Non Pharma Final File

Ethics
By Eslam Ashraf Fahmy

https://t.me/splenotes
Eslam Fahmy
00201011922837
Ethics
Ethics Law
• Unenforceable norms and values guide behavior • Values written into enforceable standards of behavior
• There are no specific laws • Laws are enforced by the justice system.
❖ Main ethical principles (Basic principles of ethics) → Moral rules
1- Autonomy • The right of individuals to self-rule and make decisions about:

1- what will happen to their bodies.
2- what choices will be made among competing options
3- what they choose to take, or not take, into their bodies
4- choice among health care providers
5- choice of refusing medical treatment.
• Exceptions to the theory of autonomy:
– weak paternalism: if one lacks the ability to make an autonomous decision, then it is
up to health care provider
– the harm principle: making the wrong decision or a decision that will cause harm to
themselves.
Privacy: another rule within the principle of autonomy which means the right of the
individual to control his or her affairs without interference.
2- Beneficence • To do good (Benefit the patient).
3- Non-maleficence • Prevention of harm and the removal of harmful conditions.
4- Justice • Treat all patients fairly (Fairness and equity to all)
• Example: Ask the patient to stand in que.
❖ Principles of professionalism:
1- Accountability • Activities, responsibilities and results
2- Altruism • Do the best for the best interest of the patient. (Not self-interest)
3- Duty • Commitment to the service
4- Honor • Highest standard of behavior and good conduct.
5- Integrity • Adherence to ethical principles and refusal to violate personal codes.
❖ Common characteristics of professionalism

1- Knowledge
2- Ethics
3- Social sanction = Public trust
❖ Competence, Trustworthiness, and Caring
• Pharmacists should be aware of the basic moral responsibilities that all health care practitioners have toward
their patients. There are three characteristics that a pharmacist should possess:
1- Pharmacists must be competent.
• They must possess the knowledge base that at least minimally allows them to carry out their Functions as
reliable therapeutic experts.
2- Pharmacists must be trustworthy.
• Patients must know that they can seek the confidential advice and assistance of their pharmacist and that their
wishes will be carried out.
3- Pharmacists must care for and about their patients.
• As the 1995 American Pharmaceutical (now Pharmacists) Association (APhA) Code of Ethics directs, -A
pharmacist places concern for the well- being of the patient at the center of professional practice."
• pharmacists who do spend time with their patients and attempt to understand their concerns are much more
likely to be viewed as caring.
❖ Ethical principles and moral rules:
Veracity • Pharmacists should be honest in their dealings with patients. (Telling the truth)
• violation of veracity may be ethically justifiable (as with the use of placebos)
• patients have a right to expect that pharmacist will be frank in dealings with them.
Fidelity ❖ it means that the pharmacists demonstrate loyalty to their patients, regardless of
the length of the professional relationship
❖ Trust and keep promises.
1- Covenantal fidelity:
• is often described as an intimate and spiritual commitment between individuals.
• Examples would include the fidelity of marriage and the fidelity between a member
of the clergy and his or her congregation.
2- Contractual fidelity
• It does not involve a level of commitment beyond that owed another as the result
of a binding agreement.
• An example of this form of fidelity would be the relationship one might have with a
contractor such as a plumber or electrician.
Informed Consent • What and how much information about a medication should be given to a patient
• patients must be fully informed about the benefits and risks of their
participation in a clinical trial, taking a medication, or electing to have surgery,
and this disclosure must be followed by their autonomous consent.
• Informed consent is obtained:
Formally Informally
For legal and ethical reasons Whenever a pharmacist counsels a
Ex: clinical trials, research, surgery patient and dispenses a medication to a
patient, a type of informal occurs. The
patient is informed about the benefits
and any risks of the drug, and then
decides whether to take it or not.
Confidentiality • Revealing information about a patient's medications to members of the family
• Medical confidentiality need not be requested by patients; all medical information,
is considered confidential, unless the patient grants approval for its release.
Refuse or give Ethical situations:
privileged information – Members of the health care team may have access to confidential medical records
without the consent of the patient.
– A patient who expresses a desire not to have information reveal to a member of the
health care team.
– Exceptions: Weak paternalism, Harm principle
Full disclosure • Inform the patients about Benefit and risk then decide what to do.
Patient centered care • Pre-vision information about the patient:
• Culture competition – Confidentiality – Full disclosure
Patient adherence • Help the patient to stick to the drug dose and time (Help not to force)
Respect for persons • Duty to the welfare of the individual, particularly described in religion.
Excellence • Efforts and commitment of life-long learning and ongoing professional development
Humanism • Respect and compassion for others
Distributive justice • Equal distribution of the benefits and burdens of among all members of society.
• Pharmacists do not always provide care with equal dedication to all patients.
• Patient's socioeconomic status often impact the level and intensity of care provided
by health care professionals.
• Medicaid patients are sometimes provided a much lower quality of care than a patient
who is a cash-paying customer or who has a full coverage drug benefits plan.
• Justice demands that the focus be on patients and their medical needs, not on the
financial impact on the health care professional.
❖ Macro ethical issues vs Micro ethical situations
Macro ethical issues Micro situations

issues that are not specific to a given pharmacist, but issues that may confront individual pharmacists in the
rather are those that must be addressed by all course of their daily practice.
pharmacists and by society in general.
• Abortion • The use of placebos
• Assisted suicide • Patient confidentiality
• Genetic engineering • Informed consent
• Rationing of and access to health care
• Organ transplantation
• In vitro fertilization.
Sometimes, macro issues are manifested in micro situations. This is especially true with socially controversial issues.
For example, a pharmacist may receive a prescription for a drug and know that it is intended for use in an assisted
suicide. Not only must the pharmacist deal with the legal issues involved, but also with the ethical responsibility as a
health care professional. A further complication in such situations is the influence of the pharmacist's personal beliefs
in choosing the course of action.
❖ Ethical conflicts and issues in health care
Law and Ethics

Example 1 Example 2
what should a pharmacist do when a patient's what if the medication is a controlled substance
prescription for heart medicine has been used for pain control in a terminally ill patient?
depleted, no refills remain, and the prescriber is
unavailable?
Most pharmacists would do the ethical thing and The potential for legal action from drug
provide such patients with a few doses to hold enforcement authorities might make a
them over until a new prescription can be pharmacist reluctant to dispense extra doses,
obtained, even though this course of action is even though the patient might be in just as much
illegal need.
Assisted Suicide • Medical euthanasia (mercy killing) has long been an ethical issue
• Legally it is not set yet whether to support or to prohibit.
• From an ethical perspective, the key issue remains whether assisted suicide violates the
Hippocratic responsibilities of health care practitioners to do no harm.
– Those who advocate its availability to patients suggest that allowing a patient to continue
to experience unrelenting pain is doing harm.
– They suggest that patients have the right to make an autonomous decision to end their
life; their opponents worry that legal assisted suicide would be abused.
Human Drug • Two important ethical aspects of human drug experimentation are
Experimentation 1- The role of the institutional review board ORB
• Review protocol for ethical purposes, clinical experiments or before animal studies
• Making sure that the rights and welfare of the patient-subject are protected
• evaluate and approve informed consent forms used in conjunction with the research
2- The use of placebos.
• placebos are agents devoid of pharmacologic activity and have served as a point of
comparison for determining therapeutic efficacy
• Patients do not receive any benefits (beneficence)
Eslam Fahmy
00201011922837
Eslam Fahmy
00201011922837
Questions
1) The Drug Enforcement Administration (DEA) regulations require pharmacies to keep controlled
substances records, including prescriptions for at least ……….
a) two years
b) three years
c) four years
d) five years.
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2)………… are issues that are not specific to a given pharmacist, but rather are those that must be
addressed by all pharmacists and by society in general.
a) Macro ethical issues
b) Micro ethical issues
c) Micro situations
d) Macro situation
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3) revealing information about a patient's medications to members of the family is example of:
a) patient confidentiality
b) informed consent
c) informed refusal
d) express consent
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4) Pharmacist must possess the knowledge base that's at least minimally allows them to carry out their
Functions as reliable therapeutic experts. This is called:
A) Competency.
b) Caring
c) Trustworthiness.
d) Knowledge.
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5) …………………………… is the right of individuals to make decisions about what will happen to their
bodies, what choices will be made among competing options, and what they choose to take, or not take,
into their bodies, choice among health care providers, and the choice of refusing medical treatment.
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) justice
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6) …………………….. indicates that you act in a manner to do good.
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) justice
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7) ……………………. is sometimes used more broadly to include the prevention of harm and the removal of
harmful conditions.
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) justice
8) ……………………….. means that the pharmacists demonstrate loyalty to their patients. Pharmacists have
an obligation of fidelity to all their patients, regardless of the length of the professional relationship.
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) Fidelity
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9) ……………………. is the ethical principle that instructs pharmacists to be honest in their dealings with
patients?
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) veracity
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10) ……………………refers to the equal distribution of the benefits and burdens of society among all
members of this society.
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) distributive justice
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11) euthanasia means:
a) Autonomy
b) Beneficence
c) Nonmaleficence
d) mercy killing
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12) if one lacks the ability to make an autonomous decision, then it is up to health care provider, this is
called:
a) weak paternalism
b) strong paternalism
c) the harm principle
d) autonomy.
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13) making the wrong decision or a decision that will cause harm to themselves is called:
a) weak paternalism
b) strong paternalism
c) the harm principle
d) autonomy.
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14)………………. are unenforceable norms and values guide behavior
a) ethics.
b) morals.
c) laws.
d) rules.
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15) ………………………. values are written into enforceable standards of behavior
a) ethics.
b) morals.
c) laws.
Eslam Fahmy
d) rules.
00201011922837
Pharmacogenomics

Eslam Fahmy
Pharmacogenomics 00201011922837
Precision medicine • An approach to disease treatment and prevention that takes in consideration
genes, environment and life style.
Pharmacogenomics • Component of precision medicine
(PGX) • Study relation // variation in multiple genes and variability of drug response
Pharmacogenetics • Study relation // variation in single gene…… and variability of drug response
Nucleotide • Basic structural unit of DNA & RNA
Gene • Stretch of nucleotides that codes for a single protein
DNA • Genetic material that is the main component of chromosome

• Double helix
Genotype • Set of unique genes that determine specific trait in a person (Creativity)
Phenotype • Observable trait of genotype (gene responsible for blue eye color)
Polymorphism • Genetic variation is common 1% or more

• Genetic variation is inherited
Mutation • Genetic variation is rare less than 1%
Single nucleotide • Change in a single nucleotide in a genetic sequence.
polymorphism (SNP)
Homozygous → 2 alleles are identical.
Heterozygous → 2 alleles are different.
Eslam Fahmy
00201011922837
Abacavir HLA-B (5701) • ↑ HLA-B (5701) → Hypersensitivity

Allopurinol HLA-B (5801) • Hypersensitivity
Carbamazepine HLA-B (1502) • ↑ HLA-B (1502) → severe dermatologic reactions
Oxcarbazepine "Steven-Johnson-Syndrome" → Not prescribed
• At risk population → At south Asia
Phenytoin HLA-B (1502) • Hypersensitivity
Fosphenytoin
Clopidogrel CYP2C19*2 • Prodrug that needs CYP2C19*1 for activation.
CYP2C19*3 • If CYP2C19*2,3 are present → clopidogrel will not be
converted into the active form → ↑ CVS events
Voriconazole CYP2C19 • Patients with intermediate or PM have two-folds to four-
folds higher voriconazole exposure.
• No dose adjustments or genetic recommendations.
Warfarin CYP2C9*2 • ↑ CYP2C9 *2,3 → ↓ warfarin metabolism → ↑ bleeding
CYP2C9*3 • ↑ VKORC1 → ↑ warfarin sensitivity → ↑ bleeding
VKORC1 • Lower doses should be started
Celecoxib CYP2C9 • ↑ CYP2C9*3 → ↓ Celecoxib clearance
• Use with caution and at lower doses
Codeine CYP2D6 • ↑ CYP2D6 → ↑ metabolism of codeine to morphine
• ↓ CYP2D6 → ↓ metabolism of codeine to morphine
• Morphine high dose cause side effects such as:
respiratory center depression.
Risperidone CYP2D6 • ↑ CYP2D6 → Fast metabolizers → High exposure
Atomoxetine • ↓ CYP2D6 → Poor metabolizers
Fluoxetine
Tamoxifen CYP2D6
Trastuzumab HER2 • HER2 (Positive) → Take the drug
Pertuzumab • HER2 (Negative) → Do not take the drug. ❌
Lapatinib
Emtansine
Azathioprine TPMT • ↓ TPMT → ↑ Risk of Myelosuppression
6-Mercaptopurine • Drug should be not given or given at low dose.
Capecitabine DPD • ↓ DPD → Severe toxicity
5-flurouracil • Diarrhea, Neutropenia and Neurotoxicity
Primaquine G6PD • ↓ G6PD → Hemolytic anemia
Rasburicase • At risk population → African and Mediterranean
Cetuximab KRAS mutation • KRAS (Positive) → No response → Not use
Panitumumab • KRAS (Negative) → Response → use
• KRAS is G-protein in the EGFR pathway
• Cetuximab and Panitumumab inhibit EGFR
Imatinib CD117 • Imatinib is indicated for patients with CD117 mutation
Maraviroc CCR5 • Maraviroc is a CCR5 receptor antagonist
Irinotecan UGT1A1*28 • ↑ UGT1A1*28 → Neutropenia
• Homozygous with higher risk
Lenalidomide Chromosome 5q • Chromosome 5q deletion → Myelodysplastic syndrome →
deletion Hematologic toxicity.
Eslam Fahmy
Avoid if positive (+) → HLA-B & KRAS https://t.me/splenotes
Avoid if negative (-) → HER2 00201011922837
• HER2 → use if positive avoid if negative • HLA-B → Avoid the drug if positive
• TPMT → ↓ TPMT → ↑ risk of myelosuppression • KRAS → Avoid the drug if positive
• DPD → ↓ DPD → Severe toxicity (DNN)
• G6PD → ↓ G6PD → Hemolytic anemia
Pharmacogenomics questions
1- Which of the following is correct?

a. Phenotype is the observable trait that results from gene expression
b. Humans have one copy of each chromosome
c. If the alleles are identical, it is called heterozygous genotype
d. If the alleles are different, it is called homozygous genotype
2- Pharmacogenomic testing shows a female patient with breast cancer is HER2 positive. She is
likely to benefit from which of the following?
a. Ivacaftor
b. Leuprorelin
c. Trastuzumab
d. Rituximab
3- A child is rapid metabolizer of CYP2D6. How would his body respond?

a. Codeine would be rapidly metabolized to morphine
b. The child will have reduced opioid response
c. Codeine will not be converted into morphine
d. The child will have severe diarrhea
4- A Chinese patient is going to be started on carbamazepine. He should be tested for:

a. HLA-B*1501 allele
b. HLA-B*1502 allele
c. He does not need pharmacogenomic testing as he is from Asian descent
d. A gene because if he is found to have at-risk allele, he is more likely to experience agranulocytosis with the
use of carbamazepine.
5- A patient is found to have been lacking in functional CYP2C19 enzyme activity. What would be
your recommendation?
a. He should not receive Clopidogrel
b. He should not receive any CYPC19 enzyme inhibitors such as omeprazole or fluoxetine
c. If clopidogrel is administered, he will have increases INR
d. He is an ideal candidate to receive Clopidogrel
6- Which of the following best describes chromosome?

a. Building blocks of DNA, composed of four bases: adenine (A), Guanine (G), Thiamine (T) and Cytosine (C)
b. Organized into 23 pairs (46 chromosomes) as a supercoil structure
c. A stretch of DNA that codes for a single protein
d. Double helix molecule containing noncovalently bonded nucleotides
Eslam Fahmy
00201011922837
Types of Healthcare Cost Categories:
Direct
Direct medical
Fixed Capital • For setting up the service.
• Counselling rooms equipment.
Labor • Salary of pharmacists
Overhead • For running the service
• Lighting , heating , cleaning , rent
Semi fixed • Staff
Variable • Drugs, blood products, disposable equipment
Hospitalization
Ambulance services – Nursing services
Home medical visits / Clinic visits
Emergency department visits
Diagnostic tests
Direct non-medical • Patient and family expenses (e.g. transportation, caring)
• Travel costs (bus, gas, taxi)
• Hotel stays for patient or family
• Child care service for children of patients
• Food (Meals-on)
Indirect • Costs of ↓ productivity (e.g., morbidity and mortality costs).

