ADVERSE DRUG REACTIONS

KEY POINTS
Adverse drug reactions (ADRs) may be
augmented (Type A) or bizarre ( Type B);
Type A reactions may be due to excessive or
unwanted pharmacological effects,
withdrawal reactions, delayed effects or
failure to individualize dosage;

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 Many Type B reactions have an

immunological or genetic basis and are

normally unrelated to dosage.
At the time of marketing a new drug, not all
ADRs may be known;
Factors Influencing ADRs include multiple
drug regimens, multiple disease states, type
of drug, route, formulation and dosage, age,
gender, race and extent of compliance with
medicines;
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 Causality of ADR can be categorized using

set criteria;
The Yellow Card scheme is used by the

CSM as one type of postmarketing

surveillance;
Pharmacists can play an important role in

identifying, documenting, monitoring and

preventing ADRs in their routine practice;
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 Pharmacists

should report suspected ADRs

to the CSM or to regional monitoring centres
on Yellow Cards;

Hospital pharmacists

should report
particularly ADRs to drug initiated and
monitored within hospital specialist units;

Community pharmacists should report

particularly ADRs to non-prescription

medicines
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MEDICINES INFORMATION
KEY POINTS
All pharmacists have a responsibility to

provide information and advice about any

medicine supplied by them or under their
authority. It is vital that this information
should be reliable, accurate and up to date;

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 Pharmacists need to be familiar with the key

reference sources that are useful for

common types of questions ( e.g. drug
interactions, side-effects, drug use in
pregnancy) and to be able to critically
appraise and evaluate the information
found. A systematic search strategy should
be adopted when dealing with enquiries or
clinical problems;
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 Remember, the worst question is the one

that is not asked. Continue to question drug

therapy issues as this can only enhance
your experience, expand your knowledge
and, most importantly, benefit your patients,
Never settle for poor or inadequate answers.

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The Evaluation of Medicines

Key Points
Pharmacists are involved extensively in

evaluating medicines, their use and

information about medicines;
The Committee on safety of Medicines (CSM)
requires granting a product licence for a new
drug;
Clinical trials take place in three phases :
Phase I- determines the basic toxicity and
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tolerability,

Phase II establishes efficacy and confirms

the dosage,
Phase III determines safety and efficacy on
a larger sample;
Postmarketing studies enable comparisons to

standard therapies, establishment of new

indications and are required to establish many
adverse reactions to drugs;
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 Evidenced-based medicine seeks to identify

the available evidence to answer specific

clinical questions, critically appraise if and
apply it to individual patients or to populations;
There are several organizations in the UK
providing evaluated evidence of the efficacy,
safety and economy of medicines;
Drug utilization review (DUR) assesses the
patients of drug use un particular clinical
situations;
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 Drug Use Evaluation ( DUE) relates drug use

to patient outcome;
Methods for studying DUR and DUE include
the use of drug purchase records, drug issue
records; prescription records, medical
records and specifically designed recording
systems;
Patient questionnaire methods can provide
useful information about the use of nonprescription drugs.
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PHARMACOECONOMICS
Key Points
Pharmacoeconomics applies the principles

of economic evaluation to pharmacy;

Some of the basic economic concepts are
scarcity, choice and opportunity cost which
can be applied to the medical field;
There are recognized steps in carrying out
any economic evaluation;
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 Applications of the principles of costing may

be straightforward but can be difficult,

especially when applying discount;
Cost-minimization analysis (CMA) is applied
when outcomes are the same and relative
cost is the variation;
Cost-effectiveness analysis ( CEA) is applied
when both outcomes and cost can vary and
is frequently applied in pharmacy and
medicine;
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 Cost-utility analysis ( CUA) involves the

concept of quality of life to assist in informing

resource allocation;
Cost-benefit analysis (CBA) is complex, but

should allow informed resource allocation

within the whole economy, not just in health;

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 CBA may use implied values, human capital

or willingness-to-pay-methods;
To accommodate decision-taking in health

care, modelling and sensitivity analysis

methods can be used;
Any published pharmacoeconomics analysis

requires careful appraisal to ensure the

internal and external; validity.
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Formularies and Guidelines

Key Points
A formulary is a list of drugs which are

recommended and available for prescribing;

A formulary may contain prescribing policies

or treatment protocols, which detail the use of

drugs in specific medical conditions;
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 A clinical guidelines is a series of

systematically developed statements to

assist
practitioner and patient decision about
appropriate health care for specific clinical
circumstances;
Formularies, clinical guidelines and

prescribing policies are tools used to promote

rational and cost-effective prescribing;
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 Compiling a formulary or guideline is a

valuable educational exercise;

Pharmacists should work with others to

compile formularies and guidelines;

Drugs are selected for inclusion in a

formulary on the basis of efficacy, toxicity,

patient acceptability and cost;
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 Use of a formulary containing a restricted

number of drugs may reduce the incidence of

adverse drug reactions, interactions, and lack
of efficacy;
For a formulary to be accepted, there should

be widespread consultation on its content;

A formulary should be easy to se and

professionally presented and revised at least

every 2 years;
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 A formulary management system

is required
to provide systems for considering the
inclusion of new drugs, deleting drugs and
supplying non-formulary drugs;

Information should be provided to

prescribers on their adherence to a

formulary to encourage its use;
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 Prescribing data can be useful both in

developing a formulary and feeding back on

performance;
Recommendations

in clinical guidelines are

often graded according to the strength of the
evidence on which they are based;

Ideally a mixture of methods should be used

to encourage the use of formularies and

guidelines.
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Responding to Symptoms
Key Points
Pharmacists are recognized and used as

sources of advice on patients symptoms and

medicine;
Medicines are increasingly being re-regulated
to allow pharmacy sale, thus encouraging
self-medication;
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 A wide mix of skills is required by the

pharmacist to respond competently to

symptoms presented by patients;
Open questions are best in the early stages

of finding out about symptoms, using closed

questions to seek clarification of specific
aspects;
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 A process of structured questioning should

be used to ensure adequate collection of

available information and determine whether
a patients symptoms represent a self-limiting
condition or the possibility of a more serious
illness which requires a medical opinion and
referral to a doctor;
Various mnemonics are useful to assist the

questioning process;
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 Patients may require professional assistance

in the choice of OTC medicines;

Non-drug treatment should be offered where

appropriate, including lifestyle advice;

A quiet area

where privacy and

confidentiality can be provided should be
available;
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 Particular care is required when dealing with

symptoms in young children, pregnant

women, the elderly and patients with some
chronic diseases;
Duplication of OTC and prescribed medicines

can sometimes have serious consequences;

There are a number of clinically significant
drug interaction involving OTC medicines;
Pharmacists must be alert to the possibility of
misuse
of OTC medicines.
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Counselling
Key Points
Counseling is an important part of the role of

the pharmacist and there are many

opportunities for counseling;
Counseling is for the benefit of patients and
purchasers of medicines;
The importance of counseling is recognized
in many official documents;
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 The prescription is a useful guide to possible

counseling needs;
The extent to which patients should be told

about side-effects will vary from one patient

to another;
Counseling should be used to reinforce the

label and compliances and warn against the

potential for interactions;
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 Some groups can be identified as requiring

special counseling- the elderly, where there

have been previous problems, parents of ill
children;
It may be necessary

to limit the amount of

information given during counseling to avoid
confusion and meet patients need;
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 Checking is important in ensuring

the effectiveness of counseling;

A busy setting is a barrier to effective
communication;
Patients are becoming more aware that

pharmacists can give valuable advice;

Counseling is not a lecture patients must
be given the opportunity to ask questions.
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