This presentation contains explanation of Rational prescribing,dispensing and use of drugs.

1. Final Professional
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2.  Rational Prescribing
 Rational Dispensing
 Problems of Irrational Drug Use
 Learning about drug use problem
 Sampling to study drug use
 Indicators of drug use
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3. Basic Pharmacology
Principal mechanisms of pharmaceutical action, metabolism,
absorption, distribution, and elimination. Knowledge about
interactions between medicines and living systems at theoretical level.
Clinical Pharmacology
Study medicine with regard to clinical efficacy, risks, clinical
pharmacokinetics, drug-drug interactions, drug disease interactions,
drug genetic interactions, the concepts of clinical trials, and
pharmacoeconomics. How to use medicines properly and rationally at
more practical level.
Therapeutics
The use of pharmaceuticals to treat disease. Practical application of
basic and clinical pharmacology.
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4. Rational Use of Drugs
Rational means “based on or in accordance with reason or logic”
“Rational use of drug means the right drug for the right patient, in
the right dose, at right time, by the right route and should be
economical.”
WHO Definition
“Patient receiving medication appropriate to their clinical needs, in
appropriate doses, for an adequate period of time and at the lowest
cost to them and their community”
Also Defined as, “ The safe, effective, appropriate and economic
use of drugs.”
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5. Explanation
Safety: All drug posses side effects, less or more. The safety aspects
of drug can be assessed from different angles such as;
Severity of the disease
Available treatment options
Long term and short term treatment
Effectiveness: How the drug works in daily practice.
Efficacy: When drug used in particular disease in particular number
patients and it shows its maximum therapeutic effects.
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6. Appropriateness: How the drug is being prescribed and
used by the patient?
Appropriate indications
Appropriate dosage and administration
Appropriate dispensing and duration of treatment
Appropriate patient counseling
Economical: Does not, only relates to “price”. Cost
effectiveness approach should be adopted
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7. Approaches to achieve Rational use of drugs
1. Patient Problem
Understand the causes of the problem of patient
Detail history of the illness
Medication history of patient
2. Diagnosis
 Past medical history
 Including medication history (OTC/ Prescription medicine)
Present complaints (lab findings)
If patient is not diagnosed accurately then the therapy is termed
as irrational therapy or treatment .
Accurate diagnosis is a prerequisite for rational therapy.
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8. 3. Therapeutic objectives
 Relieving symptoms
Preventing disease
Combination of both
4. Treatment option
 Treatment options (Drug of choice or changes in life style)
If drug is required, then selection is based on;
• Efficacy
• Safety
• Suitability
• Cost Effective
• Ease of administration
• Storage requirements
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9. 5. Start treatment
 Drug should be prescribed & start drug administration
 Educate the patient about the beneficial and side effects of
drug
How the patient should deal with side effects
 Next visit should be planed for patient to assess the treatment
6. Result of the treatment
Result is obtained from physical examination and from the lab
investigations.
If the patient responds to therapy, it is termed as rational therapy
and if vice versa then assess the problem from step 1.
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10. 7. Conclusion of therapy
Judge from the results;
1) Therapeutic goals achieved?
2) Patient problems solved?
If these questions are not answered then
1)Verify whether the patient showed compliance or not?
2) Do all the diagnosis again
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11. Rational use of drug can be achieved by drug use
process (DUP) indicators
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13. Core interventions to promote more rational use of medicines
1. A mandated multi-disciplinary national body to coordinate
medicine use policies
2. Clinical guidelines
3. Essential medicines list based on treatments of choice
4. Drugs and therapeutics committees in districts and hospitals
5. Problem-based pharmacotherapy training in undergraduate
curricula
6. Continuing in-service medical education as a licensure
requirement
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14. 7. Supervision, audit and feedback
8. Independent information on medicines
9. Public education about medicines
10. Avoidance of perverse financial incentives
11. Appropriate and enforced regulation
12. Sufficient government expenditure to ensure availability of
medicines and staff
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15. Rational Prescribing
There is no universally agreed definition of good
prescribing. The WHO promotes the rational use of medicines,
which requires “ patients receive medications appropriate to
their clinical needs, in doses that meet their own individual
requirements, for an adequate period of time, and at the lowest
cost to them and their community”.
The prescriber should have the following four aims:
1) Maximize effectiveness
2) Minimize risks
3) Minimize costs
4)Respect the patient's choices.
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Basic Professional Behaviors Expected in Practice
Professional behavior Ethical principle
Do the very best you can for every patient Beneficence
In all cases, do no harm Nonmaleficence
Tell the patient the truth Veracity
Be fair Justice
Be loyal Fidelity
Allow the patient to be the ultimate decision maker Autonomy/paternalis
m
Always protect your patient's privacy Confidentiality

