PRACTICE SCHOOL REPORT

On

FUNDAMENTALS OF PHARMACEUTICAL CARE AND MEDICAL

WRITING

Submitted in Partial Fulfilment of the Requirements for the Degree of

Bachelor of Pharmacy

by

GURNOOR

B. Pharm 7th Sem, 4th Year

(Registration no. 403200000047)

University Institute of Pharmaceutical Sciences

Panjab University, Chandigarh

Supervisor:
Professor Kanwaljit Chopra
Professor Anil Kumar
Dr. Anurag Kuhad
Dr. Sandeep V. Pawar
Dr. Sangeeta P. Sah

1
 University Institute of Pharmaceutical Sciences

INDEX

S.NO. TOPICS INSTRUCTOR PAGE NO.

3-5
1 Communication Prof. Kanwaljit
skills Chopra

6-7
2 Drug Utilization Prof. Anil Kumar
Research

8-9
3 Medical Writing Dr. Anurag Kuhad

10-13
4 Pharmacovigilance Dr. Sangeeta P. Sah

14-19
5 Interpretation of Lab Dr. Sandeep V.
Tests Pawar

2
EXERCISE 1
COMMUNICATION SKILLS
Communication is the transfer of information meaningful to those involved. It is the process
in which messages are generated and sent by one person and received and translated by
another person. The goal of all communication is understanding. In fact, a message is
successful only when both the sender and the receiver perceive it in the same way. However,
the meaning generated by the receiver can be different from the sender’s intended message.
Effective communication skills are a critical element for patients, pharmacist and doctors.
Communication skill may be in verbal or non-verbal way

OBJECTIVES OF PHARMACIST-PATIENT COMMUNICATION

 To create a good interpersonal relationship.
 To educate patient about disease and treatment.
 To counsel the patient for non-drug therapies
Poor communication skill between pharmacist and patient may leads to following:
 Inaccurate patient medication history.
 Inappropriate therapeutic decisions.
 Leads to patient confusion, patient disinterest and patient non-compliance.
Communicating with Health Professionals:
➤ Effective communication between pharmacist and physicians, nurses and another
pharmacist are essential.
➤ Following are some instruction and advantages of effective and clear communications
between different health professionals involved in patient care services:

 A good doctor-patient communication has the potential to help in regulating

patients' emotions, facilitate comprehension of medical information and to allow
for better identification of patient's needs perception and expectations.
 Patient's reporting good communication are more likely to be satisfied with their
health care, and especially relevant information for accurate diagnosis of their
problems, follow advice and adhere to the prescribed treatment.
 A more patient centered communication may provide the satisfactory results from
patient as well as from doctor.
 A pharmacist must notify within a reasonable time after renewing the prescription.

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  Pharmacists are periodically required to contact prescribers to manage drug
interaction or suggest changes to therapy that could ensure the best possible
patient outcomes.
 Manage the drug related problem by providing your therapeutic recommendation
to the prescriber including how to manage this situation.
 Always endeavour to include a reference to the evidence that supports your
recommendations this can increase the prescribers comfort level with this and
future recommendations.

STRATEGIES TO IMPROVE COMMUNICATION

Explain Things Clearly in Plain Language
 Slow down the pace of your speech
 Use plain, non-medical language “Blood pressure pill” instead of “antihypertensive”
 Pay attention to patient’s own terms and use them back
 Avoid vague terms “Take 1 hour before you eat breakfast” instead of “Take on an
empty stomach”

Focus on Key Messages and Repeat

 Limit information Focus on 1-3 key points
 Develop short explanations for common medical conditions and side effects
 Discuss specific behaviors rather than general concepts What the patient needs to do
 Review each point at the end

Use a “Teach Back” to Check Understanding Teach Back Scripts:

I want to make sure I explained everything clearly. If you were trying to explain to
your husband how to take this medicine, what would you say?
 Let’s review the main side effects of this new medicine. What are the 2 things that I
asked you to watch out for?
 Show me how you would use this inhaler.

Effectively Solicit Questions

 Don’t say: Do you have any questions? Did you take your doses correctly?
 Instead say: What questions do you have? How did you take your doses last
month?”

