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Questions and Answers
What is the minimum time that a controlled drug register must be kept after the last entry if it does not include records of destruction?
What is the minimum time that a controlled drug register must be kept after the last entry if it does not include records of destruction?
Which of the following is NOT a requirement for electronic registers?
Which of the following is NOT a requirement for electronic registers?
What must be included when making amendments to a controlled drug register?
What must be included when making amendments to a controlled drug register?
Why is it considered good practice to maintain a running balance of controlled drugs?
Why is it considered good practice to maintain a running balance of controlled drugs?
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What should be ensured about backups for electronic registers?
What should be ensured about backups for electronic registers?
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What type of information must a controlled drug register entry include?
What type of information must a controlled drug register entry include?
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What is a requirement for the access to electronic registers?
What is a requirement for the access to electronic registers?
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How long should a controlled drug register that includes records of destruction be kept?
How long should a controlled drug register that includes records of destruction be kept?
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What must be included in the CD register when receiving controlled drugs?
What must be included in the CD register when receiving controlled drugs?
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Which of the following is required when a controlled drug is supplied?
Which of the following is required when a controlled drug is supplied?
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What should be done if it is not reasonably practicable to record a transaction in the CD register on the day of the transaction?
What should be done if it is not reasonably practicable to record a transaction in the CD register on the day of the transaction?
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What is the requirement for making corrections in the CD register?
What is the requirement for making corrections in the CD register?
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When authorized individuals record in the CD register, how should the entries be organized?
When authorized individuals record in the CD register, how should the entries be organized?
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What is a requirement for the format of the CD register?
What is a requirement for the format of the CD register?
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What details must be recorded about the prescriber when a controlled drug is supplied?
What details must be recorded about the prescriber when a controlled drug is supplied?
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What happens to out-of-date controlled drugs according to the safe custody regulations?
What happens to out-of-date controlled drugs according to the safe custody regulations?
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What is the frequency recommended for checking running balances of liquid CDs?
What is the frequency recommended for checking running balances of liquid CDs?
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In case of a discrepancy found during a check, what is the required action?
In case of a discrepancy found during a check, what is the required action?
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What must be recorded when a Schedule 2 controlled drug is collected by a healthcare professional?
What must be recorded when a Schedule 2 controlled drug is collected by a healthcare professional?
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Which of the following is NOT a required element of a legal requisition for controlled drugs?
Which of the following is NOT a required element of a legal requisition for controlled drugs?
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What is the recommended practice for checking running balances?
What is the recommended practice for checking running balances?
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What should a pharmacist do if the identity of a collector of a controlled drug is not known?
What should a pharmacist do if the identity of a collector of a controlled drug is not known?
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Which type of registers may become a legal requirement as electronic records are increasingly used?
Which type of registers may become a legal requirement as electronic records are increasingly used?
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What is the purpose of the footnote or margin note when correcting a discrepancy?
What is the purpose of the footnote or margin note when correcting a discrepancy?
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Who is responsible for supplying written requisitions for controlled drugs under the defined roles?
Who is responsible for supplying written requisitions for controlled drugs under the defined roles?
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What is encouraged as good practice when a controlled drug is delivered by a pharmacy?
What is encouraged as good practice when a controlled drug is delivered by a pharmacy?
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Study Notes
Controlled Drug Registers
- Those authorised to possess Schedule 2 CDs must keep records of all receipts and supplies
- Each drug, strength and form must have a separate paper register or distinct section in an electronic register
- The register must be a bound book unless it's electronic
- Entries should be in chronological order and made the day of the transaction or the following day if that is not reasonably possible
- Amendments must have a footnote or margin note with the person's name, signature, GPhC number, and date
- No cancellations, obliterations, or alterations to entries are permitted
- The register must be kept at the premises for 2 years after the last entry, or 7 years if it includes records of destruction
- Records are required for:
-
CDs Received
- Date of receipt
- Name and address of supplier
- Quantity received
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CDs Supplied
- Date of supply
- Name and address of the person or firm supplied
- Details of the person or firm's authority to possess
- Quantity supplied
- Details of the person collecting the drug (patient, patient's representative or healthcare professional) and if a healthcare professional, their name and address
- Whether proof of identity for the patient, their representative or healthcare professional was requested
- Whether proof of identity for the person collecting the drug was provided
-
CDs Received
- Entries must be in ink or indelible
- Electronic registers can be used only if:
- The author of the entry is identifiable
- Entries cannot be altered after the initial entry
- All data is logged and can be retrieved for audit
- Adequate backups are made
- Access is controlled to prevent unauthorised or unnecessary access
- The information can be viewed without interrupting the dispensing process
- It can be printed out if needed
Running Balances
- Keeping a running balance of CDs is not a legal requirement but it is considered good practice
- Balances should be checked regularly
- The aim of running balances is to quickly identify irregularities or discrepancies
- When checking running balances, the pharmacy should have a documented Standard Operating Procedure (SOP) regarding checking methods and dealing with discrepancies
- Discrepancies should be resolved and then documented with margin notes or footnotes in the register
- Running balance checks should be recorded, signed, and dated, ideally with two registered pharmacists or technicians present
- This process is likely to become a legal requirement with increased use of electronic registers
Collecting Schedule 2 Controlled Drugs
- It's a legal requirement to establish whether the person collecting the CD is the patient, their representative, or a healthcare professional
- If it is the patient or their representative, proof of identity should be requested unless it is already known
- If it is the healthcare professional, proof of identity should be requested unless it is already known and the professional's name and address must also be recorded
- Pharmacists may exercise discretion based on professional judgment if proof of identity is not available
- All collection information must be recorded in the CD register
- It is good practice to have the collector sign FP10s (even for Schedule 3 drugs) to help establish an audit trail for dispensing controlled substances
- If a CD is to be delivered by the pharmacy, then the driver is considered the collector and must sign on behalf of the patient, but there should be a process to confirm delivery to the patient
Requisition for Schedule 2 and 3 Controlled Drugs
- Requisitions are also referred to as "signed orders"
- This transaction falls under the definition of wholesale dealing
- The CD supplier MUST obtain a written requisition before delivering CDs to the following:
- A practitioner
- Person in charge of a hospital, organization providing ambulance services or care home
- Senior nurse in charge of any department of a hospital or nursing home
- Person in charge of a laboratory
- Owner or master of a ship with no doctor on board
- Master of a foreign ship in a GB port
- Installation manager of an offshore installation
- A supplementary prescriber
- A nurse or pharmacist independent prescriber
- An operating department practitioner
- A special requisition form (FP10CDF in England) is a legal requirement, except for hospices and prisons.
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Description
This quiz tests your knowledge on the regulations and requirements for maintaining Controlled Drug Registers. It covers aspects such as record-keeping, entry protocols, and the duration for which records must be retained. Enhance your understanding of the legal standards surrounding Schedule 2 controlled substances.
