Handling of Inhaler Devices: a Practical Guide for Pharmacists

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

PHARMACEUTICAL SERVICES DIVISION MINISTRY OF HEALTH MALAYSIA

DISCLAIMER

Unless otherwise specifically stated, the information contained in this book is made available to pharmacists by the Ministry of Health (MOH) and Clinical Pharmacy Committee (Respiratory Specialty),[CPC(RS)], Pharmaceutical Services Division (PSD), MOH for use as a guide and may not reflect the realities of an actual setting in each institution. The purpose of this book is to standardise counseling on inhaler devices by pharmacists.

Neither the Ministry of Health, CPC (RS), PSD, MOH nor any other agency or entities thereof, assumes any legal liability or responsibility for the accuracy, completeness, nor usefulness of any information, product or process disclosed in this book.

Reference herein to any specific commercial product, process, service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the CPC (RS), PSD, MOH or any entities thereof.

The views and opinions of the CPC (RS), PSD, MOH expressed therein do not necessarily state or reflect those of the other institutions in Ministry of Health or any agency or entities thereof.

ACKNOWLEDGEMENT

The Clinical Pharmacy Committee (Respiratory Specialty) of the Pharmaceutical Services Division, MOH is grateful to all those involved either directly or indirectly in the preparation of this guide. This committee would also like to express its appreciation to relevant drug companies who have provided information on the various inhaler products and their permission for allowing us to include the relevant diagrams of their products in this book.

ADVISORS

Eisah binti A. Rahman Senior Director of Pharmaceutical Services Division,MOH

Hasnah binti Ismail Director of Pharmacy Practice and Development, Pharmaceutical Services Division, MOH

EDITORIAL COMMITTEE

Abida Haq Syed M. Haq Abdol Malek bin Abd. Aziz Pharmaceutical Services Division, MOH Melaka Hospital

Sameerah binti Shaikh Abdul Rahman Shahirah binti Zainudi Pharmaceutical Services Division, MOH Selayang Hospital

Nurul Adha binti Othman Suhadah binti Ahad Pharmaceutical Services Division, MOH Melaka Hospital

Sarah a/p Nagalingam Pharmaceutical Services Division, MOH

Tengku Malini binti Tengku Mohmed Noor Izam Pharmaceutical Services Division, MOH

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS (MAIN COMMITTEE)

Abdol Malek bin Abd. Aziz Marzirah binti Ibrahim Melaka Hospital Tuanku Ampuan Najihah Hospital, Kuala Pilah

Shahirah binti Zainudi Nicholas Leow Chun Wei Selayang Hospital Sibu Hospital

Suhadah binti Ahad Nurulhayati binti Abdul Jamal Melaka Hospital Sultanah Nur Zahirah Hospital Kuala Terengganu

Chong Meng Fei Rohaya binti Sulaiman Pulau Pinang Hospital Tengku Ampuan Afzan Hospital, Kuantan

Chow Foong Yan Suzana binti Mustafa Raja Permaisuri Bainun Hospital, Ipoh Queen Elizabeth Hospital Kota Kinabalu

Jaya Muneswarao a/l Ramadoo @Devudu Syaziyah binti Ahmad Kulim Hospital Sultanah Bahiyah Hospital Alor Setar

Lim Yan Chun Wong Hui Shean Sultanah Aminah Hospital, Johor Bahru Tuanku Ampuan Najihah Hospital Kuala Pilah

HANDLING OF INHALER DEVICES : A PRACTICAL GUIDE FOR PHARMACISTS (CONTRIBUTORS)

Ang Yu Joe Nor Aziah binti Idris Adibah Yuhana Ismail Nor Hafizah binti Salehudin Chan Yeen Yee Norehan binti Abdul Rashid Chen Siaw Ming Norhafidah binti Othman Chong Mei Fei Norhayati binti Mustapha Chong Mei Yoong Nurah Zainal Abidin Chow Foong Yan Nur Eillena binti Mat Deris Karen Wong Yoke Sim Ong Ser Via Kho Zhi Min Phan Hui Seng Kon Ee Wen Rohaya Sulaiman Kuah Lean Fung Roksanah binti Shaukat Ali Lai Siok Wah Rosminah binti Mohd Din Lee Chui Peng Soh Kwang Chin Lee Sock Hui Suzana binti Mustafa Mastura binti Safie Tan Jou Ann Ng Min Mei Wah Mei Chin Noorulhida binti Ishak Wong Yee Cheat Noorliana binti Ismail