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POINTS OF SPECIAL CONSIDERATION
 Never give misleading/false hopes.
 Never give a hopeless outlook.
 Never lose temper with patient.
 Never give sarcastic comments to patient.
 Patiently explain to him and ensure that he has understood.
 Maintain privacy of the patient
GATHER RULE
 G: GREET THE PATIENT WARMLY
 A: ASK ABOUT COMPLAINTS/HELP NEEDED
 T: TELL ABOUT CHOICE AVAILABLE/DISEASE
 H: HELP PATIENT TO UNDERSTAND
 E: EXPLAIN FINAL PLAN
 R: RETURN VISITS PLAN

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EXERCISE 2
DRUG UTILIZATION RESEARCH
Drug utilization research can be defined as “an eclectic collection of descriptive and
analytical methods for the quantification, the understanding and the evaluation of the
processes of prescribing, dispensing and consumption of medicines, and for the testing of
interventions to enhance the quality of these processes”
The discipline may be seen as the bridge between pharmacoepidemiology and health services
research. It is also closely connected to clinical pharmacology, with the principal aim of drug
utilization research being to facilitate the safe and effective use of medicines in populations. •
Research in drug utilization began to develop in the 1960s. Some pioneering studies focused
on assessing differences in drug utilization between countries or regions. Other studies
focused on factors influencing the prescribing patterns of physicians.
In 1977, the WHO defined drug utilization research as ‘studies on the marketing,
distribution, prescription and the use of drugs in a society, with special emphasis on the
resulting medical, social and economic consequences’
Drug utilization research focuses on various medical, social and economic aspects of drug
use. Medical consequences include the risks and benefits of drug therapy, while social aspects
can be related to inappropriate use. Economic issues deal with the cost of medicines and
treatment for patients and society
Dug utilization research in Clinical Pharmacology:
Drug utilization research is also connected to the discipline of clinical pharmacology.
Researchers in this field study pharmacokinetics (what the body does to the drug) and
pharmacodynamics (what the drug does to the body). The original aims of clinical
pharmacology were to develop new medicines and to determine the balance between drug
benefit and risk in clinical trials. In recent years, the scope of clinical pharmacology has
widened to include exploration of drugs as therapeutic agents and assessment of the
beneficial and adverse effects of the use and the deliberate misuse of drugs. Clinical
pharmacology has a strong focus on pharmacovigilance activities, such as the reporting,
collecting and evaluation of ADRs; however, clinical pharmacologists are also engaged in
promoting rational drug use through medical education, drug information centers, therapeutic
drug monitoring services and drug and therapeutic committees.
While clinical pharmacology studies the ‘absolute’ efficacy of a drug in clinical trials under
ideal conditions, drug utilization research and pharmacoepidemiology study the ‘real ‐world’
effectiveness of medicines and attempt to identify and quantify risks that are difficult to
observe or assess in clinical trials or spontaneous reporting systems.
Furthermore, drug utilization research includes assessment of the appropriateness of drug use
and expenditure.

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The applied drug utilization research sections are designed to illustrate recent developments
in drug utilization research from different perspectives. The chapters are grouped under the
following headings:
o Section A: Comparative drug utilization research
o Section B: Drug utilization and health policy
o Section C: Drug utilization in specific populations
o Section D: Drug utilization in specific therapeutic areas
o Section E: Determinants of drug utilization
o Section F: Adherence and drug utilization research
o Section G: The role of drug utilization within the field of pharmacoepidemiology
o Section H: Assessment and improvement of the quality of medicine use

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EXERCISE 3
MEDICAL WRITING
Medical writing involves creating well-structured scientific documents that include clinical
research documents, content for healthcare websites, health magazines, journals and news.
Medical writing can be classified into two types: Regulatory medical writing and Educational
medical writing. Regulatory medical writing involves writing documents for regulatory
agencies seeking approval for devices, drugs and biologics.
This includes clinical trial data, regulatory submission documents, post approval documents,
etc. Educational medical writing is writing documents about devices, biologics and medicine,
specifically for general studies.
A medical writer, also referred to as medical communicator, is a person who applies the
principles of clinical research in developing clinical trial documents that effectively and
clearly describe research results, product use, and other medical information. The medical
writer develops any of the five modules of the Common Technical Document. The medical
writers also ensure that their documents comply with regulatory, journal, or other guidelines
in terms of content, format, and structure.
Medical writing as a function became established in the pharmaceutical, medical device
industry] and Contract Research Organizations (CROs) because the industry recognized that
it requires special skill to produce well-structured documents that present information clearly
and concisely. All new drugs go through the increasingly complex process of clinical trials
and regulatory procedures that lead to market approval. This demand for the clear articulation
of medical science, drives the demand for well written, standards-compliant documents that
medical professionals can easily and quickly read and understand. Similarly, medical
institutions engage in translational research, and some medical writers have experience
offering writing support to the principal investigators for grant applications and specialized
publications.
Examples of medical writing include:
 Research-based documents and scientific papers.
 Educational materials on new diseases.
 Promotional materials on new drugs or scientific applications.
10 Medical writers have to delve deep into clinical data, case reports, scientific literature and
regulatory documents and pore over them without denouncing a single piece of information.
Medical writing is a career that requires a mix of people skills. You need to understand your
customers' expectations, endure numerous, often contradictory, rewrites, graciously accept
criticism of your writing, and persuade others to meet your deadlines so you can meet theirs.
All aspiring medical writers do need at least a bachelor's degree. However, there is no one
universal degree program intended specifically for medical writers. People come to this
career field with a variety of backgrounds and academic qualifications.
Skills required by a medical writer include:

