Management of Parkinson’s Disease in Primary and Secondary Care for patients with compromised swallow or those patients deemed Nil By Mouth. To aid the management and treatment of Parkinson’s patients with compromised swallow and those nil by mouth. AUTHORS: Alison Waldron (Acute Clinical Nurse Specialist in Parkinson’s disease) Steven Shanu (Resident Pharmacist) Sarah Baig (Medicines Information/Neurology Directorate Pharmacist) Dr Janine Barnes (Neurology Specialist Pharmacist) Dr Shams Duja (Consultant in Elderly Care) Dr Alistair Lewthwaite (Consultant Neurologist) Trudy Gaskin (Parkinson’s disease Nurse Specialist – community based) VERSION CONTROL June 2014 August 2014 December 2014 1.0 Consultation with Dr Martin GP and Dr Bowen Palliative Care Consultant This is a new document Consultation with consultants in secondary care Review of document – version 1.1 Dr Michael Dr Stellman Dr McGrath Dr Ijaola Dr Lewthwaite Dr Douglas Version 1.1 Circulated to GP’s PBP’s DGNHSFT Consultants DGNHSFT Nurses Dudley CCG Dudley MBC NOC Project Support CCG Head of Commissioning 1 A translation service is available for this document. The Interpretation/Translation Policy, Guidance for Staff is located on the intranet under Trust-wide Policies. Section 1 2 3 4 5 6 7.0 7.1a) 7.1b) 7.2 a) 8.0 9.0 10.0 11.0 12.0 13.0 Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Contents Page Number Introduction Statement of Intent Scope Definitions Duties & Responsibilities Consequences of missing Parkinson’s medicines Parkinson’s disease management in patients – secondary care Patients with a compromised swallow or nil by mouth in secondary care Hospital – Surgery/NG patients (flow chart) 3 3 3 3 3 4 4 Patients with a compromised swallow or Nil by Mouth in primary care Nasogastric administration of Levodopa and Dopamine agonist Conversion table for transdermal delivery Drugs to avoid in Parkinson’s disease Apomorphine guidelines Contact details References and acknowledgements Common oral medicines used in Parkinson’s disease Commonly used drugs to avoid in Parkinson’s disease Conversion algorithm Conversion charts Review and monitoring adherence to guideline 4 5 5-6 6-7 8 8 8 9 9 10 11 12 13 14 2 1. INTRODUCTION Clinical experience and audit has revealed that Parkinson’s patients who are nil by mouth (NBM) or experience swallowing difficulties are experiencing lack of consistency in their prescribing of medication. This guideline aims to standardise treatment with respect to appropriate timings, doses and formulations for patients. 2. STATEMENT OF INTENT This document is designed to rationalise the prescribing in this patient group. 3. SCOPE The Parkinson’s disease Specialist Nurses are responsible for the day to day management of Parkinson’s disease patients both in hospital and in the community. The Pharmacists are responsible for specialist advice on specific medicines management and appropriate use of dose calculators. The consultant lead and medical team is responsible for the day to day medical management of Parkinson’s disease The Area Clinical Effectiveness Committee will oversee the ratification of the guideline and appropriate review. 4. DEFINITIONS CK MAO-B NBM NG NMS Pd L-Dopa COMT CR 5. Creatinine Kinase Monoamine oxidase B inhibitor Nil by mouth Nasogastric Neuroleptic Malignant Syndrome Parkinson’s disease Levodopa Catechol-o-methyl transferase Controlled release DUTIES & RESPONSIBILITIES For patients managed in primary care please contact Trudy Gaskin (Parkinson’s disease Nurse Specialist) or Dr Janine Barnes (Neurology Specialist Pharmacist). For secondary care patients please contact Alison Waldron (Acute Clinical Nurse Specialist in Parkinson’s disease), Dr Shams Duja (Consultant in Elderly Care) or Dr Alistair Lewthwaite (Consultant Neurologist). Review and update of this guideline will take place every 3 years. 