Document

Approved 25.3.09 Version 1 Review by:March 2011 1

Appendix K

Legal Requirements and

Good Practice Guide

For the Management Of Controlled Drugs

In Primary Care

Incorporating Example Standard Operating Procedures


General Guidance 1.0 Introduction The Controlled Drugs (Supervision of Management and Use) Regulations 2006 came into effect on the 1st January 2007 as a result of the Government’s response to the Fourth report of the Shipman Inquiry. It is a requirement of these regulations that organisations (including contractors) should have approved Standard Operating Procedures (SOPs) for the handling of controlled drugs. The main drive of these revised regulations is to ensure that robust systems are in place for the management of controlled drugs, including a clear audit trail for all stages in the handling of Controlled Drugs in primary care. It is the aim of this document to provide GP surgeries with guidance and example Standard Operating Procedures to enable them to achieve this. Every effort has been made to ensure that the information provided in this document is accurate and up-to-date. However, the legal and regulatory framework governing Controlled Drugs is continuing to change significantly and readers should always check that they are referring to the most up-to-date version of this guide, as well as cross-checking with other recognised sources of information e.g.

• A Guide to Good Practice in the Management of Controlled Drugs in Primary Care (England).Second Edition. National Prescribing Centre. Feb 2007 http://www.npc.nhs.uk/controlled_drugs/cdpublications.htm

The Health Act (2006) and “The controlled Drugs (Supervision of Management and Use) Regulations 2006 (Statutory Instrument 2006 No 3148)” provides the legislation governing the role and responsibilities of the CD AO, and introduced a statutory duty of collaboration on all healthcare organisations and other local and national agencies to share intelligence on controlled drugs issues through a local intelligence network led by the PCT.

2.0 PCT role and responsibilities: The PCT has a statutory duty to appoint a Controlled Drugs Accountable Officer (CD AO) who is responsible for ensuring the safe and effective use and management of CDs within local organisations (including private providers, hospices etc) and must have regard to best practice in relation to the management of CDs. The Health Act (2006) and “The controlled Drugs (Supervision of Management and Use) Regulations 2006 (Statutory Instrument 2006 No 3148)” provides the legislation governing the role and responsibilities of the CD AO.


The main aspects are: • The PCT is required to and has appointed a Controlled Drugs Accountable

Officer who is responsible for ensuring the safe and effective use of Controlled Drugs (CDs) within the PCT, and across all independent Contractors as part of the statutory requirements.

• The CD Accountable Officer for NHS Kirklees is Neill McDonald, Assistant Director of Medicines Management.

• Ensure safe systems and processes for the management of Controlled Drugs are in place across NHS Kirklees, and within organisations handling controlled drugs within this geographical area.

• Ensure appropriate arrangements are in place to comply with Misuse of Drugs legislation.

• Ensure adequate and up-to-date SOPs are in place in relation to the management and use of CDs in all settings.

• Ensure arrangements are in place for witness of destruction / disposal of date expired CDs.

• Introduce systems for the regular monitoring and audit of the management and use of CDs. CD prescribing, Analysis and Cost (PACT) data is analysed to highlight unusual patterns of prescribing (e.g. quantities, frequency ,length of supply) by the Medicines Management Team.

• Arrange periodic inspection of practices to ensure that they are complying with CD regulations.

• Ensure that all contractors and providers of services complete and return a “Controlled Drugs Statutory Return” at least every 24 months.

• Ensure staff who are involved in the handling and management of controlled drugs have received training appropriate to their role.

• Maintain a database of concerns relating to incidents and relevant individuals

• Assess and investigate concerns and take action where necessary. • Establish a Local Intelligence Network to facilitate the sharing of

information and concerns. This information may be shared with the police, social services, Commission for Social Care Inspection and The Royal Pharmaceutical Society of Great Britain and other designated Accountable Officers as deemed appropriate.

• Ensure that the PCT has an up to date policy on the Management of Controlled Drugs

3.0 GP Surgery role and responsibilities: 3.1 Introduction: It is the responsibility of GP surgeries to ensure that they have processes in place which enable them to comply with current regulations and good practice guidance regarding all aspects of Controlled Drug management.


The information contained within this document is based on national guidance and regulations in respect to the management of Controlled Drugs. Practices may wish to adopt or adapt this guidance to suit their own circumstances, however, any modifications MUST follow current regulations and good practice – a summary of which is contained within this document. 3.2 Designated Senior Heath Professional: It is the responsibility of each GP practice to nominate a designated senior health professional (this may be the governance lead, prescribing lead or the senior GP partner). This person has overall responsibility for the management of controlled drugs within the practice. This responsibility includes:

• Ensuring storage and record keeping of CDs complies with current regulations and good practice;

• Having up to date SOPs in place for all processes involving CDs at the practice, which have been read, signed and dated by all appropriate staff.

• Investigating discrepancies or incidents involving controlled drugs when they occur, and maintaining records of such investigations.

• Reporting unresolved discrepancies or other concerns regarding controlled drugs to the PCT Accountable Officer as soon as possible.

• Make available, upon request, all documentation relating to Controlled Drugs management within the practice to the PCT Controlled Drugs Accountable Officer or an officer appointed by him / her to undertake investigations / inspections, including CD registers, CD stocks etc.

• Independent contractors (GPs, Dental practitioners etc) will be required to complete a statutory declaration (at least every two years) on the management of controlled drugs which will include details on: prescribing, storage, administration, disposal etc., and to identify if there are any special circumstances that might explain seemingly unusual or high patterns of prescribing and supply.

• Further information on the PCTs supervision and monitoring of Controlled Drugs can be found in the PCT “Controlled Drugs Policy”.

4.0 Community Pharmacy responsibilities 4.1 Introduction: It is the responsibility of Community Pharmacies to ensure that they have processes in place which enable them to comply with current regulations and good practice guidance regarding all aspects of Controlled Drug management. The information contained within this document is based on national guidance and regulations in respect to the management of Controlled Drugs. Pharmacies may wish to adopt or adapt this guidance to suit their own circumstances, however, any modifications MUST follow current regulations and good practice – a summary of which is contained within this document.


4.2 Designated Senior Heath Professional / Controll ed Drugs Lead It is the responsibility of each community pharmacy to nominate a designated person to take overall responsibility for the management of controlled drugs within the pharmacy, this will usually be the pharmacist manager. This responsibility includes:

• Ensuring storage and record keeping of CDs complies with current regulations and good practice;

• Having up to date SOPs in place for all processes involving CDs within the pharmacy, and should include SOPs covering delivery of controlled drugs by delivery drivers if this occurs.

• Ensuring that staff have read, understood, signed and dated all SOPs which relate to their work activities in relation to Controlled Drugs.

• Investigating discrepancies or incidents involving controlled drugs when they occur, and maintaining records of such investigations.

