N2SFormulary Policy

Version / v1.1
Ratified by / CG team & Board of Directors
Date ratified / July 2016
Description / Policy and processes for the use of drugs related to a surgical or endoscopic procedure and individual response requirements for all N2S providers.
Name of originator/author / Rachael Follows
Date of Issue / 1 April 2017
Review Date / July 2019
Reference No. / V1.1
Circulation / Directors, Managers, Clinical Staff
Version / Date / Version Created By: / Version Approved By: / Comments
V1.0 / 22.7.16 / Rachel Follows / CG team & Board of Directors / Next review dates July 2019

1.0Introduction

2.0Scope

3.0Policy Statement

4.0Roles and Responsibilities

5.0Guidance for the Formulary Sheets

6.0Plans and Policies to be read in conjunction with Formulary Policy

7.0References and Reading

8.0Appendix 1 Formulary Template

1.0 INTRODUCTION

N2S are committed to providing a high quality service to patients, and to safeguarding the health and well being of patients undergoing procedures. The Formulary provides standards and a process for the safe administration and management of local anaesthetic, conscious sedation, and sedo analgesia and associated drugs for patients during their procedures.

2.0 SCOPE

Members of staff within the scope of this document are;-

  • N2SBoard of Directors and Officers.
  • Practice Managers
  • Clinical and administrative staff providing N2S activities.

3.0 POLICY STATEMENT

Any N2S patient who is proposing to have a procedure will be offered the appropriate local anaesthetic, sedation or analgesia relief to provide a reduction or abolition of pain or discomfort during the procedure.

The N2S formulary will act as standard drug reference policy for all medications used within the service sites for patient care.

The N2S formulary will use a standard approach to each drug given, except where there is an accepted range of either drug or dose given e.g. choice of local anaesthetics for a procedure. Where consensus has not been reached between clinicians,e.g. a clinician does not use the standard accepted drug and there are differing practices, the Medical Director will review and discuss with the clinicians involved, before making a final decision on behalf of N2S.

Any member of health care staff who are involved in the preparation, administration, or disposal of drugs, must adhere to their professional guidelines as well as local policy e.g. General Medical Council, Nursing and Midwifery Council.

N2S processes will meet Association for Perioperative Practice (2008) Standards and recommendations for surgery in primary care standard 4.1 Local anaesthesia: managing the risk.

Policies and procedures are in place for the administration and management of local anaesthesia to ensure that patients are cared forcompetently and safely. All members of the surgery team have sufficient knowledge and experience in the principles and techniques of administering and caring for patients undergoing local anaesthesia procedures.

Where national or professional standards exist around the administration and management of patients receiving drugs, these will be included within the formulary and additional service specific local policy for the clinical procedures provided.

Each formulary sheet will be updated annually and resubmitted to the central N2S database. Where changes have occurred, these will be ratified within the clinical governance agenda.

Any new drugs being proposed in clinical practice e.g. change to analgesia, or new drug for use in a new or existing procedure must have a formulary sheet submitted, agreed and ratified by the by the Board of Directors prior to use. The Medical Director has discretion to review and allow the drug to be used in the event of meetings not being held, and patient care or safety potentially affected.

Drugs not in standard clinical use for the surgical or endoscopic procedures, those in research or clinical trials or unlicensed will not be used for N2S patients.

As part of the consent process, the use of any drugs before, during or after the procedure, including post-operative analgesia, will be discussed by the clinician responsible for carrying out the procedure, or delegated to an appropriately trained and competent team member.

4.0 ROLES AND RESPONSIBILITIES

The Board of Directors and Officershave ultimate responsibility for ensuring that N2S provides safe and effective services. Therefore, the Board of Directors and Officers are responsible for ensuring all staff adhere to this policy.

TheBoard of Directors and Officers will be notified of, provide advice, and ensure appropriate action is taken for drug related incidents in accordance with this policy.

It is the responsibility of each service site director to ensure the formulary details reflect clinical practice being undertaken, and that each formulary entry has been signed as appropriate and safe by a clinician using the drug for patient procedures.

The Medical Director hasdiscretion to review and allow a new drug to be used, where patient care or safety could be potentially affected during periods between Board of Director meetings and governance review.

Where consensus has not been reached between clinicians, e.g. a clinician does not use the standard accepted drug and there are differing practices, the Medical Director will review and discuss with the clinicians involved, before making a final decision on behalf of N2S.

