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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Prepared for Department for International Development (DFID) 27th June 2015 A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya

Private Sector Innovation Programme for Health (PSP4H) Insert job reference

Prepared for Department for International Development (DFID)

27th June 2015

A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

Insert job reference

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno ii

Contact Information

Cardno Emerging Markets (UK) Ltd

Oxford House, Oxford Road

Thame

Oxon

UK

OX9 2AH

Telephone: +44 1844 216500

http://www.cardno.com/

Document Information

Prepared for Department for

International Development

(DFID)

Project Name Private Sector Innovation

Programme for Health

(PSP4H)

Date 27th June 2015

http://www.psp4h.com

Implemented by a Cardno Emerging Markets consortium:

With partners:

Funded by the UK Government:

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno iii

Acronyms

DFID - Department for International Development

KEMSA - Kenya Medical Supplies Authority

MEDS - Mission for Essential Drug Services

PSP4H - Private Sector Innovation Programme for Health

GSK - GlaxoSmithKline

PPB - Pharmacy and Poisons Board of Kenya

RSA - Research Solutions Africa

Tabs - Tablets

GIZ - German Technical Cooperation

NCDs - Non-Communicable Diseases

COPD - Chronic Obstructive Pulmonary Disease

LMICs - Low and Middle-Income Countries

M4P - Making Markets Work for the Poor

WHO - World Health Organization

IDI - In-depth Interview

FGD - Focus Group Discussion

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno iv

Definitions

> “Drug seller”: For purposes of this survey a drug seller was defined as any person who dispenses, sells

or prescribes drugs or any other instrument necessary for the administration of drugs in a licensed

chemist/pharmacy or any health facility. Drug sellers interviewed met the following criteria:

Solely or mostly responsible for making decisions relating to purchase of drugs in the facility or

outlet and;

Facilities/drug outlets that stocked or sold medicines for asthma treatment.

> “Health provider”: For purposes of this survey was defined as a person who provides healthcare services

to consumers. Healthcare providers interviewed met the following criteria;

Person(s) who diagnosed and prescribed drugs in a facility;

Person(s) who diagnosed and prescribed medicines for asthma treatment.

> For purposes of this survey formal outlets were defined as outlets registered and regulated by authorities

such as the Pharmacy and Poisons Board (PPB) and health facilities that are registered with the relevant

Ministries.

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno v

Recommended Citation

Private Sector Innovation Programme for Health (PSP4H). 2015. A Study to Examine Uptake and

Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya. Nairobi:

PSP4H.

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno vi

Foreword

The Private Sector Innovation Programme for Health (PSP4H) is a three-year DFID funded action research

program implemented by Cardno Emerging Markets and Consortium partners. The overall objective of the

PSP4H program is to learn and document lessons on how a market systems approach might benefit pro-

poor health interventions. PSP4H partnered with GlaxoSmithKline (GSK) to undertake market research with

a view toward increasing access to an affordable and effective asthma relief medicine (Ventolin Rotacap®)

developed by GSK for the low income population or mass market in Kenya.

Asthma is one of the most rapidly-growing non-communicable diseases in Kenya, with causes primarily

pointing to urbanization. Asthma currently affects four million Kenyans who have become pre-disposed due

to risk factors such as air pollution, tobacco smoking, occupational exposures and allergen exposures. Both

prevention and treatment with good quality asthma medicines are critical to reducing the disease burden.

This study was conducted in three counties in Kenya where asthma prevalence has previously been

documented as high: Nairobi, Nyeri, and Uasin Gishu counties.

The summary findings clearly depict low uptake of Rotacap/Rotahaler in the mass market category where

conversion of tablet asthma patients to an inhaled form of medication is a key factor. The study found that

there is low awareness of the new product in the market and the cost/pricing model needs to be

reconsidered in addition to packaging of the product. Overall the market research presents robust baseline

data for GSK to redefine their marketing and distribution strategy for Rotacap to penetrate the mass market

and reach their target group. PSP4H will collaborate with GSK to implement this strategy.

Ron Ashkin Team Leader PSP4H Nairobi June 2015

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno vii

Acknowledgement

PSP4H would like to acknowledge Research Solutions Africa, the market research company who undertook

the study with lead consultants Teresa Ouma, Jasper Gosselt and Collins Athe. PSP4H would like to express

its gratefulness to all consumers, health providers and retail pharmacy stakeholders who were interviewed in

Nairobi, Nyeri and Uasin Gishu counties for their time and sharing their views. Every effort has been made to

accurately represent views and opinions expressed.

Special thanks to the PSP4H team – Ron Ashkin, Chris Masila, Rachel Gikanga, Pamela Godia, Mildred

Kottonya, Dorothy Mbuvi, Veronica Musembi, Ambrose Nyangao, Dolapo Olusanmokun, Daniel Shikanda,

Salome Wawire and Patricia Guchu; the GlaxoSmithKline (Kenya) team: John Musunga, Dr. Peter Kamunyo,

Thrity Engineer, Jacob Oloo, Naomi Mutinda and Shem Otin. Special thanks go to all the study participants

whose insights form the basis of this report.

Finally, we thank DFID for their support to conduct this study enabling the PSP4H Programme to provide

recommendations on improving access to quality and affordable asthma medicines for the low income

population in Kenya.

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno viii

Executive Summary

The main objective of the market assessment was to understand the low uptake of the GlaxoSmithKline

(GSK) asthma reliever Ventolin Rotacap®/Rotahaler® by Kenya’s working poor, and poor performance of

the asthma reliever in relation to similar medicines in the market. Primary market research was conducted to

understand the gaps and areas to be strengthened regarding product uptake and performance of the GSK

asthma reliever in relation to similar products in the market. The outcome of the market assessment is to

provide recommendations of possible directions for GSK in terms of marketing and distribution of the asthma

relief product and other possible areas of intervention that PSP4H can undertake with regards to asthma

management for the working poor.

Both quantitative and qualitative approaches were utilised in data collection. The assessments were carried

out with a wide range of participants. These included providers (prescribers of asthma medicines), drug

sellers (dispensers of asthma medicines such as pharmacists), consumers, commercial chain actors

including wholesalers and distributors in three different counties selected by PSP4H. Face to face interviews

were conducted using quantitative questionnaires, focus group and key informant guides.

Below is a summary of the key findings of the assessment:

> The study confirms a rather low market penetration of Rotacap/Rotahaler among drug sellers and

health providers as compared to the most stocked and requested medicines in the market. Most

drug sellers report that Rotacap/Rotahaler is a slow moving product.

> The study shows that on average every tenth visitor at an outlet or health provider is an asthma

patient. This number is fairly steady, indicating that prevalence of treatment-seeking asthma patients

is consistent across the three counties. In Nairobi drug suppliers reported an average of (11.8) while

health providers reported an average (9.4). In Nyeri drug suppliers (11.1), health providers (10.9)

and in Uasin Gishu drug suppliers (11.8), health providers (9.4). The figure seems to be consistent

with the national average of 10% of the Kenyan population.

> Reasons for low uptake:

Low demand for the Rotahaler/Rotacap was the most obvious reason as indicated by drug

sellers. Some reported that it is rarely prescribed.

Another important reason is that Rotacap/Rotahaler is relatively new in the market and

according to respondents not very well known. Some stated that its marketing has been

poor hence there is a lack of knowledge of the product in the market.

An indirect observation is that inhalers are not used as much as tablets and syrups among

the working poor. Only the cheapest inhaler in the market (the Ventolin Evohaler) has

reached high market penetration rates. Hence, lack of familiarity with inhalers might be

another reason contributing to the low uptake.

Inhalers are generally perceived as costly: This might also reflect on the Rotahaler, while

in reality the Rotahaler’s proposition is different from other inhalers.

Competitiveness of the GSK Rotacap/Rotahaler: The proposition of the

Rotocap/Rotahaler is different from other inhalers in the market. Rotahalers are given out for

free and patient is charged for the Rotacaps only, whereas other inhalers are generally priced

per inhaler.

Price: In comparison to the price of an inhaler (sales price start at KSh 250), the price of a

single Rotacap capsule (KSh 7) which seems more affordable compared with other inhalers.

In comparison to the price of most tablets (sales price between KSh 2 and KSh 5), the price

of a Rotacap is comparatively expensive (KSh 7).

The sale price of a bottle of syrup starts at KSh 50.

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27th June 2015 Cardno ix

Though inhalers in general are not considered to be cheap, price is hardly mentioned

specifically as a reason why outlets or providers do not stock the Rotacap/Rotahaler. Price

seems not to be a barrier for outlets and providers but is a barrier for consumers.

Besides the price, the competiveness of a product depends on other factors such as its

relative performance, availability, promotion, communication and design.

Availability: The Rotacap/Rotahaler is not (yet) widely available in the market. On availability

Rotacap/Rotahaler is less competitive as the Ventolin Evohaler or tablets and syrups that are

stocked by most providers/outlets. Most outlets and all health providers that stock

Rotacap/Rotahaler are in Nairobi and Nyeri. Only few outlets from Uasin Gishu have the

medicine in stock.

Performance: The survey did not look at the specific performance or efficacy as compared to

other medicines. However inhalers are perceived to be fast relievers and effective treatments.

