Pharmacy school

• Based on hospital
pharmAcy
 MODULES;1
TOPIC1; Introduction to clinical research and basic clinical
trials

What is Clinical Research?

Clinical research is a branch of healthcare science that investigates the effectiveness, safety, and
optimal use of medications, medical devices, diagnostics, and treatment regimens. The primary
aim is to enhance patient outcomes, prevent diseases, and understand human health better.
Clinical research is crucial for developing new therapies and advancing medical knowledge.
Clinical research typically involves studies on human participants and can be observational or
interventional. Observational studies analyze health outcomes in groups without interference
from researchers, while interventional studies, often called clinical trials, involve experimental
interventions to assess their impact on participants.

A type of research study that tests a new treatment or intervention in humans to determine if it's
safe and effective. Clinical trials are considered the "Gold Standard" of clinical research and are
the primary way researchers determine if a new treatment is effective.

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 Importance of Clinical Research
Clinical research is fundamental to medicine because it provides evidence to support
new therapies and treatment methods. It addresses health questions, improves patient
care, and develops standards for disease prevention and treatment. Importantly,
clinical research also involves ethical considerations, ensuring that participants' rights
and safety are prioritized. Clinical research is important because it helps us understand
how to diagnose, prevent, treat, and cure diseases and disabilities. It also helps us
improve patient health and keep people safe.
❖Some key benefits of clinical
research include:
Discovery of new treatments: Research contributes to finding effective
therapies for diseases like cancer, diabetes, and Alzheimer's.
Safety and efficacy: Trials ensure that new medications or interventions are
safe and effective for widespread use.
Guiding policy: Evidence from clinical research informs healthcare guidelines,
policies, and regulations.
. Opportunity to Help Communities:
Monitoring of Health: ...
Potential for More Effective Treatments
Gain access to new and possibly effective
treatments or medicine available only …….. 2
PHASES OF CLINICAL TRIALS

Clinical trials progress through several phases, each with specific

goals and participant numbers. The phases include:

Phase I Trials: These trials test new treatments on a small group of

healthy volunteers or patients to evaluate safety, dosage range, and
side effects.
Phase II Trials: This phase expands to a larger group of participants
to determine efficacy and monitor for any adverse effects.
Phase III Trials: In Phase III, the trial grows to involve a larger
population to confirm efficacy, monitor side effects, and compare
the new intervention to standard treatments.
Phase IV Trials: These post-marketing studies continue after FDA
approval, providing information on risks, benefits, and optimal use
in a general population.

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 Basic Concepts in Clinical Trials
Design

Clinical trials are designed based on the study

objectives, which influence the methodology.
Common designs include:
Randomized Controlled Trials (RCTs): Considered the "gold standard," RCTs
randomly assign participants to an intervention or control group to minimize
bias.
Placebo-Controlled Trials: A placebo is used to assess whether the
intervention’s effect is genuinely due to the treatment rather than participants’
psychological response.
Double-Blind Trials: Neither the participants nor researchers know who
receives the intervention, reducing bias and increasing the reliability of results.

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 History and Evolution of Clinical Trials

The concept of clinical trials dates back centuries, with early practices such as
observation of medicinal plant effects. However, modern clinical trial methodology
began in the 18th century with Dr. James Lind’s scurvy experiment. Lind's study involved
dividing sailors into groups and giving each group a different treatment, marking one of
the earliest recorded controlled trials.
Modern clinical trials, as we know them, began in the mid-20th century with the
establishment of structured methodologies, randomization, and placebo controls. This
period also saw the establishment of ethical guidelines, such as the Nuremberg Code
and the Declaration of Helsinki, following unethical practices in earlier studies (e.g., the
Tuskegee Syphilis Study). These guidelines laid the foundation for today’s ethical
standards in research.

