Flashcards in Whole sale medicines Deck (22)
How can you supply prescriptions without a prescription?
1. Emergency Supply
2. Pandemic Exemptions
3. Whole sale deals
4. Patient Group Directions
5. Signed Order
Describe the rules behind a pandemic exemption?
1. The department of health would usually declare if there's a pandemic or imminent in place
2. This allows emergency supply to occur without the need for an interview
3. When there is a serious or potential risk to human health, provisions are in place to allow supply of medicines against a protocol
4. Collection point does not need to be in a pharmacy or under supervision of one
What is the definition of whole sale dealing?
1. Selling, supplying, procuring, holding or exporting medicines to another EEA country for the purpose of them to:
2. Sell or supplying the product to people
3. Administering it or causing it to be administered to one or more human beings
4. Happens in the duration course of business carried out by that person
Who needs a whole dealers license (WDA (H))?
1. Persons operating in the UK
2. Procuring, holding, supplying or selling medicinal products for humans sourced in UK or another EEA state to anyone
3. Importing medicinal products from a non-EEA state for export to another non-EEA state
4. Exporting products to a non EEA state
When is a whole dealers license not entirely necessary?
1. A group of medicinal practitioners or retailers to distribute products in bulk and divide stock amongst themselves
2. Holders of manufacturer licenses
3. Certain supplies of medicines
4. WDA(H) does not authorise distribution of medicinal product by way of whole dealing
What does the whole dealers license not authorise in terms of medicinal products?
1. Distribution of a medicinal product by the way of wholesale dealing
2. Unless marketing authorisation is inputted
Is it possible to supply controlled drug scheduled 2 to 5 with a whole dealers license?
Need a home office CD license to legalise the supply
Would UK pharmacies need a WDA (H) provide prescription medication to other pharmacies and UK health care providers (nursing homes, GP surgeries, private hospitals)?
1. NO: If only for small quantities of the medication for treatment or onward supply to their patients
2. Has to be only occasionally done
3. Not for profit
4. Supply is not wholesale
5. Supply is necessary for the patients needs
For non WDA (H) pharmacists, what do pharmacists need to record?
1. Received an invoice or order for the supply
2. Written a record for the supply (preferably in the POM register) or keeping an invoice
3. Price recorded to show that it wasn't for profit (pharmacy to pharmacy transition)
4. May need to add administration and delivery costs to the pricing etc
5. Need to be written that it's for a individual patient by the pharmacist
How do you apply for a WDA (H) license, what fees apply and how long does it last?
1. Contact the Process Licensing Section of the MHRA
2. Initial fee and fees for inspections
3. Initial license is continuous
How do you apply for a Home office CD license?
1. Need to apply directly to home office
2. Fees are required to be paid
3. Licenses are issued for one year and must be renewed
What are the five requirements of a WDA (H) holder?
1. Ensure continued supply of medicinal products
2. Keep documents to facilitate withdrawal or recall, maintain an emergency plan for this purpose
3. Keep records of receipt and dispatch
- Name of products
- Quantity received and dispatched
- Name and address of person supplying the products to
4. Distribute to someone who's allowed to distribute medicines or administer them to the public
5. Suitably experienced responsible person
What is a signed order or written requisition?
Communication between a purchaser and pharmacist to request a medicine to be used within the pharmacist practice
Give example of a signed order in schools?
1. Stocks of salbutamol are held incase of an emergency
2. Headteacher or principle of school needs to sign a written order with the required headings (Name, strength, form etc)
3. Only small amounts can be bought from pharmacies
In terms of signed orders, what are the pharmacists required to keep and for how long?
1. Pharmacists are required to keep the invoice or a copy or make an entry in the POM register
2. Record needs to be kept for 2 years
What must an entry in a POM include?
1. Date of the POM
2. Name, quantity, strength and formulation of the POM
3. Name and address of business you supplied to
4. Reason behind supplying
What is a controlled drug requisition form and what does it require on it?
1. FP10CDF form that are necessary for the supply of a controlled drug must be written in writing before the supplier delivers it to recipients
2. Signature of recipient
3. Name and address of recipient
4. Profession or occupation of recipient
5. Total quantity of drugs
6. Purpose of the requisition
What are the legal requirements to process the requisition forms (sending to the NHS agencies)?
1. Mark the requisition with indelibly ink with suppliers name and address
2. Retain a copy of requisition for 2 years
3. Send the relevant original requisition to FP34PCD form
4. Need to use a private controlled drug account number in order to submit NHS prescriptions
When do the processing requisition requirements not apply to sending to relevant NHS agencies?
1. Person responsible for dispensing and supply of medicines at a hospital, care home or hospice- who must mark and retain the original requisition for 2 years
2. Pharmaceutical manufacturers and wholesalers
3. Against a midwife supply order
4. Against veterinary requisitions (original should last 5 years)
What is the most important section to record for CD requisitions?
1. Details of authorities to possess: prescriber or license holder details
3. Form used
4. Form used: FP10CDF
5. organisation code
6. Practice code
A midwife supply may request which following drugs?