HANDLING INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACIST

CONTENT

PAGE NUMBER

Abbreviations……………………………………………………………………………. ix

Introduction ……………………………………………………………………..………. x

1 METERED DOSE INHALER (MDI)

1.1 Introduction ……………………………………………………………………… 1

1.2 Directions For Use 2 ………………………………………………………………...

1.3 Maintenance ……………………………………………………………………. 7

1.4 Determining Contents Of An MDI Canister ………………………………… 9

1.5 Summary Of Metered Dose Inhalers …………………………………………. 10

1.6 References ……………………………………………………………………… 15

2 TURBUHALER®

2.1 Introduction ……………………………………………………………………… 16

2.2 Directions For Use

A. Preparing A New Turbuhaler® (Priming) ……………………………...... 17

B. Used Turbuhaler® ………………………………………………………….. 18

2.3 Maintenance ……………………………………………………………………. 23

2.4 How To Know When The Turbuhaler® Is Empty? …………………………... 23

2.5 Determining The Functionality Of The Device When In Doubt ……………. 24

2.6 Summary Of Turbuhaler® ……………………………………………………… 25

2.7 References ……………………………………………………………………… 27

HANDLING INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACIST

PAGE NUMBER 3 EASYHALER®

3.1 Introduction ……………………………………………………………………… 28

3.2 Directions For Use

A. Preparing The Powder Inhaler For First Use ……………………………. 30

B. Delivering The Medication …………………………………………………. 31

3.3 Maintenance ……………………………………………………………………. 35

3.4 How Do You Know When Your Easyhaler® Is Empty? …………………….. 35

3.5 Summary Of Easyhaler® ………………………………………………………. 36

3.6 References ……………………………………………………………………… 38

4 ACCUHALER®

4.1 Introduction ……………………………………………………………………… 39

4.2 Directions For Use ……………………………………………………………... 40

4.3 Maintenance ………………………………………………………………….. 42

4.4 Summary Of Accuhaler® ……………………………………………………….. 43

4.5 References ……………………………………………………………………… 44

5 HANDIHALER®

5.1 Introduction……………………………………………………………………… 45

5.2 Directions For Use …………………………………………………………….. 46

5.3 Maintenance …………………………………………………………………….. 53

5.4 Summary Of HandiHaler® …………………………………………………… 55

5.5 References ……………………………………………………………………. 56

vii

HANDLING INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACIST

PAGE NUMBER

6 SPACER DEVICES

6.1 Introduction ……………………………………………………………………… 57

a) BI Tube ………………………………………………………………………. 58

b) Chamber With Mouthpiece ………………………………………………... 58

c) Chamber With Mask ………………………………………………………... 59

6.2 Directions For Use

6.2.1 BI Tube ……………………………………………………………….. 60

6.2.2 Chamber With Mask ………………………………………………… 63

6.2.3 Chamber With Mouthpiece ………………………………..…..……. 66

6.3 Maintenance

6.3.1 BI Tube ……………………………………………………………..… 69

6.3.2 Chamber With Mask Or Mouthpiece ………………………………. 69

6.4 References …………………………………………………………………….. 71

7 PEAK FLOW METER

7.1 Introduction ………………………………………………………………….… 72

a) A "Normal" Peak Flow Rate …………………………………………...…… 72

b) Measuring Reversibility Of Airflow Obstruction ………………………...... 73

c) Determine A "Normal" Peak Flow Rate …………………………………… 73

7.2 Directions For Use ……………………………………………………………... 74

7.3 Maintenance …………………………………………………………………… 77

7.4 References …………………………………………………………………….. 78

viii

HANDLING INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACIST

ABBREVIATIONS

BI Tube Boehringer Ingelheim Tube

BP British Pharmacopoeia

CFC Chlorofluorocarbon

COPD Chronic Pulmonary Airway Disease

LABA Long-acting beta-2 agonist mcg Microgram

MDI Metered Dose Inhaler

PEFR Peak Expiratory Flow Rate

SABA Short-acting beta-2 agonist

HANDLING INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACIST

INTRODUCTION

Asthma and Chronic Obstructive Pulmonary Disease (COPD) can lead to chronic morbidity and mortality throughout the world and their prevalence has increased considerably over the past 20 years.

Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs and increased inflammation) when airways are exposed to various risk factors.

COPD consists of chronic bronchitis and emphysema, two commonly co-existing diseases of the lungs in which the airways become narrowed. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time.

An inhaler or puffer is a medical device used for delivering medication into the body via the lungs. It is mainly used in the treatment of asthma and COPD. Recent studies have shown that incorrect inhaler technique prevent patients from receiving maximal benefits from medications. Poor medication delivery leads to reduced quality of life, more frequent and longer hospital stay and poor control of the symptoms of asthma such as wheeze, cough and breathlessness.

“Handling of Inhaler Devices: A Practical Guide for Pharmacists” is a collaborative effort involving pharmacists within the Ministry of Health from all states. This guidebook aims to provide pharmacists, prescribers and other health care professionals with standard inhaler techniques to assist patients.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

METERED DOSE INHALER (MDI)

1.1 INTRODUCTION

An inhaler is a medical device that administers medication to the lungs in an aerosolised form for the measurement of asthma, chronic obstructive pulmonary disease (COPD) and other respiratory conditions. The most commonly used type of inhaler is the metered dose inhaler (MDI). This type of inhaler consists of a small canister that holds the medicine. The medicine is administered in a metered dose, which saves the users from having to measure their dosage. MDIs are used to administer bronchodilators, anticholinergics and steroids.

A MDI consists of 2 major components: the canister and an actuator (or mouthpiece). The canister itself consists of a metering dose valve with an actuating stem. The formulation resides within the canister and is made up of the drug, a liquefied gas propellant and, in many cases, stabilising excipient. The actuator contains the mating discharge nozzle and generally includes a dust cap to prevent contamination.

Picture 1: Cross Section of a Metered Dose Inhaler.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

1.2 DIRECTIONS FOR USE

STEP 1:

Remove the mouthpiece cover. Remain standing or seated upright to obtain the full dose of each actuation.

STEP 2:

Hold the inhaler in an upright position as shown in diagram.

Note: May use both hands for patients with difficulty in handling the device.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

Shake the MDI 3 - 5 times in an up-down motion before each puff to mix the contents of the canister. If the device is being used for the first time, prime it by actuating the canister mid-air until an even spray is obtained.

3-5X

Note: Each shake constitute from top to bottom, back to top again.

STEP 4:

Exhale slowly and completely through your mouth before holding your breath.

DO NOT exhale into the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 5:

Device should be held at an upright position. Insert into mouth with no obstruction to the mouthpiece with the head slightly tilted.

DO NOT bite the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

2 STEP 6: Begin inhaling slowly through the mouth (NOT nose) (1) and simultaneously 1 actuate the MDI ONCE (2). Continue inhalation for about 3-5 seconds until the lungs are full (3). 3

STEP 7:

Hold breath for 4-10 seconds.

It is recommended to leave the inhaler in the mouth while holding breath.

Note: Ability to hold breath for less than 4 seconds, consider use of a spacer. No extra benefit for holding breath more than 10 seconds.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 8:

Remove inhaler (1) from mouth and exhale slowly (2). 2 1

STEP 9:

Wait 30 seconds to 1 minute before repeating step 3-8 if subsequent doses are required.

STEP 10:

Close cap and keep the inhaler in a dry place.

Note: 1. Patients should be advised to gargle with water after using certain types of MDIs e.g. Anticholinergics and Inhaled Corticosteroids (ICS). 2. If on two types of inhalers (steroid & bronchodilator), it is recommended to use the bronchodilator first and wait for 5 minutes before using the steroid.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

1.3 MAINTENANCE

} It is important to keep the device clean to: ◦ Prevent medication accumulation. ◦ Prevent blockage over the nozzle.

} Clean the plastic mouthpiece only, NOT the metal canister.

} Clean at least ONCE A WEEK.

} For inhalers that are not used for more than 2 weeks, it should be primed before use.

STEP 1:

Remove the mouthpiece cover and canister

from the actuation body.

DO NOT use detergent or soap.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 2:

Wash the actuator from the top with running tap water for 30 seconds.

Repeat by running tap water through the mouthpiece of the actuator for 30 seconds.

STEP 3:

Let the actuator dry overnight after shaking off as much water as possible.

Note: If the patient needs to use the MDI during exacerbation, shake the actuator dry and then actuate twice away from face to ensure no blockage. The inhaler is ready for use.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 4:

When the actuator has dried, assemble the canister to the actuator body. Ensure a tight Blocked nozzle fit.

Shake the device well and actuate twice away from face to ensure no blockage.

Replace the cap and store the device safely before the next use.

Clean nozzle

1.4 DETERMINING CONTENTS OF AN MDI CANISTER

} It is hard to determine the remaining contents of the MDI.

} The floating/immersion technique is no longer endorsed by a panel of experts.

