Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5593_Библиотеки_им_академика_М_И_Перельмана.pdf
X
- •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

Socio-behavioural aspects of health and illness CHAPTER 3
positive effects of social support in different stages of
illness can be summarized as follows:
*
In the prevention of illness it can reduce insecurity
and anxiety
*
In the acute stage of illness it has a calming effect
giving a sense of security
*
In the rehabilitation phase it can improve
adherence to medical regimens.
The side-effects to the patient of excessive social support or poor quality support may include increasing
the passiveness of the patient, creating dependence,
reducing self-confidence and self-esteem and causing
feelings of shame and guilt.
KEY POINTS
*
Social and behavioural issues can help explain
non-biological aspects of health
*
Illness is a person’s reaction to a perceived
alteration of body or mind, while disease is
something which is professionally defined
*
Health has been defined by the WHO as a ‘state of
complete physical, mental and social well-being
and not merely the absence of disease and
infirmity’
*
Apart from biophysical factors, health is also
affected by behavioural, environmental and socioeconomic determinants
*
People react differently to symptoms as a
consequence of many factors
*
Family, culture, gender and age influence response
to symptoms
*
Type A behaviour is more closely associated with
illness than Type B behaviour
*
The knowledge which a person has will affect his
response to illness
*
According to the health belief model, the patient’s
perception is most important in determining
patient behaviour and decisions
*
The theory of reasoned action suggests that beliefs
give rise to attitudes, which form intentions which
lead to behaviour
*
The conflict theory can be used to explain rational
and irrational decision making
*
People use a wide range of coping mechanisms
when under stress
*
Humans may not reach decisions logically for many
reasons, with biases being particularly important
*
Behaviour is seldom changed as a result of
providing facts, but results from a long series of
stages
*
Through the self-care philosophy, patients are
increasingly encouraged to be responsible for their
own health, placing increasing demands on
pharmacists
*
The 1978 Alma Ata Declaration defines the content
of primary care which should be available to all
*
Demographic, cultural and socio-economic factors
influence the use of health services
*
Social support networks may be primary,
secondary or tertiary and are important for the
health of individuals
39

This page intentionally left blank

Chapter Four
Socio-behavioural aspects of
treatment with medicines
K. Hannes Enlund
4
STUDY POINTS
*
Functions of medicines
*
Societal perspectives on rational use of medicines
*
Factors affecting the treatment process with
medicines
*
Sociological and behavioural aspects of use and
prescribing of medicines
*
A sociological perspective of pharmacy and the
pharmacy profession
*
Measuring outcomes
Introduction
In attempting to understand the treatment proc ess
with medicines we can partially apply the same
theoretical models as for illness behaviour presented
in the previous chapter (see also Fig. 3.1). It is also
feasible to regard the treatment process from a
macro and a micro perspective. The macro perspective includes an analysis of the different systems and
structural components in place to ensure a rational
use of medicines, which is one of the primary goals
ofthesystem.Themicroperspectiveincludesthe
patient level and the interaction between patient
and practitioner.
When explaining patient behaviour in taking or not
taking medicines and the interaction with the environment we can, for example, use the social learning
theory and the concept of self-efficacy (see p. 33).
The health belief model (see p. 31) has been used to
explain patients’ adherence in taking medicines. In
addition, we need to understand the behaviour of
the physician when prescribing the medicines and
dealing with the patient. Likewise our interest is to
understand the behaviour of the pharmacist and the
patient–physician–pharmacist interactions. Different
models and theories provide a slightly different perspective on the use of medicines, and the adequacy of
the theory often depends on the question being
addressed. Because this is a relatively new research
area there are still many gaps in our understanding of
the different processes involved and their interactions.
Functions of medicines
Social and behavioural scientists have proposed that
medicines and use of medicines also serve important
latent functions for the individual and society. In this
context it is important to have a wide definition of the
word ‘medicines’. The functions may be the same as
the approved medical uses or may be hidden functions. Barber and later Svarstad have identified a long
list of these functions:
*
Therapeutic function – the conventional use of
medicines to prevent, treat and cure disease
*
Placebo function – to show concern and satisfy
patient
*
Coping function – to relieve feelings of failure,
stress, grief, sadness, loneliness
*
Self-regulatory function – to exercise control over
disorder or life
*
Social control function – to manage behaviour of
demanding or disruptive patients, hyperactive
children
*
Recreational function – to relax, enjoy company of
others, experience pleasurable feelings

SECTION ONE Pharmacy practice and society
*
Religious function – to seek religious meaning or
experience
*
Cosmetic function – to beautify skin, hair and body
image
*
Appetitive function – to allay hunger or control the
desire for food
*
Instrumental function – to improve academic,
athletic or work performance
*
Sexual function – to increase sexual ability
*
Fertility function – to control fertility
*
Research function – to gain knowledge and
understanding of human behaviour
*
Diagnostic function – to help make diagnosis
*
Status-conferring function – to gain social status,
prestige, income.