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 Excellent knowledge of the English language.
 Faultless communication skills, both written and verbal.
 Attention to detail.
 Analytical skills and able to interpret data.
 Organization and patience.
 The ability to work well within a team

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EXERCISE 4

PHARMACOVIGILANCE
Pharmacovigilance – the study of the safety of marketed drugs under the practical conditions
of clinical use in large communities – involves the paradox that what is probably the most
highly regulated industry in the world is, from time to time, forced to remove approved and
licensed products from the market because of clinical toxicity

DIAGNOSING ADVERSE DRUG REACTIONS

There are two types of adverse drug reactions. Type A reactions are common, predictable,
usually dose dependent and appear as excessive manifestations of the normal
pharmacology/toxicology of the drug; they are seldom fatal. Type B reactions are uncommon,
unpredictable, often independent of dose and usually represent abnormal manifestations of
the drug’s pharmacology/toxicology; they involve relatively high rates of serious morbidity
and mortality.

Aim of Pharmacovigilance
• To improve patient care and safety in relation to the use of medicines, and all medical and
paramedical interventions
• To improve public health and safety in relation to the use of medicines
• To contribute to the assessment of benefit, harm, effectiveness and risk of medicines,
encouraging their safe, rational and more effective use
• To promote understanding, education and clinical training in pharmacovigilance and its
effective communication to health professionals and the public

Functions of Pharmacovigilance
 Collect reports , data, ADR’s etc.
 Analyses and assesses the reports.
 Promotes the safe use of drugs.
 Creates appropriate structures and means of communication needed to perform its
tasks.
 Identifying new information about hazards associated with medicines.
 Preventing harm to the patients.

10
Pharmacoepidemiology is the study of the use of, and effects of, drugs in large numbers of
people. As the term implies, this form of enquiry uses the methods of epidemiology; it is
concerned with all aspects of the benefit–risk ratio of drugs in populations.
Pharmacovigilance is a branch of pharmacoepidemiology but is restricted to the study, on an
epidemiological scale, of drug events or adverse reactions. ‘Events’, in this context, are
happenings recorded in the patient’s notes during a period of drug monitoring; they may be
because of the disease for which the drug is being given, some other intercurrent disease or
infection, an adverse reaction to the drug being monitored or the activity of a drug being
given concomitantly. They can also be because of drug–drug interactions

Objectives of ADR Monitoring:

1. To detect the nature and frequency of ADRs
2. To Assist the drug regulatory authority, Public Health
programs and scientists to minimize ADRs.
3. Providing Updated drug safety information to heath care
professionals.
4. Dissemination of information by designing proper
education program to consumers.
5. To identify risk factors that may predispose, induce or
influence the development, severity and incidence of
ADRs.

Fig: ADR Reporting

Importance of Pharmacovigilance:
Adverse Event Reporting: Collecting and analyzing data on adverse events reported by
healthcare professionals, patients, and drug manufacturers.

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Signal Detection: Identifying potential safety signals or trends in adverse events that might
indicate previously unknown risks associated with a drug.

Risk-Benefit Assessment: Evaluating the risks versus benefits of medications to make

informed decisions about their use in clinical practice.
Post-Marketing Surveillance: Monitoring drugs after they have been approved and
marketed to detect and address any previously unrecognized adverse effects.
Regulatory Compliance and Reporting: Ensuring compliance with regulatory requirements
for reporting adverse events to regulatory authorities like the FDA (Food and Drug
Administration) or EMA (European Medicines Agency).
Communication and Information Sharing: Facilitating the dissemination of safety
information to healthcare professionals, patients, and regulatory agencies to promote
medication safety and awareness

ADR Detection Methods

 Passive surveillance
 Spontaneous reporting system (SRS)
 Case series

 Stimulated reporting

 Active surveillance
 Sentinel sites
 Drug event monitoring Registries

 Comparatives observational studies

 Cross sectional study
 Case control study
 Cohort study

 Targeted clinical investigations

 Descriptive studies
 Natural history of disease
 Drug utilization study

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Conclusion:
 Current progress in pharmacovigilance is marked by increasing use of databases and
by attempts to make the process more proactive and organized.
 Attempts are being made to augment the spontaneous, random nature of the
generation of pharmacovigilance data and to make the process more systematic and
structured.
 There has been a coming together of academic, regulatory and industrial interests
across many countries to produce the guidance documents for the conduct of
pharmacoepidemiology studies.