Keep a spare one. The shaking method can be done to estimate the remaining contents of the MDI canister but it does not reflect the actual content of the canister.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

1.5 SUMMARY OF METERED DOSE INHALERS

STRENGTH INHALER/PROPELLANT/ DAILY DOSE PER PUFF GROUP ADVERSE EFFECT REMARKS PACKAGING (MCG) MINIMUM MAXIMUM

SALBUTAMOL BP 100 Adult and 100 - 200 mcg 2400 mcg 1. Slight tremor (particularly in the Short-acting (ASTHALIN®) children hands) beta-agonist

400 doses 2. Headache (SABA) 3. Peripheral dilatation Exercise 200 mcg 15 minutes before 4. Palpitations induced exercise bronchospasm 5. Tachycardia 6. Arrhythmias

7. Disturbances of sleep and Acute 400 mcg every 2400 mcg exacerbation behavior in children 10 minutes 8. Muscle cramps 9. Hypersensitivity reactions

including paradoxical bronchospasm, urticaria, angioedema, hypotension, pulmonary oedema, erythema multiforme

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STRENGTH INHALER/PROPELLANT/ DAILY DOSE PER PUFF GROUP ADVERSE EFFECT REMARK PACKAGING (MCG) MINIMUM MAXIMUM

IPRATROPIUM BROMIDE 20 Adult and 60 mcg 240 mcg 1. Gastrointestinal motility disorders (e.g. Anticholinergic (ATROVENT®)/200 doses children constipation, diarrhea, vomiting) ≥ 6 years 2. Dryness of the mouth 3. Increased heart rate, palpitations, supraventricular tachycardia, atrial fibrillation 4. Urinary retention 5. Cough 6. Local irritation Children 60 mcg 7. Mydriasis < 6 years 8. Increased intraocular pressure, narrow-angle glaucoma, eye-pain 9. Skin rashes or urticaria 10. Pruritus 11. Angio-edema of the tongue, lips and face 12. Laryngospasm

IPRATROPIUM BROMIDE 21/120 Adult 42/240 mcg 252/1440 1. Headache or dizziness Anticholinergic MONOHYDRATE & mcg 2. Nervousness, tachycardia, fine tremor and short SALBUTAMOL SULPHATE or palpitations acting beta- (COMBIVENT®)/200 doses 3. Dryness of mouth agonist 4. Dysphonia (SABA) 5. Ocular complications 6. Allergic type reactions

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STRENGTH INHALER/PROPELLANT/ DAILY DOSE PER PUFF GROUP ADVERSE EFFECT REMARK PACKAGING (MCG) MINIMUM MAXIMUM

BUDESONIDE/300 doses 200 Adult 200 mcg 1600 mcg 1. Mild irritation of the throat and thirst Glucocorticoid 2. Candidiasis of the mouth and throat 3. Cough

4. Generally reversible hoarseness of

the voice 5. Bad taste and dryness of the throat C/hildren 6. Paradoxical bronchoconstriction 2 – 7years 200 mcg 400 mcg 7. Headache 8. Nausea > 7 years 200 mcg 800 mcg 9. Tiredness

10. Diarrhea 11. Skin reaction 12. Osteoporosis BECLOMETHASONE 100 Adult 300 mcg 800 mcg DIPROPIONATE ® For Beclomethasone dipropionate only: (BECLAZONE )/200 doses 1. Secondary hypocortisolism 2. Cataract 3. Glaucoma

Children 100 mcg 400 mcg > 6 years

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STRENGTH INHALER/PROPELLANT/ DAILY DOSE PER PUFF GROUP ADVERSE EFFECT REMARK PACKAGING (MCG) MINIMUM MAXIMUM

® CICLESONIDE (ALVESCO )/ 160 Adult 160 mcg 320 mcg Side effects are similar with Budesonide Glucocorticoid 60 doses PLUS:

1. Epistaxis

2. Nasopharyngitis 3. Bruising 4. Cataracts 5. Glaucoma

FLUTICASONE PROPIONATE 125 Adult 100 mcg 2000 mcg 1. Mouth and throat candidiasis (FLIXOTIDE®)/120 doses 2. Hoarseness (patients are advised to gargle after using the medication) 3. Paradoxical bronchospasm 4. Cutaneous hypersensitivity reactions 5. Headache 6. Giddiness or dizziness Children 100 mcg 200 mcg 7. Sleep disorders 4 -11years 8. Migraine 9. Paralysis of cranial nerves 10. Mood disorders

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STRENGTH INHALER/PROPELLANT/ DAILY DOSE PER PUFF GROUP ADVERSE EFFECT REMARK PACKAGING (MCG) MINIMUM MAXIMUM

FLUTICASONE PROPIONATE 25/50 Adult and 25 mcg 50 mcg 1. Transient tremor Glucocorticoid & 25/125 children ≥ (1 puff (2 puffs 2. Subjective palpitations and and long 25/250 4 years Salmeterol Salmeterol headache SALMETEROL XINAFOATE acting beta- alone) alone) 3. Cardiac arrhythmias (atrial ® ® agonist (SERETIDE EVOHALER )/ fibrillation, supraventricular 120 doses tachycardia and extrasystoles) (LABA) 4. Athralgia 5. Hypersensitivity reactions such as rash, edema and angioedema 6. Side effects for fluticasone are similar with Flixotide®

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

1.6 REFERENCES

1. Clark AR. MDIs: physics of aerosol formation. J Aerosol Med 1996; 9 Suppl: S19–S26. 2. Fink JB. Metered-dose inhalers, dry powder inhalers and transitions. Respir Care 2000; 45(6):623–635. 3. Dolovich MB, Fink JB. Aerosols and devices. Respir Care Clin N Am 2001; 7(2):131–173. 4. Tomlinson HS, Corlett SA, Allen MB, Chrystyn H. Assessment of different methods of inhalation from salbutamol metered dose inhalers by urinary drug excretion and methacholine challenge. Br J Clin Pharmaco 2005, 60:6 605–610. 5. Fink JB, Rubin BK. Problems with Inhaler Use: A Call for Improved Clinician and Patient Education. Respir Care 2005; 50(10):1360 –1374. 6. Hesselink AE et al. Determinants of an Incorrect Inhalation Technique in Patients with Asthma or COPD. Scand J Prim Health Care 2001; 19:255–260. 7. Basheer YK et al. Handling of inhaler Devices in Actual Pulmonary Practice: Metered-Dose Inhaler Versus Dry Powder Inhalers. Respir Care 2008; 53(3):324 –328. 8. Wanda HTH et al. Assessment of Inhalation Technique in Children in General Practice: Increased Risk of Incorrect Performance with New Device. Journal of Asthma 2008, 45:67–71. 9. Fink JB, Rubin BK. Problems with Inhaler Use: A Call for Improved Clinician and Patient Education. Respir Care 2005; 50(10):1360 –1374. 10. David A. Warrell, Timothy M. Cox, John D. Firth, Edward J. Benz. Oxford Textbook of Medicine 4th Edition. Oxford University Press, 2005; p1305. 11. http://en.wikipedia.org/wiki/Inhaler. 2009

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

2. TURBUHALER®

2.1 INTRODUCTION

Turbuhaler® is an easy-to-use, multiple-dose, inspiratory flow-driven dry powder inhaler. Currently there are 4 types of Turbuhaler® which are Budesonide (Pulmicort®), combination of Budesonide/Formoterol (Symbicort®), Formoterol (Oxis®) and Terbutaline (Bricanyl®).