A societal perspective on rational use of medicines
Defining rational use
Rational use of medicines has been defined as the safe,
effective, appropriate and economic use of medicines.
The definition as such seems to be clear and straightforward, but how do we define ‘safe’ and the other
components of the definition? Safety relates to aspects
like relative and absolute safety.It is well knownthat all
medicineshave side-effects, some less and some more.
The safety aspect has to be assessed from many different angles, e.g. the severity of the disease, the
available treatment options including medicines and
non-medicines options, long-term or short-term treatment, whether the medicine isto cureor control symptoms, any risks of overdoses and other possible factors.
Effectiveness relates tothe question of how wellthe
medicine works in daily practice when used by unselected populations and patients having co-morbidities
and other medications. Efficacy relates to a clinicaltrial
type of situation, where we want to know the maximum effect of the medicine in a particular disease and
when it is optimally used in selected patients with
as few confounding factors as possible, such as comorbidities and other medicines used simultaneously.
Appropriateness refers to how a medicine is being
prescribed and used in and by patients, including
aspects such as appropriate indication, with no contraindications, appropriate dosage and administration.
Duration of treatment should be optimal and the
medicine should be correctly dispensed with appropriate and sufficient information and counselling. To
achieve the intended effects, the medicine also needs
to be correctly used by the patient.
The economic aspect does not refer merely to
price; rather, a cost-effectiveness approach needs to
be applied, where all factors are assessed. A somewhat
more expensive medicine may be preferable to a less
expensive medicine, for example because it has better
treatment outcomes or fewer side-effects. We should
also be aware of hidden costs, such as a need for more
extensive laboratory tests, which may increase the
total cost of a particular treatment (see Ch. 19).
National medicines policy
Ensuring rational use of medicines requires that there
are appropriate structures in place and that the processes involved are functioning well. The starting
point and frame of reference is the national medicines
policy (NMP). The role of an NMP is usually discussed in the context of medicine-related issues in
developing countries. In industrialized countries it
has received much less attention, because many key
issues and policies regarding medicines and their rational use are already in place. However, the global
crisis in healthcare financing, especially the medicines
budget, has created a momentum to look more closely
at medicine policies in industrialized countries too.
When trying to understand the general principles that
can be applied to all countries it is helpful to use the
guidelines that have been proposed for developing
countries, and from there try to understand how the
system works and what might be the strong and weak
points in each particular country.
The NMP can be seen as a guide for action, including the goals and priorities set by the government, the
main strategies and approaches. It also serves as a
framework in the coordination of different activities.
Depending on cultural, historical and socio-economic
factors there are differences in objectives, strategies
and approaches between countries, but some common components can be distinguished. The goals for
an NMP can be divided into:
*
Health-related goals, which entail making essential
medicines available, ensuring the safety, efficacy
and quality of medicines, and promoting rational
prescribing, dispensing and use of medicines
*
Economic goals, which may include lowering the
cost of medicines and providing jobs in the
pharmaceutical sector
*
National development goals, which may include
increasing the skills of personnel in pharmacy,
42

Socio-behavioural aspects of treatment with medicines CHAPTER 4
medicine, etc. and encouraging industrial activities
in the manufacturing of medicines.
There is further discussion of these issues in Chapter
7.
Ensuring safety of medicines
Why is it important to regulate and control the medicine sector with special laws and regulations? The
medicine sector is of concern to the whole population.
Most citizens will use medicines and related services
on a regular basis and therefore the functioning of the
sector is of common interest. There are also many
parties involved – patients, healthcare providers, manufacturers and sales people – requiring detailed rules
for interaction and functioning. The consequences
from the lack of medicines or their misuse might be
serious. History has shown that informal controls
are not sufficient or respected. Generally there is
little disagreement about the need to regulate the
medicine sector; the disagreement lies rather in the
extent to which it should be regulated.