• Reporting unresolved discrepancies or other concerns regarding controlled drugs to the PCT Accountable Officer as soon as possible.

• Make available, upon request, all documentation relating to Controlled Drugs management within the Pharmacy to the PCT Controlled Drugs Accountable Officer or an officer appointed by him / her to undertake investigations / inspections, including CD registers, CD stocks (currently inspection of community pharmacies is undertaken by the RPSGB inspectorate)

• Independent contractors (GPs, Dental practitioners, Pharmacies etc) will be required to complete a statutory declaration (at least every two years) on the management of controlled drugs which will include details on: prescribing, storage, administration, disposal etc., and to identify if there are any special circumstances that might explain seemingly unusual or high patterns of supply.

• Further information on the PCTs supervision and monitoring of Controlled Drugs can be found in the PCT “Controlled Drugs Policy”.

5.0 Dental Practice Responsibilities As for GP practice responsibilities in section 3 above. 6.0 Legislation "Controlled Drug" (CD) means a drug as classified in Schedule 1, 2, 3, 4, or 5 of the Misuse of Drugs Regulations 2001 (this is an amendment to the 1985 regulations) . (see appendix 1 for summary of legal requirements, and appendix 2. for full list of drugs) The Misuse of Drugs Act 1971 is the legal Act governing the management of Controlled drugs, and permits this through its supporting regulations.


The primary purpose of this legislation is to prevent, as far as is possible, the misuse of drugs identified within the legislation. It does so by imposing a total prohibition on the possession, supply, manufacture, import or export of any of the drugs named except as allowed by the regulations or by licence from the Secretary of State. Use of CDs for medicinal purposes is permitted through the Misuse of Drugs Regulations 2001. These regulations define the classes of person who are authorized to supply and posses CDs whilst acting in their professional capacity, and lay down the requirements under which these activities may be carried out. The Health Act (October 2006) introduced a number of additional Statutory Duties on NHS trusts and health professionals, and introduced the role of the Controlled Drugs Accountable Officer (CD AO) whose duty it is to ensure the safe and effective use of controlled drugs within the PCT (including independent contractors). 7.0 Schedules of Controlled Drugs (see appendix 2) There are 5 “schedules” relating to the control of CDs, with Schedule 1 having the tightest level of control, and schedule 5 the least tight (see appendix 2 for full listing of drugs in Schedule 1 to 5). • Schedule 1 CDs, e.g. LSD and cannabis may only be possessed or used by

persons with a Home Office licence for research or other special purpose. • Schedule 2 includes the opiates, the major stimulants, secobarbital and other

substances e.g. amphetamine. • Schedule 3 includesTemazepam, the barbiturates, Buprenorphine,

Pentazocine and Flunitrazepam and Midazolam. • Schedule 4 contains anabolic and androgenic steroids and most of the

benzodiazepines. • Schedule 5 contains preparations of certain CDs e.g. Codeine syrup

(25mg/5ml & 15mg/5ml), Pholcodine (5mg/5ml) and Morphine (10mg /5ml), which are exempt from full control when present in medicinal products of low strength.


Legal Requirement

Good Practice

1. Controlled Drugs Stationary All stationary relating to controlled drugs is classified as controlled stationary. Practices must have in place strict procedures (SOPs) governing their storage and management. 1. Controlled Drug Register Controlled drug registers are classed as secure stationary, and must be stored in a locked drawer / cupboard only accessible to appropriate staff. Please note it must not be locked inside the CD cupboard. 2. Controlled Drug Order book (Holme Valley Memor ial Wards Only) CD order books are classed as controlled stationary, CD order books must be stored in a locked secure location at all times only accessible to designated staff, and must not be locked inside the CD cupboard. 3. Controlled Drug Requisitions (contractors and PCT provider services) In January 2008, a new “controlled drug requisition” form (FP10CDF) was introduced by the Department of Health. These forms have been provided to all pharmacies and GP practices, and should be used for all orders for stock CDs (including stock for the doctors bag) from / between community pharmacies. These requisitions have unique serial Numbers. Supplies of these forms, and a register of their serial numbers (including when used) should be stored in a suitable locked receptacle (eg drawer / cupboard / safe) separate to CD stock drugs, and should only be accessible to designated staff. 4. CD prescription forms

• For forms FP10CDF “controlled drug requisition” contractors need to record the serial number of any blank forms, and record when these have been used, and who they have been used by. Ideally this should be recorded in a specific section of the practices record book for recording prescription pads received / issued.

• Practitioners who have been issued with prescription forms

FP10 (MDA), and FP10 (PCD) should maintain a log of prescriptions issued to patients including those that have not been issued due to error / cancellation at the point of prescribing etc. This log should be used to check the serial numbers of those prescriptions left the next time the prescription pad is used to ensure no prescriptions have been lost / stolen.


There are two specific prescription forms available for CD prescribing in Primary Care: • FP10 (MDA) – Instalment prescription form for drug

addicts • FP10 (PCD) – Private CD prescription form

In both instances, these are classed as controlled stationary, and must be stored securely (in a suitable locked receptacle), with a record of the serial numbers of prescription pads that are held in stock, and those that are in use and by which practitioner (private CD pads relate to specific individual Doctors, and may only be used by that named doctor). The record book / register of CD prescription pad serial numbers must be remote to that of stocks of CD prescription pads. Only designated staff should have access to the records and stocks of prescription pads. 2. Controlled Drug Stock (GP practices) • Practitioners must NOT use patient-specific prescriptions for

CDs to replace or “top-up” their Doctors bag or practice stock, even if the stock was used for that patient initially. To do so could be considered as an offence under the Theft Act, and may be seen as a means of obtaining CDs by deception.

• Medicines prescribed for an individual patient must be

supplied to, and used by, that patient only.

• Stock levels should be kept to a minimum. Practices should review their CD usage when assessing their current need for CD stock. The level of stock held should be reviewed at least annually.

• Supplies of naloxone 400 micrograms in 1ml (an antidote

to opiate induced respiratory depression) are required in the same clinical storage locations where diamorphine and morphine injections are stored. The minimum recommended amount is 3 x 1ml ampoules.

3. Controlled Drugs Stock (other settings) • Medicines prescribed for an individual patient must be

supplied to, and used by, that patient only. • Stock CDs may be administered to any patient with a legal

as for GP practices


prescription if the patient is on an inpatient unit / ward (i.e. an inpatient prescription card signed by a doctor for Holme Valley Hospital wards)

4. Ordering / Purchase of Controlled Drugs • Controlled drugs may be obtained from community

pharmacies or from registered wholesalers both for practice use or for stock upon the production of a written requisition (applies only to schedule 2 and 3 CDs).

