Document 6505305

Clinical Algorithm 1 Consensus on how to conduct a TOBI® Podhaler® (tobramycin) test dose. Penny Agent, Professional Lead for Physiotherapy & Deputy Director of Rehabilitation & Therapies, Royal Brompton & Harefield NHS Foundation Trust. This educational material is based on the proceedings of a one-­‐day Novartis advisory board meeting on ‘Optimising Dry Powder Inhalation Administration in CF Patients’. The content of this toolkit was developed by the expert panel of cystic fibrosis specialist physiotherapists and nurses who attended the meeting. Novartis funded the production of the toolkit and has reviewed the content for technical accuracy. Novartis did not provide editorial input to the content. The advisory meeting and the development of the materials were funded by Novartis. In April 2013 an expert panel of cystic fibrosis (CF) specialist physiotherapists and nurses was convened for a one-­‐day advisory board meeting, funded by Novartis. The purpose was to identify and address the training and educational needs of healthcare professionals involved in TOBI® Podhaler® test dosing, particularly those who may be new to the process. As chair of this panel, I am delighted to introduce the educational resources that have been developed as a result of our discussions. These resources are intended to support CF specialist physiotherapists and nurses on the recommended test dose pathway for TOBI® Podhaler®. The expert panel At the time of the consensus meeting, the expert panel had carried out over 300 successful test doses and so was able to offer guidance and support on the test dose procedure based on real world experience. The panel are as follows: Penny Agent (Chairperson)
Professional Lead for Physiotherapy & Deputy Director of Rehabilitation & Therapies, Royal Brompton & Harefield NHS Foundation Trust
Catherine Brown Specialist CF Physiotherapist, West Midlands Adult CF Regional Centre, Heartlands, Birmingham
Kairen Griffiths
CF Nurse Specialist, Aberdeen Royal Infirmary
Katie Ferguson
Clinical Lead Physiotherapist, Cystic Fibrosis, Kings College Hospital
Mark Butler
Clinical Nurse Specialist, Cystic Fibrosis, London Chest Hospital
Emma Forster
Specialist CF Physiotherapist, Bristol Royal Infirmary
Lisa Morrison
Specialist CF Physiotherapist, Gartnavel General Hospital, Glasgow
Date of preparation November 2013
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Clinical Algorithm 2 The challenges of CF treatment It is important that patients with CF use the correct technique to administer TOBI® Podhaler® to ensure that they receive the optimal treatment effect. Medical treatment for CF is demanding and adherence to medical treatment is crucial because poor adherence may imply poor health outcomes.1 There is increasing recognition among Healthcare Professionals that managing and promoting adherence to treatment is an essential component of CF care. Research indicates that patients with CF adhere more to some treatment components than others and adhere to some treatments less than 50% of the time.2 In fact, the World Health Organization estimates that adherence to long-­‐term therapy across chronic illnesses in developed countries averages 50%.3 By sharing our experience and advice on test dosing, the panel hopes that specialist physiotherapists and nurses will be more confident in training patients on how to use TOBI® Podhaler®. In particular they will be able to address the typical issues with technique that were identified by the panel, as follows, which may lead to poor compliance and adherence: • Habitual coughing • Incorrect mouth/lip position on the inhaler mouthpiece • Too fast/too slow inspiration with the inhaler • Rate and depth of breath • Positioning of the tongue/teeth behind the inhaler • Problems with adherence Date of preparation November 2013
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Clinical Algorithm 3 Practical educational solutions Taking these challenges into consideration, it was clear to the panel that conducting an optimal test dose would be a powerful first step in enhancing the treatment benefits for patients and improving adherence. An ideal test dosing procedure was proposed by the panel that focuses on all three key stages of the test dose: 1. Pre-­‐administration stage: the patient should be educated and informed on all key aspects of TOBI® Podhaler® before it is administered. 2. Test dosing stage: correct technique demonstrated, patient’s technique observed and corrected. 3. Follow-­‐up stage: ensure opportunities for observing/correcting technique and promoting adherence to treatment. During the meeting the advisory board members identified several educational needs and proposed the content of a TOBI® Podhaler® Test Dose Toolkit. The toolkit includes: •
Template algorithms for how to set-­‐up and conduct a test dose and three examples of proformas/checklists have been included, for you to utilise or adapt – from The Royal Brompton & Harefield NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and University Hospitals Bristol NHS Foundation Trust. •