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This model links to the four key principles of biomedical
ethics:
beneficence,
non-maleficence,
justice and veracity,
and respect for autonomy (confidentiality and consent),
and can be applied to decision making at both an individual
patient level and when making decisions about medicines for
a wider population, for example in a Drug and Therapeutics
Committee. One of the strengths of this model is the
consideration of the patient's perspective and the recognition
of the inherent tensions between the four key aims.
For further readings: (Clinical Pharmacy and therapeutics by Roger Walker)

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Another popular framework to support rational prescribing
decisions is known as STEPS
 Safety
Tolerability
Effectiveness
Price
Simplicity

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A framework for good prescribing

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Criteria for rational prescribing
1. Appropriate diagnosis (Depend upon clinical and lab
investigations)
2. Appropriate indication (Drug therapy is safe and effective)
3. Appropriate drug
4. Appropriate patient (hypersensitivity, contraindicated drugs in
certain patients)
5. Appropriate dosage (pediatric, geriatric, or having concomitant
disease)
6.Appropriate duration
7. Appropriate route of administration
8. Appropriate information
9. Appropriate monitoring (both by patient & prescriber)

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Rational Dispensing
The well controlled preparation and supply of medicine to the
ultimate right patient in response of the prescription of the
prescriber is called rational dispensing.
OR
Interpretation and evaluation of a prescription, selection and
manipulation or compounding of a pharmaceutical product,
labeling and supply of the product in an appropriate container
according to legal and regulatory requirements, and the provision
of information and instructions by a pharmacist, or under the
supervision of a pharmacist, to ensure the safe and effective use by
the patient.

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Requirements/Knowledge for rational dispensing
i). Stability of dispensed medicine and their ingredients
ii). Principles of compounding
iii) Dosage form and dosage schedule
iv) Physical, chemical and therapeutic incompatibilities
v) Packaging materials and methods
vi) Labeling procedures
vii) Legal requirements

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Dispenser
A qualified individual who “prepares” and “gives out” the
remedies/medicine according to the physician prescription. The
dispenser must have a sound knowledge of Pharmacology,
medicinal chemistry, microbiology, pharmatechnology, forensic
pharmacy, pharmaceutical calculations etc. He/She must know
about the stability of the dispensed medicine and the ingredients,
physical, chemical and therapeutic incompatibilities, labeling and
packing material etc.

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Dispensing process/rational dispensing
Dispenser assumptions that;
1) The prescriber has made
correct diagnosis,
selected correct drug,
dosage and quantity
2) Patient has access to the dispensary or pharmacy

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Important steps of rational dispensing
1. Receiving of Prescription
The dispenser receives the “correct” prescription from the
prescriber directly or through Patient. It can be through Phone,
oral/verbal and/or online computer system.
 Origin of the prescription
 Validity of the prescription
 Relevant instructions
 Information about patient
 Therapeutic appropriateness
 Economic considerations
 Communication with prescriber for unclear instructions

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2. Interpretation of prescription
 Name of the drugs
 Dosage, administration and duration
 Availability of drugs
 Retrieves drugs from storage area
3.Checking of the prescription
 Check the expiry date and storage condition of the prescribed
drug.
 Follow FIFO rule
 Checks and counter check (identify strength & dosage form)

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4. Filling of prescription
The dispenser should have true knowledge of the medication and its
proper use and can:
Precisely dispense products
Re-check drugs and dosages
5. Labeling of prescription (identification of drugs and
instructions)
The dispenser communicates in correct way to take the medication
to the patient through
 labels with patient’s name, drug name and directions for use, date
of dispensing, identity of dispenser
Identity of prescriber
 symbolic instructions in case of illiterate patients
Use of auxiliary labels
Name and sign of dispenser

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6. Handling of prescription
The patient understands the instructions from the dispenser. The
dispenser will:
Repeat orally the labeled instructions
Ask the patient to repeat the instruction
Emphasizes the need for compliance
Providing warnings and cautions
Gives special attention to certain cases ( pregnant women, those
with visual/hearing problems, children and elderly patients, those
taking multiple medications
7. Instruction for patients
Comply with the instructions for therapy

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8. Record
Dispenser keeps accurate records of the following operations
Enters details of encounter on patient profile card
Enters in prescription register
Completes inventory records
There are many potential areas in which the dispenser can make
mistakes. Dispensing requires trained, skilled, responsible
individual, proper policies and incentives must be provided to
attract such personnel and develop this profession

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Inappropriate or irrational prescribing
Good prescribing is sometimes defined as the lack of irrational
prescribing. Prescribing can be described as irrational for many
reasons:
 Poor choice of a medicine
Polypharmacy or co-prescribing of interacting medicine
Prescribing for a self-limiting condition
Continuing to prescribe for a longer period than necessary
Prescribing too low a dose of a medicine
 Prescribing withouttaking account of the patient's wishes.

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Consequences of irrational prescribing
Inappropriate or irrational prescribing can result in
serious morbidity and mortality, particularly when childhood
infections or chronic diseases such as hypertension, diabetes,
epilepsy and mental disorders are being treated.
Inappropriate prescribing also represents a waste of
resources and, as in the case of antimicrobials, may harm the
health of the public by contributing to increased antimicrobial
resistance.
Over-willingness to prescribe stimulates inappropriate
patient demand and fails to help the patient understand when
they should seek out support from a health care professional.

