Non-prescription supply of medicines 1

Question 1

How can you supply medicines without a prescription?

Answer 1

1) Emergency supply
2) Pandemic exemptions
3) Wholesale dealing
4) Patient Group Directions (PGDs)
5) Signed orders

Question 2

discuss the supply of a drug in a Pandemic

Answer 2

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

Question 3

what is Wholesale dealing ?

Answer 3

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

Question 4

who needs a Wholesale Dealer’s Licence?

Answer 4

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

Question 5

when is a Wholesale Dealer’s Licence not necessary?

Answer 5

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

Question 6

do pharmacists need a WDA(H) license for if they engage in commercial trading (including export) ?

Answer 6

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

Question 7

do pharmacists need a WDA(H) license for if they are supplying to other UK healthcare providers?

Answer 7

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.

Question 8

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)?

Answer 8

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

Question 9

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

Answer 9

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)

Question 10

how do you apply for a WDA(H) ?

Answer 10

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

Question 11

outline the requirements of a WDA(H) holder

Answer 11

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”

Question 12

Who can you wholesalers deal to?

Answer 12

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

Question 13

what is a Signed order/Written requisition?

Answer 13

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

Question 14

outline What needs to be on a signed order?

Answer 14

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

Question 15

discuss the Supply of salbutamol inhalers to schools

Answer 15

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

Question 16

what is the record keeping process for Signed orders?

Answer 16

1) Pharmacists required to keep either the order/invoice (or a copy) relating to the supply of POMs
2) Or make an entry in the POM register
3) Records and/or signed orders need to be kept for two years following the date of supply
4) Good practice to do both for audit purposes

Question 17

what information must a signed order entry in the POM register include?

Answer 17

1) Date the POM was supplied
2) Name, quantity and where it is not apparent, formulation and strength of the POM supplied
3) Name and address, trade, business or profession of the person to whom the medicine was supplied
4) The purpose for which it was sold or supplied
5) Where the supply involves a Sch 2 CD a separate entry needs to be made in the CD register
- For audit purposes, should include how much you charged

Question 18

when is a Controlled Drug Requisition form necessary and who is exempt?

Answer 18

1) must be used for the purposes of requisitioning Schedule 2 and 3 Controlled Drugs (CDs) in the community.
2) In England, it is unlawful for a supply to be made, in the community, against a non-standard requisition form (applies to CDs for both human and veterinary use)
3) The requirement to use the mandatory form now also includes paramedics and the person in charge or acting person in charge of an organisation providing ambulance services.
4) Hospices and prisons are exempt from the requisition requirements and are not required to use the mandatory form
- FP10CDF – England

Question 19

what are the legal requirements for a Controlled Drugs Requisition form?

Answer 19

1) Signature of the recipient
2) Name of the recipient
3) Address of the recipient
4) Profession or occupation of the recipient
5) Total quantity of drug (doesn’t have to be both in words or figures)
6) Purpose of the requisition
- Faxed or photocopied requisition NOT acceptable
- Legislation requires that a requisition in writing must be obtained by the supplier BEFORE delivery of any Sch 2 or 3 CDs to most recipients
- In an emergency, a Dr or Dentist can be supplied Sch 2 or 3 CDs on the undertaking that a requisition will be supplied within the next 24 hours
- Messengers must have written authorisation

Question 20

outline the Processing requirements and procedure for Requisition Forms
- (marking and sending to the relevant NHS agency)

Answer 20

A LEGAL requirement to:

1) Mark the requisition indelibly with the supplier’s name and address (i.e. the name of the pharmacy) when received – where pharmacy stamp is used, this must be clear and legible
2) Retain a copy of the requisition for 2 years from the date of supply
3) Send the original requisition to the relevant NHS agency using the FP34PCD form
4) Community pharmacies require a private controlled drug account number when submitting FP10PCD Private forms and FP10CDF requisition forms. Different account to the NHS account number used to submit NHS prescriptions

Question 21

discuss when Processing requirements for a requisition do not apply to the supply.
- (marking and sending to the relevant NHS agency)

Answer 21

1) when supply is made by a person responsible for the dispensing and supply of medicines at a hospital, care home, hospice, prison or organisation except ambulance services who must mark and retain original requisition for 2 years
2) By pharmaceutical manufacturers or wholesalers
3) Against a midwife supply order
4) Against veterinary requisitions (the original requisition should be retained for 5 years)

Question 22

A registered midwife may request the following controlled drugs: Diamorphine, Morphine Pethidine. what must the Requisition Form contain?

Answer 22

1) Name of the midwife
2) Occupation of the midwife
3) Purpose for which the controlled drug is required
4) Total quantity of the drug to be obtained
5) Signature of an appropriate medical officer

Question 23

would a requisition form be required for the following:

1) hospital pharmacy -> a request on behalf of a ward or department within the same legal entity?
2) hospital pharmacy -> a request on behalf of a ward or department which is not part of the same legal entity?
3) community pharmacy- > request from a hospital, GP or veterinary surgeon

Answer 23

1) approved form not required
2) approved form must be used
3) approved form must be used