The Practice Managers/site leadswill

  • be the nominated person responsible for the receipt and distribution of Medicines and Healthcare products Regulatory Agency (MRHA) alerts to clinical and support staff within their service site, including visiting clinicians.
  • be responsible for a service site specific Medicines Management Policy, to which N2S and associated staff are expect to comply with.
  • be responsible for each formulary sheet is submitted to the central formulary database electronically, and is held in electronic and written versions within each surgical or endoscopy clinical area.
  • ensuretheir staff are aware of and comply with this policy.

All staffwill:-

  • support the development of drug specific formulary sheets, and associated policies.
  • follow their own professional requirements on the managing medicines, and local policies.
  • where clinically involved in the management of patients, have knowledge and experience of the appropriate pharmaceutical reversal agent.
  • share information with colleagues on medicines and alerts.
  • report any adverse drug reactions, patient safety incidents or medicines incidents through the significant event reporting system.

Clinicians

It is the responsibility of the clinician undertaking the procedure, or authorising the administration of drugs to:-

  • ensure they have sufficient knowledge and experience of the principles and techniques of administering the drugs within the formulary, and how to manage any side effects and serious adverse reactions.
  • delegate the administration of drugs and management of the patient in accordance with their own professional requirements.
  • report any adverse drug reactions or patient safety incidents using the Yellow Card System

5.0 GUIDANCE FOR THE FORMULARY SHEETS(Appendix 1)

  • Each drug used, or with the potential to be used e.g. reversal agent, with a procedure should be recognised and listed within a formulary sheet.
  • The information provided for each drug should be from the British National Formulary 2015 ( This should include any notes on drugs and preparation.
  • If a drug is used within a service site, utilising different routes depending on the procedure, a formulary sheet must be written for each procedure and method of administration e.g. lidocaine injection and lidocaine spray.
  • Where the drug has a special category related to the Medicines Act 1968 or Misuse of Drugs Act 1971, or any subsequent amendments or agreements, this should be identified, and an explanation given e.g. information related to the storage of a controlled drug.
  • Where a reversal agent may be used, this must be included within the formulary sheet as well as on its own sheet.
  • Treatment of adverse reaction, or toxicity must be included on each sheet.
  • Maximum safe doses must be given where associated with a drug.
  • Where there is professional guidance as to the use or mean level of drug used, this should be incorporated.
  • Information for patients or carers post procedure, including advice on preventing harm should be provided. Local policies should be written to include this in written information to patients.
  • Each formulary sheet must be signed by a clinician who is knowledgeable and experienced in using the drug and undertaking the associated procedure.

6.0 PLANS AND POLICIES TO BE READ IN CONJUNCTION WITH FORMULARY POLICY

N2S Consent Policy

N2SResuscitation and Dealing with Emergencies Policy

N2S Significant Event Policy

N2S Transfer and Discharge Policy

Service site specific policies for Medicines Management.

7.0 REFERENCES/READING

Association for Perioperative Practice (2008) Standards and recommendations for surgery in primary care

General Medical Council (2013) Good practice in prescribing and managing medicines

Nursing and Midwifery Council (2007) Standards for medicines management

8.0 APPENDIX 1. FORMULARY SHEET TEMPLATE


Date of approval / 06/01/2015
Expiry date ( no more than one year from above date / xx/xx/20xx

CLINICAL PROCEDURE

Indication / Category of patients e.g. patients undergoing cataract extraction
Inclusion criteria / Patient groups included e.g.All patients with American Society of Anaesthesiologists (ASA) classification I – II wishing IV sedation for the endoscopic procedure
Exclusion criteria / BNF and local exclusions
Cautions / need for advice or referral / BNF and local exclusions
Action if patient excluded or declines treatment
Action if patient experiences adverse event / e.g. reversal agent or algorithm drug management. Include drug/dose/route and special instructions.

DRUG

Name, strength & form
Legal status / e.g. POM, Controlled Drug
Route or method of administration
Dosage & frequency
Maximum safe dose / National or professional guidance on dose
Maximum or minimum treatment period
Administration/ dispensing by / e.g. endoscopist
Quantity supplied / ( for post procedure drugs only)
Follow up / e.g. care required after administration of the drug whilst still in N2S care – supplementary oxygen, pulse oximetry monitoring)
Advice to patient / carer

RECORD OF ADMINISTRATION

Record of administration or dispensing / e.g.Operation sheet, Controlled Drug Register

N2SFormulary Policy. Written September 2015. Review July 2019

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