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SPLE Preparation

Course
College of Pharmacy, PNU
Day 1

23/12/2018 College of Pharmacy, PNU SPLE Preparation Course


Day 1 Schedule

Day 1 : 23 Dec 2018


Time Topic Speaker SPLE Exam
Area
9.00-9:30 Biochemistry Dr. Asmaa 1.2
9:30-9:45 Microbiology Related to Human Disease Dr.Najwa 1.3
9:45-10:30 Immunology Dr. Areeg 1.4
4.4.3
10:30-11:30 Health Care Delivery Systems and Public Health Dr.Ayedh 3.1
Pharmacy Practice Management 3.4
Medication Dispensing and Distribution Systems 3.10
11:30-12:30 Clinical Pharmacology and Therapeutic Decision Dr.Alaa / Dr. 4.6
Making Madonna/dr bushra/
dr badriya
12:30-1:30 Lunch Break
1:30-2:10 Pharmacy Law and Regulatory Affairs Dr. Elham 3.5
Ethical Decision Making 3.7
2:10-2:50 Professional Communication Dr. Kholoud 3.8
3.9
Social and Behavioral Aspects of Pharmacy Practice 2
Disclosure

▰ The authors of these presentation have nothing to disclose concerning the


possible financial or personal relationship with commercial entities that may
have a direct or indirect interest in the subject matter of these materials.
▰ This material is NOT comprehensive and not a reference to study for SPLE, it
is only a study guide
▰ SPLE study references are available on:
https://www.scfhs.org.sa/examinations/TrainingExams/OverallEntranceExam/
Documents/Saudi%20Pharmacist.pdf
▰ It is the pharmacist/student responsibility to review the references mentioned
in the link above before the exam
▰ For more information about the exam and exam blueprint visit:
https://www.scfhs.org.sa/examinations/Documents/Saudi%20Pharmacist%20
Licensure%20Examination%20Blueprint.pdf

23/12/2018 College of Pharmacy, PNU SPLE Preparation Course


23/12/2018 College of Pharmacy, PNU Dr.Asmaa Saleh
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THANK YOU
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SPLE
1.3 Microbiology
By
Prof. Dr. Nagwa Ghaly

23/12/2018 College of Pharmacy, PNU Dr.Nagwa Ghaly


Cells: fundamental
Click units of life
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23/12/2018 College of Pharmacy, PNU Dr.Nagwa Ghaly


Bacterial Cell Structure

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Cell walls of bacteria

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Gram +ve cell wall

Gram –ve cell wall

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Fimbriae Versus Flagella

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Metabolic Needs

Nutritional Energy Environmental


Requirements Factors

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Bacterial Growth Curve

TURBIDITY Stationary
(cloudiness)

Autolysis
Log

Lag

TIME

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Basic virus structure

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OVERVIEW

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Causes of URT infections
1- Bacteria
• Streptococcus pyogenes: is the only
common primary bacterial cause of pharyngitis
with or without tonsillitis.
• H. influenzae type b -----> epiglottitis.
• C. diphtheria -------- > diphtheria.

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Causes of URT infections

2- Viruses :
• Rhinoviruses (> 100 types).
• Corona viruses.
• Adenoviruses.

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Bacterial Infections of Lower
Respiratory Tract
1- Strept. pneumoniae
2- Haemophilus influenzae
3- Klebsiella pneumoniae
4- Chlamydia pneumoniae
5- Mycoplasma pneumoniae
6- Legionella pneumophila
7- Mycobacterium tuberculosis.
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Major causes of meningitis:
• A-Bacteria:
1- Gram stainable
1-Neisseria meningitidis
2-Haemophilus influenzae
3-Streptococcus pneumoniae

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• 2- Acid fast bacilli
Mycobacterium tuberculosis.

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• B- Viruses (Aseptic meningitis)
1-Enteroviruses (Echo,Coxsackie,polio)
2-Paramyxoviruses (Mumps)
3-Herpes simplex viruses

• C- Fungi:
1-Candida albicans
2-Cryptococcus neoformans
3-Aspergillus fumigatus
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Bacterial causes of urinary tract infection

1- Escherichia coli.
2- Proteus species.
3- Enterococcus faecalis.
4- Klebsiella aerogenes.
5- Other coliforms.
6- Pseudomonas aeruginosa.
7- Staphylococcus aureus.
8- Staphylococcus saprophyticus

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Enteric Bacterial Infections
1- Enterobacteriacae
a- Salmonella
b- Shigella
c- E. coli
2- Vibrio
3- Campylobacter
4- Bacterial toxin associated food poisoning

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Sexually Transmitted Infections
• Infections that can be transmitted through:
- Sexual activity,
- Skin to Skin contact,
- Body fluids,
- From mother to baby in childbirth
• Three broad categories:
1- Discharge diseases
2- Ulcer diseases
3- Wart diseases
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1- Discharge Diseases of Genital Tract
Infection

• Increase in fluid discharge in male and female


reproductive tracts
• Includes
1- Gonorrhea,
2- Chlamydia infection

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2- Ulcer Diseases of Genital Infection
• Three common infectious conditions resulting
in ulcers on a person’s genitalia
1- Syphilis (Treponema pallidum)
2- Chancroid (Haemophilus ducreyi)
3- Genital herpes (Herpes simplex virus 1,2)
• Having one of these diseases increases the
chances of infection with HIV because of the
presence of open lesion.
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3- Wart Diseases of Genital Infection
• Human papillomavirus (HPV)
– Causative agents of genital warts
– An individual can be infected with HPV without
having warts.
• Molluscum Contagiosum
– Wart-like growths on the mucous membranes or
skin of the genital area

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THANK YOU
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1.4. Immunology
Dr. Areej Elmahdy

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• Immunology: is the study of our protection from foreign
molecules or invading organisms and our responses to them.
These invaders include viruses, bacteria, protozoa or even
larger parasites.
• Immunization: means how to provide body with immunity
against diseases to prevent or limit infection by
microorganisms such as bacteria, virus and fungi.
• Antigen: is foreign material causing an immune response
e.g. pollen grain, bacteria, fungi, virus and organic pollutants

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• Antibodies: are specific substances formed in the body in
response to antigenic stimulation and react specifically with
antigen that stimulate their production. They are called
immunoglobulin (Ig)

• Immune System: It is our immune system that enables us to


resist infections. The immune system is composed of two
major subdivisions:
I- The innate or nonspecific immune system
II- The adaptive or specific immune system.
• The innate immune system is our first and second line of
defense against invading organisms, while the adaptive
immune system acts as a third line of defense .
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Innate Immunity
Characteristics
• Exists naturally at birth.
• Non–specific.
• Rapid response to microbes (the first line of defense against
infection).
• No immune memory (innate immunity cannot be enhanced
by the second stimulation of the same antigen).

Immune memory: Exposure of the immune system to a


foreign antigen enhances its ability to respond again

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First Line of Defense of innate immunity
A. Anatomical barriers to infections
1. Skin
• The intact skin acts as the first line of defense against invading
organisms.
• The outer layer of skin (epidermis) is a very effective physical
barrier against invasion by microorganisms.
• Moreover, the superficial cells are continually peel off when
die, so, they eliminate the organisms colonizing the skin.

2- Respiratory tract: Continuous movement due to the


covering cilia helps to expel M.o from respiratory tract.
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B. Mucus membranes and their secretions
▪ Sebaceous glands secretion contains fungicidal fatty acids,
which constitute effective barrier against fungal infections.
▪ Skin secretions also contain many other microbial
substances include sweat gland secretion, in addition to
acidity of sweat (pH 5.5)
▪ Nasal secretions contain mucopolysaccharides, which have
antiviral effect.
▪ Vagina is resistant to infection during childbearing years as a
result of lactic acid production by lactobacilli
▪ Frequent flushing action of urination prevent bacteria from
entering the system via urethra.
▪ The flushing action of tears helps prevent infection of the
eyes.
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C. Normal microbiota

• Normal microbiota help protect the body by competing with


potential pathogens.
• Various activities of the normal microbiota make it hard for
pathogens to compete
➢Consumption of nutrients makes them unavailable to
pathogens.
➢Create an environment unfavorable to other microorganisms
by changing pH.

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Second Line of Defense of innate immunity

A. Inflammation
• Non specific response to tissue damage.
• Characterized by: redness, heat, swelling, and pain.
• Two types: Acute & Chronic.

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Types of inflammation
Acute inflammation
▪ Develops quickly and is short lived.
▪ Is usually beneficial.
▪ Important in the second line of defense
• Dilation and increased permeability of the blood vessels
• Migration of phagocytes
• Tissue repair
Chronic inflammation
▪ Develops slowly and lasts a long time.
▪ Can cause damage to tissues.

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Stages of Inflammation

1. Vasodilation of blood vessels: by histamine, kinins,


prostaglandins, and leukotrienes released by damaged cells.
➢ Vasodilation allow WBCs and clotting factors to enter the tissue.
2. Attract more phagocytes to the area (The reason why the body
has an inflammatory response).
➢ Phagocytes destroy microbes, as well as dead and damaged host cells.
3. Tissue Repair: Dead and damaged cells are replaced.

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B. Fever

• A body temperature over 37C.


• Hypothalamus acts as body’s thermostat
• Endotoxin produced by microbe causes phagocytes to release
interleukin–1 (IL–1), which is an endogenous pyrogen.
• IL-1 production causes the hypothalamus to secrete
prostaglandin which resets the hypothalamic “thermostat”
• Communication with the brain initiates muscle contractions,
increased metabolic activity, and constriction of blood vessels
which raises the body’s temperature.
• Decrease in IL-1 production results in the body’s temperature
returning to normal.
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C. Antimicrobial substances

1) Coagulation system
2) Lactoferrin and transferrins
3) Lysozyme
4) Interferons
5) The complement system

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1. Coagulation system :
▪ Activated after tissue injury.
▪ Products of the coagulation system are directly antimicrobial.
▪ For example, β-lysin, a protein produced by platelets during
coagulation can lyse many Gram-positive bacteria.