o Lost wages (morbidity)
o Income forgone because of premature death (mortality)
Intangible • Anxiety
• Pain and suffering
• Fatigue
• Inconvenience
• Grief
Opportunity • Economic benefit forgone when using one therapy instead of the next best alternative therapy.
• Lost opportunity - Revenue forgone
Incremental • Additional cost that a service or treatment alternative imposes over another compared with the additional effect, benefit, or outcome it provides.
Eslam Fahmy
00201011922837
Models of Pharmacoeconomic Analysis
Cost Minimization Analysis Cost Benefit Analysis Cost Effectiveness Analysis Cost Utility Analysis
(CMA) (CBA) (CEA) (CUA)
Example • Comparing drug A to drug B • The benefit to cost ratio of: • Drug A (5$) and drug B (10$) • Measure the effect of an
• Drug A saves you 5$ ✓ Hiring a pharmacist = 1.25 • Both have the same action intervention on health units
• Hibiotic & Augmentin  Automated system = 1.15 • Drug B cause no gastric that measure both quantity
Pharmacist is better than the irritation as drug A. and quality of life.
automated system. • Aspirin and Aspirin enteric • Cancer patient without
coated treatment lives for short time
in great pain but with
treatment lives for longer time
in less pain
Type of Equivalent Economic Clinical Humanistic
outcome
Outcome Assumed to be equivalent in Monetary outcome ❖ Natural units Quality Adjusted Life Year
measurement comparable groups analysis. Dollars $ • mmHg blood pressure (QALY)
unit • mmol/L blood glucose = utility X expected length of time
• Case cure yes or no
Cost
measurement Dollars $ Dollars $ Dollars $ Dollars $
unit
Notes • The two drugs must be ❖ Measured by: ❖ Both must have the same ❖ Outcomes assess patient's
equivalent therapeutically • Human Capital (HC) unites to be compared. functional status or quality of life
then we determine the least • Willingness To Pay (WTP) ❖ Calculated by: ❖ Calculated by:
costly alternative. • Average Cost Effectiveness • Rating Scales (RS)
Ratio (ACER) • Standard Gamble (SG)
• Incremental Cost Effectiveness • Time Trade-Off (TTO)
Ratio (ICER)
• Symptoms Free Days (SFD)
• % healed
Eslam Fahmy
00201011922837
❖ Pharmacoeconomic definition:
• Description and analysis of the cost of drug therapy to healthcare systems and society.
Eslam Fahmy
00201011922837
Economic outcome assessment
Cost • The value of the resources consumed by a program or drug therapy of interest.
Total • All expenses directly and indirectly.
Average • The average cost per unit of output.
Marginal • Extra cost of producing one extra unit of output.
Incremental • Additional cost.
Operating • Supports the operation to provide the output.
❖ Types of Healthcare Cost Categories: direct, indirect, intangible, incremental, opportunity
Consequence • The effects, outputs, and outcomes of the program or treatment alternative.
• Types of outcomes (ECHO model)
Economic • The direct, indirect, and intangible costs compared with the consequences of medical treatment alternatives.
Clinical • The medical events that occur as a result of disease or treatment (e.g., safety and efficacy end points)?
Humanistic • The consequences of disease or treatment on patient functional status or quality of life along several
dimensions (e.g., physical function, social function, general health and well-being, and life satisfaction)
Positive • Is a desired effect of a drug (efficacy or effectiveness measure), possibly manifested as cases cured, life-years
gained, or improved health-related quality of life (HRQOL).
Negative • Is an undesired or adverse effect of a drug, possibly manifested as a treatment failure, an adverse drug reaction
(ADR), a drug toxicity, or even death.
Intermediate • Can serve as a proxy for more relevant final outcomes.
• Example: achieving a decrease in low density lipoprotein cholesterol levels with a lipid-lowering agent is an
intermediate consequence that can serve as a proxy for a more final outcome such as a decrease in MI rate
Perspective • the point of view from which a pharmacoeconomically study is conducted.

• It is important to understand the study perspective because it determines which outcomes and costs will be measured.
Ex: If comparing the value of Alteplase (tissue plasminogen activator, or t-PA) with that of Streptokinase.
From a patient or societal perspective From a small community hospital's perspective
t-PA may be the best-value alternative because a 1% reduction in streptokinase may represent a better value because it provides
mortality rates is observed in this large population. similar outcomes for less money.
❖ Common perspectives include those of the:
1- Patient.
2- Provider.
3- Payer.
4- Society.
Economics
1 Cost types
2 In cost utility analysis which one is the outcomes?

Adjusted quality of life
3 What is the benefit of pharmacoepidemiology

Utilization of drug
4 The economic study for life adjusted year quality?

CUA
Know the difference between direct medical, non-medical, indirect and intangible costs
cost of medicine and cost of loss productive

Direct and indirect
Primary Resources
Defination Primary resources contain first-hand information, meaning that you are reading the author’s own account
on a specific topic or event that s/he participated in.
Review articles or editorials are not primary literature.
Examples journal articles of original research, conference papers, dissertations, technical reports, patents.
several types of publications considered primary, including controlled trials, cohort studies, case series,
and case reports.
Adv ● Access to detailed information about a topic
● The ability to personally assess the utility and validity of study results.
● Tends to be more recent than tertiary or secondary literature.
Dis Adv ● Misleading conclusions based on only one trial without the context of other researches,
● The need to have good skills in medical literature evaluation,
● The time needed to evaluate the large volume of literature available.
Secondary resources
Defination Secondary resources include indexing and abstracting systems that organize and provide easy retrieval of
primary resources.
Examples ● MEDLINE (through PubMed, EBSCO, Ovid),
● Academic Search Premier,
● Cochrane Database of Systematic Reviews,
● Iowa Drug Information Service (IDIS),
● International Pharmaceutical Abstracts (IPA),
● Embase/Excerpta Medica,
● Biosis Previews/Biological Abstracts,
● CancerLit, SedBase, Reactions,
● Clin-Alert, Current Contents, and Toxline. Proper training
Tertiary Resources
Defination Tertiary sources consist of primary and secondary source information which has been collected
and distilled. They present summaries of or an introduction to the current state of research on a
topic, summarize or condense information from primary and secondary sources
Examples ● electronic databases (e.g., Micromedex, Lexicomp)
● review articles.
● Facts and Comparisons
Dis Adv 1- The lag time associated with publication, resulting in less current information
2- The information in a tertiary text may be incomplete due either to :
a- Space limitations of the book or
b- Incomplete literature searches by the author
3- errors in transcription, human bias, incorrect interpretation of information, or a lack of expertise by
authors.
CONSUMER HEALTH INFORMATION
National Library of Medicine: http://www.medlineplus.gov FDA: http://www.fda.gov/cder
Thomson Health Care: http://www.gettingwell.com Merck: http://www.merckhomeedition.com
National Women’s Health Information Center: http://www.4women.gov
Eslam Fahmy
00201011922837
Drug information resources
Definition Examples Advantages Disadvantages
1 ry • First hand information, • Study designs 1- Access to detailed 1- Misleading conclusion based on the results of only
meaning that you are • Journal article of original research information about a topic. one trial without the context of other researches.
reading author's own • Conference papers 2- Ability to personally 2- Need good skills in medical literature
account on specific topic. • Dissertations assess the validity and 3- Time needed to evaluate large volume of data
• Technical reports utility of study results. available.
3- More recent than 2ry or
• Patents
3ry resources
2ry • Indexing and abstracting • Medline (PubMed, EBSCO, Ovid)
systems that organize • Iowa drug information service (IDIS) ❌❌❌ ❌❌❌
• provide easy retrieval of 1 ry
• International pharmaceutical
resources. abstracts (IPA)
• LexisNexis Review articles
• Google scholar
ry • 1ry and 2ry resources • Textbooks/Books 1- Lag time between publication and tertiary resource
3
information which has been • ATLAS ❌❌❌ 2- Information in 3ry resource may be incomplete
collected and distilled. • Treatment guidelines 3- Errors in transcription and interpretations
• They present summaries. • Dictionary 4- Human bias
• Encyclopedia 5- Lack of experience
• Electronic data bases
a- Micromedex
b- Lexicomp
• Facts and comparisons
• Review articles in journals
Review articles and editorials are not 1ry resources.
❖ Consumer health information:
National library of medicine www.medlinelus.gov

FDA www.fda.gov
Thomson health care www.gettingwell.com
Merck www.merckhomeedition.com
National women's health information center www.4women.gov
Eslam Fahmy
00201011922837
Text books Databases/Applications

Adverse drug • Meyler's side effects of drugs • Dailymed
reactions • Side effects of drugs annual 40 • EMC
• EMA
• Drugs@FDA
• Medscape
• Drug.com
• Rxlist
Pharmaceutical • Trissel's stability of compounded formulations ❌❌❌
compounding • Remington the science and practice of pharmacy
• Pediatric drug formulations
IV medications • Handbook of injectable drugs • ASHP's interactive handbook on
compatibility and • King guide to parenteral admixtures injectable drugs
stability • Pediatric injectable drugs
Renal dose • Drug prescribing in renal failure ❌❌❌
adjustment • The renal drug handbook
• Renal pharmacotherapy
Medication safety • Drugs in pregnancy and lactation • Lexicomp
in pregnancy and • Drugs during pregnancy and lactation • Micromedex
lactation • Hale's medications and mothers' milk • Medicines Complete
• Brigg's drugs in pregnancy and lactation • Clinical Key
Drug interactions • Stockley's drug interactions • Lexi interact
Drug laboratory • Basic skills in interpreting laboratory data
interference • Laboratory tests and diagnostic procedures
Pediatric dosage • Pediatric injectable drugs
recommendations • Neonatal formulary
Pharmacokinetics • Winter's basic clinical pharmacokinetics
• Applied biopharmaceutics and pharmacokinetics
Pharmacology • Basic and clinical pharmacology
• Good and Gilman's the pharmacological basis of
therapeutics
Pharmacotherapy • Pharmacotherapy a pathophysiologic approach • Uptodate
• Pharmacotherapy principles and practice • Dynamed plus
• Micromedex
• Access Pharmacy
• Access medicine
• Clinical Key
• BMJ best practice
Toxicology • Goldfrank's toxicologic emergencies • NIH
• Casarett and Doull's toxicology • LiverTox
• Poisoning and drug overdose • Toxnet
Herbal, natural ❌❌❌ • NIH - Dietary supplements label
products and database
alternative • Medline plus – Herbs and supplements
medicine • Altmedex
International • Martindale the complete drug reference
drugs
Identification of ❌❌❌ • Identidex
unknown pills • Lexi-drug ID
Clinical trials ❌❌❌ • Pubmed
• ClinicalTrials.gov
Eslam Fahmy
00201011922837
Color drug refrences
Orange book FDA • Provides a list of approved drug products and indicates which drugs can be
interchanged (e.g. Zocor can be substituted with simvastatin)
Pink book CDC • Provides information on epidemiology and vaccine-preventable diseases
Purple book FDA • Provides list of biological drug products and indicates which biological
products are biosimilar
Red book Pharmacy • Provides drug pricing information

(Micromedex)
Red book Medicine • Summaries of infectious diseases

(AAP) • Summaries of antimicrobial treatments
• Summaries of vaccination
Yellow book CDC • Provides health information for healthcare professionals who advise
international travelers of health risks, vaccines and prophylaxis medications.
Green book FDA • Provides information about approved animal drug products
Eslam Fahmy
00201011922837
Questions
1- Which of the following statements is TRUE about tertiary resources?
a) Tertiary resources should not include a bibliography.
b) Textbooks usually include the most recent literature and/or information.
c) Tertiary resources include computer databases and textbooks
d) The credentials and expertise of the authors of a tertiary resource are not important
===========================================
2- Which of the following resources would be appropriate for identifying a drug manufactured in a foreign
country?
a) Martindale: The Complete Drug Reference
b) Clinical Pharmacology
c) Trissel's stability of compounded formulations
d) AHFS
===========================================
3- Which of the following resources could be appropriate for identifying the tablets with the imprint code of
APO-K 600?
a) Identidex
b) Lexi-Drugs ID (Lexicomp Online)
c) Brigg's drugs in pregnancy and lactation
d) A and B
===========================================
4- Which of the following resources could be appropriate for determining the adverse effects of ginkgo
biloba?
a) Altmedex
b) Natural medicines database
c) Trissel's stability of compounded formulations
d) A and B
===========================================
5- Which of the following resources would be appropriate in evaluating the drug interaction between
Clopidogrel and escitalopram?
a) Lexi-Interact
b) Trissel's stability of compounded formulations
c) Stockley's drug interactions
d) A and C
============================================
6- Which of the following resources would be appropriate for determining whether Amlodipine causes
edema?
a) Brigg's drugs in pregnancy and lactation
b) Trissel's stability of compounded formulations
c) Meyler's side effects of drugs
d) Stockley's drug interactions
=============================================
7- What resource should be used when searching for the most current clinical trials on the use of novel
anticoagulants for pulmonary embolism?
a) Pharmacotherapy, the pathophysiologic approach
b) PubMed
c) Uptodate
d) Micromedex
1- Drug information or Adverse drug reactions or International Drugs
- Le xi-Drugs multinational,
- AHFS
- Micromedex Drug Points
- Drug Points (summarized)
- DRUGDEX (detailed)
- Wolters Kluwer Clinical Drug Information,
- Gold Standard Drug information
- BNF
- Martindale
- Dailymed – EMC - Drugs@FDA – EMA – Medscape - Drugs.com – Rxlist
 Special for Adverse drug reactions

- Myler
2- Pharmaceutical Compounding
- Comoundingtoday.com
3- IV medications Compatibility and stability

- Trissel and Teddy Bear
- ASHPs
4- medication safety in pregnancy and lactation

- Briggs Drug
5- Drug interactions
- stockeys
- Lexi-Interact
6- Pharmacotherapy
- DISEASEDEX
- Clinical Overviews
- Ferri’s Clinical Advisor
- Harrison Internal Medicine ,
7- Toxicology
- Goldfrank's Toxicology - Poisoning and Drug overdose Lexi-Tox
- Myler
8- Natural Products
- Natural Products Databas
- Altmedex
- Naturalmedicines
9- Unknown Pills
- Identidex
- Lexi-Drug ID
Drug information
1 Phase 1 of drug development

pharmacokinetics study in human
2 Review article is
secondary resource
3 Color drug references
4 USP 797
Sterile
5 Which the following have error in prescription

Abbreviation
6 What is the lowest level of evidence in the evidence pyramid

Idea and opinion
7 You are having a study that you want to represent the number data on it what
Is the best way
Quantitive
8 Type of error when you discovered mistake drug before reaching to patient
category B
9 Name of system that help doctors in make decisions for choice the drug
health theoretical model
10 pharmacokinetic in which phase

0
11 Small sample which phase
1
12 Large sample which phase
3
13 Pharmacovigilance which phase
4
14 Side phase
2
15 When the pharmacopeia put the drug as phase 4 ?
Safety
16 how many phases applied to drug to be approved by FDA ?

4 phases
17 if a medication error happened, the first person to refer to ?

Prescriber
18 Benefits of using the unit - dose system ?

To decrease medication errors ( dose errors
19 Type of pharmacist salary?

Direct medical
20 Committee consists of five members

IRB institutional review board
21 Example direct medical cost and an indirect cost
22 USP General chapter
23 Directly decrease medication errors ?

Mandatory reporting
24 Medication characterized by low cost fast moving ?

Bulk medication
25 If the doctor ask the patients about side effects , these considered which type of pharmacovigilance
?
Active pharmacovigilance
26 Mission and vision , which type of planning?

strategic planning
27 example of ethical principles

Justice
28 tertiary resources example ?

