SOUTHERN DERBYSHIRE MENTAL HEALTH NHS TRUST MEDICINES CODE

2000-2003 - POLICIES AND PROCEDURES TO MANAGE THE CLINICAL RISKS ASSOCIATED WITH THE USE OF MEDICINES

Provided and shared by kind permission of Dr. Dave Branford, who did the work, for you to use as you wish to help develope your own Medicines Code. March 2000. It took ages to convert this from a Word document to a web .html document, so I hope the effort was worth it. As ever, if you use the cursor to copy the text, you can then paste it into a Word or other word-processing document and then manipulate it.

MEDICINES CODE 2000-2003

CONTENTS

1 Introduction

2 Definitions

3 General Principles

4 Prescribing of Medicines

5 Ordering and Receipt of Medicines

6 Pharmacy Services

7 Preparation and Administration of Medicines

8 Transport of Medicines

9 Storage of Medicines

10 Losses or Discrepancies

11 Disposal of Medicines No Longer Required

12 Patient's Own Medicines

13 Self-Administration of Medicines By Patients

14 Custody and Safe-Keeping of Medicine Keys

15 Checking of Stock Balances

16 Use of Essential Oils and Complementary Medicines

17 Use of Unlicensed Medicines

18 Clinical Trials Involving Pharmaceutical Products

19 The Medicines Related Duties Performed by Health Care Workers

20 Medical Gases

21 Medication Errors

22 Medicine Defect Reporting

23 Community Based Practitioners

24 Consent to Treatment

25 Illicit Substances

26 Compliance Aids

27 Day Hospitals and Respite Care

1 INTRODUCTION

The Department of Health requires that NHS Trusts establish, document and maintain an effective system to ensure that medicines are handled in a safe and secure manner.

There have been a number of changes since the last edition of the Southern Derbyshire Mental Health Trust Medicines Code:

New professional practices concerning the use of medicines have developed and continue to develop.
New healthcare practitioners are dealing with medicines as a routine part of their day-to-day work.
The use of new information technology to assist the medicine use process requires new policies and procedures.
The concepts of patient focused care and patient empowerment require a fresh approach to some long-established practices.

Clinical governance and risk management are high on the Trust's agenda.

This Medicines Code defines the policies and procedures to be followed within the Southern Derbyshire Mental Health Trust (SDMHT) for the prescribing, ordering, dispensing, storing and administering of medicines. The SDMHT Medicines Code is not intended to apply to any other NHS Trust.

All staff working within the Trust who are involved in some way with the use of medicines, must familiarise themselves with the correct procedures contained in this Code. Those in charge of wards and departments are responsible for ensuring that their staff, especially new starters and locum staff, follow procedures in this Medicines Code, which may differ from procedures elsewhere. Copies of the Code will be available in all wards and departments.

The procedures also apply to medical staff, nursing staff and other types of staff from other NHS Trusts or from private practices, who are contracted to work in the SDMHT on a sessional basis. Managers who contract for these services must make it explicit within the written contract that these sessional staff must follow the procedures described in this Code.

SDMHT staff working in other NHS Trusts, including the Acute Trust, should follow the Medicines Code in these other Trusts, which may differ from the SDMHT Code.

2 DEFINITIONS

2.1 Staff Definitions

Throughout this Code, certain specialist titles describe healthcare staff who have defined responsibilities regarding the management of medicines. Only staff with contracts (or honorary contracts) of employment to work in Southern Derbyshire Mental Health Trust (SDMHT) are recognised as having any involvement with medicines. Throughout, the term "Practitioner" is used. This is a general term used to describe a qualified medical practitioner, nurse, pharmacist or other authorised healthcare employee.

Appointed Practitioner in Charge

The senior practitioner appointed in charge of a ward or department eg Ward Manager, Superintendent Physiotherapist.

The Director of Pharmacy, together with senior managers, must agree and authorise named individuals to be given these responsibilities.

In situations where the person in charge is not from a professional background appropriate to take such responsibility (eg community team leader with a social work background) another member of the team must undertake the role of Appointed Practitioner in Charge.

Assigned Practitioner in Charge

The senior practitioner on-duty for the ward or department, who has been rostered as the professional in charge for that shift.

Designated Practitioner

Any registered practitioner identified by the Appointed Practitioner in Charge as competent and appropriate to perform a specific function. The designation as such has been communicated to and accepted by the Designated Practitioner. If the practitioner is based in the community the term used is Designated Community Practitioner.

Designated Complementary Therapist

Any practitioner of a complimentary therapy (see Section 16) who has obtained the appropriate qualification from a recognised organisation, and is approved by the Trust.

Authorised Pharmacy Staff

Any qualified pharmacist or pharmacy technician authorised by the Director of Pharmacy as competent and appropriate to perform a specific function.

Authorised Employee

A member of staff who has following training, been authorised by the SDMHT to undertake specific duties in relation to medicines.

2.2 Process Definitions

Medicine

Any substance or combination of substances presented for treating or preventing disease. Any substance or combination of substances which may be administered with a view to making a medical diagnosis or restoring, correcting or modifying physiological or psychological functions.

Prescribe

To authorise in writing the supply of a medicine.

Dispense

To prepare a clinically appropriate medicine for a patient for self-administration or administration by another. The act of dispensing includes supply and also encompasses a number of other cognitive functions (e.g. checking the validity of the prescription, the appropriateness of the medicine for an individual patient, assembly of the product). These functions are performed under the supervision of a pharmacist.

Supply

To supply a medicine to a patient/carer for administration.

Administer

To give a medicine by either introduction into the body, (e.g. orally or by injection) or by external application (e.g. cream or ointment).

Group Protocol (Standing Order)

A specific written instruction for the supply and administration of named medicines in an identified clinical situation in the absence of a written prescription. It has been drawn up within the Trust by doctors, pharmacists and other professionals and approved by the Drugs and Therapeutics Committee.

3 GENERAL PRINCIPLES

3.1 Medicines, whether for internal or external use, will be regarded, for the purpose of this Code, as comprising the following categories:

Controlled Drugs controlled under the provisions of the Misuse of Drugs Act 1971, with stringent requirements for supply, storage and administration.
All other medicines and medicinal products prepared for administration to patients and which are controlled by the Medicines Act 1968. This also includes many diagnostic agents, X-ray contrast agents and medical gases.

Whilst less stringent regulations apply than in the case of Controlled Drugs, they must be treated with care.
All complementary medicines eg aromatherapy, herbal or homeopathic remedies. These products are used for therapeutic purposes and require the same safeguards as other medicines.
Other pharmaceutical preparations.

Disinfectants, reagents and other preparations not used directly to treat patients. The use of these products in hospital is still subject to certain rules:

It is important to understand that procedures listed in this document apply to all medicines used in SDMHT. These include topical lotions, applications, intravenous infusions, medicated dressings and complementary medicines.

3.2 The responsibilities of the various practitioners associated with the prescribing, ordering, dispensing, storing and administration of medicines are as follows:

It is a requirement that all Health Authorities designate a senior pharmacist to be responsible for the organising, monitoring and reporting of a system for assuring the safe and secure handling of medicines. In the SDMHT the designated senior pharmacist is the Director of Pharmacy.
In most situations medical staff are responsible for prescribing medicines for patients. They and any other authorised prescriber must comply with legislation, the Southern Derbyshire Prescribing Guide and the Medicines Code when performing these duties.

A record showing appointment and signature of all prescribers (including locum appointments) must be notified to the Director of Pharmacy and updated upon any change by the appropriate manager.

The Appointed Practitioner in Charge of a ward or department is ultimately accountable for the stock of all medicines held and is responsible for ensuring that Medicines Code procedures are followed correctly and that the security of medicines is maintained.
A record showing appointment and signature of all Appointed Practitioners in Charge must be notified to the Director of Pharmacy and updated upon any change by the appropriate manager.
The Assigned Practitioner in Charge of the ward or department is responsible for the stock of medicines held in the ward or department and for ensuring that stocks of Controlled Drugs, if held, correspond with the details shown in the register. The Appointed Practitioner in Charge is responsible for ensuring that this is carried out.
Pharmacists are responsible for the stock of medicines held in the pharmacy, their manipulation and preparation into user ready presentations and for their supply to wards and departments. They are also responsible for advising on the safe, effective and economic use of medicines.These responsibilities include advising practitioners on the storage of medicines in clinical areas. Authorised Pharmacy Staff will inspect the stocks of medicines held on the ward or department at any time to ensure the medicines are in date and stored under the proper legal and environmental conditions. This will occur at least every three months.
The administration of medicines is the responsibility of the Assigned Practitioner in Charge of the ward or department who may delegate these duties to a Designated Practitioner, but who must exercise supervision as is necessary. It is the responsibility of the Appointed Practitioner in charge to ensure that the Designated Practitioner has received the relevant training and experience before being allowed to take on responsibility for medicine procedures.
Practitioners in training must be given every opportunity to become proficient in medicines related activities under appropriate supervision. The supervising Practitioner has responsibility for medicine procedures at such times.
The responsibilities for medicine procedures that may be held by various grades of practitioner are indicated in this document. Practitioners must be aware of the tasks they may or may not to perform.

4 PRESCRIBING OF MEDICINES

4.1 Medicines may only be prescribed on official SDMHT prescription stationery. Details that must be included on the prescription are:

Patient's name, including aliases.
Date of birth or age.
Ward name, or number, or name of department.
Patient's hospital number and/or NHS number.
Known sensitivities to medicines.

No more than one current prescription sheet must exist at any one time for any patient. Where more than ten medicines are prescribed regularly, a second sheet may be used, which must be stapled to the first. In such circumstances both prescription sheets must indicate the existence of a second sheet. When a patient is re-admitted, including for respite care, a new prescription sheet must be used. The prescription sheet of patients transferred from one SDMHT site to another does not require to be rewritten. When patients are transferred from other Trusts, prescriptions must be rewritten within 24 hours (48 hours at weekends or 72 hours at a bank holiday). In addition to the main prescription sheet there may be a chart incorporating IV fluid regimen, an anticoagulant chart and any other officially agreed special chart. The main prescription sheet must make reference to any therapy indicated on separate special charts.

4.2 Initiation of Treatment

It is important to recognise that in most situations only medical staff have the authority to prescribe medicines for hospital inpatients or for patients attending day hospitals or clinics.
Practitioners must not administer to patients medicines that have not been authorised by medical staff or other authorised prescribers.
This authorisation must be in writing, in the form of a prescription in advance of the administration of the medicine.