3 6. CONSEQUENCES OF MISSING PARKINSON’S DISEASE DRUGS Medication is crucial in optimal management of Parkinson’s disease. If medication is not given it can result in the deterioration in patients’ symptoms, including reduced swallow, risk of aspiration, speech problems, increased risk of falls and increased dependence on nursing staff. At worst it may develop into Neuroleptic Malignant Syndrome. Neuroleptic Malignant Syndrome Rare Due to sudden withdrawal of PD medication Hyperthermia, muscle rigidity, altered level of consciousness, autonomic instability and elevated serum creatinine kinase (CK) level Onset within 1 to 9 days Major complications are respiratory, renal and cardiovascular failure Carries significant mortality People with Parkinson’s disease are admitted to hospital for many reasons, very often unrelated to their Parkinson’s. However if this is not managed appropriately on admission it can lead to delayed recovery, delayed discharge and poor outcomes for patients and their families. 7.0 PARKINSON’S DISEASE MANAGEMENT IN PATIENTS – SECONDARY CARE 7.1A) PATIENTS WITH A COMPROMISED SWALLOW OR NIL BY MOUTH IN SECONDARY CARE (Adapted from the NHS Tayside Administration of Medicine in the Peri-operative period) Many people with Parkinson’s disease present to surgical specialties for the management of conditions unrelated to their Parkinson’s. The decision to discontinue, or accidentally omit medication pre-operatively can cause severe harm including inability to swallow, speak or move increasing the risk of aspiration pneumonia, falls and fractures. It can precipitate an acute withdrawal syndrome similar to Neuroleptic Malignant Syndrome which can be fatal. If possible Levodopa treatment should be continued throughout the peri-operative period. Selegiline and Rasagiline are both monoamine oxidase inhibitors (MAO-B) and can interact with anaesthetic agents. The COMT inhibitors Entacapone, Tolcapone and Stalevo (Entacapone plus Levodopa) can all interact with Adrenaline, Isoprenaline and Noradrenaline. The anaesthetist should be informed. If prolonged surgery expected or if oral route is going to be compromised post-operatively it may be worthwhile converting a patient to Rotigotine transdermal patch pre-operatively. Discuss with Parkinson’s nurse specialist/Neurology specialist pharmacist but in an emergency the online conversion calculator can be used to switch to Rotigotine transdermal patch. See online calculator Note: bedside swallow test used by nurses on some wards is designed for stroke patients only. Swallow problems are very common in Parkinson’s, particularly during an intercurrent illness. 4 7.1 b) HOSPITAL FLOW CHART If you think the patient’s swallow is compromised follow the following algorithm: Contact Acute Acute Clinical Clinical Nurse Nurse Specialist Specialist for for Parkinson’s Parkinson’s disease disease –– Bleep Bleep 5026 5026 Contact Refer to to Speech Speech and and Language Language therapy therapy via via Soarian Soarian Refer If unable to contact Parkinson’s Disease Specialist Nurse continue through flow chart Hospital contact – Alison Waldron – Bleep 5026 (Acute Clinical Nurse Specialist in Parkinson’s disease) Can the patient tolerate a nasogastric (NG) tube? YES Follow NG administration guidelines (section 8) NO Convert to Rotigotine patch – see Hub 7.2 a) PATIENTS WITH A COMPROMISED SWALLOW OR NIL BY MOUTH IN PRIMARY CARE Due to the characteristics of Parkinson’s disease, patients may experience symptoms which lead to changes in their ability to swallow safely. In turn this may lead to life threatening conditions and reduced quality of life. It is therefore important to recognise and inform patients and their families of the warning signs of a swallowing disorder in order to provide early intervention and work with patients and their families in appropriate management and advance care planning. Early warning signs of a compromised swallow Drooling Coughing or choking on food and / or drink Food sticking/pouching Changes to speech Frequent chest infections Cognitive changes Changes to a patients swallow may develop gradually or more quickly depending on the cause. It is therefore necessary to assess patient’s individual circumstances and history to determine the next appropriate actions. 