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 EXERCISE 5
KIDNEY FUNCTION TEST
Kidney function tests are routine check-ups used to monitor kidney health. They help
diagnose problems early, long before symptoms appear
Most of these tests measure the Glomerular Filtration rate (GFR) which assesses how
efficiently your kidneys clear waste from your system
Symptoms which show that kidney function test need to be done:
 Some conditions such as Diabetes or Hypertension
 Blood in Urine (haematuria)
 Painful Urination (dysuria)
 Frequent Urge to Urinate
 Problems with starting to Pee

Common causes for Abnormal Kidney Function Tests

 Dehydration: It will decrease Blood flow to your kidneys and make them work less
efficiently.
 Diabetes: Diabetes can damage Kidneys due to high blood sugar levels causing
abmormal test results such as elevated protein levels in urine
 Urinary Tract Infections: UTIs can cause inflammation and damage to your kidneys
results in abnormal kidney function tests such as proteinuria and haematuria
 Hypertension: If left uncontrolled, it can damage blood vessels in your kidney and can
result in abnormal kidney tests such as elevated creatinine levels in your blood

BLOOD UREA NITROGEN (BUN)

This tst measures the amount of urea nitrogen in your blood

Liver produces Nitrogen combines Urea travels from

ammonia by with other elements liver to kidney via URIN
breaking down e.g.C, H, O to form bloodstream &
proteins which urea.
healthy kidney
E
contains nitrogen filter out waste
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Methods:
1. Fearon Method 2. Enzymatic Method

NORMAL BUN LEVELS:

 ADULT MALE: 8 to 24 mg/dl
 ADULT FEMALE: 6 to 21 mg/dl
 CHILDREN (1-17 YR): 7 to 20 mg/dl
Higher BUN levels Lower BUN levels

 Acute or Chronic renal failure  Liver failure

 Dehydration  Malnutrition
 Congestive heart failure  Overhydration
 Shock  Lack of protein in diet
 Antianabolic and nephrotoxic
drugs

Treatments:
Proper hydration is the most effective way to lower BUN levels. A low-protein diet
can also help lower BUN levels. A Medication can be recommended to lower BUN
levels. However, abnormal BUN levels don’t necessarily mean you have a kidney
condition. Certain factors, such as dehydration, pregnancy, high or low protein intake,
steroids, and aging can impact your levels without indicating a health risk.
BLOOD UREA:
METHOD USED- DIACETYL MONOXIME
REAGENTS-
 Sodium tungstate (10%)

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 Two thirds sulphuric acid

 Colour Reagent-- sol. A – Dissolve 1g diacetyl monoxime, 0.2 g thiosemicarbazide, and 9

gm sodium chloride in distilled water. Dilute up to 1 litre.
Sol. B – add 60ml conc. Sulphuric acid and 10ml of 85% phosphoric acid to 800ml of
distilled water. Dissolve 0.1g ferric chloride in the acid mixture cool and make up to 1L.
REAGENT MIXTURE- Mix sol. A and sol. B in equal volumes just before use.
Normal range of blood urea- adult- 15-40 mg/dl
2.5- 7.0 mmol/L
Urea Creatinine Ratio:
 Elevated ratio: >100:1
 Reduced ratio: <40:1
 In the presence of raised creatinine, urea disproportionately higher than creatinine
suggests a prerenal cause such as hypovolaemia, heart failure or shock.
Causes of elevated Urea Creatinine Ratio
 Prerenal renal failure - hypovolaemia, sepsis, renal venoconstriction
Causes of Reduced Urea Creatinine Ratio
 Severe liver failure
 Low protein intake - low protein diet, malnutrition, malabsorption, alcoholism
 Muscle breakdown - body building, rhabdomyolysis
 Pregnancy

SERUM CREATININE:
Breakdown products of creatinine phosphate from muscle and protein metabolism. Serum
creatinine is the most commonly used indicator of renal function.
METHOD USED- JAFFE’S TEST
The colorimetric method was used to determine creatinine levels in blood and urine.
PRINCIPLE-
 Creatinine reacts with picric acid in an alkali sol to form an orange-colored complex.
 The reaction is Called Jaffe reaction
 Proteins with serum are precipitated with sodium tungstate and sulphuric acid.
 Then protein-free filtrate containing creatinine reacts with picric acid in an alkaline
medium to form orange-colored creatinine picrate.
 The sample color is measured at 540 nm using a green filter.
 Color and intensity are compared with a known amount of standard creatinine.
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  Normal range of creatinine- 0.7- 1.3 mg/dl for adult males
0.5 -1.1 mg/dl for adult females.