The recognised exceptions to this are listed as follows:

In areas where there are no resident prescribers and in cases of clinical urgency a verbal instruction is acceptable (see later).
Certain medicines may be administered at the practitioner's discretion against an agreed Group Protocol. In each instance a record of the administration must be entered on the prescription sheet or as stated in the group protocol and signed by the Designated Practitioner.
Specialist practitioners and clinical pharmacists involved in certain services may be authorised to modify dose regimens and, in certain instances, to initiate or stop medicine therapy in accordance with protocols approved by the Drugs and Therapeutics Committee.
Dieticians are Designated Practitioners authorised to initiate the use of dietetic products by prescribing them on a patient's in-patient prescription sheet or special chart.

Medical students are not permitted to prescribe medicines.

4.3 Range of medicines to be prescribed.

Only medicines approved for use by the SDMHT Drugs and Therapeutics Committee and the District Prescribing Advisory Group (PAG) will be prescribed. The Southern Derbyshire Prescribing Guide provides details of the medicines approved for use.

Limited exception is given to patients' own medicines, medicines undergoing clinical trial and specialist therapy for individual patients that have been agreed with the Director of Pharmacy.

Hospital doctors must not recommend medicines that are not approved to General Practitioners.

A defined procedure must be followed in order to request a new medicine for use within the Trust. Details of the procedure are available from the Director of Pharmacy.

4.4 Function of the Prescription Sheet

To provide a permanent record of the patient's treatment with medicines.
To indicate the patients' sensitivity to medicines.
To facilitate the provision of the correct medicine from the pharmacy.
To direct the administration of the medicine to the patient.

4.5 Use of the Prescription Sheet

A well written prescription sheet enables the rapid and accurate interpretation of the medicines required by the patient. All prescriptions must be written in black ink to facilitate legible faxing. It includes the following information:

4.5.1 Date: Indicates the date the treatment commences or on the date of admission. This start date must be carried forward to any rewritten prescription sheets in the future. A change of dose or frequency of administration is regarded as a new prescription and must be written with a new start date.

4.5.2 Name and Form of the Medicine: The approved or accepted name of the medicine must be written clearly in CAPITAL LETTERS. A medicine may have numerous brand names but only one approved name. If the medicine is a compound (with no approved name) or has unique release properties or bioavailability, then the brand name will be accepted. The form of a medicine must be specified; solid dose is understood unless otherwise stated. Non-approved abbreviations of the name of the medicine, eg CBZ for carbamazepine, must not be used.

4.5.3 Dose and Route of Administration: The dose must be expressed in metric units, avoiding decimal points wherever possible by using whole units, ie 125 micrograms rather than 0.125mg. The word "micrograms" must be written in full and not abbreviated to mcg, to avoid confusion with milligrams (mg). The word "Unit" must be written in full rather than abbreviated to "U" or blood unit symbol "O", which can frequently be confused with a "0" and may lead to 10 times the dose of insulin or heparin being administered in error. Roman numerals (eg ii) are also the cause of medication errors and must not be used. The following abbreviations are standard means of indicating the routes:

Ext	External use	PR	Per Rectum
IM	Intramuscular	PV	Per Vagina
Inh	Inhalation	SC	Subcutaneous
IV	Intravenous	SL	Sublingual
Neb	Nebulisation	Top	Topical
O	By Mouth
PO	By Mouth

All other routes of administration must be written out in full.

4.5.4 Times of Administration: The times of administration must be specified by the prescriber in the appropriate column on in-patient prescription sheets.

Abbreviations such as 'bd' 'tds' are only to be used for as required (PRN) medicines and on take home/outpatient prescription sheets. The following abbreviations are standard means of indicating a dose regimen:

OD	Once a day
OM	Each morning
ON	Each night
BD	Twice daily
TDS	Three times daily
QDS	Four times daily
Mane	Morning
Nocte	At bedtime
Protocol	As per protocol
PRN	As required (with indication and interval stated).

All other dose regimens must be written out in full.

Depot injections should be prescribed with the time interval expressed using the term "every" (eg every 3 weeks rather than 3 weekly which can be misinterpreted. This can be abbreviated as 3/52.)

4.5.5 Signature of Prescriber: Each prescription item must be validated by the full signature of a registered medical practitioner or authorised prescriber. The signature should be legible or the printed name of the prescriber should be written next to the signature.

Doctors' initials or abbreviated signatures are not an adequate means of identification or authorisation.

4.5.6 Cancellation of Treatment: It is important that a suitable means of cancellation of the prescription is adopted, such as a bold line being drawn diagonally across the prescription. The cancellation must be dated and signed in full.

When the 'stop date' box is used in anticipation of the treatment cancellation date, this indicates that at 12.00 midnight on the date specified the prescription must be discontinued and no further doses are to be administered.

Cancellation of areas of the medicine administration record by the prescriber is also another permitted method of indicating when the medicine should be administered and when it should be discontinued.

4.5.7 Length of Treatment: Inpatient prescriptions are valid for a maximum of 63 days, community prescriptions for 6 months. After this period, treatment must be re-written if it is to be continued. If the prescription becomes ambiguous or unclear at any time, the practitioner responsible for the administration of the medicine or the pharmacist must request the prescriber to rewrite it.

4.5.8 Sensitivities: The prescriber is responsible for entering any known sensitivity in the appropriate section of the prescription sheet and transferring these to subsequent sheets. Where there are no known medicine sensitivities, "None Known" must be entered into this prescription sheet box and signed.

It is also important for a warning label concerning known medicine sensitivity to be attached to the outside cover of both the patient's medical and nursing notes, to highlight this information to other prescribers in the future.

Nurses and other practitioners should assist in identifying medicine sensitivities.

4.5.9 Once Only Doses (Stat Doses)

Medicines that are intended to be given once only must be prescribed in the 'once only' section of the prescription sheet.

4.5.10 "As Required" Prescriptions (PRN)

The 'as required' section of the prescription sheet must only be used for those medicines to be given at the practitioner's discretion according to the needs of the patient.
An entry in the nursing records must give reasons for administration and outcomes. This will be subject to periodic audit.
The minimum interval between doses and indication for administration must be clearly specified by the prescriber. It is also good practice to stipulate the maximum dose to be given in a 24 hour period.
The 'as required' prescription must be reviewed regularly by a doctor to determine its clinical need. To prevent the accumulation of unnecessary 'as required' prescriptions the following guidelines should be observed:-

- Any PRN that has not been required for 3 months should be cancelled.

- Not more than one medicine from any BNF therapeutic category should be prescribed as a PRN at any one time.

- Not more than two medicines should be prescribed as a PRN at a time for any one indication.

Some "as required" medicines may be prescribed according to written protocols agreed by the Drugs and Therapeutics Committee. These medicines may be prescribed 'as protocol'.
Prescribing a medicine on an 'as required' basis provides a useful method of assessing the person's requirements for medicines such as anticholinergics, analgesics and hypnotics.
Medicines originally prescribed 'as required', but which are needed regularly as indicated by the administration record, must be reviewed and rewritten in the regular prescription section.
Once a patient's medical condition has improved there may be less requirement for medicines such as hypnotics, anxiolytics, and anticholinergics, analgesics and laxatives. The 'as required' prescription should provide a useful strategy to ensure that medicines that are no longer required do not continue.
Care must be taken not to duplicate medicines being taken regularly and thus overdose the patient. Combination analgesics frequently contain paracetamol, which may already be prescribed in the regular section of the prescription chart. Rapid dose escalation using combinations of PRN and regularly prescribed antipsychotic drugs is one of the most commons causes of sudden death and neuroleptic malignant syndrome in schizophrenia.

4.6 Verbal Orders

In areas where there are no resident prescribers and in cases of clinical urgency a verbal order is acceptable. The following procedure for verbal orders will apply:

The doctor gives the verbal order to a Designated Practitioner.
The Designated Practitioner must write the message directly on to the appropriate section of the prescription sheet indicating:

"Verbal order from ........"

A second Designated Practitioner, where available, should read the message back to the prescriber who must then confirm it.
The Designated Practitioner must record in the patient's care record "verbal order by telephone" and provide details of the date, time, message, name of prescriber and the practitioner's signature.
The prescription must be signed within 24 hours by the prescriber or a deputy by arrangement. After 24 hours the prescription is no longer valid and the medicine must no longer be administered unless signed as described.

When a Community Designated Practitioner receives a verbal order to alter the dose of a medicine or alter the dose or time interval of a depot antipsychotic drug the prescription must be signed within one week. After one week the verbal order is no longer valid.

N.B.

It is unacceptable for a verbal message to be given for a Controlled Drug.
The Designated Practitioner retains the right to refuse to take a verbal message to administer a medicine.

A pharmacist may receive a verbal order from a prescriber to alter or add a prescription item. All alterations must be made in green ink and signed by the pharmacist. The pharmacist must read the alteration or addition back to the doctor who must then confirm it. The prescriber must sign any new prescription within 24 hours.

Where possible the prescriber should be encouraged to make required amendments to prescriptions in person.

4.7 Group Protocols (Standing Orders)

It is necessary that all medicines administered by a practitioner are given on the authority of an authorised prescriber. In some areas certain medicines are routinely initiated by practitioners in accordance with a Group Protocol. This is a written procedure, authorised by the Trust in advance, such that it does not require a prescription.
Any protocol proposed by a practitioner must be approved by the Appointed Practitioner in Charge, the consultant and the Director of Pharmacy and ratified by the Drugs and Therapeutics Committee. The contents of the Group Protocol must comply with that outlined by the Crown Report 1998 and include the following information:

Details of the condition or situation to which the protocol applies.
Characteristics of the staff authorised to take responsibility for the supply or administration of medicines under the Group Protocol.
A description of the treatment available under the Group Protocol.
The management and monitoring of the Group Protocol.
It is the responsibility of the Appointed Practitioner in Charge of each ward, department or area to ensure that if medicines are administered without a written prescription then a valid and current Group Protocol is available to guide practitioners in their area and that the person administering the medicine has received training about the protocol.
Copies of approved Group Protocols must be available in each area and must reflect accurately practice in that area.
A record of this type of administration must be entered in the "Non-Medical Practitioner Initiated Therapy" section of the prescription sheet and signed by the Designated Practitioner. A Designated Practitioner can only administer a medicine initiated by themselves and not by another Practitioner.
The SDMHT Drugs and Therapeutics Committee is responsible for ensuring that Group Protocols are reviewed annually and for approving new editions, revisions and deletion of Group Protocols must be approved by the SDMHT Drugs and Therapeutics Committee. A record of the review must be on the documentation.