5 A referral should be completed requesting an assessment from speech and language therapists and dietician service. Advice should also be sought from Trudy Gaskin (Parkinson’s disease Nurse Specialist) and / or Dr Janine Barnes (Neurology Specialist Pharmacist). To access these professionals through the Dudley Rehabilitation Service a combined referral form is available on the HUB, Dudley Group of Hospitals webpage or telephone 01384 323145. In some situations it may become necessary for a patient to be transferred to hospital for nasogastric or percutaneous endoscopic gastrostomy. Medication changes can be made by using this guidance and conversion charts below. If a patient is recognised to be in the palliative / end of life care stages of Parkinson’s disease please refer to the Palliative Care guidelines. 8. NASOGASTRIC ADMINISTRATION OF LEVODOPA AND DOPAMINE AGONIST On occasions it may be necessary to administer Parkinson’s medications via an NG tube temporarily although these recommendations can be followed for long term enteral administration. Normal prescription Co-Beneldopa (Madopar) Method of administration/alternative Madopar dispersible, same doses as tablets. CR formulations require a slight dose reduction. 12.5 mg Benserazide + 50 mg Levodopa. 25 mg Benserazide + 100 mg Levodopa. Tablets disperse in 10 ml of water within 2 minutes to give a cloudy white dispersion that flushes via an 8Fr NG tube without blockage Co-Careldopa (Sinemet) Standard formulations disperse in water alternatively convert to equivalent dose of dispersible Co-Beneldopa. Tablets disperse readily when placed in 10 ml of water to form a bright yellow dispersion that settles quickly but flushes via an 8Fr NG tube without blockage. Care must be taken to administer whole dose owing to the tendency for settlement to the bottom of the container/syringe.2 CR formulations require a slight dose reduction.1 6 Sinemet (Co-Careldopa) Madopar (Co-Beneldopa) Sinemet 62.5mg tablet Madopar 62.5mg dispersible tablet Sinemet 110mg tablet Madopar 125mg dispersible tablet Sinemet Plus 125mg tablet Madopar 125mg dispersible tablet Sinemet 275mg tablet 2 x Madopar 125mg dispersible tablet Half Sinemet CR 125mg tablet Convert to ordinary formulation dose Sinemet CR 250mg tablet Convert to ordinary formulation dose Entacapone Disperses less easily Enteral tubes will need to be flushed well after use Stalevo (combination of Co-Beneldopa and Entacapone) Give equivalent doses of Co-Beneldopa dispersible as above and Entacapone as above.2 Rasagiline Contacted the manufacturer, unfortunately no information is available on crushing. Consider switch to Selegiline if patient unable to swallow Selegiline Zelapar ( Melt (dissolves on the tongue) 1.25mg equivalent to 10mg Selegiline – If patient able to take buccal tablets, alternatively crush tablets. Syrup preparation 10mg/5ml (only for enteral tubes)2 Amantadine Liquid available (50mg/5ml) – for enteral tubes only Amantadine hydrochloride is freely soluble in water.2 The capsules may be opened and mixed with water and administered immediately via an enteral feeding tube.1,2 Ropinerole Maintain same doses – Crush tablets. Tablets disintegrate rapidly when placed in 10 mL of water to give fine dispersion that flushes via an 8Fr NG tube without blockage.1 Ropinerole XL Convert to standard Ropinerole Crush as above 7 Ropinirole Controlled Release Ropinirole (XL) Starter pack N/A 1mg tds 4mg/day 2mg tds 6mg/day 3mg tds 8mg/day 4mg tds 12mg/day 6mg tds 16mg/day 