Controlled drugs Flashcards
What legislations are applicable to CDs and pharmacy include?
The misuse of Drugs Regulations 2002
The misuse of Drugs Act 1971
The misuse of Drugs Regulations 1973 as amended
The health Act
Controlled drugs regulations 2013
What does the misuse of drugs regulations 1971 do?
It imposes prohibitions on the possession, manufacture, import and export of CDs except where permitted by the 2001 regulation.
what does the Health act 2006 do?
It introduced the concept of an ‘accountable officer’ and required healthcare organisations and services to have standard operating procedures in place for using and managing CDs.
What does the Responsible pharmacist regulations 2008 state?
registered pharmacists: it requires a range of pharmacy procedures for managing CDs in their pharmacies and the steps that they should take if an incident occurs or concern relating to CDs arise.
What are organisation policies and procedure that ensure the management of CDs
Security- access to CDs
Ordering and receipt
Record keeping- audit requirements
Prescribing and clinical monitoring
Administration-witness requirements too
Supply- prompt access to ensure care is not compromised
Denaturing and disposal-witness requirements too
Use and storage of patients with CDs
Investigations and reporting concerns
What is the roles of a controlled drug accountable officer?
Oversight of the monitoring and auditing of the management, prescribing and use of CDs
Ensuring that systems are in place for recording concerns and incidents involving CDs and the operation of these systems
Appointment of authorised witness for destruction of CDs
CLASSES OF CD
Give examples of schedule 3 drugs
Phenobarbital, Gabapentin, Tramadol, Buprenorphine, Midazolam
CLASSES OF CD
Give examples of schedule 4 drugs part I
Benz POM
Benzodiazepines;diazepam
Non-benzodiazepines; zopiclone
Sativex
CLASSES OF CD
Give examples of schedule 4 part II controlled drugs
Anabolic POM;
Contains most of the anabolic and androgenic steroids and growth hormones.
CLASSES OF CD
Give examples of schedule 5 CD
How long are their prescription valid for?
Low strengths of dihydrocodeine, codeine, pholcodine, and morphine.
6 months
CLASSES OF CD
How long are schedule 1 to 4 prescription valid for?
28 days
CLASSES OF CD
Can the EEA and Swiss HCP prescribe schedule 3 to 5?
yes just NOT schedule 2 or 3
CLASSES OF CD
what schedule of drugs need an invoice to be retained for 2 years?
Schd 3 and 5
SUPPLY AND POSSESSION
Who can supply, possess and procure schd 2 to 4 according to the 2001 regulation
Pharmacists, doctors and dentists
SUPPLY AND POSSESSION
Who can lawfully possess CDs 2 to 4
Also if:
Home office licence (can also supply)
Those covered by the home office licence group authority ( can also supply)
Classes of people specified in 2001 regulation
Patients who have been prescribed them
Dependent on class of drug given as well
SUPPLY AND POSSESSION
Who can adminster schedule 2 to 4 drugs
A doctor, dentist, pharmacist or nurse IP acting in their own right.
Supplementary prescriber acting in accordance with clinical management plan
A person acting in accordance with the directions of a prescriber who can prescribe CDs.
SUPPLY AND POSSESSION
Who can administer and prescribe schedule 1?
Those with Home office licence
SUPPLY AND POSSESSION
What is needed for a pharmacy to import and export CD
A licence( if not being used for self administration)
SUPPLY AND POSSESSION
when are requisition forms needed
For schd 1, 2 and 3 drugs
when stocks of the relevant controlled drugs are to be obtained in the community, including from wholesalers
SUPPLY AND POSSESSION
What are the legal requirements for a controlled drug requisition?
Signature of recipient
name of the recipient
Address of the recipient
Profession or occupation
Total quantity of drug
Purpose of the requisition
SUPPLY AND POSSESSION
what is the approved mandatory requisition forming England
FP10CDF
SUPPLY AND POSSESSION
What are the legal requirements when a requisition is received?
Mark the requisition indelibly with the supplier’s name and address; where a pharmacy stamp is used this must be clear and legible.
Send the requisition to the relevant NHS agency
Retain a copy for two years
SUPPLY AND POSSESSION
The processing requirements do not apply when the supply is made for which cases?
If supply is made;
By a person responsible for the dispensing and supply of medicines of a hospital, care home, prison or Ambulance services who must mark and retain the original requisition for two years.
By pharmaceutical manufacturers or wholesalers
Against veterinary medicines requisition should be retained for five years
CD PRESCRIPTIONS
What are TEN things that needs to be on on CD prescription
- Name and address of the patient
- Name and address of prescriber
- Signature
- Date (INCLUDING date of supply)
- Total quantity in words and figures
- specific direction e.g take one as directed not just as directed
- name, dose, strength of medication
8.Formulation - Dental should say ‘for dental use only’
- patient age if younger than 12
- Prescriber identification number
INSTALMENT DIRECTION FOR SCHEDULE 2OR 3 CONTROLLED DRUGS
What is it?
