Non-prescription supply of medicines 1 Flashcards
How can you supply medicines without a prescription?
1) Emergency supply
2) Pandemic exemptions
3) Wholesale dealing
4) Patient Group Directions (PGDs)
5) Signed ordersy
discuss the supply of a drug in a Pandemic
1) In the event of a pandemic or imminent pandemic being declared by the DoH, emergency supply requirements are relaxed (you do not need to interview the patient)
2) When there is a serious or potentially serious risk to human health, provisions are also in place to allow the supply of medicines against a protocol from designated collection points
3) Collection points would not need to be a registered pharmacy and would not need to take place under the supervision of a pharmacist
what is Wholesale dealing ?
1) Selling or supplying; or procuring or holding or exporting medicines to another EEA State for the purposes of
- sale or supply, to a person who receives it for purposes of selling or supplying the product; 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
who needs a Wholesale Dealer’s Licence?
Persons operating from the UK, if in the course of their business they are engaged in:
1) procuring, holding, supplying or selling medicinal products for human use sourced in the UK or another EEA member state, to anyone other than a member of the public
2) Importing medicinal products from a non-EEA state for export to a non-EEA state
4) Exporting medicinal products to a non-EEA state
when is a Wholesale Dealer’s Licence not necessary?
1) The activities of a group of retailers or practitioners who buy medicinal products in bulk and divide the stock amongst themselves
2) Holders of a Manufacturer’s license (do not require a wholesale dealers licence to sell their own products)
Certain supplies of medicines by pharmacies
3) 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
do pharmacists need a WDA(H) license for if they engage in commercial trading (including export) ?
1) Pharmacists who engage in commercial trading (including export) of medicines, not solely as part of their professional practice, can only do so if they hold a WDA(H)
2) If a WDA(H) is required, then if supplies include CD’s (Sch 2-5) then will also need a Home Office CD license to legalise the supply
do pharmacists need a WDA(H) license for if they are supplying to other UK healthcare providers?
1) MHRA interpretation: community and hospital pharmacies supplying to other UK healthcare providers who need to hold small quantities of medicines for treatment or onward supply to their patients are not considered a commercial dealing and a WDA(H) would not be required in such situations.
- UK healthcare providers include nursing homes, private hospitals, GP surgeries etc.
when community and hospital pharmacies may need to obtain small quantities of a medicine from other pharmacies what criteria needs to be met in order to not need a WDA(H)?
1) On an occasional basis
2) Quantity of medicines supplied is small
3) Not for profit
4) Supply is not for onward wholesale distribution
5) Medicines are needed to fulfil an individual patient’s needs
- The regulation does not depend on quantities but is focused on the purpose of the transaction
would a pharmacist need to create a record for supply of medicines without having WDA(H)?
- what does the pharmacy need to record with regards to pharmacy-pharmacy transactions
1) 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
2) The MHRA has not stated what quantity of medicines would need to be supplied before a WDA(H) is required
3) for pharmacy-pharmacy transactions, the price of the medicine should be recorded – this should be ‘reasonable’ and show that the transaction was not for profit
4) When determining the price structure can add additional costs, but these must be justified.
5) Make sure that you are satisfied that the supply to another pharmacy are for the individual needs of patient (get it in writing)
how do you apply for a WDA(H) ?
1) 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
2) For Home Office CD license applications you need to apply directly to the Home Office
- Fees are required to be paid
- Licenses are issued for one year then need to renew
outline the requirements of a WDA(H) holder
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 despatched,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”
Who can you wholesalers deal to?
1) The range of persons and organisations that a pharmacist can wholesale to is controlled by legislation and may also be restricted to certain medicines for certain purposes
2) E.g other wholesale dealers, doctors, dentists, any person lawfully conducting a retail pharmacy business, clinics or independent medical agencies, first aid organisations, RNLI, HM Armed Forces
3) Doesn’t include non-medical prescribers
what is a Signed order/Written requisition?
1) A communication between a purchaser and a pharmacist to request a medication to be used within that purchaser’s practice
2) Sch 17 of the HMR 2012 states which persons or organisations must provide a written signed order/invoice e.g optometrists, podiatrists
3) For others where having a signed order/invoice is not outlined in legislation, it’s good practice to do so
4) Be wary where supply of medicines includes the transfer of high value items and multiple packs to other pharmacies, multiple transactions to the same pharmacy in a short period as this may be seen as wholesale dealing
outline What needs to be on a signed order?
Legislation does not specify the details that need to be included on a signed order, however:
1) Name, quantity and where it is not apparent, formulation and strength
2) Name and address, trade business or profession of the person to whom medicine is supplied.
3) Purpose for which the medicine sold/supplied
4) Signature of requisitioner
5) Date of sale/supply
discuss the Supply of salbutamol inhalers to schools
1) Legislation that enables schools to hold stocks of salbutamol inhalers, which can be supplied in an emergency by persons trained to administer them
2) Supply requires a written order signed by the principal or head teacher of the school and containing the usual particulars
3) 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
4) Pharmacists should try to verify the school and head teacher/principal details before supplying
