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- •Pharmaceutical Practice
- •Contributors
- •Preface
- •Acknowledgements
- •About this book
- •The NHS drugs budget
- •The NHS workforce
- •The current and future roles ofpharmacists
- •Introduction
- •The changing role of pharmacy
- •The extended role
- •The profession
- •Pharmacy education
- •Conclusion
- •Introduction
- •Healthcare systems
- •Education of pharmacists
- •Registration as a pharmacist
- •Community pharmacy
- •Hospital pharmacy
- •Conclusion
- •Introduction
- •Defining health and illness
- •Dimensions of health
- •Determinants and models ofhealth
- •Process of illness
- •Health knowledge, beliefs andattitudes
- •Decision analysis andbehavioural decision theory
- •The treatment process
- •Introduction
- •Functions of medicines
- •A societal perspective onrational use of medicines
- •Use of medicines
- •Pharmacies and the pharmacyprofession
- •Outcomes of medical treatment
- •Introduction
- •What is public health pharmacy?
- •Wider determinants of health
- •Lifestyle determinants of health
- •Measuring deprivation
- •Changing habits and lifestyle
- •Conclusion
- •Introduction
- •Types of cost sharingarrangements
- •Protection mechanisms andexemptions
- •Impact of cost sharing on druguse and health outcomes
- •Impact of cost sharing onpatients and healthcareprofessionals
- •The role of communitypharmacies
- •Conclusion
- •Introduction
- •The World Health Organization
- •WHO’s work in essentialmedicines
- •The essential medicinesconcept
- •The Model List of EssentialMedicines
- •The WHO Model Formulary
- •The need for essentialmedicines for children
- •Conclusion
- •Introduction
- •Clinical governance
- •Quality
- •Clinical governance andpharmacy
- •Professional governance andregulation procedures inpharmacy
- •When things go wrong
- •Introduction
- •Human error models
- •Risk management tools
- •Risk to patients in the pharmacysetting
- •Developments in health policy
- •National Patient Safety Agency(NPSA)
- •The risk management process
- •Conclusion
- •Introduction
- •What is continuing professionaldevelopment?
- •CPD cycle
- •Recording CPD
- •Fitness to practise
- •Conclusion
- •Introduction: what is audit?
- •Relationship between practiceresearch, service evaluationand audit
- •Types of audit
- •What is measured in audit?
- •The audit cycle
- •Learning through audit
- •Introduction
- •Morals, values and ethics
- •Ethical theories
- •Principlism and the four ethicalprinciples
- •Principlist ethics and research
- •Morals and law
- •Applied and professional ethics
- •Ethical issues in health care
- •Ethics and pharmacy
- •Conclusion
- •Introduction
- •Assumptions and expectations
- •What is communication?
- •Listening skills
- •Questioning skills
- •A model for guiding thepharmacist–patient interview
- •Patterns of behaviour incommunication
- •Empathy
- •Barriers to communication
- •Confidentiality
- •Special needs
- •Difficult situations in pharmacy
- •Conclusion
- •Introduction
- •What is teamwork?
- •The healthcare team
- •The community healthcare team
- •Role of the pharmacist inteamwork
- •Conclusion
- •Introduction
- •Why keep records?
- •What to record?
- •Barriers to record keeping
- •The future of records
- •The Data Protection Act 1998
- •Confidentiality
- •Records of supply
- •Clinical governance records
- •Consultation records
- •Introduction
- •Independent prescribing
- •Supplementary prescribing
- •Patient group directions
- •Minor ailment schemes
- •Influences on prescribing
- •Clinical governance inprescribing
- •Code of Ethics
- •Introduction
- •The prescribing process
- •Evidence-based medicine
- •Different types of formularies
- •Formulary development
- •Formulary managementsystems
- •Safety, efficacy and economy
- •Pre-marketing studies
- •Post-marketing studies
- •Pharmacoeconomic evaluationof medicines
- •Drug utilization review andevaluation
- •Introduction
- •Extent of use of CAM
- •Reasons for use of CAM
- •Regulation of CAM
- •Pharmacy and provision of CAM
- •Efficacy and safety of CAMapproaches
- •The future for complementarymedicines
- •Introduction
- •Routes of administration
- •Dosage forms
- •Introduction
- •The concept and growth ofself-care
- •Getting information from thepatient
- •Drawing together information
- •Picking up on non-verbal cues
- •Outcomes from the consultation
- •Conclusion
- •Introduction
- •Where does information existand how can it be retrieved?
