2- Getting the right medicine to the right person Flashcards
Wholesaling
The Medicines and Healthcare products Regulatory Authority (MHRA) is the regulatory body with the responsibility for oversight and enforcement of the wholesale distribution of medicines
Wholesaler Licence Requirements
- Hold a wholesaler licence – wholesale distribution authorisation (WDA)
- Comply with the Good
Distribution Practice (GDP) standards - Responsible Person
Pharmacies supplying stock to another pharmacy within the same legal entity are not required to have a ____
WDA
Which legislation - WDA?
Medicines Act 1968
Who can be supplied?
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
What can cause wholesaling and medicine shortages?
Measures are in place to minimise medicines shortages
Limiting those medicines which can be traded or exported.
Legal and ethical issues
SSPs
serious shortage protocols
What happens if there is a SSPs?
In England, Wales and Northern Ireland enable pharmacists to make amendments to prescriptions and supply an alternative medicine to those in short supply. SSPs are specific to each home country
NAME = where a GP requests something for use during home visits or an optician requests a medicinal item for use during eye examinations.
Written requisitions
(‘signed order’)
NOT considered wholesale distribution, as long as:
The transaction takes place on an occasional basis
The quantity of medicines supplied is small
The supply is made on a not for profit basis
The supply is not for onward wholesale distribution.
What are the Written requisitions requirements?
No legally defined details as to the content required
Local standard operating procedures (e.g. local NHS Trust policies or company SOPs) may require templates to be used.
Recommended details include:
Date
Name, quantity and, where it is not apparent, formulation and strength
Name and address, trade, business or profession of the person
Purpose for which it was sold or supplied.
Signature of prescriber.
Written requisitions supply
Only complete packs (including PILs) can be supplied
No need to label the medication
Good practice to make an entry in the POM register at the time of supply
Requisition is retained within the pharmacy for 2 years from the date of supply
Optometrist and Podiatrist Signed Orders
- can be given directly with certain POMs, signed patient order from any registered optometrist or podiatrist
- medicine that can be legally sold/ supplied
- practitioner - provide sufficient advice to enable patient to use medicine safely and effectively
What is the pharmacist role in optometrist and podiatrist signed orders?
should ensure that the medicine is labelled accordingly as a dispensed medicinal product
Appropriate record must be made in the POM register.
Any additional counselling