4.8 Specialist Practitioner and Clinical Pharmacist prescription amendments

A number of Specialist Practitioner and Clinical Pharmacist roles have developed. These provide specialist therapeutic services which may include dose adjustment or, in some cases, the initiation, continuation or discontinuation of therapy.
These specialist roles may become more widely established following the recommendations concerning these types of duties in Part 2 of the Crown Report. The report clarifies and defines terms such as Dependent and Independent Prescriber and the role of professions outside medicine in prescribing medicines .
It is important to make a clear distinction between a Group Protocol and the Specialist Practitioner and Clinical Pharmacist prescription amendments. The initiation and modification of a prescription made by a practitioner in the above manner is not restricted to the "Non-Medical Practitioner Initiated Therapy" section of the prescription sheet. Such changes may be made on the main part of the prescription sheet and used by Designated Practitioners for the administration of medicines.
In all cases where a specialist therapeutic service is provided, practitioners must be adequately trained and authorised for the duties they are required to perform. The modification of the prescription must be in accordance an agreement between senior medical and pharmacy staff. The SDMHT Drugs and Therapeutics Committee must approve all such agreements.
In the lifetime of this code, arrangements to initiate standard treatments according to agreed protocols may emerge. The Appointed Practitioner in Charge must ensure that any agreed protocols in use are valid and current and have been approved by the Drugs and Therapeutics Committee.
Where a Specialist Practitioner or Clinical Pharmacist has modified or initiated a supply of medicine, a record must be made on the appropriate prescription sheet, and the patient's records if these are available. Details of the entry must include the change of the medicine, dose regimen, route of administration or formulation and must be signed and dated.

5. ORDERING AND RECEIPT OF MEDICINES

During the lifetime of this Code an alternative system of supply, ordering and receipt of medicines called "one stop dispensing" may be introduced in SDMHT. In order to allow for that change the procedures relevant to both "one stop dispensing" and the traditional "ward stock" systems are provided.

The traditional ward stock system incorporates some or all of the following features.

Ward stocks which are medicines commonly prescribed for the patients of the ward. Ward stocks are retained on the ward regardless of whether they are currently prescribed for any patient.
Named patient medicines which are supplied for a particular patient. Once the patient is discharged from the ward the medicines are returned to the pharmacy. Named Patient medicines are also known as 'individual supplies'. Medicines for patients who regularly receive planned respite care may remain on the ward for future use.
Medicines to take out (TTO's) which are specifically supplied for an individual patient who has authorised leave from the ward or who is to be discharged.

One stop dispensing incorporates some or all of the following features:

Use of patient's own medicines
Individual patient supplies, with directions
The supply of original packs
Self administration by patients
Up to 28 day discharge

Procedures relevant to one stop dispensing are covered in Section 5.4.6

5.1 Controlled Drugs

The responsibility for ordering, receipt and storage of Controlled Drugs is that of the Assigned Practitioner in Charge of the ward/department. By agreement, this responsibility may be transferred to Authorised Pharmacy Staff providing the regular ward stock topping-up service.
Controlled Drugs can only be ordered from the pharmacy by submitting a requisition from the official Controlled Drugs Requisition Book. Ordering is restricted to an Assigned Practitioner in Charge or Authorised Pharmacy Staff. All Assigned Practitioners who may order Controlled Drugs must provide the Pharmacy Department with specimen signatures.
All Controlled Drugs must be delivered to wards or departments in a tamper evident package. Where appropriate a porter or messenger may deliver Controlled Drugs in a tamper evident package. The porter or messenger must sign a Drugs Delivery Record Sheet. A Designated Practitioner must receive the package and sign the Drugs Delivery Record Sheet. The Designated Practitioner signs for receipt of a tamper evident pharmacy container. If the Controlled Drugs are to be collected by a Designated Practitioner, the appropriate part of the Controlled Drugs Requisition Book must be signed and the medicines transported back to the ward in a sealed package
A Designated Practitioner, must check the contents of the package containing controlled drugs against the requisition. Any discrepancy must be reported to the pharmacy IMMEDIATELY. If correct, the Designated Practitioner must sign the requisition. The Designated Practitioner must enter the new stock into the Controlled Drugs register on the appropriate page, witnessed by another Designated Practitioner, Authorised member of the Pharmacy Staff or an Authorised Employee who must verify the stock level and sign the register. The medicines must then be immediately locked away.
Where sealed packs of Controlled Drugs are supplied with tamper evident seals, there is no requirement to open these packs for stock checking purposes.
Controlled Drugs must be stored in a locked, red light alarmed medicines cupboard, approved by pharmacy and reserved for the sole storage of Controlled Drugs. Access must be limited to Designated Practitioners, Pharmacists or Authorised Pharmacy Technicians.
Registers and Requisition Books for Controlled Drugs are controlled stationery and obtainable only from the pharmacy. Requisition books should be locked away.
Orders and records must be in permanent ink and must be retained for two years.

5.2 All other Stock Medicines

5.2.1 Ordering of Stock Medicines

A Designated Practitioner or Authorised Member of the Pharmacy Staff shall be responsible for ordering medicines from the pharmacy for the purposes of maintaining ward stocks.

Stock medicines may be ordered by:

Supplying a written requisition from the appropriate order book, or an order sheet signed by a Designated Practitioner.
Using a Fax Machine to send a copy of the above.
By means of the pharmacy technician top-up service.
Using computer technology - where this is used access to passwords and terminals shall be restricted to Designated Persons.

5.2.2 Delivery of Stock Medicines

All medicines must be delivered to wards/departments in a secure container.

Where appropriate, a porter or messenger may deliver medicines in a tamper evident package or locked box. The porter or messenger must sign a Drugs Delivery Record Sheet. A Designated Practitioner must receive the package or box and sign the Drugs Delivery Record Sheet. The Practitioner signs for the receipt of a tamper evident pharmacy container or locked box.

Medicines may be collected by a Designated Practitioner or approved messenger and transported back to the ward in a tamper evident pharmacy package or locked box.

5.2.3 Receipts and Records

The Designated Practitioner must:

Check the medicine against the delivery note
Sign the note and keep it (for 2 years) as a record that the supply was complete.
Lock the medicines in the medicine cupboards immediately.
Report any discrepancies to the Pharmacy immediately.

5.3 Named Patient Medicines

Medicines for named patients may be ordered by:

Submitting a signed order plus a patient's prescription sheet for a supply of a new named patient supply of a medicine
Using a Fax Machine to send a copy of a signed order and prescription sheet.
By means of the pharmacy top-up service.
Using computer technology - where this is used access to passwords and terminals shall be restricted to Designated Persons.

If patient's own medicines are available, they may be used with the patient's consent, providing they comply with the standards set out in section 12. These should only be used until the Pharmacy Department is next open with the 'Traditional Ward Stock System', but may be used for longer with the 'One Stop Dispensing System'. Patients' own medicines will be further inspected by pharmacy staff on their next visit to the ward.

Where the 'One Stop Dispensing' system is operational, ward stock pre-packs partially labelled with directions may be used provided the practitioner completes the instructions, date and patient's name on the label. This item must then be stored in the patient's individual medicine cabinet or compartment of the medicine trolley.

Only in cases of clinical urgency must the on-call pharmacist be contacted for items. The supply of the majority of medicines will not be urgent and can be left to the next time the Pharmacy Department is open. The on-call pharmacist will assist ward staff to determine what is clinically urgent.

It may not always be possible to have individual medicine supplies available from the pharmacy for the next medicine administration round. Nursing/practitioner staff must make maximum use of patients' own medicines and ward stock pre-packs. If the medicines have been ordered and have not yet been supplied by the pharmacy the Designated Practitioner must record "O" (Omitted) on the medicine administration chart, and enter the reason in the patients' notes.

5.3.1 Delivery of Named Patient Medicines is the same as for Stock Medicines.

5.3.2 Receipt of Named Patient Medicines

All named patient medicines coming into a ward/department shall be received by the Designated Practitioner, the same as for Stock Medicine.

5.4 Medicines 'To Take Out' (TTOs)

5.4.1 Ordering of TTOs

TTOs can be ordered by:

Submitting a Discharge Form or Leave Form together with the inpatient prescription sheet.
Using a fax machine to send a copy of the above.
Using computer technology - where this is used access to passwords and terminals shall be restricted to Designated Persons.

N.B. Controlled Drugs cannot be supplied to a patient until the original prescription has been received by the Pharmacy.

5.4.2 The delivery of TTOs is the same as for Stock Medicines .

5.4.3 All TTO medicines coming into a ward or department shall be received by a Designated Practitioner, who must:

Check them against the medicine card, leave card or TTO form to confirm that all details are correct i.e. name, medicine, dose, directions.
Lock them in the medicines cupboard immediately.
Report any discrepancies to pharmacy immediately.

5.4.4 The top copy of the interim discharge letter should be sent to pharmacy whenever TTOs have been ordered. A copy of the interim discharge letter should also be sent to the GP and a copy stored in the patient's notes.

5.4.5 It is important that the patient received adequate information about their medicines prior to discharge. The patient should know the purpose of the medicine, how to take it and for how long it is to be taken. This is a shared responsibility of the Designated Practitioner and Authorised Pharmacy Staff. It is the responsibility of the Designated Practitioner who discharges the patient from the hospital to ensure that the patient has received adequate information about their medicines.

5.4.6 One Stop Dispensing

Supplies of inpatient medicines dispensed for the individual patient can be issued on discharge, provided:

the medicines stored in their individual medicines cabinets or ward medicine trolley correspond to those prescribed on the discharge prescription,
the medicines have a label including the name of the medicine, the directions for use, the name of the patient and the date of dispensing,

Where the discharge prescription differs from the medicines in the patient's cabinet or when there are insufficient supplies of medicines, the ward staff must contact the Pharmacy Department to make arrangements for the required discharged medicines to be dispensed.

5.4.7 Controlled Drugs to Take Out

Controlled drugs to take out should be ordered on a TTO form or leave card which has been written up by a medical practitioner in accordance with current legal requirements. The top copy of the original prescription must be sent to pharmacy for dispensing.