Conclusion
Clinical research and clinical trials are essential to advancing medicine and
improving patient outcomes. By adhering to structured phases, ethical standards,
and rigorous methodologies, clinical trials help identify safe and effective
treatments. As medical science evolves, clinical research will continue to be
indispensable in finding solutions to complex health issues, shaping the future of
healthcare.
https://www.//clinical-trials-introduction-presentation/741256 5
 MODULES; 2 Community Pharmacy

TOPIC - ‘’ Dispensing of Medicines ‘’

‘’Introduction to the Dispensing of Medicines ‘’

The dispensing of medicines refers to the process of preparing and providing
prescribed medications to patients, ensuring that the correct drug is given in the
right dose, form, and quantity. The primary role of dispensing is carried out by
licensed pharmacists in hospitals, pharmacies, or clinics. The practice of dispensing is
an integral part of the healthcare system, focusing on ensuring safe, effective, and
appropriate use of medicines.
Pharmacists must possess in-depth knowledge of pharmacology, therapeutic
guidelines, drug interactions, patient counseling, and legal regulations to safely
dispense medications.

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https://www.//dispensing-pharmacy/239442790
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 1. The Role of Pharmacists in Dispensing Medicines

Pharmacists are healthcare professionals who are responsible for the safe, accurate, and
appropriate dispensing of medications. Their role extends beyond simply providing
drugs to patients. They are critical in ensuring that medicines are used in ways that
improve the overall health and well-being of individuals.

•Prescription Review: Pharmacists carefully examine prescriptions to confirm the

right medication, dosage, and frequency. They assess for potential errors such as drug
interactions, allergies, or contraindications.
•Patient Counseling: Pharmacists provide information to patients on how to properly
use the prescribed medications, side effects, potential interactions with other drugs,
and the importance of adherence to the treatment plan.
•Drug Information Expert: They are knowledgeable about various medications and
act as an information resource for both patients and healthcare professionals.
•Medication Management: Pharmacists ensure that patients are using the right
medications and follow-up to track outcomes and monitor for any adverse effects.
•Collaboration with Healthcare Teams: Pharmacists often work closely with
physicians, nurses, and other healthcare providers to create effective treatment plans
and provide optimal care.

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 2. The Process of Dispensing Medicines
3.1 Receiving the Prescription
Prescription Verification: When a patient submits a prescription, the first step is verifying
its authenticity and checking for accuracy. This includes confirming the prescribing
physician’s details, patient information, and the prescribed medication.
Assessment of Medical History: The pharmacist may inquire about the patient’s medical
history, current medications, allergies, and other relevant factors that could influence the
prescription.
3.2 Preparing the Medication
Formulation and Dose Calculation: The pharmacist will prepare the medication in the
prescribed dosage form (e.g., tablet, liquid, injection) and quantity. For example, they
may need to adjust liquid medication doses based on the patient's weight.
Labeling and Instructions: The pharmacist labels the medication with clear instructions,
including the medication name, dosage, frequency, special instructions (e.g., "take with
food"), and warnings (e.g., "may cause drowsiness").
3.3 Review for Drug Interactions and Safety
Checking for Drug Interactions: Pharmacists use databases or references to
check if the prescribed medication might interact with other drugs the patient
is taking, which could lead to side effects or reduced efficacy.
Patient History Review: The pharmacist will also consider the patient’s health
status, including kidney or liver function, which may affect drug metabolism. Page 9
 3. Patient Counseling and Education

Effective patient counseling is an essential part of dispensing medicines. It ensures

that patients understand how to take their medication, recognize potential side
effects, and adhere to prescribed regimens.
Pharmacists educate patients on:
Correct Administration: Demonstrating the proper way to administer oral, topical, or
medications.
Side Effects: Educating patients on common side effects and how to manage them
(e.g., nausea, dizziness).
Missed Doses: Explaining what to do if a dose is missed, such as taking it as soon as
remembered unless close to the next dose.
Medication Adherence: Pharmacists emphasize the importance of adhering to the
prescribed regimen to achieve the best possible therapeutic outcome.

