SUPPLY AND ADMINISTRATION OF MEDICINES BY MIDWIVES WORKING WITHIN MID ESSEX HOSPITAL MATERNITY SERVICES CLINICAL GUIDELINES Register No: 11005 Status: Public Developed in response to: DoH recommendations NMC rules and regulations Trust requirement Contributes to CQC Outcome: 9, 11 Consulted With Post/Committee/Group Date Anita Rao/ Alison Cuthbertson Ellen Makings Alison Cuthbertson Su Ames Paula Hollis Ros Bullen- Bell Chris Berner Emma Neate Claire Fitzgerald Clinical Director for Women s, Children s and Sexual Health Directorate Chief Medical Officer Head of Midwifery Patient Safety Officer Lead Midwife Acute In-patient Services Lead Midwife Community Services Lead Midwife Clinical Governance Antenatal and Newborn Screening Co-ordinator Specialist Pharmacist June 2017 Professionally Approved By Miss Rao Lead Consultant for Obstetrics and Gynaecology June 2017 Version Number 3.0 Issuing Directorate Obstetrics and Gynaecology Ratified By DRAG Chairmans Action Ratified On 11 th September 2017 Implemented on: 10 th October 2017 Trust Executive Sign Off Date October 2017 Next Review Date September 2020 Author/Contact for Information Susannah Denhart, Practice Development Midwife Policy to be followed by (target staff) Midwives, Obstetricians, Paediatricians Distribution Method Intranet & Website. Notified on Staff Focus Related Trust Policies (to be read in 04071 Standard Infection Prevention conjunction with) 04072 Hand Hygiene 06036 Guideline for Maternity Record Keeping including Documentation in Handheld Records 09060 Injectable Medicines Policy 09070 Control of medicines in a clinical area 08083 Controlled drugs policy 08085 Storage of medicines in clinical areas Document History Review: Version No Reviewed by Active Date 1.0 Sarah Moon May 2011 1.1 Sarah Moon NMC regulations update July 2011 2.0 Gemma May July 2014 3.0 Susannah Denhart, Practice Development Midwife 10 th October 2017 1
INDEX 1. Purpose 2. Equality and Diversity 3. Scope of Practice 4. Medicines Legislation 5. Methods of Supplying of administration of Medicines 6. Standards of Proficiency and Administration of Medicines 7. Record Keeping 8. Storage and Transportation 9. Disposal of Medicinal Products 10. Implications for Student Midwives 11. Staff and Training 12. Infection Prevention 13. Professional Midwifery Advocates 14. Audit and Monitoring 15. Guideline Management 16. Communication 17. References 18. Appendices Appendix A Current Authorised list of Patient Group Direction Medicines for the Administration and Supply of Medications by Midwives within MEHT Appendix B - PGD for the administration and supply of medication by Midwives within MEHT Agreement Form Appendix C- Agreement by Approved Practitioner PGD for the administration and supply of medication by Midwives within MEHT for the Practitioners personal file Appendix D- Agreement by Approved Practitioner connected to each PGD 2
1.0 Purpose 1.1 To promote the safe, secure and effective use of medicines to ensure patients get the maximum benefit from the medicines they need, while at the same time minimising potential harm. 1.2 To enable Registered Midwives to administer and supply a range of medicines to patients, without a medical prescription, in accordance with the schedule outlined in the appendices attached. (Appendix A, B, C and D) 1.3 To ensure that the Trust complies with the regulations that govern the administration and supply of medicines to patients in this Trust through the Medicines Act 1968, Prescription Only Medicines (Human Use) Order 1997 (the POM Order), the medicines (Pharmacy and General Sale Exemption) Order 1980, the Medicines (Sale and Supply) Regulations 1980. 2.0 Equality and Diversity 2.1 Mid Essex Hospital Services NHS Trust is committed to the provision of a service that is fair, accessible and meets the needs of all individuals. 3.0 Scope of Practice 3.1 This guideline should be read in conjunction with the Trust s controlled drugs policy (08083); Policy for the administration of medicines to inpatients of MEHT (08103), the Nursing and Midwifery Council s (NMC) documents, NMC Midwives Rules and Standards (2012), The Code: Standards of Conduct, performance and ethics for nurses and midwives (2008); NMC Standards for medicines management (2010) 3.2 This guidance is aimed at Registered Midwives that have an active Nursing and Midwifery Council (NMC) registration. 4.0 Medicines Legislation 4.1 The Medicines Act 1968 was introduced following the Thalidomide tragedy. 4.2 Medicinal products fall into one of three categories: (Refer to Appendix B) General Sale List Medicines (GSL) Pharmacy Medicines (P) Prescription only medicine (POM) 5.0 Methods of Supplying of administration of Medicines (Refer to Appendix A, B) Patient Specific Directions (PSD) Patient Groups Directions (PGD s) Midwives Exemptions Midwife Independent/Supplementary Prescribing 3