Legislation and regulation include different healthrelated laws, pharmacy law, trademark and patent
laws, criminal law, international treaties (e.g. on narcotic and psychotropic drugs) and governmental
decrees. Sometimes there may be a lack of political
will or a weak infrastructure to enforce the laws.
When looking at the legal situation in the medicine
sector in different countries, the problems seem to be
more often in the enforcement of legislation than in
the lack of legislation.
Registration of medicines is a key tool in assuring
the safety, quality and efficacy of a new medicine
being introduced on the market. In this connection
the new medicine wi ll also be scheduled to a certain
category such as prescription or over the counter
(OTC) medicine. The infrastructure that will assure
quality, safety and efficacy can be ascertained by
licensing and inspection of manufacturers, distributors and the premises, b ut also by setting some standards on the professionals working there. There is
wide international cooperation in this field among
the different competent authorities. Nevertheless
every now and then the media have reports abou t
counterfeit products an d toxic produc ts sold to the
public, sometimes with disastrous consequences.
News such as somebody having replaced glycerin
with diethyleneglycol in paracetamol syrups
intended for small children should not be possible
with all the controls in place today.
Pharmaco-epidemiological studies are used to assure the safety of new medicines after they have been
accepted on the market. This kind of information can
supplement that available from pre-marketing studies;
it can also give a better quantification of the incidence
of known adverse drug reactions (ADRs), and also of
the beneficial effects. For ethical and other reasons it
is not always suitable to perform clinical trials on
certain patient groups such as children, elderly people
and pregnant women in the early phase of a new
product. It is also important to establish how other
medicines and diseases may alter the positive effects.
New types of information not available from premarketing studies, such as rare undetected ADRs,
long-term effects that manifest only after long use or
after long latency periods, and effects with low frequency are also the concern of pharmaco-epidemiological
studies. Further aspects on the safety and evaluation
of medicines are dealt with in Chapters 19 and 47.
Ensuring the availability of
medicines
Availability of medicines is one of the key requirements in a well functioning pharmaceutical system.
This includes a functioning manufacturing and importation system of medicines, good procurement and
distribution practices. These functions are often taken
for granted in industrialized countries, while in developing countries they are key issues for a functioning
system. In developing countries the maintenance of a
constant supply of medicines, keeping them in good
condition and minimizing losses due to spoilage and
expiry are issues that need to be solved to assure the
availability of medicines to the population.
With more and more sophisticated new medicines,
the prices of new products are beyond reach for a
large part of the population if no mechanisms like
price control or reimbursement/insurance systems
are in place. Economic availability of medicines will
be a major policy issue in all countries during the next
few years. With national medicine budgets increasing
annually by more than 10%, there is a doubling of the
budget every 5–6 years.
Use of medicines
Medicine (drug) use or utilization studies and pharmaco-epidemiological studies during the last 25 years
have basically tried to describe who are using the
43

SECTION ONE Pharmacy practice and society
medicines and how much are being used. On a macro
level, factors influencing medicine consumption include among others: size of population, age and gender distributions, occupational structure, income
levels (gross national product), availability of health
services, number and type of health facilities, number
and type of personnel, social insurance and reimbursement mechanisms.
Medicine use studies have also been used to identify different types of ‘irrational use’, e.g. overuse of
psychotropics and antibiotics in the 1970s and 1980s
(such as people using them, when not indicated, for
too long periods and habitual use of analgesics every
morning without a medical reason). There has also
been a lot of interest in the ‘underuse’ of medicines
for major chronic diseases such as hypertension, diabetes and elevated lipids (not starting or stopping
treatment, ‘drug holidays’, taking only half of what
is prescribed). Underuse, together with misuse or
erratic use (wrong way of administration, taking with
contraindicated medicines/food, etc.), has been one
of the main focuses of patient adherence studies.
From these studies we know something about the
use of medicines and its clinical, social and economic
consequences (see also Ch. 46).
Attempts to understand the medicine use behaviours of patients have been less common. However,
more recently, a new research line has emerged using
qualitative research methods such as in-depth interviews. These studies have focused more on what people think about their medicines, on their motives
when taking or not taking them, their attitudes and
beliefs about medicines and their experiences and
expectations.