2. Lactoferrin and transferrin :


By binding iron, an essential nutrient for bacteria, these proteins
limit bacterial growth.

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3. Lysozyme
• They are found in high concentrations in tears.
• They are found in almost all body fluids except urine, CSF and
sweat.
• In addition, they are present intracellularly within phagocytes.
• They have mucolytic activity, splitting off the cell wall of Gram-
positive bacteria causing lysis.

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4. Interferons
• It is a glycoprotein.
• It act non specifically to inhibit the spread of viral infections.
• -IFN and -IFN: produced by virus infected cells. Mode of action
is to induce uninfected cells to produce antiviral proteins (AVPs)
that inhibit viral replication.
• -IFN: produced by lymphocytes. Causes neutrophils and
macrophages to phagocytize bacteria. Also involved in tumor
immunology.

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5. The complement system
• The complement system is the major humoral non specific defense
mechanism.
• It is a complex series of approximately 30 serum proteins.
• The complement system has three major activities :
• Initiation of the inflammation.
• Identifying materials for removal by phagocytic cells (opsonization).
• Lysing a susceptible bacterial cell.

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Cells of Innate Immunity

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Cellular Elements of Blood
Cell Type # Cells/mm3 Function
Erythrocytes (RBC) 4.8-5.4 million Transport O2 and CO2

Leukocytes (WBC) 5000-9000 Various


A. Granulocytes:
1. Neutrophils (70% of WBC) Phagocytosis
2. Basophils (1%) Produce histamine
3. Eosinophils (4%) Toxins against parasites
some Phagocytosis
B. Monocytes/Macrophages (5%) Phagocytosis

C. Lymphocytes (20%)
(B cells) Antibody production
(T cells) Cell mediated adaptive immunity
NK cells (natural killer) Killing of virus infected cells and
cancer cell
Platelets 300,000 Blood clotting

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Cells of innate immunity
White Blood Cells (WBCs):
▪ White blood cells or leukocytes serve as defenders against infection.

WBCs are classified into:


A. Granulocytes:
▪ Leukocytes that contain cytoplasmic granules & are known as
granulocytes.
1. Neutrophiles/Polymorphonuclear cells (PMNs)
▪ PMNs are motile phagocytic cells that have lobed nuclei.
▪ They contain two kinds of granules the contents having antimicrobial
properties.
▪ Most abundant WBCs (~50-60%).
▪ Efficient phagocytes.
▪ Most important cells of the innate immune system.
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2. Basophils
▪ Activation leads to degranulation, releasing histamine, serotonin, and
eosinophil chemotactic factor (soluble molecules which attract and
guide the movement of cells such as phagocytes in the inflammatory
response.)
3. Eosinophils
▪ Attracted to parasites (helminths or protozoa).
▪ Secretes toxic basic proteins onto parasite surface.
▪ Parasite-specific IgE greatly enhances binding to parasite.

B. Monocytes/Macrophages
▪ Monocytes migrate from the blood and develop into macrophages
and dendritic cells in tissues.
▪ Phagocytosis of microbes in tissue (while neutrophils are present
only in blood).
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Antigen presenting cells

▪ A specialized subset of cells.


▪ These are a heterogeneous population of leukocytes that play an
important role in innate immunity and act as a link to the adaptive
immune system by participating in the activation of helper T cells
(Th cells).
▪ These cells include dendritic cells and macrophages.

C. Natural killer cells


▪ Important part of the innate immune system.
▪ Kill virus /bacteria infected cells (Intracellular pathogens).
▪ Kills cancer cells.

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Adaptive Immunity

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Adaptive Immunity
Characteristics
• Specificity: ability to distinguish pathogens due to the great diversity of
B cells and T cells.
• Self/Nonself Recognition: T cells and B cells have the ability to
recognize one’s own cells versus a pathogen (invader).
• Diversity: There are potentially billions of different antigen receptors on
B cells and T cells that recognize billions of different antigens.
• Immune memory: adaptive immunity can be enhanced by the second
stimulation of the same antigen.
• Much slower than innate immunity.
• Take effects after innate immune response. Therefore, it is the third line
of defense against infection.

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The adaptive immune response is divided into two systems:

Humoral (antibody-mediated) immunity


▪ Eliminates extracellular pathogens and makes antibodies to
eliminate pathogen and their products.

Cellular (cell-mediated) immunity


▪ Eliminates intracellular pathogens that invaded cells and regulates
the body's entire immune response.

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Cells of adaptive immune system

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Cells of the adaptive immune system
▪ The cells of the adaptive immune system are a type of leukocyte,
called a lymphocyte.
▪ All lymphocytes originate in the red bone marrow.
B cells:
▪ Are synthesized and mature in the red bone marrow, and remain in
the marrow to mature.
▪ Play a large role in the humoral immune response.
▪ B-cell receptors recognize antigen in native form (as they exist in
nature).
▪ Once activated by antigen, proliferate in blood and secondary
lymphatic organ (lymph nodes, spleen and lymphatic tissue) into two
types of cells: plasma cells that secrete antibodies and memory
cells that may be converted into plasma cells at a later time

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Cells of the adaptive immune system
T cells:
▪ Are synthesize in bone marrow but mature in the thymus.
▪ Are intimately involved in cell-mediated immune responses.
▪ T-cell receptors cannot recognize native antigen, recognize only
antigens represented by APCs (Antigen presenting cells), such as:
macrophages, dendritic cells or B cells.
▪ Several types of T cells: cytoxic T cells, helper T cells, suppressor T
cells, and memory T cells

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Immunoglobulins

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Immunoglobulins (Antibodies)
➢ Glycoprotein molecules which are produced by plasma cells in
response to an immunogen (antigen).
➢ Antibodies are the primary defense against extracellular
pathogens.

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Immunoglobulins function in three major ways:
1. Complement activation
Can result in lysis of certain bacteria and viruses.
2. Neutralization
• Neutralizing antibody is an antibody which defends a cell from an
antigen or infectious body by inhibiting or neutralizing any effect it
has biologically.
• They have the ability to neutralize function without a need for
white blood cells.
• For example: antibody to diphtheria antitoxin can prevent the
binding of the toxin to host cells thereby neutralize the biological
effects of diphtheria toxin.
3. Opsonization
• Opsonization involves the binding of an opsonin, e.g., antibody, to a
receptor on the pathogen's cell membrane.
• After opsonin binds to the membrane, phagocytes are attracted to the
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3. IgA
▪ Serum IgA is a monomer but IgA found in secretions is a dimer.
▪ IgA is the second most common serum Ig.
▪ IgA is the major class of Ig in secretions, tears, saliva, colostrum
and mucus.
▪ Normally IgA does not fix complement, unless aggregated.
▪ When IgA is found in secretions is also has another protein
associated with it called the secretory piece or T piece.

4. IgD
▪ IgD exists only as a monomer.
▪ IgD is primarily found on B cell surfaces, where it functions as a
receptor for antigen.
▪ IgD does not bind complement.

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1. IgG
▪ All IgG's are monomers.
▪ Most versatile immunoglobulin because it is capable of carrying
out all of the functions of immunoglobulin molecules.
▪ IgG is the major Ig in serum - 75% of serum Ig is IgG.
▪ IgG is the only class of Ig that crosses the placenta.

2. IgM
▪ IgM normally exists as a pentamer but it can also exist as a
monomer.
▪ IgM is the 3rd most common serum Ig.
▪ IgM is the first Ig to be made by B cells when it is stimulated by
antigen.
▪ Because of its pentameric structure, IgM is a good complement
fixing Ig
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5. IgE
▪ IgE exists as a monomer
▪ IgE is the least common serum Ig since it binds very tightly to
receptors on basophils and mast cells even before interacting with
antigen.
▪ Involved in allergic reactions.
▪ IgE also plays a role in parasitic helminth diseases.

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Antigens

Antigen (Ag): a substance that reacts with the products of a


specific immune response.

Haptens: are small molecules which could never induce an


immune response when administered by themselves but which
can when coupled to a carrier molecule.

Adjuvants: substances that can enhance the immune response to an


immunogen are called adjuvants. The use of adjuvants, however,
is often hampered by undesirable side effects such as fever and
inflammation.

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CHEMICAL NATURE OF IMMUNOGENS
Proteins
• The vast majority of immunogens are proteins.
• These may be pure proteins or they may be glycoproteins or
lipoproteins.
• In general, proteins are usually very good immunogens.

Polysaccharides
• Pure polysaccharides and lipopolysaccharides are good immunogens.

Nucleic Acids
• Nucleic acids are usually poorly immunogenic.
• However they may become immunogenic when single stranded or
when complexes with proteins.

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CHEMICAL NATURE OF IMMUNOGENS

Lipids
• In general, lipids are non-immunogenic, although they may be
haptens.
• Some glycolipids and phospholipids can stimulate T cells and
produce a cell-mediated immune response.

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Role of immunizations in disease
prevention

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Immunization
Immunization:
▪ is the means of providing specific protection against most
common and damaging pathogens.

▪ Specific immunity can result from either passive or active


immunization and both modes of immunization can occur
by natural or artificial processes.

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I. Passive Immunity
1- Naturally acquired passive immunity
• Immunity is transferred from mother to fetus through placental
transfer of IgG or colostral transfer of IgA.

2- Artificially acquired passive immunity


• Immunity is artificially transferred by injection with gamma globulin
from other individuals or from an immune animal (antiserum).
• Passive transfer of immunity with immune globulin or gamma
globulin is practiced in numerous acute infections (diphtheria,
tetanus, measles, rabies, etc.), poisoning (insect-, reptile-bites,
botulism), and as a prophylactic measure.
• This form of immunization has the advantage of providing
immediate protection, it is effective for a short duration only.