5.1 A patient specific direction (PSD) is a written instruction from a qualified and registered prescriber for a medicine including the dose, route and frequency or appliance to be supplied or administered to a named patient. Patient medicines administration chart Simple instruction in the patient s notes 5.2 Patient Groups Directions (PGD s) are specific written instructions for the supply or administration of a licensed named medicine to specific groups of patients. They are not a form of prescribing. (Refer to Appendix A) PGDs should only be used once the midwife has been assessed as competent and whose name is identified within each document (Refer to Appendix C) The administration of drugs via a PGD may not be delegated 5.3 The Prescription only Medicines (Human Use) Amendment Order 2000 (SI 2000/1917) modified the Medicines Act and allowing midwives to use PGD s. 5.4 Exemptions allow midwives to sell, supply and administer specific medicinal products directly to patient/clients. (Refer to Appendix B) 5.5 Midwives can supply and administer (but not sell): (Refer to Appendix A, B) All GSL medicines All P medicines Some POM s which includes some controlled drugs (CDs). 5.6 If the medicinal product to be supplied and/or administered is on the midwives exemption list a PGD is not required. 5.7 Exemptions are distinct from prescribing which requires the involvement of a pharmacist in the sale or supply of the medicinal product. 5.8 Exemptions also differ from the arrangements for Patient Group Directions (PGDs) as the latter must comply with specific legal criteria, be signed by a doctor or dentist and a pharmacist and authorised by an appropriate body. 6.0 Standards of Proficiency and Administration of Medicines (Refer to Appendix A for the PGD Schedule for specific authorised medicines in this Trust) 6.1 Before a midwife can use a PGD, he/she must be named and have signed the PGD documentation. This generally takes the form of signatures and names (on a list or individual forms) that are attached to the PGD itself or held by the service or organisation. (Refer to Appendix C) 6.2 Employees of NHS organisations authorising a PGD generally have indemnity attached to their status as an employee. 4
6.3 As a registrant, in exercising your professional accountability in the best interests of your patients the midwife should adhere to the following: Be certain of the identity of the patient to whom the medicine is to be administered Check that the patient is not allergic to the medicine before administering it Know the therapeutic uses of the medicine to be administered, its normal dosage, side effects, precautions and contra-indications Be aware of the patient s plan of care(care plan or pathway) Check that the prescription or the label on medicine dispensed is clearly written and unambiguous Check the expiry date (where it exists) of the medicine to be administered Consider the dosage, weight where appropriate, method of administration, route and timing and document on the once only medication section in capital letters Administer or withhold in the context of the patient s condition (i.e. digoxin not usually to be given if pulse below 60) and co-existing therapies, for example, physiotherapy Contact the prescriber or another authorised prescriber without delay where contraindications to the prescribed medicine are discovered, where the patient develops a reaction to the medicine, or where assessment of the patient indicates that the medicine is no longer suitable Clearly sign and print your name and designation in capital letters Document the drug within the once only medication section of the drug chart. This must be clearly written and in capital letters 6.4 The administration of drugs via a PGD may not be delegated. Students cannot supply or administer under a PGD but would be expected to understand the principles and be involved in the process 6.5 Where medication is already subject to exemption order legislation there is no requirement for a PGD. 6.6 Where medication is not given, the reason for not doing so must be recorded. 7.0 Record Keeping (Refer to the Guideline for Maternity Record Keeping including Documentation in Handheld Records ; register number 06036) (Refer to the NMC Guidance April 2010 record Keeping and the NMC Guidance April 2010 Standards for medicines management 7.1 Midwives are required to keep a record of supply, administration and disposal of all prescription-only medicines issued to them in the midwifery diary. 