Review article
29 patient said : “ i have pain ..... “ this considerd part of :

Subjective
30 tertiary recourse that arranged drugs alphabetically, their compatibility , stability and
administration ?
Handbook for injectable drugs
4th YEAR
2017-2018
BY:. Hasan Daghriri & Abdullelah Arishi

Study Designs
 Definition:
 Study design is an organized process used to evaluate a hypothesis to test wither
its accepted to rejected or not.
Overview of the design tree
 The Study design can be divided into two main types :

 Descriptive study and Analytical study , with their subtypes.
By: Hasan Daghriri & Abdullelah Arishi

 Descriptive study:
 We are trying to describe the outcome of something among a specific sample or
group of people (only describing what is happening) – like describing its number
or other things by time ,place and person.
 Establish the prevalence.
 No control group.
* (PO) = (P : the population or the group sample) , (O : the outcome)
 Example : The prevalence of insomnia among medical student
P= Medical student , O = insomnia
*So we are trying just to Describe how is common (prevalent) is insomnia among medical
student
* We are just Observing the outcome !
 Analytical study (PECO) :
 We are trying to Analyze or study the relationship between an Exposure and an
Outcome.
So, there must be an exposure or intervention and an outcome that we are looking to
see if the study sample is exposing to it.
* (PECO) = (P : population or group sample), ( E: Exposure or intervention), (C:
comparison group), (O: outcome)
Example : The prevalence of insomnia among medical student and its effect on
academic performance Or The effect of insomnia on academic performance among
medical student
P = medical student, E= insomnia, C= group with no insomnia, O= academic performance
So here we are trying to analyze the relationship between insomnia and academic
performance , is there an effect or no ? is it a harmful effect or protective effect ?
** Note : The exposure can be a drug , risk factor, education or other things that we
can study its effect on something (outcome).
 Types of Descriptive study (PO) :

 Case study
 Case series
 Cross-sectional study
 Incidence and prevalence
 Types Of Analytical study (PECO) :
It can be divided into two types :-

1. Observational analytical study : here we observe the relation between
exposure and outcome , just observation without changing the amount of
exposure or its dose.
It include : Cross-sectional study , Case-Control, Cohort study
2. Experimental analytical study : here we manipulate exposure, that mean
we can change the exposure dose or amount to all the study groups not
just observing.
It include : Randomized control trials
Example for analytical study : (The effect of caffeine consumption on blood sugar)
** If we want to conduct an observational analytical study : we will choose a groups of

people who consume Caffeine(E) regard its amount and another group who do not take
caffeine and we will see the blood sugar level(O) in both group does caffeine increase or
decrease blood sugar ??
** if we want to conduct an experimental analytical study : we will choose 2 groups of

people , the study group will be given caffeine of 50mg daily (same amount of exposure
in all individual), and the control group (with no exposure) will be given another drink
which has no caffeine , and we will see the blood sugar in both group.
**Note : cross-sectional study can be descriptive or analytical , it depend on your

research :
- The prevalence of insomnia among medical student using cross-sectional method
(here we detect the number of student having insomnia only)-(PO)
- The prevalence of insomnia among medical student and its effect on academic
performance (here we detect the number of insomniac student and we have a relation
that we would like to study which is the insomnia(E) and academic performance(O)-
(PECO)

 This Graph represent the hierarchy of study design , which one is stronger and more
evident .
 The RCT (randomized control trial) is the gold stander study and the most evident one .

Case-Control Study
 Type of study :
 Observational analytical study (PECO).
 In this study we are trying to see a relation between an exposure and an
outcome in which the outcome is already present and we try to see the past
history of the individual, did he expose to our exposure or no ?
 Based on the outcome ( Study begin from the outcome ).
 Exposure is a RISK, not a cause ( If the exposure associated with outcome, we
can say that the exposure X is risk for the disease Y " NOT a cause of disease Y " )
 It is retrospective study , which mean it goes back in time of the already present
outcome .
 There are two groups , one with outcome and the other without outcome
(control).
 No randomization. No intervention.
 How is it conducted ?
1st : Select 2 group of people : A case group and A control group
 The case group is the study group which has the outcome
 The control group is the group without the outcome
 Note : control group must be equivalent in most aspect of case group
(like age and other factor) but they don’t have the disease of course !
 Note : the case group must have the best confirmative test to say that
they have the outcome
nd
2 : Collect data :
 The data can be collected by using a standardized question used in both
groups , you have to ask both groups whether they exposed to the
desired exposure in the past or no , You should ask the same questions in
both with no bias to one group , you can use also other method then
equations like detecting the exposure level in blood (biomarker) .
rd
3 : Measure the association between exposure and outcome and interpret the
result.
 The used measure in Case-Control study is Odds ratio
( )
 Interpretation of the Odds Ratio :

 OR = 1  Exposure NOT related to disease(outcome)
 OR >1  Exposure POSITIVELY related to disease(outcome)
 OR <1  Exposure NEGATIVELY related to disease(outcome)
* Note : as odds ratio increase , as the strength of relation between E+O is
more .

 Example:
 The effect of caffeine(E) on insomnia(O) :
o Case Group(a+b): Group with insomnia
o Control Group(c+d) : Group with normal sleep pattern
 We will ask both groups , did you consume caffeine before ? how much and for
how long?
 Collect data from both group , and calculate odds ratio
 If result were as follow :
Diseased(Case) Non-diseased (Control)

Exposure 1200 (a) 100 (c)
Non-exposure 300 (b) 1400 (d)
Total 1500 (a+b) 1500 (c+d)
- ( ) (of both Groups)
- Case group: , Control Group:
- Then we divide the case group ratio by control group ratio to calculate odds ratio :
- , so there is a true relation between caffeine consumption and

insomnia , caffeine is a risk factor for insomnia
 Interpret : People who consume caffeine are 57 times more likely to develop
insomnia than non-caffeine consumer.
Advantage Disadvantage
Easy and quick Cannot generate incident data
Cheap and has good rank Bias (specially recall) is common
Good for rare disease Control selection can be difficult

Cohort Study
 Type of the study:
 Observational analytical study
 Aim to see the relation between the exposure and outcome among two groups
without previous outcome.
 There are two groups completely healthy or without outcome, one is exposed
and the other not exposed ( control ) , then follow the two groups in the future
to see the outcome.
 Based on exposure ( Study begin from the exposure ).
 No randomization. No intervention
 Time of the study depends on the feature of the outcome ( How long does the
outcome take to appear ? ).
 Exposure is a RISK, not a cause ( If the exposure associated with outcome, we
can say that the exposure X is risk for the disease Y " NOT a cause of disease Y " ).
 Two designs:
1. Prospective cohort design.
2. Retrospective cohort design.
1) Prospective cohort design:

o Exposure & non-exposure occur during the beginning of the study, then
followed up into the future to see the outcome.
o Requiring the collection of new data
o Can measure the incidence.
o Less liable for confounding or bias.
1st : Select 2 group of people completely free of outcomes :
 (A) Exposed group.
 (B) Control group without exposure.
nd
2 :Follow the two groups in the future then collect data about the outcome.
3rd : Measure the association between exposure and outcome and interpret the result:
 The used measure in Cohort study is Relative Risk (RR).

2) Retrospective cohort design:
o Exposure(including zero exposure or no exposure) established from past
records, and outcome determined at the beginning of the study.
o Looking back in time, thus using existing data such as medical records or claims
database
o Used to minimize the time spend in the study and decrease the cost of the study.
o More liable for confounding or bias.
1st : Select 2 large groups of exposed and not exposed from a point in the past.
2nd : See the records and determine the incidence of outcome among both.
3th: Measure the association between exposure and outcome and interpret the
result:
 The used measure in Cohort study is Relative Risk (RR).
3) Retro-Prospective cohort study:

o Combine between the two designs.

( )
 Interpretation of the Relative Risk :

 RR = 1  Exposure NOT related to disease(outcome)
 RR >1  Exposure POSITIVELY related to disease(outcome)
 RR <1  Exposure NEGATIVELY related to disease(outcome)
* Note : as relative risk increase , as the strength of relation between E+O is
more .
 Example:
 The effect of caffeine(E) on insomnia(O):
o Exposed group(b+d): Group drinking caffeine .
o Non-exposed (Control) group(a+c) : Group not drinking caffeine.
 Then follow them in the future to see insomnia development in both groups
 If result were as follow :
Non-exposed (Control) Exposed

Healthy 1200 (a) 100 (b)
Diseased 300 (c) 1400 (d)
Total 1500 (a+c) 1500 (b+d)
-
( )
- RR=
( )
( )
- RR= , so there is a positive relation between caffeine
( )
consumption and insomnia , caffeine is a risk factor for insomnia.
 Interpret : The people who consume caffeine are 4.66 times more likely to
develop insomnia than non-caffeine consumer.
Easy to understand Cannot determine the causal conclusion
Can estimate both incidence rate & Costly
incidence rate ratio
Suitable for addressing risk factors Require long time

Experimental Study
 Type of the study:
 Analytic study
 Aim to establish the causal relationship between exposure and outcome.
 It is a prospective study.
 Exposure is a CAUSE, ( If the exposure X associated with outcome Y, we can say
that the exposure X is a cause for the outcome Y ).
 Two types:
1. Randomized Controlled Trials
2. Quasi-experimental
1)Randomized Controlled Trials (RCTs):

o Characters:
 Manipulation (Trial) : Researcher does something ( Intervention ).
 Control group : Researcher introduces one or more control groups to compare
with
 Randomization ( everyone has an equal chance to be selected ) : The researcher
takes care to randomly assign subjects to the control and experimental groups
o Use Blinding process to avoid bias:
The process by which the researcher tries to make sure that as few as much people
know about which one belongs to which group , treatment or placebo, including: The
patients, the nurses and the doctors.
1st : From a pool of study, subjects/participants randomly select into two groups:
 (A) Group exposed to intervention.
 (B) Control group without intervention, or with placebo, or standard
treatment.
nd
2 : Give the first group the intervention (as drug) , and leave the control group
without intervention or with placebo, or standard treatment.
3rd : Follow them in the future to see the outcome.

 Phases of RCT:
 Phase I:
 Healthy volunteers, answers the question whether the intervention is
compatible with life.
 Phase II:
 Uncomplicated cases ,
 Does the intervention have an effect on the outcome?
 Phase III:
 The Proper RCT
 Phase IV:
 Post-marketing. In case of drug intervention, you can ask in hospitals or
clinics.
 Example:
o Exposed group(b+d): Group drinking caffeine (Intervention) .
o Control group(a+c) : Group not drinking caffeine (Non intervention).
o (Both group are selected randomly).
 Then follow them in the future to see insomnia development in both groups
 Pre-test/Post-test Control Group:
2) Quasi-Experimental Study:
o One characteristic of a true experiment is missing, either randomization
or the use of separate control group.
o Always includes the manipulation of an independent variable which

serves as the intervention.

 Example:
o (No control group)
Then follow them in the future to see insomnia development.
Or
o Control group(a+c) : Group not drinking caffeine (Non intervention).
o (Both group are not selected randomly).
o Then follow them in the future to see insomnia development in both groups
 One-shot Case Study :
 One-group Pre-test/Post-test :
Perfect design Unethical if exposure
is harmful
Unbiased if blinded Unethical if sure that treatment works
Can study all aspects of the relation risk- Expensive
exposure
Shows causality Difficult if outcome is rare

Study design
1 What Is Strongest Evidence Based Study?

Meta-analysis
2 Which book is about Compounding

USP
3 Strongest evidence study

Evidence from a systematic review or meta-analysis
4 Case series?
Case series depend on more than one patient with a similar experience or many case
reports combined into a descriptive review
5 Case report?
Case report depent on one patient
6 Rare disease , new disease which study is best?

Case series and case reports
7 Case study focus on specific time which one?

Cross sectional
8 Which one of case studies include intervention?

RCT
9 Person want to study the effectiveness of vancomycin in reducing C.diff which types of
studies he will be using?
Case report if single patient
Case series if a few patient
10 what is the type of study design were the author collects the results of high quality articles
and analyzed it to have one summary statistic?
meta-analysis
11 disadvantage of RCTs
Expensive
12 Study design is using for prevalence?

cross sectional
13 study in which we use different studies to make a conclusion ?

meta analysis
14 Studies in which data collected from different studies

systematic review
15 What is the type of Study design for smoker and non smoker at the same period of time ?
Cross sectional
16 What is the study design that used for rare disease?

Case control
17 What is the Study design that describe something happen in the past ?
Retrospective.
18 What is the study subject is control group arm active ?

Cross over
19 study the control is the same of active arm

cross over
SAIF ALGHAMDI
‫توكلت على اهلل‬
study design ‫ا‬

1- If a study is to follow a group of smokers and a group of nonsmokers time, and see which ones eventually
develop lymphoma and which.
What do you call this study design
A. Retrospective cohort study
B. Prospective cohort study
C. Cross-sectional study
D. Case-series
2- Which one of the following designs could be deemed a study

A. Cohort
‫تعتبر دراسة‬
B. Clinical trials
C. Case-control
D. Cross-sectional
3- Which of the following is an interventional study

A. Cohort
B. Ecological
C. Case-Control
D. Randomized Clinical Trial
4- Researchers compare a group of people who have diabetes with of people who have no diabetes, and looks
back in time to see characteristics of the two groups differ.Which of the following is the described study design
A. Prospective cohort
B. Case-Control
C. Experimental
D. Randomized clinical
5- Which of the following studies are more susceptible to recall bias

A. Retrospective cohort
B. Prospective cohort study
C. Randomized controlled trial
D. Non-randomized controlled trial
6- Which of the following is the type of studies considers data from multiple studies of different designs to draw
conclusions
A. Case Series
B. Double-blind study
C. Systematic Review
D. Consensus statement
7- The authors report two isolated gastro-intestinal tuberculosis in renal transplant recipients that illustrates the
difficulty of making this diagnosis and a brief review of the literature on its clinical presentation, diagnosis and
therapeutic approach.
What is the type of study in the above-mentioned abstract
A. Case-series
B. Cohort studies
C. Case-control studies
D. Cross-sectional studies
8- Scenario: A study located a group of subjects with lymphoma and went to identify which subjects are smokers
and which are not.
Which of the following study designs is used to conduct the study in the scenario
A. Case-series
B. Cross-sectional study
C. Prospective cohort study
D. Retrospective cohort study
9- Which of the following terms measures the association between the exposure and the outcome
A. P Value
B. Risk ratio
C. Standard deviate
10- Which of the following study design is the best to use to assess the awareness on the usage of vitamin D
supplements among people of Jeddah
A. Cohort study
B. Case report study
C. Case control study
D. Cross sectional stud
11- A researcher gathered all vitamin E studies from the past ten years. Vitamin E was used for a variety of condition.
The populations studied as well as the vitamin E formulations and doses were all different. The researcher
compared the incidences of cardiovascular-related mortality in those taking vitamin E supplements versus those
that did not.
Which of the following best describe this type of study
A. Meta-analysis
B. Cohort study
C. Observational study
D. Controlled clinical trial
12- A group of patients with diabetes were interviewed to determine they are currently eating fast food or
not.Which epidemiological study design is this
A. Cohort
B. Case-control
C. Cross-sectional
D. Randomized control trial
13- Which of the following is the dis advantage of conducting randomized Controlled trial
A. Expensive
B. High possibility of bias
C. Difficult to control confounders
D. Cannot be used for hypothesis testing
14- Study that investigate if drinking coffee lead to coronary hear found that there is a correlation between two
variables. Study that investigate if drinking coffee lead to coronary hear found that there is a correlation
between two variables. However drinkers are more often smokers than the average and, correlation between
drinking coffee and nicotine consumption, strong causal correlation between smoking and the incidence of
heart disease. Which of the flowing type of bias affect this study results
A. Measurement errors
B. Hawthorne effect
C. Information bias
D. Confounding
LEARNING RESOURCES
SAIF ALGHAMDI
Study Design Quiz

by Laura King, MA, ELS
CORRECT ANSWERS
Directions: Respond to the following questions based on your knowledge of chapter 20

(§20.2 §20.7; pp 838 851 in print) of the AMA Manual of Style.
1. Which type of study assesses the efficacy of the treatment intervention in a

controlled, standardized, and highly monitored setting and usually among highly
selected samples of patients?
randomized controlled trial

case series
sensitivity analysis
cost benefit analysis
2. In which type of study do participants receive more than 1 of the treatments under
investigation, usually in a randomly determined sequence and with a prespecified
amount of time (a “washout period”) between sequential treatments?
parallel design, double blind trial

noninferiority trial
prospective cohort study
crossover trial
Copyright © American Medical Association, 2011. For educational use only.
www.amamanualofstyle.com
LEARNING RESOURCES
3. In which type of study does the investigator use information already collected to look
for associations?
retrospective study
prospective study
historical study
survey study
4. In which type of study does the investigator identify a group of individuals and then
observe them for a specified period after study initiation?
retrospective study
prospective study
meta analysis
diagnostic test study
5. Which type of study assesses whether 1 or more treatments are superior to the
others?

retrospective cohort study
case control study
crossover trial
6. Which type of study follows up a similar group of individuals who are initially free of
the outcome of interest but for whom the outcomes have been defined before the
events occur?
prospective cohort study

crossover study
case series
7. Case control studies are always
prospective
retrospective
overmatched
multivariate
LEARNING RESOURCES
8. Which of type of study compares a less expensive treatment or intervention against a

treatment or intervention that is already known to be effective to assess whether the
new intervention is no worse than the existing treatment?
meta analysis
case control study
9. Which type of study compares those who have had an outcome or event with those
who have not?
case control study

case series
cohort study
meta analysis
10. Which type of study can be used to describe the experience of an individual or
institution in treating a disease?
case control study

crossover trial
case series
equivalence study
11. Which type of study is a systematic pooling of the results of 2 or more studies to
address a question of interest or hypothesis?
case control study

meta analysis
12. Which type of study generally yields estimates of likelihood ratios, sensitivity,
specificity, positive predictive values, and negative predictive values?
crossover study
cost effectiveness study
meta analysis
diagnostic test study
LEARNING RESOURCES
13. In longitudinal survey studies, the same respondents are surveyed
at several time points

at a single time point
only once
cross sectionally
14. Which type of study converts clinical measures of outcomes into monetary units,
allowing both expenses and advantages to be expressed on a single scale?

