non-prescription supply of medicine Flashcards
How can you supply medicines without a prescription?
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)
define what is the wholesale dealing of medicines
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))
To explain the conditions on sales by way of wholesale dealing
what was the pandemic exemption?
- 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
what is the three types of vaccination sites
- vaccination centre (large scale)
- hospital hubs (part of NHS trust )
- 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
what licence do you need for wholesaleing
wholesale dealer’s licence (WDA(H))
when is whole sale dealers licence not necessary
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
If your wholesale dealing includes CD’s (Sch 2-5) what other licence do you need?
Home Office CD license to legalise the supply
when does supplying small quantities of products to other healthcare professionals cause the need to not get a wholesale dealers licence?
- 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
how can you supply/send when you are a non holder of WDA(H)
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)
how can you prove that the pharmacy to pharmacy transaction is non-profitable
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
how can you prove that the pharmacy to pharmacy transaction is non-profitable
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
how can you prove that the pharmacy to pharmacy transaction is non-profitable
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
how can you apply for the WDA(H) - wholesale dealer license?
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
how can you apply for the WDA(H) - wholesale dealer license?
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