Controlled Drugs Policy
Version / 13Name of responsible (ratifying) committee / Formulary and Medicines Group
Date ratified / 18/07/14
Document Manager (job title) / Director of Medicine Management and Pharmacy (Accountable Officer)
Date issued / 28th July 2014
Review date / 27th July 2016
Electronic location / Clinical Policies
Related Procedural Documents / PHT Controlled Drugs Policy,
PHT Policy for the Safe Management of Injectable Medicines (Adults and Children),
PHT Medicines Reconciliation Policy
Key Words (to aid with searching) / Controlled drugs; CDs; medicines; pharmacy; security; morphine; prescribing; administration; destruction; balance; checking; Drugs; Drug administration; Prescription drugs; Hospital pharmaceutical services; Drug storage; Drug records; Prescribing; Medical staff; Pharmacists; Healthcare professionals; Nurses; Midwives
Version Tracking
Version / Date Ratified / Brief Summary of Changes / Author13 / 18/07/14 / Addition of tramadol guidance due to reclassification to Schedule 3. / Sarah Nolan/Karen Dutton
13 / 18/07/14 / Addition of zopiclone guidance due to reclassification to Schedule 4(I) / Sarah Nolan/Karen Dutton
13 / 18/07/14 / Additional guidance added regarding Accountable Officer role / Sarah Nolan/Karen Dutton
13 / 18/07/14 / Addition of Community Midwife section 6.2.13 / Sarah Nolan/Karen Dutton
13 / 18/07/14 / Clarification on denaturing and disposal of CDs, section 6.6.3. / Sarah Nolan/Karen Dutton
13 / 18/07/14 / Clarification that the date is required on CD prescriptions (section 6.9.2) / Sarah Nolan/Karen Dutton
13 / 18/07/14 / Amendment of Appendix A, to include tramadol and zopiclone / Sarah Nolan/Karen Dutton
CONTENTS
1. INTRODUCTION 5
2. PURPOSE 5
3. SCOPE 6
4. DEFINITIONS 6
5. DUTIES AND RESPONSIBILITIES 11
6. PROCESS 12
6.1. Stocks, Storage and Security of Controlled Drugs in Wards and Departments 12
6.2. Ordering and Receipt of Controlled Drugs 17
6.3. Administration of CDs 24
6.4. Record Keeping in the CDs Record Book 27
6.5. Controlled Drug Stock Checks 29
6.6. Disposal or Return of CDs to the Pharmacy Department 31
6.7. Patients’ Own CDs 33
6.8. Clinical Trials 35
6.9. Prescribing 36
6.10. Management of CDs in In-House Operating Theatres 39
6.11. Management of CDs by Hospital Pharmacies 42
6.12. Dealing with the Suspected Possession of Illegal Substances by Patients on Trust Premises 48
7. TRAINING REQUIREMENTS 51
8. REFERENCES AND ASSOCIATED DOCUMENTATION 51
9. EQUALITY IMPACT STATEMENT 51
10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENT 52
Appendix A: Requirements for Controlled Drugs within PHT 54
Appendix B: Example of Receipt of CD Stock in Ward/Dept. CD Record Book 55
Appendix C: Example Record of Administration in Ward/Dept. CD Record Book 56
Appendix D: Example Balance Transfer in Ward/Dept. CD Record Book 57
Appendix E: Example Correction of Error in Ward CD Record Book 58
Appendix F: Example Ward/Dept. CD Order 59
Appendix G: Example Index Page of Ward CD Record Book 60
Appendix H: Procedure when a discrepancy is discovered in the Ward Controlled Drugs Record Book 61
Appendix I: Example CD Discharge Prescription (TTO) 62
Appendix J: Example of a Theatre CD Record Book 63
QUICK REFERENCE GUIDE
This policy gives an overview of English law and good practice relating to Controlled Drugs in hospitals. It gives detailed guidance to ensure that the law is adhered to, including measures to increase the security of Controlled Drugs, and to counter fraud.
This policy is an adjunct to the Medicines Management Policy to describe in detail the processes, roles and responsibilities in relation to the management of Controlled Drugs (CDs), including:
· Stocks, storage & security of Controlled Drugs at ward or department level
· Ordering & receipt of Controlled Drugs
· Administration of Controlled Drugs
· Record keeping in the Ward Controlled Drugs Record Book
· Controlled Drugs stock checking on the ward
· Disposal/ return to the Pharmacy Department
· Patients’ own Controlled Drugs
· Clinical trials
· Prescribing of Controlled Drugs
· Management of Controlled Drugs in in-house operating theatres
· Management of Controlled Drugs in hospital pharmacies
Within the pharmacy service these activities are the subject of pharmacy Standard Operating Procedures.