Delivery and receipt of controlled drugs for TTO purposes should be as for other medicines, but storage on the ward/department should be in the controlled drug cupboard.

N.B. It is not necessary to enter the TTO into the Controlled Drug Register.

5.5 Borrowing of Medicines

Medicines must not be borrowed from a ward or department unless a supply cannot be obtained directly from the pharmacy during normal working hours. Only stock medicines may be borrowed and the complete container must be transferred to the receiving ward.
In the circumstances when medicines are borrowed, transferring medicines into another container is FORBIDDEN. The complete container must be transferred to the receiving ward.
A signed record of the transfer of medicines must be kept on both wards involved in the "borrowing transaction". The signature must be that of the Assigned Practitioner in Charge.
Controlled Drugs must not be borrowed except in an extreme emergency.

Records of the dose of a borrowed Controlled Drug must be made in the Controlled Drugs register of the ward or department who has provided the medicine; ie the dose must be booked out directly to the patient in the receiving ward. The pharmacy must be informed as soon as possible after a borrowed supply of Controlled Drug has been made.

6. PHARMACY SERVICES

The role of the pharmacy is to:

Advise on and monitor the safe, effective and economic use of medicines.
Procure medicines.
Supply and/or dispense ready to administer medicines.
Review the medication history of patients.
Provide medicines for discharge.
Advise patients on their use of medicines.

6.1 Medicines will be procured supplied and dispensed in accordance with the relevant legislation, professional standards and NHS recommended practice.

6.2 Pharmacists will monitor all new requests for medicines for patients in their care and place special emphasis on complex and potentially toxic medicines that require higher levels of monitoring. Continuing medicine treatment will be reviewed as necessary.

6.3 When a request for a new medicine has been made the pharmacist must check the prescription and other related patient records to ensure the safe, effective and economic use of medicines. Attention must be given to each step of the medicine use process. This includes the need for the medicine, the medicine selected, the dose regimen including the duration of treatment, the medicine formulation and the route of administration. In addition pharmacists must monitor for medicine interactions/adverse reactions and whether the therapy is achieving the desired therapeutic end points.

6.4 Authorised Pharmacy Staff may annotate the prescription in green ink.This annotation should ensure the approved name, dose, route and precautions are included on the prescription, to guide practitioners when they administer the medicine. All annotations must be initialled.

6.5 Where a pharmacist wishes to make a recommendation to change or modify a patient's therapy, the pharmacist must record the recommendation in the patient's notes. It is good practice to sign and date the recommendation and provide some background details. These written records must be made, in addition to any verbal communication, with the prescriber.

6.6 Patients should be advised about their medicines by Authorised Pharmacy Staff during their admission stay or period of admission. This should be a part of an agreed programme for each ward.

The Appointed Practitioner in Charge should agree with the pharmacist and consultant the arrangements for advising patients about their medicines.

Alternative arrangements for advising patients about their medicine may be provided if:

The nature of the hospital stay is less than one week
There is a need for a rapid discharge
The nature of the discussion is considered inappropriate by the consultant.
There is insufficient availability of suitably trained pharmacists

Such alternative arrangements must identify the person responsible for the provision of information and the nature of the information to be provided.

6.7 Routine supplies of newly prescribed medicines are made when the pharmacy department is open. Out of hours the on-call pharmacist will determine the clinical urgency of the items and arrange for the supply as appropriate.

6.8 Authorised Pharmacy Staff must be involved in advising on security and medicine storage conditions on the ward/unit or department.

6.9 The pharmacy must provide a medicine information service for other healthcare staff and patients.

7. PREPARATION AND ADMINISTRATION OF MEDICINES

Only medicines that have been supplied or approved for use by SDMHT Drugs and Therapeutics Committee must be administered to patients. This applies also to complementary medicinal products, eg aromatherapy oils, homeopathic medicines.

Medicines must only be prepared, checked or administered to a patient by the following categories of healthcare staff:

A Designated Practitioner
A Medical Practitioner
Authorised Pharmacy Staff
A practitioner in training, but only under the direct supervision of a Designated Practitioner.
The Designated Practitioner remains responsible for ensuring that the correct procedure takes place
Other Authorised employees

7.1 Preparation of Medicines

It is frequently during the preparation of medicines for administration that errors occur, particularly where some form of dose calculation is involved. In the majority of cases, medicines must be presented to ward areas from the Pharmacy Department in a ready-to-use form, where no further dilution or dose calculation is required.

Where the preparation of medicines is performed outside the Pharmacy Department, the following points must be observed:

Read the prescription carefully. Determine the name, dose, diluent, route for administration and expiry date.
If a dose calculation is required this information must be included as part of the prescription either by the doctor or the pharmacist so that the Designated Practitioner administering the dose is clear about the actual amount to administer. It is recommended that the Designated Practitioner checks all calculations with a second practitioner or pharmacist before administration.
Where a calculation is involved and where the medicine product is intended for intravenous administration, a second practitioner must check all aspects of the preparation of the medicines and sign and date the entry.
If the practitioner is unclear as to the correct medicine diluent or precise method for medicine preparation, he/she must obtain this information from the Pharmacy Department before proceeding.

Following medicine errors in the Trent Region, the Regional Medical Officer has recommended the practice of medical staff obtaining a second practitioner check when calculating, preparing and administering medicines.

An appropriate area for the preparation of intravenous infusions must be identified. This area should be separated from the direct patient areas and enclosed (all doors and windows should be closed). These precautions reduce the risk of microbial contamination and interruptions, which can lead to medicine errors.

7.2 Administration of Medicine

The Assigned Practitioner in Charge is responsible for ensuring that prescribed medicines are administered within 60 minutes either side of the prescribed time.
Before administration of a medicine, a practitioner must:

Read the prescription carefully.

Check authorisation of administration (Forms 38 or 39) if the patient is detained under the Mental Health Act 1983

Ascertain from the record of the administration of medicines that the prescribed dose has not already been given.

Select the medicine required and check the label against the prescription.

The practitioner must then check the identity of the patient and administer the medicine. Extreme care is required to ensure that the patient's identity is confirmed by visual recognition and verbal questioning before proceeding to administer the dose.
Medicines dispensed for an individual patient must be administered only to that patient (supplies labelled for individual patients must not be shared).
The practitioner who has administered or supervised the administration of the medicine must, at the time of administration, sign with initials in the appropriate column of the official prescription sheet.

Patients must be observed to have taken their medicines by the Designated Practitioner. Prepared medicines must not be left unsupervised unless the patient/carer self-administration procedure is being followed.

If a medicine is omitted the following codes must be entered in red on the prescription sheet:

If refused a cross 'X' recorded.
If the patient is nil by mouth and the practitioner has been given clear instructions to omit the oral doses NBM must be recorded.
'L' must be recorded when the patient is on leave
'S' must be recorded when a practitioner supervises patient self-administration
- must be recorded for a prescribed omission (eg alternate days dosing)
If a medicine is omitted for any other reason, (eg if not available) an 'O' must be recorded. In each instance an explanation must be recorded in the nursing record.

FAILURE TO RECORD THE ADMINISTRATION OF A MEDICINE OR AN OMISSION CODE CONSTITUTES A MEDICATION INCIDENT AND MUST BE REPORTED. THE SCRUTINY OF SUCH RECORDS WILL BE THE SUBJECT OF REGULAR AUDIT.

If the patient is absent from the ward, or has missed a dose for some other reason, the delayed dose can be administered at a later time provided a doctor or pharmacist has confirmed that it is appropriate to do so or that it is according to an agreed protocol. The actual time of administration must be clearly recorded in the administration record by the Designated Practitioner and appropriate entry into the patient's record is made.
Patients classified 'Nil by Mouth' prior to a diagnostic procedure or receiving an anaesthetic and undergoing ECT must have all their prescribed oral medicines administered to them at the prescribed time unless specifically advised otherwise by ECT staff. The medicines should be taken with a small amount of water to enable them to swallow these medicines. Only medicines that have been clearly marked on the prescription sheet may be omitted. It is the responsibility of the prescriber to provide clear written instructions to the nursing staff concerning the omission of prescribed doses.

7.3 Checking of Administration:

It is good practice that, wherever possible, all medicines be prepared and administered in the presence of another practitioner.

Except in extreme emergency, the following must be checked by 2 practitioners:

All medicines given by continuous administration, eg IV infusion, syringe drivers. There should be a record of the individual practitioner setting up and replenishing each intravenous infusion.
All bolus injections, IV additives and injections via drip tubing.
All injections taken from multi-dose vials. When a patient has proven competent to self-administer the medicine (eg insulin) the checking of administration need only involve one practitioner.
All medicines administered to a child under 12 years of age.

7.4 Controlled Drugs:

The administration of all Controlled Drugs must be witnessed by a second practitioner.
An entry must also be made in the ward or department Controlled Drugs register, including:

- date and time of administration,

- name of patient,

- dose administered

- full signature of both practitioners,

- remaining stock balance must be checked.

Any medicine prepared and not used, or only partly used, must be destroyed in the presence of a second practitioner. An entry must be made in the Controlled Drugs register and signed by both practitioners. Any discrepancies must be brought to the notice of the Appointed Practitioner in Charge and the pharmacy, when next open.

7.5 Practitioners must observe and note any adverse side effects of medicines and inform the responsible medical staff.

7.6 The preparation and administration of medicines by Authorised Pharmacy Staff, Designated Practitioners other than nurses and medical officers.

Authorised Pharmacy Staff may carry out medicine administration procedures only with the full approval of a medical team and then only after a written procedure has been approved by the SDMHT Drugs and Therapeutics Committee.
Other Designated Practitioners other than nurses and medical officers may only carry out medicine preparation and medicine administration procedures with the full approval of the medical team and only after a written procedure has been approved by the SDMHT Drugs and Therapeutics Committee.

7.7 Staff requiring treatment for minor ailments must be referred to Occupational Health or purchase items from a local pharmacy. Medicines dispensed as ward stock or for individual patients must not be used to treat staff.

8 TRANSPORT OF MEDICINES

8.1 Transport within hospitals

Medicines must be transported within hospitals by members of staff.
A record of the transport of medicines including signatures from the person issuing the medicine, transporting the medicine and receiving the medicine is required.
Medicines must not be left unattended at any time during transport.
When medicines are received at their final destination they must not be left unattended or unsecured. They should be handed to a Designated Practitioner and locked away in medicine cupboards at the earliest opportunity

8.2 Transport of medicines between health services premises.

8.2.1 Medicines accompanying a patient and being transferred from one hospital to another* may be transported between hospitals with the patient in an ambulance or by authorised hospital transport, or taxi. It is important that medicines are packaged securely and are labelled with the final destination.