ENZYMATIC REACTION

Causes for High levels Causes for low levels

 Renal dysfunction  Cachexia

 Dehydration  Inactive elderly or comatose
 Urinary Tract Infection patients
 Vigorous Exercise  Spinal cord injury patients
 Increased Meat Intake

 Calculating the BUN/ Creatinine ratio may suggest etiology for Renal dysfunction
 A BUN/Creatinine ratio Greater than 20 suggest a prerenal cause such as GI bleeding.

SERUM URIC ACID:

METHOD USED- Uricase Test
 The catabolism of purine, adenine, and guanine produces uric acid. At physiological
ph, uric acid is mostly ionized and present in plasma as SODIUM URATE.
 The normal serum level of uric acid is 4 to 7 mg per 100 ml.
 An elevated serum urate concentration is known as hyperuricemia
 Uric acid and urate are relatively insoluble molecules that readily precipitate out of
aqueous solutions such as urine or synovial fluid. The consequence of this is the
condition, GOUT.

METHOD USED- Uricase Test

 The catabolism of purine, adenine, and guanine produces uric acid. At physiological
ph, uric acid is mostly ionized and present in plasma as SODIUM URATE
 The normal serum level of uric acid is 4 to 7 mg per 100 ml.
 An elevated serum urate concentration is known as hyperuricemia.

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  Uric acid and urate are relatively insoluble molecules that readily precipitate out of
aqueous solutions such as urine or synovial fluid. The consequence of this is the
condition, GOUT.

SERUM CALCIUM:
If calcium levels in the urine are abnormally high, it may be a sign of:
 Hyperparathyroidism: A condition where the parathyroid gland produces too much
parathyroid hormone, which may also cause fatigue, back pain, and sore bones
 Milk-alkali syndrome: A condition that results from taking too much calcium, usually
seen in older women who take calcium to prevent osteoporosis
 Idiopathic hypercalciuria: Too much calcium in your urine without a reason
 Sarcoidosis: A disease in which inflammation occurs in the lymph nodes, lungs, liver,
eyes, skin, or other tissues
 Renal tubular acidosis: High acid levels in the blood because the kidneys don’t make
the urine acidic enough
 Vitamin D intoxication: Too much vitamin D in your body
 Use of loop diuretics: A type of water pill that works on one part of the kidney to
increase water loss by the kidney
 Kidney failure

If calcium levels in the urine are abnormally low, it may be a sign of:
 Malabsorption disorders: Such as vomiting or diarrhea, because the food nutrients
haven’t been properly digested
 Vitamin D deficiency
 Hypoparathyroidism: A disease in which the parathyroid doesn’t produce enough
of a certain hormone to keep calcium and phosphorus at proper levels
 Use of thiazide diuretics

SERUM SODIUM:
METHOD USED- ENZYMATIC METHOD
 Na is the principal extracellular cation.
 Plasma Na level 136- 145 mEq/L.
 Sodium is determined enzymatically via sodium-dependable beta-galactosidase
activity O-nitrophenyl galactosidase (ONPG) as substrate.
 The absorbance at 450nm of the product to sodium concentration.

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  Increase urine Sodium is seen in:
 Diuretic therapy.

 Dehydration.
 Adrenocortical deficiency.
 Diabetic Ketoacidosis.
 Chronic renal failure

SERUM CHLORIDE
What is a Chloride Blood Test?
A chloride blood test measures the amount of chloride in your blood. Chloride is a type of
electrolyte. Electrolytes are electrically charged minerals that help control the amount of
fluids and the balance of acids and bases (pH balance) in your body
 The normal range for chloride level -95-105 mEq
 High levels of chloride may be a sign of:
 Dehydration, Kidney disease, Metabolic acidosis, a condition in which you have too
much acid in your blood. It can cause nausea, vomiting, and fatigue
 Low levels of chloride may be a sign of:
 Heart failure, Lung disease
 Addison disease, a condition in which your body's adrenal glands don't produce
enough of certain types of hormones. It can cause a variety of symptoms, including
weakness, dizziness, weight loss, and dehydration
 Metabolic alkalosis, a condition in which you have too much base in your blood. It
can cause irritability, muscle twitching, and tingling in the fingers and toes.

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