controlled drugs 2 Flashcards
Safe custody applies to patient returned, out-of-date/obsolete stock
They must be
(marked as?)
kept separately from other pharmacy stock
clearly marked as:
‘patient returns waiting to be destroyed’
‘out-of-stock/obsolete, waiting authorised witness to destroy’
Which CD’s must be denatured?
2,3,4 ( part 1)
Denaturing of pharmacy out-of-date/obsolete stock must be
witnessed by an authorised witness
When will we also need an authorised witness
Where a CD entry is required (CD 2)
Denaturing formulations
solid dosage forms
liquid dosage forms
ampoules and vials
patches
aerosol formulations
Solid Dosage Forms (Capsules/Tablets):
Grind or crush the tablet/capsule before adding to a CD denaturing kit to ensure it is irretrievable.
If a denaturing kit isn’t available, crush and dissolve in warm, soapy water, then dispose of in an appropriate waste bin.
Liquid Dosage Forms:
Pour into a CD denaturing kit, or if not available, dispose of in an appropriate waste bin.
If a liquid bottle is empty, rinse it and dispose of the rinsings via a denaturing kit, but only if permitted by local regulations. Empty bottles can be recycled or disposed of with labels removed.
Ampoules and Vials:
For liquid ampoules, empty into a CD denaturing kit or dispose similarly to liquid formulations. The ampoule should be discarded as sharps waste.
For powder ampoules, dissolve with water, then dispose as above. Crushing is less preferable, but if done, ensure safety and dispose of the mixture properly.
Patches:
Fold and dispose of the patch into a pharmaceutical waste disposal bin or CD denaturing kit.
Aerosol Formulations:
Expel into water and dispose of as a liquid, or use absorbent material if that’s not possible, then dispose of it as pharmaceutical waste. In some cases, opening the container may be an option, but safety should be prioritized.
Patient returns - Good practice record
what do we include?
Include:
Date returned
Name / Qty / Strength / Form
Role of returning person if known
Name & Sig of recipient (person in pharmacy who’s accepted the return)
Patients name & address if known
During destruction
- GOOD PRACTICE RECORD - what do we put
Name / position / sig / date of:
Person destroying
Person witnessing
Healthcare Act 2006 - introduced the concept of what
accountable officer following the shipman inquiry
All holders of CDs must have (under health act 2006)
standard operating procedures to be in place for using and managing CDs
Who Can Be an Accountable Officer? what can and can’t they do
Must be a ‘fit, proper and suitably experienced person’
Must be a senior manager of the organisation (have experience and authority to manage situations)
SHOULD NOT routinely prescribe, supply, administer or dispose of CDs
Must have credibility and sufficient seniority to take action
What is the role of an accountable officer?
Responsibility for supervising and managing use of CDs in their organisation or setting
This includes
Responsible for the safe and secure use and management of CDs in their organisation
Ensure adequate and up to date SOPs in place for the management of CDs
Ensure monitoring and auditing of the management of CDs (in their organisations)
Ensure that staff receive education and training
Assess and investigate concerns (Raised within organisation about controlled drugs)
Record concerns regarding relevant individuals (especially about individuals)
Establish arrangements for sharing information
Produce quarterly reports of CD occurrences for the lead NHS England CDAO
Safer management of CDs: guidance on SOPs for CDs
Access (who has access)
Where should they be stored
Security in relation to storage in the pharmacy & transportation (home deliveries to patients/from hosp pharm department to other departments)
Disposal & destruction
Who is alerted if complications arise
Record keeping
Maintaining relevant registers
Where do we report incidents relating to CD’s
the accountable officer
Details of incident/concern should be recorded
Risk assessment of incident to determine seriousness of the situation)
Investigation as appropriate
Trend analysis
Role of Accountable Officer in Destruction and Disposal of CDs
Ensure adequate destruction and disposal arrangements for CDs
The AO authorises ‘authorised witnesses’ for the destruction of expired or unwanted unusable schedule 2 CDs
The AO cannot be an authorised witness (need to be removed from day-to-day things in a pharmacy, also applies to someone who is a witness)
Patient-returned CDs do not require an authorised witness for destruction but advisable to do so.
In secondary care - what is the body who checks hospitals and keeps a record of AO’s
The Care Quality Commission (CQC)
Robust systems
Procurement
Storing
Supplying
Transporting
Prescribing
Administering
Recording
Disposing
Drugs & Driving
Offence of driving whilst impaired through drugs, regardless of whether the drugs are being used legitimately
If driving is impaired may be prosecuted
even if taking as prescribed/recommended
It is also an offence to drive with certain specified drugs (e.g. diazepam, methadone, morphine) in the body above an accepted limit
Even when driving is not impaired
Advice to Patients - driving
Must not drive if you feel sleepy, dizzy, are unable to concentrate or make decisions, have slowed thinking or if you experience sight problems
See how the medicine affects you as an individual when starting a new medicine or after a dose change (before they drive)
Alcohol, even in small amounts, in combination with medicines can greatly increase the risk of accidents
Medical Defence
Limits on amounts of certain drugs in the bloodstream (e.g. diazepam, methadone, morphine)
‘Medical defence’ for those taking medicines in line with healthcare professional’s advice, provided that driving is not impaired
Travelling
Patients should be referred to the individual embassies for the countries they are travelling to for up-to-date advice.
Individuals may also need to apply for a personal licence from the Home Office in certain circumstances
Traveller’s carrying less than 3-months’ supply of CDs do not require a home office licence
It is advised they obtain a covering letter signed by the prescriber stating:
Name of patient
Travel plans
Name of the prescribed CDs
Total quantity in words and figures