Picture 1: Turbuhaler® (Adapted from http://www.astrazeneca.ca/documents/ProductPortfolio/SYMBICORT_CIL_en.pdf)

Picture 2: Different types of Turbuhaler® (Adapted from http://www.az-air.com/respiratory-products/turbuhaler/turbuhaler-the-basics)

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

2.2 DIRECTIONS FOR USE A. Preparing a new Turbuhaler® (Priming):

STEP 1:

Unscrew and lift off the cover.

“CLICK” STEP 2:

Hold the Turbuhaler® upright with the grip facing downwards.

Turn the grip as far as it will go and then turn it back as far as it will go in the opposite direction until a “CLICK” sound is heard.

Perform this procedure TWICE.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

B. Used Turbuhaler®

STEP 1:

Unscrew and lift off the cover.

STEP 2:

Hold the Turbuhaler® upright with the grip facing downwards.

DO NOT hold the mouthpiece when turning the grip.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

To load the Turbuhaler® with a dose, turn the grip as far as it will go in one direction as shown in the diagram.

“CLICK” STEP 4:

Then turn it back again as far as it will go in the opposite direction until a “CLICK” sound is heard.

The Turbuhaler® is now loaded with the desired dose and is ready for use.

Note: If the turbuhaler is accidentally dropped, a new dose should be loaded and inhaled.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 5:

Breathe out away from the mouthpiece.

STEP 6:

Place the mouthpiece gently between the lips.

Ensure a tight seal around it as in diagram.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 7:

Breathe in forcefully and deeply through the mouth only.

Note: Holding breath after inhalation is optional.

STEP 8:

Remove the Turbuhaler® from the mouth before breathing out again.

DO NOT breathe into the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 9:

Repeat step 2 - 8 if more than one dose is required.

STEP 10:

Replace the cover and store Turbuhaler® in a dry place.

Note: 1. Patients should be advised to gargle with water after using steroid containing Turbuhalers®. 2. If on two types of Turbuhalers® (steroid & bronchodilator), it is recommended to use the bronchodilator first and wait for 5 minutes before using the steroid.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

2.3 MAINTENANCE

1. Clean the outside of the mouthpiece once a week with a dry cloth or tissue.

2. Never use water or any other fluid when cleaning the mouthpiece.

2.4 HOW TO KNOW WHEN THE TURBUHALER® IS EMPTY?

Picture 3: Shows how many doses are left (Adapted from: http://www.az-air.com/respiratory-products/turbuhaler/turbuhaler-the-basics/)

Turbuhaler® has a dose indicator that shows how many doses are left in the inhaler. It moves slowly when each time a dose is loaded.

For example, Budesonide/Formoterol (Symbicort®) Turbuhaler® dose indicator marks every 10th dose, and every 20th dose is displayed numerically. When the red colour first appears in dose indicator, it shows that there are only 20 doses left.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

Terbutaline (Bricanyl®), Budesonide (Pulmicort®) and Formoterol (Oxis®)Turbuhaler® dose indicators are not displayed numerically. When the red colour first appears in dose indicator, it shows that there are only 20 doses left.

The Turbuhaler® can be safely disposed off when the dose indicator window has turned red completely. The sound heard when the device is shaken is produced by a drying agent, and not the medication. Turbuhaler® cannot be re-filled with drug and should be discarded.

2.5 DETERMINING THE FUNCTIONALITY OF THE DEVICE WHEN IN DOUBT

Dark cloth Drug

Picture 4: Determining the functionality of the device when in doubt (Adapted from: http://www.az-air.com/respiratory-products/turbuhaler/turbuhaler-function-and-use/)

Turbuhaler® makes no sound when the drug is released. Moreover, since the amount of drug delivered by Turbuhaler® is small, there is either no or only a faint taste in the mouth when the drug is delivered. This can, in some cases, lead to patients being uncertain as to whether they have received the required dose. The correct functionality of the Turbuhaler® can easily be checked by inhaling through a piece of dark cloth.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

2.6 SUMMARY OF TURBUHALER®

STRENGTH DAILY DOSE PER INHALER/PACKAGING GROUP ADVERSE EFFECT REMARK INHALATION MINIMUM MAXIMUM (MCG)

TERBUTALINE (BRICANYL®)/ 500 Adult 500 mcg 6000 mcg 1. Mouth & throat irritation Short-acting beta- 200 doses 2. Cardiac arrhythmias agonist (SABA) 3. Headache

4. Fine skeletal muscle tremor Children 500 mcg 4000 mcg 5. Paradoxical bronchospasm 3 -12 years 6. Potentially severe hypokalemia

*Use with caution in patient with hyperthyroidism

*Monitor potassium level in acute ® FORMOTEROL (OXIS )/ 4.5 Adult 4. 5 - 9 mcg 54 mcg severe asthma Long-acting beta- 4.5 mcg/60 doses agonist (LABA) 9 mcg/60 doses Children 18 mcg > 6 years

9 Adult 9 mcg 54 mcg

Children 18 mcg > 6 years

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STRENGTH DAILY DOSE PER INHALER/PACKAGING GROUP ADVERSE EFFECT REMARK INHALATION MINIMUM MAXIMUM (MCG)

BUDESONIDE & FORMOTEROL 160/4.5 Adult 160 / 4.5 1920 / 54 1. Palpitation Combination of ® mcg (SYMBICORT )/ mcg 2. Candida infection in the glucocorticoid and oropharynx 160/4.5 mcg/60 doses long-acting beta- Aldolescents 3. Mild irritation of the throat agonist (LABA) 160/4.5mcg/120 doses 4. Headache 5. Tremor Reliever therapy: 6. Coughing 1 inhalation as needed in response to 7. Reversible hoarseness of symptoms the voice 8. Side effects for Formoterol Max daily dose including reliever therapy: are similar with Oxis® 12 inhalations

BUDESONIDE 100 Adult 200 - 1600 1600 mcg Glucocorticoid (PULMICORT®) mcg Or 100mcg/200 doses &