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 MODULES 3- ‘’Clinical and hospital pharmacy’’

Processing drug information queries ;

1;Introduction to Drug Information Queries--
Drug information queries are essential to healthcare practice, as they enable patients,
healthcare professionals, and researchers to obtain accurate and reliable information
regarding drugs and their use. These queries cover a wide range of topics, such as drug
interactions, dosages, side effects, contraindications, and pharmacokinetics. Efficiently
processing these queries ensures that drugs are used safely and effectively, minimizing risks
and maximizing therapeutic outcomes. This document will explore the types of drug
information queries, methods for processing them, and the roles of various professionals
involved in providing drug information

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 1. Types of Drug Information Queries

Drug information queries typically fall into several broad categories

1.1 Clinical Drug Information Queries
These queries are often related to the therapeutic use of a drug in specific medical conditions. They may involve questions about:
Indications: What is the drug used for?
Dosage: What is the recommended dosage, and how should it be adjusted for different populations (e.g., children, elderly)?
Efficacy: How effective is the drug in treating a specific condition?
Side Effects: What are the common and serious side effects?
Drug Interactions: How does the drug interact with other medications, foods, or substances?
Contraindications: In what circumstances should the drug not be used?

1.2 Pharmacological Information Queries

These focus on the pharmacokinetics and pharmacodynamics of a drug, including:
Absorption: How is the drug absorbed into the bloodstream?
Distribution: How does the drug spread through the body?
Metabolism: How is the drug processed in the body, particularly in the liver?
Excretion: How is the drug eliminated from the body (e.g., through urine or feces)?
Mechanism of Action: How does the drug work to produce its therapeutic effects?

.3 Regulatory and Legal Information Queries

Some queries pertain to the legal and regulatory aspects of a drug, such as:
FDA Approval: Is the drug FDA-approved, and what indications are approved?
Controlled Substances: Is the drug classified as a controlled substance, and what are the legal implications?
Patent Status: Does the drug have active patent protection, and when will generics be available?
Labeling and Packaging: What information is included in the drug’s labeling, and how does it comply with regulations?
Drug Delivery and Formulation Information Queries
These queries often concern the form and delivery method of the drug:
Dosage Forms: Is the drug available as a tablet, injectable, patch, or another form?
Routes of Administration: How is the drug administered (oral, intravenous, topical)?
Stability: How long can the drug be stored before it loses potency?
Bioavailability: What percentage of the drug reaches systemic circulation and is available for 12
therapeutic effect?
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 3.’’ Role of Healthcare Professionals in Drug Information Queries’’

Several healthcare professionals are involved in processing drug information queries, and each brings unique
expertise to the table.
Pharmacists
Pharmacists play a central role in answering drug information queries. Their knowledge of pharmacology, drug
interactions, and the therapeutic use of medications allows them to provide accurate and reliable information to
patients and healthcare providers. Clinical pharmacists often work in hospitals or clinics, where they contribute to
patient care by advising on drug regimens, monitoring adverse reactions, and ensuring the safe and effective use of
medications.
Physicians
Physicians often need drug information to make informed decisions about patient care. They may
consult drug information sources to determine the most appropriate treatment for specific conditions,
taking into account drug interactions, contraindications, and patient characteristics.

Researchers and Scientists

Researchers who are involved in drug development and clinical trials also contribute to the processing of
drug information queries. They often focus on the latest findings in drug efficacy, new formulations, or novel
therapeutic applications.

Nurses and Other Healthcare Providers

Nurses and allied health professionals may need drug information to educate patients about their medications or
help administer therapies. Their role is especially crucial in providing context about how drugs fit into an overall
treatment plan.

