Regulation of Controlled Drugs Flashcards
1
Q
Legislative Framework for Controlled Drugs
A
Legislation: Medicines Act 1968, Misuse of Drugs Act 1971, The Health Act 2006
The Health Act 2006; The Controlled Drugs (Supervision and Management of Use) Regulations 2006 and 2013
2
Q
Human Medicines Regulations 2012
A
- replacing most of med act 1968 and about 200 statutory instruments with a simplified set of rules
- Part 12 sets out dealing w medicinal products
- allows certain exemptions from the general restriction, allows midwives to supply or administer morphine, diamorphine, pethidine or pentazocine
3
Q
Misuse of drugs act 1971
A
- controls and prohibits possession, import, manufacture, supply and export
- except where permitted in regulations 2012
- drugs subject to misuse CD
- Divided into classes A. B and C, depending on harmfulness when misses, determine max penalty that can be imposed
4
Q
Accountable Officer
A
role to have overarching responsibility for supervising and managing use of CDs in organisation
- overseeing the monitoring and auditing of the management, prescribing and use of CDs
- Ensuring the systems recording concerns and incidents involving CDs are in place
- Attendance at local intelligence network meetings
- Occurence Reports
- appointment of authorised witness for CD destruction
- requires healthcare organisations to have SOPS in place for using and managing CDs
- Gives power to police and other nominated people to enter premises and inspect stock and records of CDs
5
Q
Misuse of Drugs Regulations 1973
A
Imposes controls on storage of CDs
- Lockable
- Made of Metal
- Fixed to wall or floor
- Nominated Key Holder has Responsibility
6
Q
Misuse of the Drugs and Misuse of Drugs Amendment Regulations 2007
A
- Accountable officers: Nominate person or groups to witness the destruction of CDs
- Remove the requirement to maintain a CD register in a prescribed format
- Change record keeping requirements of CDs
- Reschedule Midazolam for CD 4 to CD 3
7
Q
Misuse of Drugs Regulations 2001
A
- Defines the type of person authorised to manufacture, import, export, possess, prescribe and supply CDs in their professional capacity for medical or other use
- Divide CDs into 5 schedules. Depends upon its therapeutic benefit against its harm when misused
- Schedule 1 CDs -Highest Level of Control
- Schedule 5 CD- Lowest Level of Control
8
Q
Schedule 1
A
- LDS, ecstacy, mescaline, cannabis
- The majority of drugs in schedule 1 have no recognised therapeutic use
- generally limited to research - must hold a home office licence
- practitioners may not lawfully possess these except under licence from the home office
9
Q
Schedule 2 (CD POM)
A
Includes:
- diamorphine
- morphine
- methadone
- oxycodone
- major stimulants (amfetmaines)
- ketamine
- supply is restricted to licence whole sellers, hospitals, pharmacies, doctors and dentists acting in their professional capacity
- A licence is required to import and export
- CD RX requirements apply
- Safe custody (except quinalbarbitone) apply
- CD register for supplied and obtained
- Destruction- by appropriately authorised person with authorised witness and keep record
- Prescription valid for 28 days
- Emergency supply not allowed
- Repeat Prescribing not allowed
10
Q
CD 3
A
- No register
- Includes: buprenorphine, midazolam, phenobatbircne, temazepam, tramadol
- subject to CD rx writing requirements
- Most are exempt from safe custody requirements (except temazepam and buprenorphine)
- emergency supply is not allowed (except for phenobarbital and epilepsy)
- repeat prescribing is not permitted
- Script is valid for 28 days
- Invoiced must be retained for 2 years
- Subject to full import and export control
- The requirements relating to destruction do not apply
- New to this category is pregab and gaba
11
Q
Schedule 4
A
- prescription writing as POM requirements
- Exempt from safe custody and CD entry
- Script valid for 28 days
- Subjected to full import and export control
- EEA and Swiss prescribers can legally prescribe
- Repeat prescriptions are allowed
- Emergency supplies are allowed (max 5 days)
12
Q
Schedule 4 split into two parts
A
Part I: (CD Benz POM) which contains most of Benzodiazepines (diazepam), non Benzos (Zolpiden) and Sativex (Cannabinoid oral spray)
Part II: (CD Anab POM), contains anabolic and androgenic steroids (testosterone) and growth hormones
13
Q
Schedule 5
A
- contains schedule 2 CD in low strengths (Codeine, pholcodine and morphone) which are exempt from full control
- invoiced are kept for 2 years
- a practitioner, pharmacist or a person holding an appropriate licence may manufacture or compound an SD 5 substances
- Some are available OTC
14
Q
Quantity Supplies
A
- quantity prescribed should be appropriate for clinical need of patient
- Schedule 2, 3, 4 should be limited to 30 days
