W20 Controlled Drugs (AT) Flashcards
Schedule 1 (CD LIC POM)
Examples?
- No therapeutic use
- Licence required for production, possession or supply.
- Examples include hallucinogenic drugs (e.g. ‘LSD’), ecstasy-type substances and raw opium
Heroin, LSD, cannabis
Schedule 2 (CD POM)
What are examples?
- Pharmacists can prescribe, possess, supply and procure
- Schedule 2 includes opiates (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone and ketamine
Schedule 3 (CD NO REGISTER POM)
examples?
- Less likely to be misused (and less harmful if misused)
- Minor stimulants and other drugs (such as buprenorphine, temazepam, tramadol, midazolam, phenobarbital, gabapentin and pregabalin)
Schedule 4 (CD BENZ POM OR CD ANAB
POM)
examples?
Split into two parts:
* Part I (CD Benz POM)
* Benzodiazepines (such as diazepam), non-benzodiazepine hypnotics (such as zopiclone), and Sativex (a cannabinoid oromucosal 2mouth spray)
* Part II (CD Anab POM)
* Contains most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoceptor stimulant) and growth hormones.
Schedule 5 (CD INV POM OR CD INV P):
examples?
- Preparations of certain CDs (such as codeine, pholcodine and morphine) that are exempt from full control when present in medicinal products of specifically low strengths
What is ‘Safe custody’ of controlled drugs?
- Certain Schedule 2 or 3 CDs must be stored securely under Schedule 2 of the Safe Custody Regulations
- Pharmacies, private hospitals and care homes keep relevant CDs in a ‘locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs’.
Safe custody (for info)
- Some organisations create SOPs stating that Schedule 3, 4 and 5 should be handled in the same way as CDs in Schedule 2.
- When CDs requiring safe custody are not kept securely (e.g. during the dispensing
process), they must be under the ‘direct personal supervision’ of a pharmacist. - Access to CDs (including handling of ‘CD keys’) should be documented
- Safe custody applies to patient-returned, out of date and obsolete CDs until they can be destroyed
Which schedule drugs must be kept under safe custody:
The Controlled Drugs that must be kept under safe custody are:
* Schedule 1 drugs
* Schedule 2 drugs except for some liquid preparations and quinalbarbitone (secobarbital)
* Schedule 3 drugs unless exempted under the Misuse of Drugs (Safe Custody) Regulations 1973
Common exemptions include:
* Gabapentin
* Mazindol
* Meprobamate
* Midazolam
* Pentazocine
* Phentermine
* Phenobarbital
* Pregabalin
* Tramadol
* Common Schedule 3 CDs which require safe custody include temazepam and buprenorphine
What are the Prescription requirements for Sch 2 and Sch 3 CDs? (7)
- Signature
- Date
-
Date when it was signed.
* CD prescriptions are valid for 28 days after the ‘appropriate date’ on the prescription.
* The appropriate date is either the signature date or any other date indicated on the prescription (by the prescriber) as a date before which the drugs should not be supplied – whichever is later
* The 28-day restriction includes any owing balances. - Prescriber’s address
-
Name of CD (not legally required)
* It is good practice to write the name of the medicine in full -
Form
* The formulation must be stated; the abbreviations ‘tabs’ and ‘caps’ are acceptable. It should be clear and unambiguous if the prescriber intends a supply of m/r s/r -
Strength
* The strength only needs to be written on the prescription if the medicine is available in more than one strength.
Record keeping and Controlled
Drugs registers
Running Balances and Stock Checks:
* Irregularities or discrepancies can be identified as quickly as possible.
* Should be at least once a week
* Running balances for liquid CDs can be affected by overage, residue and spillage
* Liquid balances should be undertaken to confirm the balance on completion of a bottle.
* Stock checks should be recorded, signed and dated (ideally two people should carry out checks)
* Visually check the running balance each time a CD is dispensed
* A running balance should be maintained as a matter of good practice
* It is intended that once electronic registers are in common use this will become a legal requirement
Prescription requirements
The dose must be clearly defined:
examples of legally and not legally acceptable :
Not Legally Acceptable:
* As directed
* When required
* PRN
* As per chart
* Titration dose
* Weekly (frequency not a dose)
* Decrease dose by 3.5ml every four days
* Twice a day
Legally Acceptable:
* One as directed
* Two when required
* One PRN
* Three ampoules to be given as directed (better still – three ampoules to be given over 24 hours as directed)
* One to two when required
Does not automatically indicate clinical appropriateness!
what are some extra prescription requirements?