200 mcg/100 doses 200 Children 200 - 800 800 mcg > 7 years mcg

Children 200 - 400 400 mcg 2 - 7 years mcg

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

2.7 REFERENCES

1. AZ-AIR. Part III: Consumer information on Symbicort® Turbuhaler® [monograph on the internet]. Mississauga, Ontario: AstraZeneca Canada Inc; 2009 [cited 2009 May 26]. Available from: http://www.astrazeneca.ca/documents/Product Portfolio/SYMBICORT_CIL_en.pdf 2. AZ-AIR. Turbuhaler – the basics [homepage on the internet]. AstraZeneca Inc; 2008 [cited 2009 August 23]. Available from: http://www.az- air.com/respiratory-products/turbuhaler/turbuhaler-the-basics/ 3. AZ-AIR. Turbuhaler function and use [homepage on the internet]. AstraZeneca Inc; 2008 [cited 2009 May 26]. Available from: http://www.az- air.com/respiratory-products/turbuhaler/turbuhaler-function-and-use/ 4. Editorial development by CMPMedica. MIMS:Disease Management Guide to Asthma. Petaling Jaya: United Medica Sdn. Bhd; 2008. 5. Spier S, Robert LT. Inhalation therapy for the asthmatic child. The Canadian Journal of Pediatrics.1991 December.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

3. EASYHALER®

3.1 INTRODUCTION

The Easyhaler® is a new generation, multidose dry powder inhaler preloaded with 200 doses of asthma medications. Easyhaler® has been designed to resemble a MDI in terms of the small size of the device, but importantly avoids the need to coordinate drug release and inhalation. The Easyhaler® product range currently includes four products; anti-inflammatory inhaled corticosteroids Budesonide (Giona®) Easyhaler® and Beclomethasone (Beclomet®) Easyhaler® as well as bronchodilators Formeterol Easyhaler® and Salbutamol (Buventol®) Easyhaler®. Salbutamol via Easyhaler® is at least as effective as salbutamol via Turbuhaler® in the treatment of histamine-induced bronchoconstriction (Zetterstrom et al. 2000). The efficacy via Easyhaler® is unaffected by low inspiratory flow.

Picture 1: Easyhaler® (Adapted from http://www.medscape.com/viewarticle/531818_3)

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

Picture 2: Different types of Easyhaler® (Adapted from http://www.orion.fi/en/Products-and-services/Human-prescription-medicines/Proprietary- products-portfolio/Easyhaler/)

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

3.2 DIRECTIONS FOR USE

A. Preparing the powder inhaler for first use

STEP 1:

Remove the powder inhaler from the laminated pouch.

Protective cover

STEP 2:

Insert the powder inhaler into the protective cover.

The dust cap on the mouthpiece prevents accidental actuation of the inhaler when inserting it into the protective cover.

Dust cap

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

B. Delivering the medication

STEP 1:

Remove the dust cap.

STEP 2:

Shake the device prior to each dose

After shaking, hold the device in the upright position.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

“CLICK”

STEP 3:

Press the device only ONCE between the thumb and forefinger until a “CLICK” sound is heard.

Keep holding the device in the upright position.

Note: If more than one dose is accidentally released, remove the dose from the mouthpiece by tapping it against the palm of the hand.

STEP 4:

Breathe out normally, away from the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 5:

Place the mouthpiece between lips and close tightly around the mouthpiece.

Breathe in forcefully and deeply through the mouth only.

STEP 6:

Remove the inhaler from mouth and hold breath for 5-10 seconds.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 7:

Repeat step 2-6 if more than one dose is required.

STEP 8:

Put the dust cap back on the mouthpiece.

Store Easyhaler® in a dry place.

Note: 1. Patients should be advised to gargle with water after using steroid containing Easyhalers®. ® 2. If on two types of Easyhalers (steroid & bronchodilator), it is recommended to use the bronchodilator first and wait for 5 minutes before using the steroid.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

3.3 MAINTENANCE

1. The mouthpiece can be cleaned with a dry cloth or tissue.

2. Never use water or any other fluid when cleaning the mouthpiece.

3. Inhalation powder should not be exposed to humidity. If the powder becomes damp, it is not suitable for use and should be disposed of.

3.4 HOW DO YOU KNOW WHEN YOUR EASYHALER® IS EMPTY?

Picture 3: Identification Easyhaler® is empty (Adapted from http://www.medasverige.se/vardpersonal/astma_allergi_och_kol/bilder/easyhaler)

Easyhaler® has a dose counter which indicates the number of remaining doses. The counter turns after every five actuations. When the counter turns red there are 20 doses left. A clear window on the back of the inhaler allows viewing of the powder. The device must be replaced when the dose counter indicates zero.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

3.5 SUMMARY OF EASYHALER®

STRENGTH DAILY DOSE PER INHALER/PACKAGING GROUP ADVERSE EFFECT REMARK INHALATION MINIMUM MAXIMUM (MCG)

® Common SALBUTAMOL (BUVENTOL )/ 200 Adult 200 - 400 2400 mcg Short-acting mcg 1. Tremor beta-agonist 200 doses 2. Palpitation (SABA) 3. Headache Use with caution Infrequent in patient with 1. Hyperglycaemia (high dose) hyperthyroidism 2. Tachycardia Children 200 mcg 1200 mcg 3. Muscle cramps Monitor 6 - 12 years 4. Agitation potassium level 5. Hyperactivity in children in acute severe 6. Insomnia asthma

Rare 1. Paradoxical bronchospasm 2. Allergic reactions including urticaria and angioedema

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STRENGTH DAILY DOSE PER INHALER/PACKAGING GROUP ADVERSE EFFECT REMARK INHALATION MINIMUM MAXIMUM (MCG)

® BUDESONIDE (GIONA )/ 200 Adult 200 mcg 1600 mcg Common Glucocorticoid

200 doses 1. Dysphonia

2. Oropharyngeal candidiasis

3. Bruishing

Rare Children 200 mcg 800 mcg 6 - 12 years 1. Allergic reactions

Others (if used in high doses) 1. Adrenal impairment 2. Bone density loss

3. Glaucoma 200 Adult 200 mcg 1600 mcg BECLOMETHASONE 4. Cataract ® (BECLOMET )/ 5. Skin thinning 200 doses 6. Bruising 7. Impaired growth

Children 200 mcg 800 mcg 6 - 12 years

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

3.6 REFERENCES

1. Asthma, Allergy and KOL [homepage on the internet] [cited 2009 Sept 2]. Available from: http://www. medasverige. se/ vardpersonal/ astma_allergi_ och_ kol/bilder/easyhaler. 2. Buventol Easyhaler® [Package Insert]. Findland: Orion Corporation. 3. Medscape [homepage on the internet]. Closer to an 'Ideal Inhaler' With the Easyhaler: Patient Use Inspiration Rate. 2005 [cited 2009 Sept 2];[about 6 screens]. Available from: http://www.medscape.com/viewarticle/531818_3. 4. Orion’s Portfolio of Medicines/Easyhaler. Orion Corporation [homepage on the internet]. 2009 [cited 2009 Sept 2]. Available from: http: //www.orion.fi/en/Products-and-services/Human-prescription-medicines/ Proprietary-products-portfolio/Easyhaler/. 5. Zetterstrom et al. Respiratory Medicine 2000. Nov;94(11):1097-1102. 6. Easyhaler Multidose Dry Powder Inhaler Monograph. 2008 Orion Corporation

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

4. ACCUHALER®

4.1 INTRODUCTION

Lever

Thumb grip Mouthpiece

Dose counter

Outer case

The combination of Salmeterol and Fluticasone Propionate (Seretide®) Accuhaler® is a moulded plastic inhaler device containing a foil strip with 60 blisters. Each blister contains lactose as a carrier. The blisters protect the inhalation powder from the effects of the atmosphere.