cost effectiveness analysis
equivalence study
sensitivity analysis
15. Which type of study benefits from the publication of a flow diagram showing the
flow of participants in the study, including when and why participants dropped out or
were lost to follow up and how many participants were evaluated for the study end
points?
case series
meta analysis
survey study
Scanned by CamScanner
Pharmacoepidemiology equations
Point prevalence:
Number of persons who have the disease at a specified time
Number of persons in the population at that specified time
Period prevalence:
Number of persons who have the disease at any time during a specified period
Number of persons in the population during that specified period
Cumulative incidence:
Number of new cases of a disease during a specified period
Number of persons at risk for developing the disease during that period
Incidence rate:
Number of new cases of a disease during a specified period
Total person − time of observation in population at risk during that period
Crude mortality rate:

Number of deaths for all causes during a specified period
Number of persons in the population during that period
Age-specific mortality rate:
Number of deaths for all causes during a period in a specified age category
Number of persons in that age category in the population during that period
Infant mortality rate:

Number of deaths among children < 1 year of age reported during a given time period
Number of live births reported during the same time period
Maternal mortality rate:

Number of maternal deaths reported during a given time period
Number of live births reported during the same time period
Cause-specific mortality rate:

Number of deaths for specified cause during a specified period
Case fatality:
Number of deaths from a disease during a specified period
Number of persons with the specified disease during that period
Proportionate mortality:
Number of deaths from a disease during a specified period
Total number of deaths during that period
Natality (Birth) measures:

Number of live births during a specified time period
Important note: The above equation are expressed

as per 1000 or 100000 population or both.
Done by: Meshal Alshagawi

Mean
Definition The mean is the sum of the values, divided by the total number of values.
Equation X = x1 + x2+x3…X/n
Examples Example: The data show the number of patients in a sample of six hospitals who acquired an
infection while hospitalized. Find the mean. 110, 76, 29, 38, 105, 31
Solution: X = 110 + 76 + 29 + 38 + 105 + 31 / 6 = 64.83

Median
Definition The median of a data set is the value that lies in the middle of the data when the data set is
ordered.
Equation If n is odd the equation = n + 1 / 2
If n is even the equation = n/2 , n+1/2
Examples The number of children with asthma during a specific year in seven local districts is shown. Find
the median. 253, 125, 328, 417, 201, 70, 90
‫ نرتب االعداد في البدايه‬:
70, 90 , 125 , 201 , 253 , 328 , 417
201= ‫ ارقام وتعتبر عدد فردي فنستخدم المعادلة الفردية وناخذ العدد الي في النص‬7 ‫نالحظ انه عدد االرقام المتواجده هي‬
Median = 7 + 1/2 = 4
4 ‫ في السلسه هو‬201 ‫نالحظ انه مكان رقم‬
Example: Six customers purchased these numbers of magazines: 1, 7, 3, 2, 5, 8, Find the median.
Solution: 1, 2,3 , 5 , 7, 8
‫ ارقام موجوده‬6 ‫نالحظ انه مجموعهم عدد زوجي وهو‬
MD = 6/2 , 6+1/2 = (3,3) -------🡪 The median = 3+3/2 = 3
mode.
Definition The value that occurs most often in a data set is called the mode. The mode of a data set is the
data entry that occurs with the greatest frequency
Examples The following data represent the duration (in days) of US space shuttle voyages for the years
1992-1994. Find the mode
8, 9, 9, 14, 8, 8, 8, 10, 7, 6, 9, 7, 8, 10, 14, 11, 8, 14, 11
Solution: Arrange the data in order

6, 7, 7, 8, 8, 8, 8, 8, 9, 9 9 10, 10, 11, 11, 14, 14, 14
Since 8-day voyages occurred 5times – a frequency larger than any other number the mode for
the data set is 8.
Example:
Find the mode for the number of coal employees per county for 10 selected counties in
southwestern Pennsylvania.
110, 731, 1031, 84, 20, 118, 1162, 1977, 103, 752
Solution: Since each value occurs only once, there is no-mode.
Midrange
Definition The Midrange is defined as the sum of the lowest and highest values in the data set, divided by 2.
The symbol MR is used for the midrange
Equation MR = Lowest value + Higher value / 2
Examples Find the midrange of data for the NFL signing bonuses in previous Example. The bonuses in
millions of dollars are 18, 14, 34, 11, 10, 12,
: Arrange the data in order : 10 , 11 , 12 , 14 , 18 , 34
MR = 34 +10 / 2 = 22
‫انا موضحة كل شيء عشان اللي يحب يعرف ليه لكن املستعجل يذاكر السؤال واالجابة‬
of Reaction on if dtz Removed

na.me
or dealkylation
ro demethylation 0
ifRemovebecomemorphinewhichtpotency
ifsaligiico.ci
2oHoCHs
which make aspin in
work as antiplatelet
acetyl gp bind covalent to cox1 receptor
when quinine is configured
Malaria optical
isomer
cancer
antiarrythmia
active oseltamivir
Eep sa
1004
p
phospholipid structure
B2b How to 1 duration
add polar function to C
3
Apolarity
detection
duration
Barbiturates
Dihydropyridine CCB
Just know it’s structure contain
this ring so you know if they ask
which structure is CCB
dihydropyridine
Iii
Short duration barbiturates
leaf effect on IG
MCMinhibitor
e
aspirin
natured C i
prodry statin
or
Natural statin (lovastatin structure)
say
is
g s
G
r
Basie
n
CzHz 4 2 1 2 6 C valence ee 4
0244 4 2 41 re H h I
CzH6 Cu z C6xD He
04 6
Cole
f
Edt H
Hp
p ETH
t C C H ti H GH
triplebond doublebond H
single
8 atom DJ six
‫‪C347F‬‬
‫‪d's‬‬
‫مهم نعرف ان مافي ابمير بني جاالكتا و مانوز‬
‫‪rrn‬‬
Cefn Ceelo
cefta
d d
Iniperen aretronam
Which antidepressants cause photosensitivity
TCA
‫ مو شرط لكن التفرع شرط‬N‫ال‬
TCA agents
I lg
If
night
O
g
t
C THIlNo2
2,5-Pyrrolidinedione, 3-ethyl-3-methyl
db
active form of uit D

3Ring open
Ring
407 methyl
. ‫مابينوا مكتوب تحته اسم او‬
alphy Bet awwbetaverylittle

9
a
‫ركب بس تحسبًا للي يبغى‬E‫كان كاتب اسم ا‬
2nd antihistamine
Patient need to take histamine and he will drive
2nd doesn’t induce sleeping
R 25 of
pro Ing
R
R R
Iotafidine
‫بس عشان عيونكم تتعود عالفرق‬
Ri Rr r
Rr p Rl
Rr Dz
R Hep R
Rr Rr
AmphotricinB
‫ركبات افهمو الفكرة فقط‬E‫ماهي ا‬
Break ester from the remaining
give acid alcohol

ZoH I
CooH
.
I 0
alcohol
zaH
ped
I alcohol
acid
1
Ester
Bond between acetaminophen and aspartate

‫مو فاهمة ايش يبغوا بالضبط ‪ ..‬في اختبار وحدة ‪ ١٦‬فبراير ماجاها لكن في ‪ ٣‬جاهم من قبل زي ‪ ١٢‬فبراير وكدا‬
‫ً‬
‫اص‪e‬‬ ‫خليكم عارف‪ g‬شكله‬
‫اعتقد انو يجيب مركبات كثير ويقول الفارماكوفور ‪quinolones‬‬

‫وتختاروا ا‪E‬ركب اللي جوته دي الحلقت‪ g‬بزحمتها ا‪.‬ساسية‬
‫‪6CR S‬‬
‫‪be‬‬ ‫‪only‬‬
‫‪Ine‬‬
‫‪cook‬‬
‫‪acid‬‬
‫‪Position 7‬‬
‫‪X‬‬ ‫‪halogen gpCig‬‬

‫‪f‬‬
‫‪etc‬‬
‫مدري لو هيكون يلخبط او ‪.‬‬
‫‪4 I‬‬
‫‪nine O cold‬‬
‫‪0 hes‬‬ ‫‪fo‬‬ ‫‪0‬‬
‫مش قاعدة و‪ .‬لها صحة بس ممكن نفتكرها كدا‬
‫‪O‬‬ ‫وفي دي ا‪E‬ركبات بس‬
‫‪one‬‬ ‫‪c‬‬
‫‪u‬‬
Major metabolite of Diclofenac
Choose 4
If it’s not an option
Choose 5
4 is most common
‫دي للتوضيح بس‬

The function group that responsible for antiviral activity ‫ألن املركب اتصنع منها ودا‬
‫الفرق الوحيد‬
Type of isomer? Enantiomer
:
Least dominant tautomer of histamine at
physiological pH
Which TCA undergo photo-oxidation when exposed to light

Change TCA from NSRI ( norepinephrine and
sertonin reuptake inh) to SNRI ( selective
norepinephrine reuptake inh)
‫حطيتلكم املركبات واللي لقيته وانتو اختاروا جوابكم‬
—
bioisosteres are chemical
substituents or groups with similar
physical or chemical properties
which produce broadly similar
biological properties to another
chemical compound.
‫‪Which is 5th cephalo? No‬‬ ‫اغلب الصفحة دي لزيادة معلوماتكم‪ ،‬بس املهم‬
‫‪names‬‬ ‫تعرفوا مركب خامس جنريشن و مني ينعطى بالفم‬
‫‪Which can be given orally ( with‬‬
‫)‪names‬‬
Vitamin D story
in human 7-Dehydrocholesterol
implant
Not active
Nsf active
as a
zs
as
d ive
forms
a
Calcitriol
Duras
D 3 US D2
doubleBond
analogue d vit D
H
active vs inactive Io
s
active
3OH active
metabolism
Triple double f effecton phosphocakenic .. ‫دعواتكم‬
RubaMah
‫كاتبني سؤال انو في اي مجموعة يصير ‪gluocoronidation of metoprolol‬‬
‫وهو مايصير له فحطيتلكم ايش يصير له وفني يصير عموما وانه يصير الصحاب ميتو‬
‫اللي حاب زيادة وهيزعل لو ماحل هذي ممكن توصلك ‪l‬جابة‬
‫‪d‬‬ ‫‪d‬‬ ‫‪b‬‬

‫‪r‬‬
‫‪r‬‬ ‫‪p‬‬ ‫‪e‬‬ ‫‪e‬‬ ‫‪r‬‬
‫‪d‬‬ ‫‪d‬‬ ‫‪d‬‬ ‫‪f‬‬ ‫‪d‬‬

‫‪hexaneWAM‬‬ ‫‪over decor‬‬
‫‪butane‬‬ ‫‪afar‬‬
‫ميثان( و )إيثان( بنات عم تزوج بهما رجل يدعى‬

‫)بروبان( وأسكنهم في )بيوتان( ورزق منهما )بنتان(‬
‫أسماهم )هكسان( و) هبتان( ثم تقدم لهما رجل‪ g‬هما‬
‫)أوكتان( و)نونان( وكان مهرهما عباره عن)ديكان(‬
‫ما اقدر اضمن انو بس دي االسئلة جات لكن دي اللي عرفت كيف تجي بالضبط‬
‫دعواتكم ‪..‬‬
‫‪RubaMah‬‬
Eslam Fahmy
00201011922837
Maslow's hierarchy of needs

Eslam Fahmy
00201011922837
Type of medication errors
Prescribing • Inappropriate drug selection, dose, dosage form or route of administration ‫الدكتور غلط في اختيار الدوا – جرعته – طريقة أخذه‬ ▪
Omission • Patient doesn't receive a scheduled dose of medication. ‫ن‬

)‫مرتي (نىس جرعة‬ ‫ مرات يوميا – هو خد‬3 ‫الدوا مثال‬ ▪
• 2nd most common error in the medication use process.
Unauthorized drug • Drug was not authorized by an appropriate prescriber ‫الل ن يف الروشتة أو من غي روشتة خالص‬
‫المريض خد دوا غي ي‬ ▪
‫ن‬ ‫ن‬ ▪
• Medication given to wrong patient ‫مريضي‬ ‫تان – عكست دوا‬
‫الممرضة أدت دوا لمريض ي‬
Wrong time • Drug not administered in accordance to the interval ‫ ن يف األخطاء‬1 ‫رقم‬ ▪
• 1st common error in the medication use process.
Wrong dose • The dose administered is different from that prescribed ‫الل ن يف الروشتة‬
‫خد جرعة غلط غي ي‬ ▪
Wrong dosage form • Dosage form different from that prescribed ‫مكتوبلة نيورتون حقن و انت اديتله نيوروتون أقراص‬ ▪
Wrong preparation • Reconstitution error ‫المريض غلط و هو بيحل المضاد الحيوي‬ ▪

• IV admixture compounding error
Wrong administration • Drug is given to a patient inappropriately ‫الدوا اتاخد غلط – هو عضل مثال و انت اديته وريد‬ ▪
• IM drug given IV
Deteriorated drug • Patient given expired or deteriorated drug ‫منته‬

‫ي‬ ‫مريض بياخد دوا بايظ أو تاري خ صالحيته‬ ▪
Monitoring • Patients are not monitored appropriately ▪
Compliance • Patients use medications in an inappropriate way ‫المريض مش عارف يستخدم الدوا‬ ▪
• Patient use metered dose inhaler in wrong way ‫ المريض مش عارف ستخدم بخاخة الصدر‬: ‫مثال‬ ▪
Duplication error • 2 drugs from the same class are prescribed. ‫مكتوبي ن يف نفس الروشتة‬
‫ن‬ ‫دوا ن‬
‫يي من نفس العيلة الدوائية‬ ▪
Eslam Fahmy
NCC MERP index for categorizing
00201011922837
Classification of medication errors medication errors
Error Harm Notes

No error A ❌ ❌ • Possibility of error but no error occurred.
Error + No harm B ❌ • Error did not reach patient
C ❌ • Error reach patient → cause no harm
D ❌ • Error reach patient → cause no harm, but need ↑ Monitoring
Error + Harm E Temporary harm • Treatment and intervention
F Temporary harm • Prolonged hospitalization
G Permanent harm
H Near death harm • Anaphylaxis and cardiac arrest
Error + Death I Death
❖ Medication reconciliation
• the process of comparing a patient's medication orders to all of the medications that the patient has been taking.
• This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions.
• It should be done at every transition of care in which new medications are ordered or existing orders are rewritten
Eslam Fahmy
00201011922837
Immunology definitions
Immunology • Branch of biomedical science that covers the study of all aspects of immune system.
Hapten • Small molecule which could never induce an immune response when administered alone but can induce immune response when coupled to a
carrier protein
Antigen • Foreign material causing an immune response
Antibody • Specific substance formed in the body in response to antigenic stimulation and react specifically with antigen
1st line defense 2nd line defense

1- Anatomical barriers 1- Inflammation
• Skin 2- Fever
• Cilia in respiratory tract 3- Natural killer cells
2- Mucous membrane and their secretions 4- Phagocytic white blood cells
3- Bacterial flora 5- Antimicrobial substances
• Coagulation system
• Lactoferrin and transferrin
• Lysozymes
• Interferons
Innate &
adaptive
immunity
T cell maturation occurs in the bone marrow, stored in thymus gland then circulate to various destinations.
T-lymph found intracellularly
Eslam Fahmy
00201011922837
Types of hypersensitivity reactions
A B Type 2 C D
Type 1 Type 3 Type 4
Name Immediate Cytotoxic Immune complex Delayed
Allergic Complement activation
Antigen form Soluble Cell bound Soluble Cell bound & Soluble
Humoral component IgE IgG - IgM IgG - IgM None
Cellular component Mast cells Macrophages Neutrophils T cells - Macrophages
Examples 1. Anaphylaxis 1. Blood transfusion reactions 1. Serum siCkness 1. Tubercular lesion
2. Allergies → e.g. peanut 2. ErythroBlastosis fetalis 2. Lupus 2. Contact Dermatitis
3. Hemolytic anemia 3. Graft rejection
Types of Immunoglobulins
IgG IgA IgM IgD IgE
Other name Secretory Ig Macroglobulin
Structure • Monomeric • Monomer in • Pentameric • Monomeric • Monomeric

serum
• Dimer in
secretions
Serum conc.
nd
1st → 80% Highest 2 → 10:15 % 3rd → 5:10 % 4th → 0.2% 5th → 0.002% Lowest
Half life 23 days 7 days 5 days 2:8 days 2:3 days
Size Smallest Largest
Pass placenta Yes No No No No
Fix complement Yes No Yes No No

