

what licence do you need for wholesaleing

A

wholesale dealer’s licence (WDA(H))

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7
Q

when is whole sale dealers licence not necessary

A

WDA(H) not necessary for e.g:

1) The activities of a group of retailers or practitioners who buy medicinal products in bulk and divide the stock amongst themselves
For example, the transfer of stock between pharmacy premises that belong to the same legal entity - other healthcare providers such as nursing home, private hospitals and GP

2) if you have a ‘Holders of a Manufacturer’s license ‘ (do not require a WDA(H) to sell their own products)
3) Certain supplies of medicines by pharmacies

WDA(H) does not authorise the DISTRIBUTION of a medicinal product by way of wholesale dealing, or POSSESSION for the purpose of such distribution,

UNLESS a marketing authorisation is in force in respect of the product

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8
Q

If your wholesale dealing includes CD’s (Sch 2-5) what other licence do you need?

A

Home Office CD license to legalise the supply

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9
Q

when does supplying small quantities of products to other healthcare professionals cause the need to not get a wholesale dealers licence?

A
  • On an occasional basis
  • Quantity of medicines supplied is small
  • Not for profit
  • Supply is not for onward wholesale distribution
  • Medicines are needed to fulfil an individual patient’s needs
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10
Q

how can you supply/send when you are a non holder of WDA(H)

A

For non-holders of a WDA(H), pharmacists need to have received an order/invoice for the supply and a record of the supply made – preferably in the POM register and keeping the order/invoice (see later)

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11
Q

how can you prove that the pharmacy to pharmacy transaction is non-profitable

A

the price of the medicine must be recorded - should be reasonable

-if there is additional cost then it should be reasonable - cost of medicine, delivery, holding the stock and it should be able to be justified

should be satisfied that its supplied to another pharmacy for individual needs of the patient

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11
Q

how can you prove that the pharmacy to pharmacy transaction is non-profitable

A

the price of the medicine must be recorded - should be reasonable

-if there is additional cost then it should be reasonable - cost of medicine, delivery, holding the stock and it should be able to be justified

should be satisfied that its supplied to another pharmacy for individual needs of the patient

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11
Q

how can you prove that the pharmacy to pharmacy transaction is non-profitable

A

the price of the medicine must be recorded - should be reasonable

-if there is additional cost then it should be reasonable - cost of medicine, delivery, holding the stock and it should be able to be justified

should be satisfied that its supplied to another pharmacy for individual needs of the patient

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12
Q

how can you apply for the WDA(H) - wholesale dealer license?

A

Applications for a WDA(H) should be sent to the PROCESS LICENSING SECTION (PcL) of the MHRA

There is a fee for an INITIAL license, along with a fee for any INSPECTION that is carried out

The initial license is CONTINUOUS

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13
Q

how can you apply for the WDA(H) - wholesale dealer license?

A

Applications for a WDA(H) should be sent to the PROCESS LICENSING SECTION (PcL) of the MHRA

There is a fee for an INITIAL license, along with a fee for any INSPECTION that is carried out

The initial license is CONTINUOUS

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14
Q

how do you apply Home office CD license?

A

For Home Office CD license applications you need to apply directly to the Home Office

There is a fee and licenses are only issued for ONE year

15
Q

what are the requirements for WDA(H)?

A

1) Ensure continued supply of medicinal products
2) Keep documents to facilitate withdrawal or recall, maintain an emergency plan for this purpose

3) Keep records of receipt and dispatch
     Date of receipt and dispatch
      Name of products
      Quantity received or dispatched
      Name and address of the person from whom, or to whom, the products are 
       sold or supplied

4) Distribute only to persons who may lawfully sell by retail or lawfully administer those products
5) Have a suitably experienced “responsible person”

16
Q

who can you whole sale deal to?

A

Can be sold by way of wholesale dealing to (MEP):

Practitioners e.g. doctors, vets – not non-medical prescribers
Midwives
Chiropodists/podiatrists
Optometrists, and additional supply optometrists
Paramedics
Owners and master of ship
A retail pharmacist conducting their own business
Hospitals, clinics, medical agencies, health centres.
Holders of wholesale dealers licences
Ministers of the crown, government departments
Common Services Agencies in Scotland.
A person who carries on a pharmacy business for or on behalf of the police force, a prison service or her Majesty’s forces

17
Q

how does the supply of salbutamol inhalers to schools work?

A

Legislation enables schools to hold stocks of salbutamol inhalers, which can be supplied in an emergency by persons trained to administer them

Number of salbutamol inhalers that can be obtained not specified, but schools can PURCHASE them from pharmacies provided it is for SMALL quantities and doesn’t constitute wholesale dealing

Need to obtain a signed order by the HEADTEACHER

Pharmacists may need to explain how to use the inhaler or advise on selection and use of appropriate spacer devices