8.2.2 Transport of medicines from the pharmacy department with authorised transport.

All medicines must be transported in sealed, tamper evident containers.
Containers shall be kept securely or under surveillance whilst awaiting collection from or on receipt at the designated areas.
On arrival on the wards/departments/clinics, containers should be placed in a designated area. Once delivered to the ward/department/clinic the responsibility for the security of the medicines rests with the Assigned Practitioner in Charge who will arrange that the contents be unpacked, checked and put away securely as soon as possible.
Delivery vans should not be externally distinguishable from other Health Service vans.
DELIVERY VANS SHOULD NOT CARRY ANY UNAUTHORISED PASSENGERS
Delivery vans should be locked when unoccupied.
A consignment note stating the number of containers shall be carried by the driver. The authorised person accepting the delivery must sign the note on receipt. The consignment note must be returned to the pharmacy.

8.2.3 Transportation Within Hospitals

Where the medicines are delivered to a central point. The containers must be securely stored while waiting to be transported to the wards/departments/clinics. The responsibility for the security rests with those transporting the medicines until the delivery is completed and the necessary signatures obtained.

8.2.4 Transportation by Taxis

All items must be transported in tamper-evident sealed containers. Controlled Drugs must not be uniquely identified.
A triplicate Transport Book must be completed and a copy retained in the pharmacy department. Two copies are taken by the driver. After obtaining a signature for receipt of the medicines, one copy is kept by the driver. The ward, department or clinic must retain their copy for 2 years.
Only hospital contract taxis with drivers able to produce identification bearing a photograph shall be used.
Ideally the seal number of the container should be recorded on the transport sheet.
Items must be collected from the pharmacy or an agreed designated area and delivered to the addressee or pre-arranged point.
If items are not delivered directly to the addressee the responsibility for security rests with those receiving the container until delivery is completed and documentation countersigned.

8.3 Transport of medicines to individual patients at home.

Medicines may be transported home by patients or their carers following a hospital attendance or on discharge.
Patients or carers who have left the hospital before all their medicines have been dispensed must be instructed to return to the hospital later to collect their medicines.
The transport of medicines to a patient's home at other times must be authorised by the Assigned Practitioner in Charge of the ward.
Medicines may be transported to the patient's home (or sometimes to a local Health Centre or Community Pharmacy for subsequent collection) by authorised hospital transport, taxi or by post. It is important that medicines are packaged securely and are labelled with the final destination.
A record of medicines transported including signatures from the person issuing the medicines, transporting the medicines and receiving the medicines is required for all medicines.

8.4 Transport of medicines by voluntary drivers, relatives or representatives of the patient.

Voluntary drivers, relatives or representatives of the patient may collect medicines on behalf of a patient provided the pharmacy has received prior notification of their impending arrival by the ward, day unit or department.
Voluntary drivers who receive medicines on behalf of a patient must deliver the medicines to the patient and not pass the medicines to another voluntary driver.
Voluntary drivers must carry identification of their role.
A record of medicines transported including signatures from the person issuing the medicines, transporting the medicines and receiving the medicines is required for all medicines.

8.5 Transport of medicines by Designated Community Practitioners is covered in Chapter 23.

9. STORAGE OF MEDICINES

The Appointed Practitioner in Charge is responsible at all times for the safekeeping of all medicines on their ward or department.
The design and location of all ward or department medicine storage cupboards must be approved by Authorised Pharmacy Staff and regularly monitored.
All internal and external medicines, disinfectants, and reagents must be stored in locked cupboards, trolleys or other secure cabinets - all reserved solely for medicinal products. The only exceptions to this requirement are medicines for clinical emergencies, intravenous fluids, sterile topical fluids and nutritional products and some bulky medicated dressings which, because of their bulk, are stored in a clean area (as agreed between the Appointed Practitioner in Charge and an Authorised member of the Pharmacy Staff).
Internal medicines must be stored separately from other medicines. Under no circumstances must medicines be transferred from one container to another, nor must they be taken out of their container and left loose. All medicines in transit must be in a sealed tamper evident container.

9.1 Siting of Cupboards and Trolleys.

Cupboards and trolleys must be sited where most convenient for staff, allowing adequate space and permitting surveillance to afford maximum security against unauthorised entry. Medicine cupboards must generally be sited in a clean utility room to which the general public does not have access. Cupboards must not be sited where they may be subjected to higher than average humidity or temperature. Reagent cabinets must be sited in areas where testing is carried out.

9.2 Review of Storage of Medicines

The quantities, range and storage of medicines to be stocked will be reviewed regularly by the Authorised Pharmacy Staff and the Appointed Practitioner in Charge.

9.3 Controlled Drugs

No ward or department must store Controlled Drugs unless there is an Appointed Practitioner in Charge responsible for their storage and use.

9.4 Sample Medicines

No samples (of medicines or dressings) may be left on wards or departments. Representatives of pharmaceutical companies wishing to leave samples must be referred to the Pharmacy Department.

9.5 Closure of a Ward or Department

If a ward or department is due to close, the Controlled Drugs must be handed over by an Assigned Practitioner in Charge to an Authorised member of the Pharmacy Staff who will sign the appropriate section of the register and return the Controlled Drugs to the pharmacy.

If a ward or department is to close for more than a few days, all other medicines must be returned to the pharmacy. However, if a ward is to close for only a few days, the medicines (other than Controlled Drugs) may, with the agreement of the Authorised member of the Pharmacy Staff and the Appointed Practitioner in Charge, stay on the ward provided there is adequate security to prevent unauthorised access to the cupboards.

9.6 Breach of Security

Any incident must be reported immediately and investigated by the Appointed Practitioner in Charge together with an Authorised member of the Pharmacy Staff.

9.7 Storage Accommodation:

Clinical areas may have some or all of the following medicine storage units.

Controlled Drug Cupboards - reserved solely for the storage of Controlled Drugs and secured to the wall. These cupboards may be separate from others or be inside other locked medicines cupboards used to store internal medicines. All should be with fitted with a red warning light to identify when the door is open. The lock must not be the same as any other lock in the hospital.
Internal Medicine Cupboard(s) - for the storage of tablets, liquid medicines, injections etc.
External Medicine Cupboard(s) - for the storage of creams, lotions etc.
Medicine Refrigerator - medicines are not to be stored together with food or pathological specimens, but in a separate small locked fridge. Medicines requiring storage below room temperature will be marked "Store between 2ºC and 8ºC, in a refrigerator."
Reagent Cupboard(s) - situated in the area where urine testing is carried out. Some wards may not require a separate cupboard if urine testing is only very rarely carried out but in such circumstances there should be a ward agreement about where such testing is to take place.
A Clean Storage Room - for intravenous fluids and sterile topical fluids, if no suitable cupboard is available.
Medicine Trolley - for storage of medicines in current use on the medicine administration round. When not being used the medicine trolley must be locked and secured to the wall. The trolley must not be left unattended during the medicine round. If the Designated Practitioner leaves the trolley, it must be locked immediately.
Medicines for Clinical Emergency - must be readily accessible and in a position to afford supervision to prevent unauthorised access. These must be held in a tamper evident box and must not be in a locked cupboard. Once opened the box must be returned to the pharmacy for replacement.
Named Patient Cupboards - medicines dispensed for individuals (together with the patient's own medicines) can be stored in a locked medicine cabinet at the side of the patient's bed. These cabinets must be kept locked when not in use and the keys held by a Designated Practitioner and, where self-medication is occurring, the individual patient.

9.8 Flammable Liquids, Gases, Aerosols - advice is obtainable from your local Fire and Safety Officer.

10 LOSSES OR DISCREPANCIES

10.1 Controlled Drugs

In the event of a discrepancy between the stock balance and register for Controlled Drugs, the Appointed Practitioner in Charge must immediately and thoroughly investigate the loss. A missing entry must be sought but, after an unsuccessful investigation, the discrepancy must be reported immediately to the senior manager responsible for the ward or department and the Director of Pharmacy who can then consider whether or not the police should be notified.

10.2 Other Medicines

Any loss of other medicines must be reported to the senior manager responsible for the ward or department (via the Appointed Practitioner in Charge) and the Director of Pharmacy, who can then decide on a further course of action.

11 DISPOSAL OF MEDICINES NO LONGER REQUIRED

11.1 Controlled Drugs.

11.1.1 Controlled Drugs must not be returned from the wards or departments in the pharmacy box. Controlled Drugs no longer required by a ward or department must be removed by Authorised Pharmacy Staff. Upon removal of the Controlled Drug the Authorised member of the Pharmacy Staff will enter the appropriate stock balance and sign the Controlled Drugs Register. The transaction will be witnessed by the Assigned Practitioner in Charge who will also sign the register.

11.1.2 Any Controlled Drug removed from the ward or department by Authorised Pharmacy Staff must be returned to the pharmacy department where an appropriate entry will be made in the pharmacy Controlled Drug Register. Any dose of a Controlled Drug that is prepared but not administered, including partly used syringes used in syringe driver pumps shall be destroyed on the ward or department. The destruction of the Controlled Drug must be in the presence of a second Designated Practitioner. The appropriate entry should be made in the Controlled Drug Register, which includes the signatures of the 2 practitioners involved in the destruction.

11.1.3 Controlled Drugs brought in to the hospital by the patient may be:

Used by the ward staff for administration to the patient (see Patient's Own Medicines section)
Stored for subsequent destruction*

In both of the above the Controlled Drug must be stored in the Controlled Drug cupboard, and entered in the Controlled Drug Register either on a new page specifically allocated for the patient's own medicine or on a page specifically identified for the recording of "Patients Own Medication for destruction".

11.1.4 All unwanted Controlled Drugs returned to the pharmacy must be stored in an approved secure place until the Authorised Person can witness their destruction.

11.2 Other Medicines

All out of date medicines no longer required by the ward or department must be returned to the pharmacy in a locked box. A record of the nature of the returned medicines will be made by the Designated Practitioner in the pharmacy order book.

A record of all action taken must be kept on the ward.

12 PATIENT'S OWN MEDICINES

12.1 All medicines brought into the hospital by patients remain their own property and should not therefore be destroyed or otherwise disposed of without their agreement or, if this is not possible, their relatives' agreement.

