DEFINITION:
Clinical pharmacists care for patients in all health care settings but the clinical
pharmacy movement initially began inside hospitals and clinics. Clinical pharmacists
often work in collaboration with physicians, nurse practitioners, and other healthcare
professionals.
4. Patient monitoring: Observes the signs and symptoms of that indicate the need
for reaction to drugs. Clinical pharmacist who knows correct route of administration,
the signs and symptoms of over dosages, contraindications, desired effects,
undesired effects and side effects can help in monitoring the drug therapy for safety
and efficiency, a necessity with the increasing applications of potent and toxic
chemicals and drugs. Drugs with narrow therapeutic index, or When drugs
administered in patients, who are critically ill or suffering from chronic diseases.
• Can compile and process data using computers and make it available to the
medical staff.
• May suggest an alternate therapy if applicable.
• Identify drug effect modifications due to interactions with several foods,
alcohol, smoking, environmental chemicals, as well as due to pregnancy.
• Many OTC drugs have the potential to interact with prescription drugs.
Medical audit is a logical and necessary procedure within organized teamwork. The
clinical pharmacist is either the initiator or a very active member of a functioning
committee.
1. Legislation.
2. Contractual obligation.
3. Regulation and registration of pharmacotherapy orders and
administration.
4. Regulation of clinical experiments with drugs.
5. Information per subject and per patient.
6. Pharmacotherapy-committee policy.
7. Regulation of information from the pharmaceutical industry.
8. Local or regional micro symposia per patient.
9. Formulary policy.
(i) Legislation:
The authorized pharmacist should be charged with the supervision over the
maintenance of the organization included involving the storage, the distribution and
the registration of drugs, regardless they are in the pharmacy or elsewhere in the
institution.
Clinical pharmacy must provide the means for pharmacotherapy. The follow-up
should be reviewed by pharmacist with head nurses and the medical director.
Specific problems should be discussed with the concerned members of the health
care team and regulated.
1. To ensure that there are no ethical problems that may harm patients.
2. To control trials.
3. To control pharmacotherapy through:
• Registration and processing of requests for the use of unregistered
drugs.
• Purchasing.
• Control of stock and turnover.
• Quality control.
• Supply.
• Compounding.
• Control of code and key of "blind" experiments.
• Reporting of deviation of standard operating and registration procedures
to the directorate.
(vi) Pharmacotherapy-committee:
ROLE OF PHARMACIST: A reliable and responsive TDM service depends on team work
between nurses, doctors, pharmacist, scientist and technical staff. The clinical
pharmacist should provide advice to medical staff on the appropriate use and timing of
TDM and assist with the interpretation of results. In addition the pharmacist maybe
involved in:
1. Initial selection of drug regimen. This may involve decisions about drug choice,
dose, dosing interval, route of administration and dosage form of the drug,
taking into account factors such as sex, age, body weight, race, metabolism
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES,
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status, renal function, plasma albumin concentration, use of other drugs and
laboratory results.
2. Adjustment of the dosage regimen based on TDM results and the patients
clinical response,.
3. Assessment of possible causes for unexpected results, such as non- compliance,
bioavailability problems, medication errors, drug interactions or
pharmacogenetic variability.
4. Dose adjustment for patients on haemodialysis or peritoneal dialysis.
5. Provision of poisons information.
GOALS:
1. To optimise the patients drug therapy.
2. To prevent or minimise drug related problems/medication errors.
PROCEDURE:
• The patient’s medical record should be reviewed in conjugation with the
medication administration record.
• Recent consultations, treatment plans and daily progress should be taken
into account when determining the appropriateness of current medication
orders and planning each patient’s care.
• All current and recent medication orders should be reviewed.
It includes:
1. Checking that medication order is written in accordance with legal and local
requirements.
2. Ensuring that the medication order is comprehensible and unambiguous, that
appropriate terminology is used and that drug name are not abbreviated.
Annotate the chart to provide clarification as required.
a) Untreated indication.
b) Inappropriate drug selection.
c) Sub therapeutic dose.
d) Adverse drug reaction.
e) Failure to receive drug.
f) Drug interactions.
g) Drug use without indication.
h) Over dosage.
CLINICAL REVIEW:
Clinical review is one of the integral components of medication review and should
preferably be performed on a daily basis. It is the review of the patients’ progress for
the purpose of assessing the therapeutic outcome. The therapeutic goal for the specific
disease should be clearly identified before the review.
GOALS:
PHARMACIST INTERVENTIONS:
Clinical pharmacists can audit their impact on patient care by intervention monitoring.
Some hospitals undertake these audits at regular intervals and present the results
internally or to the multidisciplinary team. Data collection forms or electronic hand-held
systems are used to collect the relevant data on a pharmacist’s interventions to improve
patient care. Examples of data collected for this purpose include the following.
1. ADRs
2. Allergy
3. Additional drug therapy required
4. Medication error
5. Medication without indication
6. Untreated condition or undertreated condition
7. Minimal or no therapeutic effectiveness
8. Therapeutic duplication
9. Patient adherence, compliance, or drug administration issue
10. Patient education
11. Communication with prescriber
12. Incorrect medication prescribed
13. Inappropriate or suboptimal dose, schedule, or route
14. Optimization of drug therapy, including improving cost-effectiveness
15. Dose advice
16. Advice on drug choice
17. Drug–drug, drug–food, or drug–disease interaction
18. Side effect/toxicity
19. Therapeutic monitoring for toxicity or effectiveness
20. Formulation
21. Compatibility
22. Formulary or protocol adherence
The Ward round participation also provides many learning opportunities for
pharmacists. It allows pharmacists to see first-hand how drugs are used and
prescribed and to see the effects of these drugs on patients. With time, pharmacists
develop an appreciation of how the patient’s own wishes and their social, cultural
and economic circumstances may influence therapeutic choices. Even for
experienced clinical pharmacists in teaching hospitals, it is very rare to finish a ward
round without gaining new perspectives on some aspect of therapeutics or patient
care. For those involved in academia and research, ward rounds allow identification
of cases for clinical teaching and publication. Not the least, ward round participation
strengthens the inter-professional relationship among various health professionals,
leading to better healthcare practice and research.
C) ADRs MANAGEMENT:
The ADRs are can be managed by following methods:
1. Assess the nature and severity of the reaction: Whether an urgent action is
required or can be managed by primary care. E.g.: whether an anaphylactic
shock or something minor.
Timing: Time of start of the reaction after giving the drug; Time taken to abate
after the stopping of drug or reducing the dose.
3. Take complete drug history - Review any History of Allergy or previous ADR:
When the drug was started, dose, other drugs, OTC and herbal. Past ADRs Long
Drug information:
• It is the current, relevant, critically examined data about drug and drug use for
given patient or situation.
• Many institutes run DIC (Drug Information Centre) for the provision of drug
information, to every group/kind of people from any place.
HISTORY:
1. First DIC was developed in University of Kentucky in 1960. In United states 80%
of the Hospitals having DIC.
2. INDIA, in infancy stage with a few centres.
3. In India beginning has been made by the professor of pharmacology Mumbai at
a govt medical college.
1. Primary Source:
Examples; articles published in journals (e.g. British Medical Journal), thesis etc.
2. Secondary source:
3. Tertiary source:
• Drug informer should understand the nature of the question and should ask all
the needed questions to get the ultimate question.
• Most specialists today use the modified systematic approach designed by ‘Host
and Kirkwood’, these are:
• Who requests?
• Med/non med personnel
• Educated/un educated personnel
• Name/location/phone/email etc., of requestor This determines the type of
response that will be given
Step III; determine and categorize the ultimate question: Putting the pieces of
information together to form ultimate question and once it has been determined; the
next step is to categorize the question.
Step IV; Develop strategy and conduct research: Strategies should be developed with a
typical algorithm with three essential components; tertiary-secondary-primary
literature.
Step Perform evaluation, analysis & synthesis: Provider should take time to evaluate
the info, analyse and then synthesize it into a good reply.
• Checking with the requestor to make sure his/her question has been sufficiently
and completely answered.
• Of vital importance is to document all the steps taken in this process.
1. Drug information canters (DICs) in general, are service providers, which provide
drug information relating to therapies, Pharmacoeconomics, education, and
research programs.
2. It provides unbiased information to health care professionals and/or patients
and consumers.
3. Many centers also provide workshops or other forms of training to enhance the
skills of healthcare professionals.
4. A drug information center is usually a unit located within and/or affiliated with a
larger organization (i.e., a pharmaceutical association, a hospital etc.).
STAFFING:
POISON INFORMATION:
HISTORY:
1. The first centers were instituted in North America and Europe during the 1950’s.
2. The International Programme on Chemical Safety (IPCS) was established in 1980
as a collaborative programme of the International Labour Organization (ILO),
the United Nations Environment Programme (UNEP), and the World Health
Organization (WHO) in order to provide assessments of the risks to human
health and the environment posed by chemicals.
• For the provision of service regarding poison and related danger, and to manage
with the poisoning Cases
• Concept initiated in Chicago in 1953
STAFFING:
1. Pharmacy team:
• Pharmacist; specialists trained in poison information and in the
management of poisoning emergencies.
• Pharmacy Technicians & Students.
2. Medical team:
Toxicologists specializing in medical toxicology are also available for
consultation.
3. Supporting team:
a. People trained in library science with computer knowledge.
b. The poison information centre is a specialized unit providing
information on poisoning, in principle to the whole community.
TOXICOVIGILANCE:
ENVIRONMENTAL TOXICITY:
BENEFITS:
E) MEDICATION HISTORY:
Regular medication review maximizes the therapeutic benefit and minimizes the
potential harm of drugs. It ensures the safe and effective use of medicines by patients.
Medication review provides an opportunity for patients to discuss their medicines with
a healthcare professional. Medication review is the cornerstone of medicines
management.
• Face-to-face review of medication with the patient and their notes, specifically
undertaken by a doctor, nurse, or pharmacist.
• Provides an opportunity to discuss what medication the patient is actually
taking and how medicine-taking fits in with the patient’s daily life.
• Review of medicines, with reference to the patient’s full notes, in the absence
of the patient and under the direction of a doctor, nurse, or pharmacist.
Who to target:
• Potential ADRs.
• Potential interactions (drug–drug or drug–food).
• Suboptimal monitoring.
• Adherence/lack of concordance issues.
• Misunderstanding of dose directions.
• Impractical directions.
• Incorrect/inappropriate dosages.
• Drugs no longer needed (e.g. one medication used to treat the side effects of
another).
• Difficulties with using certain dose forms (e.g. inhaler or eye drops).
F) PATIENT COUNSELLING:
Providing information to patients and their representatives
regarding disease, drug therapy, and duration of therapy, side effects, and life style
modifications.
Introduction:
The barriers that come in the way of conducting patient counseling are:
1. Environment:
✓ A busy pharmacy
✓ Lack of privacy
✓ Noise
✓ Physical barrier
2. Patient factors
✓ Physical disabilities
✓ Comprehensive difficulties
✓ Illiteracy
3. The pharmacist
4. Time.
Environment:
✓ Community pharmacy, hospital OP pharmacy and hospital ward are all areas
where pharmacist uses their communication skills in a professional capacity.
✓ None of these areas are ideal but an awareness of the limitation of the
environment goes part the way to resolving some of the problems.
A busy pharmacy:
✓ This may create the impression there appears to be little time to discuss
personnel matter with the patients.
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✓ The pharmacist is supervising number of difficult activities at the same time and
is unable to devote his/her full attention to an individual matter.
✓ It is important that pharmacist organize their patterns in such a way as to
minimize their impression.
Lack of privacy:
Noise:
✓ Noise levels within the working environment are an obvious barrier to good
communication.
✓ People strain to hear what is said. Comprehension is made more difficult,
particularly problem exist for hearing impaired patients.
Physical barriers:
Patient factors:
Physical disabilities:
✓ Dealing with patients who have sight or hearing impairments will require the
pharmacist to use additional communication skills.
Comprehensive difficulties:
✓ Not all people come from the same educational background and care must be
taken to assess patient’s level of understanding and choose appropriate
language.
✓ In many cases, the lack of ability to comprehend may be because English is not
the patient’s first language.
✓ Pharmacist working in areas where there is high proportion of non-English
speakers may find it useful to stop / develop their own information leaflet in
appropriate language.
Illiteracy:
✓ High proportion of people in India is illiterate. Obviously for these patients any
written materials will be meaningless. As well as, it is not always easy to identify
illiterate patient because patient may feel ashamed and are unlikely to admit it.
✓ However, if pharmacist identifies any patient who have reading difficulties,
pictorial labels can be used and additional verbal advice can be given.
Pharmacist:
✓ Not all pharmacists are natural good communicators but identifying their
strength or weakness will assist in improving our communication skills.
✓ Some of the weakness which can be barrier to good communication are listed
below:
✓ Lack of confidence.
✓ Lack of interest
✓ Laziness
✓ A pharmacist who is not prone to delicate responsibilities.
✓ If any of these characteristics is present, the reason for it should be identified
and resolved if possible.
Medication use valuation (MUE) is similar to DUE but emphasizes improving patient
outcomes and Individual quality of life; it is, therefore, highly dependent on a
multidisciplinary approach involving all professionals dealing with drug therapy. An MUE
will assess clinical outcomes (cured infections, decreased lipid levels, etc.).