It combines two pieces of information
- Amount of medicine to be supplied per instalment
- interval between each time the medicine can be supplied
Instalment prescription must have both a dose and an instalment amount specified on the prescription.
INSTALMENT DIRECTION FOR SCHEDULE 2OR 3 CONTROLLED DRUGS
When must be the first instalment of an instalment prescription be dispensed?
Within 28 days of the appropriate date, remainder of the instalments should be dispensed in accordance with instructions
The prescription must be marked with the date of each supply
INSTALMENT DIRECTION FOR SCHEDULE 2OR 3 CONTROLLED DRUGS
What are legal requirements for an instalment prescriptions?
Instalment directions with specific wording
INSTALMENT DIRECTION FOR SCHEDULE 2OR 3 CONTROLLED DRUGS
What are home office approved wording?
Please dispense instalments due on pharmacy closed day on prior suitable day
If an instalment’s collection day has been missed, please still dispense the amount due for any remaining day(s) of that instalment
Consult the prescriber if three or more consecutive days of a prescription have been missed.
Supervise consumption on collection days
Dispense daily doses in separate containers
INSTALMENT DIRECTION FOR SCHEDULE 2OR 3 CONTROLLED DRUGS
If the relevant approved wording is used for the instalment direction for schd 2 and 3 CDs, what can the pharmacist do?
Supply the balance of an instalment if the interval date is smiled
Supply treatment prior to the start date on the prescription, if this is on a day where the pharmacy is closed e.g bank holiday
COLLECTION OF DISPENSED CD
What would you do if the patient has missed three days of treatment and why ?
There is a risk the patient has lost tolerance to the drug and usual dose may cause an overdose. Contact prescriber to discuss appropriate steps.
COLLECTION OF DISPENSED CD
What would you do if there was a minor typographical error or spelling mistake or spelling mistake or where prescriber has failed to put quantity in both words and figures?
A pharmacist can amend the prescription indelibly so that it becomes compliant with legislation.
The pharmacist must also put name, date, signature, and GPhC reg no and initials
COLLECTION OF DISPENSED CD
What can a pharmacist NOT amend in a CD prescription
Missing date
incorrect dose, form or strength
PRIVATE CD PRESCRIPTIONS
what are additional legal requirements of private CD prescriptions?
Must be written on a standardised form
prescriber identification number
Pharmacies must submit original private prescription to the relevant NHS agency
Medicines that are NOT CD must NOT be written on the standardised CD form
PRIVATE CD PRESCRIPTIONS
When is a standardised form not needed for human private CD prescriptions?
where prescription is issued and dispensed within the same legal entity.
COLLECTION OF DISPENSED CD
What are the legal requirements if a drug misuser wants a representative to collect their CD meds
Pharmacist must obtain a letter from the misuser that authorises and names the representative.(Separate letter should be obtained each time)
Representative needs to provide ID
Record on the CD register should include the details of representative
If directions on prescription state that the dose must be supervised, the pharmacist should contact the prescriber before it is supplied to the representative. Verbal agreement from prescriber is fine
prescription should be annotated stating dose was not supervised in pharmacy.
COLLECTING A NORMAL CD DRUG:
what actions need to occur if collected by;
a)Patient or patients representative
b) HCP acting in professional capacity on behalf of patient
If not known by the pharmacy
a) Pharmacist may request evidence of identity ID.
b) Name, address and ID of the healthcare professional
SAFE CUSTODY
What is the requirement of the safe custody regulations?
Pharmacies keep relevant CDs in a locked safe to prevent unauthorised access to drugs.
A key log could also be used to keep an audit trail of who has had access to the keys, including overnight storage.
SAFE CUSTODY
What controlled drugs need to be kept under safe custody?
Schedule 1
schedule 2 except some liquid preparations
schedule 3 unless exempt under the misuse of Drugs Regulations 1973 as amended.
Patient returned and out of date or obsolete controlled drugs until they can be destroyed
What schedule 3 drugs are exempt from being in CD cupboard under the misuse of Drugs Regulations 1973 as amended?
Gabapentin
Mazindol
Meprobamate
Midazolam
Pentazocine
Phenobarbitol
Tramadol
Phentermine
DESTRUCTION OF CDs
What drugs need to be denatured before disposal
Advised by the home office that all schd 2,3 and 4
DESTRUCTION OF CDs
How can pharmacies legally denature CDs
requires a license or pharmacies can register an exemption known as T28 exemption without needing to obtain a licence.