Promotion/communication: Unfamiliarity with the product, both among providers/outlets as

well as consumers, is a commonly reported concern. The Rotacap/Rotahaler is not stocked

and not requested because of low awareness levels among consumers as well as providers

and drug sellers.

Design/user friendliness: The design is not being reported as an impediment to usage of

Rotacap/Rotahaler. However, some outlets/providers have concerns regarding the usability of

inhalers in general. Not all asthma patients are familiar with how to use an inhaler. Others

reported that inhalers are preferred because they are easy to use.

The main conclusions and recommendations of the study are outlined in section 7 of this report.

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno 10

Table of Contents

Acronyms iii

Definitions iv

Recommended Citation v

Foreword vi

Acknowledgement vii

Executive Summary viii

1 Background 12

1.1 About GSK 13

1.2 Problem definition 13

1.3 Objectives of the assessment 14

2 Methodology 15

2.1 Research design 15

2.2 Training of enumerators 15

2.3 Data collection methods and tools used 16

2.4 Sample size 17

2.5 Challenges faced during data collection process 17

3 Frequency of Asthma Patients 18

3.1 Patient flow and incidence of asthma patients 18

3.2 Frequency of seeing asthma patients 18

3.3 Frequency of asthma attacks 19

3.4 Stocking drugs: frequency, sources and expenditure 20

3.5 Market penetration of asthma medicines 25

4 Usage and Attitudes 29

4.1 Frequency of using asthma medicines 29

4.2 Asthma medicine decision making influencers 29

4.3 Choice factors which affect the choice of asthma medicines 30

4.4 Fast and slow moving medicines among drug sellers 30

4.5 Fast and slow moving medicines among providers 32

4.6 Price comparison asthma medicines 32

5 Diagnosis, Prescriptions and Recommendations 34

5.1 Diagnosis 34

5.2 Prescription 34

5.3 Recommended asthma drugs 35

5.4 Education material on asthma 36

5.5 Sources of information on asthma 37

5.6 Interactions with clients 37

5.7 Inhalers: perception and feedback 38

5.8 Complaints 38

6 Rotacap: Potential and Perspectives 40

6.1 Advantages of switching from oral to inhaled medication 40

6.2 Introduction of new medication: health providers & drug suppliers 40

6.3 Introduction of new Rotacap/Rotahaler: Users views 40

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27th June 2015 Cardno 11

6.4 Awareness and stocking of Rotahaler and Rotacap 42

6.5 Challenges associated with addressing asthma attacks 43

6.6 Low uptake of the Rotacap/Rotahaler 43

6.7 Asthma across counties 44

6.8 Competitiveness of the GSK Rotacap/Rotahaler 44

6.9 Adverse Drug Events (ADR) 45

7 Conclusions 46

8 References 49

9 Appendix 1 - Description of Rotacap 50

9.1 Dosage and administration: 50

9.2 Interactions 51

9.3 Adverse Reactions: 52

Tables

Table 2-1 Number of interviews achieved during the survey ...................................................................... 17 Table 3-1 Patient flow .................................................................................................................................. 18 Table 3-2 Top 10 sources of drugs in general ............................................................................................ 21 Table 3-3 List of sources per county ........................................................................................................... 22 Table 3-4 Sources of asthma drugs by facility type .................................................................................... 23 Table 3-5 Asthma medicines prescribed and requested ............................................................................. 26 Table 5-1 Common patient queries while purchasing asthma drugs .......................................................... 38 Table 6-1 Asthma prevalence across counties ........................................................................................... 44

Figures

Figure 3-1 Percentage of asthma patients seen per week ........................................................................... 18 Figure 3-2 Frequency of seeing asthma patients ......................................................................................... 18 Figure 3-3 Frequency of stocking asthma drugs .......................................................................................... 20 Figure 3-4 Frequency of stocking medicines by drug suppliers ................................................................... 20 Figure 3-5 Sources of drugs in general ........................................................................................................ 21 Figure 3-6 Percentage of sources of asthma drugs ..................................................................................... 23 Figure 3-7 Expenditure on asthma drugs by drug suppliers and health providers ....................................... 24 Figure 3-8 Expenditure on asthma drugs by patient volume and drug sellers ............................................. 24 Figure 3-9 List of asthma medicines stocked and purchased by outlets ...................................................... 25 Figure 3-10 List of asthma medicines usually prescribed and mostly requested by patients ................... 26 Figure 3-11 Usually stocked medicines: drug sellers ................................................................................ 27 Figure 3-12 Usually stocked medicines: health providers ......................................................................... 28 Figure 4-1 Frequency of sourcing medicines by drug sellers ....................................................................... 31 Figure 4-2 Fast and slow asthma medicines ................................................................................................ 32 Figure 4-3 Market prices: Inhalers ................................................................................................................ 32 Figure 4-4 Market prices: tablets .................................................................................................................. 33 Figure 4-5 Market prices: Syrups ................................................................................................................. 33 Figure 5-1 Percentage of respondents providing drugs free of prescription ................................................ 35 Figure 5-2 Recommended asthma drugs by health providers ..................................................................... 35 Figure 5-3 Recommended asthma drugs by drug sellers ............................................................................ 36 Figure 5-4 Discount and credit facilities ........................................................................................................ 37 Figure 5-5 Perception about inhalers ........................................................................................................... 38 Figure 5-6 Complaints about inhalers ........................................................................................................... 39 Figure 6-1 Awareness of Rotacap/Rotahaler ............................................................................................... 42 Figure 6-2 Current stocking of Rotacap/Rotahaler ....................................................................................... 42

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno 12

1 Background

The Private Sector Innovation Programme for Health (PSP4H) is a three year DFID-funded action research

program implemented by Cardno Emerging Markets and consortium partners. The programme is using a

Making Markets Work for the Poor (M4P) approach to strengthen for-profit health sector’s capacity to reach

the poor, and ensure that poor people get better value for the money they spend on health in the private

sector. The programme commenced with a rigorous analysis of the Kenyan health market system including

interviews with key actors in the health sector and target beneficiaries to guide the selection and

implementation of market based interventions focused on the poor.

Access to affordable, safe, efficacious and quality assured essential medicines by the poor in Kenya is a

major challenge. The poor, particularly in rural areas, rely on informal providers, predominately drug sellers.

These drug sellers are often the provider of first choice, and in some settings are the only choices of

healthcare providers. Convenience, affordability, social and cultural norms are the three primary reasons why

consumers, particularly poor consumers, use informal providers such as drug sellers. However, the quality

varies among these drug sellers. Compared to providers in the formal sector, they mostly do not adhere to

treatment protocols, have very limited training, frequently lack capacity to provide basic curative services and

are less likely to have adequate supplies of drugs. Non-communicable diseases (NCDs), which mainly

consist of cancers, heart conditions, hypertension, respiratory diseases like asthma, chronic obstructive

pulmonary disease (COPD) have become an important health burden in developing countries and a growing

disease burden. Eighty (80%) percent of all NCDs occur in low and middle-income countries (LMIC’s),

causing 8 million premature deaths annually from the major NCD risk factors. However, less than 3% of the

global development assistance for health goes to prevention and control of NCDs (GIZ and Endeva 2012).

A recent report published by German Technical Cooperation (GIZ and Endeva, 2012) and other global

pharmaceutical manufacturers titled “Bringing Medicines to Low Income Markets” states that low-income

countries like Kenya today face a double burden of disease. On the one hand, communicable diseases such

as HIV/ AIDS and malaria are still a major challenge, and are a focus of public health initiatives. On the other

hand, these countries also face a considerable burden due to non-communicable diseases (NCDs) such as

diabetes or cancer, especially in urban areas. In 2008, NCDs accounted for more deaths than communicable

diseases in this group of countries. Consequently, the top seven causes of death in low-income countries,

which together account for nearly half (48%) of all deaths, include both communicable and non-

communicable diseases. The importance of NCDs is expected to rise further in both low and lower-middle

income countries during the next years. As populations are lifted out of poverty, behavioral and disease

patterns change accordingly. Increasing income levels, rapid urbanization and aging population contribute to

the common risk factors of NCDs, such as physical inactivity or increased alcohol and tobacco consumption.

According to WHO estimates, the number of deaths in low-income countries caused by communicable

diseases will approximately halve between 2004 and 2030, while deaths attributed to NCDs will nearly

double in the same period of time.

Asthma: Asthma is a growing burden as Kenya becomes more urbanized and the population becomes more

pre-disposed to asthma risk factors like air pollution, tobacco smoking, occupational exposures, allergen

exposure and others. Asthma as defined by the Global Initiative for Asthma (GINA) is a heterogeneous

disease usually characterized by airway inflammation, defined by a history of respiratory symptoms such as

wheeze, shortness of breath, chest tightness, cough that vary over time and intensity together with variable

expiratory airflow limitation.

PSP4H is working with GlaxoSmithKline (GSK) in reviewing their marketing and distribution strategy for an

asthma reliever medicine specifically developed for the low-income population. There has been low market

uptake of the GSK asthma reliever product and poor performance amongst consumers, health providers and

supply chain actors. As a result, developing and implementing a different roll-out strategy involving

marketing, product mix/design and pricing to suit various audiences is imperative. There was also the need

to understand the asthma medicines requirements and behavioral economics for the working poor.