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II. Active Immunity
This refers to immunity produced by the body following exposure to
antigens.
1- Naturally acquired active immunity
• Exposure to different pathogens leads to sub clinical or clinical
infections, which normally result in a protective immune response
against these pathogens.

2- Artificially acquired active immunity


• Immunization may be achieved by administering live or dead
pathogens or their components (Vaccination).

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Vaccine
Definition of vaccine
▪ It is an antigen, when introduced to human body it stimulates the
body to form antibody. (Acquired artificial active immunity).

▪ It must be prepared from cultures of non-sporing bacteria.

▪ It is prepared either as stock or autogenic vaccine

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Types of vaccines
1. Live attenuated vaccines
▪ The ability of the organism to produce the disease is weakened.

▪ Examples: live vaccines for measles, mumps, rubella and chicken


pox (varicella) are used routinely.

▪ Vaccination by these weakened organisms will produced a limited


infection and the immune system of normal healthy people quickly
kill and eliminate them from the body with production of antibodies
which give the immunity to the persons.

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Types of vaccines
2. Killed vaccines
▪ These consist of whole organisms inactivated by heat, chemicals or
UV irradiation treatment. Many killed viral and bacterial vaccines
are available.

▪ Some of these are used to immunize people at risks (e.g. influenza,


hepatitis A, etc.) while others are used to immunize travelers to
different countries (e.g. cholera, typhoid etc.).

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Types of vaccines
3. Sub-unit vaccines
▪ They are inactivated bacterial toxins, such as polysaccharide material
or proteins components or purified viral antigen such as HB Ag
which stimulate the body to produce immune response.
▪ Such as tetanus and diphtheria.

4. Other novel vaccines


▪ DNA vaccines: vaccines consisting of DNA fragments that can be
transformed into host tissue.
▪ In the body, DNA converted into protein, which acts as FORIGN
material, and stimulate the immune system to produce an immune
response.

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Pharmacogenomics

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Pharmacogenomics
➢ Is the study of how an individual's genetic inheritance affects the
body's response to drugs.

➢ Involves a variety of techniques such as sequence analysis, protein


structure, genomics, micorarray analysis and others.

➢ These fields rely heavily on bioinformatics

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How are genomics used for drug target identification?

▪ The basic idea is to look for genes unique to the pathogen that are crucial
for its survival. This would be the drug target.

▪ If this is a pathogen in the host, the gene would be in the pathogen and
not in the host.

▪ If this was in the environment, the gene should be as specific as possible


for the pathogen to avoid harming other organisms that might be
beneficial.

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23/12/2018 College of Pharmacy, PNU Dr.Areej Elmahdy


How are genomics used for drug target identification?

How can this be done?


▪ To do this genomics, proteomics and bioinformatics are involved.
▪ Genome Sequencing
▪ Many pathogen (virus, bacteria, and other microorganisms) have
been sequenced.
▪ Once they are sequenced, they are annotated.

Annotation: is the process by which the functions of the different proteins


(genes) are determined.

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23/12/2018 College of Pharmacy, PNU Dr.Areej Elmahdy


THANK YOU
54

23/12/2018 College of Pharmacy, PNU Dr.Areej Elmahdy


Saudi Pharmacist Licensure Exam
SPLE
Dr. Ayed Alshamrani
Director, Pharmaceutical Care Services

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Area 3.0 – Pharmacy Practice
• Health Care Delivery Systems and Public Health (3.1)

• Pharmacy Practice Management (3.4)

• Medication Dispensing and Distribution Systems (3.10)

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


3.1 - Pharmacy Practice
3.1.1 Organization of health care delivery systems

3.1.2. Social, political, and economic factors that influence the delivery of health care in
the Kingdom of Saudi Arabia

3.1.3. Public Health and Wellness: chronic disease prevention, health promotion,
infectious disease control, demographics, physical, social, and environmental factors
leading to disease, comparing and contrasting public health with individual medical care

3.1.4 The health care delivery system compared and contrasted with that of other
industrialized nations

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Organization of Health Hare Delivery Systems
• What do you need to know?

• Health care development


• Levels of patient care
• Challenges to health care delivery system
• Delivery of health care services
• Ownership of health care systems
• Financing

M. Almalki, G. Fitzgerald and M. Clark. Health care system in Saudi Arabia: an overview. EMHJ, Vol. 17 -784-793.

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Social, political, and economic factors that influence the
delivery of health care in the Kingdom of Saudi Arabia

• Social factors
• Population:
• Growth
• Aging
• Demanding
• Changes in Disease patterns
• Economic factors
• Budgeting health care
• Factors influence budgeting
• Political factors

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Public Health and Wellness
• Disease prevention programs
• Health promotion
• Immunization programs
• Antenatal care
• Disease screening
• Infectious disease control
• Hajj requirements to control diseases
• Demographics, physical, social, and environmental factors leading to
disease
• comparing and contrasting public health with individual medical care

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


National Health Care Delivery System Vs.
Industrialized Nations
• Compare and contrast Saudi NHCS with International HCS in:
• Delivery
• Ownership
• Financing
• Organization
• Targeted groups
• Comprehensiveness

Al-Hanawi MK. The healthcare system in Saudi Arabia: How can we best move forward with funding to protect equitable and accessible care for all? Int J Healthc.
2017;3(2):78–94

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


3.4 - Pharmacy Practice Management
• Management principles (planning, organizing, directing, and controlling
pharmacy resources) applied to various pharmacy practice setting and
patient outcomes
• Personnel management
• Planning, including delineation between business and strategic planning
• Marketing of goods and services: product versus service pricing,
distribution, promotion
• Accounting and financial management
• Budgeting
• Risk management

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani
Principles of Pharmacy Management
• Planning
• Organizing
• Directing
• Controlling pharmacy resources applied to various pharmacy practice
setting and patient outcomes

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Personnel Management
• Human resources management:
• Recruitment
• Hiring
• On job training
• Staff development
• Firing

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


3.10 - Medication Dispensing and Distribution
Systems
• Systems for safe and effective preparation and dispensing of
medications in all types of practice settings

• Role of automation and technology: pharmacy informatics,


information management

• Continuous quality improvement programs or protocols in the


medication-use process, including identification and prevention of
medication errors, and establishment of error reduction programs

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Safe and Effective Medication Systems
• Traditional medication dispensing systems (unit dose dispensing
system, floor stock dispensing system)

• Automated dispensing systems


• Ambulatory services
• Inpatient pharmacy services

• Electronic information Systems


• COPE
• Clinical decision support system

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


Quality Improvement Programs
• Internal quality programs

• National quality programs

• International quality programs

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


References
• Al-Hanawi MK. The healthcare system in Saudi Arabia: How can we best move forward with funding to protect equitable and accessible care
for all? Int J Healthc. 2017;3(2):78–94
• Almalki, A., Fitzgerald, G., & Clark, M. (2011). Health care system in Saudi Arabia: An overview. EMHJ, 17(10), 784-793
• Zgarrick, David P, editor. Pharmacy Management: Essentials for All Practice Settings . 4th ed., McGraw-Hill Education, 2016
• Reference Guide for Pharmacy Management & Pharmacoeconomics by Manan Shroff
• David A. Holdford, Ph.D., Thomas R. Brown; Introduction to Hospital and Health System Pharmacy Practice, ASHP
• Al-Yousuf M, Akerele T, Al-Mazrou Y (2002). Organization of the Saudi health system. East Mediterr Health J, 8(4-5):645-653.
• Albejaidi F (2010). health care system in saudi arabia: an analysis of structure, total quality management and future challenges. J.
Perspectives in the Soc. Sci.; 2(2):794-818

23/12/2018 College of Pharmacy, PNU Dr. Ayed Alshamrani


4.6 Clinical Pharmacology
and Therapeutic Decision
Making

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Objectives:

At the end of this session, the student should be able to:


• Identify and manage drug toxicity, drug-induced
diseases, and misuse or abuse
• Monitor drug therapy for misuse, abuse, and non-
adherence
• Make therapy recommendations based on dosage
calculations, specific uses and indications of drugs and
nutritional and support therapy
• Assess pharmacotherapy considering
contraindications, therapeutic duplications, dietary
interactions, adverse drug reactions and interactions,
and allergies

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Objectives: (cont’d)

• Triage and identify when to refer patients to other


health professionals
• Recommend nonprescription and natural product
therapies
• Design patient-centered, culturally-relevant treatment
plans
• Apply evidence-based decision making to patient care
• Apply concepts of pathophysiology to clinical decision
making

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


First thing first !

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Examine your self !

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Examine your self !

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Examine your self !

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.1 Make therapy recommendations
• Guidelines are very helpful in making your clinical decisions
• Consider before planning the treatment the following:
1. PMH
2. Allergy
3. Previous or current medication
4. Compliance
5. Calculations ( CrCl, ANC, serum levels for some medications,
total daily dose, …)

References
Applied Therapeutics: Clinical Use of Drugs
Josef T. Dipiro Pharmacotherapy: A Pathophysiologic Approach
Koda-Kimble and Young's Applied Therapeutics: The Clinical Use of Drugs

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.1 Make therapy recommendations

• Before initiating clozapine for schizophrenia, what


should you check first? What is the formula? what
cutoff number of ANC? When to discontinue?

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.2 Assess pharmacotherapy plan
• Medication classes
1. Duplication
2. Contraindications
3. First line !
4. Pregnancy category
• Type of allergy
1. Anaphylactic vs intolerance
• Major drug interactions
1. Bleeding
2. Respiratory shock
• Common side effects and how to over come them if possible
References
Applied Therapeutics: Clinical Use of Drugs
Josef T. Dipiro Pharmacotherapy: A Pathophysiologic Approach
Koda-Kimble and Young's Applied Therapeutics: The Clinical Use of Drugs
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, Briggs.
10

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.2 Assess pharmacotherapy plan

• What would you recommend for a 18 month baby


with middle ear infection and has penicillin allergy?

