Document Details Title Patient Group Direction (PGD) Morphine Sulphate Oral Solution 10mg/5ml (Oramorph ) (Minor Injury Units) Trust Ref No 2088-39693 Local Ref (optional) Main points the document treatment of severe acute pain covers Who is the document aimed at? Author Rita O Brien Approval process Approved by Quality & Safety Delivery Group (Committee/Director) Approval Date 10 th January 2018 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Nursing and Quality Category Policy Sub Category Patient Group Direction Review date 30 th January 2020 Distribution Who the policy (PGD) will Minor Injury Units be distributed to Method Email notification of entry onto webpage Document Links Required by CQC yes Required by NHLSA Other Amendments History No Date Amendment 1 V1 Shropshire Community Health NHS Trust 2 3 4 5 Page 1 of 7
PATIENT GROUP DIRECTION Morphine Sulphate Oral Solution 10mg/5ml for Minor Injury Units PGD prepared by: (author / owner) David Young Lead Pharmacist Community Hospitals and MIUs 22/12/2017 Peer review by Phil Atkins Carolyn Mitchie, Cath Molineux, Clinical Lead MIUs Ludlow MIU Consultant Nurse If any signatures are missing below, then the PGD is not valid APPROVED FOR USE BY: Medicines Management Group Doctor Dr Emily Peer Associate Medical Director 10/1/2018 Pharmacist Rita O Brien Chief Pharmacist 10/1/2018 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Alison Trumper Associate Director for Quality 10/1/2018 Page 2 of 7
STAFF CHARACTERISTICS Employed or contracted by Shropshire Community Health NHS Trust Eligible practitioner with current professional registration Specialist competencies or qualifications: The clinical manager has evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in the PGD. Provide evidence of training, annual updates and Continuing Professional Development undertaken The clinical manager has proof of training by the health care professional on the legal aspects of supply or administration of medicines under a Patient Group Direction The clinical manager has assessed the competency (against the national framework) of the healthcare professional to work to a Patient Group Direction at least every 2 years Has undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation Must have access to all relevant sources of information e.g. information issued by the Department of Health (DH), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD) The practitioner needs to reinforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession s Code of Professional Conduct and Ethics. YOU MUST BE AUTHORISED BY NAME BY YOUR MANAGER UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Page 3 of 7
CLINICAL CONDITION Clinical need addressed Inclusion criteria Exclusion criteria For full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF Exclusion under this Patient Group Direction does not necessarily mean contraindicated but it would be outside its remit and another form of authorisation will be required e.g. PSD Caution / need for further advice Management of excluded patients or if patient declines Opioid analgesic for severe acute pain relief Patients one year of age and over and over 10kg in weight presenting with severe acute pain as assessed using a validated pain score tool Allergy to morphine or any other opiate based analgesic Unable to swallow or maintain own airway Children under one year of age Children under 10kg in weight Severe hepatic or renal impairment Patients under the influence of alcohol or drugs Pregnancy or breastfeeding Patients taking MAOI drugs Acute Respiratory Depression (adults<10 breaths per minute, child< 20 breaths per minute) or acute asthma exacerbation Patients presenting with a head injury with an impaired level of consciousness (GCS<12) History of convulsive disorders Risk of paralytic ileus (associated clinical features are little or no abdominal pain/local tenderness, abdominal distension, failure to pass flatus, vomiting, significantly reduced or absent bowel sounds) Delayed gastric emptying Heart failure secondary to chronic lung disease Phaeochromocytoma (tumour on adrenal gland) Hypotension (actual not estimated) where systolic<90mm Hg (adults), <80mm Hg (school children), <70mm Hg (pre-school children) Be aware of patients with drug seeking behaviours Naloxone must be available and the appropriate dose for the age/weight of the patient must be known before morphine is administered Caution should be exercised before giving a dose of morphine to a patient who has already received another opioid analgesic including Tramadol in the previous 4 hours. The effects will be additive. Shock Caution with patients taking other medication likely to tranquillise e.g. sedatives, anxiolytics, tricyclic antidepressants etc. Caution if reduced respiratory reserve such as kyphoscoliosis, emphysema, COPD or severe obesity Monitor the pain level, consciousness level, blood pressure and respiration rate Referral to A & E or a doctor if on site Document action; referral, advice given, reason for declining treatment or advice Page 4 of 7
DRUG DETAILS Name form and strength of medicine Legal classification Route / method Dose / Frequency Morphine Sulphate Oral Solution 10mg/5ml Prescription only medicine (POM). Treated as a Controlled Drug in Shropshire Community NHS Health Trust ORAL Adults and children aged 12 years and over 10-20mg (5ml-10ml) Frail/elderly may require a reduced dose of 5mg Children: AGE (years) DOSE Volume 1-2 2mg 1ml 3-4 3mg 1.5ml 5-6 4mg 2ml 7-8 5mg 2.5ml 9-10 6mg 3ml 11 7 mg 3.5ml Number of times treatment may be administered Side effects; NB side-effects may occur up to 15 minutes after administration. Full details of side effects are available in the SPC. Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at www.yellowcard.gov.uk Additional Information ONCE ONLY drowsiness nausea and/or vomiting, dry mouth, sweating, headache, hypotension confusion, constipation, abdominal pain seizures pupillary constriction SPC requires storage at < 25 degrees centigrade Stock must be locked in approved medicines cabinets with access restricted by nurse in charge Once opened the bottle has an expiry date of 3 months. Date opened must be written on the bottle Advice to patient / carer Advise not to drive until the effects have worn off (usually 4-6 hours) Advise about nature of treatment Give patient a treatment information leaflet Warn about possible sensitivities and side effects to treatment and instruct accordingly Page 5 of 7
Follow up Error reporting Refer to a doctor for further management Any incidents or near miss issues must be reported via the organisation s internal reporting system (Datix) RECORD KEEPING Documentation needed / treatment records to be kept for audit purposes A computer or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Patient s name, address, date of birth and GP Manufacturer / brand of product, batch number, expiry date Dose Date of administration, route Advice given to patient / carer Details of staff who administered (sign and print name) Details of any adverse drug reactions, and action taken including informing GP Reconciliation stock balances should be reconcilable with receipts, administration, records and disposal on a patient by patient basis. A register of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes within each service REFERENCES British National Formulary; www.medicinescomplete.com/mc/bnf/current/number74 Last accessed: 14 th December 2017 Summary of Product Characteristics www.medicines.org.uk/emc/product/902 Last accessed: 14 th December 2017 Page 6 of 7
Register of practitioners qualified to administer and / or supply Morphine Sulphate Oral Solution 10mg/5ml In Minor Injury Units under this Patient Group Direction Name of clinical team manager Signature of clinical team manager Date: All PGD documentation must be kept for 8 years and for children until the child is 25 years old A copy of this page should be retained by the authorising manager for audit purposes. Please state clinical area where this PGD is in use Healthcare professional individual declaration: I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD PGDs DO NOT REMOVE INHERANT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence. All practitioners operating in accordance with this PGD should have a current, signed copy of it readily available for reference. If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber. Name of professional Signature (please print) Authorising Manager (Must sign against each entry) Date of authorisation Page 7 of 7