• The requisition may be hand written or computer generated,

but must contain all the following information:

o The name, address and profession or occupation of the recipient (i.e. the person ordering the CDs).

o The drug name, form, strength and total quantity to be supplied (this does not have to be in words and figures).

o The purpose for which it is required (e.g. “ for practice use”)

o Must be signed by the recipient (who must be a qualified prescriber who has prescribing rights to prescribe the CD ordered).

o Date the order was generated

• If a messenger is sent to collect the CD, they must carry a note of authorisation signed by the prescriber stating that they are authorised to collect the CD.

• From January 2008 a dedicated requisition form (FP10CDF)

was introduced for the supply of schedule 1, 2 and 3 CDs (otherwise than on prescription or by way of administration). This form ensures all legal requirements for ordering CDs are met. (these forms are available from WYCSA at St Lukes’ House).

• The prescribers professional registration number should be routinely stated on the signed order / requisition to support the maintenance of the audit trail.

• Prescribers should retain all invoices for all CDs obtained

for seven years, or longer if possible. • Dispensing doctors are not expected to submit requisitions

for “bag stocks” obtained from their own dispensaries. However, dispensing practices should use their own internal systems with good audit trails.


• The FP10CDF order form must be used in normal

circumstances for CD requisition. However, in exceptional circumstances, where for example an individual may have difficulty in obtaining the form FP10CDF, a CD can be supplied in response to an order on a non-standard form, provided all the legal requirements are met (see above).

• Suppliers of CDs shall submit the original requisition for all

schedule 1, 2 and 3 CDs to the NHS Business Services Authority (prescription Pricing Division) at the end of the month in which they were supplied (applies only to supplies made from community pharmacies).

• Legally all requisitions and invoices for CDs must be kept for a

minimum of 2 years (see also best practice guidance) • Unlike community pharmacies, Dispensing Doctors cannot

supply medicines without a “wholesaler Dealer’s Licence”. Where a dispensing doctor holds a licence, the requisition would not need to be submitted to the PPD as wholesalers do not currently have to make such submissions – they may however be subject to a Home Office inspection.

Copy / Faxed orders Under no circumstances may a carbon copy or fax of an order (or requisition) be used to order / obtain supplies of a schedule 2 or 3 controlled drug. 5. Controlled Drugs Register / Recording Requirem ents The definition of a CD register in the 2001 Regulations was amended in November 2005 to allow (not require) the register to be held on a computerised system which complies with specified best practice guidance. The Regulations require that entries in

The register should • Have specimen signatures and initials are to be included

at the front or rear of each register in use, detailing the full name and professional registration number of each person


computerised registers must be attributable and capable of being audited. • Records for the receipt and supply of Schedule 2 CDs must

be kept in a CD register (CDR). • CDRs may be maintained either in a paper bound or

electronic format. • All health care professionals who hold personal stocks

(doctors bag) of Schedule 2 controlled drugs must keep their own register, and are personally responsible for keeping the relevant CD registers accurate and up to date.

• The format and requirements for CDRs are specified in

regulations 19 and 20 of the Misuse of Drugs Regulations 2001. The regulations state that registers must:

o Be bound (not loose-leaved) if paper; or an electronic

system which is in accordance with best practice guidance

o Have separate pages (in paper) or sections for each strength and form of an individual drug.

o Have the name, strength and form of the drug at the top of each page. In the case of an electronic register, it must be capable of printing or displaying the name, form and strength of the drug in such a way that the details appear at the top of each display or printout.

o Have entries in chronological order and made on the day of the transaction or the next day

o Have entries made in ink or otherwise so as to be indelible or in computerised form in which every such entry is attributable and capable of being audited and is in accordance with best practice guidance endorsed by the Secretary of State under section 2 of the NHS Act 1977.

who makes an entry in that register; • Be uniquely numbered on the front cover; • Kept for a minimum of 10 years. • Two members of staff should check all stock received or

removed, and both individuals should initial the entry in the CD register.

• It is recommended that GPs keep a record of batch

numbers of controlled drugs in the register. • Restocking of the “doctors bag” from practice stock should

be witnessed by another member of the practice staff. • Within dispensing practices, the transfer of a Schedule 2

CD from dispensary stock to the “doctors bag” should entail a record in the dispensary CDR detailing the supply and a record in the “doctors bag CDR2 detailing the receipt. This stock transfer should be witnessed by a second member of staff.

• CD stocks should be checked against the CD register at

regular intervals. Ideally these should be checked when items are received into stock, or are dispensed / administered, and as a minimum at least monthly (weekly for pharmacies where multiple entries are made each week for a particular drug / preparation) – the process and frequency of stock checks should be clearly stated within SOPs relating to the premises to which the register / stocks apply.

• Accountability for maintaining the running balance of CD

stock and for dealing with any discrepancies lies with the healthcare professional in charge of the working environment / premises where CDs are received, stored


o Not have cancellations, obliterations or alterations; corrections must be made by a signed and dated entry in the margin or at the bottom of the page.

o Be kept at the premises to which it relates and be available for inspection at any time. A separate register must be maintained for each set of premises (i.e. not just the main surgery if CDs are stored in both the main and branch surgeries)

o A separate register must be kept for each place CDs are stored (for example, the main surgery CD cupboard and a GP’s bag for home visits MUST have separate registers);

o Pages must be sequentially numbered o Be kept for a minimum of two years after the date of

the last entry, once completed (this is expected to increase to 11 years once computerised registers are in common use).

o Not be used for any other purpose o A running balance of stock will be kept in accordance

with the SOP for Running Balance Stock Check. This guidance may be found at : www.rpsgb.org.uk/pdfs/cdrunningbalanceguid.pdf

o Any discrepancies found in the running balance will be brought to the attention of named person responsible for CD’s, who will investigate the discrepancy further, and in accordance with the SOP for Discrepancy Resolution.

For controlled drugs received into stock The following details must be recorded:

o Date received o Name and address of the supplier (e.g. wholesaler or

community pharmacy) o Quantity received o Name, form and strength of the drug

and supplied / administered. If anyone finds a discrepancy, it should be investigated thoroughly as soon as possible.

• Where a patient returns a CD for destruction (to a

community pharmacy), an entry should be made in a separate CD register for returned CDs for destruction, and be witnessed by a second member of staff. This provides a clear audit trail should any questions be raised at a later date. Details within the register should include the drug name, form and strength, the quantity returned, the name and address of the person returning the CDs, and who they were originally dispensed for. (destruction of patient returned CDs may be undertaken by the pharmacist, and should be witnessed by another member of the pharmacy staff).