• Which antihypertension class/ antiepileptic


medication should be avoided in pregnancy ?

11

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.3 Refer patients to other health professionals

• Self care (OTC)


• Inclusion and Exclusion criteria
1. Self care candidate
2. Treatment with referral
3. Not a self care candidate

Reference
Community and Clinical Pharmacy Services: A Step-by-Step Approach (chapter 7)

12

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.3 Refer patients to other health professionals
• What is your treatment option :
1. A pregnant women complaining from insomnia
2. A patient complaining from dizziness and just
started on carbamazepine
3. A patient with history of HTN and complains from
headache

13

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.4 Design patient-centered, culturally-
relevant treatment plans
• Tailor each therapeutic plan according to specific
patient characteristics:
– Culturally acceptable
– Acceptable to patient beliefs
– Addresses patient social and economical concerns

References
• Cipolle RJ, Strand LM, Morley PC. Chapter 4. Patient-Centeredness in
Pharmaceutical Care. In: Cipolle RJ, Strand LM, Morley
PC. eds. Pharmaceutical Care Practice: The Patient-Centered Approach
to Medication Management Services, 3e New York, NY: McGraw-Hill;
2012.
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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.5 Apply evidence-based decision
making to patient care
• The best current evidence integrated into clinical
expertise ensures optimal care for patients.
• The four steps in the process of applying evidence-
based medicine (EBM) in practice are
a) formulate a clear question from a patient's problem
b) identify relevant information
c) critically appraise available evidence
d) Implement the findings in clinical practice.

15

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.5 Apply evidence-based decision
making to patient care
• The decision to implement results of a specific
study, conclusions of a review article, or another
piece of evidence in clinical practice depends on:
– the quality (i.e., internal validity) of the evidence
– its clinical importance
– whether benefits outweigh risks and costs
– its relevance in the clinical setting and patient's
circumstances
References:
• Chiquette E, Posey L. eChapter 4. Evidence-Based Medicine. In: DiPiro JT,
Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy:
A Pathophysiologic Approach, 9e New York, NY: McGraw-Hill; 2014.
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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.6 Recommend nonprescription and
natural product therapies
• Many drug interactions ( CYP 450 ! )
• Safety
• Efficacy

• Examples: Melatonin, Kava Kava, St john's wort,


Gingko..

17

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.6 Recommend nonprescription and
natural product therapies

• How effective is st john's wort in a depressed patient?

• What cough suppressant agent is safe for a 8 years old


patient?

18

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.7 Identify and manage drug toxicity,
drug-induced diseases, and misuse or abuse
• Recognize toxicities of commonly used drugs
and their management: Acetaminophen, beta
blockers, digoxin, opioids, calcium channel
blockers, etc..
• Identify drugs that causes Renal, Liver, and GI
disorders as well as other diseases
• Identify areas for inappropriate drug use or
potential for abuse (pain medications, chronic
medications…)

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.7 Identify and manage drug toxicity,
drug-induced diseases, and misuse or abuse
References:
• Nolin TD. Drug-Induced Kidney Disease. In: DiPiro JT, Talbert RL, Yee GC,
Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A
Pathophysiologic Approach, 10eNew York, NY: McGraw-Hill;
• Kirchain WR, Allen RE. Drug-Induced Liver Disease. In: DiPiro JT, Talbert
RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A
Pathophysiologic Approach, 10e New York, NY: McGraw-Hill;
• Philpott, H. L., et al. (2014). "Drug-induced gastrointestinal disorders."
Frontline Gastroenterol 5(1): 49-57.
• Doering PL, Li R. Chapter 48. Substance-Related Disorders I: Overview
and Depressants, Stimulants, and Hallucinogens. In: DiPiro JT, Talbert RL,
Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A
Pathophysiologic Approach, 9e New York, NY: McGraw-Hill;

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.8 Monitor drug therapy for misuse,
abuse, and non-adherence
References:
• Principle of toxicology, Karen E,Stine, Thomas M
Brown ISBN:978146650342
• UPTODATE
• Applied therapeutics: clinical use of drugs

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


4.6.9 Apply concepts of pathophysiology
to clinical decision making
• Recognize variations of pathophysiological processes
in pediatric and geriatric patients
• Recognize pathophysiological changes that leads to
alterations in current medication regimens:
– Renal deterioration
– Elevations in LFTs
– GI diseases affecting absorption of drugs
References
Applied Therapeutics: Clinical Use of Drugs
Josef T. Dipiro Pharmacotherapy: A Pathophysiologic Approach
Koda-Kimble and Young's Applied Therapeutics: The Clinical Use of Drugs
22

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Test Taking Skills

Modified from Developing Effective Test-Taking Skills from ACCP - copyrighted

23

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Our goals for this part..

• To help you understand how the questions and these


tests are constructed
• To help you develop a strategy for answering these
types of questions more accurately

24

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


How are tests constructed
• Test Makers design questions so about 60% of
all people taking the exam get the question
correct?
• Make 2 answer choices very similar

Incorrect Correct

This is why it is critical to narrow answer choices down to the two “most likely”
to be correct given the context of the question and your personal prediction of
a likely correct answer

25

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Common Issues in Testing
• Re-reading.
• Answering the wrong question.
• Impulsivity.
• You know it or you don’t.
• Need for certainty.
• Thinking that the hardest questions are at the end,
the middle, the beginning (pick one).

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Common Myths

• I have to know everything.


• I must get through all the questions at least twice.
• I can't postpone any questions.
• I have to study my weak areas first.
• I can cram the night before.

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


To Do Great

• Think like the test makers


• Know core material well
• Know differences rather than similarities
• Rehearse out loud out loud
• Take at least one Mock Exam practice

28

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


The General Outline for any question is:
Vignette – the information necessary to answer the
question, and the
Lead In – the actual question

Distractor 1
Distractor 2
Distractor 3
Distractor 4

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


The Method

• First, focus on what the question is on what the


question is asking.
– Cover the distractors and read the question.
• Second, you must make a prediction.

• Third, uncover the distractors three at a time,


eliminate the least likely.
– Uncover another distractor and again Uncover another
distractor, and again eliminate the least likely.

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


The Method

• Fourth, now you are down to two possible answer


choices (distractors).
– Make the best decision you can that fits the question and
your prediction.

• Fifth, move on.


– Do not second guess yourself. Let it go.

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


5 Tips for Success

1. Practice for the event.


2. Lay out a study schedule and stick to it.
3. Start your practice under un-timed conditions.
4. Take a diagnostic test to evaluate your relative
strengths and weaknesses.
5. As the test nears, start practicing under timed
conditions gradually increasing the timings.
6. Two weeks before the test, take a full-day mock
exam
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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Practice, Practice, Practice

1st: Practice for Accuracy


2nd: Practice for Pacing
3rd: Practice for Endurance

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Analysis of Your Accuracy

As you practice questions:


• Analyze your starred questions that you miss.
– Ask yourself WHY?
• Your goal for starred questions is 90% accuracy.
– Always the 1st priority.

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Keeping Track of your Pacing during your
timed PAPER Practice
• When your practice starts, circle question number
25, 50 and 75. Write your time goal next to the
circled question. Set your watch to noon (12:00) and
regurgitate your 3 x 5 card on the front page
• 12:35 be at # 25
• 1:10 be at # 50
• 1:45 be at # 75
• 2:20 be at # 100
• 2:20-2:30 return to review any postponed questions
Pacing MUST be at the rate that ensures the greatest
accuracy. 35

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Endurance

• As the test date approaches, be sure to practice


questions in timed blocks during the same time
frame blocks during the same time frame as the
actual event.
• Your goal is to make the test “just another day of
doing questions”.

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Lay out a schedule

• Work backwards from the exam date.


• Include:
– daily timed questions
– daily exercise
– daily review

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Planning The day before:

• Make a plan with a friend or two to give you a


"wake up" call.
• Stop all caffeine by noon (so you won't be "wired"
that night).
• Wind down: watch a silly movie take a long walk go
out to eat --- not the time for spicy food
• Get to bed on time.
• Pack your bag.

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Suggestions for your Bag
Must Have:
• Photo ID
• Admit Permit
Should Have:
• Map or GPS (with alternate routes), address & phone number of test site
• Warm Up Questions
• Ear Plugs
• 3 X 5 index
• Relaxation technique
• Allergy medicine
• Kleenex – Ibuprofen – Antacid - Bottled water – Snacks – low glycemic
index food – protein snacks
• Caffeine (if you already use it is not the day to stop)
• Cell phone (turned off)

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


Test Day
• Double your Breakfast.
• Wear something new.
• Show up early so you can do some warm up questions
before you go into the testing center – don't use the test
to warm up.
• Review your 3 x 5 card (do not take it in to the test with
you).
• Take Antacid.
• Take an aspirin or other analgesic.
• Have a Great Day.
• Just Do It!

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


How to take a high stakes exam. Some
realities:
• Time Management
• TAKE BREAKS
• NO HEAVY LUNCH
• Relax
• Warm up questions before each session
• Be prepared for anything!!!