- •Directory of useful websites
- •Searching the Internet
- •The sequence of information
- •Information services
- •Conclusion
- •Introduction
- •Information required on aprescription
- •Types of prescription forms
- •Routine procedure fordispensing prescriptions
- •Introduction
- •The working environment andprocedures
- •Equipment
- •Manipulative techniques
- •Ingredients
- •Problem solving inextemporaneous dispensing
- •Counting devices
- •Automated dispensing systems
- •Conclusion
- •Introduction
- •Expressions of concentration
- •Calculating quantities from amaster formula
- •Changing concentrations
- •Calculations where quantity ofingredients is too small to weighor measure accurately
- •Solubilities
- •Calculations involving doses
- •Reconstitution and infusion
- •Self-assessment questions
- •Self-assessment answers
- •Introduction
- •Primary and secondarypackaging
- •Packaging materials
- •Closures
- •Collapsible tubes
- •Unit-dose packaging
- •Paper
- •Patient pack dispensing
- •Introduction
- •Standard requirements forlabelling dispensed medicines
- •Additional labellingrequirements
- •Legal requirements in certaincircumstances
- •Errors in labelling
- •Self-assessment questions
- •Self-assessment answers
- •Introduction
- •Sterile product production
- •Premises
- •Environmental control
- •Environmental monitoring
- •Aseptic preparation
- •Testing for sterility
- •Introduction
- •Solutions for oral dosage
- •Solutions for otherpharmaceutical uses
- •Expression of concentration
- •Formulation of solutions
- •Oral syringes
- •Diluents
- •Introduction
- •Pharmaceutical applications ofsuspensions
- •Properties of a goodpharmaceutical suspension
- •Formulation of suspensions
- •The dispensing of suspensions
- •Introduction
- •Pharmaceutical applications ofemulsions
- •Emulsion types
- •Formulation of emulsions
- •Dispensing emulsions
- •Introduction
- •Types of skin preparation
- •Ingredients used in skinpreparations
- •Dispensing of externalpreparations
- •Transdermal delivery systems
- •Introduction
- •Suppository bases
- •Preparation of suppositories
- •Containers for suppositories
- •Shelf life
- •Labelling for suppositories
- •Patient advice
- •Introduction
- •Powders for internal use
- •Powders for external use
- •Introduction
- •Tablets
- •Capsules
- •Other oral unit dosage forms
- •The role of the pharmacist
- •Introduction
- •The inhaled route
- •Inhaled medicines used forasthma and COPD
- •The peak flow meter
- •Types of inhaler device
- •Introduction
- •Administration procedures
- •Products for parenteral use
- •Formulation of parenteralproducts
- •Large-volume parenteralproducts
- •Introduction
- •Anatomy and physiology of theeye
- •Formulation of eye drops
- •Preparation of eye drops
- •Labelling of containers
- •Instillation of eye drops
- •Formulation of eye lotions
- •Formulation of eye ointments
- •Ophthalmic inserts
- •Contact lenses and theirsolutions
- •Contact lenses
- •Hard lens solutions
- •Soft lens solutions
- •Advice to patients
- •Introduction
- •Cancer chemotherapy
- •Classification of drugs used incancer chemotherapy
- •Targeted therapies
- •Dose and schedule ofchemotherapy
- •Occupational exposure risks
- •Provision of a pharmacy-basedchemotherapy preparationservice
- •Administration of cytotoxicmedicines
- •Provision of chemotherapyat home
- •Centralized intravenous additiveservice (CIVAS)
- •Infusion stability and shelf lifeassignment
- •Introduction
- •Provision of nutritional support
- •Indications for TPN
- •Assessment of the patient inhospital
- •The nutrition team
- •Components of a TPNformulation
- •Compounding of TPN and HPNformulations
- •Compounding of HPNformulations by commercialcompanies
- •Potential complications arisingduring compounding andadministration of TPNformulations
- •Addition of medicines to a TPNor HPN bag
- •Administration of TPN/HPNformulations
- •Potential problems for HPNpatents
- •Training for HPN patients
- •Services provided by home-carecompanies
- •The British Parenteral NutritionGroup
- •Introduction to kidney diseaseand dialysis therapy

Pharmacy and public health CHAPTER 5
diabetes, cardiovascular disease, many cancers including colorectal and prostate cancers in men and breast or
endometrial cancer in women, osteoarthritis, poor selfimage and decreased life expectancy.
Increasingly the measurement of waist circumference is being undertaken as it presents a simple way of
assessing someone’s risk rather than measuring BMI.
Men are at an increased health risk if their waist measurement is 94 cm and at substantially increased
health risk if the measurement is 102 cm. Equivalent waist measurements for women are 80 cm and
88 cm.
Raising issues of weight management can be difficult
but opportunities for the pharmacist to intervene may
arise when a person complains of being unhappy with
their weight, short of breath or having mobility problems associated with back or hip pain. Alternatively,
opportunities may arise when individuals request products such as slimming aids, blood pressure monitors,
cholesterol monitoring kits, alternative or complementary therapies for use in weight loss or receive prescribed or purchased medicines for arthritis, diabetes,
cardiovascular or respiratory disease. Key advice to be
offered will need to address healthy eating and exercise.
Alcohol
Excessive alcohol intake is associated with a range of
health problems including serious liver disease, disorders of the stomach and pancreas, anxiety and depression, sexual problems, high blood pressure and cardiac
disease, involvement in accidents, particularly car
crashes, a range of cancers, including those of the
mouth, throat, liver, colon and breast, and becoming
overweight or obese.