The goal of a DUE or MUE is to promote optimal medication therapy and ensure that
drug therapy meets current standards of care. Additional objectives may include:
The steps of a DUE: The steps of a DUE are as follows. An example is shown in box 6.7.
The DTC should decide upon the objectives of the DUE and the scope of the activities
necessary. The scope can be very extensive or it can focus on a single aspect of drug
therapy and will depend upon the type of problem identified, for example:
Due to the large number of medicines available at a hospital or clinic, the DTC must
concentrate on those medicines with the highest potential for problems in order to get
the most return on the work involved. These high-priority areas include:
• high-volume drugs
• expensive drugs
• drugs with a narrow therapeutic index
• drugs with a high incidence of ADRs
• critically important therapeutic categories, for example cardiovascular,
emergency, toxicology, intravenous drugs, chemotherapy and narcotic
analgesics
• antimicrobial drugs, prophylactic and therapeutic
• drugs undergoing evaluation for addition to the formulary
• drugs used for non-labelled indications
• drugs used in high-risk patients
An Establishing DUE criterion are extremely important, and is the responsibility of the
DTC. DUE criteria are statements that define correct drug usage with regard to various
components, as shown in box 6.6. Criteria for the use of any medicine should be
established using the hospital’s STGs (assuming that they have been correctly
developed). In the absence of hospital STGs, criteria may be based on recommendations
from national or other locally available satisfactory drug use protocols, other relevant
literature sources, and/or recognized international and local experts. Credibility, and
staff acceptance, of the DUE relies on using criteria that have been developed from
reading established evidence-based medicine information from reputable sources and
that have been discussed with prescribers.
Reviewing many criteria will make the DUE process more difficult, and may impair
successful completion of the review. Therefore the number of criteria established for
each medicine is often between 3 and 5. Once the criteria are established, thresholds or
benchmarks are decided for each criterion in order to define the expectations or goals
for compliance with the criteria. Ideally one would like 100% of all cases to comply with
the criteria, but in reality this may not be possible, and a DTC might decide to set a
threshold of 90-95% compliance below which they would instigate corrective action.
Data may be collected retrospectively, from patient charts and other records, or
prospectively, at the time a medicine is prepared or dispensed. Retrospective data
collection may be quicker and is best accomplished away from the patient care areas
and distractions. The advantage of a prospective review is that the reviewer can
intervene at the time the medicine is dispensed to prevent errors in dosage, indications,
Data must be collected from a suitable random sample of charts or prescription records
from the health-care facility, usually selected by pharmacy personnel, but also by nurses
or medical records personnel. The treatment of at least 30 patients, or 100 patients for
common clinical conditions, should be reviewed per health facility or hospital. The larger
the facility and the more practitioners, the larger the number of records needed for
review and analysis. Data collection forms based on the criteria can be configured into
simple ‘yes/no’ questions or may involve the filling in of open questions. Sources of data
include patient charts, dispensing records, medication administration records,
laboratory reports, ADR reports, medication error reports, antimicrobial sensitivity
reports, and documented staff and patient complaints.
Data are tabulated in a form that corresponds to the criteria chosen for the DUE. The
percentages of cases that meet the threshold for each criterion should be calculated
and summarized for presentation to the DTC. A report of all DUE programmes that are
being conducted should be prepared on a quarterly basis.
STEP 7 Follow-up:
In every DUE, follow-up is critical to ensure appropriate resolution of any problems. Did
an intervention achieve its objective? If an intervention is not evaluated, or drug use
problems are not resolved, then the DUE will have been of no use. As a part of a follow-
up plan the DTC must assess the need to continue, modify or discontinue the DUE. Thus,
DUE activities should be evaluated regularly (at least annually) and those that do not
have a significant impact on drug use should be redesigned in order to provide
measurable improvements. Common problems associated with DUEs include unclear
responsibilities for different activities, poor prioritization of problems, lack of
documentation, lack of personnel and inadequate follow-up. If follow-up is adequate,
prescribers are likely to improve their performance in all areas knowing that they may
be reviewed in the future!
In 1993 the quality assurance coordinator reported to the DTC that the rate of
postoperative infections for abdominal surgery was considerably higher than the
national average. The pharmacy director reported that ceftriaxone, a costly and
inappropriate drug, was used for these patients. He advised that current formulary
drugs, either cefoxitin or cefotetan, would be more appropriate. The DTC decided to
undertake a DUE for prophylaxis of abdominal surgery wound infection. The chief
surgeon was a member of the DTC and he agreed with their decision to conduct a DUE
using criteria developed from recently published recommendations in the Medical
Letter.
Recommendations
• Send letter to all surgeons with information about (1) current postoperative
infection rates versus the national average, (2) criteria and recommendations
from the Medical Letter, (3) results of the DUE data collection, (4) estimated
cost impact of inappropriate drug selection and unnecessary drug use
• Remove cefoxitin from the formulary because of its disadvantages (cost and
short half-life) compared with cefotetan
• Change procedures to administer preoperative doses in the preoperative area
rather than the operating room, and instruct nursing and pharmacy staff
accordingly
• Add approved antibiotics to the floor stock in the preoperative area for
emergencies
Actions:
• Chief surgeon informed the surgical committee about the DUE and the criteria
in 1994
• A letter was sent to all surgeons in April 1994 detailing the rationale for using
cefotetan, not ceftriaxone, for prophylaxis of abdominal wound surgery
• Cefoxitin was removed from the formulary: ceftriaxone could not be removed
due to its use for other indications
• New procedures for administration were adopted in June and staff training
started in July 1994
• Antibiotics were added to preoperative floor stock in July 1994
DUR programs play a key role in helping managed health care systems understand,
interpret, evaluate and improve the prescribing, administration and use of medications.
Employers and health plans find DUR programs valuable since the results are used to
foster more efficient use of scarce health care resources. Pharmacists play a key role in
this process because of their expertise in the area of medication therapy management.
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DUR affords the managed care Pharmacist the opportunity to identify trends in
prescribing within groups of patients whether by disease-state such as those with
asthma, diabetes or high blood pressure, or by drug-specific criteria. Pharmacists can
then, in collaboration with prescribers and other members of the health care team,
initiate action to improve drug therapy for patients.
• Clinical abuse/misuse
• Drug-disease contraindications (when a prescribed drug should not be used
with certain diseases)
• Drug dosage modification
• Drug-drug interactions (when two or more different drugs interact and alter
their intended effects, often causing adverse events)
• Drug-patient precautions (due to age, allergies, gender, pregnancy, etc.)
• Approved by AMCP Board of Directors November 2009
• Formulary substitutions (e.g., therapeutic interchange, generic substitution)
• Inappropriate duration of drug treatment
2. Concurrent DUR: Concurrent review is performed during the course of treatment and
involves the on-going monitoring of drug therapy to foster positive patient outcomes. It
presents pharmacists with the opportunity to alert prescribers to potential problems
and intervene in areas such as drug-drug interactions, duplicate therapy, over or
underutilization and excessive or insufficient dosing. This type of review allows therapy
for a patient to be altered if necessary.
As electronic prescribing becomes more widely adopted, the concurrent DUR process
may be performed by the prescriber at the time of prescription transmission to the
pharmacy, allowing interventions before the drug is dispensed. An important
component of DUR will require complete and current drug and allergy records for the
patient, as well as knowledge of appropriate therapeutic interchanges for individuals. As
a safety net, pharmacists will perform a similar role as prescribers on the dispensing side
of these transactions.
• Drug-disease interactions
• Drug-drug interactions
• Drug dosage modifications
• Drug-patient precautions (age, gender, pregnancy, etc.)
• Over and underutilization
• Therapeutic Interchange
Example: Concurrent DUR often occurs in institutional settings, where patients often
receive multiple medications. Periodic review of patient records can detect actual or
potential drug-drug interactions or duplicate therapy. It can also alert the pharmacist to
the need for changes in medications, such as antibiotics, or the need for dosage
adjustments based on laboratory test results. The key prescriber(s) must then be alerted
to the situation so corrective action can be taken.
Definition: Quality assurance can be defined as the procedures which are used to set,
promote, maintain and monitor the desired standards for services and products.
Significance:
Goals:
• To monitor and evaluate the quality of clinical pharmacy services and standards
of practice
Key requirements:
• Administrative Support
Determining Priorities:
• Priority should be given to those aspects of clinical pharmacy which have the
greatest contribution to patient care (e.g. TDM, patient counseling, medication
chart review)
Setting of Standards:
Methods:
• Documentation of Procedures
• Evaluation of Compliance
• Audit of Documentation
✓ Patient drug profiles
✓ Endorsement on patient drug charts and prescriptions
✓ Written drug information answers
✓ Drug utilization reports
✓ Therapeutic drug monitoring reports
✓ ADR reports
✓ Pharmacy intervention record.
Conclusion:
1. Medication history
a. SAMPLE
b. OPQRST
c. SOAP
d. COAST MAP
2. Physical examination
a) General/IPPA
• Inspection
• Auscultation
• Palpation
• Percussion
b) Vital signs
• Temperature
• Heart rate
• Blood pressure
• Respiratory rate
c) HEENT
• Oral mucosa
• TM Eyes (Ophthalmoscopy, Swinging-flashlight test)
• Hearing (Weber, Rinne)
d) Respiratory
• Respiratory sounds
• Cyanosis Clubbing
e) Cardiovascular
• Precordial examination
• Peripheral vascular examination
3. Assessment
• Medical diagnosis
• Differential diagnosis.
B
1. BACTEREMIA -the presence of bacteria in the blood
2. BENIGN -doing no harm, not malignant
3. BILIARY -pertaining to bile, the liver, the gall bladder and the associated duct
4. BIOPSY -removal of a piece of a body tissue for diagnostic examination, usually
microscopic
5. BLOOD PRESSURE -the pressure of the blood on the elastic walls to the arteries
6. BRADYCARDIA -abnormally slow heart action
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7. BRIGHT’S DISEASE -a kidney disease accompanied by albumin in the urine
8. BRONCHITIS -inflammation of the bronchial tubes
9. BRONCHOSCOPE -a lighted instrument used for the examination of the interior
of the bronchi
10. BUCCAL -pertaining to the cheek or mouth.
C
1. CACHEXIA -a state of weakness and emaciation
2. CALCULUS -an abnormal concretion, usually composed of mineral salts,
occurring within the body CALLOSITY -a hardening and thickening of the skin
3. CANCER -exceedingly harmful. Usually rapid growth of cells
4. CARCINOMA -a cancer
5. CARDIAC -pertaining the heart
6. CARDIOGRAPH -an instrument for recording the action of the heart
7. CARRIER -an individual who harbours in his body the specific organisms of a
disease without manifesting its symptoms and thus act as a distributor or
transmitter of the infection
8. CARTILAGE -the bristle or white elastic substance attached to the bone surfaces
at the joints
9. CAST -an appliance to render immovable, displaced or injured parts
10. CATHARTIC -a drug that stimulates the evacuation of intestinal waste, a
purgative
11. CAUSALGIA -burning pain that may accompany nerve injury
12. CAVITY -a hollow space within the body or within one of its organ
13. CELL -the minute protoplasmic building unit of living matter
14. CEPHALIC -pertaining to the head
15. CERUMEN -earwax
16. CERVICAL -pertaining to the neck or cervix of any structure
17. CHANCRE -the primary lesion of syphilis
18. CHEMOTHERAPY -the use of chemical agents to treat disease
19. CHOLESTASIS -stoppage of bile flow
20. CHOREA -“St. Vitus Dance” a nervous disease characterized by involuntary
jerking muscle movements
D
1. DELIRIUM -a mental disturbance, usually temporary, marked by cerebral
excitement, wandering speech, illusions and hallucinations
2. DEMENTIA -deterioration of mental capacity
3. DEMULCENT -a bland, soothing medication or application
4. DENDRON -a branch of nerve cell
5. DEPILATORY -a preparation for removing superfluous hair
6. DEPRESSION -lowered mental and physical activity
7. DERMATOLOGY -a branch of medicine dealing with disease of skin and skeletal
muscles
8. DERMIS -the true skin
DESQUAMATION -the shedding or scaling of the skin or cuticle
9. DIAGNOSIS -the recognition of a disease by its signs and symptoms
10. DIAPHORESIS -profuse perspiration
11. DIAPHRAGM -the muscular partition between the thoracic and abdominal
cavities
12. DIARRHEA -abnormal frequency and fluidity of discharges from the intestines
13. DIATHERMY -the generation of heat in the body tissues due to resistance by the
tissues to high frequency electric currents forced through them.