8mg tds 24mg/day Pramipexole Maintain same doses – crush tablets and disperse in water2 Pramipexole PR (Prolonged Release) Convert to standard Pramipexole Crush as above Pramipexole (salt content) Pramipexole (base content) 0.125mg tds 0.088mg tds 0.25mg tds 0.18mg tds 0.5mg tds 0.35mg tds 0.75mg tds 0.53mg tds 1mg tds 0.7mg tds 1.25mg tds 0.88mg tds 1.5mg tds 1.05mg tds 9. CONVERSION TO TRANSDERMAL DELIVERY (PATCH SYSTEM) – VIA HUB 10. DRUGS TO AVOID IN PARKINSONS DISEASE For drugs to avoid in Parkinson’s disease please refer to appendix 2 11. APOMORPHINE PRESCRIBING/DISPENSING Under no circumstances should this be initiated without involvement with a Parkinson’s specialist. 11. a) HOSPITAL If a patient is admitted on Apomorphine please contact the Parkinson’s disease Nurse Specialist as soon as possible. If urgent advice is needed out of hours there is a 24 hour Apo-go helpline available on 0844 880 1327. Out of hours please contact the on-call pharmacist via switchboard. 8 11. b) COMMUNITY For any community queries regarding Apomorphine please contact Trudy Gaskin or Dr Janine Barnes via Dudley Rehabilitation Service 01384 323145 or if urgent advice is needed out of hours there is a 24 hour Apo-go helpline available on 0844 880 1327. 12. CONTACT DETAILS Alison Waldron (Acute Clinical Nurse Specialist in Parkinson’s disease), Dudley Group NHS Foundation Trust. Bleep 5026 Trudy Gaskin (Parkinson’s Disease Nurse Specialist) 01384 323145 / 0792 070 2109 Dr Janine Barnes (Neurology Specialist Pharmacist) 01384 323145/ 0782 593 2587 13. REFERENCES AND ACKNOWLEDGEMENTS 1. Smyth J, editor. The NEWT Guidelines for administration of medication to patients with enteral feeding tubes or swallowing difficulties. Print version, 2nd edition published 2012. Online version updated more frequently, available at www.newtguidelines.com (subscription required). 2. Handbook of Drug Administration via Enteral Feeding Tubes. Accessed via www.medicinescomplete.com on 12th March 2013. 3. Cabergoline vs Pergolide vs Pramipexole vs Ropinirole. Grosset et al. Movement Disorders2004;19 (11):1370-4 4. Ropinirole, Pramipexole, Cabergoline vs Rotigotine. Le Witt et al. Clinical Neuropharmacology2007; 30 (5): 256- 65 5. Ropinirole vs Requip XL. Summary of product Characteristics, Requip XL. Electronic Medicines Compendium. 6. Algorithm for estimating parenteral doses of drugs for Parkinson’s disease. Brennan K, Genever R. BMJ 2010;341 7. Acute management of PD patients with compromised swallow or NBM. Formulated by PDNS North west. 8. Acute management of Parkinson’s patients. NHS Fife. 2011. 9. NHS Tayside guide to the administration of medicines in the peri-operative period June 2012 10. NHS Dudley Parkinson’s disease prescribing guidelines for use in primary and secondary care. Access via: Parkinson’s Disease Prescribing Guidelines for use in Primary and Secondary Care 9 Appendix 1 COMMON ORAL MEDICATIONS USED IN PARKINSON’S DISEASE Type of Drug Drug Name How it Works Precautions Levodopa Co-Careldopa Co-Beneldopa Sinemet Madopar L-dopa is the precursor of Dopamine. Can be used at all stages of the disease process. Works well on stiffness and bradykinesia Becomes less effective over time. Dyskinesia Drowsiness Hallucinations Postural hypotension Dopamine Agonist Pramipexole Ropinerole Stimulates post synaptic dopaminergic receptors Nausea/vomiting Hallucinations Impulse Control Disorder Confusion Monoamine oxidase type B (MAO-B) inhibitors Selegiline Rasagiline Slows the metabolism of Dopamine Drug is a stimulant, therefore should be taken in the morning COMT inhibitors Entacapone Stalevo Blocks the metabolism of Dopamine Will increase side effects of L-dopa Anticholinergics Trihexyphenidyl (Benzhexol) Blocks the action of Acetylcholine (which breaks down Dopamine) Limited efficacy Neuro-psychiatric side effects Glutamate Agonist Amantadine Enhances the release