7.2 Midwives should ensure that records are accurate, comprehensive, timely and contemporaneous. All medicines administered must be recorded in the patient s healthcare records and treatment charts in accordance with local guidelines and the Supervisor of Midwives. 7.3 You must clearly countersign the signature of the student when supervising a student in the administration of medicines. 8.0 Storage and Transportation 8.1 Registrants must ensure all medicinal products are stored in accordance with the patient information leaflet, summary of product characteristics document found in dispensed 5
UK-licensed medication and in accordance with any instruction on the label. 8.2 Policies should be in place to ensure all storage environments meet the required standards and it is the responsibility of the registrant to check such policies are in place and are being adhered to. This is particularly important for medicines requiring storage within a limited temperature range, for example, refrigeration of vaccines when maintenance of the cold chain has to be considered. 8.3 There must be comprehensive arrangements for the security, storage and labelling of all medicines. When supplying under PGD, this should be from the manufacturer s original packs or over-labelled pre-packs so that the patient details, date and additional instructions can be written on the label at the time of supply. Registrants must not split packs. 8.4 Medicines are generally obtained from the hospital pharmacy. They are delivered to a designated area accessible by community midwives within the hospital to await collection. 8.5 During working periods non refrigerated medicines will be carried in the midwife s bag or a concealed place in the car avoiding temperature extremes. When not in use the bag must be locked in the car in a concealed position. At all other times the bag must be securely stored in the midwife s home in a secure locked fixture. 8.6 The Supervisor of Midwives has the responsibility for checking records for medicines within her area. 9.0 Disposal of Medicinal Products 9.1 A patient or their representative (who may be a registered nurse or midwife) should return unwanted prescribed medicinal products to a pharmacy for destruction to comply with the Controlled Waste Regulations 1992. (Refer to the Controlled drugs policy ; register number 08083 for the disposal of controlled drugs i.e. Morphine) 10.0 Implications for Student Midwives 10.1 Student midwives can supply or administer medicine against a PSD if they are supervised by a sign off mentor. 10.2 Student midwives can administer medicines on the exemption list, except controlled drugs, under the direct supervision of a midwife. 10.3 Only registered midwives can supply or administer medicinal products against midwife exemption orders. It can not be delegated to a student midwife. 11.0 Staffing and Training 11.1 All midwifery and obstetric staff must attend yearly statutory training which includes training and updates relating to PGD s. PGD guidance is available in all clinical areas located in the guideline folders and on the Trust s intranet. 11.2 In-house training is available for all midwives on an annual basis specifically related to medicines management and drug calculations. 6
11.3 Midwives should be familiar with the current guidance published in the British National Formulary, including the use, side effects and contra-indications of the medicines that you prescribe; available in clinical ward areas and via the intranet/ internet https://www.bnf.org/products/bnf-online/ 11.4 All midwifery staff are to ensure that their knowledge and skills remain up-to-date to enable the midwife to prescribe competently and safely; and in order to maintain and complete their portfolio for appraisal. 12.0 Infection Prevention 12.1 All staff should follow Trust guidelines on infection prevention by ensuring that they effectively decontaminate their hands before and after each procedure. 12.2 All staff should ensure that they follow Trust guidelines on infection prevention. All invasive devices must be inserted and cared for using High Impact Intervention guidelines to reduce the risk of infection and deliver safe care. This care should be recorded in the Saving Lives High Impact Intervention Monitoring Tool Paperwork (Medical Devices). 