Supplying CDs to patients and practitioners Flashcards
Safe custody requirements
Structural requirements and technical details of safes, cabinets and rooms are described in the regulations
Can apply for exemption certificate from the police to use other (non regulation) storage such as old bank safes, gun cabinets etc
Good practice says access to CDs should be documented within a policy and auditable e.g. key log, electronic access systems
In community pharmacy it is common for the pharmacist to keep the CD keys
The CDs that need to be kept in safe custody are:
Schedule 1 drugs e.g. cannabis resin
Schedule 2 drugs e.g. morphine, methadone [Exceptions are some liquid preparations and quinalbarbitone]
Schedule 3 drugs e.g. buprenorphine, temazepam [But there are quite a few exceptions. Common ones include phenobarbital, pregabalin, tramadol]
When these CDs cannot be stored in safe custody i.e. when they are being dispensed, they must be under the ‘direct personal supervision’ of a pharmacist
Patient returns and out of date or obsolete stock
Safe custody requirements apply to:
patient returns
out of date and obsolete CDs
Pharmacies are required to denature CDs (Schedule 2,3 and 4 Part I) prior to disposal, a process which renders them irretrievable
CD denaturing and disposal usually requires a licence but pharmacies can register an exemption with the Environment Agency
Sometimes CD denaturing needs to be witnessed by an authorised person
This is required where a CD register entry is needed to adjust stock levels correctly
Typically destruction of pharmacy stock of schedule 2 CDs needs to be witnessed
Patient returns do not need to be witnessed destruction (because no CD entry is needed to amend stock levels)
Witnessing destruction…..
In prisons good governance requires schedule 3 to also have registers and therefore witnessed destruction. Sch 4 – robust audit trail.
Witnesses are authorised by the Home Secretary, Secretary of State for Health or accountable officer
Typically accountable officers give authority to senior members of staff who are not involved in day to day management or use of CDs. AOs themselves do not witness.
How to dispose of CDs
Pharmacies are required to denature CDs prior to disposal
Do not put down the sink, toilet etc! Must not get into waste water system, send for incineration
All CD sch 2, 3 and 4 (part I) should be destroyed by denaturing and rendering irretrievable, then put in waste container and sent for incineration
You are not expected to modify the chemical composition or structure in this process.
CD denaturing kits are recommended by RPS in preference to DIY methods
If no denaturing kit available use DIY in preference to not denaturing
Solid dosage forms: crush, grind or open and add to denature kit. Add small amount of water. H&S - wear protective equipment, well ventilate etc
Liquids: pour on denaturing kit.
Requisition requirements
Since 2015 an approved form must legally be used to requisition schedule 2 and 3 CDs in the community (not hospices or prisons). In England these are called FP10CDF [Wales WP10CDF; Scotland CDRF (private) GP10A (NHS)]
This applies to human use and veterinary use
Hospitals do not need to use approved forms if request is from a ward or department within it (referred to as ‘the same legal entity’). In practice they usually use a carbon copy bound book, sequentially numbered so use can be audited
Legal requirements for what needs to be written on a Sch2 or 3 CD requisition:
Name of recipient
Signature of recipient
Address of recipient
Their profession or occupation
Total quantity of drug
Purpose of the requisition
Veterinary requisitions – keep original in the pharmacy for 5 years
Midwife supply orders
Registered midwife may use a MSO to obtain:
Diamorphine , Morphine or Pethidine (all sch 2)
MSO must state:
Name of midwife
Occupation
Name of person who will be administered the CD (or supplied)
Purpose for which CD is required
Total quantity to be issued
Signature of ‘appropriate medical officer’ doctor or the supervisor of local midwives authorised by NHS trust
You can check registration of midwives with NMC
Prescription requirementsSchedule 2 and 3 CDs
Date
This is the date of signing
Prescription is valid for 28 days after the appropriate date
Appropriate date is either signature date or any other date indicated on prescription as a date before which supply should not be made – whichever is later
28 day validity also applies to schedule 4 CDs