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi



“Chance Favors the Prepared Mind”
– Louis Pasteur

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23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


THANK YOU
43

23/12/2018 College of Pharmacy, PNU Dr.A.Alhubaishi,Dr.M.Yahya,Dr.B.Alsfouq,Dr.B Aloataibi


‫مباديء أنظمة الصيدلة‬
‫وأخالقيات المهنة‬

Speaker: Elham Alshammari

Faculty of Pharmacy, PNU

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫المرجع المعتمد لمبادىء ا ٔنظمة الصيدلة وا ٔخالقيات المهنة‬

‫ا ٔنظمة الصيدلة من مجموعة األنظمة السعودية من موقع هيئة الخبراء بمجلس الوزراء في‬
‫المملكة العربية السعودية‬
‫▰ ‪Bureau of Experts at the Council of Ministers‬‬
‫▰ ‪www.boe.gov.sa‬‬
‫الهيئة العامة للغذاء والدواء‬
‫‪https://www.sfda.gov.sa/AR/DRUG/DRUG_REG/Pages/drug_reg.a‬‬
‫‪spx‬‬

‫‪2‬‬

‫‪23/12/2018‬‬ ‫‪College of Pharmacy, PNU‬‬ ‫‪Dr.Elham Alshammari‬‬


3

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫نظام المنشآت والمستحضرات الصيدالنية‬

https://www.boe.gov.sa/ShowPDF.aspx?filename=b64758bf- ▪
2c39-4d03-a2b2-7595659531af&SystemID=161&VersionID=175

https://www.sfda.gov.sa/ar/drug/drug_reg/DocLib/Executiveroles ▪
forInstitutionsandPharmaceuticalProductslaw.pdf

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫الالئحة التنفيذية للنظام الصحي‬

https://www.boe.gov.sa/ViewSystemDetails.aspx?lang=ar&Syst ▪
emID=158&VersionID=172

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫ا ٔسس ومتطلبات وشروط تسجيل المستحضرات الصيدالنية والعشبية وشركاتها‬

‫‪https://www.sfda.gov.sa/ar/drug/drug_reg/DocLib/‬أسس ومتطلبات وشروط‬


‫تسجيل المستحضرات الصيدالنية والعشبية وشركاتها‪pdf.‬‬

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‫‪23/12/2018‬‬ ‫‪College of Pharmacy, PNU‬‬ ‫‪Dr.Elham Alshammari‬‬


‫نظام مزاولة المهن الصحية‬

https://www.boe.gov.sa/ViewSystemDetails.aspx?lang=ar&Syst ▪
emID=164&VersionID=178

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫نظام الهيئة السعودية للتخصصات الصحية‬

https://www.boe.gov.sa/ViewSystemDetails.aspx?lang=ar&Syst ▪
emID=156&VersionID=170

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫نظام الهيئة العامة للغذاء والدواء‬

https://www.boe.gov.sa/ViewSystemDetails.aspx?lang=ar&Syste ▪
mID=165&VersionID=179

‫ إجراءات التفتيش‬https://www.sfda.gov.sa/ar/drug/drug_reg/DocLib/ ▪
pdf.‫المعتمدة من رئيس القطاع‬

23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


‫الالئحة التنفيذية لنظام مكافحة المخدرات والمؤثرات العقلية‬

https://www.boe.gov.sa/ViewSystemDetails.aspx?lang=ar&Syst ▪
emID=272&VersionID=252 - search1

‫▻ من مجلد أنظمة األمن الداخلي واألحوال المدنية واألنظمة الجنائية‬


‫ الدليل_اإلجرا‬https://www.sfda.gov.sa/ar/drug/drug_reg/DocLib/ ▰
pdf.‫ئي‬
https://www.sfda.gov.sa/ar/drug/drug_reg/DocLib/anti_drugs.pd ▰
f
p.‫الدليل_اإلجرائي‬https://www.sfda.gov.sa/ar/drug/drug_reg/DocLib/ ▰
df
‫▻ من موقع الهيئة العامة للغذاء والدواء‬

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Ethical Principles

Required Text(s)
▰ – Vetach RM, Hadda AM. Case Studies in Pharmacy Ethics.
Oxford University Press, 2008

▰ Chapter 3: What is the Source of Moral Judgment?


▰ The Hippocratic Oath (page 293)
▰ Code of ethics for Pharmacists of the American Pharmacist
Association (APhA) (page 294)

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Distinguish Between Moral and Nonmoral Evaluations

Characteristics of Moral Evaluations


– The evaluations must be ultimate or beyond any further appeal.
– The evaluations must possess universality. All persons ought to
agree (even if they do not).
– The evaluations must treat the good of everyone alike. One’s
own welfare
– should get no special consideration.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


▪ Determine who ought to decide

▪ What kinds of acts are right?

– Consequentialism

– Deontological or “duty-based” ethics

– Other issues of normative ethics

– Beneficence and nonmaleficence

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


A Model for ethical Problem Solving

The Five-step Model


▰ Respond to the sense that something is wrong
▰ Gather information
▰ Identify the ethical problem/moral diagnosis
▰ Seek a resolution
▰ Work with others to choose a course of action

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Case

Reporting a Possibly Lethal Error: Who Needs to Know?

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1. Respond to the Sense That Something Is Wrong

▪ In Mr. London’s case, Dr. Fowler happened to notice the discarded IV


bag that led to her discovery of a drug error that may or may not have
contributed to Mr. London’s death.

▪ Dr. Fowler also experiences a sense of dread when she thinks about
reporting the error to the intensivist in charge of both patients. She
can certainly expect some type of negative reaction from Dr. Mann
based on past interpersonal interactions. She may also feel guilty
about the error that has occurred. She expresses “dismay” when she
sees the wrong drug being administered in Mr. Lucas’ room. These
negative emotions are indications that an ethical problem is present.

▪ This first step in the decision-making process merely requires one to


respond to the feeling that something is wrong. One should then move
on to the next step.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


2. Gather Information
▪ There is an old saw in ethics: “Good ethics begins with good facts.”
Clearly, to make an informed decision, one must have the facts. To
organize the numerous facts in the situation in which Dr. Fowler is
involved, one can classify them into clinical and situational
information.

▪ Clinical information deals with the relevant clinical data in the case in
question. The following types of clinical questions are relevant when
reviewing a case: What is the medical status of the patient or patients
involved in the situation? Medical his- tory? Diagnosis? Prognosis?
What drugs are involved, and what are their actions, side effects, etc.?
What is the patient’s probable life expectancy and general condition if
treatment is given? What is the patient’s probable life expectancy and
general condition if treatment is not given?

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


2. Gather Information, cont’
▪ In Mr. London’s case, the clinical information appeared to be
unambiguous. His illness was acute and life-threatening. If not treated
immediately with appropriate drug therapy and other life-saving
measures, Mr. London would certainly die from hemorrhage and
shock. Even if the treatment was effective in managing the bleeding, it
would not resolve the underlying problem of cirrhosis. Additionally,
the chance that treatment would be effective was small given the
underlying condition. The administration of heparin to a patient who is
already hemorrhaging would increase the risk of bleeding, but it may
not have hastened Mr. London’s death. As much as possible, it is
important to clarify the relevant clinical information in the case before
moving on to a more in-depth analysis of the moral relevance of these
facts.

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2. Gather Information, cont’
▪ Situational information includes data regarding the values and
perspectives of the principals involved; their authority; verbal and
nonverbal communication, including language barriers; cultural and
religious factors; setting and time constraints; and the relationships of
those immediately involved in the case.

▪ In other words, even if the clinical “facts” of a case remain constant,


changes in the situational or contextual factors, such as the values of
a key principal in the case, could change the ethical focus or intensify
the ethical conflict.

▪ Of all the situational data mentioned, the most important is the


identification and understanding of the value judgments involved in a
case.

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2. Gather Information, cont’
▪ The main players in this case are the two patients, any family involved, Dr. Fowler, Dr.
Mann, the pharmacist(s) who prepared the drugs, and members of the nursing staff
responsible for hanging the IV medications.

▪ All the individuals involved in the case possess values about many things, including
values about health, honesty, professional competence, and loyalty, to name a few.

▪ We know specifically that Dr. Mann “. . . did not tolerate mistakes.” What does this
mean in practical terms? Do individuals who make mistakes lose their jobs? The case
also includes a situational factor that impinges on the case—urgency and time
constraints.

▪ Two emergencies occurred almost simultaneously. If the two admissions to the


intensive care unit had been spaced further apart, it is possible that the error would
not have happened. We know that responsibility for the error-free care of Mr. London
and Mr. Lucas rested with various members of the health care team.

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2. Gather Information, cont’
▪ Each member’s responsibilities are distinct yet overlap.

▪ As part of the information-gathering step it is important to sort out the


various responsibilities, not for placing blame but for identifying
moral accountability.

▪ For example, Dr. Fowler may not be the one who mislabeled the IV
bags, but as evening supervisor she has overarching responsibility
for all medications that leave the pharmacy. Second, she is the one
who discovered the error. Knowledge of the error carries its own
responsibility.

▪ These are only some of the facts affecting ethical decision-making in


this case. Once all the facts are outlined, they can be examined to see
whether the situation has the characteristics of an ethical problem.

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Identify the Ethical Problem/Moral Diagnosis

▪ The ethical principles most often involved in complex cases,


such as Dr. Fowler’s situation, are (1) patient and health
professional autonomy, (2) beneficence and nonmaleficence,
and (3) justice. In this volume, veracity, fidelity, and avoidance of
killing are treated as possible principles as well. Separate
chapters presented in Part II develop each of these principles.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


3. Identify the Ethical Problem/Moral
Diagnosis, cont’
▪ At a minimum the principles in conflict in this case are
nonmaleficence and veracity. Clearly an error has occurred. In the
case of Mr. London, the degree of harm caused by the error is still in
question. Even an autopsy might not be able to deter- mine whether
the error contributed to his death. All we know for certain is that the
error deprived him of drug therapy that could have provided benefit.
The error may have caused harm to Mr. Lucas as well. He too was
deprived, at least for a while, of a treatment that could have helped
him. Thus, harms have occurred that, at this point, are unknown to
key players in the case. Nonmaleficence suggests that Dr. Fowler has
a duty to protect the pharmacist involved from having to endure the
unjustified wrath of Dr. Mann but also to prevent further harm to Mr.
Lucas by making sure he begins to receive the right drug.
Nonmaleficence would also suggest a duty to initiate procedures to
make sure this kind of error does not occur again.

