Controlled Drugs Regulations Quiz

OSPAP Programme - Controlled Drugs Part 2: Supply

• The presentation covers controlled drugs (CDs) supply, prescriptions, and regulations.
• The session dates are October 23rd/30th, 2024.
• The course is OSPAP MPHM15.

Learning Outcomes

• Understand the legal supply of CDs in Schedules 2-5 regarding possession, prescriptions (NHS and private), and requisitions.
• Know the legal and good practice standards for recording, storing, and disposing of CDs.
• Know the amendments a pharmacist can make to a CD prescription.
• Understand the regulations for supplying CDs to midwives, relating to driving, and supplied via Patient Group Directions (PGDs).
• Understand regulations for psychoactive substances.
• Learn about witness protection and its implications for CD prescriptions.
• Comprehend how travelling with CDs is regulated.
• Understand the impact of a pandemic on CD supply regulations.

Possession and Supply of CDs (Part 1)

• It is illegal to possess a controlled drug without a licence or authorization from the Home Office.
• Possession of Schedule 4 Part 2 or Schedule 5 drugs is not normally controlled.
• Patients may legally possess CDs if prescribed by a doctor, supplementary prescriber, pharmacist IP, physiotherapist IP, chiropodist/podiatrist IP, or dentist.
• Healthcare professionals must abide by regulations regarding what drugs/schedules they can supply in their professional capacity.

Possession and Supply of CDs (Part 2)

• Pharmacists can possess, manufacture, compound, and supply Schedule 2, 3, 4, or 5 drugs, only while acting within their professional capacity.
• A person authorised to supply may supply only to a person authorised to possess a controlled drug.
• A person lawfully in possession of a CD can supply the drug to the person from whom they obtained it.
• A person lawfully in possession of a Schedule 2, 3, 4, or 5 drug can supply to a doctor, dentist, or pharmacist for destruction purposes.

Possession and Supply of CDs (Part 3) - Examples

• The table details classes of individuals and the types of CDs they can possess and supply.
• Examples show various schedules and authorized persons.

Prescribing and Dispensing CDs

• Doctors and dentists can prescribe any Schedule 2-5 CDs, including cocaine, dipipanone, or diamorphine for treating addiction (if a licence is obtained).
• Nurse independent prescribers and pharmacist independent prescribers can prescribe any Schedule 2-5 CDs (excluding treatment of addiction in certain cases).
• Supplementary prescribers may administer and/or supply Schedules 2-5 CDs under a clinical management plan (CMP).
• Other healthcare professionals such as physiotherapists, chiropodists/podiatrists, therapeutic radiographers, and paramedics also have independent prescribing rights for specific types of drugs in Schedules 2-5.

Secretary of State Prohibitions

• The Home Secretary can prohibit an individual practitioner from specific CD related activities (possession, prescribing, administering, manufacturing, compounding, supplying, or authorizing administration or supply).

Prescription Requirements (Part 1)

• Prescriptions for Schedule 2 or 3 CDs must be indelible and signed by the prescriber.
• Prescriptions for patients must include the prescriber's address, the statement 'For dental treatment only' if issued by a dentist, and the patient's full name and address.

Prescription Requirements (Part 2)

• The prescription must specify the dose, form, strength, total quantity (in both words and figures), and include a date.
• The name of the drug is not a legal requirement.

Validity of Prescriptions

• Prescriptions for Schedules 2, 3, and 4 are valid for 28 days from the specified date.
• Note that the start date of the validity period is confirmed 28 days after the prescribed date.

Supply of CDs on a Prescription

• It is illegal to supply a Schedule 2 or 3 CD if the prescription doesn't meet the requirements.
• The supply must be done before the date specified on the prescription, and within 28 days, unless it is for instalment prescriptions.

Expiry of a CD Prescription

• Prescriptions for Schedule 2, 3, and 4 cannot be dispensed more than 28 days after the appropriate date.
• Prescribers can specify a different start date if required.
• The dispensing date must be recorded on the prescription.
• The full quantity must be dispensed, unless it's an instalment prescription.

Private Prescriptions for CDs

• Schedule 2 and 3 CDs require a special form (FP10PCD) in England.
• It must contain the prescriber's private CD identification number.
• The original form must be sent NHSBSA, and the pharmacy must keep a copy for two years.
• Other drugs beyond Schedule 2 or 3 should not be prescribed on this special form.

Repeat Prescriptions

• Repeat prescriptions for Schedule 2 and 3 are not permitted.
• Schedule 4 CDs have repeats allowed.
• The first dispensing for a Schedule 4 CD must be within 28 days of the prescribed date.
• No time limit exists for subsequent repeat prescriptions, except for those on instalment prescriptions.

Errors on Schedule 2 and 3 CDs Prescriptions (Parts 1 & 2)

• Pharmacists can only correct minor typographical errors, spelling mistakes, or missing quantity in words/figures, but not a combination of both.
• Correcting amendments must be in ink or an indelible method.
• Original prescriber can correct or amend the prescription.

