POMs 2 - wholesale dealing and dispensing errors

Question 1

other names for wholesale dealing

Answer 1

requisitions

signed orders

Question 2

What is wholesale dealing?

Answer 2

selling of a medicinal product is classed as ‘wholesale dealing’ if it is sold to a person who:
a) sells or supplies it to someone else
OR
b) administers it to someone else in the course of their business

(they don’t take/use product)

sale -> money must change hands

Question 3

What is needed to wholesale deal?

Answer 3

wholesale dealers licence

Question 4

authority responsible for wholesale dealers licence

Answer 4

MHRA

Question 5

Why don’t pharmacies need wholesale dealers licence?

Answer 5

don’t need licence providing supply to another pharmacy/hc practitioner:
- takes place not more than on an occasional basis
AND
- quantity supplied is small
AND
- supply is made on a not for profit basis
AND
- supply is not for onward wholesale distribution

Question 6

When would community pharmacy need wholesale dealers licence?

Answer 6

if commercial trading in medicines takes place

Question 7

Who can retail pharmacies wholesale deal meds to?

Answer 7

sale of POMs can only happen if purchaser is authorised to sell or supply the goods or to administer them to people in the course of their business/professional practice

ALSO:
- NHS trusts
- owner/master of a ship
- armed forces

Question 8

What is the request for meds written on?

Answer 8

requisition AKA signed order

Question 9

requirements for details on signed order/requisition

Answer 9

NO legal requirements for info on requisition

** UNLESS it’s a CD

Question 10

hospital pharmacies and wholesale dealing

Answer 10

hospital pharmacies that are not registered pharmacies can not wholesale deal without wholesale dealers licence

Question 11

records for wholesale dealing

Answer 11

** if pharmacy DOES NOT have licence:
- no legal obligtion to make a record in POM register as long as signed order kept for 2 YEARS from date of supply

• BUT good practice to make record in POM register (AND keep invoice for 2 years)

** if there is no signed order then LEGALLY a POM register entry must be made

Question 12

details for POM register for wholesale dealing

Answer 12

• date when POM was sold
• name, quantity, form, strength of the med supplied
• name, address, trade, business or profession of the purchaser
• PURPOSE for which the POM is sold/supplied

Question 13

pack size for wholesale dealing

Answer 13

preferable to supply whole packs

Question 14

optometrist/podiatirst signed orders for patients

Answer 14

• optometrist/podiatirsts can’t write Rx for POMs unless SP/IP
• pharmacist in retail pharmacy can supply POMs to pt if they received a signed order from optometrist/podiatirst
• this signed order it not legally a Rx so no legal requirements
• list of meds that can be supplied (drugs for supply and drugs for admin)
• only ‘drugs for supply’ can be supplied to the optometrist/podiatirst pt
• med should be labelled as dispensed med product, PIL supplied

Question 15

What is an ‘additional supply optometrist’?

Answer 15

optometrist who has undertaken additional training and can issue signed orders for a wider range of medicines

Question 16

supply of meds to schools

Answer 16

• schools can obtain adrenaline auto-injectors (AAIs) and salbutamol inhalers from pharmacy on signed order
• can be admin in emergency by trained person to pupil prescribed them and parent consent

Question 17

legal requirements for signed order from school for adrenaline and salbutamol

Answer 17

• name of the school
• name of the medicine and strength (if relevant)
• purpose for which the product is required
• total quantity required
• signed by the principal or head teacher

Question 18

How long to keep the signed order from a school for?

Answer 18

2 years

Question 19

record of signed order from schools?

Answer 19

good practice to make a record in the POM register

Question 20

What to ensure when supplying to schools?

Answer 20

pharmacist should ensure the school knows how to store and use the medicine correctly

and draw attention to the expiry date

how to use salbutmol inhaler

Question 21

What is a dispensing error?

Answer 21

an error made during the dispensing process from receipt of the Rx through to the supply of the dispensed medicine, where the error means the patient receives a medicine which differs in some way from that intended by the prescriber

Question 22

examples of dispensing errors

Answer 22

• incorrect labelling of the medicine
• a medicine intended for another patient being
  dispensed to the wrong patient
• wrong med (drug ingredient) being dispensed
• med being dispensed at the wrong strength or in the wrong dosage form
• supply of an out of date medicine

Question 23

What act controls dispensing errors?

Answer 23

Medicines Act 1968

SECTION 64:
‘No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser’

Question 24

What offence is a dispensing error?

Answer 24

criminal offence

Question 25

What provides leal defence that can be used if dispensing error is made?

Answer 25

Pharmacy Order 2018

Preparation and Dispensing Errors – Registered Pharmacies

(but still a criminal offence)

Question 26

What is the legal defence?

Answer 26

Making a dispensing error is not a criminal offence if:
- meds are prepared by a registrant (pharmacist or PT) or acting under their supervision
AND
- meds were supplied from a registered pharmacy premises
AND
- registrant was acting in the course of their profession
AND
- meds were supplied in pursuance of a Rx or from the direction of a prescriber
AND
- if you’re aware of the error there was a prompt notification of the error

** if all of these apply, this is the legal defence to section 64

Question 27

When would criminal charges apply in relation to dispensing errors?

Answer 27

if the intention was to cause harm (deliberate)

OR

criminal negligence was suspected