12.2 Medicines brought into hospital by patients should be reviewed by the admitting doctor who may or may not wish to prescribe them.

12.3 Where wards are using the traditional ward stock system it is usual for the ward to receive medicines for administration to patients solely from the hospital pharmacy. All medicines brought into hospital by patients would, following their agreement or the agreement of relatives be either taken home by the patient's relatives or sent to the pharmacy for destruction.

12.4 Medicines brought into the hospital may, with the patient's permission, continue to be used provided:

They have been prescribed on a hospital prescription sheet

and,

they are for a medicine not approved for use in SDMHT

alternative supplies are not available (eg because of night time, weekend, or bank holiday admission)

the ward has a procedure to routinely use patient's own medicines as part of "one stop dispensing".

In the case of a patient maintained on a medicine not approved by SDMHT the following options can be considered.

The patient's prescription can be modified to the nearest equivalent approved medicine

the patient can agree that their own medicine can be used.

In no instance should it be necessary for a hospital inpatient to receive a further supply of a medicine from their General Practitioner. These items may be supplied from the hospital pharmacy department by special arrangement.

12.5 Before a patient's own medicine, including controlled drugs, can be used in the hospital it must be checked by a Designated Practitioner against the following criteria:

* The medicine must be clearly labelled with:

The name of the patient.

Name and strength of the medicine.

Method and frequency of administration.

Date dispensed (do not use if dispensed more than 6 months ago).

Name and address of supplier.

* If the medicine has no dispensing label, it must not be used unless:

It is a clearly identifiable in the manufacturers original container

and

is within its expiry date.

Medicines such as glyceryl trinitrate and eye drops which have a short shelf-life once opened must not be used unless the date that the medicine container was opened is clear and within the accepted expiry date.
There must be confirmation that the medicines have been stored appropriately. e.g. items that require refrigeration such as insulin have been stored in a refrigerator.
The overall appearance of the bottle, label and medicine must be acceptable e.g. The container must be intact and clean. The medicine must be without visible sign of deterioration.
The medicine in the container must be all of the same type. If the appearance of the medicine is not uniform it must not be used.

12.6 Controlled drugs must be stored in the CD cupboard and recorded as detailed in the procedure for making entries into the Register.

12.7 If the patient's own medicines are in a compliance aid they should not be used to administer the medicines to the patients. The compliance aid is the patient's property and should be stored on the ward until such time as a decision can be made about the compliance aid and its contents

12.8 If medicines brought into the hospital by patients are to be used after the overnight (or weekend) period they must be inspected by Authorised Pharmacy Staff who will decide on their suitability. Medicines that have been visually inspected will have an inspection label attached and these are the only medicines that may be administered after the overnight (or weekend) period.

When the brand name is the only name appearing on the label and the generic name appears on the prescription the pharmacist must annotate the inpatient prescription sheet with the brand name used on the label.

12.9 If the use of patient's own medicine is the agreed policy of the ward the medicines should be stored in an individual section of the medicine trolley or if self-medicating in the patients locked medicine cabinet on the ward.

12.10 Where medicines are stored in individual medicine cabinets for self-medication it is the responsibility of the Designated Practitioner to ensure that if a patient is moved to a new location all of their medicines move with them.

Medication errors have occurred when a previous patient's medicines remaining in the cabinet have been supplied to the next patient.

12.11 At discharge the Designated Practitioner must check the patient's own medicines against the discharge prescription prior to issuing to the patient to take home. If the items are no longer appropriate advice should be given to this effect and the patient encouraged not to take the medicines home. If there has been a change of therapy or if additional medicines are required, the pharmacy service must be contacted to arrange for supplies to be dispensed.

12.12 The patient's own medicine if not required can be disposed of in one of several ways.

Patient's own medicines may be recorded and securely stored on the ward/pharmacy until returned to the patient on discharge.
If a medicine is not current therapy and with the patient's or their relatives' agreement, the medicines may be sent to the pharmacy for destruction and a record made.
If the patient insists, the medicine may be returned home. The patient and/or patient's agent shall be advised if the medicines are not safe for use. The Designated Practitioner, after consultation with the prescriber, may assume responsibility for the decision to refuse to return medicines to patients.

13. SELF-ADMINISTRATION OF MEDICINES BY PATIENTS

Patients may self-administer their own medicines following the agreement of the multidisciplinary team. The multidisciplinary team must decide whether the self-administration is fully independent or supervised as part of a medicine training scheme.
All medicines for self-administration must be kept in an individual patient's medicine cabinet, the medicine trolley or other secure storage.
In most circumstances the Designated Practitioner retains custody of the key for the patients' individual medicine cabinet. If, following a risk assessment it is felt appropriate the patient may be given custody of the key.
The Appointed Practitioner in Charge must be satisfied that the patient has sufficient understanding and ability to perform this task appropriately.
When the patient is self-administering their own medicines, a record must be made of this in the administration section of the prescription sheet.
The Designated Practitioner responsible for the care of the patient must from time to time monitor that the self-administration process is being conducted correctly. If the patient is unable to take the medicines as prescribed the self-administration process must be discontinued, although it may be reintroduced when appropriate.
Doses administered by nursing staff in addition to or instead of the self-administration must be recorded in the normal way.

On discharge the patient's medicines must be removed from the medicine cabinet and the key to the cabinet retained on the ward for reuse.

14 CUSTODY AND SAFE-KEEPING OF MEDICINE KEYS

14.1 The Controlled Drug Cupboard key must be kept on a separate key ring that can be readily identified.

The key must be kept on the person of the Assigned Practitioner in Charge or Designated Practitioner nominated by them. Responsibility remains with the Assigned Practitioner in Charge.
No practitioner can have access to the Controlled Drug cupboard except in the presence of the Practitioner officially holding the key. The key must not be handed over to medical staff.
In the event of the person in charge being inappropriately qualified, the key must be handed to an Assigned Practitioner in Charge of a ward or department in the near vicinity. This information must be made known to the staff in both the ward or department and to the manager in charge of that section.

14.2 Keys for Medicine Cupboards, Medicine Trolleys and Refrigerators

The keys for the external medicine cupboard, internal medicine cupboard, medicine trolley, medicine refrigerator and pharmacy transport box must be kept together on one key ring reserved solely for these keys. The keys must be clearly identified.
The keys must be kept on the person of a Designated Practitioner. In the event of no Designated Practitioner being on duty in a ward or department, the keys shall be handed to Designated Practitioner on a ward or department in the near vicinity. This information must be made known to the staff on both ward or department manager in charge of that section.
At Community Team bases where a number of Designated Practitioners may require access to the medicine cupboards at different times a secure system must be agreed between the Assigned Practitioner in Charge and the Director of Pharmacy.

14.3 Keys to individual patient's medicine cupboards

The master key for individual patients' medicine cupboards opens all such cupboards on the ward. The master key must be kept on the ward medicine cupboard key ring at all times and must never be issued to a patient.
Keys that open individual patient medicine cupboards must be individually numbered and stored in a locked cupboard on the ward when not in use.
If a patient is to self-medicate the appropriate numbered key may be issued to the patient who signs for receipt of this key. The key that is issued to an individual patient only opens one medicine cupboard and must be kept securely by the patient. The patient must return the key to the Appointed Practitioner in Charge on discharge or when they are no longer self-administering their own medicines.

14.4 Reagent Cupboard

The key to the reagent cupboard may be kept separately and in a place designated by the Appointed Practitioner in Charge.

14.5 Loss of a Medicine Cupboard Key

Every effort must be made to find the key or retrieve it from off duty staff. Should access to the medicine cupboard be required before the keys are retrieved the duty manager must be informed and a duplicate key may be obtained. A second set of keys must be kept with the appropriate manager or in the pharmacy department where 24-hour access is available. The keys must be clearly identified and easily accessible to the duty manager/pharmacist. Where the cupboard keys are not found a new lock must be fitted to the cupboard. If there is no duplicate key, the duty manager will arrange for the cupboard to be broken open and a new lock fitted. The pharmacy department must also be notified when it is next open.

15 CHECKING OF STOCK BALANCES

15.1 Controlled Drugs

15.1.1 It is good practice to check stock balances of all Controlled Drugs with every shift change involving a change of Assigned Nurse in Charge. The audit minimum standard is that the stock balance of all Controlled Drugs entered in the Register must be checked once a week against the actual stock held in the ward/department. There is no need to open packs with intact tamper evident seals for stock checking purposes. Where possible there should also be verification of entries in the register against entries made on individual inpatient prescriptions.

15.1.2 Two Designated Practitioners, or one Designated Practitioner and one Authorised Employee must perform the check. The Assigned Practitioner in Charge must be one of the practitioners to perform this check.

15.1.3 A record indicating this check has been carried out must be kept in a separate record book/sheet or in the Controlled Drug Register and must confirm the stock is correct. The record must be dated and signed by both Practitioners. The Appointed Practitioner in Charge must ensure that these checks are carried out.

15.1.4 The Appointed Practitioner in Charge must undertake a random check of all Controlled Drugs cupboards at least once a month and record it in the ward register.

15.1.5 It is recommended that stock balances of individual preparations be checked after every administration.

Liquid medicine stock balances can only be checked when the bottle is empty.

15.1.6 Any discrepancy must be reported to the Appointed Practitioner in Charge who must inform a pharmacist.

15.1.7 Any need for more frequent checks will be decided by the Appointed Practitioner in Charge in liaison with the Director of Pharmacy.

15.1.8 A designated member of pharmacy staff must check the Controlled Drugs balance a minimum of every three months and when overall responsibility for the medicines change e.g., change of appointment of the Appointed Practitioner in Charge. Where possible there should also be verification of entries in the register against entries made on individual inpatient prescriptions.

15.2 Other Medicines

Any need for checking stock balances of other medicines must be left to the discretion of the Appointed Practitioner in Charge. If, however, there is suspicion of abuse of medicines this must be reported to the department manager and Director of Pharmacy. In such cases it is advised that a stock balance must be recorded and regular checking introduced. If this shows discrepancies the medicine must be made subject to similar procedures as Controlled Drugs and register entries must be made whenever the medicine is administered.

16 USE OF ESSENTIAL OILS AND COMPLEMENTARY MEDICINES

Complementary Therapies are therapies that may be used in conjunction with orthodox medical, nursing and paramedical treatments to enhance patient wellbeing, quality of life and symptomatic relief.