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 Module–4 ‘’ Clinical research and Pharmacovigilance’’
Topic--Pharmacovigilance

Introduction to Pharmacovigilance
Pharmacovigilance is the science and activities related to the detection, assessment,
understanding, and prevention of adverse effects or any other drug-related problems. It is an
essential part of public health systems, ensuring that medicines are safe and effective
throughout their lifecycle. As new drugs are released into the market and are used by diverse
populations, unexpected adverse effects may surface, underscoring the importance of
continuous monitoring post-marketing. Pharmacovigilance aims to collect, evaluate, and act
on information regarding drug safety to protect patients and ensure that the benefits of a drug
outweigh its risks.

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The primary goal of pharmacovigilance is to ensure
that the use of pharmaceutical products is as safe as
possible, and that potential risks are identified,
evaluated, and managed proactivel

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 2. Objectives of Pharmacovigilance
The primary goal of pharmacovigilance is to ensure that the use of pharmaceutical products is as safe as possible, and
that potential risks are identified, evaluated, and managed proactively. The specific objectives include:
Detection of Adverse Drug Reactions (ADRs): ADRs are unintended and harmful reactions to a drug that occur at
normal therapeutic doses. Pharmacovigilance aims to identify these reactions early, especially those that were not
detected during pre-marketing clinical trials due to limited sample sizes or specific conditions.
Risk Assessment and Management: Once an ADR is identified, pharmacovigilance activities include evaluating the
severity of the reaction, the drug’s overall risk-benefit profile, and implementing strategies to minimize these risks, such
as altering drug usage guidelines or implementing recalls.
Early Warning of Potential Safety Issues: Pharmacovigilance plays a key role in detecting new safety signals,
particularly in post-marketing surveillance, where drugs are used by larger, more diverse populations. This enables
health authorities to act before significant harm occurs.
Regulatory Decision Making: The safety data collected through pharmacovigilance activities help regulatory
bodies make informed decisions regarding a drug’s use, including labeling changes, withdrawal from the market,
or restriction of use in certain patient populations.
Public Health Protection: By ensuring that drugs are safe and their risks are properly managed,
pharmacovigilance activities contribute to the overall safety and well-being of the population.

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 factors affecting pharmacovigilance:

1.Underreporting of Adverse Drug Reactions (ADRs): Many ADRs go unreported due

to factors like healthcare professionals' lack of awareness, uncertainty about causality, and
insufficient time for reporting. This limits the ability to detect and manage potential safety
concerns.
2.Data Quality and Completeness: Incomplete or poor-quality ADR reports hinder accurate
analysis. Missing information such as dosage, patient demographics, and medical history makes it
challenging to assess the true risks and benefits of a drug.

3.Geographic and Demographic Variability: Reporting rates and drug safety can
vary across regions. Cultural factors, healthcare access, and population characteristics (e.g., age,
genetics) can influence how ADRs are detected and reported.

4.Regulatory Environment: The strength of national regulatory bodies and their pharmacovigilance
systems affects how effectively drug safety is monitored. Well-resourced authorities like the FDA or EMA
have more robust systems, while weaker systems in low-income countries may struggle to detect and
address ADRs.
5.Technological Challenges: Inadequate use of modern technology for data collection and
analysis (e.g., limited integration with electronic health records or lack of advanced data mining
techniques) can delay the identification of safety signals and reduce the efficiency of
pharmacovigilance efforts.

https://www.slideshare.net/slideshow/drug-information-services-dic-and-sources/266881289#3

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 Modules –5 ‘’Public health and basics research methodology’’
Topic-
‘’Communicable diseases and Role of pharmacist in preventing
communicable diseases’’
Communicable Diseases and the Role of Pharmacists in Preventing Them
Communicable diseases, also known as infectious diseases, are caused by pathogens such as bacteria, viruses, fungi,
and parasites. These diseases are transmitted from one person to another, directly or indirectly. In the context of
global health, communicable diseases represent a significant burden, contributing to morbidity, mortality, and
economic loss. However, pharmacists play a vital role in preventing and managing these diseases, making them key
members of healthcare teams in the fight against infectious outbreaks. This comprehensive exploration outlines the
types of communicable diseases, their prevention, and the crucial role pharmacists play in reducing their transmission
and impact.