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3. Identify the Ethical Problem/Moral
Diagnosis, cont’
▪ Also at stake is the principle of veracity, the moral notion that one is
obligated to speak truthfully, especially when one’s role in the situation
makes it ethically impos- sible to keep silent. As far as we know to this
point, only Dr. Fowler knows about the error. As soon as she calls
attention to the error by stopping the octreotide IV and ordering the correct
medication from the pharmacy, others will become aware of the error too.
She believes she is obligated to tell the truth to Dr. Mann so that she can
adjust Mr. Lucas’s treatment. But there are others involved in the case who
have a claim on knowing the truth, the other members of the health care
team, such as the nurses and pharmacists, as well as Mr. London’s family.

▪ Dr. Fowler seems to feel quite certain that she has a duty to inform Dr.
Mann but isn’t as clear about her obligation to Mr. London’s family. One
could propose arguments for either telling or withholding the truth from
the family. The harm to Mr. London has already occurred and is
irreversible.
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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


3. Identify the Ethical Problem/Moral
Diagnosis, cont’
▪ The principle of nonmaleficence, or of doing no harm, could lead Dr. Fowler to be
concerned about causing unnecessary psychological stress on his family.
Traditionally, the Hippocratic ethic permits, or even requires, health professionals to
remain silent whenever information would be needlessly disturbing to patients or
families. On the other hand, the family could benefit from knowing what happened.
They could pursue legal action that would benefit them financially and may help them
gain closure over the incident. Beneficence involves balancing the burdens and the
benefits of an action, an analysis that can be extremely difficult.

▪ The ethical principle of fidelity requires that people act out of loyalty to those with
whom they stand in a special relationship, such as between health provider and
patient. The requirements of fidelity when a provider interacts with family members
are more complex, but a case could be made that, in this situation, Dr. Fowler owes it
to Mr. London’s family to let them know truthfully what happened. At this point,
exploring various courses of action requires both determining which principles are
involved and what their implications are. At that point, we can move to the fourth step
in solving the problem at hand.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


4. Seek a Resolution

▪ Several courses of action are open to Dr. Fowler: (1) She could fully
share information about the error with all those involved; (2) she
could tell Dr. Mann about the error and other internal entities in the
hospital but not inform Mr. London’s family or Mr. Lucas’s family; (3)
she could keep the knowledge to herself and not tell anyone and try
to correct the error without being caught or just let the wrong drug
continue to infuse into Mr. Lucas; or (4) she could wait to tell Dr.
Mann about the error with Mr. Lucas’s medication until she can
determine if it is having any side effects. These actions actually fall
into the categories of telling, not telling, or waiting to tell, the last
being a version of not telling. Because the error affected two
patients, the range of possible actions doubles.

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4. Seek a Resolution, cont’

▪ To determine which options are morally justifiable, one must


project the probable consequences of each action and the
underlying intention of the action as well as whether there are
moral duties that prevail independent of the consequences. This
process involves the application of the ethical principles
presented earlier and the ethical theories described below. By
following this process, one can reject some options immediately
because they would result in harm or would conflict with another
basic ethical principle.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


4. Seek a Resolution, cont’
▪ Choosing the first option would be in compliance with deontological (or duty- based) ethical theories, which
assert that the rightness of an act can be judged insofar as it fulfills some principle of duty, in this case
particularly the duty of veracity. This option would be compatible with the respect, dignity, and equality that
all human beings deserve.

▪ Telling the physician fulfills the principle of veracity the physician but leaves open what that principle
requires with regard to the family. The duty- based principles of veracity and fidelity require showing respect
for others, especially when some special relation exists. Not telling the family members does not respect the
dignity of the family members.

▪ The third option of withholding the truth about the error and not doing anything else would be hard to justify
from the perspective of these duty-based principles. Furthermore, not telling and trying to correct the error
without telling anyone about it is fraught with problems, not the least of which is the great possibility of
getting caught in the act of a cover-up. The credibility of not only Dr. Fowler but of the entire pharmacy would
be at stake should that happen.

▪ The fourth option delays the truth but holds open the possibility that it will be disclosed at a later time. This
option seems to be based on the assumption that disclosure is warranted only if the consequences require it.
This brings us to consideration of the consequence-oriented principles—beneficence and nonmaleficence.

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4. Seek a Resolution, cont’
▪ Two major versions of consequence-oriented ethics were presented in
the introduction: utilitarianism and Hippocratic ethics. Hippocratic
ethics would focus on the principles of beneficence and
nonmaleficence, but only insofar as the action has an impact on the
patient.

▪ Mr. London is dead; he cannot be affected one way or the other. Mr.
Lucas, conversely, is very likely to be affected. At least he needs to
begin immediately receiving the right medication, but that may not
require disclosure of the error. Then, too, disclosure may be
distressing to him.

▪ A good case can be made that the error should be kept between Dr.
Fowler and those who need to know in order to correct it.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


4. Seek a Resolution, cont’

▪ Utilitarianism differs from Hippocratic ethics by not focusing on the principles of beneficence
and nonmaleficence but on which consequences are relevant.

▪ Utilitarianism holds that the option that would bring about the greatest good for the greatest
number should be chosen. If telling the truth would likely produce more benefits for all the
affected parties than any other alternative, then it would be good and right. If not, it would be
bad and wrong.

▪ To decide whether the various options are right or wrong one would have to consider the
effects of each on everyone concerned. Utilitarianism would consider the effects not only on
the two patients, Mr. Lucas and Mr. London, but also on the pharmacist who apparently
made the error and the nurses who failed to check the medications and catch the error. It
would consider the families involved. Most critically, it would consider the effects on future
patients who might benefit if the error is reported and procedures are put in place to make
sure it does not happen again.

▪ We have at this point identified several possible courses of action and the implications of
various ethical principles for each of those courses.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


5. Work with Others to Choose a Course of Action

▪ No one makes decisions alone in a health care setting. The


same is true for ethical decisions.

▪ A better decision can be reached if the people who are


legitimately involved have the opportunity to openly discuss
their perceptions, values, and concerns.

▪ In a complex case such as this, Dr. Fowler should call on the


input of colleagues in pharmacy, the physician, and the
nursing staff.

▪ By discussing concerns together, they can reach a more


comprehensive decision that is ethically justifiable.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


5. Work with Others to Choose a Course of
Action, cont’
▪ It is apparent that the duty-based principles, such as autonomy, veracity, and fidelity,
push very hard toward requiring disclosure of the error—at least to Dr. Mann and
other hospital authorities and probably to the patients’ families as well.

▪ On the other hand, the Hippocratic form of a consequence-based ethic provides the
most plausible basis for supporting nondisclosure.

▪ Mr. London cannot be helped by the disclosure, and Mr. Lucas probably can be helped
as much without it.

▪ A more social form of a consequence-based ethic, such as utilitarianism, leaves us in


an ambiguous spot. Harms can come—to the families who will be placed in distress
and certainly to the pharmacist who made the error.

▪ Significant benefits from disclosure also can be expected, perhaps to Mr. Lucas but
definitely to future patients. It is possible that the family members might gain benefits
as well.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Next..
Grounding ethics in Professional code

– Case 3-1

– Case 3-2

Grounding ethics in the physician’s orders

– Case 3-3

– Case 3-4

Grounding ethics in hospital policy

– Case 3-5
Grounding ethics in the patient’s value

– Case 3-6

Grounding ethics in religious or philosophical perspectives – Case 3-7


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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Ethical Principles in Pharmacy Ethics

▪ One way to approach ethical decision-making in pharmacy is to


examine principles that describe general characteristics of
actions that tend to make them morally right. In the introduction,
the principles of beneficence (doing good), nonmaleficence
(avoiding harm), fidelity, autonomy, veracity, avoiding killing, and
justice are mentioned.

▪ Ethical problems in pharmacy practice often involve conflicts


between these principles. In other cases the moral problem
arises over the interpretation of one of these principles.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Benefiting the Patient and Others
Chapter 4
The Duty to Do Good and Avoid Harm

▪ The idea that it is ethically right to do good, especially good for the patient,
is one of the most obvious in health care ethics.

▪ The Hippocratic Oath has the physician pledge to “benefit the patient
according to [the physician’s] ability and judgment.”

▪ The 1994 APhA Code of Ethics says that “A pharmacist promotes the good
of every patient in a caring, compassionate, and confidential manner.”

▪ These are all versions of the principle of doing good for the patient. While
this seems so obvious as to be platitudinous, in fact, many serious moral
problems arise over the interpretation of this principle.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


What if...
▪ What if protecting the patient will come at considerable risk of harm to society in
general or to specific identifiable people who are not patients?

▪ What if the interests of the profession of pharmacy conflict with those of the patient?

▪ What if doing what is necessary to help the patient conflicts with the interests of the
pharmacist’s family? Is it obvious that the pharmacist should always place the
patient’s interest above those of his or her family?

▪ These are the problems of the cases in this chapter.

Benefiting Society and Individuals Who Are Not Patients

▪ According to the classical Hippocratic ethic, the health professional was, in such
cases, to choose to benefit the patient. The APhA Code of Ethics for Pharmacists
uses the language of overall good, referring to the “good of every patient.”
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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Justice
The Allocation of Health Resources
chapter 5
▪ Pharmacists often find themselves in situations in which the interests of their
patients are in conflict.

▪ The pharmacist must choose between patients or between a patient and those
who are not patients. Whether to provide medications for those who cannot pay
the full costs and shift the costs onto those who can is one example.

▪ The Hippocratic mandate to serve the interests of the patient (in the singular)
does not help.