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Causes of irrational use of drugs
1. Selection of drugs (Drug selection based upon efficacy, safety,
cost, & availability)
2. Patient requirement (Dosage form and dose adjustment in different
age groups and disease states)
3. Compliance (To improve compliance give the following
information to patient: Drug positive aspects, side effects,
precautions, warnings)
4. Incorrect prescribing/Inappropiate prescribing( A wrong drug is
prescribed)
5. Polypharmacy
6. Multiple prescription
7. Incorrect administration
8. Expensive drugs

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Factors responsible for irrational use of drugs
1. Health system
i) Unreliable Drug supply
ii) Drug shortages
iii)Heavy patient load
iv) Lack of staff
v) Lack of diagnostic tools/labs
vi)Lack of regulation enforcement
2. Prescriber
I) Internal factors
a) Inadequate training
b) Outdated prescribing practices (lack of
continuing education)
c) Misleading beliefs

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II) External factors
a) Heavy patient load
b) Profit may affect prescribers choice
3. Dispenser
i) Inappropriate training
ii) Shortage of dispensing material
iii) Short dispensing time
iv) Low status of dispenser affects the quality of dispensing
4. Patient & community
i) Cultural beliefs
ii) Patient and community beliefs about drugs
iii) Shortage of printed information

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5. Industry
i) Promotional activities
ii) Misleading claims
iii) Pharma industry against generic system

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Learning about drug use problems
Individual drug use problems take place within a system of drug
supply and within a network of beliefs on the part of providers and
patients .
To “change a problem behavior”, we must learn about the behavior
itself and about the determinants which underlie it.
Objectives of learning about a drug use problem
1. To describe a “model” for developing interventions
2. Identify potential source of “data "for learning about drug use
problems and evaluate their relative strengths and weakness
3. Understand the importance of studying “provider” and “patient”
motivation
4. Motivations and incentives when developing a program to improve
drug use

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5. Appreciate the role of qualitative research methods for
learning about drug use behaviors (by group discussions,
interview, survey/form fill)
7. Develop techniques for field visits
Changing drug use problems
The process of identifying, understanding and changing drug
use problems is similar to the process of diagnosis and
treating a clinical illness

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Schematic representation
Changing a drug use problem

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Process explanation
1) Examine
i) Identify a priority drug use issue
a) Which potential problems carry the highest clinical risk?
b) Which involves expensive/widely used drugs?
c) which are potentially the easiest to correct?
ii) Collect data to measure current practice
a) Which source of data will give you the best source of
information?
b) How large a sample is necessary to get reliable information?
c) What are the groups of interest e.g., Doctors & nurses or
public sector and mission facilities

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2) Diagnose
i) Describe in detail apparent problems in drug use
a) What specific practices are the problem?
b) What is an ideal practice
c) Who are the most important providers e.g., the influence
leaders in the community etc
d) Are there high risk patient e.g., pregnant women or young
children
ii) Identifying the apparent causes of the problem
a) What social and cultural factors influence practices?
b) What do providers know and believe?
c) What do patients expect when they visit a providers

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iii) Identify constraints to change
a) Economic factors prevent change
b) Drug supply factors will hinder change
c) work environment
3) Treat (design & implement interventions)
i) Select “target behavior” to change & design an intervention
program
a) Which behavior can be changed most cost effectively?
b) What are the possible economic consequences?
c) What are the most important appropriate interventions, give their
different costs, complexities & chances of success?
d) What personnel will be required & what training will they need?

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ii) Conduct pilot tests to determine the acceptability and
effectiveness of an intervention
iii) Implement the intervention and collect data to measure
changes
a) Is the intervention implemented as expected
b) How are the program impacts to be measured?
c) Is the data reliable?
4) Follow up
i) Evaluate the interventions success
a) Was the intervention implemented as planned?
b) What are the measureable changes e.g., Patient satisfaction,
clinical results etc.,
c) How cost effective is the intervention as compared to the
other strategies ?

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ii) Feed back results to program personnel, to providers & to
consumer to encourage them to maintain & increase positive
changes
iii) Use results to improve the impact of the program or to guide
decisions about other problems to investigate

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Who Is a Prescriber?
Or Whose Behavior Do We Change?
Physicians
Paramedics
Pharmacists
Injectionists
Patients
Clinical officers
Clinic attendants
Dispensers
Drug sellers
Relatives/friends

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Sampling to Study Drug Use
Sampling is a process by which we study a small part of a
population to make judgments about the entire population
Sampling involves selecting a number of units from a defined
population.
Sampling Unit
- The thing that is sampled: for example, a person, clinical episode,
or health facility
Study Population
- All the sampling units that could possibly be included in the
sample
Sampling Frame
- A list of all the available sampling units in the study population