Some general consumer behaviour models have
been used to explain non-prescription and prescription
purchases. In one American study the medicine
attributes that consumers rated as important included
possible side-effects, physician recommendation,
strength, prior use, price and the availability of generic
versions. Medicines are not ordinary goods and consumers acknowledge this. According to one purchase
theory, purchase motivations can also be characterized
as being either transformational (positive) or informational (negative). Positive purchases are made to enhance or generate a positive situation or state of mind
(e.g. clothes, music) and negative purchases to minimize or prevent negative situations (e.g. car service).
Negative purchases are based on (rational) choices like
perceived benefits and convenience (and therefore
require more information), while positive purchases
are more emotional and based on subjective appeal
and positive shopping experience. Research has shown
that OTC medicines and vitamins are neutral on the
positive–negative dimension and oral contraceptives
highly negative. This type of research is still not very
well developed within the pharmaceutical field.
Like general illness behaviour, medicine use occurs
in a social context. Choosing self-medication or consulting a physician to obtain prescription medicines is
not based solely on symptoms or clinical aspects. The
concept of social knowledge has been used to describe
collective understanding, which is based on available
information and nature of prior experiences. Family
members, friends, work colleagues and their experiences, books and the media in addition to our own
experiences, form the basis of social knowledge of
medicines. Montagne has described some interesting
social conceptions or fundamental principles about
medicines in peoples’ minds, which he calls ‘pharmacomythologies’.It is a common belief among laypeople
that a specific medicine produces only one ‘main’ effect, which is positive. Other effects are considered as
negative or ‘side’-effects. Likewise it is believed that a
medicine produces the same main effect every time it
is taken and in each person who takes it. This means
that medicine effects are caused by the taken medicine
and the effect of the medicine is a property residing
inside the chemical compound and not a function of
some change in a living organism. This easily leads to
the belief that medicines cure the diseases.
The general health behaviour models and theories
previously presented – such as the health belief model, theory of reasoned action, social learning theory,
conflict theory and behavioural decision theory – can
all be used to explain certain types of behaviour related to taking medicines. Basic decision-making and
problem-solving skills are important components of
patients’ seemingly rational and irrational behaviours.
As presented earlier, the choices do not always follow
the criteria of medical rationality, but may seem quite
rational to the patient. It may be useful to consider
rationality as a continuum rather than either/or. The
degree of rationality is also influenced by social knowledge and the micro and macro environment, as described earlier, as well as the actual health problem.
Improving public understanding
of medicines
During the last few years there have been different
attempts both in developed and developing countries
to improve knowledge and understanding about
44

Socio-behavioural aspects of treatment with medicines CHAPTER 4
medicines among the general public. This can be seen
as an attemptto influenceand improve (from a medical
point of view) social knowledge related to medicines
and health in general. Campaigns such as ‘Ask about
your medicines’ are good examples of this kind of
activity. A more balanced partnership between consumer-patients and healthcare providers is one of the
goals in such activities. A better appreciation of the
limits of medicines and a lessening of the belief that
there is a ‘pill for every ill’ are examples of the goals of
such efforts.
The general public also needs to develop a more
critical attitude towards advertising and other commercial information, which may often fail to give
objective inform ation about medicines. The use of
medicines should be seen within the context of a
so c i ety, c om mun i ty, fa m ily a n d i ndi v i dua l , re c ogni z ing cultural diversit y in concepts of health and illness or how medicines work. Improvement of the
public’s knowledge about medicines should start at
school. To facilitate informed choices on use of medicines, public education should be accompanied by
supportive legislation and controls on availability of
medicines. Non-governmental organizations, community groups and consumer and professional organizations should be involved in the planning and
implementation of such programmes. Effective public education requires a commitment to and understanding of the need for improved communication
between healthcare providers and patients. This
should also be reflected in the basic and continuing
education of healthcare personnel.
