PATIENT GROUP DIRECTION (PGD) FOR THE INPATIENT ADMINISTRATION OF ORAL LORAZEPAM TO WORKING AGE AND OLDER PEOPLE (includes persons in a Place of Safety suite) Version Number: 5 Patient Group Direction drawn up by: Name Ray Lyon Dr Al Amaladoss Martin McAngus Revised by Miguel Gomez Title Chief Pharmacist - Strategy Consultant Psychiatrist Matron (Interim) CRHTT AAW Lead Mental health Pharmacist - Worthing Group direction authorised by: Medical Director On behalf of the organization Chief Pharmacist Director of Nursing Date Protocol agreed 26 January 2016 Proposed review date 31 October 2018 Date Protocol expires 31 January 2019 1
PLAN OF CARE Condition treated Clinical criteria under which the patient will be eligible for treatment under the PGD Psychomotor agitation leading to possible initiation of the rapid tranquillization policy First line in 18 year olds and over with psychomotor agitation not in the context of psychosis that is subjecting the individual to extreme distress and/or putting others at risk. Second line in 18 year olds and over with psychomotor agitation in the context of psychosis that is subjecting the individual to extreme distress and/or putting others at risk where olanzapine is contraindicated. Aims of treatment or care To reduce the symptoms associated with the psychomotor agitation where it is expected to be beneficial to the patient presenting with symptoms secondary to psychiatric disturbance. Criteria under which the patient will be excluded from care within the protocol including contraindications A previous sensitivity or reaction to lorazepam or benzodiazepines Is already prescribed a benzodiazepine for anxiety or agitation Has recently undergone withdrawal from a benzodiazepine or non-benzodiazepine hypnotic or has a known previous dependency with lorazepam Borderline personality disorder Breast feeding Pregnancy Respiratory depression Severe hepatic impairment Marked neuromuscular respiratory weakness including unstable myasthenia gravis (autoimmune disease with muscle weakness) Acute pulmonary insufficiency Sleep apnoea syndrome Overt intoxication with alcohol or drugs Actions to be taken for patients who are excluded from treatment under the protocol and arrangements for referral Actions to be taken for patients who do not wish to receive, or do not adhere to, care under the protocol and arrangements for referral Follow-up treatment which may be required Evaluation of treatment/care Consider olanzapine for psychomotor agitation not in the context of psychosis if not contraindicated otherwise advice must be obtained from the doctor on call. Advice must be obtained from the doctor on call. If symptoms persist that put the client or others at risk then advice must be obtained from the doctor on call. Allow 45 minutes for the lorazepam to work. If symptoms persist that put the client or others at risk then advice must be obtained from the doctor on call. 2
MEDICINE Generic name and form(s) Lorazepam tablet. Mode of action Benzodiazepines dampen down the electrical activity of the brain by enhancing the activity of the GABA receptors. Legal status of medicine POM Potentially significant drug interactions There will be an enhanced sedative effect if given with another drug with sedative properties. Method or route of administration Oral Dose(s) and where a range criteria for deciding on a dose 2mg - 18 to 65 years old 1mg - over 65 years old Frequency of administration Once only Minimum and maximum period over which the medicine should be administered Not applicable Written advice to be given to the patient/carer on the identification and management of significant potential side effects Current version can be downloaded via the Trust Intranet 3
SUMMARY OF SIDE EFFECTS Side effect How What can be done about it? common is it? Drowsiness or Very Do not drive if you are drowsy or dizzy. lightheadedness Common Confusion Common Tell your prescriber if you experience confusion. Ataxia and tremor Common Tell your prescriber if you experience difficulty coordinating movements Muscle weakness Uncommon Tell your prescriber if you experience muscle weakness. Amnesia (memory loss) Uncommon Tell your prescriber if taking diazepam causes any memory loss. Rash Uncommon Tell the prescriber straight away if any rash develops. Respiratory depression Uncommon Increased difficulty in breathing. Discuss with your prescriber as soon as possible if this occurs. Dizziness or vertigo Rare This may wear off within a few days. Discuss with your prescriber if this persists. Headache