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Representative sample
A representative sample has all the important characteristics of the
study population from which it is drawn.
Sampling Methods
Two categories of sampling methods:
- Non-probability sampling
- Probability sampling
Non-probability Sampling Methods
Convenience Sampling
- Study units available at the time of data collection are selected for
the sample (subjects are selected because of their convenient accessibility and proximity to the
researcher)
Quota Sampling
- Different categories of sample units are included until a certain
number has been reached in each category (For example, a researcher might ask
for a sample of 100 females, or 100 individuals between the ages of 20-30)

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Sample Size
The optimal sample size is often a compromise between what is
statistically Desirable and what is practically Feasible
Types of study
i) Experimental clinical trials
ii) Non-experimental observations
a) Cohort study (In a cohort study, an investigator selects a group of non-
diseased people and follows them over time to determine if they develop a disease/outcome. The
cohort is selected based on exposure status, including both people who have been exposed and
those who have not. The main characteristic in a cohort study is that the study proceeds from cause
to effect).
b) Case control study (The case-control is a type of epidemiological
observational study. An observational study is a study in which subjects are not randomized to the
exposed or unexposed groups, rather the subjects are observed in order to determine both their
exposure and their outcome status and the exposure status is thus not determined by the researcher)

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Probability Sampling Methods
Simple Random Sampling
Systematic Sampling
Stratified Sampling
Cluster Sampling
Multistage Sampling
Simple Random Sampling
Used in situations where the number of sampling units is relatively
small
Process:
- Identify all possible units available for sampling
- Decide on the size of the sample
- Choose units by a lottery method

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Systematic Sampling
In this case sample units are selected from a numbered list of all
units in the study population by using a regular interval starting
from a random starting point.
To calculate sampling interval divide the size of the list by the
desired sample size.
Stratified Sampling
Used when the sampling frame contains clearly different categories
(strata)
For example,
Urban and rural facilities
Facilities with and without doctors
Government and mission facilities

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Process
- Organize the list of sampling units by stratum
- Select units within each stratum using a random method (simple
random sampling or systematic sampling)
Cluster Sampling
Used when, for logistic reasons, it is easier to select sample units in
groups
Process
- Select a cluster of sample units
Example: health center with multiple prescribers
Include the entire cluster or select a subsample or Select a random
sample unit to start each cluster (a house, a patient, etc.)
- Include neighboring sample units until a certain cluster size is
reached

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Multistage Sampling
Randomly select primary sampling units at the first stage:
Specific communities
Specific health facilities
Within the primary sampling units, randomly select the final
sampling units at the second stage:
Drug use encounters
Patients
Households
Sometimes in complex samples, additional stages are needed
multistage sample in which 20 health facilities are selected, and
then 30 drug use encounters are sampled within each facility.

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Collecting data to learn about drug use problem
Two steps in “learning about drug use problem” are;
 collecting data of drug use problem
 finding correct cause of problem
Methods of collecting data
Quantitative method
Qualitative method
Quantitative method
It is numeric data (counts, rates, or clarifications)
Used to identify specific problems or to measure the success of
interventions
How to collect quantitative data
1) Routinely reported data
2) Data gathered from record systems
3) Sample surveys

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Types of Quantitative method
1) Retrospectively & prospectively
2) Aggregated data(monthly drug consumption & patient specific
record
3) Detailed data (name,doses,amount,duration,cost) non detailed data
(name of drug only)
Information available in quantitative data
Data from drug (use) encounters
Facility
ID___________
Characteristics_________
Equipments ____________
Drugs available__________

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Patient
ID_________
Data________
Age_________
Gender ________
Symptoms _________
Attitudes__________
Beliefs ____________
Interaction
History __________
Examination ________
Diagnosis _________
Time spent_________
Explanation about drugs _______
Explanation about illness________

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Drugs
Name _______
Brand/generic______
Form_______
Quantity _______
Duration _________
If dispensed______
How labeled______
Cost _______
Patient charge _________
Qualitative method
Quantity data quantify the problems but do not answer that why the
problem exists.
Types of qualitative data
i) In depth discussions ii) focus group discussion
iii)Structural observations iv) structured questionnaires
v) structured patient visits

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Drug use indicators
Indicators are specific objective measures that allow the evaluation
of the baseline situation and progress in systems and the assessment
of services and interventions
Purpose of Drug use indicators
•Objective measures (Indicators) that can describe the drug use
situation in a country/region/Health facility.
•These indicators will allow Health planners, Managers and
Researchers, to make basic comparisons between situations in
different areas or at different times.
• The indicators can be used to measure the impact of the
interventions undertaken.

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•The indicators can serve as simple supervisory tools to detect
problems in performance of individual providers or Health facilities.
•The drug use indicators can be used as "first line measures" to
stimulate further questioning and to guide subsequent action.
Performing an indicator study is useful method to—
•Identify medicine use problems at the individual patient level
•Monitor medicine use by prescribers
•Evaluate the impact of interventions
Type of Indicators:
Indicators are developed to be used in measures of performance in
three general areas, related to the Rational use of Drugs in Primary
care.
* Prescribing practices by Health providers
* Patient care including both clinical consultation and
pharmaceutical dispensing.
* Facility specific factors which support RUD.