1. Study Sites: The survey covered three counties: Nairobi, Nyeri and Uasin Gishu. These study sites were identified given the high asthma prevalence1. This is based on studies done earlier in 1995 and

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27th June 2015 Cardno 13

2000 and found a lot of wheezing incidence. (Ait-Khaled, the International Study of Asthma and Allergies in Childhood Phase:247-58).

1.1 About GSK

GlaxoSmithKline (GSK) is a British multinational/global pharmaceutical company that innovatively

researches and develops a wide range of pharmaceutical products, vaccines and other consumer healthcare

products. Operating in over 120 countries globally, GSK has operations in Kenya and is one of the large

pharmaceutical companies within East Africa promoting access to good quality medicines. GSK topped the

global Access to Medicine Index in 2014 for the fourth time.

GSK mission is to help people do more, feel better and live longer. Its Vision 2020 is to increase access by

ensuring affordability. GSK’s three strategic priorities aim at increasing growth, reducing risk and improving

the long-term financial performance. Priorities will focus on business growth and diversification, delivery of

more products of value and simplify operating model.

The company model for Africa including Kenya is to encourage access to medicines especially for neglected

diseases like lymphatic filiariasis and invest in community projects mainly on basic school hygiene with a

sustainable model at the core.

GSK has embarked on strategies focusing on;

1. Introducing new products into the market.

2. Reducing prices to make them affordable to more populations.

3. Exploring investing in manufacturing in Africa with Nairobi being one of the identified regions for

manufacturing plants.

4. Exploring market access opportunities.

5. GSK's reputation for producing the highest quality medicines puts it in a leading position across

the developing world. And its profits currently show it is doing well selling drugs to counter

diseases ranging from heart disease to asthma.

The creation of a new developing markets and market access unit, signifies GSK commitment in emerging

countries health issues. The unit mainly targeted vaccines but is expanding its mandate to chronic diseases

or non-communicable diseases profile for the developing countries. Africa represents only less than 1% of

the global pharmaceutical market requirements. However in the recent future, emerging growth markets like

Kenya are leading some of the initial steps in developing the pharmaceutical manufacturing and retailing

business model within the East African region.

One of the biggest strengths with GSK is working with academia, global alliances and public private

partnerships in addressing the neglected and chronic disease conditions.

The potential benefits of GSK working with a development partner like DFID through PSP4H technical

assistance support is significant in reaching the low income population with high quality, high standard

medicine but affordable in order to reduce the asthma burden for this population and translating this to

becoming more competitive and more social business oriented or having a positive development impact.

1.2 Problem definition

In Kenya, asthma is more prevalent in cold regions and also where there is pollution or activities which pose

a number of risk factors in exacerbating asthma - like pollen, dust etc. The risk factors for asthma

development are well documented and divided into non-modifiable and modifiable factors, and they are

influenced by the interaction of multiple factors. Early on in life, asthma is more commonly seen in boys than

girls, but these changes over time, as asthma appears to become more common in adult females than

males. Non-modifiable factors include gender; genetic related and modifiable factors including allergen

exposure, infections and infestations, breastfeeding, air pollution, HIV infection, occupational exposures and

tobacco smoking.

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Generally, asthma management and control is basically addressed using reliever and controller medicines,

which are divided into various categories. The single most challenging factor in addressing asthma is in the

area of diagnosis, as the disease is predominantly found in children and there is no definitive diagnostic test.

Also, due to cultural and linguistic differences, it is often difficult to adopt a universally accepted definition of

asthma and to compare the findings accurately between regions. (DA Enarson, N. Ait Khaled, 2008)

This study specially targets the lower income population, which is a large part of the Kenyan society. The

working poor have relatively limited access to medication, especially of adequate quality. This also applies to

those who suffer from Asthma. In order to better understand the needs and barriers to medication, this

market intervention sought to improve the availability and usability of a reliever product to the working poor in

Kenya. This was a targeted market study for GSK funded by PSP4H (DFID funded) therefore not a national

survey. It is intended to solve a business problem. However, if at the end of the intervention the study

informs Ministry of Health (MOH) and Standard Treatment Guidelines (STG) for Asthma would be practical

result. We anticipate that the outcome will contribute in informing the National Guidelines and other partner’s

market penetration or increase access to essential asthma medicines for the working poor thereby

contributing to improving efficiency and propose distribution business models for supply chain actors both in

public and private sector.

The GSK asthma reliever medicine (a bronchodilator) under study is Ventolin® Rotacap® Salbutamol 200mcg

inhalation powder in a hard capsule used with a Rotahaler® (inhalation device). The Rotacap is only used for

inhalation use only (Appendix 1 shows the drug formulation details).

1.3 Objectives of the assessment

The main objective of the assessment was to understand the low uptake of the GSK Asthma reliever by the

working poor and poor performance of the asthma reliever in relation to similar medicines in the market.

The specific objectives of the assessment were:

1. To understand the consumers, health providers and commercial supply chain actors’ attitudes

and behaviors in relation to this GSK manufactured asthma medicine.

2. To examine why the current product has experienced low market uptake and poor performance.

3. To understand the competitiveness within the asthma medicines segment in comparison to the

GSK asthma reliever product.

4. To gauge the extent (perceived or real) of the asthma problem among the working poor in the

pilot counties.

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2 Methodology

This chapter discusses the methodology applied during the survey.

Overall research design

Strategy Survey

Methodology Quantitative Qualitative

Instrument Questionnaire Discussion Guide

Data collection method Face to face interviews

(F2F)

Focus Group Discussions

(FGDs)

In-depth interviews (IDIs)

Location Nairobi, Uasin Gishu, Nyeri Nairobi, Uasin Gishu, Nyeri Nairobi, Uasin Gishu, Nyeri

Sample Target 425 6 FGDs 30 IDIs

Achieved 447 (339 + 108) 6 FGDs 30 IDIs

Target respondents Health Providers

Drug Suppliers

(Pharmacies/Chemists

etc.)

Consumers

(Asthma Patients)

Consumers (Asthma

Patients)

Health Providers

Commercial chain

actors

2.1 Research design

The study design employed a cross sectional approach in the study design, using both qualitative and

quantitative methodologies.

Qualitative methodology: This involved In-depth Interviews and Focus Group Discussions (FGD), using

face-to-face interviews with approved In-depth Interview (IDI) and FGD guides respectively. All the

discussions were audio recorded.

Quantitative methodology: The quantitative survey design involved face to face interviews using pen and

paper with closed-ended questionnaires. Data was collected from dispensing outlets and from healthcare

providers in the three counties of the survey. The outlets included Public health facilities where we targeted

health providers and drug suppliers in all levels of facilities including faith-based & NGO (managed) health

facilities; health centres and dispensaries, private health facilities; health providers and drug suppliers in

hospitals and clinics and private pharmacies and chemists.

The survey covered three counties: Nairobi, Nyeri and Uasin Gishu. The study sites were identified given the high Asthma prevalence rates. This is based on studies done earlier in 1995 and 2000 and found numerous wheezing incidences in the identified areas. (Ait-Khaled N, Odhiambo J, 2007 Mar;62(3):247-58)

2.2 Training of enumerators

Research team training was undertaken on 24th and 25th February 2015 at Research Solutions Africa (RSA)

offices. The training entailed taking the team through a session to understand asthma, the background of the

study, Rotacap/Rotahaler device, as well as how to administer the two types of questionnaires to be

employed in the study. The training also incorporated mock interviews for the two types of questionnaires

which included one for drug-sellers questionnaire (dispensers) and another for health providers (prescribers)

questionnaire. While, the qualitative team did mock FGDs and IDIs to ensure that the team got familiar with

the flow of questions in each tool. Sensitization on pharmaco-vigilance and reporting of adverse drug events

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for the data collection team in relation to Rotacap/Rotahaler was conducted by the GSK Kenya team and

reporting instructions provided.

Actual fieldwork was conducted from May 5th to 28th May 2015. The quantitative survey was conducted from

May 5th to May 17th, 2015 while the quantitative exercise ended on 28th May 2015.

Pre-testing the survey tools: In order to ensure the developed tools collected the required data to meet the

objectives of the survey, a pre-test of the same was conducted in an area that did not form the sample. The

pre-test was conducted on the 26th February 2015 for two primary reasons:

To establish the logical flow of the survey tools, the understanding of the questions and;

To make any changes in the approach to be implemented during the actual data collection phase.

After the pre-test, changes were incorporated and final client approved tools were used for data collection.

Ethical approval for the study was provided by the Africa Medical Research Foundation (AMREF) review

board.

2.3 Data collection methods and tools used

The data collection exercise used both quantitative and qualitative approaches:

Quantitative - The quantitative study instruments were closed ended questionnaires administered to Health

providers (prescribers) and drug suppliers (dispensers).

Qualitative - the qualitative instruments were IDI and FGD discussion guide administered to commercial

chain actors, providers (prescribers) and consumers. The recordings obtained during the interviews were

later transcribed and thematic gridding was used to extract important contents of the discussions.

The sections covered in the survey tools were:

Providers/Drug sellers

Identification section where information about the respondent interviewed was collected for instance

organization/facility, name and position of the respondent and county.

General information section where information about frequency and diagnosis was collected.

