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PM2D Delivering Pharmacy Services > Regulation of Controlled Drugs > Flashcards

Regulation of Controlled Drugs Flashcards

1
Q

What is the misuse of drugs act 1971?

A
  1. Drugs are subject to the control of MDA and list within termed “Controlled Drugs”.
  2. Divided into Classes A, B and C for establishing the maximum penalty that can be imposed.
  3. Exceptions provided for under Regulations made under the Act.
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2
Q

What is misuse of drugs (supply to addicts) Regulations 1997?

A

Doctors needed Home office license to prescribe, administer or supply diamorphine, cocaine or dipipanone for the treatment of addiction or suspected addiction

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3
Q

What is the health act of 2006?

A
  1. All designated bodies required to appoint an Accountable Officer
  2. A duty of collaboration placed on responsible bodies to share intelligence on controlled drug issues
  3. Have up to date SOPs in place
  4. Give power to police and other nominated people to enter premises and inspect stocks and records of CDs
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4
Q

What are the rules for the controlled drugs (supervision of management and use) regulations 2006?

A
  1. Certain NHS and independent healthcare bodies- accountable officer can improve the safe management and use of CDs
  2. Bodies can co-operate- sharing of information and concerns and management of CDs
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5
Q

What is the misuse of drugs (safe custody) regulations of 1973?

A

Imposes controls on the storage of CDs which means that it must be stored in a bolted CD cabinet

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6
Q

What is the misuse of drugs and misuse of drugs (safe custody) (Amendment) regulations 2007?

A
  1. Accountable officers: nominate persons or groups to witness destruction of CDs
  2. Operating department practitioners can now order, possess and supply CDs
  3. Remove the requirement to maintain a CD register in a prescribed format
  4. Change the record keeping requirements for CDs
  5. Reschedule Midazolam from schedule 4 to 3
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7
Q

What is the misuse of drugs regulations 2001?

A
  1. Permits the use of CDs in medicine
  2. Divides CD into 5 schedules:
  3. being the highest
  4. lowest level of control
  5. Updates in 2012 include nurse and pharmacist independent prescribers
  6. Possession authorities under patient group directions (PGDs)
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8
Q

Describe schedule one?

What are some schedule 1 drugs?
What needs to be held in order to obtain schedule one drugs?
What methods are used for the destruction of schedule two drugs?
How can you only take possession of a schedule one drug?

A

Example:
1. LSD, ecstasy, mescaline, cannabis

  1. The majority of drugs in this class have no recognised therapeutic use
  2. Generally limited to research- must hold a home office license
  3. Practitioners may not lawfully possess these under license from home office.
  4. Can only be taken possession of the material except:
    - for the purpose of destruction or handing over to the police
    - under no circumstances return to schedule 1 drugs to a patient at discharge
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9
Q

Describe schedule two (CD POM)?

What are some schedule 2 drugs?
What are the prescription writing requirements are there?
What is the supply restricted to?
What needs to be recorded?
What methods are used for the destruction of schedule two drugs?
How long is the prescription valid for?
What are the rules for repeat prescribing?

A
  1. Includes diamorphine, morphine, methadone, amphetamines, and some barbiturates (and ketamine soon)
  2. CD prescription requirements apply
  3. Supply is restricted to licensed wholesalers, practitioners, hospitals and registered pharmacies
  4. A license is required to import or export
  5. CD register for supplies and obtained for schedule 2
  6. Safe custody (except quinalbarbitone) including patient returns
  7. Destruction- must be authorised
  8. Prescription is valid for 28 days
  9. Emergency supplies is NOT allowed
  10. Repeat prescribing is NOT allowed
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10
Q

Describe a schedule 3 drug and the rules which follow with it?
What are some schedule 2 drugs?
What type of prescription requirements are there?
What do you need to know about the supply?
What needs to be recorded?
What methods are used for the destruction of schedule two drugs?
How long is the prescription valid for?
What are the rules for repeat prescribing?
How long should the invoices be retained for?

A
  1. Includes: buprenorphine, midazolam, phenobarbitone and temazepam.
  2. CD prescription writing requirements
  3. Exempt from safe custody requirements (except temazepam, buprenorphine and diethylpropion)
  4. Do not need to record the supply
  5. There are no requirements relating to destruction
  6. Subjected to full import and export control
  7. Script is valid for 28 days
  8. Repeat prescribing is not permitted
  9. INVOICES MUST BE RETAINED FOR 2 YEARS
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11
Q

When is emergency supply only allowed for schedule 3 drugs?

