CHAPTER 2

METHODOLOGY

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Relevant data of the 20 cases of three specific diseases that are cirrhosis (7cases),
Ascites (7cases), Peptic ulcer disease (6 cases) were collected. All case histories
regarding patient information including patient demographics, date of admission,
disease history, medication history, pervious medication history, relevant labourity
data, diagnosis, pharmacological therapy for the disease provided in hospital, daily
progress report & medication on discharge were noted.
The importance of patient data collection from different aspects towards the drug
therapy is explained below.

A. PATIENT IDENTIFICATION & DEMOGRAPHIC

INFORMATION:
Individual characteristics of patient were recorded for the purpose of patient’s
Identification & record and to consider those characteristics of patient that should be
considered in pharmacotherapy
It mainly includes
• Name and address
• Age
• Gender
• Height & weight
• Pregnancy lactation status
• Occupation
• Living arrangements etc
I. NAME & ADDRESS
Main purpose is patient identification & future records. Sometimes fathers name or
husband name may be added in case of similar names.
Area: Some deficiencies are specific to specific areas e.g. iodine deficiency or
parasitic infections etc.
II. GENDER
Disease risk as well as frequency is affected by gender e.g. genital organ disease,
CVS disease, myocardial infarction more common in males &hypothyroid disorder,
anaemia, SLE, osteoporoses are more common in females.
III. AGE
Age can be categorized in to paediatrics, adults& geriatrics .it is important in case of
 Dosage,
 route of administration
 with respect to disease prevalence,/frequency(e.g. polio, chicken pox, measles
are more common in paediatrics)
 malignancy ,IHD ,strokes in old age
 compliance & counselling issue
 drug selection especially in paediatrics e.g. in pneumonia
IV. HEIGHT & WEIGHT
For dosage individualization e.g. body surface area, per kg dose.

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 V. PREGNANCY &LACTATION STATUS
Individual drug status is considered for safety of mother & infant. Pregnancy risk
factors A, B, C, D & X has been defined by FDA for each drug whether or not to
give a certain drug in these conditions.
VI. OCCUPATION
Job nature & timing, environmental exposures are considered to manage the dosage
schedule so that compliance can be achieved e.g. CNS depressants may cause
drowsiness, confusion for drivers and machinery operators.
VII. LIVING ARRANGEMENTS
Patients living alone or with family have an influence in the way of care giver
presence or help in drug administration otherwise nursing consultation is given. In
case of family the major concern is the kids’ safety e.g. keeps away from child,
counselling about antidotes use of child resistant container.

B. CHIEF COMPLIANTS
It is the Brief description of the reasons why the patient consulted the physician,
stated in patient own words e.g. anorexia, fever, cough weakness, pain etc. Medical
terminologies are not used in order to convey the patient’s feeling and condition
accurately.
It is important for the proper diagnosis by physician so that no symptom is left
untreated.

C. HISTORY OF PRESENT ILLNESS

It is the detailed description of chief complaints that describes the
 onset, location,
 Nature that is mild, moderate or severe,
 continuous or intermittent,
 high or low grade
 the contributing factors(exacerbating or relieving)
 the effect of any treatment given and
 Relationship with other symptoms and the degree of interference with daily
activities.

D. PAST MEDICATION HISTORIES

Patient is asked about any serious/chronic illness experienced by him in past e.g.
typhoid, CHF, asthma, nature of present illness or history of previous hospitalization.
E. SURGICAL HISTORY
History of any serious injury, any surgical procedure or blood transfusion in past.

G. FAMILY HISTORY
Relating to age & health of family members. In case of deceased relatives the reason
of death, nature & detail of death. Presence of heritable disease e.g. IHD, diabetes
mellitus, hypertension allergies in family members.

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H. SOCIAL HISTORY
Living arrangements, economical status, educational background, marital status,
number of children, hobbies, physical activities, use of any social drugs (present in
area mostly),travelling history (malaria prophylaxis).