For controlled drugs supplied the following details must be recorded:

o Date supplied o Name and address of the patient (or person / firm

supplied) o Details of the authority to possess – prescriber or

licence holder’s details (name and address registration No)

o The quantity supplied o The name form and strength of the drug supplied o Whether the person who collected the drug was the

patient, the patient’s representative, or a healthcare professional acting on behalf of the patient.

o The name and address of the healthcare professional if this person collected the drug

o Whether proof of identity was requested if the person collecting was the patient or their representative.

o Whether evidence of identity was provided by the person collecting the drug (if requested)

• When a doctor makes a supply to a healthcare professional

the doctor must record the name and address of the receiving healthcare professional. If the professional is not known to the doctor, evidence of their identity must be obtained. A record of these details must be made in the CD register (legal requirement ass of 1st February 2008)

There are commercially available CD registers which fulfil all the above requirements. The PCT would strongly recommend that practices use these. Details of suitable suppliers can be obtained from the PCT Medicines Management Team. 6. Stock checking / actions to take in the event of stock discrepancies • Accountability for maintaining the running balance of CD stock • Standard Operating Procedures (SOPs) should clearly


and for dealing with any register / stock discrepancies lies with the healthcare professional in charge of the healthcare working environment / premises where CDs are received, stored or supplied from.

• Any corrections to the register must be made in such a

manner as to not have cancellations, obliterations or alterations; corrections must be made by a signed and dated entry in the margin or at the bottom of the page, along with a reason for the entry.

• If the source of the discrepancy cannot be identified during the stock check, then a nominated member of the relevant organisation must be informed and a formal internal investigation undertaken. This may include discussion with the relevant professional body, or other inspectors. If this still does not resolve the issue satisfactorily the Police should be informed. The PCT CD Accountable Officer MUST be informed of any concerns or incidents in relation t o the management and use of CDs immediately

• If drugs are accidentally destroyed or damaged (could be in

transit), then this should be recorded in the appropriate section of CD register as soon as possible after the event in order to maintain an auditable trail.

define the actions to be taken should a discrepancy be discovered. This should include

o Checking the register for adding errors o Omissions in the recording of receipts or supplies

• Where stock / register discrepancies cannot be resolved,

this should prompt a review of SOPs for the storage and handling of CDs relating to that work environment.

• For liquid CDs it is recognised that stock discrepancies are likely to occur due to slight overages and measuring errors. This is most common with Methadone liquids. Overages are generally ij the order of 5 – 10 ml per 500ml manufacturers bottle. It is acceptable to make “reasonable stock / register” adjustments in these situations, indicating the reason for the adjustment and the entry witnessed by another member of staff – there should never be less stock than the register indicates for liquid CDs (if this is the case check for errors). The need to make adjustments will depend on the volume of use of such liquid CDs.

• All incidents should be reported in accordance with the

PCT incident reporting policy.

7. Storage in the practice / Access to CD cabinet s and keys The Misuse of Drugs (Safe Custody) Regulations 1973 lay down a number of legal requirements in respect to the storage of controlled drugs: • Schedule 2 & 3 CDs are subject to safe custody requirements

under the Misuse of drugs Regulations 1973. However all Schedule 3 CDs with the exception of Temazepam, diethylpropion, buprenorpine and flunitrazepam are exempted.

• The keys should always be kept separate from the cabinet/safe and should never be accessible to unauthorised persons.

• The room containing the cabinet/safe should be lockable

and not accessible to patients, as should the keys required for access. Where patients do need to enter the area where CDs are stored, it is good practice to that they


This in effect means that the non exempted Schedule 3 CDs must be stored in the same manner as Schedule 2 CDs.

• Schedule 2 & 3 CDs should be stored under lock and key

(with a unique and sturdy lock) in a cabinet/safe made of metal, which is secure, non portable, and complies with BS2881, and should be secured to the wall or floor with rag bolts (these bolts should not be accessible from outside the cabinet).

• The walls of the room should be constructed to a suitable

thickness using suitable materials so as to make it difficult to remove the safe / cabinet.

• The cabinet/safe must be locked after each entry and not left

open during clinic times.

• It is not acceptable to use a ‘Doctor’s bag’ as permanent storage for CDs that are intended to be used on site or to replenish a ‘Doctor’s bag’.

• The walls of the room should be constructed to a suitable

thickness using suitable materials so as to make it difficult to remove the safe / cabinet.

should be continuously supervised until such time as they leave the area.

Access to the CD cupboard / safe should be restricted to authorised persons only. (e.g. Nurse, Pharmacist, Doctor – for full listing see page 13 http://www.npc.co.uk/controlled_drugs/CDGuide_2ndedition_February_2007.pdf • The CD cabinet should be used solely for the storage of

CDs. There should be no reason why an unauthorised person without legitimate business relating to the supply or stock control of CD stock should need to access the CD cupboard. Cheque books, petty cash and other items requiring high security measures should be stored elsewhere.

• The room containing the safe/cabinet should be lockable

and tidy around the safe/cabinet area to avoid drugs being misplaced.

• Store different strengths of CDs (e.g. diamorphine and

morphine) apart. Be aware of similar packaging, especially injectables.

• Risk assess strengths of Injectable diamorphine and

morphine stocked. Lower strengths (e.g. 5mg and 10mg) are required for acute care, and higher strengths products (e.g 20mg and 30mg) are usually required for use with a syringe driver.

• If a safe is used to store CDs, and other items have to be

stored within the safe, then there should be a separate locked receptacle within the safe that keeps the CDs apart from other items.


• Access to key cupboards should be restricted and removal of keys for CD cabinet/safe should be logged, so that it is known at all times who is in possession of the keys.

• The number of sets of keys and who holds them must be

known at all times. One designated person within the premises should take overall responsibility for the keys. The cabinet/safe should only be opened by the designated person concerned, or by a person authorised by them. An emergency spare set of keys to the CD cabinet/safe should be available. These should not be stored with the normal set of keys. Access to these should also be restricted and removal from the area should also be logged.

• The CD register should be stored in an appropriate

location near to the CD cabinet/safe where the confidentiality of its contents can be maintained – it must not be stored in the CD cabinet.

• Stock should be kept to a minimum and nothing should be

displayed outside to indicate that CDs are kept within the safe/cabinet.

• The location of CD cupboards / safes should be sited such

that they are not visible to members of the general public passing outside windows etc.

• All dispensed CDs must be stored in the CD cupboard or

designated safe until they are collected. • It is recommended that all strengths of oral morphine

solution are treated as Schedule 2 controlled drugs, unless in the domiciliary setting.


• Where stock CDs are transported from one site to another, a locked receptacle should be used. Nothing should be displayed on the receptacle to indicate that controlled drugs are contained within it. The person transporting CDs in such a manner will need to sign for safe custody both when accepting the CDs for delivery, and upon delivery at the intended destination to ensure the audit trail is maintained.

8. Storage in a ‘Doctor’s bag’

• A ‘Doctor’s bag’ is defined as a locked bag, box or case and should be kept locked at all times, except when in immediate use. Legally, a ‘doctor’s bag’ is regarded, once locked, as a suitable receptacle, but a locked car is not.