Alcohol misuse currently accounts for approximately 22 000 deaths each year, with consumption
above the recommended limits of 3 units per day
for men and 2 units per day for women being
exceeded by 22% of adult females and 39% of adult
males. Of equal concern is the fact that 20% of the
population in England drink to get drunk (binge
drink). This is defined as consuming more than 8 units
for men and more than 6 units for women and is
strongly associated with involvement in accidents and
with cardiovascular disease.
Most people are sensitive about revealing the
details of their drinking habits; however, opportunities for pharmacists to raise awareness of sensible
drinking may arise when individuals present with a
hangover, headache, indigestion, or complain of
insomnia, excessive tiredness, depression, stress, being overweight or report having been involved in a
minor accident. Individuals seeking advice about testing blood pressure or dietary information, requesting
products for hangovers, painkillers or antacids, and
requesting kits to test drinks for contaminants also
present opportunities for intervention. Requests for
alternative medicines/complementary therapies that
may be used to treat alcohol-related problems, or
supplying a prescribed or over the counter medicine
known to interact with alcohol are further opportunities that may allow discussion with the individual.
Exercise
Regular exercise for adults that is equivalent to at least
30 minutes a day of moderate physical activity on 5 or
more days of the week, can help prevent or manage a
range of disorders including cardiovascular disease,
type II diabetes, musculoskeletal disorders, mental illness and a range of cancers. Children are required to
undertake at least 60 minutes ofmoderateactivity each
day to promote healthy growth, development and psychological well-being. Recent surveys have shown less
than 37% of adult men and 24% of women undertake
sufficient exercise to gain any health benefit. Older
people need to maintain their mobility and undertake
regular dailyactivity, and attempts to improvestrength,
coordination and balance may be particularly beneficial.
Clearly the amount of physical activity an individual
needs to undertake will be influenced by their daily
routine and the nature of their job. Opportunities for
the pharmacist to raise issues relating to physical activity may arise when people are unhappy with their
weight, complain of being short of breath or tired, have
mobility problems, suffer from depression or stress, or
have difficulty sleeping. Again, when an individual
seeks advice about monitoring blood pressure or cholesterol levels or requests dietary information on how
to loseweight, it may be opportune to discuss exerciserelated issues. Likewise the purchase of support equipment, for example for knees, requesting alternative or
complementary medicines to provide energy, or obtaining prescribed or purchased medicines for blood
pressure may be additional opportunities.
Measuring deprivation
Although a number of different approaches have
been developed to measure the deprivation of a
given population, most have significant limitations.
59

SECTION ONE Pharmacy practice and society
Over recent years new tools have emerged to give
more robust estimates of deprivation. One of the
most widely used measures of deprivation has been
the Townsend index, which produces a composite
score for relative deprivation based on four variables obtained from the national census undertaken
every 10 years in the UK. These variables include
proportion of:
*
Households with no car
*
Households not owner occupied
*
Unemployed economically active persons aged
16–59 years (females) and 16–64 years (males)
*
Households overcrowded.
The Townsend index has a number of limitations,
including a lack of validity in rural areas where,
unlike urban areas, ownership of a car may be a
necessity at all levels of deprivation. The Townsend
index continues to be widely used because its construction is independent of health-related variables
and the component data are captured in the national
census. However, over recent years each of the constituent countries in the UK has developed its own
approach to measuring deprivation. As a consequence it is increasingly difficult to compare deprivation across, for example, England and Wales. In
England a new index was introduced in 2004 to
measure multiple deprivation based on seven distinct domains:
*
Income: captures the proportion of the population
in an area living on low income
*
Employment: measures unemployment assessed as
the involuntary exclusion of those of working age
from work
*
Health deprivation and disability: identifies areas
with high rates of premature deaths or whose
quality of life is impaired by poor health or who are
disabled
*
Education, skills and training: captures education
deprivation for children and young people and the
level of skills and qualifications among the working
age adult population
*
Barriers to housing and services: measures wider
barriers such as household overcrowding,
homelessness, difficulty of becoming an owner
occupier and geographical barriers such as distance
to GP premises, convenience store, primary school
and Post Office
*
Crime: measures the incidence of recorded crime
in an area for burglary, theft, criminal damage and
violence
*
Living environment: measures the quality of the
indoor living environment and the outdoor living
environment including air quality and road traffic
accidents involving injury to pedestrians and
cyclists.
From the above it can be seen that the Index of
Multiple Deprivation 2004 is based on the principle
of distinct dimensions of deprivation that can be
recognized and measured separately. Individuals
may be counted in one or more domains depending
on the type of deprivation they experience. The
final deprivation score is a composite, weighted
score of each of the seven domains. In 2007 there
were 354 local authorities in England and each
could be giv en a score and a rank on the index of
multiple deprivation. The lower the rank the more
deprived the distric t.
In comparison to the English index, the Welsh
Index of Multiple Deprivation 2005 is compiled
from seven similar indicators of deprivation: income,employment,health,education,housing,access to services and environment. However, the data
sources utilized in the domains vary between the
two countries and therefore the scores obtained
cannot be used to compare deprivation in England
andWales.Evenwithinasinglecountrysmalldifferences in deprivation scores mean little and the
scores do not really allow you to determine how
much more deprived one area is compared to another. Likewise, where two areas have markedly different deprivation scores, one area may be
considered less deprived than the other, but not
moreaffluent,i.e.theindicesareameasureofdeprivatio n and not affluence.