I. PERSONAL HISTORY
 Sleep habits
 Bowel habits
 Meals regularity, frequency, food intake

J. MEDICATION HISTORY
 Medication records of prescription drugs
 Non prescription drugs
 OTC drugs
 Herbal remedies
 Response of previous medication
 For what purpose medicine was taken
 Compliance level
 Allergies
 Adverse drug reactions
 Understanding of drug therapy
 Patient health beliefs

K. ALLERGIES
Seasonal, pollen, pets, environmental contaminant other than drug allergy and
description of allergy.

L. OTHER HISTORIES
Immunization in case of paediatrics etc

M. REVIEW OF SYSTEMS
it is the question about the presence of the symptoms related to the each body system
asked orally from the patient Main purpose is to prevent omission of the pertinent
info and to know the status of each system of body.

N. PHYSICAL EXAMINATION
Only relevant positive findings are recorded about general &systemic physical
examination.

O. RESULTS OF PERTINENT LABOURITY TESTS

CBC,LFT. RFT diagnostic procedure e.g. MRI CT, ultrasound including renal &
hepatic function status

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P. DIAGNOSIS
Noted because it the indication for the drug therapy.

Q. CURRENT MEDICATION IF ANY

Prescribed drug during admission or during initial stages of treatment.

LABORATORY INVESTIGATIONS:-
Pharmacist usually monitors laboratory tests for the following purposes.
1. To assess the therapeutic effects of a drug.
2. To assess the adverse effects of a drug.
3. To determine the proper drug dosage.
4. To assess the need for additional or alternative drug therapy.
5. To prevent the misinterpretation resulting from drug interference.
REFERANCE RANGES:-
• Reference ranges vary from one laboratory to another and may depend on the
method used to perform the test; therefore clinicians should know this fact.

• The normal ranges represent collected statistical data rather than

classification of patients as having disease or being healthy.

• Laboratory errors must always be considered when test results do not

correlate with expected results for a given patient.

COMMON CLINICAL LABORATORY TESTS

LABORATORY TEST REFERENCE IMPORTANCE
RANGE

HEMATOLOGICAL
TESTS
Red Blood Cell Count M:4-6×106/µL Monitor the response to drugs
(RBC) F:3.5-5×106µL and evaluate undesired
reactions to drugs that may
cause blood dyscrasias.
Hemoglobin (Hgb) M:14-18 g/dL Determine the presence of
F:12-16g/dL hereditary hematologic
abnormality.
Hematocrit (Hct)/Packed M: 39-49% Same as above two.
Cell Volume F:35-45%
Erythrocyte sedimentation M:<15mm/h Assist in the diagnosis of acute
rate (ESR) F: <20mm/h infections, such as tuberculosis
or tissue necrosis; acute
inflammatory process; chronic

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 infections; rheumatoid or
autoimmune disorders.
RED BLOOD INDICES
Mean Cell Volume 76-96fl (femto = 10-15)
(MCV)
LABORATORY TEST REFERENCE IMPORTANCE
RANGE
Mean Cell Hemoglobin 27-33pg (pico = 10-12) It is used to assist in diagnosis
(MCH) of anemia. And provide
screening as apart of a
complete blood count
Mean Cell Hemoglobin 33-35g/dL (CBC) in a general physical
Concentration (MCHC) examination, especially upon
RBC Distribution Width 11.6-14.8 admission to a health care
(RDW) facility or before surgery.
Reticulocyte Count 50-100×103/uL Monitor response to therapy
for anaemia. And to evaluate
erythropoietic activity
4000-11000/µL It is used to monitor assist in
White Blood Cell Count confirming suspected bone
(WBC) marrow depression. It is used
to assist in determining the
DIFFERENTIAL LEUKOCYTE COUNT (DLC) cause of an elevated WBC
Neutrophils 40-75% count (e.g., infection,
Lymphocytes 20-45% inflammatory process).
Monocytes 2-10%
Eosinophils 0-6%
Basophils 0-1.5%
Platelets Count (PLT) 150-450×103/µL It is used to confirm a low
platelet count
(Thrombocytosis), which can
cause increased clotting. And
to identify the possible cause
of abnormal bleeding such as
epistaxis, hematoma, gingival
bleeding, hematuria, and
menorrhaggia.
Activated Partial 17-27 sec It measures the intrinsic
Thromboplastin time clotting system, which depends
(APTT) on factors VIII,IX,XI &XII
and the factors involved in the
Prothrombin Time (PT) & PT=11-15 sec final common pathway of the
International Normalized INR= 2.0 to 3.0 or 2.5 clotting cascade (factors II, X,
Ratio (INR). to 3.5 & V).
Liver function tests (LFT’S)