A presentation and film on the test dosing procedure to guide you through the ideal process. Our aim is for treating centres to use these materials as guidance to conduct their own test dosing or to refine existing protocols. Recommended algorithms These algorithms have been developed by the expert panel in order to support specialist physiotherapists and nurses with preparing for and conducting a test dose. There are two algorithms, as follows: 1. Clinical algorithm: a recommended process for setting up and conducting a test dose of an inhaled CF antibiotic therapy, providing information on when to assess lung function, how to determine whether a patient has passed or failed the test dose and when to refer Date of preparation November 2013
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Clinical Algorithm 4 to local protocols for specific guidance or information. 2. Test dose algorithm: a recommended process for conducting a test dose for TOBI® Podhaler®. This algorithm provides guidance on how to support a patient during the test dose and at what points to remind them about optimal technique. It also mentions other educational aspects that should be communicated during the test dose process. I hope you find these materials helpful to you in conducting test doses with TOBI® Podhaler® and supporting your patients to get the most from their treatment. Penny Agent Professional Lead for Physiotherapy & Deputy Director of Rehabilitation & Therapies, Royal Brompton & Harefield NHS Foundation Trust. Date of preparation November 2013
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Clinical Algorithm 5 A recommended algorithm for setting up and conducting a test dose of an inhaled CF antibiotic therapy This algorithm is based on consensus by an expert panel of CF physiotherapists and nurses who met in April 2013 at a Novartis advisory board meeting, under the chairmanship of Penny Agent, Professional Lead for Physiotherapy & Deputy Director of Rehabilitation & Therapies, Royal Brompton & Harefield NHS 4
Foundation Trust. Clinical algorithm: test dose set up
!
!
Date of preparation November 2013
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Clinical Algorithm 6 Guidance on using the clinical algorithm TOBI® Podhaler® is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis (CF). 5 Consideration should be given to official guidance on the appropriate use of antibacterial agents.
5-­‐7
The TOBI® Podhaler® is simple and convenient to use and is well tolerated by patients. In order for patients to get the most benefit from TOBI® Podhaler® during the test dose and into the future, it is important that they use it with the correct technique. The clinical algorithm describes the overall set-­‐up of a test dose, including measurement of FEV1 before and after the test dose, recommendations on how to determine a pass or fail and what to do in the case of a failed test dose. This algorithm can act as a template to assist CF centres in developing their own protocols for TOBI® Podhaler® or for other inhaled therapies. Please also refer to the accompanying TOBI® Podhaler® test dose algorithm provided separately, which gives more detail on the steps within the TOBI® Podhaler® test dose. Together, the two algorithms illustrate the importance of ensuring that three key stages of the process are adequately addressed: 1. Pre-­‐administration: the patient should be educated and informed about all key aspects of TOBI® Podhaler® or any other inhaled therapy before it is administered. 2. Test dosing: correct technique should be demonstrated and the patient’s technique observed and/or corrected throughout the test dose* (also see the accompanying test dose algorithm). 3. Follow-­‐up stage: ensure opportunities for observing/correcting technique and promoting adherence to treatment and providing an opportunity for the patient to discuss any questions/concerns. *Top tips for the test dose • Suggest that the patient uses the TOBI® Podhaler® in front of a mirror until they get used to it. • Suggest that the patient looks up at the wall where it m eets the ceiling as this will help the powder go into the lungs, rather than hitting the back of the throat. • Explain that it is a breath in and not a suck into the m outh. You can count to 5 slowly while they hold their breath. Date of preparation November 2013
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Clinical Algorithm 7 The test dose and measuring lung function
This part of the clinical algorithm shows when to measure lung function in relation to the test dose. It also highlights the need to refer to your unit protocol regarding using a bronchodilator before the test dose and regarding when to reassess lung function after the test dose. Clinical algorithm: test dose set up
!
*FEV1 should be
measured before
and after the
TOBI® Podhaler®
test dose.5
!
The first dose of
TOBI® Podhaler®
should be given
under
supervision.5
Give the first dose of
TOBI® Podhaler® after
using a bronchodilator if
this is part of the current
regimen for the patient.5
Refer to your unit’s
protocol for timing of
FEV1 reassessment.4
5
*Safety and efficacy have not been studied in patients with FEV1 <25% or >75% predicted. Date of preparation November 2013
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Clinical Algorithm 8 Passing the test dose
This part of the algorithm explains how to determine whether your patient has passed the test dose. Clinical algorithm: test dose set up
!
!
In this consensus algorithm a reduction
in FEV1 less than 15% is suggested as
indicating the patient has passed the
test dose. Some units use 10% or a
different percentage reduction in FEV1,
so check your local protocol.4
!