E
1. EMBOLUS -a clot or portion of a clot that has broken away from its site of origin
and flows freely in the circulatory until it lodges in a narrow vessel
2. EMBOLISM -an obstruction of a blood vessel by a clot of blood
F
1. FAINT -loss of consciousness due to insufficient blood in the brain
2. FATIGUE -weariness resulting from overexertion of the body or in the mind
3. FEBRILE -pertaining to fever
4. FECES -the residue from the digested food, which is discharged from the
intestines
5. FESTER -to suppurate superficially (as in a festering wound)
6. FETIC -having disagreeable odour
7. FETUS -a term applied to the unborn child after the third month of pregnancy
8. FEVER -abnormally high body temperature
9. FIBROUS -composed of oil or containing fibre
10. FIMBRIATED -fringed FLACCID -weak, lax, or lacking muscle tone
11. FLATUS -gas in the intestine or stomach
12. FLEX -to bend
13. FLUOROSCOPE -a device used for examining deep structures by means of the
roentgen rays (x-ray) FOREIGN BODY -any substance lodged in a place where it
does not belong
14. FRACTURE -a break in the bone
15. FRICTION –rubbing
16. FUMIGATION -exposure to disinfecting fumes
17. FUNCTION -a normal action of a part of an organ or body
18. FUSION -the joining together of two adjacent parts or bodies.
G
1. GAIT -a manner or style of walking
2. GALL -the bile
3. GANGRENE -the death of a part of a tissue
4. GASTRIC -pertaining to the stomach
5. GASTROENTOROLOGY -branch of medicine dealing with disease of the stomach
or intestine GASTROINTESTINAL -pertaining to the stomach or intestines
6. GAVAGE -passing food into the stomach through a tube
H
1. HALLUCINATION -seeing, hearing, or feeling something when there is no
objective stimulus HELIOTHERAPY -disease by composing the body to the sun
rays, particularly in the morning (between 6- 7am)
2. HEMATEMESIS -vomiting of blood
3. HEMATOLOGY -the study of blood
4. HEMATOMA -a clot of extraverted blood
5. HEMATURIA -discharge of blood in the urine
6. HEMIPLEGIA -paralysis of side of the body
7. HEMACHROMATOSIS -a disorder of Iron metabolism with excessive deposits of
iron in the body tissues, specially the liver, skin and pancreas (LSP*)
8. HEMOGLOBIN -the pigment of red blood cells that carries oxygen
9. HEMOPHILIA -a congenital condition characterized by delayed clotting of blood
10. HEMOPLYSIS -blood stained sputum or expectoration of blood
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES,
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11. HEMORRHAGE -bleeding, an escape of blood from the arteries
12. HEMORRHOIDS -a distortion on the veins of the anal region
13. HEMOTHORAX -presence of blood in the pleural cavity
14. HEPATITIS -inflammation of the liver
15. HEREDITY -the inheritance of physical or mental characteristics from ancestors
16. HERNIA -the protrusion of a loop or knuckle of an organ or tissue through an
abnormal opening HERPES -fever blisters, cold sores
17. HICCUP -an involuntary spasmodic contraction of the diaphragm caused by the
irritation of the phrenic nerve, which produced a sharp, respiratory cough
18. HIRSUTISM -abnormal hairiness particularly in women (eg, Menoxidil, (Dilantin),
Phenytoin for anticonvulsant)
19. HORMONES -a chemical substance produced in an organ which is carried to an
associated organ by the bloodstream, influencing its functional activity
20. HYDRONEPHROSIS -distension of the pelvis and calyces of the kidney with urine,
as a result of obstruction of the ureters
21. HYDROTHERAPY -the use of water in the treatment of disease
22. HYDROTHORAX -the collection of watery fluid in the pleural cavity
23. HYPERALGESIA -increased sensitivity to pain
24. HYPERCHOLESTEROLEMIA -excess cholesterol in the blood
25. HYPEREMIA -excessive blood in the part of the body due to local or general
relaxation of the arteries HYPERGLYCEMIA -excess of glucose in the blood
26. HYPEROPIA -farsightedness
27. HYPERTENSION -chronic elevation of the blood pressure
28. HYPERTROPHY -a diseased enlargement of a part of the body or organ
29. HYPNOSIS -an artificially induced passive state resembling the trance
30. HYPNOTIC -an agent that produces sleep or drowsiness
31. HYPOCHONDRIA -a morbid anxiety about health
32. HYPODERMOCLYSIS -injection of fluids into the tissue under the skin
33. HYPOGLYCEMIA -an abnormally low amount of sugar in the blood
34. HYPOGONADISM -diminished activity of the testes and the ovaries
35. HYPOKALEMIA -a deficiency of potassium in the blood
36. HYPOMANIA -mania of the mild type
37. HYPOTENSION -chronic depression of the blood pressure
38. HYPOTHERMIA -a low body temperature which may be fatal
39. HYSTERIA -lack of emotional control or actions
40. HYSTERECTOMY -the surgical removal of the uterus
J
1. JAUNDICE -a yellowish discoloration of the skin due to bile
2. JURISPRUDENCE -the application of study of legal principles
K
1. KELOID -a scar on the skin consisting of dense tissues, found often in the Negro
race
2. KERATITIS -inflammation of the cornea
3. KETONURIA -presence of ketone bodies in the urine
4. KETOSIS -increase of ketone bodies in the body tissue and fluid
5. KOPLIK’S SPOTS -bright red spots in the mouth and throat in the early stages of
measles
6. KYPHOSIS -an abnormal increase in the thoracic curvature of the spine giving a
“hunchback” appearance
L
1. LACTEALS -lymph vessels in the intestines
2. LARYNGITIS -inflammation of the larynx
3. LATENT -a condition that is concealed or not manifested
4. LATERAL -pertaining to a side
5. LAVAGE -washing out of an organ, such as the stomach or bowel
6. LAXATIVE -mild cathartic that promotes evacuation of the intestines
7. LENS -a transparent crystalline structure in the eye that converges or scatters
light rays to focus images on the retina
8. LENTIGO -small brownish pigmented areas on the skin due to an increase
amount of melanin, commonly known as “freckles”
9. LESION -a break in the body tissue such as a swore or wound
10. LETHARGY -a state of stupor, dullness, indifference, lack of feeling
11. LEUKEMIA -a disease of the blood-forming organs characterized by uncontrolled
increase in the number of leukocytes
M
1. MALAISE -a vague feeling of bodily discomfort
2. MALIGNANT -deadly, tending to go from bad to worse
3. MALINGERING -a deliberate feigning or exaggeration of the symptoms of illness
or injury, usually to arouse sympathy
4. MALPRACTICE -injurious or faulty treatment that results in injury loss or damage
5. MANIA -a disordered mental state of extreme excitement
6. MASTICATE -to chew food.
7. MASTITIS -inflammation of the breast
8. MASTOIDITIS -inflammation of the mastoid bone
9. MATURATION -the process of ripening or becoming fully developed
10. MEATUS -an opening to some passageway in the body
11. MECONIUM -a dark green or black fecal substances in the intestine of the full
green fetus or new born infant
12. MEDIAL -midline of the body or nearest to that midline
13. MEMBRANE -a thin layer of tissues covering a part or lining a body cavity
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES,
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14. MENARCHE -the establishment of menstruation
15. MENINGES -the membranes that covers the brain and the spinal cord
16. MENINGITIS -inflammation of the meninges.
N
1. NECROSIS -mental or psychic disorder characterized by fears, anxiety and
compulsion
2. NEVUS -a congenital circumscribed discolored area of the skin, either vascular or
nonvascular NOCTURIA -excessive urination at night
3. NUTRITION -the process of using food for growth and development
O
1. OBESE -extremely fat
2. OBSTETRICS -branch of medicine dealing with pregnancy, labour and the
puerperium
3. OINTMENT -a greasy semi-solid preparation for external use on the body
4. OLIGURIA -scanty secretion of urine
5. ONSET -the beginning of an illness when the first symptoms of disease appear
6. OOPHORECTOMY -the surgical removal an ovary or the ovaries
7. OPTHALMOLOGIST -a physician who specializes in the treatment of disorders of
the eye
8. OPIATE -a drug containing or derived from opium
9. OPTICIAN -one who grinds lenses and fits eyeglasses
10. OPTOMETRIST -one who measures vision and prescribes glasses for visual
defects ORAL -pertaining to the mouth
11. ORCHITIS -inflammation of the testicles
12. ORGAN -a group of body tissues having a particular function
13. ORIFICE -the entrance or outlet of any body cavity
14. ORTHOPEDICS -branch of surgery that deals with the correction of deformities
and chronic diseases of the bones and joints
15. ORTHOPNEA -difficulty in breathing relieved only by sitting or standing erect
16. ORTHOSIS -straightening of a deformity
17. OSSEUS -bone-like structure; pertaining to the bone
18. OSTEOARTHRITIS -a degenerative joint disease
19. OSTEOMALACIA -bone degradation due to lack of calcium
P
1. PALLOR -paleness, absence of skin pigments
2. PALPITATION -unduly rapid or throbbing heartbeat that can be sensed by the
patient
3. PALSY -loss of motion (paralysis) in a part of the body
4. PANCYTOPENIA -deficiency of all cell elements of the blood
5. PAPULE -a small, circumscribed elevation of the skin
6. PARACENTESIS -the surgical puncture of a body cavity for the aspiration of body
fluids
7. PARALYSIS -loss of motion or impairment of sensation in a part of a body
8. PARAPLEGIA -paralysis of the lower part of the body
9. PARASITES -plants or animals that lives upon or within another organism
10. PARENTERAL -not through the alimentary canal i.e., by intravenous injection or
IV route
11. PARESIS -slight or incomplete paralysis
12. PARIETAL -pertaining to the walls of a cavity
13. PAROXYSM -a sudden periodic attack or recurrence of symptoms of a diseases
14. PARTURITION -the act of giving birth to a child
15. PASSIVE -submissive or not produced by active birth
16. PATELLA -the kneecap
17. PATENCY -the condition of being freely open
18. PEDIATRICS -the branch of medicine that is concerned with children’s diseases
19. PELLAGRA -a deficiency disease or syndrome caused by lack of Niacin
20. PERCUSSION -tapping a part of the body with short, sharp blows to elicit sounds
or vibrations that aid in diagnosis
21. PERICARDIUM -the double membrane that envelops the heart
22. PERIOSTEUM -a tough, fibrous membrane surrounding the bone
23. PERIPHERAL -pertaining to the outward part of the bone
24. PHYSICAL -pertaining to the body
25. PLACEBO -an inactive or non-medicinal substance given in place of a medication
to gratify a patient without his knowledge of its actual physiologic, therapeutic
value
Q
1. QUADRIPLEGIA -paralysis of all four extremities
2. QUARANTINE -a period of detention or isolation as a result of suspected
contagion of a communicable disease
3. QUICKENING -the first movements of the foetus felt in pregnancy usually
occurring from the 16th to the 16th week
R
1. RADIALE -to diverge or spread from a common central point
2. RADIUM -a metallic element that gives off rays used in treating malignancies
3. RASH -a superficial eruption of the skin
4. REACTION -action in response to some influence or force
5. RECTUM -the distal portion of the large intestine between the sigmoid colon
and the anal canal RECUMBENT -lying down
6. RECUPERATE -to recover health or gain strength after an illness
7. RECURRENCE -the return of symptoms after their remission
8. REFLEX -an automatic response to a given stimulus
9. REGURGITATION -the return of food from the stomach soon after eating,
without ordinary efforts of vomiting
10. REHABILITATION -the restoration of an ill or injures patient to self-sufficiency or
to gainful employment at his highest attainable skill in the shortest possible
time
11. RELAPSE -recurrence of former symptoms during convalescence
12. REMISSION -the lessening in severity or subsiding the symptoms of an illness
S
1. SAC -a bag-like organ or structure; a pouch
2. SACRUM -triangular bone of the lower spine
3. SARCOMA -a type of tumour, often malignant, composed of a substance like
embryonic connective tissues
4. SATURATED -pertaining to a solution in which no more of a substance can be
dissolved
5. SCOLIOSIS -lateral curvature of the normally straight vertical line of the spine
6. SCURVY -a nutritional disease caused by an insufficient amount of fruits and
vegetables in the diet SEBACEOUS -pertaining to sebum
7. SEBORRHEA -an increase in the secretion of the sebaceous glands
8. SEBUM -an oily, fatty secretion from the sebaceous glands
9. SEDATIVE -agent that allay activity and excitement
10. SEGMENTATION -the division into smaller parts, such as that which occurs in the
zygote
11. SENILITY -a progressive feebleness of the body and mind generally associated
with aging
12. SEPTICEMIA -a systemic disease produced by pathogenic bacteria in the blood
13. SEPTUM -a dividing wall between two cavities
14. SERA -the clear portion of the blood; the clear liquid that separates from the
blood after clotting; serum (plural)
15. SHOCK -depression of the body functions due to the failure of the circulation
16. SINUS -a cavity
U
1. ULCER -an open sore on that external or internal surface of the body that causes
the gradual disintegration of the tissue
2. UMBILICUS -a small soar on the abdomen that makes the former attachment of
the umbilical cord to the foetus
3. UNCONSCIOUS -a lack of awareness of the environment with an incapability to
react to sensory stimuli
4. UREA -the end product of protein metabolism on the body and the chief
nitrogenous substance found in urine
5. UREMIA -an accumulation in the blood of substance that should have been
eliminated in the urine URINALYSIS -analysis of urine
6. UROLOGY -the branch of medicine that deals with the urinary system in the
female and genitourinary tract
7. URTICARIA -hives; an allergic reaction of the skin characterized by weal’s, which
are often accompanied by severe itching
V
1. VACCINATION -the injection of killed or modified living organism for the purpose
of treating or producing immunity to certain infectious disease
2. VALVE -a membranous structure in an orifice of passage that allows passage of
contents on one direction only
3. VARICOSE VEIN -enlarge and twisted veins, usually occurring in the legs
W
1. WON -a sebaceous cyst
2. WEAL -a smooth, slightly elevated area on the skin, usually pale with a
maddened periphery, which is often attended by severe itching
3. WOUND -an injury to any body structure caused by physical means
X
1. XANTHOSIS -a yellowish pigmentation of the skin, often the result of the
ingestion of excessive carotene rich foods such as carrots and egg yolks
2. XEROSIS -abnormal dryness of the skin, conjunctive or mucous membranes
3. X-RAY -a ray that is able to penetrate most substances, used to make
photographic plates of parts of the body and to treat diseases as well.