The Misuse of Drugs Act, 1971 controls certain classes of dangerous drugs, which are listed and known as “Controlled Drugs”. Its main purpose is to prevent the misuse of these drugs by imposing a total ban on the possession, supply, manufacture or importation of Controlled Drugs, except as allowed by regulations. The use of Controlled Drugs in medicine is regulated by the Misuse of Drugs Regulations, 2001 (as amended). Separate regulations deal with the safe custody of Controlled Drugs and their supply to substance misusers.
The 2001 Regulations set out a number of schedules, which classify Controlled Drugs (CDs) according to different levels of control – see 4. Definitions
Notes: Storage and security requirements may be increased locally at the discretion and direction of the Nursing Management in discussion with the Accountable Officer or their nominated deputy
If you are in doubt whether a product is a Controlled Drug or not; if it is in its original manufacturer’s pack it should state “CD POM” on the packaging; medicines that are Schedule 2 CDs prepared or repackaged by the Pharmacy Department for ward stock bear the words “Store in a Controlled Drug Cupboard” on the label.
1. INTRODUCTION
This policy gives an overview of English law and good practice relating to Controlled Drugs in hospitals. It gives detailed guidance to ensure that the law is adhered to, including measures to increase the security of Controlled Drugs, and to counter fraud.
This policy is an adjunct to the Medicines Management Policy to describe in detail the processes, roles and responsibilities in relation to the management of Controlled Drugs (CDs), including:
· Stocks, storage & security of Controlled Drugs at ward level or department
· Ordering & receipt of Controlled Drugs
· Administration of Controlled Drugs
· Record keeping in the Ward Controlled Drugs Record Book
· Controlled Drugs stock checking on the ward
· Disposal/ return to the Pharmacy Department
· Patients’ own Controlled Drugs
· Clinical trials
· Prescribing of Controlled Drugs
· Management of Controlled Drugs in in-house operating theatres
· Management of Controlled Drugs in hospital pharmacies
Within the pharmacy service these activities are the subject of pharmacy Work Instructions (PHPS nomenclature for Standard Operating Procedures).
The Misuse of Drugs Act, 1971 controls certain classes of dangerous drugs, which are listed and known as “Controlled Drugs”. Its main purpose is to prevent the misuse of these drugs by imposing a total ban on the possession, supply, manufacture or importation of Controlled Drugs, except as allowed by regulations. The use of Controlled Drugs in medicine is regulated by the Misuse of Drugs Regulations, 2001 (as amended). Separate regulations deal with the safe custody of Controlled Drugs and their supply to substance misusers.
The 2001 Regulations set out a number of schedules, which classify Controlled Drugs (CDs) according to different levels of control – see 4. Definitions
Notes: Storage and security requirements may be increased locally at the discretion and direction of the Nursing Management in discussion with the Accountable Officer or their nominated deputy.
If you are in doubt whether a product is a Controlled Drug or not; if it is in its original manufacturer’s pack it should state “CD POM” on the packaging; medicines that are Schedule 2 CDs prepared or repackaged by the Pharmacy Department for ward stock bear the words “Store in a Controlled Drug Cupboard” on the label.
2. PURPOSE
The purpose of this policy is to:
· Ensure the Trust complies with the legal requirements of the Misuse of Drugs Regulations (1971), the Misuse of Drugs Regulations, 2001 (as amended) all other relevant Controlled Drugs Legislation and NHS Guidance including NPSA guidance.
· Provide clear, standards and procedures for staff carrying out their duties involving Controlled Drugs.
3. SCOPE
This policy with associated procedures, applies to all staff working within Portsmouth Hospitals NHS Trust involved in:
· the safe custody and accountability of Controlled Drugs stored in their area of responsibility
· the ordering and receipt of Controlled Drugs by Wards/Departments
· the prescribing of Controlled Drugs
· the administration of Controlled Drugs to patients
· the handling of patients’ own medicines which are classified as Controlled Drugs
· record keeping in the Ward Controlled Drugs Record Book
· the management and checking of Controlled Drugs on Wards/Departments
· disposal of unwanted Controlled Drugs
Staff affected include, but is not exclusive to, doctors, nurses and midwives, Registered Operating Department Practitioners, pharmacists and pharmacy technicians, healthcare professionals and associated practitioners.
This policy should be used in conjunction with the PHT Medicines Management Policy and the PHT Policy for Safer Management of Injectables. When Controlled Drugs are to be administered via the intravenous, subcutaneous, intramuscular or epidural route, this should be undertaken only by health care professionals, who have undergone specific training and have demonstrated their competence in medicines administration.