16.1 Before any new therapy can be recognised by the Trust it must be approved by the Drugs and Therapeutics Committee. Once agreed the therapy must be used within the guidance of this code.

16.2. Qualifications

A Designated Complementary Therapist must have obtained an appropriate qualification. Having obtained the qualification they must then ensure that the practice of the complementary therapy is in line with the scope of professional practice and code of conduct of the accreditation body for the therapy.

Before any complementary therapy is practised the following must be viewed by the Appointed Practitioner in Charge of the ward or department.

The therapist's certificate or a copy of the syllabus studied, if still available
Details of the organisation providing the training
Examination results
Membership of a recognised national body/professional body

15.3

NB Qualifications that have been gained wholly by correspondence or over short courses will not usually be accepted.

16.3 Insurance

Members of Trust staff practising complementary therapies as part of their duties will be indemnified by the Trust. Private therapists contracted to provide a service must have personal indemnity insurance.

16.4 Competence

The interests and welfare of the patient are paramount and the Designated Complimentary Therapist has a duty of care to ensure that their skills and knowledge are updated and that they remain competent to practice the therapy.

The therapist has responsibility for the whole course of treatment and any delegation of tasks to others must be according to agreed written protocols approved by the Appointed Practitioner in Charge.

16.5 Responsibility of the Appointed Practitioner in Charge

The Appointed Practitioner in Charge is accountable for ensuring:

The use of the therapy has been approved by the Drugs & Therapeutics Committee.
The Designated Complementary Therapist has accepted personal accountability in accordance with their scope of practice and the code of conduct of the appropriate accreditation body.
The Therapist has an appropriate qualification.
A regular review of the practice.
A system of monitoring clinical practice is in place.

In the circumstances of the Appointed Practitioner in Charge also being the Designated Complementary Therapist the responsibilities lie with the next in line manager.

16.6 Consent

The patient or advocate for the patient must give informed consent for the practice of a specific complementary therapy. The multidisciplinary team members involved in the patient's care must be consulted by the therapist before any treatment is carried out.

16.7 Documentation

The Designated Complementary Therapist must document within the patient's care plan the therapy practised, and maintain within the care plan notes of treatments given, dates and evaluations of the outcome of treatments. All documentation should be in line with the standards of the Trust on note keeping and the relevant accreditation body of the Complementary Therapist.

It is not appropriate for a patient (even if they are suitably qualified) to practice a complementary therapy on health services premises or to solicit other patients as prospective customers.

17 USE OF UNLICENSED MEDICINES

17.1 In the UK no medicine can be marketed for human use without a Product Licence (PL) granted by the Licensing Authority (Ministry of Health). The PL specifies the indications for which a product may be used and also the dose, route of administration etc. Licensing arrangements are determined by the Medicines Act 1968 and implemented through the Medicines Control Agency (MCA).

17.2 Unlicensed medicines fall into 5 broad categories:

Products derived from licensed medicines and prepared by the NHS or commercial unit with a "specials" manufacturing licence or prepared in a hospital pharmacy under a Medicines Act exemption.

Eg liquids for patients with swallowing difficulties

low dose formulations for children

intravenous preparations

Products whose licence has been abandoned, suspended, revoked or not renewed
Products for which a licence has yet to be given, but available and licensed outside the UK.
Clinical Trial medicines.
Medicines used outside the terms of the Product Licence eg unlicensed indication, dose, route.

17.3 Negligence Liability

Prescribers have a duty in common law to take reasonable care and to act in a way consistent with the practice of a responsible body of their peers of similar professional standing. In using an unlicensed medicine the prescriber must act responsibly and with reasonable care and skill. Not to meet these standards lays the prescriber open to claims of negligence liability.

17.4 Strict Product Liability (or liability without fault)

The Product Liability Directive (EEC/85/374) and the Consumer Protection Act 1987, makes the producer or supplier liable for damage caused by a defect in the product. The product can be considered defective on the basis of what the patient is entitled to expect. This may be affected by the verbal and written information and warnings given to the patient.

17.5 Practical Implications

The responsibility for use of unlicensed medicines lies with the prescriber. Mechanisms must be in place to ensure that a prescriber knows when a medicine prescribed/supplied is unlicensed and that he/she is aware of his/her responsibilities.

Unlicensed medicines should only be used to fulfil the special needs of an individual patient (MCA). Use of an unlicensed medicine on a wider scale eg for routine stock use, must be approved by the Drugs and Therapeutics Committee.

17.6 Trust Procedure

The pharmacy department will advise prescribers of the unlicensed nature of the medicine at the time of dispensing.
A signed record of this communication is required, using the appropriate forms.
Prescribers should consider carefully the use of unlicensed medicines and only use this form of therapy when the benefits outweigh the risks and where there is no licensed alternative available.
Prescribers must obtain consent to treatment and inform the patient of the medicines' licence status. The patient must also be informed that the effects of an unlicensed product will be less well understood than those of a licensed product.
Prescribers should inform their medical colleagues (especially General Practitioners) of the medicine's licence status when advising them to use unlicensed medicines.

18. CLINICAL TRIALS INVOLVING PHARMACEUTICAL PRODUCTS

18.1 Liability issues relating to clinical trial medicines

18.1.1 When a prescriber takes part in a study initiated by a pharmaceutical company, it is for the company to obtain a Clinical Trials Certificate or Clinical Trials Exemption.

18.1.2 When a prescriber initiates a medicine study using an unlicensed medicine he or she must notify the Licensing Authority giving details of the trial and the method of supply of the medicine to be used. The Licensing Authority has 21 days to raise objections, although the Authority may extend this to up to 63 days if required. If no objections are forthcoming the trial can start.

18.1.3 Before starting the trial and only when the study has been approved by the local ethical committee, prescribers must seek no fault compensation cover from their employer for the research subject, ensure that their medical defence organisation membership permits the proposed activity, and if the study is sponsored by a pharmaceutical company, that it will comply with the ABPI's guidelines on compensation.

18.1.4 At the end of a study a prescriber may wish to continue to prescribe the trial medicine for those patients who have benefited, but such a provision must be included in the original protocol. If there is no such provision it would be possible to continue using the medicine on a "named patient" basis but in this event the ethical committee must be consulted, as must the Licensing Authority and the manufacturer. The legal standing of the medicine or animal safety data may make a longer period of human exposure unjustified.

18.2 Responsibilities of the Pharmacy Department

The legal and indemnity issues surrounding supply of clinical trial materials are complex. Once a medicine trial has received ethical committee approval, the trialist must approach the Director of Pharmacy and seek agreement for the clinical trial supplies to be made to patients via the pharmacy department. The Director of Pharmacy must ensure that all legal, indemnity and professional issues are adequately covered before agreeing to the trial proceeding.

18.3 In no circumstance must clinical trial material be supplied to patients via a source other than the pharmacy department. Medical/nursing staff would not be covered by Trust indemnity arrangements if they supplied clinical trial materials to patients in this unauthorised way.

19 THE MEDICINES RELATED DUTIES PERFORMED BY HEALTH CARE WORKERS

Health Care Workers who have successfully completed certain assessments of the NVQ in Care may be authorised by the Trust to assist a Designated Practitioner to perform the following:

Check the medicine label with the prescription sheet as a second check. (This does not apply to injectable medicines.)
Administer oral and topical medicines (including inhaler, eye and ear drops) to a patient once prepared and checked by a Designated Practitioner.
Check Controlled Drugs with a Designated Practitioner.
Check the patient's name and hospital number against the prescription sheet with a Designated Practitioner.
Check discharge medicines with a Designated Practitioner against a discharge prescription.
Witness the self-administration of medicines either in a ward or in a patient's home following patient specific assessment and training by a Designated Practitioner.

19.1 Health Care Workers may be authorised by the Trust to perform the following duties independently.

Administer medicines to a particular patient following training by a Designated Practitioner.

19.3 Duties that cannot be performed by Health Care Workers

Preparation and supply of medicines
Administration of medicines by injection, rectally or vaginally
Use of intravenous infusion pumps
Administration of Controlled Drugs
Supply of discharge medicines

With the development of NVQ 4 qualification future training may provide opportunities for Trust-wide agreement of changes to any of the above.

20 MEDICAL GASES

All medical gases used in the Trust are Licensed Medicines and as such are subject to the Medicines Act and must be treated in the same way as any other medicines.

20.1 Before a medical gas is administered to a patient, written authority from a prescriber must be obtained. This authority must include the name, and concentration of the medical gas (where appropriate), the method of administration and the rate of flow. This can be achieved by:

An inpatient prescription for an individual patient
Group Protocol authorising the administration of a medical gas in an emergency.

20.2 A Designated Practitioner administering a medical gas to a patient must make a written record that treatment with the particular medical gas has been initiated on the prescription sheet.

20.3 More details on the procurement, storage and supply of medical gas cylinders, and the issues associated with medical gasses together with Health and Safety information will be found in the Southern Derbyshire Acute Hospitals Trust Policy and Procedures Manual on Medical Gases.

21. MEDICATION ERRORS

Definition

A medication error is a preventable incident associated with the use of medicines which may put a patient at risk. Such incidents may be related to any of the steps of the medicine use process. This includes prescribing, dispensing and administration of the medicine and the transfer of information.

21.1 Medical Review of the Patient

The well-being of the patient is of prime importance following a medication error. The error must be reported as soon as possible to an appropriate member of the medical staff who will decide whether any further action is needed.

21.2 Monitoring and Reporting System

One of the responsibilities of the Drugs and Therapeutics Committee is to oversee a monitoring and reporting system with the objective of preventing medication errors.

The objective of a reporting system is improvement in care and not the disciplining of staff. The Drugs and Therapeutics Committee should advise professional managers of the need to focus on systems rather than on individuals.
This system will be in addition to the general clinical risk incident reporting arrangements established in the Trust. Although some serious incidents involving medicines may be reported via both systems, it is anticipated that a much larger number of less serious and near miss reports will also be reported to the Drugs and Therapeutics Committee.
A medication error/untoward event related to medicines monitoring form must be completed by the Assigned Practitioner in Charge and by the individual concerned. Details of the incident and of the immediate action taken should be given.
Copies of the completed form should be sent to the Director of Nursing and the Director of Pharmacy.

21.3 Review of Medication Errors

The Director of Pharmacy and Director of Nursing should meet monthly to review the medication error reports, to establish trends and to take action intended to prevent such errors. Action may involve system redesign and improvement and/or education, training and competency assessment of employees on any aspect of medicine use.