• The person in lawful possession, or an individual

authorised by them, must always retain the keys.

• The “Doctor’s bag” can be lockable either by key or by combination lock

• In the practice they should be stored in a safe place

away from patient areas where the confidentiality of its contents can be maintained.

• When taken out of the practice (including at home) they

should be locked, secure and out of the reach of others. They should not be left in a vehicle overnight, or in a vehicle left unattended for long periods of time. External temperatures may have a significant effect o n the stability of medicines and suitable precautions should be taken to protect them for example keeping them in suitable insulated containers.

• Stock levels should be kept to a minimum and informed

by previous requirements. Doctors should review their CD usage when assessing their current need for CD stock (oral preparations of CDs would not routinely be considered essential items to be carried in a ‘Doctor’s bag’).

• Normally only one strength of each CD should be kept

in a ‘Doctor’s bag’ in order to minimise the risk of


confusion, error and inappropriate administration.

• It is good practice for the doctor or delegated member of staff to undertake a monthly stock check of CDs held within their ‘Doctor’s bag’. This process also provides a good opportunity to check for any out-of-date (or late expiry) stock.

9. Prescribing and Prescription Requirements CDs prescriptions may be computer generated (except the signature) and are subject to a number of requirements (except temazepam, phenobarbital, phenobarbital sodium and preparations containing them) The prescription MUST comply with the following requirements: • Be in ink or otherwise so as to be indelible • Specify the name and address of the person issuing it (ie the

prescribers address). • If issued by a dentist, have written on it the words “for dental

treatment only”. • Specify the patient’s full name, address and age, where

appropriate (legal requirement to include age for patients under 12 years being prescribed any prescription only drug) (an –mail address or PO Box is not acceptable. “No fixed abode” is acceptable as an address for a homeless person).

• Specify the name and form of the drug • Specify the strength of a preparation • Specify the dose to be taken • Specify either the total quantity (milligrams) or the total

number of dosage units to be supplied in words and figures • Be signed by the prescriber with their usual signature (this

must be handwritten) and dated by them (the date does not have to be handwritten)

• Specify, in the case of a prescription for a total quantity

• The quantity of drugs prescribed should be appropriate for the clinical need of the patient.

• The quantity of Schedule 2, 3 & 4 CDs prescribed at

any one time should not exceed 30 days supply . Where the prescriber believes that a supply in excess of 30 days is indicated and will not pose an unacceptable risk to the patient. A justification for the decision should be recorded in the patients notes in the event that a decision needs to be justified at a later date.

• Repeat prescriptions for Schedule 2 and 3 CDs should not

routinely be issued. Patients being prescribed these drugs should be reviewed regularly.

• Particular care should be taken to ensure clarity of dosage

instructions where systems such as syringe drivers are being used.

• Include weight and the intended dose in milligram per

kilogram on prescriptions for children. • Where possible include the patient’s NHS number (this will

become a legal requirement in future amendments to the regulations) – this includes private CD prescriptions.


intended to be dispensed in installments (FP10MDA), a direction specifying the number of installments, the amounts and the intervals at which they are to be dispensed.

• Where a prescription is handwritten, it should all be written by the prescriber and not by a third party (except for Phenobarbital – where it may be written by a third party, but signed by the doctor)

• Phenobarbital – the total quantity still needs to be in words

and figures but the date no longer has to be handwritten. • Supplementary prescribers may prescribe any CD when

acting under and in accordance with the terms of a clinical management plan.

• Independent nurse prescribers are restricted in the range and

formulations of CDs they can prescribe and the conditions they can prescribe them for – this can be accessed at:.

http://www.dh.gov.uk/assetRoot/04/13/37/47/04133747.pdf Dispensing • in order for a schedule 2 or 3 CD to be dispensed, it must

comply with the legal requirements as above. In addition, the pharmacist (or person dispensing) must ensure that the address of the prescriber is within the United Kingdom, and that they are familiar with the prescribers signature or have no reason to suppose that it is not genuine.

• As it is now a legal requirement for pharmacists to ascertain

the role of anyone collecting a schedule 2 CD supplied against a prescription, you may wish to advise the patient or their representative at the time of prescribing that they may be asked for identification.

• Prescriptions for Schedule 2, 3 & 4 CD may only be

dispensed up to 28 days from the date prescribed (d ate

• The prescriber’s details should also include a contact

telephone number, and the PCT area in which they are working in addition to their name and address.

• Any space on the prescription form that has not been

written on must be blanked off (e.g. by drawing a line through it) to reduce the opportunity for fraud.

• If a prescriber makes a domiciliary visit, and a CD is

administered or a handwritten prescription for a CD is issued, it is good practice to make a note of this on the patient’s computer record as soon as practicable after the event.


on the prescription). For Schedule 2 and 3 CDs supplied on form FP10MDA, the first installment must be dispensed within the 28 day validity period

Copy / Faxed prescriptions Under no circumstances may a carbon copy or fax of a prescription / order be used to order / obtain supplies of a schedule 2 or 3 controlled drug. 10. Emergency Supplies 1. Emergency supplies to a practitioner • A practitioner who requires a Schedule 2 or 3 CD urgently,

where he / she is unable to supply a signed order / requisition, can request a CD to be supplied as an emergency.

• The CD may be supplied provided he / she gives an

undertaking to supply a written signed order / requisition within 24 hours.

• Failure to provide the requisition within the allotted time scale

is a criminal offence on the part of the requesting practitioner. 2. Emergency Supplies to a patient Emergency supplies (as defined in the Medicines Act) of schedule 2 and 3 CDs for a specific patient are not permitted at the request of the patient or a medical practitioner. The only exception is phenobarbitol for the treatment of epilepsy.

11. Errors on Prescriptions

• Where a CD prescription needs to be amended, the


person who originally signed the prescription must amend it. If the prescribing doctor is not available, then the doctor on duty must issue a new prescription to replace the prescription with the error – the original prescription must be destroyed.

In certain circumstances, Pharmacists are permitted to supply Schedule 2 CDs against prescriptions that have specific, minor technical errors where the prescriber’s intention is clear. Errors which may be amended by pharmacists are:

• Minor typographical errors or spelling mistakes • Where the total quantity of the CD prescribed, or the total

number of dosage units as the case may be may be specified in either words or figures but not both (i.e. they may add either the words or figures to the CD prescription if they have been omitted).

As a safeguard to these error corrections, the pharmacist must satisfy two pre-conditions before amending the prescription and supplying the CD:

• He/she must be satisfied on reasonable grounds, having exercised due diligence, that the prescription is genuine and that he is supplying the drug in accordance with the intention of the prescriber.

• Any correction must be marked so as to be attributable to the pharmacist to ensure it is readily identifiable for the purpose of audit.