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’
4. DEFINITIONS
The 2001 Regulations classify Controlled Drugs into five schedules according to the different levels of control attributed to each. Preparations in Schedules 1, 2, 3, and 4 of the Misuse of Drugs Regulations 2001 (and subsequent amendments) are identified throughout the BNF.:
Schedule 1 (CD Lic).
Schedule 1 drugs include hallucinogenic drugs such as coco leaf, lysergide, “ecstasy” and mescaline. Production, possession and supply of drugs in this Schedule are limited, in the public interest, to research or other special purposes. Only certain persons can be licensed by the Home Office to possess them for research purposes. Practitioners (e.g. doctors, dentists and veterinary surgeons and pharmacists may not lawfully possess Schedule 1 except under licence from the Home Office.
Schedule 2 (CD POM).
Pharmacists and other classes of person named in the 2001 Regulations have a general authority to possess, supply and procure Schedule 2 Controlled Drugs when acting in that capacity. Schedule 2 included opiates (e.g. diamorphine, morphine, methadone), major stimulants (e.g.amphetamines) and quinalbarbitone.
Schedule 3 (CD No Register POM).
Schedule 3 Controlled Drugs include minor stimulants and other drugs (such as buprenorphine, temazepam, midazolam, tramadol and phenobarbital) that are less likely to be misused (and less harmful if misused) than those in Schedule 2.
While safe custody requirements apply, currently most drugs in this schedule are exempted. Schedule 3 controlled drugs that do require safe custody include temazepam and buprenorphine. Phenobarbital, midazolam and tramadol do not legally require safe custody but within PHT midazolam is kept in a locked CD cupboard (with the exception of midazolam kept in transfer and intubation trolleys; transfer boxes and intubation grab bags on the Department of Critical Care). There is no legal requirement for records of receipt or administration of Schedule 3 drugs to be kept in the Ward Controlled Drugs Record Book but within PHT security requirements have been increased in some clinical areas at the discretion of Nursing Management in conjunction with the Accountable Officer. See Appendix A.
Schedule 4, Part I (CD Benz POM) and Part II (CD Anab POM)
Schedule 4 is split into two parts:
· Part I (CD Benz POM) – contains most of the benzodiazepines including zopiclone (but not temazepam nor midazolam) and ketamine.
· Part II (CD Anab POM) – contains most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoceptor stimulant) and growth hormones.
Security requirements may be increased at the discretion of the Nursing Management in conjunction with the Accountable Officer. See Appendix A.
Schedule 5 (CD Inv).
Schedule 5 contains preparations of certain controlled drugs (such as codeine, pholcodine and morphine) that are exempt from full control when present in medicinal products of specifically low strength. Please see the Medicines Management Policy for security of medicines.
Security requirements may be increased at the discretion of the Nursing Management. See Appendix A.
Administer
To give to a patient a medicinal product, dressing or medical device, either by introduction into the body, either orally or by injection, etc., or by external application (e.g. application of an ointment or dressing).
ADR
Adverse Drug Reaction
APC
Area Prescribing Committee
ATOs
Pharmacy Assistant Technical Officers
BNF
The British National Formulary (latest edition).
Bioavailability
The rate and extent to which a medicine releases its active ingredient(s) within the body, to become pharmacologically available at the site(s) of action.
CIVAS
Centralised Intravenous Additives Service
Clinician
A health care professional who is engaged in the direct examination, diagnosis, treatment
and care of patients.
Clinical Support Worker
A clinical support worker is not registered with a professional body. They may be registered within the Trust. For the purposes of this policy these include:
· Healthcare Support Workers (HCSW)
· Pharmacy Assistant Technical Officers (ATOs)
· Nursery Nurses
· Dental Nurses
· Clinical/ Medical Technicians
Controlled Drugs (CDs)
Medicines that are liable to misuse, that are subject to special controls under the Misuse of Drugs Act, 1971.
Controlled Stationery
Any stationery which, in the wrong hands, could be open to abuse within the system to obtain medicines fraudulently.
COSHH
Control Of Substances Hazardous to Health
CQC
Care Quality Commission
DOH
Department of Health
Dispense
To prepare and/or give out a clinically appropriate medicinal product to a patient for self administration or for administration by another, usually a healthcare professional. Dispensing must be in response to a legally valid prescription. The act of dispensing should be accompanied with the provision of advice to the patient on safe and effective use of these products.
FMG
Formulary and Medicines Group
GMC