Sources section where the respondents identified the essential asthma medicines that they

prescribe, different prescriptions for adults and children and mode of prescriptions (verbal/written).

The respondents were also asked about the stock of asthma medication in their facilities, sources of

the medications, frequency of sales, expenditure on asthma drugs and dispensing of the drugs with

respect to prescription.

Inhalers section where the respondents indicated their perception of inhalers, complaints received on

inhalers and how they are handled and also their opinions of oral medication versus Inhalers.

Rotacap section where the respondents were asked about their awareness of Rotacaps and

Rotahalers, pack sizes of asthma relievers suitable for patients and attributes patients look for in a

reliever.

Consumers

General information section where information about the respondents was collected for instance

name and occupation of respondent. Also discussed were the respondents’ understanding of asthma

(definition of asthma) and causes of asthma.

Experiences with Asthma section where the respondents identified causes, triggers of asthma

attacks including frequency of attacks and ways of addressing the attacks.

Asthma treatment/medication section where the respondents were asked to indicated places of

seeking treatments, treatments and prescriptions given, sources of medication, effectiveness of

medication, frequency of purchase and amounts used.

Inhalers usage section which addressed use of inhalers by respondents, preference with regards to

oral tablets/capsules and inhalers and their interest in using fast reliever inhaler.

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Asthma reliever products where the respondents indicated the reliever products known and used,

sources, price and their manufacturers. The respondents were also asked about challenges

associated with addressing asthma attacks and how they should be handled and by whom.

2.4 Sample size

A total of 447 face to face interviews were conducted of which 339 interviews were held with healthcare

providers (prescribers) while 108 interviews were conducted with drug sellers (dispensers). A total of 30 Key

Informant Interviews were conducted with 10 health providers, 15 consumers and 5 commercial chain actors

including wholesalers. The focus groups were 6 in total, 2 of which were conducted with consumers (asthma

sufferers) in each county required by the survey.

Table 2-1 Number of interviews achieved during the survey

County

Survey category

Face to face interviews In-depth Interviews Consumers

Achieved number of interviews Achieved number of interviews Achieved

number of

FGDS

Health Providers

(Prescribers)

Drug sellers

(dispensers)

Health

Providers

(Prescribers)

consumers Commercial

Chain actors

Consumers

Nairobi 53 171 4 5 5 2

Nyeri 19 66 3 5 0 2

Uasin Gishu 36 108 3 5 0 2

Total 108 339 10 15 5 6

TOTAL

447

30

6

2.5 Challenges faced during data collection process

Some of the challenges faced during the data collection process are as outlined below:

i. Some respondents were not willing to disclose prices and sources of their drugs, it took some

probing and persuasion for respondents to respond to questions referring to prices and sources.

ii. It was challenging to get appointments, postponements of interviews occurred due to respondent’s

busy schedules. This was a specific challenge faced with providers, drug sellers and commercial

chain actors.

iii. Time spent conducting one interview was longer than what had been anticipated. Most interviews

took longer than the expected time because some respondents were interviewed in their work places

resulting in a number of interruptions in the course of the interviews.

iv. For some interviews, especially with the commercial chain actors the questions had to be

restructured so that they could fit their answer into the context.

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3 Frequency of Asthma Patients

3.1 Patient flow and incidence of asthma patients

Most health providers serve up to 10 asthma patients per week; generally drug suppliers see more asthma

patients than health providers while most of them report visitor numbers of more than 10. The ratio of asthma

patients to all patients shows rather high consistency across the three sampling regions. The table below

shows roughly every 10th patient is an Asthma patient. The numbers reflect the total number of asthma

patients per week divided by the overall total number of patients per week.

Table 3-1 below shows that roughly every 10th patient is an Asthma patient

Table 3-1 Patient flow

Regions Drug suppliers Health providers

Nairobi 11.8 9.4

Nyeri 11.1 10.9

Uasin Gishu 10.9 6.6

Average 11.4 9.4

Figure 3-1 Percentage of asthma patients seen per week

3.2 Frequency of seeing asthma patients

Most health providers see asthma patients at least weekly. A large proportion see asthma patients on a daily

basis. The figure below shows frequency of seeing asthma patients.

Figure 3-2 Frequency of seeing asthma patients

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3.3 Frequency of asthma attacks

Frequency of asthma attacks: consumer’s views

Asthma attacks are frequent during the cold season with a range of weekly attacks to every three weeks

being considered severe enough to seek treatment. Attacks which occur within one week are considered to

be extremely severe. During the hot season, attacks reduce to an attack every three months.

Treatment is not sought with every attack; available medication is often the first to be used and when no

medicine is available, some home remedies are used as the first treatment option before seeking the

respondent’s usual medicine at an outlet. A treatment is often sought when attacks worsens. Frequency of

attacks was linked to environment and exposure to asthma triggers. Some of the home remedies listed by

the survey participants included:

Steaming:

o Using eucalyptus leaves and covering the patient with a blanket.

o By boiling water, dipping feet in water and covering a patient with a blanket, placing a warm

towel on the forehead for 20 to 30 minutes.

o Using plain boiled water.

Patient is given garlic or ginger to chew (for patients who do not react to garlic).

Rubbing menthol on the nostrils.

Asthma triggers: consumers views

Asthma triggers reported to included;

1. Allergic reactions to conditions such as:

Exposure to cold, dust and smoke;

Strong scents like perfumes /chemicals/smelly garbage;

Certain spices & foods (garlic most mentioned amongst spices);

Paint.

2. Stress and sudden variations in emotions.

3. Drug management:

Skipping medication or change of dosage.

4. Environment/weather conditions;

Change in weather conditions/change of environment/unfavorable environment such as enclosed

environments or working in a garden with napier grass or pollen.

“…‘… Anger can trigger attacks when you are so upset and you are unable to breathe”.

“..When you do activities in a rush and you don’t breathe well that also causes attacks …”

“…Mine is after every three months, it depends on the triggers if I come across dust, garlic it can happen

anytime especially that garlic so I avoid that...”

“…It depends on the environment and exposure to triggers. For instance right now I am just feeling well but if

I happen to go to a cold place and I don’t have my medication I will be affected…”

“..I used to see in my kids like if I got upset and yelled at them or something of the sort then their mood

changes and they get those attacks even if she was happy if she gets upset she gets those attacks…”

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3.4 Stocking drugs: frequency, sources and expenditure

Frequency of stocking medicines

The study established that asthma drugs are regularly stocked with most drug suppliers stocking medicine

on a weekly and in some instances on a daily basis. The frequency of stocking seems to go up slightly as

the number of clients of drug suppliers increases. Location of the drug suppliers (and proximity of the

suppliers of drugs) seems to affect the frequency. In Nairobi almost a third (32%) of the suppliers stock drugs

on a daily basis, whereas in Uasin Gishu and Nyeri this is only one fifth (22 and 19% respectively).

Figure 3-3 Frequency of stocking asthma drugs

No. of clients per week Daily Weekly Fortnight Monthly Quarterly

1-99 20% 54% 7% 16% 2%

100-199 26% 56% 10% 8% 0%

200-299 21% 62% 6% 11% 0%

300-499 31% 48% 6% 15% 0%

>500 34% 51% 3% 12% 0%

Figure 3-4 Frequency of stocking medicines by drug suppliers

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Sources of drugs in general

The vast majority of the drug suppliers source drugs from wholesalers. Among the most popular wholesalers

for medicines are Transwide and Transchem based in Nairobi. In the table below the top ten are ranked

based on the frequency with which they were reported by the drug suppliers. The table indicates the regions

served (based on the results from the survey).

Figure 3-5 Sources of drugs in general

Table 3-2 Top 10 sources of drugs in general

Sources Nairobi Nyeri Uasin Gishu

Hellel Pharm X

Transwide X X X

Transchem X X X

Othaya Pharm X

Nila Pharmacy X X

Njimia Pharmaceuticals X X

Pharm and Allied X

Range Chem X

Lifecare X

Pilot X

All drug sellers reported their main source per asthma drug (30 medicines in total, both generic and

branded). In the table (next page), suppliers are ranked based on the frequency they were reported across

all drug sellers and medicines. Nairobi has the widest range of suppliers while some large suppliers serve

both Nairobi and Nyeri. Some of the top wholesalers and distributors include Transchem, Nila, Njimia, and

Range Chem). In Uasin Gishu Pilot and Life Care are the most important suppliers. Transwide has a vast

network in all three regions, followed by Kentons.

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Table 3-3 List of sources per county

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Sources of asthma drugs

Wholesalers are the primary source for asthma drugs; drugs suppliers (sellers) predominantly source their

asthma drugs from wholesalers. Health providers purchase their asthma medicines from more diverse

sources; over 20% get their medicines from KEMSA. MEDS is the primary source for 10% of the drug

suppliers while wholesalers seem to mainly provide the private outlets which are the majority in the sample.

KEMSA mainly supplies the public facilities, whereas out of the 14 faith based facilities, 7 were supplied by

MEDS.

Figure 3-6 Percentage of sources of asthma drugs

Table 3-4 Sources of asthma drugs by facility type

Public facility Private outlet Faith based facility/outlet

Total 21 67 14

Wholesaler 2 50 4

Pharmacy 0 4 0

Sales person 0 0 0

Manufacturer/factory 0 2 0

KEMSA 19 2 1

MEDS 0 5 7

NGO 0 0 2

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Expenditures and patient volume

Only one fifth of the drugs suppliers and health provider’s monthly expenditures on asthma drugs exceeds

KSh 20,000.