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Alanine Aminotransferase M:10-50U/L Monitor response to treatment
(ALT) F:10-35U/L of liver disease. And to
compare serially with
Aspartate aminotransferase
(AST) levels to track the
course of liver disease.
LABORATORY TEST REFERENCE IMPORTANCE
RANGE
Aspartate M:10-50U/L
Aminotransferase (AST) F:10-35U/L It is used to monitor response
to therapy with potentially
hepatotoxic or nephrotoxic
drugs.
Alkaline phosphatase 41-133U/L Evaluate signs and symptoms
(ALP) of various disorders associated
with elevated ALP levels, such
as biliary obstruction,
hepatobiliary disease and bone
marrow disease including
malignant process.
Albumin 3.4-4.7 g/dL Assess the nutritional status of
hospitalized patients,
especially geriatric patients,
evaluate chronic illness;
evaluate liver disease.
Protein Total 6-8g/dL or 60-80 g/dL Hypoproteinemia usually
indicates Hypoalbuminemia,
because albumin is the major
serum protein.
Serum Bilirubin Bilirubin Total= It is used to assist in
<1mg/dL or differential diagnosis of
<20µmol/L obstructive jaundice; assist in
evaluation of liver disease;
monitor the effects of drug
reactions on liver function tests
&monitor jaundice in new born
babies.
Blood Urea Nitrogen 8-18mg/dL or
(BUN) 3-6.5mmol/L It is used to evaluate renal
function. Monitor the effects of
drugs known to be nephrotoxic
or hepatotoxic, evaluate
hemodialysis therapy and
assess nutritional support.

Serum Creatinine (Scr) M: 0.6-1.2mg/dl It is used to evaluate known or

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 F:0.5-1.1mg/dL suspected impairment of renal
function; assess a known or
suspected disorder involving
muscles in the absence of renal
disease; estimate creatinine
clearance.
LABORATORY TEST REFERENCE IMPORTANCE
RANGE
Creatinine clearance M:85-125ml/min, Used to determine the
(CLcr) F:75-115ml/min individualized dosage in case
of drugs excreted renally,
determine renal function before
administering nephrotoxic
drugs.
SERUM ELECTROLYTES AND MINERALS
Sodium (Na) 135-145mmol/L or To monitor the effectiveness of
135-145mEq/L drug therapy, especially
diuretics.
Chloride (CL) 95-105 mmol/L or To monitor or effectiveness of
95-105mEq/L drug therapy to increase or
decrease serum chloride levels.
Potassium (K) 3.5-5mmol/L or It is used to evaluate the effects
3.5mEq of drug therapy, especially
diuretics. Evaluate the
response to treatment for
abnormal potassium levels.
Bicarbonate (HCO3) 22-32mmol/L or It is one of the most important
22-32mEq/L buffer systems in maintaining
normal body fluid pH.
Magnesium (Mg) 0.75-1.25mmol/L or It is used to determine
1.5-2.5mEq or electrolyte balance in renal
1.8-3mg/dL failure and chronic alcoholism.
Evaluate cardiac arrhythmias.
Phosphate 0.8-1.6mmol/L or It is used to assist in
(PO4)/Phosphorus 2.5-5mg/dL establishing a diagnosis of
hyperparathyroidism.assist in
evaluation of renal failure.
LIPID PROFILE
Total Cholesterol (TC) Desirable <200mg/dL It is used to assist in
or 5.18mmol determining risk of
Borderline cardiovascular disease. To
200-239mg/dLor assist in the diagnosis of
5.18-6.19mmol/L nephritic syndrome, hepatic
High >240mg/dL or disease, pancreatitis and
>6.2mmol/L thyroid disorders.
High density lipoprotein (HDLC)= >35mg/dL It is used to assist in

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Cholesterol (HDLC) & or 0.91mmol/L determining risk of
Low density lipoprotein (LDLC)=<130mg/dL cardiovascular disease. To
Cholesterol (LDLC) or <3.37mmol/L investigate
hypercholesterolemia in light
of family history of
cardiovascular disease.
LABORATORY TEST REFERENCE IMPORTANCE
RANGE

