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AMAN - Pharmacy Law and Ethics > Regulation of Controlled Drugs > Flashcards

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

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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
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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

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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
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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
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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
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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

AMAN - Pharmacy Law and Ethics (20 decks)

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