Document Details Title Patient Group Direction (PGD) CO-CODAMOL 30/500 TABLETS FOR MINOR INJURIES UNITS Trust Ref No 1956-35206 Local Ref (optional) Main points the document treatment of moderate pain covers Who is the document Clinical staff in Minor Injury Units aimed at? Author Rita O Brien, Chief Pharmacist Approval process Approved by Quality and Safety Delivery Group (Committee/Director) Approval Date 8 March 2017 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Nursing and Operations Category Policy Sub Category Patient Group Direction Review date 31 March 2019 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 yes Other Amendments History No Date Amendment 1 March 2017 Scheduled review no changes 2 3 4 5 Page 1 of 7
PATIENT GROUP DIRECTION CO-CODAMOL 30/500 TABLETS FOR MINOR INJURIES UNITS PGD prepared by: (author / owner) Peer review by Lead clinician consulted in the development of this PGD Rita O Brien Chief Pharmacist 7/2/2017 Carolyn Mitchie ENP / IP Ludlow MIU Wendy Davies Whitchurch MIU Andrew Thomas Head of Nursing and Quality 16/1/2017 18/1/2017 9/2/2017 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 10/2/2017 Pharmacist Rita O Brien Chief Pharmacist 7/2/2017 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Steve Gregory Director of Nursing and Operations 8/3/2017 Page 2 of 7
STAFF CHARACTERISTICS Employed or contracted by Shropshire Community Health NHS Trust Eligible professional with current 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 Caution / need for further advice Management of excluded patients Action for patients not wishing to receive care under this PGD Moderate pain after injury for patients in minor injuries units Patients who are 12 years and over Children under 12 years of age Children between 12 and 18 years having tonsillectomy or adenoidectomy for the treatment of obstructive sleep apnoea Individuals who are pregnant or breast feeding History of hypersensitivity to codeine, paracetamol or any components of the preparation Patients under the influence of alcohol Patients taking hypnotics, centrally acting analgesics, opiods, monoamine oxidase inhibiting antidepressants (MAOI), tricyclic antidepressants or psychotropic drugs Patients with a history of drug abuse, dependence and severe chronic alcoholism Individuals with severe constipation Patients presenting with head injury, impaired level of conciousness or increased intracranial pressure Acute respiratory depression/asthma attack Acute abdominal conditions Patients known to have severe renal or hepatic impairment The elderly and debilitated may need lower doses taken less frequently Patients who have taken paracetamol based products, or opiate based products within the previous 4 hours Referral to specialist doctor or General Practitioner Document action Consider reasons for declining Inform General Practitioner Record in patient record Page 4 of 7
DRUG DETAILS Name form and strength of medicine Co-Codamol 30/500 Tablets (Each tablet contains 30mg of Codeine and 500mg of Paracetamol) Legal classification Prescription only medicine (POM) Black triangle warning? No Use within licence? Yes Route / method Oral Dose / Frequency One or two tablets up to four times a day, not more than every four hours. Maximum of 8 in 24 hours Number of times treatment may be administered Quantity to be supplied or administered Side effects 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 28 or 30 Tablets depending on original pack size. Light headedness, dizziness, sedation, shortness of breath, nausea, vomiting, constipation, rash, pruritis SPC requires storage at room temperature Stock must be locked in approved medicines cabinets with access restricted by nurse in charge. Advice to patient / carer Advise about nature of treatment Give patient a treatment information leaflet Warn about possible sensitivities and side effects to treatment and instruct accordingly Follow up Referral to doctor or independent prescriber if necessary Error reporting Any incidents or near miss issues must be reported via the organisation s internal reporting system (Datix). Page 5 of 7
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 68 Last accessed: 17/01/2017 Summary of Product Characteristics www.medicines.org.uk Last accessed: 17/01/2017 NICE guidance NG48 https://www.nice.org.uk/guidance/ng38/chapter/recommendations#initial-painmanagement-and-immobilisation Last accessed 17/2/2017 Page 6 of 7
Register of practitioners qualified to administer and / or supply CO-CODAMOL 30/500 TABLETS FOR MINOR INJURIES 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