3) Platelets.
A. RBCs (erythrocytes)
1. The RBC count, which reports the number of RBCs found in a given volume of blood, provides
An indirect estimate of the blood’s Hb content. Values are oft en reported in cells/microliter (_L)
or cells/litre and less commonly as cells/cubic millimetre (mm3). Normal values are
2. The Hct or packed cell volume (PCV) measures the percentage by volume of packed RBCs in
A whole blood sample after centrifugation. The Hct value is usually three times the Hb value
and is given as a percentage or fraction of 1 (42% to 52% or 0.42 to 0.52 for men; 37% to 47% or
0.37 to 0.47 for women).
a. Low Hct values indicate such conditions as anaemia, over hydration, or blood loss.
3. The Hb test measures the grams of Hb contained in 100 mL (1 dL) or 1 L of whole blood and
provides an estimate of the oxygen-carrying capacity of the RBCs. The Hb value depends on the
Number of RBCs and the amount of Hb in each RBC.
a. Normal values are 14 to 18 g/dL for men and 12 to 16 g/dL for women.
4. RBC indices provide important information regarding RBC size, Hb concentration, and Hb
weight. They are used primarily to categorize anemias, although they may be affected by average
a. MCV is the ratio of the Hct to the RBC count. It essentially assesses average RBC size and
reflects any anisocytosis.
(1) Low MCV indicates microcytic (undersize) RBCs, as occurs in iron deficiency.
(2) High MCV indicates macrocytic (oversize) RBCs, as occurs in a vitamin B12 or folic acid
deficiency.
(2) Low MCHC indicates hypochromia (pale RBCs resulting from decreased Hb content), as
occurs in iron deficiency.
d. Red blood cell distribution width (RDW) is a relatively new index of RBCs. Normally; most
RBCs are approximately equal in size, so that only one bell-shaped histogram peak is generated.
Disease may change the size of some RBCs—for example, the gradual change in size of newly
produced RBCs in folic acid or iron deficiency. The difference in size between the abnormal and
the less abnormal RBCs produces either more than one histogram peak or a broadening of the
normal peak. This value is used primarily with other tests to diagnose iron deficiency anemia.
(1) An increased RDW is found in factor deficiency anemia (e.g., iron, folate, vitamin B 12).
5. The reticulocyte count provides a measure of immature RBCs (reticulocytes), which contain
Remnants of nuclear material (reticulum). Normal RBCs circulate in the blood for about 1 to 2
days in this form. Hence, this test provides an index of bone marrow production of mature RBCs.
b. Increased reticulocyte count occurs with such conditions as haemolytic anemia, acute blood
loss, and response to the treatment of a factor deficiency (e.g., an iron, vitamin B 12, or folate
deficiency). Polychromasia (the tendency to stain with acidic or basic dyes) noted on a peripheral
smear laboratory report usually indicates increased reticulocytes.
c. Decreased reticulocyte count occurs with such conditions as drug-induced aplastic anemia.
6. The erythrocyte sedimentation rate (ESR) measures the rate of RBC settling of whole,
uncoagulated blood over time, and it primarily reflects plasma composition. Most of the
sedimentation effect results from alterations in plasma proteins.
b. ESR values increase with acute or chronic infection, tissue necrosis or infarction, well
established malignancy, and rheumatoid collagen diseases.
(3) Differentiate conditions with similar symptomatology—for example, angina pectoris (no
change in ESR value) as opposed to a myocardial infarction (increase in ESR value)
B. WBCs (leukocytes)
1. The WBC count reports the number of leukocytes in a given volume of whole blood.
a. Normal values range from 4,000 to 11,000 x103 cells/mm3 (or 109 cells/L)
b. Increased WBC count (leukocytosis) usually signals infection; it may also result from
leukaemia, tissue necrosis, or administration of corticosteroids. It is most oft en found with
bacterial infection.
c. Decreased WBC count (leukopenia) indicates bone marrow depression, which may result from
metastatic carcinoma, lymphoma, or toxic reactions to substances such as antineoplastic agents.
2. The WBC differential evaluates the distribution and morphology of the five major types of
(Lymphocytes and Monocytes). A certain percentage of each type makes up the total WBC
count.
(2) Neutrophilic leukocytosis. This describes a response to an appropriate stimulus in which the
total neutrophil count increases, oft en with an increase in the percentage of immature cells (a
shift to the left). This may represent a systemic bacterial infection, such as pneumonia (Table 30-
2).
(a) Certain viruses (e.g., chickenpox, herpes zoster), some rickettsial diseases (e.g.,
Rocky Mountain spotted fever), some fungi, and stress (e.g., physical exercise, acute hemorrhage
or hemolysis, acute emotional stress) may also cause this response.
(3) Neutropenia, a decreased number of neutrophils, may occur with an overwhelming infection
of any type (bone marrow is unable to keep up with the demand). It may also occur with certain
viral infections (e.g., mumps, measles), with idiosyncratic drug reactions, and as a result of
chemotherapy. Neutropenia is defined as an absolute neutrophil count (ANC) of <1000
cells/mm3. Some define absolute neutropenia as an ANC of <500 cells/mm3.
The ANC is calculated by multiplying the percentage of neutrophils by the total WBC count:
b. Basophils stain deeply with blue basic dye. Their function in the circulation is not clearly
understood; in the tissues, they are referred to as mast cells.
(1) Basophilia, an increased number of basophils, may occur with chronic myelogenous
leukaemia (CML) as well as other conditions.
(2) A decrease in basophils is generally not apparent because of the small numbers of these cells
in the blood.
c. Eosinophils stain deep red with acid dye and are classically associated with immune reactions.
Eosinophilia, an increased number of eosinophils, may occur with such conditions as acute
allergic reactions (e.g., asthma, hay fever, drug allergy) and parasitic infestations (e.g.,
trichinosis, amebiasis).
(2) Lymphopenia, a decreased number of lymphocytes, may result from severe debilitating
illness, immunodeficiency, or from AIDS, which has a propensity to attack TH4 cells.
(3) Atypical lymphocytes (i.e., T lymphocytes in a state of immune activation) are classically
associated with infectious mononucleosis.
e. Monocytes are phagocytic cells. Monocytosis, an increased number of monocytes, may occur
with tuberculosis (TB), subacute bacterial endocarditis, and during the recovery phase of some
acute infections.
C. Platelets (thrombocytes). These are the smallest formed elements in the blood, and they are
involved in blood clotting and vital to the formation of a hemostatic plug after vascular injury.
1. Normal values for a platelet count are 150,000 to 300,000/mm3 (1.5 to 3.0 x 1011/L).
2. Thrombocytopenia, a decreased platelet count, can occur with a variety of conditions, such as
idiopathic thrombocytopenic purpura or, occasionally, from such drugs as quinidine and
sulphonamides.
A. Liver enzymes
1. Levels of certain enzymes (e.g., LDH, ALP, AST, and ALT) increase with liver dysfunction.
2. These enzyme tests indicate only that the liver has been damaged. They do not assess the
liver’s ability to function. Other tests provide indications of liver dysfunction.
B. Serum bilirubin
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES,
KANTEPUDI (V), GUNTUR, AP. Page 74
1. Bilirubin, a breakdown product of Hb, is the predominant pigment in bile. Effective bilirubin
conjugation and excretion depend on hepatobiliary function and on the rate of RBC turnover.
2. Serum bilirubin levels are reported as total bilirubin (conjugated and unconjugated) and as
direct bilirubin (conjugated only).
b. Unconjugated bilirubin travels to the liver, where it is separated from albumin, conjugated
with diglucuronide, and then actively secreted into the bile as conjugated bilirubin (direct
bilirubin), which is filtered by the glomerulus.
3. Normal values of total serum bilirubin are 0.1 to 1.0 mg/dL (2 to 18 mmol/L); of direct
bilirubin,
BILIRUBIN METABOLISM:-
a. Hemolysis increases total bilirubin; direct bilirubin (conjugated) is usually normal or slightly
increased. Urine colour is normal, and no bilirubin is found in the urine.
b. Biliary obstruction, which may be intrahepatic (as with a chlorpromazine reaction) or extra
hepatic (as with a biliary stone), increases total bilirubin and direct bilirubin; intrahepatic
cholestasis (e.g., from chlorpromazine) may increase direct bilirubin as well. Urine colour is dark,
and bilirubin is present in the urine.
C. Serum proteins:
1. Primary serum proteins measured are albumin and the globulins (i.e.α, β, γ )
a. Albumin (4 to 6 g/dL) maintains serum oncotic pressure and serves as a transport agent.
Because it is primarily manufactured by the liver, liver disease can decrease albumin levels.
b. Globulin (23 to 35 g/L) relates to the total measurement of immunoglobins (antibodies) found
in the serum and function as transport agents and play a role in certain immunological
mechanisms. A decrease in albumin levels usually results in a compensatory increase in globulin
production.
2. Normal values for total serum protein levels are 6 to 8 g/dL (60 to 80 g/L).
1. Renal function may be assessed by measuring blood urea nitrogen (BUN) and serum
creatinine.
Renal function decreases with age, which must be taken into account when interpreting test
values.
a. These tests primarily evaluate glomerular function by assessing the glomerular filtration rate
(GFR).
b. In many renal diseases, urea and creatinine accumulate in the blood because they are not
excreted properly.
c. These tests also aid in determining drug dosage for drugs excreted through the kidneys.
a. Renal azotaemia results from renal disease, such as glomerulonephritis and chronic
pyelonephritis.
b. Pre-renal azotemia results from such conditions as severe dehydration, hemorrhagic shock,
and excessive protein intake.
c. Post-renal azotemia results from such conditions as ureteral or urethral stones or tumours and
prostatic obstructions.
3. Clearance—a theoretical concept defined as the volume of plasma from which a measured
amount of substance can be completely eliminated, or cleared, into the urine per unit time—can
be used to estimate glomerular function.
B. BUN
1. Urea, an end product of protein metabolism, is produced in the liver. From there, it travels
through the blood and is excreted by the kidneys. Urea is filtered at the glomerulus, where the
tubules reabsorb approximately 40%. Thus, under normal conditions, urea clearance is about
60% of the true GFR.
2. Normal values for BUN range from 8 mg/dL to 18 mg/dL (3.0 to 6.5 mmol/L).
b. Increased BUN levels may indicate renal disease. However, factors other than glomerular
function (e.g., protein intake, reduced renal blood flow, blood in the gastrointestinal tract)
readily affect BUN levels, sometimes making interpretation of results difficult.
C. Serum creatinine
1. Creatinine (CR), the metabolic breakdown product of muscle creatine phosphate, has a
relatively constant level of daily production. Blood levels very little in a given individual.
3. Normal values for serum creatinine range from 0.6 to 1.2 mg/dL (50 to 110 mmol/L).
a. Values vary with the amount of muscle mass—a value of 1.2 mg/dL in a muscular athlete may
represent normal renal function, whereas the same value in a small, sedentary person with little
muscle mass may indicate significant renal impairment.
b. Generally, the serum creatinine value doubles with each 50% decrease in GFR. For example, if
a patient’s normal serum creatinine is 1 mg/dL, 1 mg/dL represents 100% renal function,
D. Creatinine clearance
1. Creatinine clearance, which represents the rate at which creatinine is removed from the
blood by the kidneys, roughly approximates the GFR.
a. The value is given in units of millilitres per minute, representing the volume of blood cleared of
creatinine by the kidney per minute.
2. Calculation requires knowledge of urinary creatinine excretion (usually over 24hrs) and
concurrent serum creatinine levels. Creatinine clearance is calculated as follows:
Where ClCR is the creatinine clearance in millilitres per minute, CU is the concentration of
creatinine in the urine, V is the volume of urine (in millilitres per minute of urine formed over the
collection period), and CCR is the serum creatinine concentration.
3. Suppose the serum creatinine concentration is 1 mg/dL, and 1440 mL of urine was collected in
4. Incomplete bladder emptying and other problems may interfere with obtaining an accurate
timed urine specimen. Thus, estimations of creatinine clearance may be necessary. These
estimations require only a serum creatinine value. One estimation uses the method of Cockcroft
and Gault, which is based on body weight, age, and gender.
5. Determination of GFR. The modified diet in renal disease (MDRD) equation is considered a
more accurate measurement of GFR than other equations used to estimate renal function
(e.g., Cockcroft –Gault) in patients with reduced GFR and is used in staging renal disease. Patients
must have a serum creatinine concentration.