MISCELLANEOUS
Blood Glucose It is used to screen Diabetes
Fasting Blood Sugar 60-110mg/dL mellitus, Monitor anti diabetic
Random Blood sugar <140mg/dL therapy assist in the diagnosis
of insulinoma, evaluate
disorders of carbohydrate
metabolism and identify
hypoglycaemia.
Glycated (Glycosylated) 3.9-6.9% It is used to assess long term
Hemoglobin AIC (method dependent) glucose control in Diabetes.
(HbA1C)

DRUG RELATED PROBLEMS:

Many valuable drugs are judged improperly by physicians who fail to give adequate
attention to the necessity of individualizing the dosage regimen for each patient. Here
main responsibility of pharmacist is;
• Counseling the patient concerning the safe and appropriate utilization of his
medicine
• Monitoring the drug utilization of the patient by referring to the patient’s
medication profile.
• Serving as a health advisor to the patient by providing advice on non
prescription products and by referring the patient to a physician or an
appropriate health agency.
• Serving as a health educator to the community particularly in matters relative
to medication usage.
• Serving as a source of drug information to the physician and thereby either
directly or indirectly influencing the selection of the drug or drug product for
the patient.

DEFINATION OF DRUG RELATED PROBLEM

“A DRUG-Related Problem is an event or situation involving drug therapy that
negatively interferes with a patient’s health.”
Or
“A Drug-Related Problem is an event or circumstance involving drug therapy that
actually or potentially interferes with desired health outcomes.”

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 Drug-related problems can result in an increase in hospital admissions as well as an
increase in morbidity and mortality. The problems relating to the use of medicines
are manifold. They may differ in pharmacological, pathological, epidemiological and
legal respects, and may have different consequences, for example, as regards
scientific study, regulation or rational use. Pharmacovigilance is concerned with all
such problems: adverse effects and interactions as well as problems relating to
ineffectiveness, inappropriate use, counterfeiting, and dependence or poisoning.
Practically all drug related problems can be classified in one basic system, taking
into account their characteristics and distinctions. This system distinguishes between
appropriate and inappropriate drug use, dose-related problems, and types A (drug
actions), B (patient reactions) and C (statistical) adverse effects.
As defined, drug-related problems include the following categories.
• medical indication for drug therapy but no drug
• wrong drug being used
• suboptimal dose of correct drug
• too much of correct drug (overdose or accumulation)
• adverse drug reactions
• drug interactions (drug-drug, drug-food, and drug-laboratory)
• patient not receiving drug (e.g. non adherence) or
• No medical indication for drug therapy (e.g. unnecessary drug therapy)

1). Untreated conditions

The patient has a medical condition that requires drug therapy but is not receiving for
that condition.
2). Drug use without indication
The patient is taking a medication for no medically valid condition or reason.

3). Improper drug selection/ Drug Choice Problem

The patient's medical condition is being treated with the wrong drug or a drug that is
not the most appropriate for the special needs of the patient.
Or
Patient gets or is going to get a wrong (or no drug) drug for his/her disease
and/or condition.
PROBLEMS:
Inappropriate drug (not most appropriate for indication)
Inappropriate drug form (not most appropriate for indication)
Inappropriate duplication of therapeutic group or active ingredient
Contra-indication for drug (Pregnancy/breast feeding)
No clear indication for drug use

4). Sub therapeutic dosage

The patient has a medical problem that is being treated with too little of the correct
medication. Below the dosage levels used to treat diseases. Drug dose too low or
dosage regime not frequent enough.

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5). Over dosage
The patient has a medical problem that is being treated with too much of the correct
medication. Drug dose too high or dosage regime too frequent.

6). Adverse drug reactions (ADRs)

The patient has a medical condition that is the result of an adverse drug reaction or
adverse effect. In the case of older adults, ADRs contribute to already existing
geriatric problems such as falls, urinary incontinence, constipation, and weight loss.
PROBLEM:
Side effect suffered (non-allergic)
Side effect suffered (allergic)
Toxic effects suffered

7). Drug interactions

The patient has a medical condition that is the result of a drug interacting negatively
with another drug, food, or laboratory.
PROBLEM:
Potential interaction
Manifest interaction

8). Failure to receive medication

The patient has a medical condition that is the result of not receiving a medication
due to economic, psychological, sociological, or pharmaceutical reasons.