Prescribing
Functions of prescriptions
Besides the pharmacological-therapeutic use, physicians may sometimes use medicine knowingly or
unknowingly for other reasons too. According to
Smith (2002), these can b e either patient or phy-
sician centred. He has also presented a long list of
latent functions of prescriptions in addition to their
intended and recognized functions (method of therapy, legal document, record source and means of
communication). Medicines may be used to stimulate the patient’s expectations for recovery and to
meet patients’ expectations, e.g. the use of antibiotics for viral infections or boosting a patient’smorale in intractable diseases. The physician may also
want to gain some time to diagnose the condition
more precisely. The medicine also legitimizes the
physician–patient r elationship. The prescription is a
sign of the physician’s power to he al and his efforts
to try to heal and care for the patient. For the
patient the prescription is a sign and symbol that
they really are ill. Thus it also legitimizes their sick
role and confirms that they have fulfilled one of
the obligations of the sick role, to try to become
well again (p. 30). Finally the physician uses the
prescription to communicate to the patient that the
office visit is over. Sometimes it may be difficult
to distinguish b etween rational/pharmacological
and non-pharmacological use of medicines. It can
also raise ethical dilemmas, for example when
purposely using placebos. Is the physician in this
case cheating and/or behaving in a paternalistic
way, when he should h ave an honest and trustful
physician–patient relationship?
The process of prescribing has gained a lot of interest lately because of ever increasing medicine costs
and the concern for rational prescribing from a clinical point of view (see also Ch. 17). Before this,
social scientists had studied aspects such as the
decision-making process in prescribing and the
adoption of new medicines, using the ‘diffusion
of innovations’ theory. Concern about prescribing
habits is not new. In 1752 the famous Swedish physician and botanist Carl von Linne mentioned in a
paper 21 different reasons for irrational prescribing,
including factors like outdated knowledge, wrong
diagnosis and chemical incompatibility, which are
still relevant aspects when assessing rationality of
prescribing. It is noteworthy that he used pharmacy
records as his source of information.
Choosing the right medicine
Therapeutic effect is the most important criterion
when the physician decides which medicine to prescribe. When treating severe cases this aspect is even
more important. A second consideration is the incidence and severity of side-effects. It has been shown
that physicians tend to concentrate on a few serious
side-effects. The medical situation often determines
the acceptable level of side-effects. Economic aspects
have a lower priority than the first two dimensions.
Low cost or actual amount paid by the patient has a
minor role due to reimbursement systems in place in
most industrialized countries. If patients pay, the physician gives more attention to cost. Patient convenience and compliance may be decision criteria in
45

SECTION ONE Pharmacy practice and society
Figure 4.1*The factors which must be balanced in treating
patients (after Barber).
situations when medically similar preparations are
available, e.g. suppositories not being recommended
when oral preparations are feasible. When prescribing
for children, taste may be an important factor to consider (see Ch. 30).
In studies concerning the adoption of new medicines, it was shown that those physicians at the centre
of a professional network tended to be innovators and
started prescribing the new medicine at an early point.
An early adopter in one therapeutic area might not
necessarily be an early adopter in another therapeutic
area. The opinion of colleagues is important; two physicians in close contact with each other tend to start a
new medicine at the same time. Also the type of
practice is an important factor. Physicians working
alone adopt a new preparation more slowly than those
working in group practices.
Barber has shown the dilemma the physician faces
when choosing the right medicine. The problem is
summarized in the question of how to find the right
balance between the areas shown in Figure 4.1:
*
Maximizing the effectiveness of treatment
*
Minimizing the side-effects
*
Minimizing costs
*
Taking into account patient’s wants and wishes.
Models to study prescribing
Several studies have tried to find typical characteristics of prescribing physicians and their work settings
that would explain both irrational prescribing and
prescribing in general. Basically three types of models
and approaches have been used:
*
Models focusing on demographic and practice
variables which give descriptive information about
what and how physicians tend to prescribe. These
variables are often difficult or impossible to change,
but these types of study point to where the focus
should be put and indicate possible points for
intervention
*
Models focusing on psychosocial issues related to
physician–patient interaction
*
Models focusing on cognitive theories behind
prescribing decisions. These studies focus on how
physicians evaluate the available information and
their decision-making process.
There seems to be no general competency to prescribe rationally, since a physician may prescribe
rationally in one area and irrationally in another.
This could be expected if, for example, an ophthalmologist prescribed for cardiac conditions. Younger
and more recently graduated physicians usually
seem to prescribe more rationally than older physicians. It has been found that physicians with a negative attitude towards the use of medicines for
social problems tend to prescribe fewer psychotropic medicines. The availability of non-medicine
alternatives (e.g. cognitive therapy) reduces benzodiazepine prescribing. Also the social environment
may be important in prescribing, for example during
the Gulf War, benzodiazepine prescribing doubled
in Israel compared with the period before and after
the conflict. A more cosmopolitan attitude and a
more critical attitude towards commercial information were associated with more careful prescribing
of risky medicines in one study. Another study
showed that ‘less rational prescribers’ , defined as
those with a high rate of benzodiazepine prescriptions, rely more on commercial information from
the pharmaceutical industry than others. Professional satisfaction and reading professional material
seem to translate into better prescribing.