Where, Pcr is serum creatinine. For females, multiply the result by 0.742; for African Americans,
multiply by 1.210.
c. The MDRD equation has not been validated in patients _ 18 years of age, pregnant women,
patients _ 70 years of age, other ethnic groups, patients with normal kidney function who are at
an increased risk for chronic kidney disease, and patients with normal renal function.
d. Many institutions are routinely reporting MDRD-derived GFR estimation for patients as a
routine component of a blood chemistry study. This value should be used to assist the clinician in
staging a patient’s degree of renal dysfunction and is not a substitute for creatinine clearance as
estimated by the Cockcroft and Gault equation, which should be used for drug dosing in renal
impairment. The MDRD estimate has not been evaluated for the purpose of drug dosing.
1) Hypothyroidism
• Primary
• Secondary
• Tertiary
2) Hyperthyroidism
1. Free T4 test
2. Total serum T4 test
3. Serum T3 resin uptake test
4. Free T4 index test
5. Total serum T3 test
6. TSH ( thyroid stimulating hormone )
7. TRH (thyroid regulating hormone)
8. Radioactive iodine uptake test
1) Free T4 test:
6) TSH test:
7) TRH test :
• Radioactive iodine uptake test is used to assess intrinsic function of the thyroid
gland
• This test is not specific and the reference range should be adjusted based on
local population
• This test is indirect measure of thyroid activity.
Subject with normal thyroid gland
• Thyrotoxicosis
• Iodine deficiency
• Post thyroiditis
• Withdrawal rebound after thyroid hormone/ anti thyroid drug therapy
Decreased radioactive iodine uptake noted in:
• Acute thyroiditis
• Euthyroid patients
• Patients on exogenous thyroid hormone therapy
• Patients taking anti-thyroid drugs
• Hypothyroidism.
The heart is a muscular organ in most animals, which pumps blood through
the blood vessels of the circulatory system. Blood provides the body
with oxygen and nutrients, as well as assisting in the removal of metabolic
wastes.] In humans, the heart is located between the lungs, in the middle
compartment of the chest.
CARDIAC DISORDERS:-
• coronary heart disease
• stroke
• other cardiovascular diseases
• hypertensive heart disease
• inflammatory heart disease
• Rheumatic heart disease.
They are:
1. LABORATORY TESTS
2. CARDIAC BIOMARKERS
3. NON LABORATORY TESTS.
1) LABORATORY TESTS:
• White blood cell count (WBC) is the number of white blood cells in a volume of
blood.
Normal range is generally between 4,300 and 10,800cells per cubic millimete
(cmm).
• White blood cell (WBC) differential count. White blood count is comprised of
several different types that are differentiated, or distinguished, based on their
size and shape. The cells in a differential count are lymphocytes,
monocytes, eosinophils and basophils.
• Red cell count (RBC) signifies the number of red blood cells in a volume of
blood.
Normal range: 4.2 to 5.9 million cells/cmm.
This can also be referred to as the erythrocyte count and can be expressed in
international units as 4.2 to 5.9 x 1012cells/liter.
• Haematocrit (Hct). This is the ratio of the volume of red cells to the volume of
whole blood.
Normal range: 42% to 52% for men.
• Mean corpuscular volume (MCV) is the average volume of a red blood cell.
This is a calculated value derived from the haematocrit and red cell count.
Normal range may fall between 80 to 100 fentoliters (a fraction of one millionth
of a liter).
2) CARDIAC BIOMARKERS:-
• Cardiac biomarkers are substances that are released into the blood when the
heart is damaged or stressed.
• Measurement of these biomarkers is used to diagnose, monitor.
• Cardiac biomarker tests are used to help and detect the presence of ACS and
cardiac ischemia and to evaluate their severity as soon as possible so that
appropriate therapy can be initiated.
• The current biomarker test of choice for detecting heart damage is troponin.
Protein found in skeletal and contractual fibers of the heart (cardiac muscle)
Timing
Elevated Troponin: Patients with elevated Troponin I levels, normal CK-MB and no
Creatine Kinase:
Myoglobin:
1) Electrocardiography:
• Atrial enlargement,
• Ventricular hypertrophy(enlargement of the ventricles),
SIGNIFICANCE:
2) Exercise Electrocardiography:
• Stress tests - assesses the heart’s conduction system during exercise when the
demand for oxygen increases.
• Measures the patient’s responses to work load.
4) CHEST X-RAY:-
• The chest x-ray is the most commonly performed diagnostic x-ray examination.
• A chest x-ray makes images of the heart, lungs, airways, blood vessels and the
bones of the spine and chest.
• An x-ray (radiograph) is a non-invasive medical test that helps physicians
diagnose and treat medical conditions.
• Imaging with x-rays involves exposing a part of the body to a small dose
of ionizing radiation to produce pictures of the inside of the body
• X-rays are the oldest and most frequently used form of medical imaging.
• one in which the X-rays pass through the chest from the back (posterior-
anterior view), and
• One in which the X-rays pass through the chest from one side to the other
(lateral view).
6) COMPUTED TOMOGRAPHY:
• A CT scan is an x-ray procedure that combines many x-ray images with the aid of
a computer to generate cross-sectional views of the body.
• Cardiac CT uses the advanced CT technology with intravenous (IV) contrast
(dye) to visual anatomy, coronary circulation.
➢ Cardiac CTs are used to evaluate:
1. Sodium is the major cation of the extracellular fluid. Sodium, along with chloride (Cl),
potassium
(K), and water, is important in the regulation of osmotic pressure and water balance between
Intracellular and extracellular fluids.
2. The sodium concentration is defined as the ratio of sodium to water, not the absolute
amounts of either. Laboratory tests for sodium are used mainly to detect disturbances in water
balance and body osmolality. The kidneys are the major organs of sodium and water balance.
4. Patients with kidney, heart, or pulmonary disease may have difficulty with sodium and water
balance. In adults, changes in sodium concentrations most oft en reflect changes in water
balance, not salt imbalances. Therefore, sodium concentration is oft en used as an indicator of
fluid status, rather than salt imbalance.
5. Control of sodium by the body is accomplished mainly through the hormones aldosterone and
antidiuretic hormone (ADH).
a. ADH is released from the pituitary gland in response to signals from the hypothalamus. ADH’s
presence in the distal tubules and collecting ducts of the kidney causes them to become more
permeable to the reabsorption of water; therefore, concentrating urine.
7. Hypernatremia usually results from a loss of free water or hypotonic fluid or through excessive
sodium intake. Free water loss is most oft en associated with diabetes insipidus, but fluid loss can
B. Potassium (K)
1. Potassium is the most abundant intracellular cation (intracellular fluid potassium averages
141mEq/L). Approximately 3500 mEq of potassium is contained in the body of a 70-kg adult.
Only 10% of the body’s potassium is extracellular. Normal values are 3.5 to 5.0 mEq/L or mmol/L.
2. The serum potassium concentration is not an adequate measure of the total body potassium
because most of the body’s potassium is intracellular. Fortunately, the clinical signs and
symptoms of potassium deficiency—malaise, confusion, dizziness, electrocardiogram (ECG)
changes, muscle weakness, and pain—correlate well with serum concentrations. The serum
potassium concentration is buffered by the body and may be “normal” despite total body
potassium loss.
Potassium depletion causes a shift of intracellular potassium to the extracellular fluid to maintain
potassium concentrations. There is approximately a 100 mEq total body potassium deficit when
the serum potassium concentration decreases by 0.3 mEq/L. This may result in misinterpretation
of serum potassium concentrations as they relate to total body potassium.
4. Potassium is regulated by
Potassium can be shifted into cells with alkalemia and after administration of glucose and insulin.
6. Hyperkalaemia most commonly results from decreased renal elimination, excessive intake, or
from cellular breakdown (tissue damage, hemolysis, burns and infections). Metabolic acidosis
may also result in a shift of potassium extracellularly as hydrogen ions move into cells and are
exchanged for potassium and sodium ions. As a general guideline, for every 0.1 unit, pH change
from 7.4, the potassium concentration will change by about 0.6mEq/L. If a patient has a pH of 7.1
and measured potassium of 4.5mEq/L, the actual potassium concentration would be
Correction of the acidosis in this situation will result in a dramatic decrease in potassium unless
supplementation is instituted.
C. Chloride (Cl):
1. Chloride is the major anion of the extracellular fluid and is important in the maintenance of
acid–base balance. Alterations in the serum chloride concentration are rarely a primary indicator
of major medical problems. Chloride itself is not of primary diagnostic significance. It is usually
measured to confirm the serum sodium concentration. The relationship among sodium, chloride,
and HCO_3 is described by the following:
- +
Cl + HCO-3 + R = Na
1. The carbon dioxide (CO2) content represents the sum of the bicarbonate (HCO-3)
concentration and the concentration of CO2 dissolved in the serum. The HCO-3/CO2 system is the
most important buffering system to maintain pH within physiological limits. Most disturbances of
acid–base balance can be considered in terms of this system. Normal values are 22 to 28 mEq/L
or mmol/L.
(Bicarbonate ions bind hydrogen ions to form carbonic acid). Clinically, the serum HCO -3
concentration is measured because acid–base balance can be inferred if the patient has normal
pulmonary function.
SENSITIVITY TESTING:
It is the degree of activity of the selected antimicrobial agent against the infecting
bacterial strains.
INTRODUCTION:
• Usually almost all the bacteria in infectious disease are drug resistant.
• Hence sensitivity test is performed to select the correct antimicrobial drug of
choice.
• It may also help to identify the pathogen.
LIMITATIONS:
1) Diffusion technique:
Dilution sensitivity tests usually measures the minimum inhibitory concentration (MIC)
or minimum bactericidal concentration (MBC) required to kill the bacteria.
• Careful standardization
• Broth and agar medium
• Antimicrobial solution
• Incubation time and
• Dilution time.
General requirements for sensitivity testing:
1. Sensitivity testing agar.
• Suitable media include Mueller Hinton agar, Iso sensitest agar and Gibco
sensitivity testing agar no.2.
• Mueller Hinton agar(MHA)
Composition
2. ANTIMICROBIAL DISC:
ANTIMICROBIAL RESISTANCE:
1. Natural resistance
2. Acquired resistance
3. Cross resistance.
NATURAL RESISTANCE:
CROSS RESISTANCE:
• Left and right lungs are in the pleural cavity of the thorax.
• Right lung has three lobes, but the left has only two lobes; space is thus
provided for the heart.
• Lungs are connected to pharynx by trachea.
• Trachea splits into left and right main stem bronchi that deliver inspired air to
respective lungs.
DEF: - Pulmonary function tests are a group of procedures that measure the
function of the lungs, revealing problems in the way a patient breathes. The
tests can determine the cause of shortness of breath and may help confirm lung
diseases, such as asthma, bronchitis or emphysema. The tests also are
performed before any major lung surgery to make sure the person won't be
disabled by having a reduced lung capacity.
Contraindications
• Lung volume tests indicate the amount of gas contained in the lungs at various
stages of inflation.
1) Tidal volume:
• The volume measured from the point of the TV where inhalation normally
begins to maximal inspiration is known as IC.
• Reference range: 500 ml + 3.1 L = 3.6 L.
• Amount of air that is inhaled with maximal inhalation after the normal
inhalation.
Or
• The volume measured from the “top” of the TV, (i.e. the initial point of normal
exhalation) to maximal inspiration is known as the IRV.
• Reference range: 3.1 L.
4) Expiratory reserve volume:
• Amount of air that is exhaled with maximal expiration after the normal
exhalation.
Or
• During exhalation, the volume from the “bottom” of the TV (ie. Initial point of
normal inhalation) to maximal expiration is referred to as ERV.
• Reference range: 1. 2 L.
5) Slow vital capacity:
• It is the volume of the gas remaining in the lungs at the end of the TV
• It is the sum of the ERV and RV [2.4L]
• An increased FRC usually represents hyperinflation of the lungs and indicates
airway obstruction.
• FRC decreases in diseases that affect many alveoli (pneumonia) and by
restrictive changes (fibrotic pulmonary tissue changes)
• TLC minus RV
Or
Maximum volume of air exhaled from maximal inspiratory level. (60‐70 ml/kg)
5000ml. VC ~3 TIMES TV FOR EFFECTIVE COUGH.
• Changes in FVC measurement from baseline reflect the degree of current airway
obstruction.
• FEV0.5, FEV1, FEV3 are the amounts of air exhaled after 0.5 , 1 and 3 seconds
respectively
• Of these, FEV1 has the most clinical relevance, primarily as an indicator of the
large airway functions.
Drug information is current, critically examined, relevant data about drugs and drug use
in a given patient or situation.
A. Current information uses the most recent, up- to-date sources possible.
Primary Resources:
Researcher’s and manufacturer’s information Patents containing original information
regarding the discovery of drug Reports containing scientific data before product can be
sold, supplied or represented
• Scientific journals
• Provide original studies or reports
E.g. Clinical trial, case series, case report
• Scope is narrow
• Good when topic is new or new data has been published
Disadvantages:
Secondary Resources:
• Abstract or index which summarizes the information arising in primary source
• Indexing and abstracting services are valuable tools for quick and selective
screening of the primary literature for specific information, data, citation, and
articles
• Three types of abstracts:
1. Telegraphic abstract (only string of words)
2. Indicative abstract (structured in sentence )
Advantages:
Pharmacists should obtain and evaluate the original article because abstracts may not
include enough information to critically evaluate the study.