Figure 3-7 Expenditure on asthma drugs by drug suppliers and health providers

In line with what is expected, drugs sellers with higher volumes spend more on asthma medicines than

outlets with smaller volumes as illustrated on the figure below.

Figure 3-8 Expenditure on asthma drugs by patient volume and drug sellers

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3.5 Market penetration of asthma medicines

The following top 6 asthma medicines have >70% penetration among drug suppliers:

1. Salbutamol syrup (2x),

2. Franol tablets,

3. Ventolin tablets,

4. Prednisone tablets,

5. Ventolin Evohaler.

Rotacap/Rotahaler reaches 17% market penetration among outlets. This is significantly lower than the

medicines listed above.

Figure 3-9 List of asthma medicines stocked and purchased by outlets

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Asthma medicines: Market penetration among health providers

The asthma medicines that have a high penetration among drugs suppliers have a high penetration (>50%)

among health providers. Discrepancies between drug suppliers and health providers are reported for

Aminophyllin and Franol as illustrated in the figure below;

Figure 3-10 List of asthma medicines usually prescribed and mostly requested by patients

Table 3-5 Asthma medicines prescribed and requested

Medicines Drug Suppliers Health Providers

Salbutamol 60ml syrup 86% 71%

Aminophyllin 10ml Ampoule (Vial) 37% 74%

Salbutamol 100ml syrup 71% 72%

Ventolin Evohaler 100mcg 71% 63%

Prednisone 5mg tablet 81% 75%

Ventolin 4mg tablets 83% 76%

Franol tablets 84% 51%

Asthma medicines stocked per region

In Nyeri inhalers seem to be more readily available than in Nairobi and Uasin Gishu. One of the reasons

attributed to this could be that the sampled outlets in Nyeri have higher patient volumes than the ones in

Uasin Gishu and Nairobi. Due to higher patient volumes, these outlets might stock a wider variety of asthma

medicines. Health providers (figure 12) show a similar distribution as drug suppliers (figure 11). Figures for

health providers might be less representative due to small sample sizes.

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Figure 3-11 Usually stocked medicines: drug sellers

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Figure 3-12 Usually stocked medicines: health providers

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4 Usage and Attitudes

Tablets are the most frequently used asthma medicines for adults, while syrups were reported to be the most

frequently used medicines for children. Tablets are preferred because of their affordability while children

prefer syrups because of ease of administration. The same asthma medicine with high penetration rates

among drug suppliers and providers also seems to have a high penetration rate among users, as established

by frequent reference by users.

4.1 Frequency of using asthma medicines

Frequency of usage of asthma medicines by consumers was reported to be dependent on predisposing

factors such as weather and the environment. Asthma medicines are more frequently used during cold

weather when attacks were said to be more frequent or when an individual is predisposed to unfavorable

environments. The majority of consumers do not use asthma medicines daily; some consumers skip their

medication therefore not adhering to doctor’s prescription of daily usage. Usually when under an attack,

consumers used their usual asthma drugs immediately. However, when the asthma condition is controlled

usage of asthma drugs is less frequent or stopped altogether.

4.2 Asthma medicine decision making influencers

A consumer’s choice of asthma medicine on a continuous basis mainly depends on who and what influences

the consumer.

Who

Healthcare providers, mainly doctors: these are the most trusted source in terms of decision to initiate

usage or preference change from one medicine to another.

Drug sellers are often the first point of contact in the case of an attack. Consumers tend to trust and

listen to them as they are viewed to be professionals.

Social networks including family members, friends and colleagues especially those who have had relief

from asthma by use of a particular medicine. They are often consulted on efficacy (perceived or real) of

the asthma medicine they used.

Financiers of the working poor often determine the source of treatment.

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What

The cost (If a prescribed drug is expensive then one opts for a cheaper solution).

Availability of the drug.

A new brand of medicine which is well-advertised, therefore the consumers are aware of the drug,

especially if the drug is providing desired results.

Government approval for using a medicine.

Credit & discount facilities.

“… At times when you go to the pharmacies they recommend some and since you feel that they are the

professionals you just go for that…”

“Someone who is asthmatic or who has used a certain drug/brand and it worked well for them, you are likely

to try it and see if it works for you as well. “

4.3 Choice factors which affect the choice of asthma medicines

In reference to choice factors, again a provider is important in terms of initiating usage of a particular

medicine and altering selection of asthma medicines. However, consumers did not mention this when

considering choice factors in continuous usage. The list below indicates the choice factors considered per

segment.

Tablets

The key choice factors included;

Cost: tablets were reported to be affordable.

Availability and accessibility: tablets were reported to be widely available and are often found in every

outlet such that even if a consumer forgets to carry a tablet while travelling, they are likely to access the

same tablet.

Syrups

Key aspects influencing the choice of syrups included;

Ease of usage especially for children;

Availability;

Cost;

Accessibility.

Inhalers

The key factors which facilitate choice of inhalers included;

Efficacy: Inhalers were reported to be the most effective and fast relievers of asthma;

Long-lasting effect;

Ease of usage.

4.4 Fast and slow moving medicines among drug sellers

Medicines with high frequency of sourcing are likely to be the medicines with high turnover, which are:

Ventolin tablets;

Prednisolone syrup;

Franol tablets;

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Salbutamol syrup;

Prednisone tablet;

Franol syrup;

Predsol syrup.

Rotacap/Rotahaler is not regularly sourced.

A number of medicines are left out because of a low base (n<30). These medicines are likely to be sourced

infrequently. The figure below illustrates the frequency of sourcing medicines by drug sellers.

Figure 4-1 Frequency of sourcing medicines by drug sellers

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4.5 Fast and slow moving medicines among providers

The market space for inhalers in Kenya has around 10 different brands/medicines, of which some come in

two or three variants. Only the Evohaler seems to be widely adopted by the market. Another 6 variants are

stocked by between 15% and 25% of the drugs sellers and prescribed by roughly 10% to 20% of the health

providers. Rotacap/Rotahaler competes within this league. Another group of inhalers found was at less than

10% of the drugs sellers and prescribed by only a fraction of the health providers.

Figure 4-2 Fast and slow asthma medicines

4.6 Price comparison asthma medicines

Inhalers: market prices

The price comparison compared the medicines up to the smallest unit (tablet, bottle, etc.). Most of the inhaler

medicines are sold per inhaler (device), whereas the Rotahaler is given out for free and only the Rotacaps

are sold. Because of its specific proposition, the unit price of the Rotacap (per capsule) stands out.

Figure 4-3 Inhalers: market prices

The Rotahaler is free of charge. If Rotacaps are prescribed to a patient for the first time, the Rotahaler is given for

free upon purchase/collection of the Rotacaps.

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Rotacaps are purchased at KSh 4.5 per capsule and sold to consumers at KSh 7 per capsule. The most

popular inhaler in the market is Ventolin Evohaler, apart from the Rotahaler as the cheapest variant of inhaler

on the market. Market prices range between KSh 170-250 (Ventolin Evohaler GENERIC) and 1,430-1,700

(Foracort 400ug/6ug) depending on the prescription for short term or long term asthma control.

Tablets: market prices

Most tablet prices range between KSh 1 and KSh 3 to purchase. Sales prices range between KSh 2 and

KSh 5. Excluded from the graph are the Montiget tablets. The median purchase price is between KSh 30

and 50 (5mg/10mg brand and generic). The median sales prices are between KSh 45 and 65. All these

tablets are stocked by majority of the drug sellers and health providers, except for the Aminophylin 100mg.

Figure 4-4 Tablets : market prices

Syrups: market prices

Syrups are sold between KSh 50 and 200, depending on the quantity and brand. Most affordable are the

Salbutamol Syrups, followed by Franol. Predinisolone is more expensive. The generics tend to be slightly

cheaper than the originals.

Figure 4-5 Syrups: market prices

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5 Diagnosis, Prescriptions and Recommendations

5.1 Diagnosis

Diagnosis of asthma by providers

Providers reported diagnosis to be clinical based on patient’s assessment, patient history and physical

examination; there are no laboratory tests done or any other tests. The main reason for this kind of diagnosis

is lack of diagnostic equipment, which was reported to be expensive and out of reach. Providers reported

that asthma is poorly case-defined and is sometimes hard to identify with certainty.

Signs and symptoms associated with asthma were listed as below:

The symptoms of asthma

Wheezing

Coughing

Tight chest

Sputum production

Breathlessness

Diagnosis of asthma: consumers views

Diagnosis was reported to be done by physical examination across ages and regions. Few consumers

reported that their diagnosis had been done by medical examination such as x-rays. Such examination was

reported to be done in government hospitals often with referrals from a health facility.

“…. We went to hospital many times he was given piritons for 6 months he was still severe then after a while

I was given a referral letter to Kenyatta. After the test they diagnosed him with asthma. He used to get faint;

he would run short of breath and start wheezing, after Kenyatta National Hospital, he is now better…”

“There is a hospital I went to I was very sick, I found a nurse instead of helping me, she was telling to control

my cough, and I was getting an attack, barely able to breathe.”