Safe Custody of CDs (Parts 1 & 2)

• CDs requiring safe custody must be kept in a locked cabinet or room, under direct pharmacist supervision at all times.
• There are specific regulations for equipment and safe design.
• Carefully documented procedures must be in place to track access to CD keys.

CD Registers (Parts 1-3)

• People authorized to possess Schedule 2 CDs must keep records of all receipts and supplies, in a register.
• The CD register can be electronic or paper based.
• Separate register entries are needed for each drug type, strength, and form. All relevant data (e.g., dates, quantities, names, supplier details) must be recorded.
• Records must be chronological and must not be altered or cancelled.

Controlled Drug Registers (Part 4)

• Registers must show specific details for each entry (e.g., name of the person who supplied the drug).
• They must include proof of identity check for the person collecting the drugs.

Controlled Drug Registers (Part 5 - Electronic)

• There should be a detailed audit trail using electronic registers.
• Records must be protected from unauthorized alterations or access.
• There should be data logs for tracking purposes.

Controlled Drug Registers (Part 6 - Running Balances)

• Keep track of quantities on hand and use a margin note and footnote to correct any mistakes or discrepancies.
• Pharmacists should regularly check and re-record running balances, ideally weekly.

Collection of Schedule 2 CDs

• The person collecting the Schedule 2 CD must have their identity verified.
• If the person is a patient or representative, evidence of identity should be requested.
• If the person is a healthcare professional, evidence of identity and their details are required.
• Pharmacists have discretion when there is lack of evidence.

CD Requisitions (Schedule 2 & 3 - Parts 1-3)

• Requisitions are needed to supply CDs (Schedule 2 and 3).
• Specific forms (e.g., FP10CDF) are necessary and should be signed by the recipient.
• Suppliers must satisfy that details are genuine.
• Copies should be kept in the pharmacy.
• These rules do not apply to CDs supplied within the same hospital.

Hospital Requisitions (Schedule 2 & 3)

• Hospitals have a separate legal entity in regard to obtaining CDs.
• Bulk/global orders using standard forms can be made for the whole year.
• The legal entity will need to maintain records carefully.

Midwives and CDs (Parts 1 & 2)

• Registered midwives can possess and administer diamorphine, morphine, and pethidine as needed.
• The supply must be supported by a specific order signed by a relevant designated medical officer – and this needs to be maintained in the register for two years.

Destruction of CDs

• All CDs in Schedules 2, 3, and 4 must be denatured before disposal.
• Special equipment and handling are required via denaturing kits.
• The Environment Agency may issue specific permits relating to denaturing.
• Proper procedures are needed for handling out-of-date stock and returned items.

Denaturing Controlled Drugs (Parts 1-3)

• There are specific rules for denaturing different types of CDs, (solids, liquids, parenteral and patches).
• Proper disposal method must follow disposal of CD and be properly disposed of.
• Standard guidance and procedures for denaturing methods are provided in the Medicines Ethics.

Psychoactive Substances

• The Psychoactive Substances Act 2016 bans the sale, supply, and production of psychoactive substances (legal highs).
• Possession of these items is illegal without a license or relevant exemptions.
• A list of permitted and exempted substances is available.

Emergency Measures (Pandemic)

• The government introduced temporary emergency measures for CDs during a pandemic.
• These measures are based on emergency situations (lack of supply).
• Guidelines cover aspects like emergency supply, enabling instalment prescriptions, and supply of CDs, including naloxone under exceptional circumstances.

Drugs and Driving

• Driving under the influence of specific drugs with certain thresholds is illegal.
• Some drugs may be prescribed, but care must be taken to advise patients of the potential implications.
• Medical defence can be available if drugs are taken as prescribed.

Patient Group Directions (PGDs)

• PGDs can be set up to cover administering and supplying certain controlled drugs to patients.
• Some professionals are not allowed to prescribe, supply or administer controlled drugs.

Witness Protection

• Patient address is a legal prescription requirement.
• In cases such as witness protection, alternate addresses may be used but need to be verified and documented.
• Home Office advice for using alternate addresses is available.

Travelling with CDs

• A letter signed by the prescriber is recommended while travelling with CDs with a three-month supply.
• Detailed information about the rules and regulations in each country must be verified from relevant embassies or high commissions.

Other Issues and Standard Operating Procedures (SOPs)

• There are other areas associated with CDs (e.g., information sources, special handling).
• Standard Operating Procedures must be in place and cover CD security, ordering, record keeping, supply, transport, denaturing and the investigation of concerns.

Test your knowledge about the legal requirements surrounding controlled drugs and prescriptions. This quiz covers regulations regarding possession, prescription validity, and the responsibilities of pharmacists. Dive into the specifics of Schedule 2 and 3 drugs and their management.