Non Prescription Supply of Medicines 1

Question 1

How can you supply medication without a prescription?

Answer 1

• emergency supply
• Pandemic exemptions
• wholesale dealing (restricted list of people - not directly to patients)
• PGD
• Signed orders (Restricted list of orders, not directly to patients)

Question 2

Pandemic Exemptions

Answer 2

• in the event of a pandemic, emergency supply is relaxed
• under certain situations medicine can be collected from designated collection points, which doesn’t have to be a registered pharmacy or take place under the provision of a pharmacist

Question 3

Wholesale Dealing Definition

Answer 3

• Selling or supplying, or procuring or holding or exporting medicines to a person who received it for purposes of:
• selling or supplying product (to anyone other than a member of public)
• 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 dealers licence

Question 4

Wholesale Dealers Licence

Answer 4

WDA not necessary for
-activities of a group of retailers or practitioners who buy medicinal products in bulk and divide the stock amongst themselves
for example, transfer of stock between pharmacy premises that belong to same legal entity
-holders of a manufacturers licence don’t require WDA to sell their own products
-certain supplies of med by pharmacies

-WDA does not authorise the distribution of 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 5

What does WDA(H) mean for pharmacists?

Answer 5

• pharmacists who engage in commercial trading (including export) of meds, not solely as part of their professional practice, can only do so if they have WDA(H)
• of wholesale dealing includes CD2-5, then will also need a home office CD licence to legalise the supply

Question 6

What about supplying to other pharmacies and healthcare providers?

Answer 6

MHRA interpretation: community and hospital pharmacies supplying to other UK healthcare providers who need to holds all quantities of meds for treatment or onward supply to their patients is not considered a conical dealing and WDA(H) not required
-this includes when community and hospital pharmacies may need to obtain small quantities of a med from other pharmacies, however must meed following criteria in order not to need a WDA

Question 7

What is following criteria for not needing WDA(H) when community and hospital pharmacies need small quantities of medicines from other pharmacies?

Answer 7

• on occasional basis
• quantity of supply is small
• not for profit
• supply is not onward wholesale distribution
• medicines are needed to fulfil and individual patients needs
• dont need to label product when wholesale dealing

Question 8

MHRA and no WDA(H)

Answer 8

• MHRA not stated what quantity of med to supply before a WDA is required
• mostly has to do with the purpose of the transaction (a clear distinction from supplying to meet healthcare needs vs a commercial trade)
• for non holders of WDA, pharmacists need to have received an order/invoice for the supply and record of supply made, preferable im POM register and keeping order and invoice

Question 9

Pharmacy-Pharmacy transaction requirements

Answer 9

• price of med should be recorded, show reasonable price and that it was not for purpose of profit
• additional costs should be stated and explained. Reasonable costs include administration costs, holding stock, delivery
• make sure that pharmacies tis satisfied that the supply to another pharmacy is for the individual needs of the patient

Question 10

Applying for licenses

Answer 10

• Application for WDA should be sent to the process licensing section of the MHRA
• there is a fee for an initial licence, along with a fee for any inspection that is carried out
• the initial licence is continuous
• for home office CD licence application you need to apply directly to home office, there is a fee and licenses are only issues for one year

Question 11

Requirements of WDA(H) Holder

Answer 11

1) ensure continued supply of med products
2) keep documents to facilitate withdrawal or recall, maintain and emergency plan for this purpose
3) keep records of receipt and dispatch
- date of 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 12

Who can you wholesale deal to?

Answer 12

• the range of persons and organisations that a pharmacist can wholesale to is controlled by legislation and may also be trusted to certain meds for certain purposes
• eg other wholesale dealers. doctors, dentists, any person lawfully conducting a retail pharmacy business, clinics or independent medical agencies
• doesnt include non-medical prescribers

Question 13

Supply of salbutamol inhalers to schools

Answer 13

• legislation that enables schools to hold stocks of salbutamol inhalers, which can be supplied in an emergency by persons trained to administer them
• number of inhalers not specified, however can obtain from pharmacies and provided it small quantities and doesn’t constitute to wholesaling
• need to get a signed order from principal or head teacher
• pharmacist may need to explain how to use the inhaler or advise on selection and use of appropriate spacer devices

