Formulary Manuals & Treatment

Guidelines
DR MBURU
CLINICAL PHARMACIST

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CLINICAL GOVERNANCE TOOLS
Clinical governance is a system through
which healthcare providers are
accountable for continuously improving
the quality of their services and
safeguarding high standards of care.
Tools used are:
◦ Formularies
◦ Treatment guidelines

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FORMULARY MANUAL
Introduction
 It is drug centered and contains summary of drug
information on a selected number of drugs.

 The information is organized in therapeutic groups.

A therapeutic formulary contains detailed and

comprehensive therapeutic information on each of the
drugs listed and may also include guidelines for rational
prescribing.

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Information in a Formulary Manual

A. Introduction information
 Acknowledgments (individuals and agencies who
contributed, explanation of how drug information is
presented in manual);

 List of abbreviations;

 Introduction (development of manual, intended uses)

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Information ctd

B. Basic Information for each drug

 Generic name;
 Dosage form(s) and strength(s);
 Main indications (diseases and conditions for which
a drug is given);
 Pharmacology (may include pharmacokinetic data);
 Contraindications (reasons not to give the drug);

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Information ctd
 Precautions (such as pregnancy, breastfeeding,
certain health conditions);
 Side effects (major and minor, with estimated
frequency);
 Dosage schedule (dosage form, frequency, duration,
pediatric dosage, dosage adjustments for the elderly
and for the renal or liver disease);
 Instructions and warnings;
 Drug interactions (most common or severe).

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Information ctd
C. Supplementary Information on Each Drug
 Price;
 Level-of-use code;
 Regulatory category (prescription only, over-the-
counter, controlled narcotic drugs);
 Storage guidelines;
 Patient counseling information;
 Labeling information;
 Brand names and synonyms;
 National essential drugs list reference number;
 Stores catalog number.

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Information ctd

D. Prescribing and Dispensing Guidelines

 Rational prescribing;
 Principles of prescription writing;
 Use of placebos;
 Special requirements for inpatient prescriptions;
 Guidelines on quantities to be supplied;
 Special requirements for controlled drug
prescriptions;

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Information ctd
Prevention and reporting of adverse drug
reactions;
Dispensing guidelines (correct dispensing
practices, patient counseling);
List of cautionary and advisory labels;
Table of drug interactions (highlighting most
common and most severe).

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Information ctd
E. General Drug Use Advice (optional)
 Use of intravenous (IV) additives (general guidance,
table with recommended quantities);
 Prescribing in special situations (pregnancy,
breastfeeding, renal or liver disease, the elderly,
children, terminal care);
 Poisoning (general information, antidotes for common
poisons, telephone for poison centre if one exists);
 Treatment of snakebites, insect stings.

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Information ctd
F. Other components
 Metric units;
 Adverse drug reaction reporting form;
 Formulary revision form;
 Indexes (by generic name, brand name, therapeutic
category).

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Developing a Formulary Manual

A. Establish a National formulary Committee.

 The formulary committee could be the national drug
committee itself or a smaller subcommittee of it.
 Ideally, the formulary committee should include a
clinical pharmacist or pharmacologist, a physician,
and additional prominent medical specialists as
required, to prepare or review sections related to
their areas of expertise for accuracy and
completeness.

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Developing ctd

B. Secure an agreement on the content, structure,

and format of the formulary.
 The formulary committee should propose the
content, structure, general arrangement of the
information, and layout for approval by the national
drug committee.

 The committee should use models such as the BNF

to save time and effort.

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Developing ctd
C. Appointment of an Editor.
 One person (or a maximum of two co-editors) should
be appointed to draft the text of the formulary.

 The editor should have an understanding of the

pharmaceutical, pharmacological, and clinical aspects of
the information required and of the level of language
appropriate for the target audience.

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Developing ctd
D. Review the Draft.
 Once the first draft has been produced, it should be
presented to the formulary committee for review.

 The committee should call upon other experts to resolve

issues in dispute or to assist in the review of specialized
drugs or topics. The accepted amendments are then
incorporated into the text. This second draft should be
widely distributed

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Developing ctd
E. Review and produce new editions
 As therapeutic practices change and amendments are
made to the national list of essential drugs, these must
be reflected in the formulary, along with proposed
revisions submitted by users.
 Once a sufficient number of revisions has been received
and accepted, it is necessary to repeat the development
process to produce a new edition.
 It is important that new editions be produced regularly
to maintain the usefulness and credibility of the
formulary

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Practical Issues in Formulary Development
 

 In developing a formulary, consideration needs to the given

to such issues an sequencing, presentation of the
information, which information to include, size of the
publication, inclusion of brand-name drugs, and pricing
choices.

a. Sequence of Drug Monographs

 Structuring the drug information by therapeutic class is
better than following alphabetical order. It places each drug
in its therapeutic context and helps minimize duplication of
drugs.

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Practical Issues ctd
b. Presentation of Drug Information.
 Information of drugs can be presented in text or tables. Tables
are useful if the information is brief and for comparisons among
drugs. When information is more extensive, however, text is
more appropriate.
c. Size of the publication.
 A formulary can be pocket-size for day-to-day use or a larger
desktop reference for occasional use. If the focus is on
individual drugs, the formulary is probably most useful as a
desktop reference. If it is more comparative and evaluative, with
information on indications, dosages, and cost, including drugs of
first choice, it should probably be pocket-size. A loose-leaf
edition is not recommended, because pages tend to disappear
and updates are not always properly inserted.

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Practical Issues ctd
d. Inclusion of Brand-Name Drugs
 Although the drug monographs should always appear
under the generic name of the drug, it may be useful to
list common brand names.
 If these names are included, they should appear in
italics, both in the main text and in the index, so that
they are easily identifiable.
 This enables prescribers who are not yet familiar with
generic names to locate the required monograph easily.
Cross-references are helpful.