A

Only with phenobarbitone for treatment of epilepsy

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12
Q

Describe Schedule 4 CD drugs and the rules that follow it?
What are the prescription writing requirements?
What do you need to record?
How long is the script valid for?
Who can possess schedule 4 drugs?
Give some examples of schedule 4 drugs?

A
  1. Prescription writing as per POM requirements
  2. Exempt from safe custody and CD entry recording
  3. Script is valid for 28 days
  4. Cannot possess without an appropriate prescription
  5. Possession by practitioners and pharmacists acting in their professional capacities is authorised
  6. Subjected to full import and export control
  7. Example of drugs:
    Part 1: benzodiazepine drugs and others such as zolpidem
    Part 2: anabolic and androgenic steroids including testosterone, clenbuterol and also growth hormones
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13
Q

Describe schedule 5 drugs and the rules that follow it?

How long must the invoices be kept for?

What does holding an appropriate license mean for a practitioner or pharmacist or appropriate person?

A
  1. Includes schedule 2 CDs like codeine, pholcodine and morphine, but they are in schedule 5 as they are in low strength formulations
  2. Invoices must be kept for 2 years
  3. Appropriate license means you can manufacture schedule 5 substances
  4. Some are available as OTC
  5. Safe practice would be to contact the prescriber to confirm it
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14
Q

What is difference on a CD prescription compared to a normal POM prescription?

A
  1. Dose needs to be specific: “ONE as directed” but not “as directed”
  2. Date is valid for 28 days
  3. Important:
    Ensure that the quantity of the preparation or number of unit doses: 20 tablets as well as Twenty tablets
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15
Q

What can pharmacists do about technical errors found on a CD prescription?

A
  1. Pharmacists can supply against prescriptions that have:
    - Minor typographical errors or spelling mistakes
    - The total quantity must be specified in either words or figures but not both
  2. Need to ensure Rx is genuine and supplied in accordance to prescriber
  3. Must amend Rx with indelible ink on main body of script, clearly show amend ends and sign, date and GPhC reg no
  4. All other amendments or omissions must be corrected by original prescriber
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16
Q

What rules must be followed when collecting a dispensed CD?

A
  1. Legally required to determine who is collecting schedule 2 CD
  2. Ask for proof of identity (unless already known to the pharmacist)
  3. Pharmacist has the discretion to decide to supply even if ID is not provided
  4. Good practice for the person collecting is to sign the back, instalment Rx only needs to be signed once.
17
Q

How do you deal with owings of CDs?

A
  1. Owings- CD register must be for the quantity actually supplied.

2, A further entry must be made with the remaining balance is supplied.
Example: supply 8 on one day, record in register, supply remainder 12 on another day, record in register again.

  1. The owing balance for Sch 2, 3 or 4 CDs cannot be dispensed later than 28 days after the appropriate date on the prescription
  2. Sch 5 CDs, the balance of an owing cannot be collected more than 6 months after the appropriate date
18
Q

What are the rules that follow for a private prescription form when it comes to CDs?

A
  1. Private Rx for only Sch 2 and 3 must be written on designated prescription form
  2. But not when CDs are issued and dispensed in hospital
  3. England- FP10PCD
  4. Private prescriber identification number must be included in the form (this is different to the professional reg no.)
  5. The original Rx for Sch 2 and 3 should be submitted to the NHS business services authority for england along with a CD submission form
19
Q

What are the requisition requirements for obtaining a CD?

A
  1. 30th November 2015, must use the standardised CD requisition form
  2. A requisition in writing must be obtained by the supplier (pharmacy) before delivery of any Sch 2 or 3 CD to recipients e.g. GP, hospitals or care homes
  3. In an emergency, a doctor or dentist can be supplied with a Sch 2 or 3 CD if they obtain a requisition within 24 hours
20
Q

What must the requisition sheet include?

A
  1. Signature of the recipient
  2. Name of the recipient
  3. Address of the recipient
  4. Profession or occupation
  5. Total quantity of the drug
  6. Purpose of requisition
21
Q

What are the CD instalments?

A
  1. Instalments are when the total quantity is divided and given at specified intervals
  2. Schedule 2 CDs, buprenorphine (Sch 3) or with naloxone (Sch 3) or diazepam (sch 4) can be dispensed to substance misusers.
    - this is done in instalments for the treatment of drug addiction
22
Q

What prescription form must be used for CD instalments and how many day supply can it be for?

A
  1. FP10 (MDA) blue form under NHS or privately

2. No more than 14 days supply

23
Q

What additional information needs to be included on a FP10MDA prescription?