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Core Indicators
Core indicators are those considered to be highly relevant,
important and useful
The core prescribing indicators measure general prescribing
tendencies within a given setting, independent of specific
diagnoses.
Many critical questions in drug use have to do with whether
health care providers follow appropriate diagnostic procedures
and whether they select products and dosage schedules to fit
underlying health problems.
However, determining the quality of diagnosis and evaluating
the adequacy of drug choices is a complex undertaking in
practice, and beyond the scope of the core indicators.

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After a first drug use study with selected indicators has been
carried out to determine overall prescribing performance, it
will usually be necessary to undertake more health problem-
specific investigations and make an assessment of the quality
of diagnosis and treatment

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Facility Indicators
* Availability of essential drug list or formulary
* Availability of key drugs.
Availability of standard treatment guideline (STG)
These indicators are of activity based measures, meant to describe
practices in a representative sample of Health facilities. The drug
use indicators can be collected at one time in a cross sectional
survey, or otherwise. For a basic cross sectional survey about 20
health facilities can be selected to represent a larger group of
facilities.

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Care Drug use Indicators
I. Prescribing indicators
* Average number of drugs per encounter
* Percentage of drugs prescribed by generic name
* Percentage of Encounters with an antibiotic prescribed
* Percentage of encounters with an injection prescribed
•Percentage of drugs prescribed from essential drug list or formulary.
II. Patient care Indicators
* Average consultation time
* Average dispensing time
* Percentage of drugs actually dispensed
* Percentage of drugs adequately labeled
* Patients knowledge of correct dosage

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The prescribing indicators can be based on either Retrospective or
prospective data.
Retrospective data describe the drug use during patient list that
took place in the past. These data can be collected from medical
records kept in the Health facilities.
Prospective data describes the drug use during patient visits that
takes place on the day of the indicator survey.

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Complementary drug use indicators
Complementary indicators are those additional measurements
considered to be relevant and useful.
These indicators represent measures of performance that can be used
in addition to the core indicators are no less important than the core
indicators, but the data to measure them may often be more difficult
to obtain, or their interpretation may be highly sensitive to the local
context. The required data can be collected in a drug use survey with
core indications. The complementary indication are suggested as
additional measures of drug use.

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Complementary drug use indicators can be
* Percentage of patients treated without drugs
* Average drug cost per encounter.
* Percentage of drug costs spent on Antibiotics
* Percentage of drug costs spent on Injections
* Prescriptions in accordance with treatment guidelines
* Percentage of patients satisfied with the care they received
* Percentage of health facilities with access to impartial drug
information.

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Performing an Indicator Study
Determine objectives, priorities, and indicators
•Determine study design according to objectives
•Monitoring over time, comparing facilities
•Cross-sectional survey, time series
•Evaluating interventions
•Randomized controlled trial, pre/post with
control, time series
•Define indicators and data collection procedures
•Pilot-test procedures

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Train data collectors
•Randomly select facilities (at least 20 if
possible) in the region from which to collect
data
•Obtain approximately 30 medicine use
encounters for each facility (100 if only one
facility is chosen)
•Analyze data
•Provide results to DTC for evaluation and
follow-up

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Results can be used as follows—
•Describing current treatment practices
•Comparing the performance of individual facilities or
practitioners
•Periodic monitoring and supervision of specific
medicine use behaviors
•Identifying potential medicine problems that affect
patient care
•Assessing the impact of an intervention

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Hospital Antimicrobial Indicators
Introduction/Background (1)
•These indicators and manual is intended as
a rapid assessment tool to identify problems
with antimicrobial use in their hospitals.
•Designed to evaluate and improve
antimicrobial use.
•Indicators will allow basic comparisons of
antimicrobial use both in one hospital over
time and between hospitals.

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Hospital Antimicrobial Indicators
Introduction/Background (2)
•Indicators can be used at the district, regional,
or referral hospital level.
• Tool can be used by
• hospital administrators,
• drug and therapeutics committees (DTCs),
• researchers and program managers

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Hospital Indicators
•Existence of STG for infectious diseases
•Existence of an approved hospital formulary list or
Essential medicine list
•Availability of a key set of antimicrobials in the
hospital stored on the day of the study
•Average number of days that this key set of
antimicrobials are out of stock over 12 months
•Expenditure on antimicrobial medicines as a
percentage of total hospital medicine costs

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Prescribing indicators (eight indicators)
•Percent of hospitalizations with one or more
antimicrobials prescribed
•Average number of antimicrobial medicines
prescribed per hospitalization
•Percent of antimicrobials prescribed consistent with
formulary list
•Average cost of antimicrobials prescribed from
hospitalizations with one or more antimicrobial
prescribed
•Average number of doses of surgical antimicrobial
prophylaxis for Cesarean Section procedures
•Percent of pneumonia patients who are prescribed
antimicrobials in accordance with STG
•Percent of antimicrobials prescribed by generic name