Changing habits and lifestyle
To assist people in making changes to their habits and
lifestyle there is a need to recognize the part played by
socio-cultural influences and the environment. There
are many models that are used to help understand the
change process. One that has found use within public
health is the ‘three Es model for lifestyle change’.In
this model three stages are identified:
*
Encouragement
*
Empowerment
*
Environment.
Encouragement involves raising awareness that may
include the use of adverts, leaflets, one-to-one
advice and targeted campaigns. This stage of the
60

Pharmacy and public health CHAPTER 5
changeprocessisusedtoactasatriggerforpeople
to make healthy choices, or at least consider the
healthy options. By itself, encouragement is unlikely to bring about sustained change in the population
without empowerment and changes to environmental factors.
Empowerment involves the education and development of the individual and the community. Central
to empowerment is the development of knowledge,
life skills and confidence that will enable individuals,
groups or populations to make the healthy choice.
This process will be enhanced by the pharmacist,
who can instil confidence in patients rather than
undermining them, and by making changes to environmental factors.
Environment changes are targeted at the social,
cultural, economic and physical surroundings in
which people live and work. These changes aim to
make the healthy choice the easy option.
A good example that can be used to illustrate
this process is the need for the wider population to
reduce their intake of salt to less than 6 g per day.
Encouragement could involve a campaign to raise
awareness of the daily intake of salt and the harmful effect of excessive intake; empowerment might
target the labels on food and ensure they are easy
for everyone to understand and to know what they
are consuming; changes to the environment could
involve a reduction in the salt content of prepared
foods by manufacturers and the availability of low
salt options in supermarkets and restaurants, thereby making it easier for consumers t o reduce dietary
salt intake.
Conclusion
This chapter has highlighted the key determinants
of health and focused on areas of li festyle advice
where t he pharmacist has traditionally contributed
to the public health agenda. Hopefully it is apparent
to the reader that to make a substantive contribution to public health, pharmacy will need to build
on its current roles. Some public health pharmacy
roles, such as assessing the health and social needs
of communities through involvement in surveillance, surveys and information gathering exercises,
acting as an advocate for local communities on
health issues, and building sustainable communities
or working in partnership with relevant statutory
and voluntary services to promote and protect the
health of the public, may be seen as roles best
undertaken by individuals who choose to specialize
in public health. Nevertheless, a large number of
public health activities can be undertaken from a
pharmacy, whether it is located in the community
or hospital sector. Some of these are identified in
Box 5.3.
Box 5.3
Examples of public health roles that could be
undertaken by most pharmacies
*
Develop closer working relationships with
local authorities and other non-pharmacy
bodies to influence the wider determinants of
health
*
Develop community leaders and health champions
from within pharmacy
*
Develop pharmacy services in deprived areas to
provide additional pharmaceutical support and
tackle health inequalities
*
Provide information and advice to the public on
health improvement and health protection
*
Improve medicines and health literacy of patients,
public and carers
*
Provide access to, or signpost, health information
resources and services
*
Provide lifestyle advice for individuals with disease
risk factors
*
Provide services to promote self-care
*
Promote health literacy and participate in national
campaigns
*
Provide stop smoking services
*
Provide sexual health services, e.g. emergency
hormonal contraception (EHC), Chlamydia
screening, free condoms
*
Provide healthy weight programmes
*
Provide safe use of alcohol services
*
Provide health screening services
*
Encourage immunization uptake and provide
immunization services
*
Monitor and track safe use of medicines including
reporting of adverse reactions
*
Promote safe, efficient and effective use of
prescribed and purchased medicines
*
Develop medicines management programmes for
those with chronic conditions
*
Make pharmacies more accessible for difficult to
reach groups, e.g. men, teenagers
61

SECTION ONE Pharmacy practice and society
KEY POINTS
*
Pharmacist have many opportunities to promote
health
*
Public health pharmacy can be defined in many ways
*
More than 70% of the factors affecting an
individual’s health are outside the domain of the
health services
*
Public health has improved markedly during the
past 150 years
*
During this time, social inequalities have widened,
with disadvantaged groups showing little
improvement
*
A wide range of factors affect the health of an
individual, some of which are fixed, while others
can be modified
*
Both employment and unemployment are
associated with adverse health effects
*
Air pollution is associated with raised morbidity
and mortality
*
It is with individual lifestyle determinants that
pharmacists have had a traditional role
*
Community pharmacists may offer support with
smoking cessation, weight management, exercise
and problems with alcohol
*
Measures of deprivation vary from one country to
another
*
While these details vary, the main factors are
income, employment, health, education, housing,
crime and the environment
*
To help people change lifestyle or habit, think –
encouragement, empowerment, environment
62

Chapter Six
Types of patient charges for medicines
and their impact
Ellen Schafheutle
6
STUDY POINTS
*
Know the reasons for charging patients for (part of)
their prescribed medicines
*
Define the different types of co-payments for
medicines
*
Understand the effect of patient charges on uptake
of medicines
*
Differentiate between essential and less essential
medicines, and the differing effect of charges on
them
*
Define patient groups that are likely to be most
susceptible/vulnerable to the impact of medication
cost
*
Describe strategies patients use to manage or
reduce medication cost
*
Describe strategies healthcare professionals,
especially pharmacists, can use to help patients
cope with medication cost sharing issues
Introduction
Healthcare expenditure has been rising steadily over
the past decades, and with the ever evolving advent of
new technologies and treatments this trend is likely to
continue. In the developed world payment for health
care is usually covered by third-party payment systems to which the population (or members) contribute in the form of regular insurance premiums or
taxes. However, paying for health care and medicines
through such third-party providers removes the price
barrier to consumption, as healthcare services become
– or rather appear – free to the patient on access.