Tertiary Resources:
Compilations of knowledge in the field
Advantages:
1. The author, publisher, or both: What are the author 's and publisher's areas of
expertise?
2. The year of publication (copyright date) or last revision date?
3. The edition of the text: Is it the most current edition?
4. The presence of a bibliography: I f a bibliography is included, are important
statements accurately referenced? When were the references published?
5. The scope of the textbook or database: How accessible is the information?
6. Alternative resources that are available (e.g. , primary and secondary sources,
other relevant texts).
Other sources:-
1. Libraries
2. Research associations
3. Government bodies
4. Information Centre in industries
5. Analyst labs
6. Poison centers.
• http://dda.gov.np/
• http://www.nepalpharmacycouncil.org.np/
Available resources:
1. For drugs manufactured in the United States, the following resources are available:
2. For drugs manufactured in foreign countries, the following resources are available:
• The physicians and other health care often contact the pharmacist for opinion
on various aspects of the therapy.
These responses can only be made after careful analysis of the available studies by the
pharmacist.
Issues
• Many assume that only high quality information meets the qualifications for
publication.
• The reality is that much of the medical literature fails to meet standards for well
conducted studies.
• Researchers may have lack of knowledge in study design and statistical analysis
to perform well conducted study. Or maybe the reviewers of the journal may be
deficient in such knowledge.
• Randomized Controlled Clinical Trials are considered as true experiment and are
the gold standard for determining cause and effect relationships. Mostly they
are put in the primary journals.
Literature Evaluation
In case of peer review rejection the study can be submitted to alternate journals for
consideration.
A. Clinical studies may also be published in other forms such as abstracts following
presentation at scientific meetings which are rarely detailed enough to allow
clinical decisions to be based on their results;
• Assess the investigators expertise and training in the area been studied
preferably track record of previous research. Check the disclosures such as –
affiliations of authors, the funding for the study.
2. Title/ Abstract
• Title of the article should be brief and catch the attention of the readers
interested in the topic. And it should not be biased or indicate the authors
preference’s viz., “study on the superiority of drug A against drug B in xyz
diseased patients.
• Abstract is the road map of a study. It is less time consuming and by scanning
the abstracts, readers should be able to determine whether the study is of
interest and deserves further reading.
• Structured abstracts for clinical studies include the following sections: objective,
research design, clinical setting, participants, interventions, main outcome
measurements, results, and discussion.
3. Introduction
• This will contain the background information for the study and states study
objectives and hypotheses.
• The background information states that the study is important and ethical. It
familiarizes the readers with the research subject. Previous investigations and
their limitations; need of the present study; and should clarify that the benefits
of the study outweighs the risks tot eh patients entering the study.
Superscriptions of references made for cross references.
• Study objectives or goals should be precise and clearly stated that it will not
confuse the readers and come to an erroneous conclusion regarding study
results.
• The ill stated objective shows that the study was not well planned.
4. Methodology
• The main contents of the methodology can include: the research site, study
period, ethical committee approval statement, study design, study population,
instrumentation, and statistics used for the investigation.
Study Design:
• In parallel study the patients/ subjects (either the control or the treatment
group) receives only one treatment throughout the study. Whereas in case of
cross-over study subjects receive all study drugs.
• Parallel studies are appropriate in case when therapies are definitive or when
disease states are self – limited (e.g., antimicrobials for infectious diseases).
• Cross – over studies are appropriate in case diseases are chronic and/or variable
(e.g., glaucoma, migraine headache). In this study the error caused by
variability among subjects are minimized since the each subject serves as his or
her own control .
A B C D
Drug X Drug X
Randomization
Drug Y Drug Y
A B C d
Drug A
Randomization
Drug B
❖ Randomization
Study Criteria:-
Inclusion criteria:
• List the subject characteristics that must be present for enrolment into the
study.
Exclusion criteria:
• List the characteristics in the target population that should not be included in
the study. / fine tuning of the subjects.
• Subjects who are harmed by the therapy or who may confound the results of
the study.
Diagnosis criteria for the disease state should be clearly defined. (Clinical, laboratory
and demographic criteria that justifies the diagnosis).
• The reader should check whether the enrolled subjects represent the patients
routinely encountered in the clinical practice.
Sample size
• Samples are used because of logistic, financial, and resource constraints that
prohibit studying an entire population.
• The study needs a relevant sample size. Depends on the study objectives and
design.
• Many investigators add 10 – 20% of the sample size calculation keeping in mind
about the drop outs or death of the subject that can happen during the study.
• In case of multicentre study it should be mentioned and make sure that the all
the centres understand the protocol and receives adequate training in the
conduct of trial.
• A minimum level of sample can be presented as pilot study that give rise to
further research or hypotheses.
Controls
• Two types of controls mainly used in the clinical trials: a) placebo control, and b)
active control.
• Historical controls ate used in case the use of the previously used drug is no
longer ethical. The criteria’s and variables of the historical control should be
similar to the current study. Time of data collection effects the patient
response.
• All the interventions and care should be similar in both the control and
treatment group.
Outcome variables
• Similar in regard to clinical and socioeconomic factors that may affect the
treatment outcome. And diminishes the investigator and patient bias.
• Blinding: Single, Double or Triple blinding. This improves the validity of the
study.
Compliance
Statistical analysis
Results
Data
• Data should present the actual numbers rather than percentage values since
this can be use for the calculation purposes or the readers own analysis.
• Study validity – whether the result was actual treatment related consequence
and can it be generalized.
Conclusions/ Discussions
References
Acknowledgments
• Individuals who contributed to the research effort but do not qualify for
authorship.
Goal:-
General rules:-
• Organize the information before starting to write (what and how to write)
• Use proper spelling and grammar
• Preferably avoid passive voice throughout
• Avoid writing in the first person and second person wherever possible
• Prepare a document in a presentable manner (neat)
• Keep things as simple and direct as possible
• Consider whether tables or graph or figures would make the document simpler
• Avoid using abbreviations or acronyms (or quote at first instance in parenthesis)
• If the document is long, use sub headings
• Present it in correct order as required
• Write in your own words.
At first make sure that all of the information is down on paper. Once that occurs, go
back, revise and perhaps reorganize the document.
It should contain:
• Introduction
• Body
• Conclusion.
Introduction:
Body:
Conclusion:
• Sub divide the document further in a logical order and as appropriate when
necessary
• Always focus end point.
INTRODUCTION:
DRUG EVALUATION:
THERAPEUTIC ADVICE:
PHARMACEUTICAL ADVICE:
DISSEMINATION OF INFORMATION:
RESEARCH:
PHARMACOVIGILANCE:
• Drug information centres often have a role in programs which monitor adverse
drug reactions. Enquiries about a potential adverse reaction can lead to reports
of suspected reactions and research may be required to assess the likelihood
that a drug has contributed to a reaction or for subsequent patient
management.
TOXICOLOGY:
RESOURCES:
Drug information centres should have the following resources for effective
functioning:-
PERSONNEL:
MANAGEMENT:
• The centre should maintain its own library of commonly used resources.
Additional books and other publications should be accessible in hardcopy or
electronically from external sources.
• An adequate literature search requires an understanding of available sources
and their limitations, and training in the use of indexing terms and functions.
FACILITIES:
FINANCE:-
• A drug information centre should have an independent source of income and
status guaranteeing its stability and objectivity.
• Funding from external organizations cannot be accepted unless the centre’s
neutrality is guaranteed.
• Services should be provided free of charge to enquirers or through a contract
arrangement which does not discourage appropriate use of the service to
support quality healthcare.
• Separate charges may be made for specific reports which do not directly relate
to individual patient care.
• Sufficient expenditure to maintain up-to-date resources is essential for the long-
term viability of the centre.
TRAINING:-
Specific training is required for drug information practice. In addition to clinical
knowledge and experience, drug information practitioners require:
QUALITY ASSURANCE:-
1. An effective retrieval system is essential to locate previous enquiries, monitor
workload and categorise the types of enquiries received.
2. It can also facilitate quality assurance programs based on analysis of selected
enquiries and failed deadlines.
NETWORKING:-
Cooperation between drug information centres can help to optimise limited resources
and enhance overall service levels. Networking can involve two or more centres, and
includes regional, national and international links. Networks provide opportunities for:
F) POISON INFORMATION –
(ORGANIZATION AND
INFORMATION RESOURCES):-
Functions:
Benefits:
Location:
• The Centre should be located at a leading hospital with emergency & intensive
care services as well as the medical library and lab.
Staff:
• Suitable office furniture & facilities for the storage of confidential data.
• Specific areas should arrange for answering telephone enquiries, consultation
with patients, and preparation of documents, staff meetings and secretarial and
administrative work.
• Additional desk space is needed at centers using computer equipment and on-
line databases, air conditioning and humidity control may also be necessary.
• PIC’s should their own libraries & facilities for handling and reproducing
documents.
• A fax machine is necessary for communicating the information rapidly among
centers and hospitals during emergency.
PHARMACOVIGILANCE:
The word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare
(Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse
drug reactions, or ADRs, which are defined as any response to a drug which is
noxious and unintended, including lack of efficacy.
DEFINITION:
SCOPE:
Patients are main end users of medicine. Patient information leaflet relating to
medicine to be provided to the patient to increase the advantages of the
medication and to reduce the risk associated with them. It is essential for Risk
AIMS OF PHARMACOVIGILANCE:
Over the last decade, it has been increasingly recognized that the scope of
pharmacovigilance needs to be extended beyond the strict confines of detecting
new signals of safety concerns. Globalization, consumerism, the resulting
explosion in free trade and communication across borders, and increasing use of
the Internet have all contributed to a change in the way people access medicinal
products and information about them. These changing patterns in drug use
require a shift in the approach to pharmacovigilance, more specifically, towards
one that is more closely linked, and thus better able to respond, to the prevailing
patterns of drug use within society.
• Largely predictable
• Usually dose-dependent
• Incidence and morbidity high
• Mortality low.
• Usually unpredictable
• Might not be picked up by toxicological screening
• Not necessarily dose-related
• Incidence and morbidity low
• Mortality high.
The ADRs can become apparent sometime after the drug has been used. This can
make it difficult to determine whether or not the drug caused the reaction.
MECHANISMS:
1) Pharmaceutical causes
2) Pharmacokinetic causes:
a) Absorption
b) Distribution
c) Metabolism
d) excretion
3) Pharmacodynamics causes
a) Drug receptor
b) Homeostatic mechanism
c) Disease.
1) PHARMACEUTICAL CAUSES: -
EXAMPLES:
TOXICITY.
2) PHARMACOKINETIC CAUSES: -
ABSORPTION: -
DISTRIBUTION: -
METABOLISM: -
EXAMPLES:
EXCRETION: -
3) PHARMACODYNAMIC CAUSES:-
DRUG RECEPTOR:
The drug elicits their response by combining with receptors, the amount and sensitivity
of receptors may leads to ADRs.
HOMEOSTATIC MECHANISM:
EXAMPLE: atropine produce increased heart rate and produce tachycardia in some
people whereas same dose in in affective in some other individuals.
DISEASE: the pharmacological effect may be not apparent in healthy individual may be
unmasked by undercurrent disease.
1. Age
2. Renal impairment
3. Hepatic impairment
4. ‘frailty’
5. Polypharmacy
6. Previous history of ADRs
7. Genetics.
The first four factors predispose to type A reactions because they are
determinants of drug toxicity, but the remaining factors predispose to type A or
type B reactions.
The WHO-UMC system has been developed in consultation with the National
Centres participating in the Programme for International Drug Monitoring and is
meant as a practical tool for the assessment of case reports.
Most ADRs are not reported and this can lead to delays in identifying important
reactions. The reasons for failure to report ADRs have been called the ‘seven
deadly sins’. Pharmacists should attempt to address these and encourage their
medical and nursing colleagues to report ADRs, in addition to sending in their
own reports. The regulatory authorities in many countries have systems for
reporting
1. Complacency — a mistaken belief that only safe drugs are allowed onto
the market and that these will not cause serious ADRs
2. Fear of involvement in litigation, or of a loss of patient confidence
3. Guilt that a patient has been harmed by a prescribed treatment
4. Ambition — to collect and publish a personal series of cases
5. Ignorance of what should be reported or how to make a report
6. Diffidence — a reluctance to report an effect for which there is only a
suspicion that it is drug-related
7. Lethargy — this may include a lack of time or interest, inability to find a
report card, etc.
EVALUATION OF ADRs
The cause(s) of each suspected ADR should be evaluated on the basis of the:
1. Was there a temporal relationship between the onset of drug therapy and the
adverse reaction?
2. Was there is dechallenge; i.e., did the signs and symptoms of the adverse
reaction subside when the drug was withdrawn?
Drug monitoring:
1. To assess the reaction: Emergency care/admission if ADR is Serious or life
threatening; primary care; or seeks specialist advice.
2. To review the treatment: Either withdraw the suspected drug or reduce
the dose.
3. To manage the symptoms of ADR and provide supportive therapy.
4. To record the ADR in the individual’s health record.
1. Premarketing Studies:
Timing: Time of start of the reaction after giving the drug; Time taken to abate
after the stopping of drug or reducing the dose.