Date of preparation November 2013
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Clinical Algorithm 9 Failing the test dose This part of the algorithm explains how to determine if your patient has failed the test dose and what to do next. In this consensus algorithm a reduction in FEV1 greater than 15% is suggested as indicating the patient has failed the test dose; however, you should take into account factors such as whether the patient was feeling completely well on the day of the test dose and use your clinical judgment when making the decision as to whether a patient has passed or failed the test dose on this occasion and when a follow-­‐up test dose appointment should be made. Clinical algorithm: test dose set up
!
!
In this consensus algorithm a reduction in FEV1 greater than 15% is
suggested as indicating the patient has failed the test dose. Some units use
10% or a different percentage reduction in FEV1, so check your local
protocol and refer to the treating physician.4
!
Check your local protocol
regarding if and when to perform
another test dose and whether to
use a bronchodilator or not.4
Date of preparation November 2013
If the patient has failed the test dose, use
your clinical judgment to decide whether
to take no further action or make a new
appointment for a test dose.4
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Clinical Algorithm 10 References 1.
2.
3.
4.
5.
6.
7.
Bregnballe V et al. Patient preference and Adherence 2011:5;507-­‐515 Kettler L et al. Thorax 2002;57:459-­‐464 World Health Organization. Adherence to long-­‐term therapy: evidence for action. 663 Geneva: 2003 Data on file TIP13-­‐E003. Optimal Administration of Dry Powder Inhalation Therapies by CF Patients: Advisory Board Meeting. April 2013 TOBI Podhaler Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/24989/spc Konstan MW, et al. J Cyst Fibros. 2011;10(1):54-­‐61 Konstan MW, et al. Pediatr Pulmonol. 2011;46:230-­‐238 Date of preparation November 2013
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Clinical Algorithm 11 Here follows 3 examples of checklists/proformas for recording patient details and results
during the test dose. Please also refer to your local protocols.
Physio use: Appt booked (date and time)…………………………………………... DRUG RESPONSE ASSESSMENT PROFORMA
APPROPRIATE OUTPATIENT PRESCRIPTION ATTACHED
(we are unable to complete tests for outpatients without a script)
PATIENT NAME:
Patient Telephone #
Inpatient / Outpatient
HOSPITAL NO:
DATE OF REFERRAL:
REFERRING DOCTOR:
REFERRING DOCTOR BLEEP #
Important information i.e.
infection
control/communication
barriers/SpO2
CONSULTANT:
DOCTOR’S SIGNATURE:
The following must be completed in full for appointment to be booked.
PRE TEST BRONCHODILATOR: ___________________DOSE_____________
TYPE OF TRIAL:
Antibiotic
Hypertonic Saline
MEDICATION: _______________________ DOSE: _____________________
Mix with: Water / Salbutamol 2.5mg / Salbutamol 5mg / Terbutaline 5mg
®
®
applicable for TOBI Podhaler )
Please select (not
Post test bronchodilator (if needed):________________DOSE____________
-----------------------------------------------------------------------------------------------------------Baseline
FEV1: ___________________
SpO2 during test: _____________________%
Immediately Post
FEV1: ____________________
% Change: ___________________________
Subjective Symptoms:____________________________________________
20 Mins Post: (if required)
FEV1_____________________
Safe for Use: Yes / No
% Change_____________________________
Therapist signature____________________________
Reproduced with kind permission from the Royal Brompton & Harefield NHS Foundation Trust.
Date of preparation November 2013
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Clinical Algorithm 12 Patient Name:
Hospital no:
Date of trial:
TOBI PODHALER TRIAL
Tobi Podhaler can induce broncho-spasm and/or coughing. It is important that the first dose should
be administered in the hospital setting with access to resuscitation facilities, and a formal trial
undertaken with lung function monitoring before and after the dose, and recording of adverse
symptoms.
Name:
Hospital No:
TOBI podhaler prescribed
Patient Information Leaflet Provided
Adverse Symptoms explained
Spirometry
Ventolin administered pre-podhaler
Tobi Podhaler administered and correct technique taught
Spirometry post ventolin and podhaler
% constriction calculated
Repeat spirometry at 20 mins (if necessary)
FEV1 Pre –neb
FEV1 Post -neb
% Constriction
□
□
□
□
□
□
□
□
□
FEV1 20 mins Post
Pre FEV1 – Post FEV1 x 100
Pre FEv1
ACCEPTABLE % CONSTRICTION IS 10%
D/W Medics if greater than 10%
Trial Outcome:
Plan:
Name……………………………. Signature………………………….