28 day validity applies to any owing balances
Dose
Must be clearly defined
Strength
Only needed if more than one strength exists
If a prescription is for more than one strength of a medicine then each strength must be prescribed separately
Total quantity
Must be written in both words and figures (e.g. twenty eight, 28)
If formulated in dosage units express as dosage units (not for example mg), if liquid express as volume e.g. ml
2 packs of 28 is acceptable (two packs of twenty eight)
Quantity prescribed
Recommended by governments of UK that a max of 30 days supply of schedule 2, 3 or 4 CDs is on prescriptions
There is no legal restriction however; you should check why more is needed and must consider if it is clinically justifiable
Name of patient
Address of patient
‘No fixed abode’ / NFA allowed. P.O. box not allowed
Dental prescriptions
‘For dental treatment only’ is needed
Instalment directions
If supplies are to be made in instalments, a valid instalment direction is required (see lecture 5)
When dispensed you must mark the prescription with the date of supply in indelible ink to indicate it is ‘spent’. In practice this is usually the pharmacy stamp. For electronic prescriptions, see CPE guidance –need electronic audit trail. Dispense notification may be suitable.
Collection of dispensed Sch 2 controlled drugs
Pharmacist is legally required to determine who the collector is (patient, patient’s representative, healthcare professional).
Patient or their representative – may request evidence of identity unless known (supply decision is at your discretion)
Healthcare professional – unless already known, ask for name, address (work) and evidence of identity. If not shown supply at your discretion
Good practice for collector (sch 2 and 3) to sign back of prescription in CD collector box
A bit about CD registers
Each register should be kept at the premises to which it applies
You must keep the register for TWO years from date of last entry
You can keep original form or copied/scanned and kept in approved computerised form
Inspectors (e.g. GPhC) may ask to see the CD register and other details of stock receipts and supplies
Making CD register entries
You must make entries chronologically
You must enter them promptly and legally within 24 hours
They must be in ink/indelible (or computerised)
Entries must NOT be altered in any way – no cancelling out, obliteration etc
Corrections must be made by dated notes in the margin or bottom of page. Mark clearly who made the correction (e.g. name, signature/initials, GPhC number)
Running balances and stock checks
The running balance aims to help discrepancies and irregularities be spotted quickly
A Standard Operating Procedure should cover the balance check process and how to deal with discrepancies (separate to CD handling SOP)
Once weekly balance check is usual but may be more or less frequent depending on circumstance
Liquids – visual checks, measure volumes periodically and check balance at end of a bottle (i.e. when whole bottle volumes so can easily tally accurately). Be aware of overages!
Ideally two people should do the check. Check should be recorded, signed and dated by the healthcare professional(s) doing the check
Register & POM book entries for private prescriptions for Sch 2 CDs
Legally if dispensing a CD sch 2 drug from private prescription, you do not need to make a POM book entry as a CD register entry is made.
BUT best practice says you should do BOTH (and therefore required in APPS class)
Cross refer POM reference no. into CD register, on label and on prescription.
Invoices
This gives a good summary of prescription and requisition requirements around supply of CDs.
Note – invoices must be kept for 2 years for scheduled 3 and 5 CDs
In practice keep all invoices. NICE advise you keep them for 6 years in case of HM Revenue and Customs checks.
Summary so far
Controlled drugs are classified into 5 schedules. There are varying levels of control on possession, supply and procurement
In practice, schedules 2, 3, 4 (part 1 and part 2) and 5 are used therapeutically
Schedule 2 and 3 drugs need to be stored in the controlled drugs cupboard (with some exceptions)
Controlled drugs cabinets or other approved storage facilities must meet legal requirements
There are additional requirements placed on requisitions and prescriptions by the MDR for Sch 2 and 3 CDs which you need to know thoroughly
There are also requirements around record keeping and collection of Sch 2 CDs