Getting patients to contribute something when accessing health care is thus seen as the reintroduction of
such a price barrier, with the aim of deterring unnecessary access and medicines use, and thus reducing
potential waste. Such contributions or payments
borne by patients are commonly referred to as cost
sharing, as they make a contribution to the actual cost
of treatment. Besides creating a cost barrier to (unnecessary) demand, cost sharing also creates another
form of revenue to the healthcare provider.
Cost sharing can be levied on some or all types of
health care. In some countries patients have to pay
when visiting a doctor. In the UK, for example,
patients have to contribute considerably towards dental and optical care, but visits to family doctors and
hospitals are free. One particular form of cost sharing
that is relatively easily defined, identified and implemented is on prescribed medicines. The impact of this
cost has been widely studied and is of particular interest to pharmacists, which is why it is the focus of
this chapter.
Types of cost sharing arrangements
Essentially, there are three types of cost sharing for
medicines, i.e. the cost the patient has to pay themselves, out-of-pocket, in order to obtain prescribed
medication. These are a:
*
Flat rate fixed charge, usually called a prescription
charge
*
Percentage co-payment system
*
Deductible system.
A prescription charge is a fixed fee that is payable per
item on a prescription, or per prescription (containing

SECTION ONE Pharmacy practice and society
one or more items). Flat rate prescription charges are
independent of actual drug cost and exist in Austria
and the UK. They are used in combination with other
forms of cost sharing in Finland and Germany.
Percentage co-payment (also termed ‘co-insurance’)
is probably the most common form of cost sharing and
is based on a percentage payment of actual drug cost.
The percentage amount that is payable by the patient
can vary depending on the type of medicine and the
seriousness of the underlying pathology. In France, for
example, patients have to pay 35% of actual cost
towards medicines that are classed as being of
major therapeutic value, but have to contribute 65%
for those where therapeutic value is judged as moderate or low. Certain drugs, treating conditions that
are considered as ‘not usually of a serious nature’,may
need to be paid in full, and many drugs that are available to buy over the counter (OTC) from pharmacies
fall into this category.
In a deductible system a patient has to pay 100% of
the cost of their prescribed medication up to a set
amount (the deductible), after which the cost is subsidized. This system is often combined with a percentage co-payment or prescription charge once the
deductible has been reached.
Protection mechanisms and exemptions
In many countries cost sharing arrangements are accompanied by mechanisms to protect vulnerable
groups against undue or excessive expenses for drugs.
Such protection mechanisms can take the form of
reduced (i.e. subsidized) payments, exemptions, caps
on expenditure, or complementary insurance to cover
all or part of out-of-pocket cost sharing. These protection mechanisms may be available to all (e.g. complementary insurance), or apply to particular types
of drugs, e.g. essential drugs treating chronic or lifethreatening conditions. They may also apply to particular groups in the population, who can access
prescribed drugs at a reduced or no cost (i.e. exempt).
Criteria that usually define vulnerable groups and
qualify for exemption or subsidy are:
*
Clinical conditions – commonly those defined as
chronic or life-threatening and requiring essential
medication, usually implemented as a list of
qualifying conditions or drugs. (In the UK, for
example, patients requiring medication for type I
or type II diabetes are exempt.)
*
Level of income – where people on low incomes are
protected against undue expense.
*
Age – childre n are exempt in Austria,
Germany, Ireland, New Zealand, Sweden
and the UK; older peopl e are exempt or have
reduced cost sharing arrangements in
Australia, Austria, Belgium, Canada, Denmark,
Ireland, New Zealand, Portugal, Spain, the
UKandtheUS.(NB:definitionsfor‘children’
and ‘older people’ differ in the different
countries, the latter being linked to retirement in
some.)
Caps on co-payments
Only a few countries (e.g. New Zealand and Sweden)
have reduced medication co-payments for high
users, but many have some form of cap. Caps are
sometimesalsoreferredtoasout-of-pocketmaximums and define the maximum amount a patient
should be asked to cost share. Caps can either apply
per prescription or be annual caps. Caps per prescription exist, for example in Taiwan. Annual caps
are probably more common and can either apply
to the whole of the population (e.g. Sweden and
Norway) or only to certain groups, such as the
chronically ill (e.g. Denmark, Finland and Germany).