of Dopamine. Anticholinergic properties Mild effect Short lived Insomnia 10 Appendix 2 COMMONLY USED DRUGS TO AVOID If patient already stabilised on therapy review and monitor Table highlighting drugs to avoid (and use) when treating hallucinations and nausea: Drug Chlorpromazine Treatment of Hallucinations /Confusion X Fluphenazine X Perphenazine X Trifluoperazine X Flupenthixol X Haloperidol X Quetiapine Clozapine (specialist initiation only) Treatment of Nausea / Vomiting Metoclopramide X Prochlorperazine X Domperidone Cyclizine Ondansetron Vigilance is required with the use of Antihistamines ¹ Antidepressants ¹ Antipsychotics ¹ Antihypertensives e.g Calcium Channel Blockers ¹ Key: x– – ¹ – Not recommended Recommended Vigilance required 11 Appendix 3 CONVERSION ALGORITHM Algorithm for estimating equivalent Levodopa dosages for Rotigotine patch This is the Parkinson’s UK validated calculation tool for conversion of oral Parkinson’s medications to transdermal patch. This has been incorporated into the online Rotigotine convertor. 1. Calculate adjusted Levodopa Equivalent Daily Dose (LEDD): [(A) + (B)] x 0.55 = -------mg (A) Total adjusted daily Levodopa dose. Total daily Levodopa dose in mg (excluding Benserazide or Carbidopa). X 0.7 (if MR/CR) or (B) Total adjusted daily Dopamine agonist estimate Levodopa equivalent dose Total daily Dopamine agonist in mg X 100 (if on Pramipexole/ Cabergoline/ Pergolide X 1.3 (if on COMT inhibitor) or X 20 (if on Ropinerole) X 0.91 (if MR/CR and on COMT inhibitor) X10 (if on Bromocriptine/ Apomorphine = ------mg = ------mg (the above figures refer to each medications Levodopa equivalent factor) 2. Calculate dosage for Rotigotine transdermal patch = Adjusted LEDD / 20 = ------mg Maximum Rotigotine dose of 8mg in 24hrs (for monotherapy) Maximum Rotigotine dose of 16mg in 24hrs (Adjunctive therapy) Round to the nearest 2mg (max of 16mg) and prescribe as 24hr patch DO NOT CUT PATCH. Available as 1mg//2mg/3mg/4mg/6mg/8mg patches (can use more than one patch). 12 Appendix 4 CONVERSION CHARTS Conversion table for Dopamine Agonists Ropinirole Controlled Release Ropinirole Rotigotine transdermal patch 0.088mg tds Starter pack N/A 2mg/24 hrs 0.25mg tds 0.18mg tds 1mg tds 4mg/day 4mg/24hrs 0.5mg tds 0.35mg tds 2mg tds 6mg/day 6mg/24hrs 0.75mg tds 0.53mg tds 3mg tds 8mg/day 8mg/24hrs 1mg tds 0.7mg tds 4mg tds 12mg/day 10-12mg/24hrs 1.25mg tds 0.88mg tds 6mg tds 16mg/day 14mg/24hrs 1.5mg tds 1.05mg tds 8mg tds 24mg/day N/A Pramipexole (salt content) Pramipexole (base content) 0.125mg tds Conversion table for Levodopa Current Levodopa regime (standard release) Rotigotine transdermal patch equivalent Co-Beneldopa or Co-Careldopa 62.5 bd 2mg/24hrs Co-Beneldopa or Co-Carel dopa 62.5 tds 4mg/24hrs Co-Beneldopa or Co-Careldopa 62.5 qds 6mg/24hrs Co-Beneldopa or Co-Careldopa 125 tds 8mg/24hrs Co-Beneldopa or Co-Careldopa 125 qds 10mg/24hrs Conversion table for Stalevo Current Stalevo regime Rotigotine transdermal patch equivalent Dispersible Co-Beneldopa (May need to give smaller, more frequent dosing) 50/12.5/200 tds 6mg/24hrs 62.5mg qds 100/25/200 tds 10mg/24hrs ≡125mg qds 100/25/200 qds 14mg/24hrs ≡125 mg 5 times daily 150/37.5/200 tds 16mg/24hrs ≡ 125 mg 6 times daily 13 APPENDIX 5 – REVIEW AND MONITORING ADHERANCE TO GUIDELINES Lead Tool Frequency Reporting Arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Adherence to this guideline through actual and near miss incident reporting All Health Care Professionals DATIX Incident Reporting System Quarterly Quarterly Aggregated Report of Incidents to the Clinical Quality Safety and Patient Experience Committee Depending on Compliance, outcome and clinical or operational area – Director Lead or Manager assigned. Directorate Risk Management Groups Inpatient audit Alison Waldron Audit Every 6 months Report to Directorate Depending on outcome – Lead Consultant will act