- This is good practice and not legal requirement but use your professional judgement, but prescribers should justify why ore than 30 days is needed in all cases
15
Q
CD RX requirements
A
- For all CD 2 and 3
- An example is given on an FP10, but requirements are same when prescribed on private rx and any other prescriber
- patients full name
- patients address or DOB
- Drug name, strength, quantity and formulation
- Prescriber name
- Quantity should bee in words, as well as figures
- Signature in prescriber hand writing
- Date must be valid for 28 days, (6 months if schedule 5)
- dose needs to be specified, one as direct is acceptable but not as directed
16
Q
Pharmacists can supply against prescription that have:
A
- Minot typographical errors or spelling mistakes
- total quantity specified in either words or figures but not both
17
Q
Technical Errors (Amendments)
A
- Pharmacists need to be satisfied with Rx in genuine and supply is in accordance with prescribers intention
- Must amend RX with indelible ink on main body of script, clearly show amendments are made by them, sign, data GPhC reg no)
- All other amendments or omissions must be corrected by original prescriber
18
Q
Collection of Dispensed CD
A
- Pharmacist is legally required to determine who is collecting CD 2
- Ask for proof of identity (unless pharmacist already knows them)
- Pharmacist has the discretion to decide to supply even if ID is not provided
19
Q
CD Register
A
For all CD 2 and Sativex (Schedule 4 part 1) received or supplied by pharmacy
- No fixed format of CD register but certain headings and info must be recorded
- Separate page must be used for each strength and form of the drug
- Must be kept at premises to which it relates to be available for inspection at any time
- Not be used for any other purpose
20
Q
What must you do when CD obtained by supplier
A
- Date CD was obtained
- Name and address from who it was obtained
- Quantity
21
Q
CD Register requirements when supplying
A
- Name of prescriber or licence holder details
- Name and address of patient
- Date supplied
- Quantity and form supplied
- Whether ID was requires
- whether ID was provided
- Details of person collection (Schedule 2)
- entry must be made on same day or next day
- kept for 2 years from date of last entry
- entries not cancelled, correction made by star
- running balance good practice and enter prescriber identification number and name and registration number of pharmacist supplying
22
Q
Electronic CD Registers
A
- regulations require that every computerised entry must be attributable and capable of being audited
- must be accessible from premises and capable of being printed
- must ensure safeguards are incorporated into software to ensure author of each entry is identifiable; entries cannot be altered at a later date
23
Q
Owning of CDs
A
- ownings: CD Register must only record what is actually supplied. A further entry must be made with the remaining balance is supplied
- Owing balance for schedule 2, 3, or 3 CDs cannot be dispensed later than 28 days after the appropriate date on prescription
- for Schedule 5, the balance of an owing cannot be collected more than 6 months after appropriate date
24
Q
Private CD Prescriptions
A
- Private human Rx for Schedule 2 and 3 CDs must be written on the designated pink rx form
- Not when CDs are issued and dispensed in hospital , or issued by a vet
- FP10PCD
- same legal prescription requirements apply
- Prescriber identification number must be included (Different to their professional reg no)
- The original RX for schedule 2 and 3 should be submitted to the relevant NHS agency along with a CD submission form
- Good practice to keep copy of FP10PCD
- Goof practice to keep a copy in POM register and CD register is Legal
25
Q
CD Destruction
A
- Pharmacy contractors must have appropriate arrangements in place for the safe disposal of CD
- home office advises that all schedule 2, 3, 4, should be denatured before being placed into waste containers
- Pharmacists should use CD denaturing kits to denature CDs wherever possible
26
Q
Patient Returns
A
- can accept CD from patients from their own home or care homes
- Cannot accept waste medicine from care homes which provide nursing care
- A record should be made (not in CD register) for patient returned Schedule 2
- No legal requirement to destroy them in the presence of an authorised witness, but is good practice to do so
27
Q
Date Expired Stock
A
- For expired, unwanted Schedule 2 stock, destruction required it to be witness by an authorised person
- For schedule 3, it would be good practice to have staff witness the denaturing
- accountable officers can authorise people or groups of people to witness the destruction
28
Q
List of aspects that must be recorded in CD resider
A
- Date of Destruction
- Name, strength, form and quantity of drug
- Signature of authorised witness
- signature of professional destroying it