Reports from Drugs and Therapeutics Committee about medication errors should be sent regularly to the Clinical Governance Committee.

22 MEDICINE DEFECT REPORTING

The following procedure applies when a defect is found or is suspected in any medicine.

1. Inform the Pharmacy who will advise on all reporting, recording and investigating on the defect.

2. Retain any remaining product and any associated products or equipment (eg administration sets, infusion devices etc).

3. Record the details of the product and defect.

4. If the product has been administered to a patient inform the doctor responsible for the patient and record the defects in the patients' notes.

5. Report the incident to the Appointed Practitioner in Charge of the ward or department.

If a drug defect is suspected after the Pharmacy Department's normal opening hours contact the on-call Pharmacist.

23. COMMUNITY BASED PRACTITIONERS

For each community team base where medicines are stored, a suitably qualified practitioner must be designated as the Appointed Practitioner in Charge. This Appointed Practitioner in Charge is ultimately accountable for the stock of all medicines held, ensuring that Medicine Code procedures are followed correctly and that the security of medicines is maintained.

23.1 Designated Community Practitioners should possess a properly authenticated identification card stating the right to carry medicines. The range of medicines will be specified on a list carried separately and will be agreed by the Appointed Practitioner in Charge and Director of Pharmacy.

23.2 All medicines carried by the Community Practitioner must be prescribed as a specified dose for a named patient by a prescriber. Additional medicines may be carried to allow for breakages or emergencies.

23.3 Each medicine to be carried must be accompanied by the written prescription on the relevant medicine card and the dose administered must be recorded.

23.4 All medicines will be supplied by the pharmacy and must be kept in a separate locked medicine cupboard to which the Designated Community Practitioners have access.

23.5 The Designated Community Practitioner must keep the medicine:

In a locked case when visiting a patient.
In a locked case out of sight within the locked boot of a car when travelling between visits.

Whenever practicable unused medicines should be returned to the medicine cupboard at the team base for overnight and weekend storage. Where this is not possible, they may be stored in a locked cupboard or drawer at home but not for longer than 72 hours.

23.6 Medicines no longer required by patients should be disposed of by returning them to the pharmacy of origin.

24. CONSENT TO TREATMENT

24.1 Wherever possible the medicines proposed to treat a patient should be discussed with the patient. The discussion should be carried out in such a way that the patient is able to contribute and express agreement or disagreement with the proposed treatment.

24.2 "Consent" is the voluntary and continuing permission of the patient to receive a particular treatment, based on an adequate knowledge of the purpose, nature, likely effects and risks of the treatment including the likelihood of its success and any alternative to it. Permission given under any unfair or undue pressure is not consent (Mental Health Act 1983 Code of Practice).

24.3 It is the duty of everyone proposing to give treatment to use reasonable care and skill, not only in giving information prior to seeking a patient's consent, but also in meeting the continuing obligation to provide the patient with adequate information about the proposed treatment and alternatives to it.

24.4 Discussions about the drug treatment and consent to treatment should ideally be when treatment is initiated. It should be recorded in the medical notes the nature and outcome of the discussion together with an assessment of the capacity of the patient to consent. If the patient is too ill at the time of the initiation of prescribing the prescriber should seek further consent when the patient is well.

24.5 Information given by pharmacists or other practitioners about the treatment should be provided in addition to that undertaken by the prescriber rather than as an alternative.

24.6 Treatment of those without capacity to consent.

When a patient is incapable of consent to treatment medicines can be prescribed for them in their best interests under the common law doctrine of necessity. The treatment must be:

necessary to save life, or prevent a deterioration of, or ensure an improvement in, the patient's physical or mental health;

and

be in accordance with the practice accepted at the time by a reasonable body of medical opinion skilled in the particular form of treatment in question.

24.7 Treatment of those detained under the Mental Health Act 1983.

The Mental Health Act 1983 provides the prescriber with a 3 month period to develop a treatment programme to meet the patient's needs. Even though the Act allows treatment without consent the prescriber should observe the same principles of seeking consent described above. The 3 month period starts on the occasion when medicines for mental disorder were first prescribed.

Medicines after 3 months.

A system should be in place to remind the Responsible Medical Officer (RMO) at least 4 weeks before the expiry of the 3 month period. The RMO should:

Seek the patient's consent to continuing medication.
Record the discussion in the medical notes including an assessment of the patient's ability to consent.
If the patient consents to continued treatment complete a Form 38.
If the patient refuses consent or is deemed unable to provide a reliable consent the RMO must request a second opinion doctor (SOAD) visit from the Mental Health Act Commission.

If the SOAD agrees with the RMO that treatment is necessary and should be given the SOAD will complete a Form 39.

Practitioners must not administer medicines to patients detained under the Mental Health Act 1983 after the 3 month period without first ensuring that a valid Form 38 or Form 39 has indicated that the treatment can be given.

25. ILLICIT SUBSTANCES

Southern Derbyshire Mental Health Trust is an illicit substance free zone. This includes all substances/drugs/medicines of any category other than those specifically prescribed for the patient.

25.1 Any person found to be in possession of, dealing in or taking substances thought to be of an illicit nature will be notified to the police and may be prosecuted.

If the person is a patient, the consultant's agreement to prosecute must be obtained.

25.2 If any substance thought to be of an illicit nature is either found on the ward or taken from a patient the following procedure should be followed.

The substance should be sealed in an official package provided by the police.

* On the package should be a description of the substance, together with where and when it was found
Both the Assigned Practitioner in Charge and a second Designated Practitioner should sign the package.
If the substance is associated with any particular patient a description of the substance and the circumstances should be recorded in the patient's notes.
The police should be notified.
The substance should be stored in the Controlled Drug Cupboard until collected by the police.

The Assigned Practitioner in Charge should NOT:

Send the substance to the pharmacy.
Request the pharmacist to dispose of the substance.
Return the substance to the patient or relative.
Attempt to analyse the substance.

25.3 Drug Screening

There are occasions when the knowledge about whether a patient has taken an illicit substance may inform and assist clinical decision.

These include:

When the patient's behaviour suddenly deteriorates and the ingestion of an illicit substance is thought to be a possible cause.

When there is a need routinely, to check that a patient is remaining free of illicit substances.

When a patient is admitted or has been on leave and is suspected of taking an illicit substance.

A witnessed urine sample should be obtained from the patient and sent to the laboratory for testing.

There are rare occasions when a result of a drug screen is needed immediately. On such occasions a positive result would result in immediate action by a practitioner (eg discharge from the ward, refusal of admission). A drug testing strip may then be used.

26 COMPLIANCE AIDS

Non-compliance with medicines is a major cause of relapse and admission to hospital. There are many factors which can lead to non-compliance with medicines. These include:

A poor understanding of the need for medicines.
A poor understanding of how to take the medicines.
Forgetfulness
Inability to open the containers.
Poor sight.
A complicated regime of medicines.

For some people a compliance aid may assist a person to continue self-medication and remain out of hospital.

26.1 Before there is any agreement to provide medicines in a compliance aid a full assessment of the reason for non-compliance should take place. It may be that the provision of a compliance aid may not be of benefit.

26.2 Compliance aids vary but most require to be replenished on a weekly basis. Before compliance aids are issued and the patient trained to use them arrangements must be made for their regular replenishment.

26.3 The act of filling a compliance aid involves re-dispensing. Only Authorised Pharmacy Staff are allowed to re-dispense medicines. Other practitioners may:

Assist patients to full their own compliance aids.
Train patients to use a compliance aid as part of a ward based training scheme.

27. DAY HOSPITALS AND RESPITE CARE

A variety of arrangements may be in place to prescribe and provide medicines for patients who attend Day Hospitals or who receive respite care.

Good liaison is vital to ensure that at all times both General Practice and hospital based practitioners are aware of all the medicines to be received by the patient and, who is responsible for the prescription, the supply and the administration of each medicine.

27.1 The prescribing of medicines for patients who attend day care is usually the responsibility of the General Practitioner. In some situations a hospital prescriber may wish to take responsibility for part or all of the prescribing. These situations include:

If the hospital prescriber wishes to start a new medicine and stabilise the patient on that medicine before requesting the General Practitioner to take over the responsibility.
If arrangements to continue supervision of the prescribing of medicines still remains with the hospital prescriber.
If the prescription is subject to continual change.
If there is no other reliable method of ensuring that the patient receives the medicine.

In such situations the prescriber will prescribe the medicines using a day hospital medicine card and if the medicine is to be administered at the day hospital will also be used to provide a record of medicine administration.

27.2 Patients who attend day care will be encouraged to self-administer their own medicines received from their community pharmacy and prescribed by their General Practitioner. In some situations it may be necessary for some or all of the medicines to be administered by a Day Hospital Designated Practitioner. In such situations the following should occur:

Confirmation with the patient's carers and General Practitioner and inspection of the patient's own medicine
Completion of a prescription sheet of solely the items that are to be administered or supplied to the patient.
Recording in the care notes of the complete list of medicines that the patient is receiving at other times using the "medicines being given at home form".
Where a patient receives medicines other than those administered at day care, cross reference must be made on the front of the medicine card to those medicines.

If for any reason a difference between the medicine provided by the patient and those prescribed on the medicine card occurs the prescriber should be contacted to clarify the prescription.

27.3 If medicines are to be administered at the day hospital it is usual for the patient or home carers to provide the medicines from the patients own supply. In some situations the medicines may be supplied from the hospital pharmacy. These situations include:

When the patient or carer fails to provide a suitable supply.
When a hospital prescriber wishes to initiate a short course of treatment or a new medicine.
When arrangements for the General Practitioner to take over the responsibility for prescribing have not been completed.

27.4 Respite Care

For patients admitted for respite care, it is usual for the patient or home carers to provide the medicines from the patients' own supply. The Designated Practitioner should:

Confirm with the carers prior to admission that the necessary medicines to span the period of respite care will be provided by the carer.
Confirm with the patient's General Practitioner prior to admission the medicines to be prescribed for the patient.
Confirm with the hospital prescriber that the patients own supply agrees with the account provided by the carer and the General Practitioner. Once the confirmation has taken place the medicines will be prescribed using a hospital prescription sheet.

If all attempts to receive a supply from the carer fail or the supply of medicines is thought unsuitable to use an emergency supply will be made from the hospital pharmacy.

SDMHT MEDICINES CODE 2000-2003