Neutralize toxins Present in milk 1st primary immune Differentiation of Type 1
(Colostrum) response after allergic lymphocytes hypersensitivity
stimulus (Allergic reactions)
Vaccinations

Eslam Fahmy
00201011922837
Abbreviations
DTap • Diphtheria, Tetanus, Pertussis

Tdap • Tetanus, Diphtheria, Pertussis
DT • Diphtheria, Tetanus
HBV • Hepatitis B Vaccine
HAV • Hepatitis A Vaccine
HibV • Hemophilus Influenza B Vaccine
HPV • Human Papilloma virus Vaccine
PCV • Pneumococcal Conjugated Vaccine
PPSV • Pneumococcal Polysaccharide Vaccine
IPV • Inactivated Polio Vaccine
MCV • Meningococcal Conjugate Vaccine
MPSV • Meningococcal Polysaccharide Vaccine
MenBV • Meningococcal B Vaccine
MMR • Measles, Mumps, Rubella
ZVL • Zoster Vaccine Live
RV • Rota Vaccine
IIV • Inactivated Influenza Vaccine
LAIV • Live Attenuated Influenza Vaccine
BCG • Bacille Calmette Guerin → Vaccine for TB (Tuberculosis)
TIG • Tetanus ImmunoGlobulin

HBIG • Hepatitis B ImmunoGlobulin
VZIG • Varicella zoster ImmunoGlobulin
IVIG • IntraVenous ImmunoGlobulin
IGIM • ImmunoGlobulin IntraMuscular
❖ Types of immunity
Active immunity Passive immunity

Produced by Individual own immune system An animal or human antibody and transferred
Acquired by 1- Active disease = Antigen (Ag) 1- Antibody (Ab) = Immunoglobulins (Ig)
2- Vaccination (Live, attenuated – Inactivated)
❖ Role of Passive immunity:

1- Prophylaxis of infectious disease
• Tetanus immunoglobulin (TIG)
Unknown history Known history
Minor wounds Td • If last Td dose received within 10 years → No treatment
(10) • If last Td dose received more than 10 years → Td only
Major wounds Td + TIG • If last Td dose received within 5 years → No treatment
(5) • If last Td dose received more than 5 years → Td + TIG
• Hepatitis B immunoglobulin (HBIG)
1- Pregnant woman with Hepatitis B when she delivers the baby must be given → Hepatitis B vaccine (HBV) + HBIG
2- Nurse infected with Hepatis B patient blood must be given → Hepatitis B vaccine (HBV) + HBIG
HBV + HBIG → administered at different body sites.
2- Prophylaxis therapy
• Varicella zoster immunoglobulin (VZIG) → Given to patients (Leukemia or ↓ immunity) exposed to varicella zoster
3- Treatment of Antibody deficiency
• 1ry Immunodeficiency or as chronic lymphocytic leukemia must be given →
• IVIG (intravenous immunoglobulin) or IGIM (Intramuscular immunoglobulin) every 2 to 4 weeks to maintain immunity.
❖ Types of Vaccines:
Live, attenuated vaccines Inactivated vaccines

Produced by Modifying the virus or bacteria to give Fraction of the virus or the bacteria such as cell
immunity wall polysaccharides
Disease Do not produce disease (but may) Unable to produce disease
Notes Not given in immunocompromised Can be given in immunocompromised
↓ virulence of pathogen by attenuation
Attenuated means weakened but still life/viable
Generally, provide life-long immunity
❖ Live attenuated vaccines

Yellow ROME In Best Place
Yellow • Yellow fever
ROME • Rubella - Rota
• Oral Polio & Oral Typhoid Varicella
• Measles & Mumps Zoster (ZVL)
• Epidemic typhus Smallpox
In • Influenza (LAIV) Chickenpox
Best • BCG
Place • Plague
Eslam Fahmy
00201011922837
Live vaccine + Inactivated vaccine • Can be given at the same time (on the same day)
• Can be given separated without regard to the spacing
Inactivated vaccine + Inactivated vaccine • Can be given at the same time (on the same day)
• Can be given separated without regard
Live vaccine + Live vaccine • Must be given at the same time (On the same day)
• If separated the spacing must be 28 days
Live vaccine + Antibodies • Must be separated
❖ Vaccine storage
• Most vaccines require refrigeration (2O – 8O C)
• ZOSTRAVAX required to be frozen (≤ –15O C)
• MMR can be stored in refrigerator or freezer → Bottom self of refrigerator
Vaccine Stability Temperature Comment
Tetanus (T) 1 hour. 2–8
MCV 3 hours 2–8 Protect from light
OPV 3 hours -20
BCG 4 hours 2–8 Protect from light
• Protect from light → MCV, BCG, Measles
• OPV after opening can be kept (2-8) for 6 months
❖ Vaccines administration routes
Majority are IM only except
IM or SC SC only Oral only
• IPV → Inactivated polio vaccine • MMR • OPV → Oral polio vaccine
• PPSV → Pneumococcal Polysaccharide Vaccine • Varicella • RV → Rota virus vaccine
• ZOSTRAVAX
❖ Vaccination and pregnancy
Vaccines given in pregnancy Vaccines contraindicated in pregnancy

1- Tdap: During each pregnancy ideally between 27, HPV 1-
36 weeks gestation (Last 3 months) MMR 2-
3-
Varicella
2- IIV (Inactivated Influenza Vaccine) → give immunity ZVL 4-
to child during pregnancy and 6 months after birth. BCG 5-
LAIV 6-
All live vaccines
Pregnant woman is more liable for influenza complications.
❖ Vaccination and Antibiotics
• Some vaccines may contain small amount of certain antibiotics (neomycin, streptomycin, gentamycin, polymyxin B)
to prevent bacterial contamination during manufacture process.
• MMR, IPV, ZVL
 Patients with allergy to these antibiotics must not be given these vaccines.
❖ Vaccination and egg allergy
The following vaccines may contain traces of egg proteins:
MMR
Influenza vaccine • Egg allergy with just hives → Take the vaccine
• Egg allergy with angioedema, respiratory distress, light headache, recurrent emesis; or who
require epinephrine or emergency medical intervention → Vaccine is given under
supervision of a health care provider who is able to manage sever allergy.
Yellow fever vaccine • Higher amounts of egg proteins → Allergy specialist is recommended before vaccination
❖ Vaccinations before Haj
1- Annual influenza flu vaccination
+ Polio + Corona + Zika
2- MCV (Meningococcal)
❖ Saudi MOH vaccination schedule
Birth BB (BCG + Hep B) → 12 hours from birth • A = Hep A

2 months DR BHIP • B= Hep B
4 months DR BHIP • D = DTaP
6 months DO BHIP • H = Hib
9 months MeaM • I = IPV
12 months MMR MOP ......... • O = OPV
18 months MMR DOV AH • M = MCV4
24 months A • Mea = Measles
School entry MMR DOV .......... • MMR = MMR
(4-6) years • P = PCV
• R = RV
• V = Varicella
❖ Adverse effects of vaccines:

1- Injection site reactions (Pain, swelling, Erythema "redness") → Major side effects
2- Fever
• It is important to monitor patients for at least 15 minutes following administration.
• Sever allergy handled with Epinephrine, diphenhydramine and CPR
❖ When avoid vaccines (Contraindications)
1- Live vaccines in pregnancy.
2- Live vaccines in immunocompromised patients
a- Patient receiving cancer chemotherapy
✓ Live vaccines can be given after chemotherapy has been discontinued for at least 3 months.
b- Recent hematopoietic cell transplant (HCT)
c- Biologic agents (TNF inhibitors, Rituximab, Etanercept
d- All vaccines with CD4 < 200 cells/mm3
e- Receiving daily corticosteroids
f- All vaccines causing sever allergy (Anaphylactic shock)
g- All vaccines in moderate to severe illness with or without fever →→ Given with caution (Not contraindicated)
❖ Key Considerations in special population
Preterm birth
• Immunize based on chronological base
• Do not reduce the recommended dose
• Delay Hep. B vaccine until the baby is:
1- More than 2 kg body weight or
2- More than 30 days old
Patients receiving corticosteroids
✓ Live vaccines may be administered to patients receiving the following:
Topical steroids Any dose • Live vaccines given immediately

Systemic steroids less than 2 mg/kg/day "low or moderate dose" • Live vaccines given immediately
≥ 2 mg/kg/day for less …than 14 days • Live vaccines given immediately
≥ 2 mg/kg/day for more than 14 days • Live vaccines should be delayed at least
1 month after stopping the steroid.
Influenza (Flu)
Inactivated influenza vaccine (IIV) Live attenuated influenza vaccine (LAIV)
Can be given with Influenza Antiviral Drug (IAD) like Not given with Influenza Antiviral Drug (IAD) like
Tamiflu (Oseltamivir) Tamiflu (Oseltamivir)
• IAD cessation → wait 48 hours → Take LAIV
• LAIV → wait 2 weeks → Take IAD
If IAD administered within 2 weeks of LAIV, the
vaccine dose should be repeated 48 hours after the
last dose of antiviral medication
 LAIV should not be given to:
1- Patient with severe allergic reaction to LAIV
2- Patient allergic to eggs
3- Pregnant woman
4- Child (2:17) receiving aspirin or aspirin containing
5- Child (2:4) with asthma or wheezing in past year
6- Immunosuppressed patient
7- Patient taken antiviral in the previous 48 hours
• Influenza viruses undergo shift and drifts; therefore, every year new influenza (flu) vaccine is formulated and must
be administered every year.
• New influenza season start approximately in November (11) every year
• The new vaccine must be started in October (10) as it takes about 2 weeks after vaccination for antibodies to
develop and provide protection.
Child less than 9 years given 2 doses in one flu season, one is a booster dose. → (In 1st time only)
Influenza vaccine normally taken once per year but it can be taken twice (every 6 months) in high risk patients.
High risk patients include (COPD, HTN, Dyslipidemia, Female, Old)
 Not used for children (0:6) months
Influenza vaccine is given every year even if you do not need it.
Inhaled influenza vaccine → FluMist
Tetanus
Unknown history Known history

Minor wounds Td • If last Td dose received within 10 years → No treatment
(10) • If last Td dose received more than 10 years → Td only
Major wounds Td + TIG • If last Td dose received within 5 years → No treatment
(5) • If last Td dose received more than 5 years → Td + TIG
Less than 7 years ✓ DTap

Above 7 years ✓ TD – Tdap
Adult ✓ Adult should receive one Td booster every 10 years.
✓ Adult should replace 1 Td booster with a Tdap dose once in their life time.
• Td vaccine wears off after 10 years
Eslam Fahmy
00201011922837
Hepatitis
Hep. A • Hep A vaccine is recommended for travel to most parts of the world.
• Total doses = 2
Hep. B • Hepatitis B vaccine is given in a 3-doses series at 0, 1, 6 months.
• Minimum duration 4 weeks between two vaccines.
• If a 2nd dose vaccine was given too soon (before minimal interval) → don't count this incorrect
dose and repeat it after the minimal time has passed since the incorrect dose.
• Total doses = 3
• Pregnant woman with Hepatitis B when she delivers the baby must be given → (HBV) + HBIG
• Nurse infected with Hepatis B patient blood must be given → (HBV) + HBIG
• HBV + HBIG → administered at different body sites.
• Preterm birth → Delay Hep. B vaccine until the baby is:
1- More than 2 kg body weight or
2- More than 30 days old
Hep. C • There is no vaccine available to provide protection against hepatitis C
Varicella zoster
• Zoster vaccine must not be given to the patient currently treated for shingles or post-herpetic neuralgia. It can
be administrated once the symptoms are resolved. (Disease symptoms are cleared)
• Varicella zoster immunoglobulin (VZIG) → Given to patients (Leukemia or ↓ immunity) exposed to varicella zoster
Others
HPV ❖ Human Papilloma virus vaccine
1- ↓ incidence of infertility
2- ↓ incidence of cervical cancer
3- can cause syncope → patients remain seated for at least 15 minutes after receiving the vaccine.
֍ Brand name → Cervarix (bivalent), Gardasil (quadrivalent)
RV 1- The 1st dose of RV → before 14 weeks
2- The last dose of RV → before 8 months
Hib  Haemophilus influenza vaccine should not be given over 5 years child.
Hg  Thimerosal (Mercury) containing vaccine → Autism
BCG ✓ BCG vaccine has the maximum age → Life-long immunity
PCV - PPSV ✓ Pneumococcal vaccine given to patients older than 65 years
MCV ✓ Emergency staff at hospital should receive meningitis vaccine.
Eslam Fahmy
00201011922837
Notes
Taking antibiotics shouldn't prevent vaccination.
Antibiotics will not affect how your child's body responds to vaccine.
Cyclosporin is an immunosuppressant given after organ transplant.
Td • Td vaccine wears off after 10 years

BCG • BCG vaccine has the maximum age (Life-long immunity)
Pathogen Disease Vaccine