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Production issues in Formulary Development

A. Manuscript production and layout

It is important to define a standard style for chapters, tables,
and monographs before requesting outside experts to write
sections of a publication. If this is not done, large differences
in approach, level of detail and style can be expected. It is
cumbersome and time-consuming, and expensive to correct
these differences at a later stage.

If manual will be produced using an in-house computer and

word processing program , staff should be familiar with word
processing features that can assist in producing a well –
organized, easy to use manual.
 

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Production issues ctd…
B. Printing
 Time and money can be wasted if the formulary is printed in
the wrong format or to the wrong quality standard. Key
aspects of printing include page size, paper quality, printing
quality, cover design, quality of cover material, and binding.
The most widely used formulary manuals are pocket –size.

C. Distribution
 A clear, systematic, and realistic distribution channel should be
drawn up before the manual is sent to the printer. Apart from
distribution through government mail, alternative strategies are
distribution through workshops, professional associations, or
sales or adding the manuals to regular drug supplies.

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TREATMENT GUIDELINES

 The terms standard treatment guidelines, treatment

protocols and prescribing policies are used to indicate
systematically developed statements to help
practitioners or prescribers make decisions about
appropriate treatments for specific clinical conditions.

 Treatment guidelines exist for different levels of

healthcare centers, ranging from general prescribing
guidelines for paramedical workers in rural areas to
detailed protocols for tertiary health care centers in
wealthy urban areas.
 

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Potential benefits of Treatment Guidelines

A. For Health Officials

 Identification of cost effective treatments for common
health problems;

 Basis to assess and compare quality of care;

 Vehicle for integrating special programs (Control of

diarrheal diseases, acute respiratory infection,
tuberculosis, malaria etc.) at the point of primary health
care provider.

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Potential Benefits ctd

B. For supply management staff

 Identification of which drugs should be available for
the most commonly treated problems;

 Facilitationof prepackaging of course- of- therapy

quantities of commonly prescribed items;

 Drug demand more predictable , so forecasting

more reliable

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Potential Benefits ctd
C. For Health care providers
Expert consensus on most effective , economic treatment for
a specific setting;
Opportunity for providers to concentrate on correct diagnosis
Quality of care standards
Basis for monitoring and supervision
D. For patients
Encouragement of adherence to treatment through
consistency among prescribers;
Most cost effective treatments are provided
Improvement in the availability of drugs
Better treatment

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Information in Treatment Guidelines

A. Diagnostic criteria
 Diagnostic criteria are essential when disease may
present in different stages of severity.

 They need to indicate when treatment is needed and

when it is not such as in the treatment of fever and
cough.

 Required investigations may be indicated

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Information ctd
B.Treatment of First Choice
 The section on the first choice treatment (drug or non
drug) contains the most information for the prescriber.

 It should include the choice of drug, its usual dosage

schedule and, when needed adapted dosage schedule for
children, for patients with concurrent liver or renal
diseases for the pregnant patients and the elderly, and
for other high risk groups

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Information ctd
C. Important contraindications and Side Effects
 This section should list both relative and absolute
contraindications; groups at special risks should be
highlighted.
 Side effects should be broken down into reactions that
are self limiting and those that may require a change in
therapy

D. Important drug information, Warnings, and precautions

 This highlights the information that the patient should
be given by both the prescriber and the dispenser.

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Information ctd

E. Referral Criteria
These criteria describe when to refer patient to a
higher level of care.
 
F. Cost of Treatment
Information on the cost of treatment is useful if
alternatives are proposed. However it means the
guidelines have to be updated regularly. The
information can be presented as price ranges such as
cheap, moderate and expensive or as price tags.
  
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Information ctd

 G. Index
 Although treatment guidelines are usually disease
centered; many prescribers also use them to check on
specific drugs or dosage schedules. For this reason an
index with both drug names and health problems makes
the manual more useful.
 

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SPECIAL PATIENT
POPULATIONS

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Definition
Special patient populations require more health care
services and/or specialized health care services than
other people.
Include:
 pregnancy
 breastfeeding
 renal disease
 liver disease
 the elderly
 children
 terminal/palliative care
 chronically ill and disabled

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HEALTH EDUCATION AND
PROMOTION

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Definition
Health education is a social science that
draws from the biological, environmental,
psychological, physical and medical sciences
to promote health and prevent disease,
disability and premature death through
education-driven voluntary behavior change
activities.

Health promotion enhances quality of life

for all people.
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Cont…
Health education objectives:
◦ Provides knowledge
◦ Develops positive attitudes towards health
issues
◦ Promotes decision-making.

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The role of a pharmacist/ pharmaceutical
technologists
1) Ensuring that new personnel are trained
properly in the policies and procedures
of the pharmacy.
2) Providing drug information as necessary
to the pharmacy, medical and nursing
staff.
3) Communicating with nurses and
physicians concerning medication-
administration problems.
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…Roles
4) Counseling patients on:-
a) medication to be self –administered in the
hospital.
b) Discharge medication
5)Providing in-service education to pharmacists,
physicians, nurses ,interns, medical ,pharmacy and
nursing students.
6)Participating in public health education ,prevention
and control of poisoning.
7) Participating in health promotion activities Eg????

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Egs of health promotion activities
 Chronic disease awareness and prevention
 Maternal and infant health promotion
 Tobacco use and substance abuse
prevention
 Injury and violence prevention
 Mental and behavioral health promotion
 Nutrition, exercise and obesity prevention
 Reduction of risky behaviors

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