Picture 1: Cross Section of Accuhaler®.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

4.2 DIRECTIONS FOR USE

Check that the dose counter read 60, indicating the full number of doses.

“CLICK” STEP 1:

Hold the outer case in one hand and put the thumb of the other hand on the thumb grip to open the Seretide® Accuhaler®.

Push the thumb grip as far as it will go until a “CLICK” sound is heard.

“CLICK” STEP 2:

Hold the device horizontally with the mouthpiece towards the patient.

Slide the lever as far as it will go as in diagram until another “CLICK” sound is heard to load a dose in the device.

Note: Never hold the inhaler with the mouthpiece pointing downwards during or after loading a dose, as the medication can be dislodged. Always keep it horizontal.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

Hold the Accuhaler® away from mouth and breathe out completely.

DO NOT breathe into the device.

STEP 4:

Put the mouthpiece into the mouth and ensure a good seal.

Breathe in forcefully and deeply through the mouth only.

STEP 5:

Remove the Accuhaler® from the mouth and hold breath for 10 seconds or as long as possible.

DO NOT breathe into the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

“CLICK” STEP 6:

Close the device by sliding the thumb grip back to its original position until a “CLICK” sound is heard.

The lever will return to its original position and will be reset.

STEP 7:

Repeat step 1-6 if more than one dose is required.

Note: 1. Patients should be advised to gargle with water after using the Seretide® Accuhaler® 2. Number 5 to 1 appear RED to warn that there are only a few doses left.

4.3 MAINTENANCE

1. Wipe the mouthpiece of the Seretide® Accuhaler® with a dry cloth or tissue to clean it.

2. The Accuhaler® is recommended to be cleaned at least ONCE A WEEK.

3. The content of the device is susceptible to moisture. For this reason keep it in a dry place away from humidity.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

4.4 SUMMARY OF ACCUHALER®

STRENGTH DAILY DOSE PER INHALER/PACKAGING GROUP ADVERSE EFFECT REMARK INHALATION MINIMUM MAXIMUM (MCG)

SALMETEROL & FLUTICASONE 50/100* Adult and 1 inhalation 2 inhalations 1. ß2-agonist treatment side effects Combination of ® adolescents PROPIONATE (SERETIDE )/ 50/250 (50/100) * (50/100) * like tremor, palpitations, cardiac glucocorticoid (> 12 years) 60 doses arrhythmias etc. and long-acting 50/500 OR OR 2. Arthralgia beta-agonist 3. Hypersensitive reactions like (LABA) 1 inhalation 2 inhalations rash, oedema and angioedema 4. Hoarseness and candidiasis of (50/250) (50/250) *Not available the mouth in MOH Drug OR OR 5. Possible systemic steroid effects Formulary like Cushing’s syndrome and (updated 1 inhalation 2 inhalations adrenal suppression November (50/500) (50/500) 2009)

Children 1 inhalation 2 inhalations > 4 years (50/100) * (50/100) *

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

4.5 REFERENCES

1. Chrystyn H. The Diskus™: a review of its position among dry powder inhaler devices. Int J Clin Pract. 2007 Jun; 61(6): 1022–36. 2. Lavorini F, Magnan A, Dubus JC, Voshaar T, Corbetta L, Broeders M, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008; 102(4): 593–604. 3. Rau JL. Practical problems with aerosol therapy in COPD. Respir Care. 2006 Feb; 51 (2): 158–72. 4. Seretide™ Accuhaler™ [package insert]. Ware (UK): Glaxo Wellcome Operations; 2005. 5. Kesten S, Zive K, Chapman KR. Pharmacist knowledge and ability to use inhaled medication delivery systems. Chest 1993; 104(6): 1737-42.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

5. HANDIHALER®

5.1 INTRODUCTION

HandiHaler® is a device to deliver Tiotropium bromide (Spiriva®) into the lung. Tiotropium bromide (Spiriva®) comes in light green, hard gelatine capsule-containing powder form and contains 18 mcg tiotropium blended with lactose monohydrate as a carrier. Spiriva® capsules should not be swallowed and must be used with HandiHaler® device only.

Spiriva® is not a rescue medicine and should not be used for acute exacerbation.

Picture 1: Spiriva® capsules.

Picture 2: HandiHaler®. 45

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

5.2 DIRECTIONS FOR USE

STEP 1:

Open the dust cap by pressing the green piercing button.

Note: ® Some HandiHaler devices may require the dust cap to be manually opened upwards.

STEP 2:

Pull the dust cap upwards to expose the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

Open the mouthpiece by pulling it upwards.

STEP 4:

The blister cards are perforated in the middle.

Tear the card along the perforation.

Note: ® 1. Store Spiriva capsules in a dry place. 2. Keep away from extreme heat or moisture.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 5:

Carefully open the blister cavity by peeling back the aluminum foil until ONE capsule is fully visible.

DO NOT exceed the STOP line.

Note: In case a second capsule is exposed to air accidently, it has to be discarded. The capsule should be removed from the blister pack just before using it.

STEP 6:

Remove the capsule from the blister pack.

Note: DO NOT swallow the capsule.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 7:

Place the capsule in the centre of the chamber.

STEP 8:

Close the mouthpiece firmly until a “CLICK” sound is heard.

“CLICK”

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 9:

Hold the HandiHaler® device with the mouthpiece pointed upright.

Press the green piercing button 1 completely as shown in diagram before releasing it.

This will make holes in the capsules to allow the medication to be delivered 2 when inhaled.

STEP 10:

Breathe out completely.

DO NOT breathe into the mouthpiece.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 11:

Place the HandiHaler® horizontally to the mouth and close the lips tightly around the mouthpiece.

Breathe in slowly and deeply at a rate sufficient to hear the CAPSULE VIBRATE.

STEP 12:

Remove device from the mouth and hold breath for 5-10 seconds or as long as possible.

Then resume normal breathing.