Additional guidance is available at: www.rpsgb.org.uk 12. Private Prescriptions for CDs • Private prescription forms (FP10PCD) are to be used for

private prescribing of Schedule 2 & 3 CDs. • GPs who wish to prescribe CDs privately will need to register,

• The PCT will only register doctors who are on the PCT performers list, and who have had a satisfactory GP appraisal within the last 12 months.


via the PCT Accountable Officer, with the NHS Business Services Authority (Prescription Pricing Division).

• Once registered, private CD prescription pads are ordered in

the same manner as other prescriptions through West Yorkshire Central Services Agency based at St Luke’s House.

• Community pharmacies may only dispense private CD

prescriptions on the new form FP10PCD. • Community pharmacies must submit the original FP10PCD

form to the PPD on a monthly basis – submission forms are available to download from the NHS Business Services Authority website. Note pharmacies must request a unique private CD registration No from the PCT Accountable Officer which needs to be annotated on all submissions for FP10PCD.

13. Instalments and Prescribing for Addicts • Prescribers may only prescribe diamorphine, dipipanone or

cocaine to substance misusers for treatment of addiction if they hold a licence, issued by the Home Office. Practitioners should refer any substance misuser who requires these drugs to the Kirklees Substance Misuse Service operated through Lifeline.

• Only the FP10 (MDA) form can currently be used for

installment prescribing for the management of substance misuse for Schedule 2 CDs, buprenorphine or diazepam. The prescription must specify the number of installments, the intervals to be observed between installments; if necessary to include instructions for supplies at weekends or bank holidays, the quantity to be supplied in each installment.

• A maximum of 14 days supply only is permissible per

• It is good practice for the duration of the installments to be set out on the prescription, e.g. ‘dispense daily for five days starting on x date’.

• It is good practice to specify the actual amount to be

collected at each installment • It is good practice to clearly state which doses should be

taken under supervised consumption (eg supervised consumption of daily dose on Mondays to Fridays inclusive, and two days supply to take home on Fridays for Saturday and Sunday doses) .

• It is good practice to indicate that doses of methadone


prescription form. • The first installment must be supplied within 28 days of the

date entered on the prescription. • When a prescriber wishes the patient to be able to collect the

remainder of an installment prescription (when the patient fails to collect on the specified day) the prescription must be marked: "Supervised consumption of daily dose on specified days; the remainder of supply to take home. If an installment prescription covers more than one day and is not collected on the specified day, the total amount prescribed less the amount prescribed for the day(s) missed may be supplied."

• Private prescribers cannot use the FP10 (MDA) forms but can ask for private prescriptions to be dispensed in installments but patients will be charged the full dispensing fee each time, which would normally make this an expensive option.

liquid that can be taken home are dispensed in bottles with one dose per bottle. The prescription should state “dispense in daily bottles”.

• Where the prescriber of an instalment prescription

contacts the dispensing pharmacy to cancel a prescription, it is good practice to document the cancellation:

o In the instalment dispensing records section of the prescription – to prevent accidental supply should the client attend the pharmacy

o Make a note of the cancelation in the patients PMR record, indicating who cancelled the prescription, when (date and time), and ideally the prescription prescribing date and serial number.

14. Palliative Care • It is good practice to only prescribe quantities of CDs that

are needed by the patient for effective symptom control. Consider the need to prescribe enough to cover weekends and bank holidays.

• The good practice principles for managing CDs described

earlier in these guidelines apply equally to the palliative care situation.

• Where prescribers are prescribing high doses of CDs

(most commonly, for palliative care), it is recommended that the specialist palliative care team are contacted for advice and support, wherever feasible. Any actions resulting from such a contact should be recorded in the


patient’s notes. • If a prescriber is prescribing high doses of CDs for a

patient, particularly where prolonged use is expected, then it is recommended that this is reported to the Accountable Officer at the PCT to aid the interpretation of routine PACT data.

• Palliative care patients may obtain CD prescriptions from

more than one source, e.g. hospitals, hospice, Out of Hours service and GPs etc. In such circumstances one professional in the locality should ideally take on a co-ordinating role – this may be the district nursing teams.

15. Preparation and Administration of Controlled D rugs • Any person may legally administer any Schedule 5 CD to any

other person. • A doctor, dentist or any person acting in accordance with the

directions of a doctor or dentist, may administer any controlled drug specified in schedules 2,3 and 4.

• Nurse Independent prescribers or any person acting in

accordance with their directions can administer a limited range of CDs. http://www.dh.gov.uk/assetRoot/04/13/37/47/04133747.pdf

• Supplementary prescribers are permitted, when acting under and in accordance with the terms of a clinical management plan, to administer and or/or supply or direct any person to administer CDs in schedules 2,3,4 and 5.

• A carer / relative can, with consent, administer a CD that has

been individually prescribed for a third party. (this includes

• The person prescribing the CD should not, except in exceptional circumstances, personally undertake all of the following tasks: preparation, dispensing, transportation and administration of the CD.

• A record of each administration should be kept in the

relevant patient clinical notes. This should specify the date, time, strength, presentation, form / route of administration and the dose, as well as the name and occupation of the person administering it.

• A record should also be made in the CD register relating to

where the CD was obtained. Wherever possible a second healthcare professional should witness administration and initial the entry in the CD register.

• The extemporaneous preparation of methadone mixture is

not generally recommended. Where methadone mixture is prepared on site from methadone powder – SOPs must be in place covering all aspects of the preparation.


home carers so long as they are competent to do so and have received the appropriate training and support).

• Practices holding stocks of CDs for administration / supply to

patients will need to ensure that they have Standard Operating Procedures (SOPs) relating to these activities.

16. CD Collection by a Patient or Patient Represen tative • Any person collecting CDs against a Schedule 2 CD

Prescription (NHS or private) should be asked to provide evidence of identity, and to sign the back of the prescription form in the declaration box.

• If no evidence of identity is available, the pharmacist is able

to use discretion to decide whether to supply the CD or not. If identity is not confirmed, this should be recorded in the CD register.

• Where concerns exist and the identity of the person collecting

CDs is unknown and cannot be confirmed, supply should be refused until adequate ID can be provided.

• The name of the patient or the patient’s representative (and

role / relationship to the patient) collecting the supply must be recorded in the CD register. The time and date of collection may be a future recording requirement.

• Where there are concerns re the identity of the person

collecting, do not dispense the prescription – contact the appropriate authorities immediately.

• Under no circumstances should CDs be posted to the patient

as a method of delivery. The dispensed prescription must be collected either by the patient or by their representative, or


delivered by a member of the pharmacy / dispensary staff. 17. Destruction of Controlled Drugs “Expired Stock ” • The destruction of Schedule 1 and 2 CDs must be witnessed

by a person authorized to do so by the PCT Accountable Officer (for large pharmacy multiples, the PCT in which the head office of the company resides may give permission to company representatives to witness destruction of CDs in any of their pharmacies nationally – a copy of the authorization has to be sent to all PCT accountable officers)

• Authorised persons cannot delegate the task of witnessing the

destruction of CDs and cannot witness the destruction of CDs that have been supplied to them or by them.