5.2 Prescription

By and large, both drug sellers (pharmacists) as well as health providers sell asthma drugs mainly on

prescription. However, drugs sellers sell more of their asthma drugs prescription-free than health providers.

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Figure 5-1 Percentage of respondents providing drugs free of prescription

Note: For some drugs the base is rather small (between 20-30), however the overall trend is evident

5.3 Recommended asthma drugs

Asthma drug recommendations for children and adults

In general syrups are considered to be recommendable to treat asthma with children. All other medicines

(Inhalers, tablets, vials) are recommended for adults. Tablets seem to be preferable over the inhalers.

Figure 5-2 Recommended asthma drugs by health providers

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Figure 5-3 Recommended asthma drugs by drug sellers

Change of prescription

Prescriptions are often changed by the drug sellers and the reasons are varied. The drug sellers

(pharmacists) change prescriptions on the basis of two main determinants: availability and affordability.

Other key factors considered by drug sellers in changing of asthma medicines included; the cost of medicine,

whether the medicine is affordable to the consumer and whether the medicine is available. Sometimes a new

market entrant is considered. Even though the drug sellers largely sell asthma medication on prescription,

they do try and change prescriptions based on patient’s requests to reduce the cost of medicine. Key factors

often considered by providers include efficacy and drug reactions.

“..Sometimes the pharmacist tries to change my medication, they do but I refuse because they say the

medicine is the same it’s the company that is different. They do try to change even when I have enough

money…”

5.4 Education material on asthma

Consumers are often given information on some aspects of asthma. Information is provided either as part of

routine facility health talks or one on one sessions with individual patients. Common aspects mentioned by

most providers include:

Triggers, whether pathogens or viral infections in the cold season:

Management of asthma; and

Administration of asthma medicines.

Educational materials that would be appreciated by providers include: cards or fliers, a toll free hotline with

providers on call 24hrs for asthma patients and videos which patients can watch at waiting rooms and can

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still be used as one to one education material (the video option was a suggestion from the well-established

government facilities).

It was reported that currently there are no educational materials on asthma. Although treatment guidelines

are available, healthcare providers still need practical information that translates guidelines to enable them

better diagnose and manage asthma.

5.5 Sources of information on asthma

Sources of information on asthma according to the survey consumers included the following;

Pharmacists

Social networks (Friends, family, colleagues etc.)

Internet

Doctors

Herbalists

Facility health talks

The most trusted sources are pharmacists and doctors as they are seen as professionals. On issues to do

with asthma, herbalists were reported to be the least trusted source of information.

5.6 Interactions with clients

Credit, discount and common queries

Patients usually try to negotiate about the price of medicines. 90% of the drugs sellers and 78% of the health

providers reported that most customers bargain. Around 40% of the health providers and drugs sellers sell

medicines on credit. Most common queries from patients when purchasing or receiving drugs are shown

below.

Figure 5-4 Discount and credit facilities

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Table 5-1 Common patient queries while purchasing asthma drugs

5.7 Inhalers: perception and feedback

Drugs sellers are quite convinced about the efficacy of the inhalers. Inhalers are fast relievers with minimal

side effects. There seems to be some room for improvement in making patients familiar with using the

inhalers. Although reference lacks for other medicines, inhalers are perceived as not affordable, which may

result in inhalers not being available as generics.

Note: the graph shown is for drugs sellers only. Results for health providers are similar.

Figure 5-5 Perception about inhalers

+/- Consumer’s perception of inhalers

+ Better efficacy in terms of immediate /instant relief in comparison to tablets and syrups “The inhaler because there is nothing like taking after ten minutes or something of the sort it reacts immediately if you have an attack the inhaler will help you because the tablet works slower, and the inhaler gives you fast relief.” To be medication for chronic or strong attacks

+ Better dosage management; minimal errors in over or under dosage common with syrups or tablets

- Expensive; out of reach and largely for well do to persons in the society “….the inhaler is expensive and some people cannot afford it….”

- Not easily available at the nearest drug outlets like tablets and syrups

- Not easy to use in public places. Tablets were said to be an easy reliever to use in public places. Inhalers draw attention and can easily cause stigma

5.8 Complaints

Most health providers and drugs sellers don’t receive any complaints regarding the inhalers they sell or give

out.

Common patient queries while purchasing asthma drugs Drug sellers Health providers

Discount on drugs cost 74% 73%

Original drugs 63% 57%

Generic drugs 61% 48%

Reduced prices 45% 37%

Mostly one usage dosage 42% 49%

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Figure 5-6 Complaints about inhalers

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6 Rotacap: Potential and Perspectives

6.1 Advantages of switching from oral to inhaled medication

The majority of both health providers (75%) and drugs sellers (74%) see benefits of patients switching from

oral to inhaled medication. Advantages of inhalers were said to include quick relief, ease of administration

and quick speed of administration with minimal side effects. Disadvantages of switching from oral to inhaled

medication includes cost (could be expensive) and perceived difficulty of administration.

Advantages according to health providers (n Advantages according to drugs sellers (n)

Work faster/quick reliever (27) Fast reliever/Works faster (136)

Better to use/effective (21) Effective (37)

Minimal side effects (14) Easy and quick to administer (20)

Easy and quick to administer (14)

Disadvantages according to health providers (n) Disadvantages according to drugs sellers

Expensive (7) Expensive (21)

Most patients prefer tablets (5) Oral is easier to administer (11)

Patients have different needs (5) Inhalers only for attacks/emergency, short acting, only

severe patients (10) Can become addictive/body can become resistant (6)

6.2 Introduction of new medication: health providers & drug suppliers

Suppose a quick asthma reliever tablet/capsule but requiring use of an inhaler and whose active ingredient is Salbutamol is introduced in the market, would you be interested in stocking such type of medication?

Both 73% of the health providers and drugs sellers would be interested in stocking. 14% of the drugs sellers

indicate they are already stocking this, whereas 9% of the health providers confirm stocking this already.

Drug Sellers – If yes, why? (n=287) Health Providers – If yes, why? (n=88)

Would be much effective (120) It has an effective ingredient (36)

Quick reliever, works faster (99) It is cost effective (17)

Salbutamol is widely used, preferred (21) It is easy to use (10)

Serves patients resisting other inhalers (20

Drug Sellers – If no, why? (n=44) Health providers – If no, why? (n=20)

Expensive/not affordable (6) Most patients have no information (8)

Not known by patients or doctors (5) Expensive (4)

Not preferred or requested by clients (4) Patients will be overdosed (2)

6.3 Introduction of new Rotacap/Rotahaler: Users views

Majority of consumers expressed willingness to use salbutamol, key consideration factors included;

Affordability

Cost effectiveness (the value expected of the reliever given the cost)

Efficacy (Quick reliever)

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Users familiarity with salbutamol thus ease of reference

Availability “..I should get it at my nearest shop, I shouldn’t travel far to look for it…….”

Ease of usage

Minimal or no side effects

Time saving because the number of hospital visits will be reduced.

Availability

Pack size (If I can purchase a tablet on a daily or weekly basis depending on my income, I would be very

happy)

Dose management (seemingly no possibilities of under or over dosage).

“…Like I said we are all interested in getting better medicine, accessible in the market and affordable, like the

inhaler for Ventolin it is available in all chemists. So that one you are talking about, as long as it’s affordable

and available, everyone will go for it...”

“..I should get it at my nearest shop, I shouldn’t travel far to look for it…….”

Preferred pack size and other attributes

Pack size: The preferred pack size of a new asthma reliever would be a pack that contains 10

tabs/capsules. Other sizes mentioned are 1, 5, 20, up to 100.

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6.4 Awareness and stocking of Rotahaler and Rotacap

Awareness of both Rotahaler and Rotacap stands around 35% among health providers and 45%-50%

among drugs sellers.

Figure 6-1 Awareness of Rotacap/Rotahaler

A fifth of the drugs sellers are currently stocking Rotahaler and Rotacap. For health providers this is slightly

over 15%.

Figure 6-2 Current stocking of Rotacap/Rotahaler

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Awareness of Rotahaler and Rotacap - consumers

A majority of the survey patients were not aware of Rotacap or Rotahaler. The few who had heard about it

reported that it is not easily accessible or in their usual nearest outlet. Information about Rotacap or

Rotahaler had been received from healthcare providers at health facilities, mainly government outlets.

Pharmacists are considered the most accessible providers, thought of as professional and honest.

Considering the ease of access and the consumer’s views, pharmacists maybe key in provision of

information as regards Rotacap and Rotahaler.

6.5 Challenges associated with addressing asthma attacks

Affordability “It’s expensive you have to have the money at the end of the day medicine have to be part of

your daily expenditure” for the working poor who lives on less than 2 dollars a day, affording medicine daily is

a challenge. Price is a barrier to inhaler purchase because it costs the patient more to purchase an inhaler

than a tablet.

Lack of finances; for the working poor asthma patient, income is only enough for essentials, they often

prefer to buy food for the family rather than purchase drugs until a severe attack occurs

Accessibility “.. Accessibility of asthma drugs for the working poor is a challenge, because they can only get

them in government hospitals that are where they get them at a subsidized rate...”

Stigmatization “When people realize you have asthma they start looking at you like you are about to die that

is the perception they get scared and just look at you like your days are numbered..”