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 ‘’Overview of Communicable Diseases’’

Communicable diseases have been the leading cause of illness and death worldwide,
particularly in low- and middle-income countries. These diseases spread through
various mechanisms, including air (respiratory transmission), water, blood, sexual
contact, vector organisms (such as mosquitoes), and contaminated surfaces. Some of
the most common communicable diseases include:
Respiratory Infections: Such as influenza, tuberculosis, and COVID-19, which spread
through respiratory droplets.
Gastrointestinal Infections: Caused by pathogens like Salmonella, E. coli, and
Norovirus, often transmitted through contaminated food or water.
•Vector-borne Diseases: Malaria, dengue fever, and Zika virus, spread by mosquitoes.
•Sexually Transmitted Infections (STIs): Including HIV/AIDS, chlamydia, and gonorrhea.

Vaccine-preventable Diseases: Such as measles, polio, and whooping cough, which

can be prevented through vaccination.
The global burden of communicable diseases is still substantial, with pandemics
like the COVID-19 pandemic highlighting the importance of early prevention,
effective treatment, and public health interventions.

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 3. ‘’Challenges Faced by Pharmacists in Disease Prevention’’

Despite their significant role, pharmacists face several challenges in contributing to the
prevention of communicable diseases:
Lack of Public Awareness: Many people are unaware of the importance of
vaccination, proper hygiene, or the role of pharmacists in preventing infectious
diseases.
Limited Authority: In some regions, pharmacists are restricted in their ability to
administer vaccines, conduct health screenings, or provide certain types of advice,
limiting their direct impact.
Resource Constraints: In many countries, pharmacists may not have the necessary
resources, infrastructure, or support to carry out extensive disease prevention
programs effectively.

Cultural Barriers: Misconceptions and cultural beliefs about vaccinations or health

practices can hinder the pharmacist’s efforts in promoting disease prevention.

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‘’The Pharmacist’s Role in Preventing Communicable Diseases’’
Pharmacists, due to their accessibility, knowledge of medicines, and patient care skills, play a critical role in
preventing the spread of communicable diseases
1.Promoting Vaccination--
Administer Vaccines: In many countries, pharmacists are authorized to administer vaccines, especially
flu shots and travel vaccines. This role has expanded in recent years to include vaccines for conditions
like COVID-19, pneumonia, and shingles.
2.Patient Education: Pharmacists educate patients on the importance of vaccinations in preventing diseases like measles, whooping
cough, and hepatitis. They can address concerns, clarify misconceptions, and encourage vaccination compliance

3.Advocacy and Outreach: Pharmacists play a critical role in advocating for vaccination programs in the community,
especially in rural or underserved areas where access to healthcare may be limited.
2.Promoting Hygiene and Infection Control
Practices- Hand Hygiene: Pharmacists encourage regular handwashing or use of hand sanitizers to reduce the transmission of germs.
This has been a key message during the COVID-19 pandemic and remains an essential preventative measure for a range of
infectious diseases.
3.Use of Personal Protective Equipment (PPE): Pharmacists educate individuals, especially those at higher risk (e.g.,
immunocompromised individuals), about the importance of using PPE like face masks, gloves, and eye protection to prevent exposure to
communicable diseases.
4.Cleanliness and Disinfection: They can advise on proper cleaning and disinfection techniques, especially in settings like
homes, schools, and hospitals, where pathogens can spread quickly
5.Education and Public Awareness-
Public Awareness Campaigns: Pharmacists may participate in or lead campaigns focused on prevention, vaccination, hygiene, and safe
practices to reduce the spread of infectious diseases.
6.Counseling and Advice: In addition to promoting hygiene practices, pharmacists provide counseling on how to
recognize the symptoms of communicable diseases, when to seek medical advice, and how to reduce the risk of
transmission to others.

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