DESTRUCTION OF CDs
What drugs need to be witnessed by an authorised person?
What records need to kept?
Drugs that need to be registered in the CD register that are expired, obsolete, and unwanted so schd 2. But not those returned by patients.
Those returned by the patient do not need records kept
Schd 2 an entry should be made in the CD register
DESTRUCTION OF CDs
How should CDs be destroyed?
Should be denatured and deemed irretrievable, before being put in pharmaceutical waster bin.
DESTRUCTION OF CDs
What are the different methods of destruction for solids dosage forms?
Grind or crush the tablet before adding to the CD denaturing kit
DESTRUCTION OF CDs
What is a method of destruction for liquid dosage form?
Pour into CD denaturing kit
or pour into another suitable product
When bottle is emptied, small amount may remain so bottles can be rinsed.
The empty bottle can be rinsed
DESTRUCTION OF CDs
What is a method of destruction for ampoules and vials?
Open ampoules (if containing liquid) into CD denaturing kit or in the same way as liquid formulations
For powder containing ampoules, open kit and add water to dissolve powder, this mixture should be added to the denaturing kit.
or crush ampoules in empty container then add soapy warm water or suitable product.
DESTRUCTION OF CDs
What is a method of destruction for patches?
remove backing
fold patch over itself
place into a waste disposal or denaturing kit
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
What drugs need to be added to the CD register?
schd 1 and 2
and sativex
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
what must be recorded for CDs received?
Date of supply
Name and address of recipient
Quantity received
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
What must be recorded for CDs supplied?
Date supplied
Name and address of recipient
Details of authority to possess-prescriber or licence holders details
Quantity supplied
Details of patient or representative or HCP
Whether proof of identity was requested and whether it was provided
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
How should CD registers be organised?
Different sections for each class
within each class, separate page is used for different strengths and formulations for each drug.
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
How should entries be made?
Entered chronologically
entered promptly- the day of or the day after
Made in ink or indelible
Unaltered-entries cannot be cancelled- corrections must be made by dated marginal notes. (this correction must include name, initials, GPhC number of corrector)
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
How long should registers be kept following the date of the last entry?
Two years
RECORD KEEPING AND CONTROLLED DRUG REGISTERS
What is the aim of keeping a running balance?
how often should stock checks be done?
To ensure that any discrepancies or irregularities are identified as soon as possible.
At least once a week
CANNABIS AND CANNABIS BASED PRODUCTS:
Give examples of licensed cannabis based products.
what are they indicated for?
What is their legal category
Sativex-
used for moderate to severe spasticity in MS schd 4 CD
Nabilone-
N+V caused by chemotherapy and if unresponsive antiemetic treatments
POM
Epidyolex-
Seizures associated with Lennox-Gastaut syndrome
schd 5 CD
CANNABIS AND CANNABIS BASED PRODUCTS:
What do the following products contain
Sativex
Nabilone
Epidyolex
S-Cannabis extracts containing THC and CBD
N-synythetic non-natural cannabinoid
E-cannabidiol
CANNABIS AND CANNABIS BASED PRODUCTS:
What is Dronabinol contain?
what is it indicated for?
Legal category?
Not classified as a licence product but synthetic compound.
A synthetic, nature identical version of THC
Schedule 2 drug
Used to treat loss of appetite in those with AIDS
N+V caused by chemo if unable to use conventional anti-emetic treatments.
CANNABIS AND CANNABIS BASED PRODUCTS:
what is CBPM?
Who can prescribe it?
Cannabis based products for medicinal use
Prescribing is limited to specialist doctors on the GMC’s Specialist register.
CBPM DEFINITION
What are the THREE broad requirements a CBPM should satisfy?
1.The product is or contains cannabis, canners resin, cannabinol or cannabinol derivative
2.It is produced for medicinal use in humans
3.It is a product that is regulated as a medicinal product, or an ingredient of medicinal product.
CANNABIS AND CANNABIS BASED PRODUCTS:
Who should decide to commence treatment of CBPM
Joint decision between prescriber and patient/carer
Clinician should consider; the patient, the clinical condition, the clinical effectiveness and safety that cannot be met by licensed medicines.
CANNABIS AND CANNABIS BASED PRODUCTS:
What schedules are CBPMs?
When prescribing what does the patient need to know
SCHD 2
Patient is involved in the decision
Made aware that it is unlicensed (a note of this needs to be made in patients medical records)
CANNABIS AND CANNABIS BASED PRODUCTS:
What standards must a private prescription for CBPM meet?
Must meet the legal requirements for schedule 2 CDs and must be on standardised form
Must specify prescribers six digit ID number