Some countries also have systems where medication
co-payments are tax deductible (e.g. Ireland and
Portugal).
Complementary insurance
Complem entary insurance covering the cost o f prescription co-payments is another form of protection
mechanism; patients who have bought this type of
insurance do not have to cost share or, if they are
asked to pay an amount out-of-pocket, are subsequently reimbursed. Complementary insurance is
widespread in France (mutuelle)butcanalsobe
found in a number of other countries. In England,
Scotland and Northern Ireland a so-called prepayment certificate (PPC) exists, which can be
bought to cover the cost of any prescription charges
over a 3- or 12-month period, thus providing a cap
through advance payment. The problem with complementary insurance and PPCs is that they only
allevia te the financial burden for those that can
afford to purchase this cover, which raises equity
concerns.
64

Types of patient charges for medicines and their impact CHAPTER 6
Impact of cost sharing on drug use and health outcomes
Impact on drug consumption
A large body of international literature exists showing
that cost sharing reduces access to health services in
general (where cost sharing applies), and use of prescribed medication in particular. This is, of course,
one of the aims of having such a policy in place,
whereby patients respond to cost sharing by assessing
whether a visit to their doctor, and the use of prescribed medication in particular, are seen as important
enough to warrant the relevant out-of-pocket payment. For unnecessary visits or self-limiting conditions that patients may be able to treat themselves
(either through self-care or the use of self-medication
remedies, for example), avoiding the use of formal
health care may be the most appropriate action. This
will save cost to the patient, as no cost sharing is
incurred, or possibly a reduced amount is paid if
OTC remedies are purchased. It further reduces resource use by the health service itself (third party
payment), which is the aim of a cost sharing policy.
Differential effect on essential
and less essential medication
Cost sharing should therefore only affect patient demand that may not be entirely clinically necessary. It
should thus also only affect the use of less essential
medication. The latter is defined as medication that
provides symptomatic relief without having an effect
on any underlying disease process (see Table 6.1 for a
more detailed definition). Indeed, the negative effect
of cost sharing on drug utilization has been found to be
more pronounced for non-essential drugs, but it does
also reduce the use of essential medication (Soumerai
et al 1987; Stuart & Grana 1998). As the terminology
suggests (see Table 6.1), essential drugs are those
whose withdrawal would have important effects on
morbidity and mortality, and thus a cost-related reduction in essential medication is likely to have a
negative effect on health outcomes.
Effect on health outcomes
Even though there are not as many studies that show
that a cost-related reduction in the use of essential
medicines impacts negatively on health outcomes,
convincing large-scale evidence does exist. Tamblyn
et al (2001) used interrupted time series analysis to
examine the effect of the Quebec drug policy reform, where a 25% co-payment and income linked
caps were introduced. Using a random sample of
93 950 elderly persons and 55 333 adult welfare
recipients, the authors showed that the use of essential drugs decreased by 9.12% and 14.42% in the
two groups; and the use of less essential drug s decreased by 15.14% and 22.39% respectively. The
authors further demonstrated an increase in emergency department visits and serious adverse events
(defined as hospitalization, nursing home admission
or mortality) in association with the decrease of
essential drugs use, but not in association with the
reduction in less essential drugs. They thus established a causal link between the reduction in drug
use in response to cost sharing and a negative effect
on health outcomes.
Table 6.1 Definitions of essential and non-essential medications (Tamblyn et al 2001)
Drug category Definition Drugs included in categories
Essential drugs ‘Medications that prevent deterioration in health
or prolong life and would not likely be prescribed in
the absence of a definitive diagnosis’
Less essential drugs ‘Medications that may provide relief
of symptoms but will likely have no effect on the
underlying disease process’
Insulin, anticoagulants, angiotensin
converting enzyme inhibitors, lipid-reducing
medication, antihypertensives, furosemide,
b-blockers, antiarrhythmics, aspirin, antivirals,
thyroid medication, neuroleptics, antidepressants,
anticonvulsants, antiparkinson drugs, prednisone,
b-agonists, inhaled steroids, ciclosporin
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SECTION ONE Pharmacy practice and society
Furthermore,Rice &Matsuoka (2004)and Lexchin
& Grootendorst (2004) provide two independently
published reviews of the literature on the impact of
prescription medicine fees on drug and health service use, as well as health status. They both conclude
that cost sharing leads to a decrease in essential
drug use and a decline in health status in vulnerable
populations.
Negative effect on healthcare
use and resources
If cost-related reduction in the use of essential medication leads to worse health outcomes, this will invariably lead to an increased use of healthcare services
(such as increased numbers of visits, increased hospital admission and additional treatment and medication). This, in turn, will have an effect on resource use,
as all such increased health service use will need to be
funded. It is thus important to note that any savings in
drug spend (due to a reduction in drug use because of
cost sharing) may be offset by cost increases in other
healthcare areas. However, very few studies exist that
have demonstrated such a link. Soumerai et al (1994)
assessed the effect of a Medicaid imposed cap, allowing a maximum of three prescriptions a month, on 268
permanently disabled, non-institutionalized patients
with schizophrenia. They demonstrated a decrease in
the use of essential mental health drugs and a concomitant increase in the use of acute mental health
services among low-income patients. They estimated
that the average increase in mental healthcare costs
per patient during the cap exceeded the savings in
drug costs to Medicaid by a factor of 17. From a
societal perspective this runs counter to the aim of
any cost sharing policy.