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•Average duration of prescribed
antimicrobial treatment
•Percent of patients that have a Cesarean
Section procedure that receive Surgical
Antibiotic Prophylaxis according to hospital
guidelines (or international guidelines)

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Patient care indicators
•% of doses of prescribed antimicrobial medicines
actually administered
•Average duration of stay of patients who receive
antimicrobials
•Supplemental indicator
•Number of antimicrobial medicine sensitivity tests
reported

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Results of Indicator Studies
•Conducting a indicator study will allow comparisons
of antimicrobial use both in one hospital over time
and between hospitals
•General and specific problems with antibiotic use can
be identified using these indicators
•After problems have been detected, investigators will
need to interpret the meaning of the results in the
context of the hospital (size, type of patient, level of
complexity) and probe more deeply to uncover
possible underlying causes

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Medical error Case Study
Objectives
 Learn step-by-step what to do when medical error
occurs and how to report it.
 Learn how to identify root cause of a medical error
and how to prevent its recurrence.
 Motivate your colleagues to foster a patient safety
culture

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The Story occurred On Sunday morning, Mr. Xy had
attended my clinic due to marked polyuria. His RBS
was 28.8 mmol/L, otherwise he was completely
normal.
I’ve prescribed N. saline 1.5 L , IV, over 2 hours and
5.0 u of regular insulin by direct IV push / 30 minutes,
until his RBS is 9.0 mmol/l.
I’ve been called to give the IV injection, Which was
easily done.
Twenty minutes later, my patient was very much
apprehensive, sweating and started shivering. His
RBS was 0.8 mmol/l.
The Story My nurse had told me that I’ve pushed 50.0
u of regular insulin in the IV line.

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CASE A
A 74 year old man brought to the cardiology department was admitted few
days by the renal unit on account generalized weakness of excessive
sweating and vomiting of 2 days duration. He developed excessive
sweating in the evening. The sweating which was sudden on onset was not
associated with exertion. There was associated breath difficulty and
dizziness. There were episode of loss of consciousness but no history of
abdominal pain.
Physical Examination
Gen
Weak, appearing elderly man, afebrile, acyanosed but sweaty.
Vital signs
T 36.5
R.R 34/min
P.R 74/min
B.P 124/85mmHg
ABD soft and non-tender, active bowel sounds
Hs S4, S1, S2
I/O 1450ml (oral), 1900ml (urine)
Chest clear

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Laboratory Result
Na+ 139mEq/L (135-152)
K+ 2.7mEq/L (3.7-5.1)
Cl 105mEq/L (95-105)
HCO3 18mM/L (12)
Uric acid 7.5mg/dl (3.0-7.0)
BUN 15mg/dl (8.25)
CR 125ml/min (125)
Assessment-IHD with background pre- hypertension
Medication History
Tab. Ramipril 5mg daily
Tab. Metoprolol 50mg b.d
“ Lasix 20mg b.d “
Augmentin 625mg b.d
“ A S A 75mg daily
“ Metronidazole 400mg tds “
Isosorbid dinitrate 5mg b.d SC
Heparin 5000 I.V/ 12hrly

80. 80
CASE B
A 77year old female diabetic patient was admitted on account of
chest tightness, insomnia and headache for 3days.There was
associated chest pain aggravated by activities but revealed at rest.
No history of vomiting or loss of consciousness. There was easy
fatigability and not a known hypertensive patient.
Physical Examination
Gen
Well-nourished old woman in distress
Vital signs
PR 70/min regular thickened arterial wall
B.P 148/78mmHg
ABD within normal limits
CNS Grossly intact
Hs S1,S2 no murmur clear

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Result
Na 140mEq/L (135-145)
K 51mEq/L (40-90)
Cl 105mEq/L (100-106)
Glu 150mg/dl (70-110)
HCO3 27mmol/L (24-30)
Ca 8.8mg/dl (9-11)
Assessment-IHD with background of HBP (systolic) and diabetes
mellitus
Medication History
I.V Augmentin 1.2g stat: 600mg 8hourly Tab. Daonil 5mg daily
Tab. Isosorbide dinitrate 5mg daily Tab. Metformin 50mg b.d
Tab. A S A 150mg daily Tab. Lisinopril 2.5mg daily
Tab. Lipitor 10mg daily Tab. Lasix 40mg daily
Tab. Metoprololtartarate 50mg daily Tab. Aldactone 25mg daily

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CASE C
A 40 year old woman was presented with 3 weeks history of chest pain
and dyspnoea at the medical outpatient clinic. She also had a sudden
retrosternal pain which radiated to all part of her body with associated
weakness and breathlessness but no loss of consciousness and no
seizure. There was associated palpitation and progressive dyspnoea
on exertion and associated polyuria nocturea and polydypsia but no
cough and leg swelling. No family history of hypertension and
diabetes.
Physical examination
Gen
Young woman not in distress.
Vital signs
B.P 140/90mmHg
Chest Bilateral rales and pleural rib
ABD Benign
HS S1,S2 No murmur. Obese with striae
P.R 80/min, good vol. Reg.