Pertussis (b) Whooping cough DTap - TDap
Mycobacterium tuberculosis (b) Tuberculosis BCG
Lung obstruction influenza vaccine + Pneumococcal vaccine
Varicella zoster Chicken pox ZVL
Eslam Fahmy
00201011922837
Eslam Fahmy
00201011922837
Questions
Which of the following vaccines can be a. Influenza vaccine
administered either intramuscularly or b. PPSV23
subcutaneously? c. PCV13
d. MCV
Which of the following vaccines is a. Hepatitis A vaccine
recommended at birth in KSA? b. Hepatitis B vaccine
c. Meningococcal vaccine
d. Polio vaccine
Which of the following is the most a. Fever
common adverse reaction to an b. Injection-site reaction
inactivated vaccine? c. Headache
d. Myalgias
How long does it take before a flu vaccine a. Immediately
provides you with maximum protection b. 5 days
against the flu? c. 2 weeks
d. 30 days
Healthy children over what age should not a. 2 years
receive the Hib vaccine? b. 5 years
c. 7 years
d. 9 years
A 60-year-old patient is currently a. Yes, she should receive the vaccine at this time
undergoing chemotherapy for treatment b. Yes, she needs to receive a dose of the vaccine now, and an
of acute myeloid leukemi She has had 3 additional dose after completion of chemotherapy to
outbreaks of shingles over the past 7 ensure a full immunogenic response
c. No, she should not receive the vaccine due to her diagnosis of
years. Can she receive zoster vaccine
cancer and because she is currently receiving chemotherapy
(ZOSTAVAX) now? d. No, she does not need to receive the vaccine because it will
not help since she has experienced past outbreaks
Which of the following patient is at the a. A 70-year-old female with COPD, HTN and dyslipidemia
highest risk of developing complications b. A 74-year-old male who lives in old care nursing facility
from infection with the influenza virus? c. A 67-year-old otherwise healthy female
d. A 72-year-old-male recently diagnosed with hypertension
A 24-year-old patient is receiving a. No, because he is currently receiving antiviral therapy
oseltamivir 75mg PO once daily. Can he b. Yes, because he is only receiving the prophylaxis dose of
receive influenza vaccine now? oseltamivir
c. Yes, he can receive inactivated influenza vaccine (IIV) now
d. Yes, he can receive live-attenuated influenza vaccine (LAIV)
24 hours after completion of antiviral drug therapy
Children under the age of 9 years require 2 a. It is their first time to receive the vaccine
doses of influenza vaccine in the same b. They have not had an influenza vaccine for the past 3 years
season if: c. They have a weakened immune system
d. They had 2 influenza vaccines the previous year
What is the minimum interval between the a. There is no minimum interval; they can be given at any time
administration of two inactive vaccines? b. They must be spaced 28 days apart if not given
simultaneously
c. They must be spaced 14 days apart if not given
simultaneously
d. They must be spaced 7 days apart if not given
simultaneously
Vaccination is available against which of a. Hepatitis A
the following hepatitis types? b. Hepatitis B
c. Hepatitis C
d. Hepatitis A & B
For which case, would it be best to a. MMR for a 6-year-old boy with HIV and a CD4 count of 650
withhold vaccination until a later date (i.e. cells/mm3
delay the vaccine)? b. MMR for a 6-year-old girl receiving etanercept for juvenile
arthritis
c. Inactivated flu vaccine for a 1-year-old with otitis media
d. Tdap for a pregnant 27-year-old female with gestational
diabetes
Which of the following vaccines is usually a. Influenza vaccine
not given until after the child's first b. MMR vaccine
birthday? c. DTap vaccine
d. Hib vaccine
Which of the following is a a. Pregnancy
contraindication to inactivated influenza b. Breastfeeding
vaccine? c. Anaphylaxis to a previous dose of influenza vaccine
d. Egg allergy
Which of the following vaccines is strongly a. Haemophilus influenza vaccine
recommended for people going for Hajj? b. Pneumococcal vaccine
c. Meningococcal vaccine
d. Tuberculosis vaccine
A 28-year-old female comes to the a. She should not receive the vaccine because she had the flu
pharmacy during influenza season asking and has now protective antibodies
for advice on whether she needs to receive b. She should not receive the vaccine because she is not in a
the influenza vaccine. She recently high-risk group
c. She should only receive the vaccine if she wants to boost
recovered from a documented case of
her titers
influenza virus. What is your
d. She should receive the vaccine
recommendation?
At which of the following age, it is a. 2 years
recommended to switch from DTaP to b. 5 years
Tdap? c. 7 years
d. 10 years
The immunity of which of the following a. MMR vaccine
vaccines generally wears off after 10 b. Varicella vaccine
years? c. Pneumococcal vaccine
d. Td vaccine
If a 2nd dose of a vaccine was given too a. Restart the entire series
soon (before the minimal interval time has b. Do not count this incorrect dose and repeat it after the
passed), the correct course of action would minimal time has passed since the incorrect dose
be: c. Do not worry about it and continue with the next dose as
scheduled
d. Double the next dose
An 18-year-old received MMR vaccine at a. They were given correctly, and her daughter is now
her first clinic visit and the varicella vaccine protected
2 weeks later. Her mother wants to know b. They were given too close together, and her daughter
if this method was acceptable. Which of should have both vaccines repeated in 1 month
c. They were given too close together, and her daughter
the following is the correct response?
should receive the varicella vaccine 1 month from the date
of the previous varicella vaccine
d. They were given too close together, and her daughter
should receive another MMR vaccine 1 month from the
date of her previous varicella vaccination
A patient received an MMR vaccine 2 days a. Hep B vaccine
ago. The patient returns because his school b. Meningococcal vaccine
informed him he needs more vaccines. c. LAIV
Which of the following vaccines can he not d. He can receive any vaccine today
receive today?
Herpes zoster vaccine (for shingles) can be a. He should receive it right away, without regard to previous
given even if the patient had a case of illness
shingles. If the patient come into the b. He should wait 1 month after the disease symptoms have
pharmacy and state they had a recent case cleared
c. He should wait 1 year after the disease symptoms have
of shingles, how long should they wait
cleared
before vaccination?
d. He should wait at least until all disease symptoms have
cleared
A child should not get a vaccine if he/she: a. has a mild cold
b. is taking antibiotics
c. has had a severe allergic reaction to a previous dose of the
same vaccine
d. developed a fever following a previous dose
Meningococcal vaccination was given to a a. 4 years
child at 12 months (second dose). A b. 6 years
booster dose can be given at what age? c. 8 years
d. 10 years
Which of the following is an example of a. Antibody transfer from mother to fetus
active immunity? b. Antibody transfer to the child through breastfeeding
c. Injection with tetanus toxoid
d. Injection with tetanus immunoglobulin
A 2-year-old has egg allergy (reaction was a. Advise against administering either the MMR or the flu
noted to include angioedema and hives, vaccine
however, the patient can tolerate eggs in b. Recommend that a physician with expertise in allergy
baked goods). He is about to receive MMR management administer both vaccines
c. Recommend administering both the MMR and the influenza
and influenza vaccines first time. What
vaccine as usual
would be the best recommendation?
d. Recommend administering the MMR vaccine but not the
influenza vaccine
An acute moderate-to-severe illness is a. Precaution
considered a(n) …………. to vaccination. b. Indication
c. Contraindication
d. Recommendation
Which of the following is an example of a. Fever
local reaction to vaccine at the injection b. Malaise
site? c. Redness
d. Myalgias
A live vaccine is created by reducing the a. Radiation
virulence of a pathogen by the process of: b. Inactivation
c. Mutation
d. Attenuation
A person received LAIV. Five days later, he a. He does not need to repeat LAIV dose
was diagnosed with flu and oseltamivir b. He needs to repeat LAIV dose 24 hours after completion of
was prescribed for 5 days. Which of the therapy with oseltamivir
following is best regarding his LAIV c. He needs to repeat LAIV dose 48 hours after completion of
therapy with oseltamivir
vaccine?
d. He needs to repeat LAIV dose 2 weeks after completion of
therapy with oseltamivir
Quick Reference Guide #702 - Vaccine Age Limits by Licensure in the United States
Updated 1-29-2016
Note: These are the age limits by FDA licensure, not necessarily the ages recommended by the ACIP.
Vaccines and Trade Names Minimum Age* Maximum Age**
DTaP (Daptacel, Infanrix & Tripedia) 6 weeks 6 years
DTaP-HepB-IPV (Pediarix) 6 weeks 6 years
DTaP-IPV/Hib (Pentacel) 6 weeks 4 years
DTaP-IPV (Kinrix) 4 years 6 years
DT (Pediatric) 6 weeks 6 years
Td (Adult) (Decavac & Generic) 7 years No upper limit
Tdap (Boostrix) 10 years No upper limit
(Adacel) 10 years 64 years
ACIP recommends Tdap for children 7-10 yrs. who did not complete DTaP series and adults 65 years and older
HepA Pediatric (Vaqta & Havrix) 1 year 18 years
Adult (Vaqta & Havrix) 19 years No upper limit
HepA & HepB (Twinrix) 18 years No upper limit
HepB
Pediatric (Engerix-B & Recombivax HB) Birth 19 years
Merck Adult (2 doses) (Recombivax HB) 11 years 15 years
Adult (Engerix-B & Recombivax HB) 20 years No upper limit
HepB & Hib (Comvax) 6 weeks 4 years
Hib (ActHIB & PedvaxHIB) 6 weeks 4 years
(Hiberix) 6 weeks 4 years
HPV4 (Gardasil) 9 years 26 years
HPV9 (Gardasil 9) 9 years 26 years
HPV2 (Cervarix) 10 years 25 years
Trivalent Inactivated Influenza (TIV) 6 months No upper limit
(Fluzone)
0.25-mL prefilled syringe 6 months 35 months
0.5-mL prefilled syringe 36 months No upper limit
0.5-ml vial 36 months No upper limit
5.0-mL multi-dose vial 6 months No upper limit
(Fluzone High Dose) 65 years No upper limit
(Fluzone Intradermal) 18 years 64 years
(Fluvirin) 4 years No upper limit
(Agriflu) 18 years No upper limit
(Afluria) 6 months*** No upper limit
(FluLaval) 18 years No upper limit
(Fluarix) 3 years No upper limit
Live Attenuated Influenza (LAIV) (Flumist) 2 years 49 years
IPV (Ipol) 6 weeks No upper limit
Meningococcal MCV4 (Menactra) 9 months
55 years
MCV4 (Menveo) 2 years
MPSV (Menomune) 2 years No upper limit
MenB (Trumenba & Bexsero) 10 years 25 years
Meningococcal & Hib Hib-MenCY (MenHibrix) 6 weeks 18 months
MMR (M-M-R-II) 1 year No upper limit
MMRV (ProQuad) 1 year 12 years
Pneumococcal PCV13 (Prevnar 13) 6 weeks 5 years & 50 years and older
PPV23 (Pneumovax23) 2 years No upper limit
Rotavirus RV5 (RotaTeq) & RV1 (Rotarix)
Dose #1 6 weeks 20 weeks****
Last dose 32 wks. RotaTeq, 24 wks. Rotarix
Varicella (Varivax) 1 year No upper limit
Zoster - Shingles (Zostavax) 50 years No upper limit
* Minimum Age is the earliest age at which the vaccine can be administered according to the vaccine’s licensure.
** Maximum Age is the age through which the vaccine can be administered according to the vaccine’s licensure.
Individuals older or younger than the listed ages should not receive the vaccine unless the Advisory Committee on Immunization Practices
recommends administration of the vaccine, or if a physician orders the vaccine outside the licensed ages.
Hepatitis B vaccine is the only vaccine that should be administered prior to 6 weeks of age.
*** ACIP recommends Afluria for persons 9 years of age and older and not for children 6 months through 8 years of age.
**** ACIP recommends first dose no later than 14 weeks, 6 days, however, Rotarix licensure allows first dose as late as 20 weeks of age.
IMM 702
‫ﺟﺪول اﻟﺘﻄﻌﻴﻤﺎت اﻟﻮﻃﻨﻲ‬
‫‪Vaccine‬‬ ‫اﻟﺘﻄﻌﻴﻢ‬ ‫اﻟﺰﻳﺎرة ‪Visit‬‬
‫•‬ ‫‪BCG‬‬ ‫درن‬ ‫•‬ ‫ﻋﻨﺪ اﻟﻮﻻدة‬

‫•‬ ‫‪Hepatitis B‬‬ ‫اﻟﺘﻬﺎب ﻛﺒﺪي )ب(‬ ‫•‬ ‫‪At Birth‬‬
‫•‬ ‫‪IPV‬‬ ‫ﺷﻠﻞ أﻃﻔﺎل ﻣﻌﻄﻞ‬ ‫•‬

‫•‬ ‫‪DTaP‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﺒﻜﺘﻴﺮي‬ ‫•‬
‫‪Hepatitis B‬‬ ‫ﻋﻤﺮ ﺷﻬﺮﻳﻦ‬
‫•‬ ‫اﻻﻟﺘﻬﺎب اﻟﻜﺒﺪي )ب(‬ ‫•‬
‫•‬ ‫‪Hib‬‬ ‫اﻟﻤﺴﺘﺪﻣﻴﺔ اﻟﻨﺰﻟﻴﺔ‬ ‫•‬ ‫‪2 Months‬‬
‫•‬ ‫*)‪Pneumococcal Conjugate (PCV‬‬ ‫اﻟﺒﻜﺘﻴﺮﻳﺎ اﻟﻌﻘﺪﻳﺔ اﻟﺮﺋﻮﻳﺔ@‬ ‫•‬
‫•‬ ‫**‪Rota‬‬ ‫ﻓﻴﺮوس اﻟﺮوﺗﺎ@@‬ ‫•‬
‫•‬ ‫‪IPV‬‬ ‫ﺷﻠﻞ أﻃﻔﺎل ﻣﻌﻄﻞ‬
‫•‬
‫•‬ ‫‪DTaP‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﺒﻜﺘﻴﺮي‬
‫•‬
‫•‬ ‫‪Hepatitis B‬‬ ‫اﻻﻟﺘﻬﺎب اﻟﻜﺒﺪي )ب(‬ ‫•‬ ‫ﻋﻤﺮ ‪ ٤‬ﺷﻬﻮر‬
‫•‬ ‫‪Hib‬‬ ‫اﻟﻤﺴﺘﺪﻣﻴﺔ اﻟﻨﺰﻟﻴﺔ‬
‫•‬ ‫‪4 Months‬‬
‫•‬ ‫*)‪Pneumococcal Conjugate (PCV‬‬ ‫اﻟﺒﻜﺘﻴﺮﻳﺎ اﻟﻌﻘﺪﻳﺔ اﻟﺮﺋﻮﻳﺔ@‬
‫•‬
‫•‬ ‫**‪Rota‬‬ ‫ﻓﻴﺮوس اﻟﺮوﺗﺎ@@‬
‫•‬
‫•‬ ‫‪OPV‬‬ ‫ﺷﻠﻞ اﻃﻔﺎل اﻟﻔﻤﻮي‬ ‫•‬
‫•‬ ‫‪IPV‬‬ ‫ﺷﻠﻞ أﻃﻔﺎل ﻣﻌﻄﻞ‬ ‫•‬
‫•‬ ‫‪DTaP‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﺒﻜﺘﻴﺮي‬ ‫•‬ ‫ﻋﻤﺮ ‪ ٦‬اﺷﻬﺮ‬
‫•‬ ‫‪Hepatitis B‬‬ ‫اﻻﻟﺘﻬﺎب اﻟﻜﺒﺪي )ب(‬ ‫•‬ ‫‪6 Months‬‬
‫•‬ ‫‪Hib‬‬ ‫اﻟﻤﺴﺘﺪﻣﻴﺔ اﻟﻨﺰﻟﻴﺔ‬ ‫•‬
‫•‬ ‫*)‪Pneumococcal Conjugate (PCV‬‬ ‫اﻟﺒﻜﺘﻴﺮﻳﺎ اﻟﻌﻘﺪﻳﺔ اﻟﺮﺋﻮﻳﺔ@‬ ‫•‬
‫•‬‫‪Measles‬‬ ‫اﻟﺤﺼﺒﺔ اﻟﻤﻔﺮد‬
‫•‬ ‫ﻋﻤﺮ ‪ ٩‬أﺷﻬﺮ‬
‫•‬‫‪Meningococcal Conjugate‬‬ ‫اﻟﺤﻤﻰ اﻟﺸﻮﻛﻴﺔ اﻟﺮﺑﺎﻋﻲ اﻟﻤﻘﺘﺮن‬ ‫•‬
‫)‪quadrivalent (MCV4‬‬ ‫‪9 Months‬‬
‫•‬‫‪OPV‬‬ ‫ﺷﻠﻞ اﻃﻔﺎل اﻟﻔﻤﻮي‬ ‫•‬

‫•‬‫‪MMR‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﻔﻴﺮوﺳﻲ‬ ‫•‬ ‫ﻋﻤﺮ ‪ ١٢‬ﺷﻬﺮ‬
‫•‬‫*)‪Pneumococcal Conjugate (PCV‬‬ ‫اﻟﺒﻜﺘﻴﺮﻳﺎ اﻟﻌﻘﺪﻳﺔ اﻟﺮﺋﻮﻳﺔ@‬ ‫•‬ ‫‪12 Months‬‬
‫•‬‫‪Meningococcal Conjugate‬‬ ‫اﻟﺤﻤﻰ اﻟﺸﻮﻛﻴﺔ اﻟﺮﺑﺎﻋﻲ اﻟﻤﻘﺘﺮن‬ ‫•‬
‫)‪quadrivalent (MCV4‬‬
‫•‬ ‫‪OPV‬‬ ‫ﺷﻠﻞ اﻃﻔﺎل اﻟﻔﻤﻮي‬

‫•‬
‫•‬ ‫‪DTaP‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﺒﻜﺘﻴﺮي‬
‫•‬
‫•‬ ‫‪Hib‬‬ ‫اﻟﻤﺴﺘﺪﻣﻴﺔ اﻟﻨﺰﻟﻴﺔ‬ ‫•‬ ‫ﻋﻤﺮ ‪١٨‬ﺷﻬﺮ‬
‫•‬ ‫‪MMR‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﻔﻴﺮوﺳﻲ‬ ‫•‬ ‫‪18 Months‬‬
‫•‬ ‫‪Vericella‬‬ ‫اﻟﺠﺪﻳﺮي اﻟﻤﺎﺋﻲ‬
‫•‬
‫•‬ ‫‪Hepatitis A‬‬ ‫اﻻﻟﺘﻬﺎب اﻟﻜﺒﺪي )أ(‬ ‫•‬
‫ﻋﻤﺮ ‪ ٢٤‬ﺷﻬﺮ‬
‫•‬ ‫‪Hepatitis A‬‬ ‫اﻻﻟﺘﻬﺎب اﻟﻜﺒﺪي )أ(‬ ‫•‬ ‫‪24 Months‬‬
‫•‬ ‫‪OPV‬‬ ‫ﺷﻠﻞ اﻃﻔﺎل اﻟﻔﻤﻮي‬
‫•‬ ‫ﻋﻨﺪ دﺧﻮل اﻟﺼﻒ‬
‫•‬ ‫***)‪DTaP(Td‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﺒﻜﺘﻴﺮي )اﻟﺜﻨﺎﺋﻲ اﻟﺒﻜﺘﻴﺮي(@@@‬ ‫•‬ ‫اول ا¸ﺑﺘﺪاﺋﻲ‬
‫•‬ ‫‪MMR‬‬ ‫اﻟﺜﻼﺛﻲ اﻟﻔﻴﺮوﺳﻲ‬ ‫•‬ ‫‪School Entry‬‬
‫•‬ ‫‪Varecilla‬‬ ‫اﻟﺠﺪﻳﺮي اﻟﻤﺎﺋﻲ‬
‫•‬
‫@ ﻟﻘﺎح اﻟﺒﻜﺘﻴﺮﻳﺎ اﻟﻌﻘﺪﻳﺔ اﻟﺮﺋﻮﻳﺔ )‪.( PCV13‬‬
‫@@ ﻟﻘﺎح اﻟﺮوﺗﺎ اﺣﺎدي‪.‬‬
‫@@@ ﻳﻌﻄﻰ اﻟﺜﻨﺎﺋﻲ اﻟﺒﻜﺘﻴﺮي اﺑﺘﺪاء ﻣﻦ ‪ ٧‬ﺳﻨﻮات‪.‬‬
SAIF ALGHAMDI
Herbal Medicine
Black cohosh: Contain high concentration of estrogen