Many physicians base their selection of medicines
on their own experience, which may not be an accurate base for rational selection. The probability of
observing rare but important side-effects is very small
for an individual physician. The same biases that were
mentioned earlier affecting patients’ decision making
also affect physicians’ decision making. If they have
high initial positive expectations before starting a new
treatment, the outcomes will be interpreted in a way
that meets these expectations. Negative aspects will
not be accounted for. Only positive aspects transform
into writing more new prescriptions. Irrational prescribing is also often legitimized by positive personal
experiences from prescribing or using that medicine.
High medical uncertainty may also contribute to irrational prescribing. On the other hand it may also result in seeking information from many sources to
reduce this uncertainty.
46

Socio-behavioural aspects of treatment with medicines CHAPTER 4
Certain patient factors also influence the probability of receiving a prescription for psychotropic medicines. The most widely studied factors have been age
and gender. The elderly are usually prescribed more
than younger people, which may be a reflection of a
higher rate of symptoms and psychological distress.
There is also a tendency to write more repeat prescriptions for the elderly, partly reflecting the type of
medication being prescribed. Women are prescribed
psychotropic medicines more often, which is partly
explained by a higher consultation rate. The sex of the
physician does not seem to influence this tendency to
prescribe more for women. Physicians’ expectations
that women have more psychological–emotional disorders that can be treated successfully with benzodiazepines may also partly explain the difference.
Influencing prescribing
Providing information and employing educational programmes to change physicians’ prescribing behaviour
has become an integral part of the pharmacist’snew
role. Pharmacists participate in this kind of activity as
part of their daily work, but also in formal trials or
programmes in community and institutional settings.
Several experimental studies have shown that pharmacists providing information and educating physicians
produce positive effects on knowledge and attitudes,
but the effects on prescribing behaviour have usually
been modest. Providing physicians with printed material alone will not influence prescribing habits.
Individual feedback coupled with one-to-one education is the method most likely to be successful.
Educational outreach or academic detailing has been
studied and practised for the last 20 years. It follows
the same principles as do medical representatives for
pharmaceutical companies in their promotional activities. The basic principles are that physicians need to
be interviewed in their own office where they are most
receptive, the facilitators (often pharmacists) should
be well presented and briefed, and the messages
should be concise, clear and relevant to the prescriber.
The programme should also be ongoing with repeat
visits on a regular basis to maintain the contact and
keep the messages up to date. The second major strategy includes managerial and regulatory activities such
as use of limited lists (e.g. for reimbursement purposes), hospital or regional drug and therapeutic committees and formularies, structured medicine order
forms (e.g. special forms for narcotics), drug utilization
review (DUR) and treatment guidelines.
Pharmacies and the pharmacy profession
Historically a pharmacy has been the place for preparing and dispensing medicines. The first known
pharmacy was established in the year 766 in Baghdad.
In Europe the first pharmacies date back to the 11th
century. In ancient times the same person acted as
both doctor and pharmacist, i.e. diagnosed, prescribed and prepared the medicines for the patient.
But in 1231 the German emperor and king of Sicily,
Frederick II of Hohenstaufen in the edict of Palermo,
legally separated the professions of medicine and
pharmacy. Physicians were to diagnose and prescribe
medicines, while pharmacists were to be responsible
for preparing the medicines and providing these to the
patients. Pharmacies were also designated to certain
areas, where they had the monopoly of selling medicines. Certain physicians were also to oversee the
work of pharmacists. Frederick also laid down rules
about the education of healthcare professionals.
These and other provisions given by him were the
basis of legislation and practice of pharmacy in many
European countries until the 20th century.
Elsewhere the distinction between the medical
and pharmaceutical professions has not always been
so clear and we can still find dispensing doctors today.
However, in most countries, through the last centuries, pharmacists have acted as the ‘poor man’s doctor’, diagnosing and prescribing. It should be
remembered that the classification of medicines into
prescription and OTC medicines has happened only
fairly recently. Some other countries have similar legislation in place, but it is not enforced. The system of
dispensing doctors has been defended based on availability and grounds of patient convenience. The problems related to the system are an apparent conflict of
interest, which is present when the income of the
physician depends on the volume and price of medicines prescribed. This problem has been highlighted
in Japan, which also has one of the highest costs of
medicines per capita in the world and where prescription medicines are mainly distributed by physicians.