▪ It seems ethically crass simply to count up the total amounts of good and harm
and choose the course that maximizes total social outcome regardless of the
impact on the individuals affected. That could lead, for instance, to refusing
to provide services to those who are not useful to society or to those who
can benefit only modestly from the pharmacist’s services.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


▪ Justice among patients ́ Case 5-1, 5-2

▪ Justice between patients and others ́ Case 5-3, 5-4

▪ Justice in public policy ́ Case 5-5, 5-6

▪ Justice and other ethical principles ́ Case 5-7

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Autonomy
Chapter 6

Questions to ask your self what is the difference between..

▪ Autonomy..

▪ Paternalism..

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


▪ Autonomy is both a psychological and a moral term.

▪ Psychologically, autonomy is a term describing the mental state of persons


who are free to choose their own life plans and act on those plans
substantially independent of internal or external constraints.

▪ No one is “fully autonomous” in the sense of being totally free from internal
and external constraints. Some people may be totally lacking in
autonomy—infants and the comatose, are examples.

▪ Many people whom we call nonautonomous, however, possess some


limited capacity to make their own choices. Small children, the mentally
retarded, the mentally ill, and the senile all may be able to make limited
choices based on their own beliefs and values and yet are hardly
autonomous enough to be called self-determining in any meaningful way.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


▪ For purposes of public policy, we assume that persons below the
age of majority, usually 18, unless proven other- wise, are lacking
sufficient autonomy for a range of publicly significant decisions.

▪ We admit that a particular 16-year-old may have both the internal


knowledge and intellectual capacity and be sufficiently free from
external constraints to be as autonomous as some adults.

▪ Occasionally courts will recognize such minors as “mature” for


purposes of making medical decisions on their own. But the
working presumption is that minors lack competence to make many
substantially autonomous decisions.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


▪ Classical Hippocratic ethics in the health care professions has been committed
to the principle that the health care worker should do whatever is necessary to
benefit the patient. This has been understood to include violating the autonomy
of the patient.

▪ Pharmacists, in the name of Hippocratic paternalism, have refused to tell


patients the names of drugs they are taking, filled prescriptions for placebos,
refused to dispense drugs believed dangerous, and engaged in all manner of
violations of the autonomous choices of patients. They have done so not out of a
concern to protect the welfare of others or to promote justice, but rather out of
concern that the patient would hurt himself or herself.

▪ Classical Hippocratic professional ethics contains no moral principle of


autonomy. By contrast, the moral principle of autonomy says that patients have a
right to be self-determining insofar as their actions affect only themselves.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


▪ Determine whether a patient is autonomous ́ Case 6-1, 6-2

▪ External constraints on autonomy ́ Case 6-3

▪ Overriding the choices of autonomous persons ́ Case 6-5, 6-6

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Veracity
Dealing Honestly with Patients
Chapter 7
▪ The code of the American Pharmacists Association has for many years considered
truthfulness part of the essential character of the pharmacist.

▪ ́The 1969 version of the APhA Code of Ethics states that a pharmacist “should strive to
provide information to patients regarding professional services truthfully, accurately, and fully
and should avoid misleading patients regarding the nature, cost, or value of these
professional services.”

▪ The 1995 revised code states that a pharmacist “acts with honesty and integrity in
professional relationships.” This provision is followed with an interpretation that reads, “A
pharmacist has a duty to tell the truth and to act with conviction of conscience.”

▪ While ethics that focus on consequences evaluate whether to lie by trying to determine
whether a lie will produce positive benefits, ethics that emphasize features other than
consequences, such as respect for persons, hold that there is something simply wrong
about lying.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


What patients should be told?

▪ The condition of doubt Case 7-1

▪ Lying in order to benefit

Protecting the patient by lying (Case 7-2)

Protecting the welfare of others (case 7-3, 7-4)

▪ Special cases of truth telling

Patients who don’t want to be told (case 7-5)

Family members who insist the patient not be told (case 7-6)

▪ The right of access to medical record (case 7-7)

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


The Condition of Doubt

▪ In pharmacy the condition of doubt may stem from the


pharmacist having only a limited understanding of a patient’s
condition as well as the knowledge that someone else on the
health care team is better informed.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Fidelity
Promise-Keeping and Confidentiality Chapter 8

▪ The contract, covenant, commitment, or promise that


establishes the relationship between provider and patient rests,
in part, on the ethics of keeping promises.

▪ The principle underlying the idea that one has a duty—other


things being equal—to keep a commitment once it is made is
sometimes called the principle of fidelity.

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


The limits on the promise of confidentiality

▪ Breaking confidence to benefit the patient (case 8-2)

▪ Breaking confidence to benefit others (case 8-3)

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


Avoidance of Killing
Chapter 9

▪ Active killing vs. letting one die (case 9-2, 9-3)

▪ Withholding vs. withdrawing treatment (case 9-4)

▪ Direct vs. indirect killing (case 9-5)

▪ Justifiable omissions (case 9-6)

▪ Voluntary and involuntary killing

▪ Killing as punishment

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23/12/2018 College of Pharmacy, PNU Dr.Elham Alshammari


WISH YOU ALL
THE LUCK
51
[Professional Communication]
[Social and Behavioral Aspects of Pharmacy
Practice]

KHLOOD ALDOSSARY, BSCPHARM, PHARMD


DEPARTMENT OF PHARMACY PRACTICE
COLLEGE OF PHARMACY, PNU

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


I. PROFESSIONAL COMMUNICATION SKILLS
➢Communication abilities (appropriate verbal, nonverbal, visual,
and written) with patient and caregivers, including empathetic
communication
➢Communication abilities with other health care providers
➢Assertiveness and problem-solving techniques in relation to
difficult social and professional conflicts and situations
➢Measurement and use of health literacy in pharmacy
communications
➢Development of cultural competency in pharmacy personnel such
that services are respectful of and responsive to the health beliefs,
practices, and cultural and linguistic needs of diverse patient
populations 2

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


I. PROFESSIONAL COMMUNICATION SKILLS
➢Communication abilities (appropriate verbal, nonverbal,
visual, and written) with patient and caregivers, including
empathetic communication
➢Communication abilities with other health care providers
➢Assertiveness and problem-solving techniques in relation to
difficult social and professional conflicts and situations
➢Measurement and use of health literacy in pharmacy
communications
➢Development of cultural competency in pharmacy
personnel such that services are respectful of and responsive
to the health beliefs, practices, and cultural and linguistic
needs of diverse patient populations
3

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


I. PROFESSIONAL COMMUNICATION SKILLS
▪It is a science and practice of transmitting information
in a meaningful way to those involved
▪ The goal of all communication is understanding
➢ Nonverbal communication includes the following:
◦ Tone of voice
◦ Rate and volume of speech
◦ Facial expression
◦ Eye contact
◦ Gestures/touch
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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


NONVERBAL VS. VERBAL COMMUNICATION

▪Nonverbal communication involves a complete mix of


behaviors, psychological responses, and environmental
interactions through which we consciously or
unconsciously relate to another
▪ Approximately 55% to 95% of all communication can be
attributed to nonverbal sources!

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


IMPORTANCE OF NONVERBAL COMMUNICATION

Nonverbal communications are important for three reasons:


▪First, they mirror innermost thoughts and feelings
▪Second, it is difficult to “fake” during an interpersonal
interaction
▪Third, congruence between verbal and nonverbal
messages; otherwise, people will be suspicious of the
intended meaning of your message

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


NONVERBAL EXPRESSIONS

▪ Kinesics, (body movement)


▪ Proxemics (distance between persons trying to
communicate)
▪ Elements of the physical environment in which
communication takes place
▪ Distracting factors

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


KINESICS

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


KEY COMPONENTS OF KINESICS
▪Varied eye contact (consistent, but not a stare)
▪Relaxed posture
▪Appropriate comfortable gestures
▪Frontal appearance (shoulders square to other person)
▪Slight lean toward the other person
▪Erect body position (head up, shoulders back)

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


PROXEMICS (DISTANCE BETWEEN TWO
INTERACTING PERSONS)
▪Appropriate space is that from 18-48 inches (45.7-121.9
cm) from our bodies
▪You want to stand close enough to ensure privacy
▪Patients usually indicate nonverbally whether they feel
comfortable with the distance by either stepping backward
or leaning forward

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


11

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


ENVIRONMENTAL NONVERBAL FACTORS
Examples of factors that play important roles in
communication nonverbal messages to patients:
▪ Pharmacy’s décor: the colors, the lighting, and the uses
of space
▪ The counter and related shelving serve to keep the
prescription dispensing process from the public’s view

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


DISTRACTING NONVERBAL COMMUNICATION

▪Facial expression
▪Body position
▪Tone of voice

13

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


EFFECTIVE COMMUNICATION
▪ Speaking clearly and forcefully and having an effect on others
▪ To be a good listener is critical part of the communication and
most difficult to learn
▪Listening well involves understanding both the content and the feeling

➢Skills that are useful in effective listening include:


1. Summarizing
2. Paraphrasing
3. Empathic responding

14

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


EMPATHIC RESPONDING
“Reflection of feeling” statements that:
-Verbally convey your understanding of the essence or
emotional meaning of another person’s communication
-Nonverbal communication that shows caring and attention
to the patient
The difference between an empathic and a paraphrase:
Empathy serves primarily as a reflection of the patient’s
feelings rather than focusing on the content of the
communication

15

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


EMPATHIC RESPONDING
The following examples, should illustrate the difference!
-Patient: I don’t know about my doctor. One time I go to him
and he’s as nice as he can be. The next time he’s so rude I
swear I won’t go back again
-Pharmacist:
Paraphrase: He seems to be very inconsistent!
Empathic Response: You must feel uncomfortable going to
see him if you never know what to expect!

16

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


EMPATHIC RESPONDING
The difference between an empathic and a paraphrase!
-Patient : I’m so glad I moved into the retirement village.
Every day there is something new to do. There are always
lots of things going on—I’m never bored
-Pharmacist:
Paraphrase: So there are a lot of activities to choose from!
Empathic Response: You seem to love living there!