Grade…………………………… Date……………………………….
Reproduced with kind permission from King’s College Hospital NHS Trust.
Date of preparation November 2013
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Clinical Algorithm 13 Tobi Podhaler -­‐ 112mg Tobramycin Inhalation Powder Name: _________________________ Inhaled Therapy Trial Date ____________________________________________ DOB: __________________________ Any previous reactions to Tobramycin? Yes / No If yes, please comment ___________________________________________ Address: _______________________ __________________________________________________________________ Hospital Number: ________________ __________________________________________________________________ Subjective Consent provided by patient Yes / No Auscultation: Any Other Observation? Beta2 Agonist Pre – Dose? (please indicate drug and dose) Salbutamol MDI ____________________ / Salbutamol Nebuliser____________________ Terbutaline MDI ____________________ / Terbutaline Nebuliser____________________ Symbicort ___________________ If not, why? Lung Function SpO2 / HR PEF FEV1 % on Pre L L % % % on Post 1 L L % % % on Post 2 L % L % FVC Analysis Plan 3/52 Review Agreed Yes / No via phone / email Patient aware of 3 month follow up? Yes / No Name: Signature: Band: Bleep: Inhaled Therapy Clinic Proforma 2013 Reproduced with kind permission from University Hospitals Bristol NHS Trust.
Date of preparation November 2013
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Clinical Algorithm 14 Abbreviated Prescribing Information
®
®
TOBI Podhaler 28 mg inhalation powder
(tobramycin inhalation powder)
Indication: TOBI Podhaler is indicated for the suppressive
therapy of chronic pulmonary infection due to Pseudomonas
aeruginosa in adults and children aged 6 years and older with
cystic fibrosis. Consideration should be given to official
guidance on the appropriate use of antibacterial agents.
Presentation: Each hard capsule contains 28 mg tobramycin.
The capsules are clear and colourless, containing a white to
almost white powder, with “NVR AVCI” printed in blue on one
part of the capsule and Novartis logo printed in blue on the
other part of the capsule. Dosage and administration: The
recommended dose is 112 mg tobramycin (4 × 28 mg
capsules), administered twice daily for 28 days. TOBI Podhaler
is taken in alternating cycles of 28 days on treatment followed
by 28 days off treatment. The two doses (of 4 capsules each)
should be inhaled as close as possible to 12 hours apart and
not less than 6 hours apart. The dose of TOBI Podhaler is the
same for all patients within the approved age range,
regardless of age or weight. Treatment should be continued on
a cyclical basis for as long as the physician considers the
patient is gaining clinical benefit from treatment, taking into
account that long-term safety data are not available. TOBI
Podhaler is administered by the oral inhalation route using the
Podhaler device. It must not be administered by any other
route or using any other inhaler. Each capsule should be
inhaled with two breaths and checked to ensure it is empty. The capsules must not be swallowed. Caregivers should
provide assistance to children starting treatment and should
continue to supervise them until they are able to use the
Podhaler device properly without help. Where patients are
receiving several different inhaled medicinal products and
chest physiotherapy, it is recommended that TOBI Podhaler is
taken last. Contraindications: Hypersensitivity to the active
substance and any aminoglycoside, or to any of the excipients.
Precautions: Ototoxicity: Hearing loss and tinnitus were
reported by patients in the TOBI Podhaler clinical studies.
Caution should be exercised when prescribing TOBI Podhaler
to patients with known or suspected auditory or vestibular
dysfunction. If a patient reports tinnitus or hearing loss during
therapy, the physician should consider referring them for
audiological assessment. Nephrotoxicity: Nephrotoxicity has
been reported with the use of parenteral aminoglycosides.
Nephrotoxicity was not observed during TOBI Podhaler clinical
studies. Caution should be exercised when prescribing to
patients with known or suspected renal dysfunction. Baseline
renal function should be assessed and then reassessed after
every 6 complete cycles. Monitoring of serum tobramycin
concentrations: Patients with known or suspected auditory or
renal dysfunction should have their
serum tobramycin
concentrations monitored. If ototoxicity or nephrotoxicity
occurs, then tobramycin therapy should be discontinued. The
serum concentration of tobramycin should only be monitored
through validated methods. Finger prick blood sampling is not
recommended due to the risk of contamination of the sample.