3. Take complete drug history - Review any History of Allergy or previous ADR:
Patient counsellingmethods:
The structure of the counselling session is divided into fourgroups:
Counsellingconclusionsteps:
1. Verify the patient understanding via feedback.
2. Summaries by acknowledging or emphasizing key points of information.
3. Provide an opportunity for final concerns or questions
4. Help the patient to plan, follow up and next consecutive steps.
Example:
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES,
KANTEPUDI (V), GUNTUR, AP. Page 160
1. Closed‐ended: "Do you know how to take your medication?" "Yes"
2. Leading/restrictive: "You'refamiliarwithyourmedications, aren'tyou? “Yes”
3. Open‐ended: "What did the doctor tell you about taking the
medications?
Nonverbal cues:
Appropriate nonverbal cues are also critical for effective communication.
• Facial expressions,
• bodyposture,
• tone of voice and
• The use of eye contact.
What we say and how we say it must have the same meaning. When nonverbal
cues are inconsistent with the words spoken, people tend to believe the nonverbal
message.
The following are specific habits that may interfere with an individual's ability to listen.
Also listed are recommendations for improving one's listening ability.
1. Trying to do two or more things at once. This lack of attention comes across as a lack
of interest in the other person and what they are saying to you.
Solution: Get rid of distractions.
2. Jumping to conclusions before a person has completed his or her message: The result
is you only hear part of what was said.
Solution: Stop talking, you can't listen if you are talking.
3. Communicating stereo types that you have to internalized.
Solution: React to the information, not the person.
4. Faking interest in what is being discussed.
Solution: Use good eye contact, this will help you concentrate.
5. Judging the individual based upon his or her appearance or condition.
Solution: Focus on content, nonverbal cues and the manner in which something is
said.
There are additional skills that can be used to enhance listening. These include
• paraphrasing,
• clarifying,
• summarizing and
• Feedback.
Paraphrasing allows you (the listener) to convey back to the sender the message, and allows
the sender to know that the receiver is listening. This technique encourages a dialogue.
Clarifying provides opportunities to comprehend what is being said by helping the listener or
receiver to understand the message.
Summarizing assesses whether you accurately understand the information that you heard
and enables you to verify that you process the information from the sender correctly.
Clarifying:
• What do you mean by….?
• How doyou know….?
• What do you mean….?
• I don’t understand what do you mean….?
Summarizing:
• Would an example of that be…?
• Is that like when….?
• As you’ve described it…?
Active feed-back:
• I see…
• Uh huh…
• No, I don’t feel that way, but tell me why you do…
• Yes, that’s how I’ve found it to be...
Paraphrasing:
Clarifying:
• What do you mean by….?
• How doyou know….?
• What do you mean….?
• I don’t understand what do you mean….?
Summarizing:
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V),
GUNTUR, AP.
Page 164
• Would an example of that be…?
• Is that like when….?
• As you’ve described it…?
Active feedback:
• I see…
• Uh huh…
• No, I don’t feel that way, but tell me why you do…
• Yes, that’s how I’ve found it to be...
Verification of understanding:
• Verifying understanding prevents misunderstandings.
• It is an important skill in the communication process because it is a checkpoint for
communication.
• This process involves asking the receiver to state back the message that was sent by the sender
and enables confirmation of what a person knows ... not what we think they know. This tool
confirms that the sender's message was translated as intended.
• In a pharmacist‐patient interaction, verifying understanding confirms that the patient has
received the information necessary to take his or her medication(s) properly.
• Verifying understanding can be achieved as discussed earlier by asking open‐ended questions.
For example, "Just to make sure I've discussed everything, can you tell me how you are going to take
your medication?"
Patient Medication history interviews help the pharmacist to establish rapport with the
patient, commence preliminary counselling and help to devise an on-going pharmaceutical
care plan
Sources: Patient, medication records from the hospital and other sources.
Goals
Conclusion:
Follow-up
PRESENTATION OF CASES
1. General Description:-
• Giving an oral presentation on ward rounds is an important skill for medical student
to learn. It is medical reporting which is terse and rapidly moving. After collecting the
data, you must then be able both to document it in a written format and transmit it
clearly to other health care providers.
T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V),
GUNTUR, AP.
Page 167
• In order to do this successfully, you need to understand the patient’s medical
illnesses, the psychosocial contributions to their HPI and their physical diagnosis
findings.
• You then need to compress them into a concise, organized recitation of the most
essential facts. The listener needs to be given all of the relevant information without
the extraneous details and should be able to construct his/her own differential
diagnosis as the story unfolds.
• Consider yourself an advocate who is attempting to persuade an informed,
interested judge the merits of your argument, without distorting any of the facts.
Depending on the purpose of the presentation, different parts of the database are
included.
• The same patient will be presented very differently to the cardiology consultant who
is asked to give advice on the optimal treatment for their CHF, the surgeon who is
considering aortic valve replacement, the social worker who is helping obtain
disability funding and the attending who needs to know who was admitted last
night.
• As you progress in your training, you will become expert at adapting and editing the
story to serve its various purposes. Last year you learned to collect and organize the
complete database and do a complete write-up.
• In taking your history you have gathered more information than you will include in
your write-up and likewise, your write-up contains more information than you will
include in an oral presentation.
2. Basic principles:
• An oral case presentation is NOT a simple recitation of your write-up. It is a concise, edited
presentation of the most essential information.
• A case presentation should be memorized as much as possible by your 3rd year rotations.
You can refer to notes, but should not read your presentation.
• Length – this will vary depending on your service. A full medicine presentation in attending
rounds should be under 5 minutes. A presentation in the hallway on walk rounds on
medicine should take no more than 3 minutes.
• Both are an organized reconstruction of the patient’s narrative into a coherent HPI, not a
random assortment of facts.
• Both follow the same organizational format (see #4 below)
• Separation of subjective data – derived from the patient, family and medical record and
objective data which include your physical exam and today’s lab/radiographic data.
4. Basic structure for oral case presentations – the order parallels that of the write-up:
1. Identifying Information/Chief Complaint (II/CC) – you want flesh out the bare bones
enough to make your presentation engage the listener and give them a feel for the patient
as a person.
b. Only include the race or ethnicity of the patient if it is relevant and will make your listener
weigh diagnostic possibilities differently.
c. To orient your listener, the identifying information should include the patient’s relevant
active medical problems, of which there are usually no more than four. You will list these
problems here by diagnosis only, and will elaborate on them later in the “HPI” or “other
medical problems.” Your small group facilitator should help you identify which problems are
relevant when this is not obvious.
Good Examples:
Mr Smith is a 55 year-old man with a long history of diabetes mellitus, cirrhosis, and chronic
obstructive lung disease, who presents with a chief complaint of fever and productive
cough…
Mrs Jones is a 39 year-old woman who was electively admitted for evaluation of exertional
dyspnoea. Her active problems include rheumatoid arthritis and hypertension. She was in
her normal state of health until…
Examples:
GOOD #2: …his active problems include coronary artery disease, diabetes mellitus, and
chronic obstructive lung disease….
In example 1 the listener will forget the chief complaint by the time you reach the history of
present illness.
Example2 is concise and does not interrupt the listener’s train of thought between the chief
complaint and the history of present illness; relevant information about each of these
problems should be introduced when appropriate in the “HPI” or “other medical problems.”
a. Introductory sentence:
Mr/Mrs/Ms____ was in his/her usual state of ____ (e.g., excellent health/poor health) until
____ (e.g., three days prior to admission) when he/she developed the ___ (acute/gradual)
onset of _____. The introductory sentence may include details of past medical history if the
patient’s illness directly relates to an On-going chronic disease.
b. Don’t mention that an event occurred “on Saturday”, rather refer to the time relative to
the day of admission, e.g.
Examples:
1) Mr Smith has a long history of chronic obstructive lung disease characterized by two
block dyspnoea on exertion, FEV1 of 1.0 litre, and home oxygen therapy. He was in this
usual state of health until three days prior to admission when he developed the gradual
worsening of his shortness of breath, associated with a cough productive of yellow
sputum and a fever of 102_…..
2) Mr White has a long history of coronary artery disease characterized by three
myocardial infarctions, the most recent in 1995, ventricular tachycardia treated with
amiodarone, and congestive heart failure. He was in his usual state of health, with
angina occurring once per week, until the night of admission when, while watching a
football game, he developed the acute onset of severe sub sternal chest heaviness…
3) Content of history of present illness – specifically characterize the major presenting
symptoms including patient attributions (what the patient thinks is causing the
The following is a useful mnemonic to make sure all those bases are covered:
1) C- Character, circumstances
2) L -location – deep or superficial, well or poorly localized
3) E -exacerbating factors
4) A -alleviating factors
5) R -radiation of pain
6) A -associated sx
7) S -severity on a 1-10 scale
8) T -temporal features - timing (intermittent/constant), duration, frequency, changes over time
(progressive, stable or improving)
Examples: A poorly characterized and too brief history of present illness:…admitted for
evaluation of chest pain. He was well until three weeks prior to admission when he began to
feel chest heaviness whenever he exerted himself. He saw his local doctor who prescribed
antacids with little benefit. The pain woke him last night so he came into the emergency
room for evaluation. His other problems include…
A complete example:
For example:
a. Diabetes mellitus is relevant to a patient admitted with angina. Consider each condition
separately, recounting the details in a chronological fashion. In other words, first explain the
patient’s h/o coronary disease, telling the story from the beginning to the present. Then
discuss their peptic ulcer, and then his/her COPD. In general, discuss the most important
problem first, and then present the others from next most important to least
important…….…his other medical problems include insulin-requiring diabetes for 12 years,
complicated by retinopathy, polyneuropathy, and nephropathy. His recent creatinine was
1.7…..
b. Key words and phrases summarize an on-going chronic illness and are discussed in this
section (or may be included with the HPI if they are related to the current problem as
discussed above). The key words vary with the nature of the problem. You will learn these
as you gain clinical experience and by listening to others summarize and present cases. In
general, key words emphasize date of diagnosis, its treatment, current symptoms,
complications, and any recent objective tests. ….long history of chronic obstructive lung
disease with steroid dependence and the requirement for home oxygen therapy, a 1994
FEV1 of 0.8L, and three hospital admissions for exacerbations in the last year. He has never
been intubated……two year history of congestive heart failure, felt to be secondary to
alcoholic cardiomyopathy, characterized by chronic two block dyspnoea on exertion, three
pillow orthopnoea, and ankle oedema. In addition to his long term therapy with furosemide
and enalapril, digoxin was added six months ago. An echocardiogram four months prior to
admission showed four chamber enlargement and global hypo kinesis……
c. In the case presentation you avoid presentation of irrelevant diagnoses. What is irrelevant
is not always obvious to you at your level of training and also improves with your clinical
experience. Consultation with your facilitator and preceptor will help you make this
determination. “gonorrhoea in 1945, malaria in 1940, cataract extraction in 1972, and tinea
pedis” are probably not relevant during presentation of the diabetic with crescendo angina.
You must know all of the patient’s problems and include them in your write-up, but
presentation of problems which are not relevant to the current active problems only
distracts your listener.
1) Provide a list of all prescribed medications and a list of any relevant non-prescription
medications.
We are more than our habits and marital status. Please don’t try and reduce patients to
these facts alone. Summarize their social history into a brief (2-3 sentences) paragraph
commenting on their current life situation including work, living situation, and support
systems, and any on-going social issues of note. It is often the social history that explains
why the patient has fallen ill now, as opposed to some other time or not at all:
patients may have chaotic lives and little social support so don’t have the help they need to
follow therapeutic recommendations, few financial resources and can’t afford their meds,
depression and feelings of hopelessness about their conditions, etc.
6. Physical Examination:
a) General description – be colourful, allow the listener to visualize the patient. “The patient
was short of breath” is inferior to “the patient was sitting on the edge of the bed, leaning
forward and gasping for breath.”
b) Vital signs should always be mentioned, including postural changes if relevant.
c) Mention only the relevant positive findings and relevant negative findings. An example of
the latter includes (in the dyspnoeic patient) “the exam is remarkable for clear lungs
bilaterally.” Use concise but complete descriptions of positive findings.
a. This takes the following form: “…the patient’s major presenting problem is ____ (best
positive statement you can make; say “chest pain” and avoid statements like “rule-out
myocardial infarction”). The differential diagnosis includes ____, ______, and _____. The
diagnosis of _____ appears to be the most likely of these because ______..
Example: …..the patient’s main problem is chest pain, which could be due to a myocardial
infarction, a dissecting aortic aneurysm, pericarditis, and a variety of other diagnoses such
as pneumonia, pulmonary embolus, or oesophageal disease. MI seems most likely, because
2. History of present illness too brief – 90% of correct diagnoses come from the history
alone; do not sabotage your listener’s understanding of the case by omitting important
information. The HPI portion of the oral presentation, as a general rule, should take 1/3 to
1/2 of the presentation time. Common pitfalls include incomplete characterization of the
major symptoms, omitting pertinent negatives or positive ROS questions, and omitting
specific information about past history that relates to the present problem.
3. Failure to use parallel reference points – in both write-ups and oral presentation, relate
time in “hours/days/weeks prior to admission”. Avoid “at 2:00 in the morning of last
Wednesday” or “on May 25th; instead, say “three hours prior to admission”, or “at 2:00 am,
three days prior to admission”.