Rare This should wear off within a few days. Paracetamol can be taken but discuss with your prescriber if this persists. Changes in saliva production Rare This should wear off within a few days. If the mouth is drier sugar-free boiled sweets, chewing gum or eating citrus fruits may help. Discuss with the prescriber if this persists. Blood disorders Rare Any sore throat, fever, bruising or nose bleeds should be reported to your prescriber immediately. Disinhibition (loss of self control and inhibitions) Rare Tell your prescriber if your behaviour changes in any way. Jaundice Rare If you notice any yellowing of the skin or eyes contact your prescriber straight away. Depressed mood Rare Irritability Aggression Nightmares Hallucinations Very common = more than 1 in 10 people affected Rare Rare Very rare Very rare Common = between 1 in 10 and 1 in 100 people affected Tell your prescriber if taking diazepam causes any changes in mood, perception or thinking ability. Uncommon = between 1 in 100 and 1 in 1,000 people affected Rare = between 1 in 1,000 and 1 in 10,000 people affected Very rare = less than 1 in 10,000 people affected AUDIT TRAIL Records required for a documented audit trail A completed lorazepam oral PGD To be completed after each administration and kept administration form by the Designated Practitioner. Record the administration on the drug To be recorded on the Medicines Administered Under chart Protocol or Patient Group Direction section of the of the drug chart. Trust Incident Form To be completed in the event of a suspected adverse drug reaction. The incident must be reported immediately to the relevant doctor or pharmacist. Report on suspected Adverse Drug To be completed for any significant adverse event. Reactions, form in back of the BNF or online at http://yellowcard.mhra.gov.uk 4
COMPETENCY Designation (tick appropriate box) Community Mental Health Nurse Crisis Resolution Senior Nurse Practitioner Charge Nurse Ward Manager Modern Matron Competency/Qualifications (tick when checked) Registered Mental Nurse (Part 3) or RN (M) (Part 13) Senior registered nurses with band 6 status or above CPD portfolio with evidence of related study in the last 12 months Has attended the Trust's PGD foundation course Has attended within the last two years the Trust s PGD psychotropic drug course Has successfully completed the 'Key topics of Pharmacy' questionnaire for lorazepam tablets. Evidence checked by: Name Designation Signature Review of competency Competency expires 5
AUTHORISATION OF DESIGNATED PRACTITIONERS TO USE THE PATIENT GROUP DIRECTION Date valid from: Date of expiry: This confirms that I: Name: understand the PGD have attended the Trust PGD Foundation Course have attended the Trust s PGD psychotropic drug course am of the opinion I am competent to implement the PGD effectively agree to work within the PGD Signature: Date: SIGNATURE OF TEAM MANAGER Name: Date: REFERENCES 1. BNF 68, September 2014 2. Lorazepam SPC 16.01.2015 (Genus pharmaceuticals) 6
Designated Practitioner Oral Lorazepam PGD administration form Patient s Name Age Patient s Ward/Unit Symptoms being treated Reason for administration including non-pharmacological interventions attempted first Expiry date of the product Confirm that: Please initial o Only one dose of 1mg/2mg was administered Dose: o I have signed the drug chart in the MAUP and PGD section o Verbal consent was obtained o The details have been recorded in the patient s notes o The details of any adverse reaction have been forwarded to the patient s general practitioner, if applicable Record any adverse reactions 7
Signed by Date Make 2 copies. Keep a copy, put original in the patient s notes (or upload to Carenotes ), and send one copy to your manager. 8
KEY ASPECTS OF PHARMACY QUESTIONNAIRE (To be completed without access to the PGD or drug text books, eg BNF.) Key aspects of pharmacy for oral lorazepam Professional's name: Job Title: 1. Symptoms/criteria under which the patient will be eligible for treatment under the PGD 2. Forms and strengths available 3. Mode of action 4. Exclusion criteria 5. Dose 6. Route of administration 7. What potentially significant side effects and drug interactions are there? 8. What written/verbal advice must be given to the patient/carer on the identification and management of significant potential side effects? I confirm that at the time of completion the answers provided showed an acceptable level knowledge. Name: Designation: Signature: Date: 9
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