- To treat Panful of menstruation
- To treat Hot flashes caused by menopause
Q- Cranberry:
- To treat Recurrent UTI
Q- Saw palmetto:
- To treat urinary symptoms of Benign Prostatic Hyperplasia BPH
Echinacea: Immunostimulants
- Supportive therapy for Respiratory tract infection
- To treat Common cold and flu
- To treat Ulcer
- In case of hard to treat superficial wounds
Feverfew:
- To treat Migraine headache
Ginkgo biloba:
- Increase cerebral blood flow
- SE: Bleeding in overdose
- Monitor: INR – PT
Milk thistle: Active of ( Silymarin )

- To treat Chronic inflammatory liver disease
- To treat Cirrhosis
Q- St. John's Wort:

- To treat Anxiety and Depressant
- SE: Liver microsomal enzyme inducer
- SE: Decrease the effect of any drug take it with it
Kava Kava:
- To treat Anxiety and Depressant
Hepatotoxic Plant: Kava Kava – Liferoot
Herbal Medicine + Dietary Supplement NEED monitoring INR and PT:

- Ginkgo biloba
- Garlic
- Co-enzyme Q10
Dietary Supplement
- Its not approved by FDA

- BUT its undergo Good Manufacturing Practice (GMP)
Fish oil: Omega 3 – EPA – DHA:
- Prevent Cardiovascular disease

- To treat ADHD
Garlic:
- To teat High cholesterol and HTN

Chondroitin + Glucosamine:
- To treat Osteoarthritis
Co-enzyme Q10:
- Antioxidant
Melatonin:
- To treat Sleep regulation in people work in different shifts.
Green tea: Contain Vitamin K
- Antioxidant
- You have to decrease concentration of warfarin
Folic acid: Pregnant
- To Prevent Neural tube defect
Vitamin C-E + Beta carotene:
- Antioxidant
- Protect from free radical
Eslam Fahmy
00201011922837
Protein
❖ Essential and non-essential amino acids

Essential Non-essential
I Isoleucine The rest

Love Lysine
Lucy Leucine
Very Valine
Much Methionine
Please Phenylalanine
Try Tryptophan
To Threonine
Help Histidine
Arginine Arginine
• Glycine and Taurine amino acids → conjugation in liver

• There are 4 amino acids that are considered the best when it comes to producing keratin: Cysteine, Lysine,
Arginine and Methionine. M A L C →→ Present in hair and nail.
Lipid
Essential fatty acids Non-essential fatty acids

• Linolenic acid • Palmitic acid
• Linoleic acid • Oleic acid
Carbohydrates
Monosaccharides • Glucose
• Galactose
• Fructose
Disaccharides • Sucrose
• Maltose
• Lactose
Polysaccharides • Starch
• Glycogen
• Cellulose
Eslam Fahmy
00201011922837
Abbreviations
AC • Before meal
PC • After meal
PRN • As needed (Dangerous abbreviation)
HS - BT • At bedtime
PO • By oral
PR • By rectum
OD • Once a day
BID • Twice a day
TID • Thrice a day
QID • Four times a day
Tw • Twice a week
QD • Every day
QOD • Every other day
QH • Every hour
QAM • Every morning
QPM • Every night
Q4H • Every 4 hours
BD • Before dinner
BBF • Before breakfast
Per diem • Daily – Per day
C • With
CC • Cubic centimeter
S • Without
Rx • Treatment
Hx • History
Dx • Diagnosis
Fx • Fracture
G - Gm • Gram
Gr • Grain
Oz • Ounce
Mg • Milligram
Mcg • Microgram
Meq • Milliequivalent
TSF • Teaspoonful = 5 ml
IM • Intramuscular
IV • Intravenous
ID • Intradermal
SC - SQ • Subcutaneous
SOS • If needed
Cap • Capsule
Eslam Fahmy
00201011922837
Antidotes
Poison/Drug Antidote
Anticholinergics (Atropine, Benztropine • Physostigmine
Xss CNS depression from Diazepam
Isoniazid (INH) • Vitamin B6 (Pyridoxine)
Valproic acid • L-carnitine
Methotrexate (MTX) • Leucovorin
Methemoglobinemia inducing agents: • Methylene blue
Nitrites, Nitrates
Digoxin • Digibind, Digifab
Beta blockers • Glucagon
Calcium channel blockers • Calcium - Glucagon
Opioids (Morphine, Heroin, Codeine, Fentanyl • Naloxone – Naltrexone - Nalmefene
Benzodiazepine (Diazepam, Zolpidem • Flumazenil
TCA (Imipramine, Amitriptyline) • Sodium bicarbonate
Warfarin • Vitamin K1 (Phyto-menadione)
Heparin • Protamine sulfate
Dabigatran • Idarucizumab
Thrombolytics • Aminocaproic acid
(Streptokinase, urokinase, alteplase, Reteplase) • Tranexamic acid
Nerve gases • Atropine followed by Pralidoxime (2-PAM)
Organophosphorus insecticides
Carbamate insecticides • Atropine
Cyanide gas • Sodium thiosulfate – Amyl nitrite – Na nitrite
Chlorine gas • Sodium bicarbonate
Carbon monoxide • 100% O2
Hydrogen sulfide • Sodium nitrite
Methanol • Ethanol – Fomepizole – Folic acid - Leucovorin
Ethylene glycol • Ethanol – Fomepizole - Pyridoxine
Iron (Fe) • Deferoxamine
Lead (Pb) • D-Penicillamine – CaEDTA – Dimercaprol – DMSA - BAL
Arsenic • BAL
Thallium • Prussian blue
Mercury • BAL – DMSA
Cupper • D-penicillamine
Lithium (Li) • Sodium bicarbonate - Polystyrene sulfonate
Paracetamol/Acetaminophen • N-Acetyl cysteine (NAC)
Aspirin (Salicylic acid) • Alkalinization (NaHCO3)
Sulfonylurea • Octreotide
Insulin • Dextrose 50%
Crotaline snake bites (e.g. Rattle snakes) • Crotalidae anti-venom (CroFab)
Black widow spider venom • Latrodectus anti-venom
Brown recluse spider bite • Loxosceles anti-venom
Scorpion sting • Scorpion anti-venom
Clostridium botulinum • Botulinum anti-toxin
Sevelamer controls high blood levels of phosphorus in people with chronic kidney disease who are on dialysis.
Eslam Fahmy
00201011922837
Drugs used in pregnancy
Hypertension Methyldopa
Labetalol
Hydralazine
HTN + Hypoproteinemia + Seizures MgSO4
Asthma Cromolyn (Category B)
Gestational diabetes Insulin
Metformin
Headache Paracetamol
DVT Heparin not Warfarin (Category X)
Tonic clonic seizures Valproic acid + Folic acid
Epilepsy Lamotrigine or levetiracetam
Depression (Mild) Fluoxetine
Hypothyroidism Levothyroxine
Hyperthyroidism Propylthiouracil (PTU)
Methimazole
Nausea and vomiting Cyclizine
UTI Nitrofurantoin
UTI + G6PD deficiency Cefuroxime
Otitis media Azithromycin
Chlamydia
Syphilis Benzathine penicillin - Penicillin (Ampicillin)
Vaginal discharge + Candida albicans Clotrimazole
Herpes (Genital infection) Acyclovir 400 bid for 7 days
Hepatitis B Tenofovir
HIV Abacavir and Lamivudine
Malaria Chloroquine, Hydroxychloroquine
Trichomoniasis Metronidazole
 Contraindications
• Misoprostol category X cause abortion
• Vitamin A is contraindicated in high doses
• Castor oil is contraindicated as laxative
• ACEi cause renal dysfunction in fetus
• Naproxen cause uncontrolled bleeding to baby
• Finasteride cause genital malformation to infant
• Warfarin (category X) cause cranial facial abnormalities → nasal bone hypoplasia
❖ Notes
• Inactivated influenza vaccine can be given in pregnancy
• Glargine (long acting) is category B
• Paracetamol oral and rectal is category B – when taken IV is category C
• Sensitive to ampicillin give Erythromycin
❖ Doses
Dose of Thyroid Hormone in Pregnancy? 1.0 - 2.0 microgram/kg/day
Eslam Fahmy
00201011922837
Vitamins & Minerals

Eslam Fahmy
00201011922837
Vitamins
Lipid soluble vitamins
Vitamin Name Function Deficiency
A Retinol • Antioxidant • Night blindness
ß-carotene• Vision → prevent xerophthalmia • Extremely dry skin, hair & nails
D Cholecalciferol • Bone growth → absorption of Ca++ • Rickets, Osteomalacia
• ↑ risk of cardio vascular diseases
E Tocopherol • Anti-oxidant → protect cell membranes • RBCs damage → sickle cell disease →
• Spermatogenesis Thalassemia
• Fertility → used in infertility cases
K Phylloquinone • Blood clotting • Bleeding
• Necessary for factors 10 – 9 – 7 - 2
Water soluble vitamins
B1 Thiamin • CHO metabolism through cofactors • Beri-Beri
• Fatigue and lack of concentration
B2 Riboflavin • Energy metabolism • Riboflavinosis
• Itching and burning eyes
• Cracks and sores in mouth and lips →
Stomatitis
B3 Niacin • Growth hormone • Pellagra →
• ↓ cholesterol • Dermatitis, Diarrhea, Dementia
• Vasodilator (VD) • Niacin flush caused by high doses.
B5 Pantothenic • CHO, protein, fat metabolism • Rare
• Enhance healing of sores and burns
B6 Pyridoxine • Protein and fat metabolism • Neurological symptoms
• Treat pregnancy vomiting • Microcytic anemia
• Antidote for INH
B7 Biotin • Beneficial in skin, hair and nails • Alopecia, anorexia, nausea, vomiting
B9 Folic acid • Synthesis of nucleic acid • Megaloblastic anemia
Month before and • Formation of blood cells • Neural tube defect
during pregnancy
• Activates B12 • Recommended in pregnancy.
B12 Cobalamin • Synthesis of nucleic acid • Pernicious anemia
• Activates B9
C Ascorbic acid • Anti-oxidant • Scurvy
• ↑ immunity → ↓ duration of cold • Gingivitis
• Production of collagen
• promote healing and skin repair
• ↑ activity of drugs used to treat H. Pylori
Vitamin D3(Cholecalciferol) Vitamin D2 (Ergocalciferol)
D3 is more effective than D2
Vitamin D is used in chronic kidney disease (CKD) to ↓ PTH
Vitamin D ↓ Breast cancer risk
Vitamin D is used with patient using corticosteroids for 6 months.
Vitamin D, in either D2 or D3 form is considered biologically inactive until it undergoes 2 enzymatic
hydroxylation reactions.
 Vitamin A in high doses (more than 15000 IU) is contraindicated in pregnancy.
 Vitamin B12 is absorbed by intrinsic factors.
 Vitamin B3 (Niacin) in doses above 500 mg daily causes transient increase in liver enzymes.
Eslam Fahmy
00201011922837
Minerals
Mineral Function Deficiency
Calcium • Makes up bone and teeth • Children → stunted growth
• Muscle contradiction and laxation • Adults → bone loss (osteoporosis)
• Blood pressure – Clotting
• Nerve functions
Chromium • Helps insulin to move glucose from blood • Abnormal glucose metabolism
to cells
Fluoride • Makes bones and teeth stronger • Tooth decay
• Helps teeth to resist decay
Iodine • Component of thyroid hormone • Goiter
• Regulate growth, development and • Cretinism
metabolism
Iron • Part of hemoglobin • Anemia
• Weakness
• Headache
• Reduced immunity
• Low cold tolerance
Magnesium • Mineralization of bones and teeth • Weakness
• Helps enzymes functions • Muscle twitches
• Muscle contraction and nerve • Confusion
transmission • Convulsions
Phosphorus • Present in bones, teeth, DNA and • Weakness
phospholipids • Bone pain
Potassium • Maintain normal electrolyte balance • Muscular weakness
• Muscle contraction and nerve • Paralysis
transmission • Confusion
Selenium • Anti-oxidant works with vitamin E • Keshan disease
• Muscle pain
• Low sperm
• Fragile red blood cells
• Heart damage
Sodium • Maintain normal electrolyte balance • Muscle cramps
• Muscle contraction and nerve • Mental apathy
transmission • Loss of appetite
Zinc • Part of insulin • Failure to growth (Kids)
• Helps many enzymes function • Dermatitis
• DNA repair • Loss of taste
• Taste perception • Poor healing
• Immune function • Sex retardation
• Wound healing
• Sperm
Vitamin C → ↑ Iron absorption.

Eslam Fahmy
00201011922837
Vitamins and minerals doses
Adult Pregnant Breast feeding Geriatric
Ca+2 1000 mg/day 1200 mg/day - 1200 mg/day
Vitamin D 600 IU 600 IU 600 IU 600 IU
800 IU → above 70
Vitamin C ♂ 90 mg - - -
♀ 75 mg
Vitamin A ♂ 1000 mcg 900 mcg 1200 mcg -
♀ 800 mcg
Folic acid ♂ 400 mcg 600 mcg 500 mcg -
♀ 400:800 mcg
FeSO4 1200 mg/day (1x1) - - -
325 mg/day (1x3)
Elemental Fe 150 mg/day (1x1) - - -
50 mg/day (1x3)
‫) أو‬Vitamin( ‫في االمتحان بيغطي على اسم‬

‫) في الرسمة و يقولك ده اسمه ايه؟‬Mineral(
Eslam Fahmy
00201011922837
NOURA ALGHARABI
ADHERENCE
In medicine, patient compliance (also adherence, capacitance) describes the degree to which a
patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance
Medication adherence can be assessed through both direct and indirect measures. Indirect measures
include both subjective (self-report measures such as questionnaire and interview) and objective (pill
count and secondary database analysis) measures and constitute the mainstay of assessing medication
adherence.
MEASURING ADHERENCE : METHODS, APPLICABILITY , AND

CHALLENGES IN LOW -RESOURCE SETTINGS
The correct assessment of medication adherence is universally recognized as a medical
challenge. The practical methods for estimating medication adherence (direct and indirect
methods) along with the lacunae in their application in low-resource settings are described below
[12,18].
Direct (objective) measures

These measures can be used to validate subjective measures and provide the most accurate
estimate of medication adherence. However, they are not feasible for a large population,
nonclinic and community settings and also require substantially more resources compared to
indirect methods.
Direct observation of therapy

The patient act of consuming the recommended medication is observed by an external observer
like a family member or a trained provider. It can be considered as the closest to the gold
standard for assessing medication adherence. Direct observation of patient adherence by
attendants or family members can be used to corroborate patient testimony or when the patient is
incapable of reporting adherence like in children or dementia patients. When a family member is
specifically involved in supporting patient adherence like through reminders for medication
intake or application of an injectable drug, direct observation becomes a particularly useful
measure for assessing medication adherence.
Drug assays and biomarkers

These methods are limited by the need for obtaining patient blood and urine samples, differing
rates of drug metabolism which renders it difficult for quantification of drug concentration of
very fast-metabolizing and very slow-metabolizing drugs which remain in the blood in small
concentration even after drug cessation. There is also a tendency for patients to improve their
adherence just before physician appointments (white coat adherence) while remaining
nonadherent in the intervening periods [9].
NOURA ALGHARABI
Indirect measures
These methods imply that the medication intake has been initiated and is being used by the
patient. They can be both subjective and objective measures. Most indirect measures rely on
calculating an average percentage of medication consumed or refilled over time. However,
treatment outcomes are also related to treatment execution factors such as timing of drug intake
and correctness of drug dosage, especially for nonpill regimens which remain unassessed with
these standard measures for assessing medication adherence.
Indirect subjective measures