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


EMPATHY AND EFFECTIVE COMMUNICATION

Empathy has many positive effects on a pharmacist’s


relationships with patients. It helps patients:
◦ Come to trust you as someone who cares about their
welfare
◦ Understand their own feelings more clearly
◦ Facilitates the patient’s own problem-solving ability

18

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


NONVERBAL ASPECTS OF EMPATHY
▪Establishing eye contact while talking to patients
▪Leaning toward them slightly with no physical barriers
▪Having relaxed posture
▪Head nods and encouragements to talk
▪Tone of voice
▪Establishing a sense of privacy
▪Conveying that you have time to listen
▪Sensitivity to patients’ nonverbal cues (feelings, tone of
voice, facial expression and body posture)
19

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


I. PROFESSIONAL COMMUNICATION SKILLS
➢Communication abilities (appropriate verbal, nonverbal, visual, and
written) with patient and caregivers, including empathetic
communication
➢Communication abilities with other health care providers
➢Assertiveness and problem-solving techniques in relation to difficult
social and professional conflicts and situations
➢Measurement and use of health literacy in pharmacy communications
➢Development of cultural competency in pharmacy personnel such that
services are respectful of and responsive to the health beliefs,
practices, and cultural and linguistic needs of diverse patient
populations
20

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


ASSERTIVE PHARMACISTS
▪Take an active role in patient care
▪Initiate communication with patients rather than wait to be
asked questions
▪Convey their views on the management of patient drug
therapy to other health care professionals
▪Finally, try to resolve conflicts with others in
a direct manner but in a way that conveys
respect for others

21

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


ASSERTIVENESS SKILLS REQUIRED IN RELATING TO
PATIENTS

▪Willingness to initiate communication


▪Encouraging patients to be more assertive with you
▪Appropriate response to angry patients
▪Empathic response
▪Turn criticism into useful feedback
▪Do not transmit messages through a third party

22

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


ASSERTIVENESS SKILLS REQUIRED IN RELATING TO
PHYSICIANS
▪No need for anger/or apology
▪Always introduce yourself
▪Apologizing makes you seem insecure and unassertive
▪Do not put the physician ‘on the spot”
▪Prepare your recommendation and keep current references ‘in
reserve’
▪Do not expect a ‘pat on the back’

23

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


I. PROFESSIONAL COMMUNICATION SKILLS
➢Communication abilities (appropriate verbal, nonverbal, visual, and
written) with patient and caregivers, including empathetic
communication
➢Communication abilities with other health care providers
➢Assertiveness and problem-solving techniques in relation to difficult
social and professional conflicts and situations
➢Measurement and use of health literacy in pharmacy communications
➢Development of cultural competency in pharmacy personnel such that
services are respectful of and responsive to the health beliefs,
practices, and cultural and linguistic needs of diverse patient
populations
24

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


MEASUREMENT AND USE OF HEALTH LITERACY IN
PHARMACY COMMUNICATIONS

Health literacy is the ability to obtain, process, and


understand basic health information and services needed
to make appropriate health decisions and follow
instructions for treatment

25

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


MEASUREMENT AND USE OF HEALTH LITERACY IN
PHARMACY COMMUNICATIONS

Many factors can contribute to an individual’s health


literacy:
▪The individual’s amount of experience in the health care
system
▪The complexity of the information being presented
▪Cultural factors that may influence decision making

26

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


MEASUREMENT AND USE OF HEALTH LITERACY IN
PHARMACY COMMUNICATIONS
Literacy and health outcomes:
Persons with limited health literacy skills have
poorer health status than the rest of the population
Indeed, several studies in diverse settings have
shown that, even after controlling for a variety of
sociodemographic variables, limited understanding
of health concepts (i.e., poor health literacy) is
associated with worse health outcomes

27

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


HOW CAN I TELL IF AN INDIVIDUAL PATIENT HAS LIMITED
HEALTH LITERACY SKILLS?
1. Behaviors:
▪Patient registration forms that are incomplete or
inaccurately completed
▪Frequently missed appointments
▪Noncompliance with medication regimens
▪Lack of follow-through with laboratory tests, imaging tests,
or referrals to consultants
▪Patients say they are taking their medication, but laboratory
tests or physiological parameters do not change
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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


HOW CAN I TELL IF AN INDIVIDUAL PATIENT HAS
LIMITED HEALTH LITERACY SKILLS?
2. Responses to receiving written information:
▪“I forgot my glasses. I’ll read this when I get home.”
▪“I forgot my glasses. Can you read this to me?”
▪“Let me bring this home so I can discuss it with my children”

29

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


HOW CAN I TELL IF AN INDIVIDUAL PATIENT HAS
LIMITED HEALTH LITERACY SKILLS?
3. Responses to questions about medication regimens:
▪Unable to name medications
▪Unable to explain what medications are for
▪Unable to explain timing of medication administration

30

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


MEASURING HEALTH LITERACY

A number of instruments have been developed to assess


the health literacy skills of patients . For the most part,
these tools have been used for research. Some clinicians,
however, have used these instruments in their own clinical
settings to measure the literacy skills of a sample of their
practice’s patients

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


33

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


MEASUREMENT AND USE OF HEALTH LITERACY IN
PHARMACY COMMUNICATIONS
▪Clinician-patient communication is an important factor in
health literacy
▪Good communication is crucial for a successful clinician-
patient relationship and effective exchange of
information. Breakdowns in communication can lead to
confusion for patients, poor health outcomes, and even
malpractice lawsuits against clinicians

34

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


I. PROFESSIONAL COMMUNICATION SKILLS
➢Communication abilities (appropriate verbal, nonverbal, visual, and
written) with patient and caregivers, including empathetic
communication
➢Communication abilities with other health care providers
➢Assertiveness and problem-solving techniques in relation to difficult
social and professional conflicts and situations
➢Measurement and use of health literacy in pharmacy
communications
➢Development of cultural competency in pharmacy personnel such
that services are respectful of and responsive to the health beliefs,
practices, and cultural and linguistic needs of diverse patient
populations 35

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


DEVELOPMENT OF CULTURAL COMPETENCY IN
PHARMACY PERSONNEL
Cultural competence is the attitudes, knowledge, and
skills that allow integration and translation of knowledge
about various cultures into the practice of pharmacy.
More specifically culture competence is having the ability
to provide care to patients with diverse values, beliefs and
behaviors and to tailor that care to patients’ social,
cultural, and linguistic needs

36

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


METHODS TO IMPROVE CULTURAL
COMPETENCY SKILLS
▪Read about culture‐specific disease states and
evidence‐based intervention and practice
▪Reach out to religious leaders or organizations
▪Seek out traditional cultural healers
▪Talk with patients from diverse backgrounds in your
community
▪Continue to learn: lifelong process/requires ongoing
continuing education utilizing multiple modalities

37

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


II. SOCIAL AND BEHAVIORAL ASPECTS OF
PHARMACY PRACTICE

➢Health-, illness-, and sick-role behaviors of patients


➢Principles of behavior modification
➢Patient adherence to therapies and recommendations

38

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


BEHAVIOR IN HEALTH AND SICKNESS
1. Health behavior: “ any activity undertaken by a person
who believes himself to be healthy, for the purpose of
preventing disease or detecting disease in an asymptomatic
stage”
2. Illness behavior: “ Any activity undertaken by a person
who feels ill, for the purpose of defining the state of his
health and of his health and of discovering suitable remedy”
3. Sick role behavior: “ Activity undertaken by those who
consider themselves ill for the purpose of getting well”

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


PRINCIPLES OF BEHAVIOR MODIFICATION
Theoretical Foundations Supporting Behavior Change:
Miller and Rollnick (2002) developed a conceptual foundation and
intervention strategies, known as motivational interviewing (MI), to help
people make changes in the direction of better health.
Three components of motivation to change:
▪ Willingness, which is indicated by the amount of discrepancy patients
perceive between current health status and goals they have for themselves
▪Perceived ability or the amount of self-confidence patients feel in their ability
to initiate and maintain behavioral change (also known as self-efficacy)
▪ Readiness, which is related to how high a priority is given to these behavioral
changes

40

23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


FIVE STAGES OF THE TRANSTHEORETICAL MODEL
OF BEHAVIOR CHANGE
▪Precontemplation: unwillingness to change, lack recognition
of problem, deny seriousness of risks
▪Contemplation: acknowledging that there is a problem but
no ready or sure of wanting to make a change
▪Preparation/determination (getting ready to change)
▪Action (change is initiated)
▪Maintenance (change is established and incorporated to
lifestyle, focus is on avoiding relapse)
▪Relapse (returning to older bahavior)
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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


CORE COMMUNICATION PRINCIPLES OF “MI”
Remember the acronym *READS*:
▪Express empathy
▪Develop discrepancy
▪Roll with resistance
▪Support self-efficacy
▪Elicit and reinforce “change talk”

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


REFERENCES
▪ Robert S. Beardsley, Carole L. Kimberlin, William N. Tindall. (2007).
Communication skills in pharmacy practice : a practical guide for students
and practitioners. Philadelphia :Wolters Kluwer/Lippincott Williams &
Wilkins.
▪Weiss BD. Chicago, IL. (2007) Health Literacy and Patient Safety: Help
Patients Understand. Manual for Clinicians. 2nd ed. American Medical
Association Foundation and American Medical Association
▪Kelly J. Clark> Achieving Cultural Competency and Its Role in Pharmacy.
Available at
https://www.scrx.org/assets/journalce/culturalcompetencynoanswersnoco
mments.pdf
▪Social And Behavioral Aspects Of Pharmaceutical CareMar 25, 2009 by
Nathaniel M. Rickles and Albert I. Wertheimer

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23/12/2018 College of Pharmacy, PNU Dr.Khlood Aldossary


THANK YOU
44

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