Non-prescription supply of medicine 1

Question 1

how can you supply medicines without a prescription?

Answer 1

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)

Question 2

What are the pandemic exemptions

Answer 2

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)

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, which do not have to be a registered pharmacy or take place under the supervision of a pharmacist

Question 3

COVID 19 - what are the 3 vaccination sites?

Answer 3

In England, there arethree types of vaccination site:
- Vaccination centres, using large-scale venues, such as football stadiums and accessed by a national booking service;

• Hospital hubs, using NHS Trusts across the country; and
• Local vaccination services (LVS), made up of sites led by general practice teams working together in Primary Care Networks (PCN) and community pharmacy sites.

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

Question 4

what is wholesale dealing?

Answer 4

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))

Question 5

when is Wholesale dealer licence (WDA(H)) not required?

Answer 5

WDA(H) not necessary for e.g:
- 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

• Holders of a Manufacturer’s license (do not require a WDA(H) to sell their own products)
• Certain supplies of medicines by pharmacies (dispensed medicines - see later)

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

how can pharmacist engage in commercial trading?

Answer 6

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)

Question 7

what is required when pharmacist wholesale CD 2-5

Answer 7

If wholesale dealing includes CD’s (Sch 2-5) then will also need a Home Office CD license to legalise the supply

Question 8

What about supplying to other pharmacies and healthcare providers?

Answer 8

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………. is 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 9

When pharmacist send small quantities of medicines to other pharmacys what are the criteria for not needing a WSA(H)?

Answer 9

-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

Question 10

what is the stated quantity MHRA states that requires WDAH?

Answer 10

The MHRA has not stated what quantity of medicines would need to be supplied before a WDA(H) is required

The regulation does not depend on quantities but is focused on the PURPOSE of the transaction (a clear distinction from supplying to meet healthcare needs vs commercial trade)

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)

Question 11

What record keeping needs to be done when there is a pharmacy-pharmacy transaction?

Answer 11

It is recommended that 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

When determining the price structure can add additional costs, but these must be justified. Reasonable costs could include (as well as the cost of the medicine) administration costs, holding the stock, delivery

Make sure that you are satisfied that the supply to another pharmacy is for the individual needs of a patient (get it in writing)

Question 12

how do you apply for WDA(H) and home office CD licence?

Answer 12

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

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

Question 13

what are the requirements of a WDA(H) holder?

Answer 13

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”

Question 14

who can you wholesale deal to?

Answer 14

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

Doesnt include non-medical prescribers

Question 15

Supply of salbutamol inhalers to school

Answer 15

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 principal or head teacher

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

Question 16

Adrenaline injectors in school

Answer 16

Schools also allowed to buy adrenaline auto-injector (AAI) devices without a prescription, for emergency use in children who are at risk of anaphylaxis but their own device is not available or not working (e.g. because it is broken, or out-of-date)

The school’s spare AAI should only be used on pupils known to be at risk of anaphylaxis, for whom both medical authorisation and written parental consent for use of the spare AAI has been provided

The school’s spare AAI can be administered to a pupil whose own prescribed AAI cannot be administered correctly without delay

Any AAI(s) held by a school should be considered a spare / back-up device and not a replacement for a pupil’s own AAI(s)

Schools are not required to hold AAI(s) – this is a discretionary change enabling schools to do this if they wish

Supply for AAI also requires a written order signed by the principal or head teacher of the school

Need to verify brand and strength of AAI (different administration instructions)