Non-prescription supply of medicines (1)

Question 1

Ways a medicine can be supplied without a prescription (5)

Answer 1

Emergency supply
Pandemic Exceptions
Wholesale dealing
Patient Group Directions (PGDs)
Signed orders

Question 2

Pandemic exemptions.

a. In a pandemic, emergency supply requirements are relaxed. What does this mean?
b. When there is a serious risk to human health, how does he supply of medicines differ than usual?

Answer 2

a. A patient doesnt need to be interviewed.

b. Medicines can be supplied against protocol from designated collection points

Question 3

Pandemic exemptions.

c. What differs between a collection point and a pharmacy?

Answer 3

• Collection points do not need to be a registered pharmacy

- Doesnt need to be under the supervision of pharmacist

Question 4

Wholesale definition

This is long :’(

Answer 4

Selling/supplying/obtaining/holding/exporting medicines
to another EEA state for sale of supply
to a person who receives it for the purpose 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 5

People operating a business in the UK need a wholesale dealer’s license if they do which 3 things?:

Answer 5

• obtain, hold, supply or sell medicinal product for human use to anyone other than a member of the public
• Import AND exporting medicines between non-EEA states
• exporting medicines to a non-EEA state

Question 6

In which situations are Wholesale dealer’s license not needed? (3)

Answer 6

• Groups of retailers/practitioners buying medicines in bulk and divide stock amongst themselves
• Manufacturers license holders
• Certain medicines (by pharmacies)

Question 7

Which Act allows pharmacists to supply medicines to other healthcare professionals without needing a wholesale dealers license

Answer 7

Medicines Act 1968

Question 8

Pharmacists that commercially trade medicines which isn’t solely part of their professional practise must obtain a wholesale dealers license.

If this is needed, what other license do they need to legally supply sch 2-5 CD’s?

Answer 8

Home office CD license

Question 9

What criteria do pharmacies need to fulfil to not need a Wholesale dealer’s license when getting a small quantity of medicines from another pharmacy?

Answer 9

• Must be an OCCASIONAL basis
• Small quantity of medicines
• Not for profit
• Supply not for onward wholesale distribution
• Medicine needed to fulfil patients needs

Question 10

Give examples of UK healthcare providers that pharmacies can supply a small quantity of meds for without needing a wholesale dealer’s license
(as long as its to treat patients)

Answer 10

Nursing homes
Private hospitals
GP surgeries… etc

Question 11

When pharmacists supply non holders of WDL, they will need to receive an invoice/order for the supply, where should the order/invoice be recorded?

Answer 11

POM Register

Question 12

Where do you apply for the:

a) Wholesale dealers license
b) Home office CD license

Answer 12

a) Process licensing section of MHRA

b) Home office

Question 13

What are the 5 requirements of a WDL holders

Answer 13

1) Continued supply of medicine
2) keep documents to facilitate withdrawal/recall
3) keep records of receipt + dispatch
4) distribute only to people who may lawfully sell by retail or administer product
5) have suitably experienced ‘responsible person’

Question 14

Some persons/organisations MUST provide a written signed order/invoice (eg optometrists, podiatrists)

What needs to be on a signed order? (6)

Answer 14

• Name, quantity, form and strength
• Name, address, trade business/profession of person supplied
• purpose for which the medicine is sold/supplied
• signature of requisitioner
• Date of supply

Question 15

Legislations allow schools to purchase a small supply of salbutamol, administered by trained person during emergency
Who signs the written order?

Answer 15

Principal or head teacher

Question 16

For the supply of POMs, Pharmacists need to:

1) keep an order/invoice (or a copy) OR
2) Record the entry in a POM register

How long does the records and/or signed order need to be kept for?

Answer 16

2 years

Question 17

When keeping a record of signed orders, a record can be made in a POM register, what must this register include? (4)

(if supply involves sch 2, also needs a separate entry in CD register)

Answer 17

• Date POM supplied
• Name, strength quantity and formulation of POM
• Name + address, trade, business/profession of person supplied to
• purpose for which med supplied/sold

Question 18

CD requisition form have 6 legal requirements, what are they?

Answer 18

• signature, name and address of recipient (3)
• profession/occupation of recipient
• total quantity of drug
• purpose of requisition

Question 19

Controlled drug requisition:

1) requisition in writing must be obtained by supplier before sch 2 +3 delivered to recipient
2) HOWEVER in emergency doc/dentist can be supplied a sch 2 or 3 provided that a requisition is supplied within how many hours?

Answer 19

24

Question 20

SOME LEGAL REQUIREMENTS OF PROCESSING REQUISITION FORMS:
1) Requisition forms must be marked indelibly with suppliers name and address (the pharmacy) when received

2) original requisition sent to NHS agency
3) What do Community pharmacies need when submitting FP10PCD/FP10CDF
4) How long should the requisition COPY be kept for?

Answer 20

A private controlled drug account number

2 years

Question 21

To which examples do these requisition processing requirements do not apply?

Answer 21

• Midwife supply order
• Veterinary requisition (retain for 5 yrs)
• By pharmaceutical manufacturers/wholesalers
• Person responsible for supplying + dispensing at hosp, care home, hospice, or prison

Question 22

A registered midwife can make a request for CD’s such as : Diamorphine, Morphine and Pethidine.

What information must the order contain? 5

Answer 22

• Name and occupation of midwife (2)
• Purpose for which the CD is needed
• Total quantity needed
• Sign. of appropriate medical officer