13.0 Professional Midwifery Advocates 13.1 Professional Midwifery Advocates provide a mechanism of support and guidance to women and midwives. Professional Midwifery Advocates are experienced practising midwives who have undertaken further education in order to supervise midwifery services and to advise and support midwives and women in their care choices. 14.0 Audit and Monitoring 14.1 The risk management lead will review all risk event forms and complaints. Any immediate training or educational issues relating to lack of compliance with this guideline will be addressed on a one to one basis. 14.2 All incidents and trends analysis will be reviewed at the Maternity Risk Management Group meeting. 14.3 Audit of compliance with this guideline will be undertaken annually in accordance with the Maternity annual audit work plan. The Audit Lead in liaison with the Risk Management Group will identify a lead for the audit. 14.4 As a minimum, review of a minimum of 40 sets of health records will assess compliance with the guideline. 14.5 The findings of the audit will be reported to the Risk Management Group and an action plan developed to address any identified deficiencies. Performance against the action plan will be monitored by this group on a monthly basis. 14.6 A survey will be undertaken by the Lead Midwife for Guidelines and Audit, at least annually, to establish staff awareness of how policies should be accessed and the document management process. Any deficiencies identified will inform the staff training programme. 7
15.0 Guideline Management 15.1 As an integral part of the knowledge, skills framework, staff are appraised annually to ensure competency in computer skills and the ability to access the current approved guidelines via the Trust s intranet site. 15.2 Quarterly memos are sent to line managers to disseminate to their staff the most currently approved guidelines available via the intranet and clinical guideline folders, located in each designated clinical area. 15.3 Guideline monitors have been nominated to each clinical area to ensure a system whereby obsolete guidelines are archived and newly approved guidelines are now downloaded from the intranet and filed appropriately in the guideline folders. Spot checks are performed on all clinical guidelines quarterly. 15.4 Quarterly Clinical Practices group meetings are held to discuss guidelines. During this meeting the practice development midwife can highlight any areas for further training; possibly involving workshops or to be included in future skills and drills mandatory training sessions. 16.0 Communication 16.1 A quarterly maternity newsletter is issued to all staff with embedded icons to highlight key changes in clinical practice to include a list of newly approved guidelines for staff to acknowledge and familiarise themselves with and practice accordingly. Midwives that are on maternity leave or bank staff have letters sent to their home address to update them on current clinical changes. 16.2 Approved guidelines are published monthly in the Trust s Staff Focus that is sent via email to all staff. 16.3 Approved guidelines will be disseminated to appropriate staff quarterly via email. Regular memos are posted on the Risk Management notice boards in each clinical area to notify staff of the latest revised guidelines and how to access guidelines via the intranet or clinical guideline folders. 17.0 References Nursing Midwifery Council (2006) Standards of proficiency for nurse and midwife prescribers. NMC: London. Nursing Midwifery Council (2015) The Code: Professional standards of practice and behaviour for nurses and midwives. London: NMC Nursing Midwifery Council (2007) Standards for medicines management. NMC: London. Nursing Midwifery council (2012) Midwives Rules and Standards NMC: London. The NMC website reports these were revised in 2013 but the link to download them is broken, so not sure if they are still valid? 8
Leicester Medicines Strategy Group (2010) Leicestershire medicine code. University Hospitals of Leicester NHS Trust Leicestershire Partnership Trust, NHS Leicester City and Leicester County and Rutland PCT Still current, available at https://www.lmsg.nhs.uk/guidelines/secondary-care/medicines-code/ 9
Table to illustrate the list of Midwives Exemptions (Amendment of the POM Order 2010) Appendix A Exemption from restrictions on sale or supply: (Prescription only medicines (POM s) containing any of the following substances) Diclofenac Ergometrine maleate Hydrocortizone acetate Lidocaine Lidocaine hydrochloride Miconazole Nystatin Phytomenadione Exemptions from restriction on administration: Adrenaline Anti-D immunoglobulin Carboprost Clotrimazole 1% cream Cyclizine hydrochloride Diamorphine Ergometrine maleate Gelofusine Hartmanns Hepatitis B vaccine Hepatitis immunoglobulin Lidocaine Lidocaine hydrochloride Morphine Naloxone hydrochloride Oxytocins, natural and synthetic Pethidine hydrochloride Phytomenadione Prochloperazine Sodium chloride 0.9%. Pharmacy Medicines (P): Midwives can Supply/Administer medicines on the P list under midwives exemptions Entonox Peptac liquid Ferrous Sulpate Pregaday 10