The same conflict of interest is often mentioned in
the context of the professional and business roles
of the pharmacist, especially concerning sales of
non-prescription medicines.
There has been much discussion about the occupational status of pharmaci sts. Is pharmacy a true
profession or not? Two major approaches have been
used by academics in trying to answer the question.
47

SECTION ONE Pharmacy practice and society
One approach is to look at the functions pharmacists perform for society, asking i f they are vital for
the society. The second approach is to look at certain characteristic traits of the occupation and determine whether they fulfil typical traits of a
profession. During the last 50 years, different traits
have been mentioned by different academ ics, but
there are some common ones. In the 1950s, Lewis &
Maude mentioned the following traits that characterize a profession:
*
Registration or state certification embodying
standards of training and practice in some statutory
form
*
A fiduciary practitioner–client relationship
*
An ethical code
*
A ban on the advertising of services
*
Independence from external control.
Most authors agree that the basic traits of a learned
profession are advanced and lengthy training in a highly specialized body of knowledge. This knowledge
is to be used in the service of society and mankind.
Research and abstract reasoning are the ways of
expanding this unique body of knowledge. The services provided by a profession are also related to the
degree of impact or danger they may have on individuals or society. Besides the expert knowledge the
professional possesses, he must also exert his professional judgement to the benefit of the client.
Co-workers in the same or related occupations acknowledge the level of expertise of the profession,
which is also important in legitimating the practice.
There is also a certain level of trust that the public
must place in the work performance of the professional. Professionals themselves define which kind of
activities are allowed and what privileges members
may claim. They also define, through ethical codes
and legislation, which they have often themselves had
an opportunity to draw up, the type of controls that
guarantee the social privileges given to them (like
autonomy of action, monopoly of practice, remuneration) are not abused.
Role of pharmacists
The origin of the pharmacy profession was in the
unique knowledge base and skills needed to compound a drug product. With the growth of the
pharmaceutical industry, this function decreased
throughout the 20th century, especially in the 1950s
and 1960s. Today it is impossible for the individual
pharmacist in the pharmacy to compound similar
products to those of the pharmaceutical industry. Also
the pharmacist’s traditional role of procuring and storing crude drugs has vanished. As the pharmacist’s
knowledge about the proper preparation, storage
and handling of medicines is still greater than any
other professional group, the quality assurance
aspects of medicines are still their responsibility. Both
the society and the profession have defined that the
duty of the profession is to ensure that the medicines
provided to patients are safely and accurately dispensed. The question raised in the 1960s was whether
the status of pharmacy as a profession could be maintained if it were based solely on storing and distributing medicines. The discussion was referred to as ‘the
profession in search of a role’ . This discussion was one
contributory factor in the rise of the clinical pharmacy
movement in the USA starting in the 1960s. The
debate about the pharmacist’s role has continued
ever since, with new developments like the pharmaceutical care movement and the ‘extended role’ of
the pharmacist in the 1990s. Today there seems to
be some kind of consensus among pharmacy spokespersons that the future of pharmacy as a profession
lies in pharmaceutical care. In different countries,
however, there seem to be different interpretations
about what pharmaceutical care is all about. Another
question is to what extent the profession at the grassroot level has embraced this philosophy and to what
extent it is being practised in everyday pharmacy
practice.
International guidelines for
good pharmacy practice by
the FIP
The International Pharmacy Federation (FIP) has issued its guidelines for good pharmacy practice (GPP),
stating that the mission of pharmacy practice is to
provide medications and other healthcare products
and services and to help people and society to make
the best use of them. The concept of GPP is based
mainly on the concept of pharmaceutical care. The
patient and community are the primary beneficiaries
of the pharmacist’s actions and the pharmacist’s first
concern must be the welfare of the patient in all settings. The core of pharmacy activity is the supply of
medication and other healthcare products of assured
quality, appropriate information and advice to the
patient and monitoring the effects of their use. From
an international perspective, a rather new aspect is
the quest for the pharmacist’s contribution to the
48
Соседние файлы в папке Библиотека им академика М.И. Перельмана
