Wholesaling 3.4 Flashcards
Wholesaler licence requirements 3.4.1
Any1 trading meds to other than a patient needs to:
- Wholesale license - wholesale distribution authorisation (WDA)
- Use good Distribution Practice (GDP) standards, and pass regular GDP inspections
- Have suitable experienced responsible person on license to ensure that medicines are procured, stored and distributed appropriately.
WDA specific to human or vet meds.
WDA EXEMPTIONS:
Pharmacy supplying stock to another in same legal entity dont need WDA.
If legal entity does have WDA pharmacy supplying medicines for wholesaling must be named on the WDA.
Registered pharmacies/hospitals supplying small amount of meds to HCP for treatment or supply to patient or to other community pharmacies/hospitals to meet a patients individuals needs DONT NEED WDA IF:
. transaction takes place on an occasional basis
. Small quantity supplied
. NON profit supply
. Supply not for onward wholesale distribution
Wholesaling of CDs 3.4.2
IF WDA IS NEEDED and if supply has CD 2 to 5 a home office CD license is needed by the pharmacy.
Persons and organisations that can receive medicines 3.4.3
Persons who can be supplied with medicinal products:
* Doctors
* Dentists
* Registered pharmacies
* Hospitals, clinics and independent medical agencies
* Midwives
* Chiropodists/Podiatrists
* Optometrists and Additional Supply Optometrists
* Paramedics
* Owner or Master of Ship
* Orthoptists
* First aid organisations
* Certified first aiders
* Working for National Lifeboat Institution
* Occupational health schemes
* Drug treatment services
* NHS Trusts
Schedule 22 HMR 2012 gives full list.
Schedule 17 HMR 2012 = info on ppl who have exemptions to sell, supply or administer certain meds under specified conditions. They can also get meds by wholesale
Signed orders and record keeping 3.4.4
When POM is supplied from registered pharmacy to HCP or ORGs, an entry needs to be made in POM register OR
Signed order/invoice needs to be retained for 2 years from the date of supply. GOOD practise to do BOTH.
Schedule 17 HMR 2012 says which person/ORGs must give written signed order/invoice. If signed order is not needed to give its good practise to get 1 for audit trial.
Entry in POM register must include:
- Date of supply
- Name, quantity, where not apparent, formulation and strength
- Name and address, trade, business or profession of the person to whom the medicine was supplied
- Purpose of sale/supply
Legislation dont say what’s needed on signed order but SOPs may give template. advised to use same details required for POM register for the signed order.
If supply is made under Wholesale dealers license you need to follow GDP - Good Distribution Practice
Wholesaling and medicine shortages 3.4.5
Measures are in place to reduce shortages by limiting those medicines which can be traded or exported.
MHRA list on meds that CANT be exported to prevent UK shortage.
https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk
MANAGING MEDICINES SHORTAGES IN THE PHARMACY:
Standards for Managing Medicines Shortages in NHS Hospitals:
https://www.sps.nhs.uk/articles/best-practice-standards-for-managing-medicines-shortages-in-nhs-hospitals
Dealing with medicine shortages in community pharmacy:
https://www.rpharms.com/resources/pharmacy-guides/medicine-shortages-in-community-pharmacy
Serious Shortage Protocols (SSPs) = enable pharmacists to make changes to prescriptions and supply an ALT medicine to those in short supply. SSPs are specific to each home country. (England, Wales and NI)