83. 83
Laboratory Results
Na 136mEq/L (135-145)
K 40mEq/L (40-90)
HCO3 26mM/L (24-30)
GLU 81 mg/dl (70-110)
Cl 98 mEq/L (100-106)
Ca 10mg/dl (9-11)
Phos 4mg/dl (3-3.5)
Chol 140mg/dl (120-220)
Assessment
No peripheral edema. Patient with IHD with obesity as a risk factor;
hypertension, impaired glucose tolerance.
Medication History
Tab. Propranolol 20mg b.d Tab. Aspirin 150mg daily
”Paracetamol 1000mg daily ” Glyceryltrinitrate 0.5mg PRN
” Librium 10mg daily ” Ternormin 50mg daily
Diazepam 5mg nocte

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CASE D
A 45 year old man was presented with 5 year history recurrent
retrosternal discomfort, peppery sensation associated with late
meal at the medical out-patient clinic. Pain not associated with
exertion. No history of hematemesis. The peppery sensation
usually radiate to the upper limbs but not to the neck. No
epigastric pain. No associated nausea, vomiting,
paroxysmaldyspnoea or orthopnoea. No abdominal discomfort.
Pain not reveal by change in position. He takes wine but not
cigarette. No family history of hypertension and diabetes
Physical Examination
Gen
Restless, not sweaty. Afebrile, acyanosed, not pale, anoteric.
No peripheral lymphadenopathy
Vital signs Na 140mEq/L (135-145)
K 50mEq/L (40-90)
Ca 11mg/dl (9-11)
Cl 105mEq/L (100-106)
Total cholesterol 190mg/dl (120-220)

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Laboratory Results
P.R 110/min, regular normal
B.P 160/110mmHg
ABD Soft without masses
CNS Conscious and alert, well oriented, cranial nerves grossly
intact
H.S H.S S4, S1 and S2
Fundoscopy, Normal muscle tone
Assessment
IHD associated with HBP (Hypertension)
Medication history
Tab.Isorsorbide dinitrate 5mg b.d
Tab Propranolol 40mg b.d
” ASA 300mg O.D ” Ranitidine 150mg b.d
” Diazepam 5mg nocte Susp MMT 300ml qds
” Metchlorpramide 5mg b.d

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If angina occurs more frequently than two or three
times per week, chronic prophylactic therapy is
necessary. The three drug classes that can be used
for this purpose are Nitrates, B-blockers and
Calcium Channel Blockers. Effectiveness of nitrate
products can be assessed by decreased use of
sublingual nitroglycerin for acute attack of angina,
improvement in patient’s quality of life, that is,
ability to perform normal activities without
experiencing angina and objective assessment by
exercise testing. In the four (4) cases studied,
nitrate products used were Isosorbid dinitrate 5mg
two times daily in patient A, B and D (Table 1,2,4),
while Glyceryltrinitrate 0.5mg PRN was used in
patient C (Table 3).

87. 87
A decreased pharmacologic response in the
presence of continuously or frequently
administered nitrate is well documented and is
termed nitrate tolerance. Clinically, preventing
nitrate tolerance involves the provision of a daily
nitrate free interval (nitrate free period). The time of
day for providing of a nitrate free interval is usually
at night. Problem with nitrate free period has
therefore necessitated additional use of ß-Blockers.
ß-Blockers are effective anti-ischemic and anti-
angina agents that act to decrease myocardial
oxygen demand by decreasing heart rate and
contractility. It is recommended that all patients
with unstable angina receive ß-Blocker therapy
unless there are contraindications.

88. 88
In contract, ß-Blockers reduce myocardial
contractility and arterial blood pressure and thereby
reduce myocardial oxygen demand. A potential
problem with ß-Blockers is that they may cause
coronary vasoconstriction. With blockade of B2
receptors which mediate vasodilatation, there is
unopposed ∂-receptor mediated coronary
vasoconstriction. This is a particular concern in
patients with rest or variant angina where ß-Blockers
could potentially precipitate an angina episode. This
may necessitate the combination of Calcium Channel
blockers with ß-Blockers.

89. 89
In the four (4) cases studied, ß-Blockers were
rationally used as they were used to offset the
problem associated with nitrates free period. ß-
Blockers have several beneficial effects in Ischemic
heart disease. ß-Blockers reduce heart rate mainly
during time of sympathetic stimulation which results
in reduced cardiac work and thus reduced myocardial
oxygen demand. In addition to slowing heart rate, ß-
Blockers increase diastolic filling time resulting in
increased coronary perfusion and improved oxygen
supply. In patient A and B, metoprolol 50mg b.d was
used while in patient C & D Propranolol 20mg b.d and
40 mg b.d were used respectively. In patient D,
Propranolol was changed to Atenolol the newer
generation ß-Blocker to offset the side effect of gastric
disturbance of Propranolol.