4. Editorializing in the middle of the presentation - avoid comments like “do you even want
to hear this?” or “cardiac examination revealed a systolic murmur….well, I thought heard it,
but the resident didn’t…so maybe it isn’t there….I don’t really know….”
8. Physical findings presented without proper terminology - for example, “lymph node exam
shows some small cervical nodes” is not as descriptive as “…there were three soft tender
mobile nodes in the left anterior cervical chain which measure 1 x 1 x 2 cm each…
“Commitment to accuracy will improve your physical examination skills.
PHARMACEUTICAL CARE:
Definition: It is defined as the responsible provision of drug therapy for the purpose of
achieving definite therapeutic outcomes that improve the patient’s quality of life.
Functions:
These problems may be related to the patient’s current drug therapy, drug administration,
drug compliance, drug toxicity, ADR’s and a failure to achieve desired outcomes by the
treatment.
• Efficacy, safety, availability and cost of treatment and suitability of the treatment to
the patient should be considered while evaluating.
• The risk-benefit ratio factors should also be considered: seriousness of the disease,
complications if untreated, efficacy of drug, ADR’s.
5) INDIVIDUALISING DRUG REGIMENS: When more than one therapeutic alternative exist,
the following factors to be considered:
• Patient factors:- diagnosis, treatment goals, past medical and medication history,
contraindication, allergies, compliance
• Drug factors: - efficacy, adverse effects, dosage form, cost, drug-drug interactions.
6) MONITORING OUTCOMES:
• Prescription monitoring
• Prescribing advice to medical and nursing staff
• Medication errors and adverse reaction monitoring
• Medication history interview
• Patient education and counseling
• Pharmacokinetics and therapeutic drug monitoring
• Hospital formulary.
• Pharmacist barrier
• Practice setting constraints
• System impediments
• Intra professional barrier.
Introduction: There are more than 20,000 biomedical journals available worldwide,
approximately 9000 articles are being published every day, and Updating scientific
knowledge is a Herculean task for the healthcare professionals.
1. Format of abstract
2. Text
3. Tables/graphs
4. Reference
5. Permissible abbreviations and symbols
6. Authorship recommendation
7. Acknowledgements.
Title:
‘Title’ describes the breadth and depth of the current study and indicates the methodology
used. It is the limited possible words that adequately describe contents of the study. The
title of an article should be brief, definite and concise and should catch the attention of the
readers interested in the study.
Evaluation of Title:
1. Based on the title itself reader cannot review or discard the study.
2. Title should not contain abbreviations, proprietary names, chemical formulae, and jargons.
3. The title should inform the real subject of the article.
4. Title should not reflect its content. First impression is the best impression; the title should be
specific and studied well.
5. Title should not indicate author’s preference for any specific subject.
Abstract: An abbreviated accurate representing the contents of a document, mainly prepared by its
author(s) for publication in it. Abstract can be defined as a summary of the information in a
document. A synopsis (not more than 250 words) should be mentioned before introduction in the
article.
Evaluation of Abstract:
“Abstract” should outline a brief Summary of each section; Introduction, objectives, scope of
investigation, materials and brief Methodology, results, and conclusion which indicate study
findings. Abstract does not provide Complete information about the study and should not be used
alone to evaluate the study.
Introduction:
It serves two purposes in the study, creating readers interest in subject and providing them with
enough information to understand the study.
Evaluation of Introduction:
• Introduction should be presented, with all possible clarity, the nature and scope of the
problem investigated.
• It should provide pertinent literature to orient the reader.
• It should explain the reason why the current research is needed?
Objective:
Evaluation of Objective:
Study Designs:
The first part of this section is generally an overview of the type of study design that is
utilized in doing research. A sound study design supports study conclusion and result. Study design
should be clear and provide enough details so that potential reader can repeat the research.
1) Observational studies: Data collected from one or more group of subjects, Observational studies
may be prospective or retrospective.
2) Single blind: Either subjects or investigators are unaware of treatment allocation.
3) Double blind: Neither subjects nor investigators are aware of treatment allocation.
4) Triple blind: Subjects and investigators are unaware of treatment allocation; another group
involved with interpretation of data is also unaware of treatment allocation.
5) Parallel study: All subjects receive only one treatment.
6) Prospective: Data is collected forward in time from the start of the study.
7) Retrospective: Historical data (i.e., data referring to past events) is collected.
8) Cohort studies: Cohort studies consist of prospective observation of one or more groups with
certain characteristics.
9) Randomized control trial: Subjects are randomly allocated to either an intervention group or
control group. Randomized controlled trials are described as the “gold standard” in clinical
research.
Evaluation of Study Designs: The study design selected by an investigator should be sound
and likely to answer the research questions. Author(s) must describe study population well enough
so that the reader is able to visualize the sample population precisely under investigation.
Bias: It is a systemic variation in which treatment groups under study are treated or measured
differently on a consistent basis. Bias can mislead one to get into an erroneous outcome. The reader
should be able to find out the source of bias and its influence on the final outcome of study.
Types of bias:
Statistics: Knowledge of ‘Statistics’ can help an individual to evaluate whether the statistical
tests used in a study are appropriate or not. Different types of data (or variables) are encountered in
statistics. Errors in statistical analysis of data lead to invalid result/conclusion.
Evaluation of Statistics:
• Readers should determine whether appropriate statistical methods were used for data
analysis.
• Use of inappropriate methods will results in misleading conclusion.
• Method section of any scientific literature should include a summary description of the
statistical tests that were used to evaluate data. Qualitative and quantitative data are
examined differently .
Study Results and Analysis: Results’ should be described and presented in figures, tables,
and charts, as they are the heart of the scientific literature. Figures, tables, and charts will assist the
reader in deciding whether it is worth to read the rest of the article or to discard it. A properly
• Reader should have a proper understanding of study and should evaluate clinical and
statistical reliability of the study
• Sometimes authors try to present results in a confusing way, which most likely reflects hap
hazardous data collection and lack of clearly defined study objectives.
• Are the negative results been quoted? In case of any negative results those should be
quoted and the limitations have to be specified.
1) ‘Discussion Section’ of a study provides an opportunity for the author to interpret results and
explain their clinical importance by relating or comparing with previous work or practice.
2) ‘Conclusion’ is the author’s generated inferences, opinions and hypotheses about results. This
section should contain views that the author draws from data obtained by the study.
References:
• While writing article, authors always refer to some information from other sources.
• All these sources are listed in ‘Reference Section’, sometimes referred to as ‘Bibliography’.
Evaluation of References:
1) Are the references given? Whether appropriate and adequate references are used in
the study?
2) Are the references quoted appropriately in the research article?
3) Are the references given recent and important?
4) What is the size of ‘Reference Section’?
5) How the references are used for support, rebuttal etc.?
6) Do the references match citations in the text?
7) Authors should avoid citing their own research efforts and publication.
• Drug use is a complex process and there are many drug related challenges at various levels,
involving prescriber, pharmacists and patients.
• While medication can occur anywhere in the health care system from prescriber to
dispenser to administration and finally to patient use, the simple truth is that many errors
are preventable, and pharmacists assume active role in appropriate use of drugs.
• Pharmacy entails a health science specialty which embodies the Knowledge of
pharmacology, toxicology, pharmacokinetics and therapeutics for the care of patients.
• Health care is nearly 10 years behind other industries in its efforts to reduce the errors.
• According to studies cited in the institute of Medicine report, “to Err is Human; Building a
Safer Health System” 44,000 to 98,000 Americans die each year as a result of medical errors.
• Medication error may be nobody’s baby, but when it happens, it could well turn out to be
everyone’s worry and the reasons given for medication error range from silly to the
downright serious.
Medication errors: “A medication error is an preventable event that may cause or lead to
inappropriate medication use or patient while the medication is in the control of the health
care professional, patient, or consumer. Such events may be related to professional
practice, health care products, producers and systems, including prescribing; order
communication; product labelling packaging and nomenclature; compounding ;dispensing;
distribution; administration; education; monitoring; and use”3 Most medication errors are
considered latent.
For example: When a pharmacist fills a prescription with the incorrect medication, patients
typically realize this mistake once they have returned home and have taken the first dose.
Latent errors can be described as “accidents waiting to happen “The causes of these types
of errors are usually identifiable and can be corrected before the error reoccurs.
1. Incomplete patient information (not knowing about patients’ allergies, other medicines they
are taking, previous diagnoses, and lab results for example)
2. Unavailable drug information (such as lack of up-to date warnings)
3. Miscommunication of drugs orders, which can involve poor handwriting, confusion between
drugs with similar names, misuse of zeroes and decimal points, confusion of metric and
other dosing units, and inappropriate abbreviations.
4. Lack of appropriate labelling as a drug is prepared and repackaged into smaller units and
Environmental factors, such as lighting, heat, noise, and interruptions that can distract
health professionals from their medical tasks.
Causes for errors: In a data report indicates that pharmacists perceived the following as
causative factors for medication errors:-
Common types of medication errors: The Institute for Safe Medication Practices (ISMP)
identifies the following areas as potential causes of medication errors.
1. Failed communication: handwriting and oral communications, especially over the telephone,
2. drugs with similar names,
3. missing or misplaced zeroes and decimal points,
4. confusion between metric and apothecary systems of measure,
5. Use of nonstandard abbreviations ambiguous or incomplete orders Poor drug distribution
practices.
6. Workplace environmental problems increasing the job stress.
7. Complex or poorly designed technology.
8. Access to drugs by non-pharmacy personnel
9. Dose miscalculations
10. Lack of information to prescribers
11. Lack of patient information
12. Lack of patient understanding about his therapy.
Medication error rate: “Medication error rate” is determined by calculating the percentage
of errors. The numerator in the ratio is the total number of errors. The numerator in the
ratio is the total number of errors that they observe, the denominator is called
1) Failure to “shake well”: The failure to “shake” a drug product that is labelled “shake well
“. This will almost always lead to an under dose or over dose depending on the suspending
abilities of the diluent’s and the elapsed time since the last “shake “. Also included under
this category is the failure to “roll” insulin suspensions. Insulin suspensions should not be
shaken, they should be “rolled” in order to mix the insulin particles with the diluents
without creating air bubbles.
2) Crushing medications: Crushing tablets or capsules that the label states “do not crush”.
For example: Non-steroidal Anti-Inflammatory Drugs (NSAID’s) taken with food or antacids
and whereas, some of the medication is administered in empty stomach or before taking
food for better pharmacological & therapeutically action.
4) Sublingual tablets which should not be swallowed: Swallowing a sublingual tablet (e.g.
nitroglycerin, isosorbide dinitrade).If it is swallowed; its absorption is greatly reduced. This
will result in less symptom relief.
5) Use of inappropriate solvents: Some of the drugs (e.g. anticancer drugs) which require
reconstitution before administration. Use of inappropriate solvent may reduce the efficacy
and potency of the main drug.
Medication error prevention: The National Coordinating Council for Medication Error
Reporting and Prevention and Institute for Safe Medication Practices emphasize that
1. The Institute for Safe Medication Practices suggests a number of error prevention tools ranging
from forcing functions to independent double-check systems. Prescription orders should include
a brief notation of purpose (e.g. for cough), unless considered inappropriate by the prescriber.
Notation of purpose can help further assure that the proper medication is dispensed and creates
an extra safety check in the process of prescribing and dispensing a medication Independent
double-check systems can reduce the risk of error by way of having one person independently
check another’s work. When this procedure is properly carried out, the likelihood that two
individuals would make the same error with the same medication for the same patient is quite
low.
2. Forcing functions and constraints they allow for designing processes to ensure that errors are
virtually impossible or at least difficult to make.
Examples include: software programs with “forcing functions “that require the entry of additional
pertinent patient information before the order is completed and the medication is dispensed.
Automation and computerization of medication use processes and tasks can lessen human fallibility
by limiting reliance on memory. Examples include use of technologically and clinically sound
computerized drug information system.
3. All prescription orders should be written in the metric system except for therapies that use
standard units such as insulin, vitamins, etc. Units should be spelled out rather than writing “U”.
The change to the use of the metric systems from the archaic apothecary and avoirdupois
systems will help avoid misinterpretations of these abbreviations and symbols, and
miscalculations when converting to metric, which is used in product labelling and package
inserts.
4. Prescribers should include age, and when appropriate, weight of the patient on the prescription
or medication order. The most common errors in dosage result in paediatric and geriatric
populations in which low body weight is common. The age (and weight ) of a patient can help
dispensing health care professionals in their double check of the appropriate drug and dose
5. The medication order should include drug name, exact metric weight or concentration, and
dosage form. Strength should be expressed in metric amounts and concentration should be
specified. Each order for a medication should be complete. The pharmacist should check with
the prescriber if any information is missing or questionable.
6. A leading zero should always precede a decimal expression of less than one. A terminal or
trailing zero should never be used after a decimal. Ten-fold errors in drug strength and dosage
have occurred with decimals due to the use of a trailing zero or the absence of a leading zero.
7. Prescribers should avoid use of abbreviations including those for drug names (e.g., MOM, HCTZ)
and Latin directions for use. The abbreviations in (table-1) are found to be particularly dangerous
because they have been consistently misunderstood and therefore, should never be used.