A
  1. The total quantity in words and figures
  2. The interval between instalments (good practice to specify the dates of the instalments)
  3. The number of instalments
  4. The quantity to be supplied per instalment
  5. The total quantity to be supplied for that period
  6. Dose and instalment amount specified separately
  7. First instalment supplied no later than 28 days after the “appropriate date”
  8. The remainder of the instalments should be dispensed in accordance with instructions
  9. Prescription must be marked with the date of supply
24
Q

How would you endorse methadone?

A
  1. Endorse with the volumes dispensed at each “pick up”
  2. You receive a “professional fee” after each pickup, a CD fee, consumable allowance, container allowance and volume fees paid automatically
  3. Item level fee- £2.50 per script
  4. Packaged Dose fee- 55p can be claimed per additional bottle of oral liquid methadone supplied- must endorse PD and no* of additional packaged dose supplied
25
Q

What rules must you follow about FP10MDA collection?

A
  1. The prescription must be dispensed on the date specified
  2. If not collected on the due date that supply is no longer valid
  3. More than one day’s supply can be prescribed and collected
  4. If several days of instalments are to be collected on one day and the client does not come in on that specified day, then he/she loses the complete instalment. Endorse: NOT DISPENSED
  5. The home office has approved the use of specific wording on the FP10MDA to allow a pharmacist to supply the remaining balance if person fails to collect on date specified
  6. The client may arrange for a representative to collect with a valid note to show authority
26
Q

What does it mean if a patient misses more than 3 days of methadone?

A
  1. Risk that they will lose tolerance and the usual dose may be an overdose
  2. You should contact the prescriber over the telephone
27
Q

What are the rules for the controlled drugs register?

A
  1. For all Schedule 2 CD received or supplied by a pharmacy
  2. No fixed format of CDR
  3. Separate page must be used for each strength and form of that drug
  4. Must be kept at the premises to which it related and be available for inspection at any time
  5. Not to be used for any other purpose
28
Q

What should you record in the controlled drug registers when you obtain a CD?

A
  1. Date the CD supply obtained
  2. Name and address from whom obtained (the wholesaler)
  3. Quantity obtained
29
Q

What should you record in the controlled drug registers when you supply a CD?

A
  1. Date supplied
  2. Name and address of person (or firm) supplied
  3. Details of authority to possess- prescriber or license holders details
  4. Quantity and form (capsule or tablet) supplied
  5. Details of person collecting Sch 2 CD
  6. Whether proof of identity was requested and provided
30
Q

When should you make the CD entry, how long should you keep it for, and how do you enter corrections?

A
  1. Entries must be made on the day of the transaction or on the next following day
  2. Be kept for 2 years from the date of last entry
  3. Entries and corrections must be indelible ink
  4. Entries must not be cancelled, obliterated or altered- corrections must be made by dated marginal notes or footnotes
  5. Good practice that pharmacists should maintain a running balance of stock in the CDR and name the prescriber identification no* of the pharmacist supplying the CD
31
Q

What is the electronic CD reigsters?

A
  1. Regulation require that every computerised entry must be attributable and capable of being audited
  2. It must be accessible from the premises and capable of being printed
  3. Must ensure that safeguards are incorporated into the software to ensure author of each entry is identifiable.
  4. Entries cannot be altered at a later date
32
Q

What rules must be followed when it comes to CD destruction?

A
  1. Pharmacy contractors must have appropriate arrangements in place for safe CD destruction/disposal
  2. Home office advises all Sch 2, 3, and 4 as CDs should be denatured before placed into waste containers
  3. Practicable pharmacists should use CD denaturing kits in order to denature CDs
  4. Expired Sch 2 stock should be witnessed by authorised person and make an entry into the CDR
33
Q

What rules must be followed for patient returns?

A
  1. Community pharmacies can accept CDs returned by patients form their own homes and care homes
  2. Cannot accept waste medicines from care homes that provide nursing care
  3. A record should be made (not in CDR) for patient returned Sch 2 CD
  4. No legal requirement to destroy in presence of an authorised witness- good practice to be witnessed by another staff
34
Q

What rules must be followed for date of expired stock?

A
  1. Legal requirement to destroy expired and unwanted Sch 2 CDs in presence of an authorised witness
  2. Accountable Officers can authorise people or groups of people to witness the destruction. Previously only by the police chemist inspection officers, the RPS inspectors, and the Home Office inspectors.
  3. A record must be made in the CDR and include:
    Drug name
    Form
    Strength and quantity
    Destroyed date
    Signature of the authorised witness
    Signature of the professional destroying it.

PM2D Delivering Pharmacy Services (26 decks)

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