90. 90
In this study, there was no use of Calcium channel blockers as none
of the four patients studied was contraindicated to Beta-Blockers. In
addition Calcium channel blockers may also cause gastrointestinal
effect such as nausea and constipation thus could not have been
used in patient D where the patient was established to have
gastrointestinal disturbance. Aspirin as a prophylaxis of infarction at
75 mg to 300 mg daily have proved to be beneficial in all forms of IHD
as administered in cases A,B,C and D. In case A, 75mg Aspirin was
given daily. In cases B & C it was 150 mg daily and in case D, 300 mg
Aspirin was given every other day. This is equivalent to 150 mg daily.
Patient suspected of having unstable angina or acute myocardial
infarction should immediately be given aspirin 150mg to 300mg to
chew or swallow except in case of a definite contraindication such as
documented hypersensitivity or acute bleeding. Early administration
of aspirin has been shown to be superior to placebo in preventing
progression of unstable angina to acute myocardial infarction.
Dosage of 75-150mg/day seems to have efficacy similar to 300mg/day.
Therefore it is recommended that patients with unstable angina take
aspirin 75-300mg daily, the dosage based on clinician or patient
preference..

91. 91
Heparin confers additional pharmacotherapeutic benefit
in unstable angina and thus additional
pharmacotherapeutic benefit is established in the
rational use of Heparin 5,000 units every 12 hours in
case A. The primary goal of anticoagulant such as
Heparin is to prevent extension of the thrombus and
thus prevent acute myocardial infarction. Although
aspirin is superior to placebo in these patients, data
suggest that unfractionated heparin alone may be
superior to aspirin alone; interestingly some studies
have not shown unfractionated heparin to be superior to
aspirin or placebo. Nonetheless the expert panel that
develops the clinical practice guideline recommended
that unfractionated heparin should be administered
immediately when the diagnosis of intermediate to high
risk of unstable angina is made. In most patients,
unfractionated heparin is given along with aspirin.

92. 92
In institutions not equipped to administer unfractionated heparin
by continuous infusion, the recommended regimen is 5000U by
intravenous bolus every 4 hours for 2 or 5 days. In patient-A,
5000U heparin was administered every 12 hours along with
aspirin. This was rational administration of heparin since it was
given along with aspirin. Risk factors reduction should focus on
hypertension management and its risk factors such as diabetes
management, smoking cessation, lipid lowering therapy,
antiplatelet therapy and cardiac rehabilitation therapy exercise.
Lipid lowering drug therapy in patients with angina or prior
myocardial infarction with average or elevated serum cholesterol
concentrations has been shown to reduce cardiovascular
morbidity and mortality. Lipitor [atorvastastatin] 10mg daily was
given to patient B as lipid lowering agent [or lipid lowering drug].
rational as obesity and diabetes are coronary risk factor and this
patient is also diabetic. Diabetes and obesity as coronary risk
factors may increase cardiovascular morbidity and mortality.

93. 93
Lipitor was rationally given to reduce cardiovascular
morbidity and mortality which may result from ischemic
heart disease. Captopril Prevention Project (CAPP) trial
found Captopril to be equal to diuretics and ß -blockers in
preventing cardiovascular morbidity and mortality. ACEI
are also additive with B-blockers. In patient A, Ramipril
5mg daily was used in combination with Lasix [frusemide]
20mg daily, a loop diuretic and in patient B, with
spironolactone 25mg b.d which is a risk factor of ischemic
heart disease. In patient C & D, there was no additional
antihypertensive used apart from Propranolol, which was
changed to Atenolol, a ß blocker. The use of ß –blockers in
these patients serves both as antihypertensive and ant
ischemic.

94. 94
Metochlorpropamide, a derivative of chlorpropamide, a
first generation sulphonylurea is associated with the
highest incidence of adverse effects and drug
interactions. Metochlorpropamide was used in patient D
and there was no drug prescribed that interacted with it.
Glibenclamide, a second generation sulphonylurea is a
more potent antidiabetic agent. It tends to have fewer
drug interactions because they bind nonionically and are
present in much lower concentrations than the first
generation agents such as Metochlorpropamide. In
combination with Metformin, it is an additive therapy to
lower hyperglycemia and to prevent the risk factors with
diabetes in patient with ischemic heart disease.
Augmentin was rationally used in patient A & B as
antibiotics and in patient A in combination with
Metronidazole. There is no drug interaction reported with
any of these drugs in these patients.

95. 95
For patient D, Ranitidine 150mg b.d for peptic ulcer
was prescribed. Ranitidine minimally inhibits hepatic
metabolism of drugs including Propranolol and
Diazepam and it has fewer clinically significant drug
interactions. There was a beneficial drug interaction in
Patient D where Ranitidine was used only to increase
the bioavailability of Propranolol or Atenolol and
Diazepam.
Treatment of co-morbidities and risk factors such as
hypertension, diabetes mellitus, obesity and ulcer
should always be taken into consideration before anti-
ischemic can be rationally prescribed.