STEP 13:

To ensure that all the medicine is inhaled, repeat step 10-12.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 14:

Open the mouthpiece and dispose the empty capsule into rubbish bin as in diagram.

STEP 15:

Close the mouthpiece and dust cap for storage.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

5.3 MAINTENANCE

STEP 1:

Open the dust cap, mouthpiece and chamber as in diagram.

STEP 2:

Rinse all parts with warm water to remove any powder.

DO NOT use cleaning agents or detergents.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

Dry the HandiHaler® thoroughly by shaking off the excess water and air-drying it.

STEP 4:

It takes 24 hours to air dry, so clean it immediately after use.

Note: It is recommended to clean the device EVERY MONTH.

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

5.4 SUMMARY OF HANDIHALER®

STRENGTH PER DAILY INHALER/PACKAGING GROUP ADVERSE EFFECT REMARK INHALATION DOSE (MCG)

® TIOTROPIUM BROMIDE (SPIRIVA )/ 18 Adult 18 mcg 1. Dryness of mouth or xerostomia Long acting 30 capsules 2. Upper respiratory infections anticholinergic 3. Sinusitis *Use in children 4. Rash and adolescent 5. Cataracts under 18 years 6. Angioedema old is not 7. Bitter or metallic taste recommended 8. Tachycardia 9. Urinary retention 10. Angina pectoris 11. Hypercholesterolemia 12. Hyperglycemia

HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

5.5 REFERENCES

1. Hvizdos KM, Goa KL. Tiotropium bromide. Drugs 2002;62(8):1195-1203. 2. Van Noord JA, Bantje TA, Eland ME et al. A randomized controlled comparison of tiotropium and ipratropium in the treatment. Thorax 2000;55(4):289-94. 3. Vincken W, van Noord JA, Greefhorst APM et al. Improved health outcomes in patients with COPD during 1 years treatment with tiotropium. Eur Resp J 2002;19(2):209-16. 4. CCOHTA. Tiotropium: A potential replacement for ipratropium in patients with COPD. Issues in Emerging Health Technologies 2002;35:1-4 5. Donohue JF, van Noord JA, Bateman ED et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002;122(1):47-55.

56 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

6. SPACER DEVICES

6.1 INTRODUCTION

A spacer is a device attached to a metered-dose inhaler that aids delivery of inhaled medications and to increase the effectiveness of a metered dose inhaler (MDI). A spacer is usually used for children and elderly patients who have poor coordination to MDI technique.

The advantages of spacers are:

1. Eliminate the problem of hand-breath coordination. 2. Improve the delivery of medication and allows more medicine into the lungs. 3. Reduce throat irritation and/or fungal growth in the upper airways (e.g. candidiasis, hoarseness and bad taste).

Picture 1: The advantages using MDI with Spacer devices (Adapted from http://trudellmed.com/_Content/PDFs/AC+Fv_StudySummary.pd)

57 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

There are 2 types of spacer device, namely the extension tube (i.e. BI tube) and holding chamber (i.e. Chamber with mouthpiece & Chamber with mask).

a) BI Tube

Body

Mouthpiece

Picture 2: BI Tube MDI Adaptor

b) Chamber with Mouthpiece

MDI Adaptor Aerodynamic Chamber

Mouthpiece

Cap

Whistle Inhalation/ exhalation valve

Picture 3: Chamber with Mouthpiece (Adapted from http://trudellmed.com/Consumers/cn_aerochamber_wfv.asp)

c) Chamber with Mask

58 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

Exhalation Valve Aerodynamic Chamber Mask

MDI Adaptor Aerochamber Whistle

Inhalation Valve

Picture 4: Chamber with Mask (Adapted from http://trudellmed.com/Consumers/cn_aerochamber_wfv.asp)

Picture 5: Different types of chamber (Adapted from http://trudellmed.com/Consumers/cn_aerochamber_wfv.asp)

6.2 DIRECTIONS FOR USE

6.2.1 BI TUBE

59 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 1:

Remove the mouthpiece cover from the metered dose inhaler (MDI).

STEP 2:

Attach the large end of the BI tube to the mouthpiece of the MDI.

STEP 3:

Shake the MDI 5 times in an up-down motion (as shown in diagram) before use.

60 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 4:3:

ExhaleShake the slowlyMDI 5 times and in an completely up-down throughmotion (as your shown mouth in diagram) before holdingbefore youruse. breath.

DO NOT exhale into the BI tube.

STEP 5:

2 Press the base of the canister (1) and inhale the nebulised aerosol (2).

STEP 6:

Hold breath for 5-10 seconds.

Note: To prevent the spray from depositing on the tube, inhale immediately after pressing the canister.

61 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 7:

Wait 30 seconds to 1 minute before repeating step 3-6 if subsequent doses

are required.

STEP 8:

After use, remove the BI Tube and replace the mouthpiece cover on the MDI.

Note: The BI Tube may be left attached to the MDI.

62 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

6.2.2 CHAMBER WITH MASK

STEP 1:

Visually check for foreign objects before each use.

STEP 2:

Remove the mouthpiece cover from the MDI.

63 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

Insert the MDI into the adaptor of the chamber.

STEP 4:

While holding the chamber with MDI firmly, shake the MDI for 5 times in an up-down motion (as in diagram).

STEP 5:

Apply mask to face and ensure that there is a good seal.

64 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 6:

Press MDI ONCE at beginning of normal breath.

Breathe normally between 5-10 breaths while holding the mask firmly to your face.

STEP 7:

Slow down inhalation if the WHISTLE sound is heard.

STEP 8:

Wait 30 seconds to 1 minute before repeating step 4-6 if subsequent doses are required.

65 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

6.2.3 CHAMBER WITH MOUTHPIECE

STEP 1:

Visually check for foreign objects before each use.

STEP 2:

Remove the cap from the MDI and the mouthpiece cover of the chamber.

66 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3: 2 Insert the MDI into the adaptor of the mouthpiece (1). 1

While holding the mouthpiece with MDI firmly, shake the unit for 5 times in an up-down motion as shown in

diagram (2).

STEP 4:

Put the mouthpiece in the mouth.

67 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 5:

1 Simultaneously press the MDI ONCE (1) at the beginning of a slow and deep inhalation (2).

2 Hold breath as long as possible, between to 4-10 seconds before

breathing out through the nose.

Note: 1. Alternatively, the mouthpiece may be kept tightly in the mouth.

2. Inhale slowly through the mouth and exhale through the nose for 5 times after pressing the MDI.

STEP 6:

Slow down inhalation if a WHISTLE sound is heard.

STEP 7:

Wait 30 seconds to 1 minute before repeating step 3-6 if subsequent doses

are required.

68 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

6.3 MAINTENANCE

6.3.1 BI TUBE

• Wash the BI tube at least ONCE A MONTH with tap water and air dry. • It is not recommended to wipe the BI tube dry after washing.