“.. In school, other students will think the asthma patient is favored while teachers think that they pretend...it

is a big problem in schools..”

“..In the community people fear you they feel like you are going to infect them”

“..Our main challenge is price, we would wish to have more affordable drugs, if you can be in a position to

meet those I think we will be home and dry..” Wholesaler

“..the manufacturers should bring a reasonable cost so that the clients can be able to afford..”

wholesaler/retailer…”

Lack of knowledge about asthma medicine: in terms of where to access asthma medicine at affordable

rates.

Lack of awareness about asthma; asthma patients reported not to be aware of any policies and guidelines

that guides employment of casual laborers “I think there are no clear guidelines like in terms of employment

like when your boss tell you to swipe for example you know you can’t say no, it’s like there are no clear

guideline.”

It is restrictive: one can’t live their lives to the fullest or normally.

Unavailability of medicine.

“.. In our facility, we only have adrenaline and

aminophylline although it was pulled out of the

shelves by the government, patients therefore have

to go to other outlets or collapse at the health

facility...” health provider

“..We don’t have training from the government,

because we don’t know the new drugs in the market

nor the ones pulled out of the shelves...” Health

provider

6.6 Low uptake of the Rotacap/Rotahaler

The study confirms a rather low market penetration of the product among drug sellers and health providers

as compared to the most stocked and requested medicines in the market. Most drug sellers reported that

Rotacap/Rotahaler is not one of the fast moving medicines, but more of a slow mover.

Overall, on pricing, there were suggestions from patients that the kind costing which is done for malaria drugs

be explored for Asthma drugs, in addition, there should be intensive awareness campaigns coupled with availing the

affordable asthma drugs

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Reasons for low uptake from the study results are:

The most obvious reason as indicated by drug sellers is the low demand for the medicine. Some say it

is rarely prescribed.

Another important reason is that Rotacap/Rotahaler is relatively new in the market and according to

our respondents it is not very well known. Some stated that the marketing of the medication has been

poor.

An indirect observation is that inhalers are not used as much among the working poor as tablets and

syrups. The cheapest inhaler in the market (the Ventolin Evohaler) has reached high market

penetration rates, hence lack of familiarity with inhalers might be another reason for the low uptake.

Inhalers are generally perceived as costly. This might also reflect on the Rotahaler, while in reality the

Rotahaler’s value proposition is different from other inhalers.

6.7 Asthma across counties

Asthma prevalence: The study shows that on average every tenth visitor at an outlet or health provider is an

asthma patient. This number is fairly steady, indicating that prevalence of treatment seeking asthma patients

is more or less consistent across the 3 counties. The figure seems to be consistent with the national

average.

Table 6-1 Asthma prevalence across counties

6.8 Competitiveness of the GSK Rotacap/Rotahaler

Price

The proposition of the Rotacap is different from other inhalers in the market. Rotahalers are given out for free

and the patient is charged for the Rotacaps only, whereas other inhalers are generally priced per inhaler as

they contain the medicine within. Compared to the price of an inhaler (sales price start at KSh 250), the price

of a single capsule seems to be rather affordable. Compared to the price of most tablets (sales price

between KSh 2 and Ksh 5), the price of a Rotacap is rather expensive. The sales price of a bottle of syrup

start at KSh 50.

The actual perception of medicine being cheap or expensive depends on other factors, such as:

The length of time the medicine can be used;

The number of times the medicine can be used;

The perceived efficacy of the product.

Though inhalers in general are not considered to be cheap, price is hardly mentioned specifically as a

reason why outlets or providers do not stock the Rotacap/Rotahaler. Price is not a barrier for outlets and

providers but is a barrier for consumers.

Besides price the competiveness of a product depends on other factors such as its relative performance,

availability, promotion, communication, design.

Availability:

The Rotacap/Rotahaler are not (yet) widely available in the market. On availability Rotahaler is less

competitive as the Ventolin Evohaler or tablets and syrups that are stocked by most providers/outlets. Most

outlets and all health providers that stock Rotacap/Rotahaler are from Nairobi and Nyeri. Only few outlets

from Uasin Gishu have the medicine in stock.

Regions Drug suppliers Health providers

Nairobi 11.8 9.4

Nyeri 11.1 10.9

Uasin Gishu 10.9 6.6

Average 11.4 9.4

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Performance:

The survey did not look at the specific performance or efficacy as compared to other medicines. However

inhalers are perceived to be fast relievers and effective treatments.

Promotion/communication:

Unfamiliarity with the product, both among providers/outlets as well as consumers, is a commonly reported

concern. The Rotacap/Rotahaler is not stocked and not requested for because of low awareness levels.

Design/user-friendliness:

The design is not being reported as an impediment to usage of Rotacap/Rotahaler. However, some

outlets/providers have concerns regarding the usability of inhalers in general. Not all asthma patients are

familiar with how to use an inhaler. Others reported that inhalers are preferably because they are easy to

use.

6.9 Adverse Drug Events (ADR)

There were no reported cases of adverse drug events during the course of this survey

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7 Conclusions

Based on the outcome of the surveys some main conclusions about asthma medicines and the

Rotacap/Rotahaler in particular are as follows:

1. To understand the consumers, health providers and commercial supply chain actors’ attitudes and

behaviours in relation to this GSK manufactured asthma medicine

The Kenyan low income market for asthma medicines is mainly a tablet and syrup market and also based on health providers recommendations.

Majority of the survey patients were not aware of Rotacap or Rotahaler. Few who had heard about it,

reported that it is not easily accessible in their usual nearest outlet.

Rotacap/Rotahaler is only stocked by a minority of the drug suppliers (<20%) and health providers (<10%). It

does not belong to the fast moving asthma medicines.

The majority of the survey respondents, including both health providers (75%) and drugs sellers (74%), see

benefits of patients switching from oral to inhaled medication. Benefits of inhalers were said to include; quick

relief, easy and quick to administer with minimal side effects.

Among patients the key factors in choice of inhalers are different from tablets and syrups. Whereas inhalers

are generally seen as effective, long lasting and easy to use, tablets and syrups are chosen because of cost,

availability, accessibility and ease of use for children (syrups).

Inhalers are perceived to be unaffordable, which might also be a result of inhalers not being available as

generics. Also other perceptions might hinder further dispersion and acceptance of inhalers among potential

users. The survey reveals that some of the providers and drug suppliers perceive inhalers as potentially

addictive, only to treat attacks/emergencies, not for everyone and only to treat severe patients.

There seems to be room for improvement in making patients familiar with using the inhalers. Pharmacists

may be the key in provision of information as regards to Rotacap/Rotahaler. In the eyes of patients,

pharmacists are considered the most accessible providers, but also as professional and honest.

2. To examine why the current product has experienced low market uptake and poor performance

The study confirms a rather low market penetration of Rotacap/Rotahaler among drug sellers and health

providers as compared to the most stocked and requested medicines in the market. Most drug sellers report

that Rotacap/Rotahaler is not one of the fast moving medicines, but more of a slow mover.

Reasons for low uptake from the study results are:

> The most obvious reason as indicated by drug sellers is the low demand for the medicine. Some say it is

rarely prescribed.

> Another important reason is that Rotacap/Rotahaler is relatively new in the market and according to our

respondents the medicine is not very well known. Some stated that its marketing has been poor hence

there is a lack of knowledge of the product in the market.

> An indirect observation is that inhalers are not used as much among the working poor as tablets and

syrups. Only the cheapest inhaler in the market (the Ventolin Evohaler) has reached high market

penetration rates. Hence, lack of familiarity with inhalers might be another reason for the low uptake.

> Inhalers are generally perceived as costly. This might also reflect on the Rotahaler, while in reality the

Rotahaler’s proposition is different from other inhalers.

Other elements that were not directly tested on the respondents in the survey but might have an impact on

the uptake:

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> Patients do not feel comfortable using the Rotacap/Rothaler because of lack of clear understanding or

instructions, which might also be due to a similar lack of understanding among providers or drug

suppliers.

> The sales price of the capsules (Rotacap is sold at around KSh 7) which is higher than the sales price of

the most common tablets in the market (between KSh 2 and 5). This might be a barrier for a target group

that is largely cash driven.

> The markup on Rotacaps (difference between purchase and sales price) in combination with low volumes

resulting in relatively low revenues might not be appealing to providers and outlets.

3. To understand the competitiveness within the asthma medicines segment in comparison to the GSK

asthma reliever product

Price: The proposition of the Rotacap is different from other inhalers in the market. Rotahalers are given out

for free and the patient is charged for the Rotacaps only, whereas other inhalers are generally priced per

inhaler.

> Compared to the price of an inhaler (sales price start at KSh. 250), the price of a single capsule seems to

be rather affordable.

> Compared to the price of most tablets (sales price between KSh 2 and 5), the price of a Rotacap is rather

expensive.

> The sales price of a bottle of syrup start at KSh 50.

Though inhalers in general are not considered to be cheap, price is hardly mentioned specifically as a

reason why outlets or providers do not stock the Rotacap/Rotahaler. However, as price is not a barrier for

outlets and providers, it may be a barrier for consumers.

Besides the price the competiveness of a product depends on other factors such as its relative

performance, availability, promotion, communication, design.