Effect of cost sharing on
different population groups
Besides having differing effects on essential versus less
essential drugs, cost sharing can also affect different
groups in the population to differing extents. The
elderly, people with disabilities (including mental
health problems), those taking medication for chronic
conditions and people on low incomes are particularly
vulnerable and susceptible (Lundberg et al 1998;
Safran et al 2005; Stuart & Grana 1998). Essentially,
these are the groups that are most likely to have high
morbidity and high use of essential medication, while
being least likely to be able to afford cost sharing. To
protect them, many countries have exemptions and
other protection mechanisms in place, which have
already been mentioned.
Impact of cost sharing on patients and healthcare professionals
The preceding sections have provided insight into
the fact that medication cost sharing reduces drug
utilization, and that certain groups of patients are
more vulnerable or susceptible to this effect, particularly those on low incomes or regular medicine
users.However,thesestudiesprovidelittledetail
on how drug utilization is reduced, i.e. how individual patients cope with the cost of their m edication.
Rather than relying on the analysis o f large insurance
reimbursement or claims databases that provided
much of the above evidence, studies that employed
methodologies involving direct contact with patients
have explored this. In-depth interviews and focus
groups have provided some of the depth and
detail on how patients cope with medication cost,
and questionnaire surveys have allowed quantification of this information (Cox et al 2001; Cox &
Henderson 2002; Safran et al 2005; Schafheutle
et al 2002, 2004).
Effect of cost sharing on
patients – coping strategies
From these studies we know that patients respond to
cost sharing in complex ways. Furthermore, there are
many factors that can impact on whether patients
decide to adhere to their medication, and cost is just
one of them. Indeed, medication cost is often not an
overriding factor when patients decide whether to
adhere to their prescribed medication regimen or
not, but it can be at least a mediator. If patients perceive their condition as serious and the prescribed
treatment as one providing an important health benefit, cost is less likely to have an effect. On the other
hand, if a condition is judged to be less serious, and
where treatment may be mainly symptomatic rather
than curative, cost is more likely to impact. The evidence presented in the previous section, where cost
sharing was shown to have a greater effect on less
essential than essential medication, supports this.
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Types of patient charges for medicines and their impact CHAPTER 6
The actual amount of cost sharing is also important,
and the higher it is the more likely it is to impact on
patients’ management behaviour (called ‘price elasticity’). Patients’‘affordability factors’ are also im-
portant, where patients on lower incomes and with
competing demands on the resources they have available are more likely to be affected by cost sharing than
patients on higher incomes, without affordability
issues.
When cost sharing does affect patients’ management behaviour, patients respond by using a variety
and combination of strategies, which all aim to either
make the cost manageable or reduce it. Their use is
strongly influenced by patients’ income and affordability, where people on below average incomes are
significantly more likely to use these cost reduction
strategies than those on above average incomes
(Schafheutle et al 2004).
In order to cope with cost sharing, patients may
decide to:
*
Not have their medication dispensed at all
*
Take less of their medication to make it last longer
*
Delay having their prescription dispensed until
they have money available
*
Borrow money to pay for their prescription
*
Prioritize, i.e. get only some items dispensed if
more than one has been prescribed.
In some cases patients may also decide not to go to the
doctor to avoid getting a prescription that would then
need to be paid for, a strategy that will be particularly
prominent in systems where cost sharing also exists
for physician visits.
Patients in all types of cost sharing systems use
many of the above strategies , as they reduce
patients’ out-of-pocket expense for prescription
medicines regardless of the type of cost sh aring that
is in place. However, some strategies are o nly used
in certain systems, as their effectiveness in terms of
cost reduction depends on the particular type of cost
sharing system. A UK specific strategy, for e xample,
would be to buy a pre-payment certificate, while
the specific French strategy is to buy the complementary insurance ‘mutuelle’.Strategiesthatare
specific to patients who pay a proportional copayment are to:
*
Shop around at different pharmacies which may
offer different discounts
*
Purchase their prescribed medication cheaper in
another country (e.g. Mexico if from USA)
*
Apply to a pharmaceutical company’s Prescription
Drug Patient Assistance Program (USA).
Asking for cheaper generic drugs instead of more expensive brands is also a strategy likely to be used in
countries with proportional co-payments.
Self-medication strategies
Patients may also respond to high medication cost
sharing for prescribed medicines by opting to access
cheaper OTC remedies, if they are available. This
approach is only likely to work in systems with a flat
prescription charge, where the cost of the charge is
generally higher than the cost of many OTC products
(such as in the UK). Buying OTC products will also be
a strategy in countries where (some or all) OTC products are not prescribable (blacklisted), or are not
covered (i.e. paid for) by the healthcare system (such
as France, Germany and the Netherlands).