Bronchospasm: Bronchospasm can occur with inhalation of
medicinal products and has been reported with TOBI Podhaler
in clinical studies. The first dose of TOBI Podhaler should be
given under supervision, after using a bronchodilator if this is
part of the current regimen for the patient. If there is evidence
of therapy-induced bronchospasm, the physician should
carefully evaluate whether the benefits of continued use
outweigh the risks to the patient. If an allergic response is
suspected, therapy should be discontinued. Cough: Cough
can occur with the use of inhaled medicinal products and was
reported with the use of TOBI Podhaler in clinical studies.
Based on clinical trial data TOBI Podhaler was associated with
a higher reported rate of cough compared with tobramycin
300mg/5ml nebuliser solution. Cough was not related to
bronchospasm. Haemoptysis: Patients with haemoptysis were
excluded from the clinical studies so no data exist on the use
of TOBI Podhaler in these patients. This should be taken into
account before prescribing TOBI Podhaler, considering the
inhalation powder was associated with a higher rate of cough.
Date of preparation November 2013
The use of TOBI Podhaler in patients with clinically significant
hemoptysis should be undertaken or continued only if the
benefits of treatment are considered to outweigh the risks of
inducing further haemorrhage. Other precautions: Patients
receiving concomitant parenteral aminoglycoside therapy
should be monitored as clinically appropriate. Caution should
be exercised in patients with known or suspected
neuromuscular disorders such as myasthenia gravis or
Parkinson’s disease. In clinical studies, some patients on TOBI
Podhaler therapy showed an increase in aminoglycoside
minimum inhibitory concentrations (MIC) for P. aeruginosa
isolates tested. MIC increases observed were in large part
reversible during off-treatment periods. Safety and efficacy
have not been studied in patients with FEV1 < 25% or > 75%
predicted, or patients colonised with Burkholderia cepacia.
Long-term safety data are not available for TOBI Podhaler.
Pregnancy and lactation: There are no adequate data on the
use of tobramycin via inhalation in pregnant women. Systemic
exposure following inhalation of TOBI Podhaler is low,
however it should not be used during pregnancy unless the
benefits to the mother outweigh the risks to the foetus.
Patients who use TOBI Podhaler during pregnancy should be
informed of potential harm to the foetus. The amount of
tobramycin excreted in human breast milk after administration
is estimated to be low considering the low systemic exposure. Because of the potential for ototoxicity and nephrotoxicity in
infants, a decision should be made whether to terminate
breast-feeding or discontinue treatment with TOBI Podhaler.
Drug Interactions: No interaction studies have been
performed with TOBI Podhaler. Based on the interaction profile
for tobramycin following intravenous and aerosolised
administration, concurrent and/or sequential use of TOBI
Podhaler is not recommended with other medicinal products
with nephrotoxic or ototoxic potential. Prescribers should
consult the Summary of Product Characteristics for a full list of
potential interactions. Undesirable effects: Cough was the
most frequently reported adverse reaction in the two phase III
TOBI Podhaler clinical studies. No association was observed
in either clinical study between bronchospasm and cough
events. The most commonly reported adverse reactions in the
active-controlled clinical study with TOBI Podhaler versus
tobramycin 300mg/5ml nebuliser solution were cough, lung
disorder, productive cough, pyrexia, dyspnoea, oropharyngeal
pain and dysphonia. Four patients in the TOBI Podhaler
treatment group experienced significant decreases in hearing
which were transient in three patients and persistent in one
case. In the placebo-controlled study with TOBI Podhaler, the
adverse reactions for which reported frequency was higher
with TOBI Podhaler than with placebo were pharyngolaryngeal
pain, dysgeusia and dysphonia. Adverse drug reactions by
frequency: Very Common: haemoptysis, dyspnoea, dysphonia,
productive cough, oropharyngeal pain, cough, pyrexia.
Common: hearing loss, tinnitus, epistaxis, wheezing, rales,
chest discomfort, nasal congestion, bronchospasm, vomiting,
diarrhoea, throat irritation, nausea, dysgeusia, rash,
musculoskeletal chest pain. Not known: aphonia. Prescribers
should consult the Summary of Product Characteristics for full
information regarding side-effects. Quantities, basic NHS
price (excl. VAT) and marketing authorisation number:
224 (4x56) capsules and 5 inhalers (monthly multipack)
£1790.00 (EU/1/10/652/002); 56 capsules and 1 inhaler
£447.50 (EU/1/10/652/001). Legal category: POM. Date of
last revision of abbreviated prescribing information:
October 2013. Full prescribing information is available
from: Novartis Pharmaceuticals UK Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR. Telephone:
(01276) 698370, Email: [email protected].
Adverse events should be reported. Reporting forms
and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events
should also be reported to Novartis (01276 698370).
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