9). Drug Use/Administration Problem

Wrong or no drug taken/administered.
PROBLEM:
Drug not taken/administered at all
Wrong drug taken/administered

10). Narrow therapeutic index drugs:

Drugs identified as having a high risk of being involved in a clinically significant
drug interaction frequently have a narrow therapeutic index, a very steep dose-
response curve or potent pharmacologic effects. A toxic dose of these drugs may be
only slightly above the therapeutic dose. A slight increase in the dose may produce a
large increase in serum drug levels and clinical effect. Conversely, a slight decrease
in the plasma level of drugs with a steep dose-response curve may result in a
significant loss of therapeutic effect. Examples of such drugs include corticosteroids,
carbamazepine, Quinidine, oral contraceptives, and Rifampin. Patients receiving
drugs with a narrow therapeutic index should be monitored closely for possible
clinically significant drug interactions.

11). Polypharmacy:
Administration of many drugs together. Or administration of excessive medication.
Or

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The mixing of many drugs in one prescription. Or the practice of prescribing
multiple drugs to patients suffering from more than one malady. Or the prescription
or dispensation of unnecessarily numerous or complex medicines.

12). Medical conditions and Pregnancy:

Certain medical conditions may complicate a pregnancy. However, with proper
medical care, most women can enjoy a healthy pregnancy, despite their medical
challenges.

13). Compliance/adherence:
It refers to a patient both agreeing to and then undergoing some part of their
treatment program as advised by their doctor or other healthcare worker. Most
commonly it is whether a patient takes their medication (Drug compliance), but may
also apply to use of surgical appliances (e.g. compression stockings), chronic wound
care, self-directed physiotherapy exercises, or attending for a course of therapy (e.g.
counseling). When medication is taken as recommended is termed as “non
compliance”. It is sometimes regarded as a manifestation of irrational behavior or
willful failure to observe instructions, although forgetfulness is probably a more
common reason. Adherence can be improved by taking care to explain the benefits
and adverse effects of a drug. Reducing the frequency of administration to once, or,
at most, twice a day also makes sense, despite lack of convincing evidence that this is
effective.
Causes for poor compliance include:
• Forgetfulness
• Prescription not collected or not dispensed
• Purpose of treatment not clear
• Perceived lack of effect
• Real or perceived side-effects
• Instructions for administering not clear
• Physical difficulty in complying (e.g. with opening medicine containers,
handling small tablets or swallowing difficulties,
travel to place of treatment)
• Unattractive formulation (e.g. unpleasant taste)
• Complicated regimen
• Cost of drugs

14). Others:
a). Drug/Dose selection
The cause of the DRP’s is related to the selection of the drug and/or dosage schedule
CAUSES:
Inappropriate drug selection
Inappropriate dosage selection
More cost-effective drug available
Pharmacokinetic problems (ageing/deterioration in organ function and interactions)
Synergistic/preventive drug required and not given

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Deterioration/improvement of disease state
New symptom or indication revealed/presented
Manifest side effect, no other cause

b). Drug use process

The cause of the DRP’s can be related to the way the patient uses the drug, in spite of
proper dosage instructions (on the label)
CAUSES:
Inappropriate timing of administration and/or dosing intervals
Drug underused/ under-administered
Drug overused/ over-administered
Therapeutic drug monitoring required
Drug abused (unregulated overuse)
Patient unable to use drug/form as directed

c). Information
The cause of the DRP’s can be related to a lack or misinterpretation of information
CAUSES:
Instructions for use/taking not known
Patient unaware of reason for drug treatment
Patient has difficulties reading/understanding Patient Information Form/Leaflet
Patient unable to understand local language
Lack of communication between healthcare professionals
d). Patient/Psychological
The cause of the DRP’s can be related to the personality of the patient.
CAUSES:
Patient forgets to use/take drug
Patient has concerns with drugs
Patent suspects side-effect
Patient unwilling to carry financial costs
Patient unwilling to bother physician
Patient unwilling to change drugs
Patient unwilling to adapt life-style
Burden of therapy
Treatment not in line with health beliefs

e). Logistics
The cause of the DRP’s can be related to the logistics of the prescribing or
dispensing mechanism
CAUSES:
Prescribed drug not available
Prescribing error (only in case of slip of the pen)
Dispensing error (wrong drug or dose dispensed).

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