• When an expired stock CD is destroyed, details of the drug

must ne entered into the CD register. This should include: the name of the drug; form; strength and quantity; the date it was destroyed; the signature of the authorised person who witnessed the destruction and the professional destroying it (ie two signatures)

• Contractors are advised to be mindful of the law regarding the

disposal of pharmaceutical waste as set out by the Department for Environment, Food and Rural Affairs, and advice provided by the enforcing body, The Environment Agency. www.environment-agency.gov.uk

• Any practices or pharmacies intending to destroy CDs should contact the PCT medicines management team for further advice

• When schedule 2 CDs (plus temazepam, flunitrazepam,

buprenorphine, diethylpropion and midazolam) pass their expiry date, they should be stored in the CD cabinet / safe until destruction, but be clearly marked as “date-expired stock” to prevent them being issued in error.

• If CDs kept in the “doctors’ bag” expire, they should be

returned to the central practice stock fir future authorized destruction (entries must be made in both the practice CD register and “doctors’ bag” register of the transfer of stock). If the practice does not hold central stock then the CDs must to be destroyed directly from the doctors bag and witnessed by an authorized individual and appropriate records made in the CD register.

18. Re-use of Controlled Drugs • The Home Office states that it is illegal to recycle returned

controlled drugs. Advice from professional bodies and their codes of professional conduct / ethics also prohibits this practice.


19. Destruction of “Patient Returned” CDs • Doctors and other healthcare practitioners must not reuse

CDs that have been returned to their premises by / from patients, relatives or carers.

• Currently there is no legal requirement for “patient returned”

schedule 2 and 3 CDs to be destroyed in the presence of an authorised witness, or for a record to be maintained.

• Where CDs are returned to premises, CDs returned must be

destroyed as soon as possible. • Where patient returns are not destroyed immediately, these

returned CDs must be clearly marked as “patient returned CD fir destruction”, and stored in the CD cabinet or in an appropriate secure receptacle, but separate from normal CD stock.

• Pharmacies cannot receive waste medicine s(or CDs) from

patients in nursing homes unless the pharmacy holds a “waste management licence”.

• It is strongly recommended that doctors do not destroy patients unused CDs. Patients or their representatives should be asked to return their unwanted medicines to the local community pharmacy for destruction. Any practice intending to destroy CDs should contact the PCT Medicines Management Team for further advice.

• The quantity of “patient returned” CDs, and their

subsequent destruction, should be witnessed and countersigned, preferably by a registered healthcare professional.

• It is good practice to record all “patient returned” CDs in a

separate book / register specifically defined for that purpose. This book should ideally record the following details: Date received; name and address of the patient; name of the pharmacy / practice where the CD was originally dispensed; name, quantity and form of the CD; name and role and signature (for health professionals) of the person returning the CD; name and signature of staff receiving the CD; name and signature of the person returning the CD; name and signature of the person destroying the CD and date destroyed; name and signature of witness to the destruction plus date destroyed.

• Patients should be encouraged not to destroy their own CDs, but to return them to their community pharmacy.

• Healthcare staff should not remove CDs on behalf of

patients / relatives unless it is felt there are significant risks in leaving the CDs in the patients’ / carers’ possession. In


such instances, the healthcare professional must make a record of the removal in the patients nursing care record, which should be signed by the patient / carer indicating what has been removed. At the pharmacy, the nurse / healthcare professional should request the pharmacist to countersign the nursing care record, and also record the receipt into the CD destruction / patient returns register for destruction to maintain the audit trail.

A register for CD returns / destruction is available from the National Pharmaceutical Association for use by community pharmacies “Controlled Drugs – A Destruction Register for Returned Medicines”.

20. How to Destroy / Denature Controlled Drugs • All schedule 1 and 2 controlled drugs must be destroyed in

order to render the active ingredient irretrievable. Controlled drug denature kits must always be used.

• Special CD denature kits are available from various outlets,

including the National Pharmaceutical Association and local waste contractors.

• Fentanyl patches (and other patches) should have the backing removed and the patch folded over on itself and then placed in the medicines waste disposal bin.

• Ampoules should be opened, the liquid poured into a CD

resin kit and the ampoule itself placed in a sharps bin. • For ampoules containing dry powder, the ampoule should

be opened, and the contents reconstituted with tap water, and the resulting liquid poured into a CD resin kit and again the empty ampoule itself placed in a sharps bin.

21. Transportation and Possession of Controlled Dr ugs The Misuse of Drugs Act and supporting regulations lays down whom and in what circumstances an individual may have a controlled drug in their possession, these include: • Medical practitioners (Doctors, Dentists, Veterinary Surgeons)

• Health care professionals involved in the delivery of patient care should not routinely transport a patients own CDs to and from that patients’ home.

• Where CDs are transported, it is good practice to keep


• Pharmacists or a person lawfully conducting a pharmacy business.

• Midwives, who may possess and administer pethidine under special arrangements identified within the Medicines Act.

• Supplementary prescribers where CDs form part of an agreed Clinical Management Plan.

• Nurse independent prescribers – restricted to a specified range of CDs for specific medical conditions

• Health professionals administering and / or supplying certain specified CDs under a Patient Group Direction

• Anyone administering a CD under the direct instruction of a doctor or dentist

• A person who has been legally prescribed a CD • A third party who has been authorised (in writing) to collect a

CD on behalf of a person who is authorised to be in possession. (this could be to transport it for destruction to a pharmacy)

Full details can be found in the BNF or from the NPC website www.npc.co.uk • Nurses, midwives, doctors, pharmacists, pharmacy staff and

other healthcare professionals, plus formal carers and patient representatives, are legally allowed to transport CDs to a patient, provided the CDs have been prescribed, by an appropriate prescriber, for that patient.

these out of view during transit. • CDs should not be transported by mail, taxi services or

equivalent. If any of these methods are used, security measures must be put in place (e.g. special delivery by post, locked container if by taxi etc).

• Prescriptions for schedule 2controlled drugs should not

routinely be sent through the mail to pharmacies, but should be collected / delivered by a healthcare professional. (it is recognised that this practice may be appropriate for drug misuse services)

• Where prescriptions or CDs are transported by mail, taxi,

courier etc, then SOPs should be in developed to cover all aspects of delivery including any associated risks and their minimization.