It is further interesting to note that patients are
price sensitive when making self-medication choices
(Schafheutle et al 2004). Especially if they experience affordability issues, patients consider the price
of different OTC products and may choose a cheaper
alternative. Conversely, in some cases paying a prescription charge works out cheaper than buying one
of the more expensive OTC products, which may
make some patients more likely to visit the doctor
rather than self-medicate. (This may be different in
countries where patients have to pay out-of-pocket
when they visit a doctor.)
Involving the prescriber
Prescribers also have a number of options available to
them which allow them to, in effect, prescribe in a
way that gives patients best ‘value for money’. The
types of strategies they can use, again, depend on the
cost sharing system within which they operate. In a
flat fee charge system (e.g. Austria, Germany or the
UK), they can, for example, issue a prescription for a
longer supply or a larger pack size, as this allows
patients to obtain a larger supply for the same fixed
charge. UK and German doctors may issue a private
prescription (in the UK alongside an NHS one) for
low cost drugs whose actual price is less than the flat
fee prescription charge. In a proportional co-payment
system, physicians can issue prescriptions for cheaper
generic rather than branded items.
Physicians may try to prescribe more ‘effectively’
by issuing fewer items, provided this does not compromise the clinical effectiveness of their treatment.
They may also prescribe a drug that may be more
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SECTION ONE Pharmacy practice and society
likely to be effective straight off and not require several attempts at finding a suitable drug, each requiring
a further charge (one example being a prescription for
a proton pump inhibitor for those that pay, rather than
antagonist, in the management of dyspepsia).
an H
2
UK doctors have further mentioned issuing samples
that have been left by pharmaceutical industry representatives (thus avoiding any patient charge) or packs
that were returned unused by patients (the latter,
however, is not usually a legal strategy; Weiss et al
2001). Doctors also have a role to play in recommending money-saving options, such as the availability of
pre-payment certificates (UK) or complementary insurance, or suggesting cheaper OTC alternatives.
For prescribing doctors to be likely to use strategies
that will help patients to afford their medication,
doctors need to be aware that patients pay and that
they do, in fact, experience affordability issues. However, patients are generally reluctant or embarrassed
to raise issues of cost and affordability with their
doctor, as they consider this to be their own problem
rather than that of their doctor, whose role they see as
choosing the clinically most appropriate treatment.
Nevertheless, if cost sharing impacts negatively on
patients’ adherence to prescribed regimens, this can
undermine their effectiveness, particularly if the
medicines in questions are essential. In order for doctors to be able to find the best treatment for their
patients, they need to know whether their patients
adhere to their medication, and if not, why not.
The role of community pharmacies
In most countries, community pharmacies are the
places where patients go to have their prescriptions
dispensed. This is therefore also the place where
patients have to pay the amount that is due for medication cost sharing, which makes it likely that
patients will raise issues of cost and affordability
there. Pharmacists and their staff thus have an important role to play in response to patients’ cost and
affordability issues, and the impact this may have on
their decisions not to adhere to their prescribed medication regimen as intended. Pharmacists can support
patients to make appropriate decisions, using some of
the above mentioned patient strategies. They can, for
example, raise awareness of complementary insurance programmes (or the pre-payment certificates
in the UK), recommend generic substitution or the
purchase of a cheaper OTC product where available.
However, pharmacists will also be faced by
patients delaying prescriptions, prioritizing certain
items, i.e. getting only some dispensed, or choosing not to have any of their medication dispensed,
because they cannot afford (or do not want) to pay
the medication cost sharing amount that is due. In
some cases these requests will relate to essential medication where adherence is crucial to achieving full
health benefit. In other words, cost-related nonadherence may lead to worse health outcomes for
these patients. An example might be that a patient
only wants to get his b-agonist inhaler dispensed when
he also requires a steroid inhaler. Or patients may
choose not to take medication for hypertension, as
the effect of this medication is not immediately evident to them andany long-term benefits are intangible.
Pharmacists have an important role in advising
patients about the action and benefits of their medication and the importance of adherence in order to
fully achieve this benefit. If understanding is increased, patients who can afford to pay may choose
to do so. Nevertheless, this advice is unlikely to work
for those patients who simply cannot afford to pay the
cost sharing. In these cases pharmacists may want to
liaise with doctors and other members of the healthcare team to discuss options to support this patient’s
treatment. Pharmacists and their staff may also be
able to inform patients about the availability of income-related systems for exemptions or subsidy and
how to go about applying for them (pharmacies may
even have the relevant forms available).
To ensure that issues of cost and affordability are
raised where necessary, pharmacists could incorporate appropriate questioning into pharmaceutical care
plans, or when conducting medication use reviews.
They should also ensure that they communicate any
relevant information to the prescribing doctor and any
other relevant healthcare professionals, so that a therapeutic plan can be discussed and agreed which meets
the patient’s clinical and other needs in the best (and
most affordable) way.
Conclusion
Cost sharing for medicines is a mechanism used in
many healthcare systems with the aim of deterring
unnecessary demand and thus containing healthcare
and drug expenditure. Drug use is indeed reduced
when cost sharing is implemented, but essential as
well as less essential medicines are affected. This
can have a negative impact on health outcomes,
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