Availability:

The Rotacap/Rotahaler are not (yet) widely available in the market. On availability Rotahaler is less

competitive as the Ventolin Evohaler or tablets and syrups that are stocked by most providers/outlets. Most

outlets and all health providers that stock Rotacap/Rotahaler are from Nairobi and Nyeri. Only few outlets

from Uasin Gishu have the medicine in stock.

According to this survey, a distinct top six asthma medicines have a high penetration (>70%) among drug

suppliers and health providers. These are: Salbutamol syrup (2x), Franol tablets, Ventolin tablets,

Prednisone tablets, Ventolin Evohaler. Aminophyllin (ampoule) also reaches high penetration among health

providers. The same drugs were reported by patients as the medicines they mainly use. Rotacap/Rotahaler

are prescribed by 17% of the drug suppliers of this survey.

Performance:

The survey did not look at the specific performance or efficacy as compared to other medicines. However

inhalers are perceived to be fast relievers and effective treatments.

Promotion/communication:

Unfamiliarity with the product, both among providers/outlets as well as consumers, is a commonly reported

concern. The Rotacap/Rotahaler is not stocked and not requested for because of low awareness levels.

Design/user friendliness:

The design was not reported as an impediment to usage of Rotacap/Rotahaler. However, some

outlets/providers have concerns regarding the usability of inhalers in general. Not all asthma patients are

familiar with how to use an inhaler. Others reported that inhalers are preferably because they are easy to

use.

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4. To gauge the extent (perceived or real) of the asthma problem among the working poor in the pilot

counties

Asthma prevalence: The study shows that on average every tenth visitor at an outlet or health provider is

an asthma patient. This number is fairly steady, indicating that prevalence of treatment seeking asthma

patients is more or less consistent across the 3 counties. In Nairobi drug suppliers reported an average of

(11.8) while health providers reported an average (9.4). In Nyeri drug suppliers (11.1), health providers (10.9)

and in Uasin Gishu drug suppliers (11.8), health providers (9.4). The figure seems to be consistent with the

national average.

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8 References

1. Uijen AA, Schermer TR, Van den Hoogen HJ, Mulder J, Zantinge EM, Bottema BJ, Nederlands Tijdschrift voor

Geneeskunde: Prevalence of healthcare consumption for asthma and COPD in relation to ethnicity. 2008 May

17; 152(20):115-63

2. GIZ, Endeva and Solveig Haupt, Aline Kramer: “Bringing medicines to low income markets; A guide to creating

inclusive business models for pharmaceutical companies,, 2012, January; Page 12

3. DA Enarson, N. Ait Khaled,, C-Y Chiang, G. Marks, K. Bissel Management of asthma: a guide to the essentials

of good clinical practicals, International Union Against Tuberculosis and Lung Disease, Paris, France, 2008

4. Ait-Khaled N, Odhiambo J, Pearce N: Prevalence of symptoms of asthma, rhinitis and eczema in 13- to 14-

year-old children in Africa: et al the International Study of Asthma and Allergies in Childhood Phase III. Allergy.

2007 Mar;62(3):247-58.

5. Dr. Chakaya Muhwa: Asthma Care in Kenya: Challenges, Pitfalls and The Light at the End Of The Tunnel, ,

CIPLA Launch Meeting Presentation, Nairobi, Kenya, 2014

6. Guidelines for Asthma Management in Kenya, by Division of Leprosy, Tuberculosis and Lung Disease, Ministry

of Health, January 2011

7. Musafiri S, Joos G, Van Meerbeeck JP, Asthma atopy and COPD in Sub-Saharan countries; the challenges,

East Afr J Public Health. 2011 June; 8(2):161-3

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9 Appendix 1 - Description of Rotacap

Brand name: Ventolin® Rotacap®

Active ingredient: Salbutamol 200mcg

Formulation, Strength and Device

Ventolin® Rotacap® is an inhalation powder, in a hard capsule.

Ventolin® Rotacaps® contain a mixture of microfine salbutamol sulphate and larger particle lactose in hard

gelatin cartridges. Each Rotacap® contains 200 micrograms of salbutamol (as sulphate).

Excipients: Lactose (which contains milk protein)

Indications:

Salbutamol is a selective beta2 adrenoceptor agonist indicated for the treatment or prevention of

bronchospasm. It provides short acting (four hours) bronchodilation in reversible airways obstruction due to

asthma, chronic bronchitis and emphysema. For patients with asthma salbutamol may be used to relieve

symptoms when they occur and to prevent them prior to a known trigger.

Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with

persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to

achieve and maintain control. Failing to respond to treatment with salbutamol may signal a need for urgent

medical advice or treatment.

9.1 Dosage and administration:

Salbutamol inhaled formulations are administered by the inhaled route only, to be breathed in through the

mouth.

Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a

reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy

should be considered.

As there may be adverse effects associated with excessive dosing, the dosage or frequency of

administration should only be increased on medical advice.

Salbutamol has aduration of action of 4 to 6 hours in most patients.

Rotacaps®:

Ventolin® Rotacaps® capsules are for inhalation use only, using a Rotahaler.

RELIEF OF ACUTE BRONCHOSPASM

> Adults

200 or 400 micrograms.

> Children

200 micrograms. On demand use of salbutamol should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Warnings and Precautions).

PREVENTION OF ALLERGEN OR EXERCISE-INDUCED BRONCHOSPASM

> Adults

400 micrograms before challenge or exertion. > Children

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200 micrograms before challenge or exertion. CHRONIC THERAPY > Adults

400 micrograms 3 or 4 times daily.

> Children

200 micrograms 3 or 4 times daily.

On demand use of Salbutamol should not exceed four times daily. Reliance on such supplementary use or a

sudden increase in dose indicates deteriorating asthma (see Warnings and Precautions).

Contraindications:

Salbutamol inhaled formulations are contraindicated in patients with a history of hypersensitivity to any of its

components (see excipients).

Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened

abortion.

Salbutamol dry powder inhaler formulations are contraindicated in patients with severe milk-protein allergy or

who have a history of hypersensitivity to salbutamol or any of its formulation components (see Excipients).

Warnings & Precautions:

The management of asthma should normally follow a stepwise programme, and patient response should be

monitored clinically and by lung function tests.

Increasing use of short-acting bronchodilators, in particular beta-2 agonists to relieve symptoms indicates

deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed.

Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration

should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow

monitoring may be instituted.

Salbutamol should be administered cautiously to patients with thyrotoxicosis.

Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and

nebulised administration.

Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant

treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum

potassium levels are monitored in such situations.

As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in

wheezing after dosing. This should be treated immediately with an alternative presentation or a different

fast-acting inhaled bronchodilator, if immediately available. The specific salbutamol presentation should be

discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.

In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours,

the patient should be advised to seek medical advice in order that any necessary additional steps may be

taken.

9.2 Interactions

Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed

together.

Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

Pregnancy and lactation:

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno 52

Fertility: There is no information on the effects of salbutamol on human fertility. There were no adverse

effects on fertility in animals.

Pregnancy:

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is

greater than any possible risk to the foetus.

During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate

and limb defects have been reported in the offspring of patients being treated with Salbutamol. Some of the

mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can

be discerned, and baseline rate for congenital anomalies is 2 to 3%, a relationship with salbutamol use

cannot be established.

Lactation:

As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the

expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a

harmful effect on the neonate.

Ability to perform tasks that require judgement, motor or cognitive skills: None reported.

9.3 Adverse Reactions:

Immune system disorders Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm,

hypotension and collapse. Metabolism and nutrition disorders

Rare: Hypokalaemia. Potentially serious hypokalaemia may result from beta

2 agonist therapy.

Nervous system disorders Common: Tremor, headache. Very rare: Hyperactivity. Cardiac disorders Common: Tachycardia. Uncommon Palpitations Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and

extrasystoles. Vascular disorders Rare: Peripheral vasodilatation. Respiratory, thoracic and mediastinal disorders Very rare: Paradoxical bronchospasm. As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Salbutamol should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted. Gastrointestinal disorders Uncommon: Mouth and throat irritation. Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps. Overdosage:

The most common signs and symptoms of overdose with Salbutamol are transient beta agonist

pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).

Hypokalaemia may occur following overdose with Salbutamol. Serum potassium levels should be monitored.

Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-

acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic

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A Study to Examine Uptake and Performance of Asthma Medicines among Low Income Populations in Three Counties in Kenya Private Sector Innovation Programme for Health (PSP4H)

27th June 2015 Cardno 53

acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of

bronchospasm such as wheezing) may be indicated in the setting of overdose.

Special Precautions for Storage:

To keep the Rotacaps in good condition it is important that they are stored in a dry place and where they will

not be exposed to extremes of temperature and should be stored below 30oC.

Full Prescribing Information is available on request from GlaxoSmithKline Limited, Likoni Rd, Industrial Area, P.O. Box 78392-00507, Nairobi, Kenya. VENTOLIN and ROTACAPS are trademarks of the GlaxoSmithKline group of companies Abbreviated prescribing information prepared July 2014 from GDS 25. GSK is committed to the effective collection and management of human safety information relating to our products and we encourage healthcare professionals to report adverse events to us on +254 20 693 3200 or +254 20 653 4241 or [email protected]