6.3.2 CHAMBER WITH MASK OR MOUTHPIECE

• It is recommended to clean ONCE A WEEK.

• Remove the backpiece only.

• DO NOT remove the mask or valve assembly.

• Soak both parts for 15 minutes in a mild solution of liquid dish detergent and warm clean water.

• Agitate gently.

69 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

• DO NOT rinse the chamber as shown, as this may lead to static build up.

• If concern about potential for contact dermatitis, rinse only the mouthpiece/mask portion in water.

• Shake out excess water and allow to air dry in a vertical position.

• DO NOT rub dry.

• To reassemble, centre the alignment feature on the back piece as shown.

Note: Cleaning of the product varies between the different variants of the AeroChamber®. Please refer to each individual product information leaflet.

70 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

6.4 REFERENCES

1. Boehringer Ingelheim. Product Leaflet: Instructions of Use for Metered Aerosol Inhaling Device. 2. Corner WT, Dolovich P and Newhouse MT. Reliable salbutamol adminitration in 6- to 36-month-old children by means of a metered dose inhaler and aerochamber with mask; Pediatric Pulmonary 1989; 6:263- 267. 3. Dolovich P, Ruffin R and Newhouse MT. Clinical evaluation of a simple demand inhalation MDI aerosol delivery device. Chest 1983; 84:1. 4. Pedersen S. Spacer Devices. [updated 2003 May 21; cited 2009 May 15] Available from: http://www.ginasthma.com/download.asp?intld=107. 5. Spier S and Robert LT. Inhalation therapy for the asthmatic child. The Canadian 6. Journal of Pediatrics 1991. 7. Trudell Medical International. c1997-2009 [cited 2009 May]. AeroChamber Plus* VHC with Flow-Vu* Inspiratory Flow Indicator. Available from:http://trudemed.com/Consumers/cn_aerochamber_wfv.asp. 8. Trudell Medical International; c 1997-2009 [cited 2009 May]. Study summary: Use of the AeroChamber Plus* Valved Holding Chamber with Flow-Vu* Inspiratory Flow Indicator. Available from: http://trudemed.com/_Content/PDFs?AC+Fv_StudySummary.pd

71 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

7. PEAK FLOW METER

7.1 INTRODUCTION

Holder Scales

Marker Mouthpiece

A peak flow meter is a small portable device with a measuring gauge. It measures the force and speed that air is blown out of the lungs. This measurement is referred to as the peak expiratory flow rate (PEFR).

a) “NORMAL” PEAK FLOW RATE

Normal peak flow rate is based on a person's age, height, sex and race. A personal best normal may be obtained from measuring the patient's own peak flow rate. Therefore, it is important that patients discuss with their health care provider on what is considered as “normal”.

Once patients have learned their usual and expected peak flow rate, changes or trends of their disease condition can easily be recognised.

72 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

b) MEASURING REVERSIBILITY OF AIRFLOW OBSTRUCTION

To measure the degree of reversibility (usually increased in asthma) of airflow obstruction, perform peak flow meter measurement before and approximately 15 minutes after administering a bronchodilator by metered dose inhaler or nebuliser. Short acting Beta-2 agonists (e.g. salbutamol, terbutaline) are generally considered the benchmark bronchodilator.

c) DETERMINE A “NORMAL” PEAK FLOW RATE

Three zones of measurement are commonly used to interpret peak flow rates. In general, a normal peak flow rate can vary as much as 20 percent.

Green Zone (80-100% of patients’ usual or "normal" peak flow rate): This zone signals that patients’ asthma is under reasonably good control. It is advisable to continue the prescribed program or management.

Yellow Zone (50-80% of patients’ usual or "normal" peak flow rate): This zone signals that more attention should be given to patients’ asthma program or management. Patients are advised to consult their healthcare provider to review their regimen.

Red Zone (<50% of patients’ usual or "normal" peak flow rate): This zone signals a medical alert. Immediate decisions and actions must be taken. Patients are advised to use their rescue medications right away and consult their healthcare provider immediately.

e.g: Your You are You are You are Personal Best in the in the in the peak flow Green Zone Yellow Zone Red Zone meter if your peak flow if your peak flow if your peak flow reading is: meter reading is: meter reading is meter reading is: between:

100 above 80 80 and 50 below 50

125 above 100 100 and 63 below 63

150 above 120 120 and 75 below 75

175 above 140 140 and 88 below 88

73 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

7.2 DIRECTIONS FOR USE

STEP 1:

Place the mouthpiece on the peak flow meter.

Note: Alternatively, the originally supplied plastic mouthpiece may be detached and replaced with a disposable mouthpiece.

STEP 2:

Reset the marker to the bottom of the scale (zero or the lowest number on the scale).

74 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 3:

Hold the peak flow meter in the way

that the scale and marker is not obstructed by the fingers of the patient (As shown in diagram).

STEP 4:

Stand in an upright position and breathe in as deep as possible.

75 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

STEP 5:

Place the peak flow meter in the mouth and maintain it horizontally, closing the lips around the mouthpiece.

Make sure the opening of the mouthpiece is not blocked by the tongue.

STEP 6:

Blow as hard and fast as possible.

DO NOT tilt the head forward while blowing.

76 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

Record this reading e.g.: 500L/min

STEP 7:

Record the measurement and reset the marker to its original position at the bottom of the scale.

STEP 8:

Breathe normally and repeat step 2-7 two more times.

Note down the date, time, and highest of the 3 peak flow measurements.

DO NOT average the numbers.

Note: The highest of the 3 readings will be used to assess a patient’s PEFR.

7.3 MAINTENANCE

Most peak flow meters need to be cleaned. Follow the cleaning instructions which are available when the unit is purchased.

77 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

7.4 REFERENCES

1. Radeos MS, Camargo CA. Predicted peak expiratory flow: differences across formulae in the literature. Am J Emerg Med. 2004 Nov; 22(7):516-21. 2. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87 3. Bheekie A, Syce JA, Weinberg EG. Peak expiratory flow rate and symptom self- monitoring of asthma initiated from community pharmacies. J Clin Pharm Ther. 2001 Aug; 26(4):287-96. 4. Reddel HK, Marks GB, Jenkins CR. When can personal best peak flow be determined for asthma action plans?. Thorax. 2004 Nov; 59(11):922-4 5. Murata GH, Kapsner CO, Lium DJ, Busby HK. Patient compliance with peak flow monitoring in chronic obstructive pulmonary disease. Am J Med Sci. 1998 May; 315(5):296-301. 6. http://en.wikipedia.org/wiki/Chronic_obstructive_pulmonary_disease. 2009

78 HANDLING OF INHALER DEVICES: A PRACTICAL GUIDE FOR PHARMACISTS

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