Question 14

Adrenaline injectors in schools

Answer 14

• school now allowed to buy AAI devices without a prescription for children who are at risk of anaphylaxis and don’t have device or where device isn’t working
• the schools spare AAI should only be used on pupils known to be at risk of anaphylaxis, from whom both MA and written consent for use fo spare AAI has been provided
• any AAI in school for child considered back up and not replacement of Childs own
• schools are not required to hold AAI?
• Need to verify brand and strength of AAI (as have different administration instructions)

Question 15

Signed orders/ Written requisitions

Answer 15

• -communication between a purchaser and a pharmacist to request a medication to be used within that purchaser’s practice
• HMR 2012 states which persons or organisations must provide a written signed order/invoice eg, optometrists
• others having a signed order is not outlined but its just good practice
• be wary of how many pack sizes are being transferred to another pharmacy and the frequency this as this may be seen as wholesale dealing

Question 16

What needs to be on as signed order?

Answer 16

legislation does not specify details that need to be included on a signed order however

• name, quantity and where it is not apparent, formulation and strength
• name and address, trade business or profession of the person to whom med is supplied
• purpose for which med is sold/supplied
• signature of requisitioner
• Date of sale and supply

Question 17

Signed orders: Record Keeping

Answer 17

• pharmacists required to keep either the order/invoice (or a copy) relating to the supply of POM; or make an entry in POM register
• Records and or signed orders need to be kept for two years following date of supply

Question 18

What must entry in POM Register include for signed order?

Answer 18

• date POM was supplied
• Strength, quantity, name, form
• name and address of trade, business or profession of person to whom med is supplied
• purpose of which it was sold or supplied
• where supply involves a CD 2 a separate entry needs to be made in CD register
• for audit purposes, include how much you charged

Question 19

Controlled Drugs Requisition

Answer 19

• following the shipman inquiry, standardised CD requisition forms were introduced
• unlawful to make a supply in community against a non-standard requisition form (applied to CD 2 & 3 for both humans and ver use)
• requirement to use mandatory form now also includes paramedics and the person in charge or acting in charge of an organisation providing ambulance services
• hospices and prisons are exempt from the requisition requirements and are not required to use mandatory form

Question 20

What are standardised requisition forms:

Answer 20

FP10CDF

-professionals can download form and fill and complete, print and sign

Question 21

Legal requirements of Controlled Drugs Requisition

Answer 21

• signature of recipient
• name of recipient
• Address of Recipient
• Profession or occupation of recipient
• Total quantity fo drug
• Purpose of requisition
• fax or photocopied requisition is not acceptable
• legislations takes that requisition in writing must be obtained before supply of schedule 2/3 to most recipients
• in an emergency, a dentist can be supplied 2/3 on the undertaking that the requisition will be supplied within the next 24 hours
• messengers must have written authorisation that empowers them to receive the drugs on behalf of the recipient

Question 22

Hospital pharmacy requisitions

Answer 22

hospital pharmacy requisitions from ward or department that are presented to a pharmacy that is a separate legal entity must have requisition form FP10CDF

• home office suggests that person in charge issues a yearly bulk or global requisition form to the separate legal entity that supplies its wards or departments. The wards or departments then draw on this throughout the year using CD relqution books with duplicate pages
• person in charge issues and signs requisition, must also be signed by doc or dentist employed or engaged at hospital

Question 23

Processing Requisition forms (Making and sending to relevant NHS agency)

Answer 23

A legal requirement to:

• mark the requisition indelibly with the suppliers name and address (i.e. name of the pharmacy) when received- where pharmacy stamp is used, this must be clear and Eligible
• Send the original requisition to the relevant NHS agency
• retain a copy of requisition for two years from ate of supply
• community pharmacies require a private controlled drug account number when submitting FP10PCD forms and FP10CDF requisition forms, different account to NHS account number used to submit NHS prescriptions

Question 24

Processing requirements do not apply when the supply is made:

Answer 24

• by a person responsible for dispensing and supply of meds at a hospital, care home, hospice, prison or organisation providing ambulance service who must mark and retain the original requisition for 2 years
• by a pharmaceutical manufacturer or wholesalers
• against a midwife supply order
• against a vet requisition (original requisition should be retained for 5 years)

Question 25

Midwife supply orders

Answer 25

Register midwife may request the follow CDs:

• Diamorphine
• Morphine
• Pethidine

Order must contain the following

• Name of midwife
• Occupation of midwife
• Name of person who the CD will be administered or supplied
• Purpose of why CD is required
• Total quantity of drug obtained
• Signature of an appropriate medical officer