These can be applied in patient care or community settings as they facilitate rapid patient self-
reported assessments of medication adherence.
Patient interviews: It is used to calculate a numerical proportional value between 0 and 100
which is known as the drug adherence rates (DAR). It is calculated as the proportion of
prescribed medication pills taken by the patient over a specified time interval. However, the
results are subject to recall bias, particularly when the specified duration for the recall is long.
The cutoff value for patient adherence is based on the expected DAR required to induce
treatment outcomes. The DAR should be ≥95% or preferably 100% for antiretroviral therapy in
HIV-AIDS [26], ≥90% in tuberculosis, and ≥80% for most of the other chronic diseases [7].
When querying patients regarding their medication use, an important validated question is “have
you missed any pills in the past week?” The question has high specificity but low sensitivity due
to the patient tendency to please the physician by denying any missed doses [27,28]. Prefixing
the question with an empathetic statement like “patients often have difficulties in remembering
to take all their medications” can help reassure patients and make them more amenable to telling
the truth [13]. When quantifying the extent of medication nonadherence, a similar question can
be used, “how often you forget taking your medications” or “how often you miss taking your
medications in the previous (time interval).”
 ii.
Questionnaires for assessment of adherence for various disease conditions are

summarized in Table 1. Medication Adherence Questionnaires (MAQs) or scales with
good psychometric properties and high predictive validity are recommended for
assessment of adherence. Items in these questionnaire scales assess different aspects of
patient behavior relating to medication nonadherence such as carelessness, forgetfulness,
the frequency of missed doses, difficulty in adherence due to work, travel or when
engaged in occupational activities, perceived side effects, self-modification of medication
frequency or dosage, and adherence during weekends or extended holidays. Assessment
by questionnaire unlike other methods apart from identification of nonadherence can also
recognize behavioral causes of patient nonadherence which may be modifiable through
suitable behavior change interventions.
NOURA ALGHARABI
 iii.
Medication diaries: Patients or participants of a trial keep a record of the date and time of
consumption of each dose of medication and whether it was consumed with or without
food. This permits the investigator to assess and track patient execution of adherence.
Like self-report measures, medication diaries are susceptible to overreporting due to the
self-desirability bias of the patient. Underreporting may also occur if the patient out of
carelessness omits to record some of the medication doses taken into the diary. In patients
who are functioning illiterate, the method is not feasible unless assisted by a literate
caregiver or family member.
Indirect objective measures

These can be applied in research and administrative settings.
Electronic medication packaging devices
Electronic medication packaging devices provide real-time monitoring and feedback on
adherence performance. The most commonly used instrument is the Medication Event
Monitoring System which is a medication bottle cap with a microprocessor that records the
occurrence and time of each bottle opening. However, despite their high accuracy, the high cost
of such devices renders them unsuitable for large sample size studies [43].
Pill counts
Pill counts are calculated by counting the number of dosage units consumed by the patient
between two scheduled appointments or clinic visits. The medication bottle or strips dispensed
during the previous visit are brought by the patient. The number of pills taken by the patient is
then calculated by subtracting the count of the number of pills remaining from the total number
of pills dispensed which is divided by the product of prescribed doses and the number of days
between those two visits to obtain the proportion of days covered (PDC). However, the pill count
method cannot ascertain if the patient actually consumed the medication and if was taken as per
prescribed dose and frequency [44]. Pill count measures are cumbersome for both the patient and
the assessor and can be time-consuming. The presence of surplus medication with the patient is
also not accounted for in this method. Pill counts are also not feasible in circumstances when
patients do not usually preserve their empty medication vials and strips. However, pill count
measures have been successfully applied in public health facilities in the developing world when
estimating adherence in HIV and TB patients, diseases which are associated with considerable
stigma and discrimination. This suggests that patients are likely to adhere to pill count
requirements when it is mandated to do so. Pill count methods can evaluate medication
adherence in community settings also.
Prescription or pharmacy records (secondary database analysis)
These methods are used for assessment of refill adherence, in which prescription refilling
behavior of the patient is considered to correspond with medication intake behavior. The
pharmacy supply adherence measures are classified as based on the medication supply
(possession with the patient) and supply not made (treatment gap). Two of the most common
measures based on the medication possession are as follows: (a) Medication Possession Ratio: it
NOURA ALGHARABI
is calculated as the number of days for which medication was supplied divided by the number of
days during the period from index fill to the last scheduled refill [44] and (b) the PDC: it is
calculated as the number of days in which a medication was available with the patient divided by
the total number of days in the data analysis period [18].
Secondary database analysis has several advantages compared to self-report methods: secondary
data, when extracted from electronic records, is less prone to error and takes less time for
analysis and can be done retrospectively at any specific period, ethical issues are minimal, and
patient-related biases are absent.
A major drawback of secondary database analysis methods is their assumption that medication
possession with patients corresponds with their medication intake. Furthermore, in low-resource
settings, their application is hindered due to the following reasons: First, the validity of
secondary data analysis for assessing medication adherence is fundamentally dependent on the
data quality. Electronic health records are needed for analysis of large retrospective databases
which may be missing in these settings. Second, the utilization of pharmacy and insurance
records is unsuited to environments where a significant proportion of patients lack health
insurance and are not assigned designated physicians and health facilities for their treatment
purposes. Third, if the patient has access to private pharmacies and other health-care facilities
where medicine can be dispensed on an outdated prescription or even without it, the prescription
filling data is rendered ineffective for evaluation of patient adherence [45]. In these
circumstances, the prescription or pharmacy record has to be supplemented with patient self-
report for the duration of missing refills which undermines to a large extent the objectivity and
validity of the original measure. For instance, a patient who misses his clinic appointment can
self-report medication purchases from out of pocket. The accuracy of such statements is difficult
to verify in health systems where the fulfillment of medication refills on old prescription is not
uncommon.
NOURA ALGHARABI
CLASSI FICATI ONOFADVERSEDRUGREACTI ONS
Ty peofr eaction Feat ures Exampl es Management
TypeA: Common Toxi cef fects: digoxin Reducedoseor
Dose-Rel at ed toxicit y,ser otonin withhol d;
Relatedtophar macol ogical
(Augment ed) syndr omewi t
hSSRI s Consi deref fectsof
acti
onoft hedr ug
Sideef fect s: concomi tantt herapy
Predict
ableLowmor t
ali
ty Ant ichol inergicef fects
ofTCAs
TypeB: • Uncommon Immunol ogical Wi t
hhol dandav oidi
n
Non-DoseRel ated • NotRel atedt o react ions: penicill
in future
(Bizar r
e) phar macol ogical hyper sensi tivi
ty
actionoft hedr ug Idi
osy ncr at i
cr eactions:
•Unpr edi ct
abl e Acut epor phy ri
a
•Highmor talit
y Mal ignant
hyper ther mia
Pseudoal lergy( eg.,
ampi cill
inr ash)
TypeC: • Uncommon Hy pot hal ami c-pituit
ary- Reducedoseor
Dose-r elat edand • Rel at edt ocumul ati
ve adr enal axis withhol d;Wi thdrawal
Time- r
elat ed dose suppr essi onby mayhav etobe
(Chr onic) cort i
cost eroids prolonged
TypeD: • Uncommon Ter atogenesi s Ofteni ntractable
Time- r
elat ed •Usual lydose- r
elated Car cinogenesi s
(Del ayed) • Occur sorbecomes Tar div edy ski nesia
appar entsomet i
me
aftert heuseoft he
drug
TypeE: • Uncommon Opi atewi thdr awal Reintroduceand
Wit hdrawal • Occur ssoonaf ter syndr ome withdrawsl owl y
(Endofuse) withdr awal ofdrug My ocar dial ischemi a(β
-bl
ockerwi thdr awal)
TypeF: • Common Inadequat edosageof I ncreasedosage
Unexpect edf ailureof •Dose- related anor al cont racept ive Consi deref fectsof
ther apy • Of tencausedbydr ug- part i
cul ar l
ywhenused concomi tantt herapy
(Failure) i
nter act ion withspeci ficenzy me
i
nducer s
CLASSI
FICATI
ONOFMEDI
CATI
ONERRORS
1-Typeofe
rror
 Pr
esc
ribi
nge
rror
:Er
ror
sint
hisc
ate
gor
yar
efa
irl
ybr
oad,butge
ner
all
yf usoni
oc nappr
opr
iat
edr
ug
s
ele
cti
on,dos
e,dos
agef
orm,orr
out
eofa
dmi
nis
tra
tion.
 Wr
ongt
imee
rror
:Inge
ner
al,t
hist
ypeofe
rroroc
cur
swhe
nados
eisnota
dmi
nis
ter
edi
nac
cor
danc
ewi
th
apr
ede
ter
mine
dadmi
nis
tra
tioni
nte
rva
l.
 Omi
ssi
one
rror
:Anomi
ssi
one
rroroc
cur
swhe
napa
tie
ntdoe
snotr
ece
iveas
che
dul
eddos
eofme
dic
ati
on.
Thi
sisc
ons
ide
redt
obet
hes
econdmos
tcommone
rrori
ntheme
dic
ati
onus
epr
oce
ss,be
hindwr
ongt
ime
e
rror
s.
.
 Una
uthor
ize
ddr
uge
rror
:Thi
stypeofe
rroroc
cur
swhe
npa
ti
ent
sre
ceveadr
i ugt
hatwa
snota
uthor
ize
dby
a
nappr
opr
iat
epr
esc
ribe
r.Thi
smi
ghti
ncl
udegi
vingt
hewr
ongpa
ti
entame
dic
ati
on
 I
mpr
ope
rdos
eer
ror
:Thi
ser
roroc
cur nt
swhe hedos
eadmi
nis
ter
edi
sdi
ff
ere
ntt
hanwha
twa
spr
esc
ribe
d,
a
ssumi
ngt
hatt
hepr
esc
ribe
ddos
ewa
sappr
opr
iat
e
 Wr
ongdos
agef
orme
rror
:Thi
ser
roroc
cur
swhe
napa
ti
entr
ece
i sados
ve agef
ormdi
ff
ere
ntf
romt
hat
pr
esc
ribe
d,a
ssumi
ngt
hea
ppr
opr
iat
edo
sagef
ormwa
sor
igi
nal
lyor
der
ed.
 Wr
ongdr
ugpr
epa
rat
ione
rror
:Whe
nme
dic
ati
onsr
equi
res
omet
ypeofpr
epa
rat
ion,s
ucha
sre
cons
ti
tut
ion,
t
hist
ypeofe
rrorma
yoc
cur
.The
seki
ndsofe
rror
sma
yal
sooc
curi
nthec
ompoundi
ngofva
rious
i
ntr
ave
nousa
dmi
xtur
esa
ndot
herpr
oduc
ts
 Wr
onga
dmi
nis
tra
tiont
echni
que
:The
see
rror
soc
curwhe
nadr
ugi
sgi
vent
oapa
tie
nti
nappr
opr
iat
ely.
Exa
mpl
e:whe
nana
gentme
antf
ori
ntr
amus
cul
ara
dmi
nis
tra
ti
oni
sgi
veni
ntr
ave
nous
ly
 De
ter
ior
ate
ddr
uge
rror
:Thi
ser
roroc
cur
swhe
ndr
ugsa
rea
dmi
nis
ter
edt
ha vee
tha xpi
redorha
ve
de
ter
ior
ate
dpr
ema
tur
elyduet
oimpr
ope
rst
ora
gec
ondi
ti
ons
.
 Moni
tor
inge
rror
:The
see
rror
soc
curwhe
npa
ti
e sa
nt r
enotmoni
tor
eda
ppr
opr
iat
elye
it
hera
fte
rthe
yha
ve
r
ece
ive
dadr
ugorbe
for
ethe
yre
cei
vedadr
ug.
 Compl
ianc
eer
ror
:Thi
stypeofe
rroroc
cur npa
swhe tie
ntsus
eme
dic
ati
onsi
nappr
opr
iat
ely.Pr
ope
rpa
ti
ent
e
duc
ati
ona
ndf
oll
ow-
upma
ypl
ayas
igni
fi
cantr
olei
nmi
nimi
zi
ngt
hist
ypeofe
rror
.
CLASSI
FICATI
ONOFMEDI
CATI
ONERRORS
2
-se
ver
it
yorout
come
1.NOERROR:
 Ca
tegor
yA:Ci
rcums
tanc
esore
vent
stha
tha
vet
hec
apa
cit
ytoc
aus
eer
ror
2.ERROR,NOHARM
Ca
tegor
yB:Ane
rroroc
cur
red,butt
heme
dic
ati
ondi
dnotr
eac
hthepa
ti
ent
.
Ca
tegor
yC:Ane
rroroc
cur
redt
hatr
eac
hedt
hepa
ti
ent
,butdi
dnotc
aus
ethepa
ti
entha
rm.
 Ca
tegor
yD:Ane
rroroc
cur
redt
hatr
esul
te
dint
hene
edf
ori
ncr
eas
edpa
ti
entmoni
tor
ing,butc
aus
edno
pa
ti
entha
rm
3.ERROR,HARM
 Ca
tegor
yE:Ane
rroroc
cur
redt
hatr
esul
te
dint
hene
edf
ort
rea
tme
ntori
nte
rve
nti
ona
ndc
aus
edt
empor
ary
pa
ti
entha
rm.
Ca
tegor
yF:Ane
rroroc
cur
redt
hatr
esul
te
dini
nit
ia
lorpr
olonge
dhos
pit
al
iz
ati
ona
ndc
aus
edt
empor
ary
pa
ti
entha
rm.
Ca
tegor
yG:Ane
rroroc
cur
redt
hatr
esul
te
dinpe
rma
nentpa
ti
entha
rm.
 Ca
tegor
yH:Ane
rroroc
cur
redt
hatr
esul
te
dinane
ar-
dea
the
vent(
e.g.
,ana
phyl
axi
sandc
ardi
aca
rre
st)
.
4
.ERROR,DEATH
 Ca
tegor
yI:Ane
rroroc
cur
redr
esul
ti
ngi
npa
ti
entde
ath.
For diseases by Asma alsadeg
Sofa score = septic shock ▪
Curbs65 score = pneumonia CAP ▪
Cha2ds2vasc =atrial fibrillation ▪
Glascoma score = Central nerve system ▪
ACS ischemic heart disease has led score ▪
Child pugh score =liver disease ▪

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Ethics

By Eslam Ashraf Fahmy

❖ Main ethical principles (Basic principles of ethics) → Moral rules

1- Autonomy • The right of individuals to self-rule and make decisions about:

❖ Common characteristics of professionalism

Macro ethical issues Micro situations

❖ Ethical conflicts and issues in health care

Law and Ethics

By Eslam Ashraf Fahmy

Nucleotide • Basic structural unit of DNA & RNA

Gene • Stretch of nucleotides that codes for a single protein

DNA • Genetic material that is the main component of chromosome

Polymorphism • Genetic variation is common 1% or more

Single nucleotide • Change in a single nucleotide in a genetic sequence.

Abacavir HLA-B (5701) • ↑ HLA-B (5701) → Hypersensitivity

1- Which of the following is correct?

3- A child is rapid metabolizer of CYP2D6. How would his body respond?

4- A Chinese patient is going to be started on carbamazepine. He should be tested for:

6- Which of the following best describes chromosome?

Indirect • Costs of ↓ productivity (e.g., morbidity and mortality costs).

Perspective • the point of view from which a pharmacoeconomically study is conducted.

2 In cost utility analysis which one is the outcomes?

3 What is the benefit of pharmacoepidemiology

4 The economic study for life adjusted year quality?

cost of medicine and cost of loss productive

❖ Consumer health information:

National library of medicine www.medlinelus.gov

Text books Databases/Applications

Pink book CDC • Provides information on epidemiology and vaccine-preventable diseases

Red book Pharmacy • Provides drug pricing information

Red book Medicine • Summaries of infectious diseases

 Special for Adverse drug reactions

3- IV medications Compatibility and stability

4- medication safety in pregnancy and lactation

1 Phase 1 of drug development

3 Color drug references

5 Which the following have error in prescription

6 What is the lowest level of evidence in the evidence pyramid

10 pharmacokinetic in which phase

16 how many phases applied to drug to be approved by FDA ?

17 if a medication error happened, the first person to refer to ?

18 Benefits of using the unit - dose system ?

19 Type of pharmacist salary?

20 Committee consists of five members

21 Example direct medical cost and an indirect cost

22 USP General chapter

23 Directly decrease medication errors ?

24 Medication characterized by low cost fast moving ?

26 Mission and vision , which type of planning?

27 example of ethical principles

28 tertiary resources example ?

29 patient said : “ i have pain ..... “ this considerd part of :

BY:. Hasan Daghriri & Abdullelah Arishi

Overview of the design tree

 The Study design can be divided into two main types :

By: Hasan Daghriri & Abdullelah Arishi

 Types of Descriptive study (PO) :

By: Hasan Daghriri & Abdullelah Arishi

** If we want to conduct an observational analytical study : we will choose a groups of

** if we want to conduct an experimental analytical study : we will choose 2 groups of

**Note : cross-sectional study can be descriptive or analytical , it depend on your

By: Hasan Daghriri & Abdullelah Arishi

By: Hasan Daghriri & Abdullelah Arishi

 Interpretation of the Odds Ratio :