22. Travel overseas • With effect from 1st January 2007, only those persons

travelling for 28 days or more and carrying CDs will require a personal licence. Applications can be downloaded from: www.drugs.gov.uk

• Those travelling for a period up to three months are

When travelling abroad, CDs should be : • carried in their original packaging • Carried in hand luggage • Carried with a letter from the prescribing doctor confirming


automatically covered by the Home Office personal licence. For travel exceeding 3 months, further information is available at: www.drugs.homeoffice.gov.uk

• Those patients travelling abroad for more than 3 months will

need to make arrangements to obtain CDs from a practitioner in the country they are visiting.

the carriers name, destination, drug details and amounts. Also Check with the relative embassy / consulate of any restrictions in the country being visited.


Appendix 1 : Summary of legal requirements for the p ossession and supply of controlled drugs

Unless specifically named, full legal requirements apply for the schedule in which the drug is classified.

Requirements Schedule 2 : CD Schedule 3 : CD No Register Schedule 4: CD Benz and

CD Anab

Schedule 5: CD Inv

Full requirements

Secobarbital Full requirements

Phenobarbital Temazepam Diethylpropion Flunitrazepam

(Ronypnol)

Buprenorphine (Subutex)

Prescription requirements

Yes

Yes

Yes

Yes

No

Yes

Yes

No

No

Handwriting requirements

No

No

No

No

No

No

No

No

No

Requisitions necessary

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Records to be kept in CD register

Yes

Yes

No

No

No

No

No

No

No

Emergency Supplies allowed

No

No

No

Yes

No

No

No

Yes

Yes

Safe custody

Yes

No

No

No

Yes

Yes

Yes

No

No

Date of su pply to be marked on prescription

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Address of prescriber to be within the UK

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Stock destruction to be witnessed

Yes

Yes

No

No

No

No

No

No

No

Validity of prescription

28 days

28 days

28 days

28 days

28 days

28 days

28 days

28 days

6 months

Invoices to be kept for 2 years

No

No

Yes

Yes

Yes

Yes

Yes

Yes (1)

Yes

Import / export licence required

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

(1) Invoices relating to import / export transactions only


Appendix 2: Controlled Drug Schedules

For comprehensive and up to date lists, please refer to The Misuse of Drugs Regulations 2001, and any updates. Schedule 1 (CD Lic) This schedule contains the most strictly controlled CDs. They have no generally accepted therapeutic use and practitioners have no statutory right of access to them. (includes hallucinogenic drugs e.g. LSD, and ectstacy type substances and cannabis. Schedule 2 (CD POM) In practical terms this is the most important of the five schedules. These drugs include pharmaceutical opioids and amphetamines for medicinal use. Alfentanil Fentanyl Morphine Amphetamine Hydromorphone Oxycodone Cocaine Medicinal opium Pethidine Dexamphetamine Methadone Pholcodine Diamorphine Methylphenidate Secobarital Dipipanone Schedule 3 (CD No Register) This schedule contains most barbiturates and a small number of stimulant drugs which are not thought to be as likely to be misused as those drugs in Schedule 2, and are felt to be less harmful if they are misused. Benzamphetamine Meprobamate Phenobarbital Buprenorphine Midazolam Temazepam Flunitrazepam Pentazocine Schedule 4 Part 1 contains most of the benzodiazepines and part 2 contains most of the anabolic and androgenic steroids, together with the growth hormones

Part 1 Alprazolam Diazepam Lormetazepam Chlordiazepoxide Flurazepam Nitrazepam Clobazam Loprazolam Oxazepam Clonazepam Lorazepam

Part 2 Clostebol Fluoxymesterone Propetandrol Drostanolone Nandrolone Quinbolone Ethyloestranol Nabilone Stanozol Schedule 5 (CD Inv) This schedule contains preparations of certain CDs, e.g. codeine, dihydrocodeine, pholcodine etc, plus morphine and cocaine which are exempt from full control when present in low strength in medicinal products (e.g morphine oral solution 10mg in 5ml)


Appendix 3: Further Reading

A Guide to good practice in the management of contr olled drugs in primary care (England): Second edition; February 2007, National Prescribing Centre http://www.npc.co.uk/controlled_drugs/CDGuide_2ndedition_February_2007.pdf Health Act 2006 http://www.opsi.gov.uk/acts/acts2006/20060028.htm Misuse of Drugs Regulations 2001: Statutory Instrument 2001 No 3998 www.opsi.gov.uk/si/si2001/20013998.htm Misuse of Drugs (Amendment) Regulations 2005: Statutory Instrument 2005 No 0271 www.legislation.hmso.gov.uk/si/si2005/20050271.htm The safe and secure handling of medicines: a team a pproach. A revision of the Duthie Report (1988). RPSGB March 2005 www.rpsgb.org.uk/pdfs/safsechandmeds.pdf Final guidance — Safer management of controlled dru gs: changes to record-keeping requirements. DH October 2006 www.dh.gov.uk/assetRoot/04/13/97/02/04139702.pdf Safer management of controlled drugs: (1) guidance on strengthened governance arrangements. DH January 2007 www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4141666&chk=ATnhRu Safer management of controlled drugs: guidance on s tandard operating procedures for controlled drugs. DH January 2007 www.dh.gov.uk/assetRoot/04/14/25/63/04142563.pdf Safer management of controlled drugs: private CD pr escriptions and other changes to the prescribing and dispensing of controlled drugs. DH July 2006 www.dh.gov.uk/assetRoot/04/13/67/30/04136730.pdf Interim guidance — safer management of controlled d rugs: guidance on the destruction and disposal of controlled drugs. DH October 2006 www.dh.gov.uk/assetRoot/04/13/97/03/04139703.pdf Controlled Drugs (Supervision of Management and Use ) Regulations 2006: Statutory Instrument 2006 No 3148. http://www.opsi.gov.uk/si/si2006/20063148.htm Controlled drugs: Monitoring and inspection guideli nes – Core activities for CD monitoring and inspection work – primary care. Department of Health 27th March 2006


http://www.dh.gov.uk/assetRoot/04/13/22/58/04132258.pdf Ensuring safer practice with high dose ampoules of diamorphine and morphine. National Patient Safety Agency, Safer Practice Notice 25 May 2006 http://www.npsa.nhs.uk/site/media/documents/1789_Diamorphine_SPN.pdf Reducing dosing errors with opioid medicines: National Patient Safety Agency, Rapid Response Report NPSA/2006/RRR05. http://www.npsa.nhs.uk/patientsafety/alerts-anddirectives/rapidrr/ Guidance for pharmacists on the safe destruction of controlled drugs England, Scotland and Wales . RPSGB www.rpsgb.org.uk/pdfs/cdsafedestructionguid.pdf Improving Patients’ Access to Medicines: A Guide to Implementing Nurse and Phamacist Independent Prescribing within the NHS in England. Department of Health April 2006. http://www.dh.gov.uk/assetRoot/04/13/37/47/04133747.pdf

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