Total quantity:
* The total quantity must be written in both words and figures.
* the total number of dosage units required e.g. 10mg x 10 (ten);
* or the total quantity of drug as milligrams e.g. 100 (one-hundred) mg.
* The total quantity for liquid preparations should be the volume required e.g. 100 millilitres.
* Preferable to prescribe in dosage units.
* Total number of dosage units e.g. ‘sixty 10mg tablets’
* Multiplication of two numbers, e.g. ‘10mg tablets, 2 packs of 30 tablets [two packs of thirty tablets]’.
* The pharmacist must be satisfied that the total quantity is unambiguous.
* Different strength tablets
* Quantities for each strength must be listed in words and figures, either as:
* ‘numbers of tablets’ e.g. 7 (seven) x 8mg tabs, 14 (fourteen) x 2mg tabs or as:
* ‘milligrams’ e.g. 56 (fifty-six) mg as 8mg tablets 28 (twenty-eight) mg as 2mg tablets
* For clarity, the name of the drug should also appear each time for each different strength
Quantity prescribed:
* Recommended that the maximum quantity of Schedule 2, 3 or 4 CDs prescribed should not exceed 30 days.
* Not a legal restriction
* Prescribers should be able to justify the quantity requested
What are the Prescription requirements?
Name of patient
Address of patient
-If the patient does not have a fixed address (e.g. because he or she is homeless or under a witness protection scheme), ‘no fixed abode’ or ‘NFA’ is acceptable. Use of a PO Box is not acceptable.
Dental prescriptions:
* Where the CD prescription is written by a dentist, the words ‘for dental treatment only’ must be present.
Instalment direction
* Where the prescription is intended to be supplied in instalments a valid instalment direction is required.
Additional requirements
* When the CDs is supplied, it is a requirement to mark the prescription with the date of supply at the time the supply is made. The prescription needs to be written in indelible ink and can be computer generated.
Private Prescription requirements?
Standardised Form:
* Where the private prescription is issued and dispensed within the same legal entity (e.g. a hospital), a standardised form is not
required.
Prescriber Identification Number:
* This number is not the prescriber’s professional registration number (i.e. the GMC, GPhC number, etc.).
* Issued by the relevant NHS agency obtained from the local primary care organisation.
Submission
* Pharmacies must submit the original private prescription to the relevant NHS agency
* Medicines that are not CDs should not be prescribed on the same form. Remember the requirement to keep private prescriptions for a POM for two years
Collection of dispensed Controlled Drugs
Patient, patient’s representative or healthcare professional?
* Request evidence of that person’s identity
* For a healthcare professional, name & address should be determined
* Good practice for the person collecting a Schedule 2 or 3 CD to sign
the space on the reverse of the prescription form
Drug Misuse Patient Representative
* Letter from the drug misuser that authorises and names the representative. (this includes the police)
* Must be satisfied that the letter is genuine.
* Good practice to see the patient in person at least once a week
Record keeping and Controlled Drugs Registers:
- CD register must be used to record details of any Sch 1 and Sch 2 CDs received or supplied by a pharmacy.
- Class, strength and form at the head of each page of the CD register.
- Must be a bound book with different classes kept in a separate part
- Within each class, a separate page should be used for different strengths and formulations
- Register should be kept at the premises to which it applies
- Kept for two years from the date of the last entry
- Records can be kept in their original form or copied and kept in an approved computerised form
- Copy of the register, and other details of stock, receipts and supplies, must be made available to authorised persons (e.g. a GPhC inspector or CD liaison officer)
upon request.
All entries made in CD registers should be:
- Entered chronologically
- Entered promptly – entries must be made on the day of the transaction or on the following
day - In ink or indelible – entries and corrections must be in ink or indelible (or computerised)
- Unaltered – entries must not be cancelled, obliterated or altered
- Corrections must be made by dated marginal notes or footnotes. The register should be marked to show who the amendments made are attributable to (e.g. name, initials/signature, GPhC number if applicable).