General sales List Medicines (GSL): Midwives can supply/administer all medicines on the GSL under midwives exemptions for example: Anusol cream Panadol Paracetomol Ibuprofen Folic Acid Potassium citrate mixture Milpar Glycerine suppositories Oxygen gas (Refer to the Maternity Services Pharmacy Information File for further information regarding specific drug characteristics and contraindications) 11
Appendix B Table to illustrate the list of Authorised PGD s in Mid Essex Hospital Services Trust Medicine Dose Route Frequency Anti-emetics Prochlorperazine 12.5mg Intramuscular One dose (maximum 3 doses in 24 hours) Metoclopramide 10mg Intramuscular or orally Cyclizine 50mg Intramuscular or orally Orally or Ranitidine 150mg intramuscularly One dose (maximum 3 doses in 24 hours) One dose (maximum 3 doses in 24 hours) One dose 6-8 hourly Immunisations Mumps, Measles and Rubella Vaccine (MMR) Trivalent Seasonal Influenza Vaccine (Inactivated) 0.5ml Intramuscular One dose 0.5ml Intramuscular One dose Analgesics Co-codamol (500mg paracetamol & 30mg codeine) 500mg-1g Orally May be repeated ONCE after 4-6 hours (maximum 8 doses in 24 hours) Co-dydramol (500mg paracetamol &10mg dihydrocodeine) 500mg-1g Orally May be repeated ONCE after 4-6 hours (maximum 8 doses in 24 hours) Oromorph 10mg/5ml Orally One dose Ibuprofen Anaphalaxis 200mg and 400mg Orally May be repeated ONCE after 6-8 hours (maximum 3 doses in 24 hours) Epipen (adrenalin 300mcg) 0.3mg/ 2mls Intramuscularly One dose (Refer to the Maternity Services Pharmacy Information File for further information regarding specific drug characteristics and contraindications) 12
Women s and Children s Services This Patient Group Direction is operational from 1 st May 2014 and should be reviewed before 1 st April 2017 This Patient Group Direction has been drawn up by: Clare Macpherson Gemma May Lead Clinical Pharmacist, Obstetrics and Gynaecology Practice Development Midwife Approved by: Ms. Rao. Clinical Director, Obstetrics and Gynaecology Directorate (Signature) (Date) Claire Fitzgerald.. Chief Pharmacist (Signature) (Date) Louise Hembrough.. Director of Nursing and Governance (Signature) (Date) Ratified by Medicines Management Committee: Chairman: Dr Carol McCartney. 13
Appendix C Women s and Children s Services Agreement by Approved Practitioner PGD for the administration and supply of medication by Midwives within MEHT Statement by an Authorised midwife agreeing to act under the Patient Group Direction for the administration and supply of medication by Midwives within MEHT from 1st April 2008 and any successor patient group directions. I have received, read and fully understood the following documents: 1. The Supply and Administration of Medicines by Midwives Working Within Mid Essex Hospitals Maternity Services Clinical Guideline Registration No: 11005 2. Patient Group Direction for the administration and supply of medication by Midwives within MEHT operational from 1 st April 2008 and a renewed 3 yearly I have received training and I am competent and confident to administer any medicinal product under this PGD I agree to act as an Approved Practitioner within the terms of this PGD and to administer or supply medicinal products in accordance with the Policy for the use of Medicines and this PGD. In return, Mid Essex Hospital Services NHS Trust (the Trust) accepts vicarious liability for the Approved Practitioner acting under the terms of this PGD. I understand that by agreeing to act as an Approved Practitioner under this PGD I am extending my role and job description. I understand that my acceptance of this extension of my role and job description has not been a compulsory requirement of the Trust. Name of Approved Practitioner :...... (Block Capitals) Signature:...... Date:... (1 copy for Approved Practitioner; 1 copy to be kept by Manager) 14
Appendix D Women s and Children s Services Agreement by Approved Practitioner Patient Group Direction for administration or supply of medication by Midwives within MEHT I confirm that I have read and understood the content of this patient group direction, and that I have received appropriate training in order to implement it effectively. Name Signature Date 15