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PERSPECTIVE PHARMACY (MODULE 6) FINALS
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PHARMACISTS ROLE IN HANDLING
MEDICATION AND IT'S ROLE IN
HEALTHCARE
Coverage for Finals:
 Drug Discovery and Development
 Category and Therapeutic Classification of Drugs
 Different Dosage forms
 Health Products in the Market
 Pharmacists Role in Healthcare, Health
Promotion, Drug Information, Dissemination,
and Medication Therapy
 Management Roles of Pharmacists as a
Supervising Pharmacist in Retail Outlets
DRUG DISCOVERY AND DEVELOPMENT
1. DISCOVERY AND DEVELOPMENT
Historically, drugs were mostly found by
identifying active ingredients from traditional
medicines or purely by chance.
Afterward, classical pharmacology was used to
investigate chemical libraries including small
molecules natural products, or plant extracts and
find those with therapeutic effects.
 Target Identification & Validation - Finds a gene
or protein that has therapeutic effect,
characteristics are then recorded.
 Hit Discovery Process - Compound screening
assays are developed.
 Assay Development & Screening - Evaluates the
effects of the new drug candidate at the
cellular, molecular, and biochemical levels.
 High Throughput Screening - Uses data
processing/control software, liquid handling
devices, and sensitive detectors to rapidly
conduct millions of pharmacological, chemical,
and genetic tests identifying active
compounds, genes, or antibodies that affect
human molecules.
 Hit to Lead - In the Hit to Lead (H2L) process,
small molecule hits from an HTS are evaluated
and optimized in a limited way into lead
compounds.
 Lead Optimization - In the lead optimization (LO)
process, the lead compounds discovered in
the H2L process are synthesized and modified
to improve potency and reduce side effects.
Lead optimization conducts experimental
testing using animal efficacy models and
ADMET tools, designing the drug candidate.
 Active pharmaceutical ingredients (APIs) -are
biologically active ingredients in a drug
candidate that produce effects.
 All drugs are made up of the API or APIs and
excipients.
 Excipients are inactive substances that deliver
the drug into the human system. (Ex. binders,
sweetening agents, colorants)
 High Potency Active Pharmaceutical Ingredients
(HP APIs) are molecules that are effective at
much smaller dosage levels than standard
APIs.
 The drug discovery process ends when one lead
compound is found for a drug candidate, and
the process of drug development starts
2. PRECLINICAL RESEARCH
Drug development begins with preclinical research
to determine the efficacy and safety of the drug.
Researchers determine the following about the
drug:
 Absorption, distribution, metabolization,
and excretion
 Potential benefits and mechanisms of action
 Best dosage, and administration route
 Side effects/adverse events
 Effects on gender, race, or ethnicity groups
 Interaction with other treatments
 Effectiveness compared to similar drugs
 In Vivo, In Vitro & Ex Vivo Assays
- In vivo, preclinical research examples are the
development of new drugs using mice, rat,
and dog models.
-In vitro is research conducted in a laboratory.
Ex vivo uses animal cells or tissues from a non-
living animal.
 In Silico Assays
-test systems or biological experiments
performed on a computer or via computer
simulation.
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•Drug Delivery methods include oral, topical,
membrane, intravenous, and inhalation.
- Physiological barriers in animal or human
bodies may prevent drugs from reaching
the targeted area or releasing when they
should.
- The goal is to prevent the drug from
interacting with healthy tissues while still
being effective.
 Formulation Optimization & Improving cabin
- Formulation optimization is ongoing
throughout preclinical and clinical stages.
- It ensures drugs are delivered to the proper
place at the right time and in the right
concentration.
3. CLINICAL DEVELOPMENT
 Complexity of Study Design, Associated Cost &
Implementation Issues
- Trials must be safe and efficacious and be
completed under the drug development
budget.
- This rigorous process must be set up correctly
and enroll many volunteers to be effective.
 Clinical Trials - Dose Escalation, Single
Ascending & Multiple Dose Studies
- Proper dosing determines medication
effectiveness.
 Biological Samples Collection, Storage &
Shipment
- During clinical trials, biological samples are
collected, stored, and shipped from testing
sites according to global standards and
regulations.
- Transport containers of biological samples
may include dry ice packs or other
temperature stabilizing methods.
- Different requirements apply to different
types of biological samples.
 Pharmacodynamic (PD) Biomarkers
- "What drugs do on the body"
- Drug's effects on the target human area, and
link drug regimen and biological responses
 Pharmacokinetic Analysis
- "What the body does to a drug
- Determines the theory of how a new drug
behaves in the human body
- Volume of distribution, clearance, and
terminal half-life
 Drug (Analyte) & Metabolite Stability in
Biological Samples
- Stability is important in determining
human drug efficacy.
- Drug and drug metabolites are susceptible
to degradation, which can lower drug
concentration over the life of the drug.
 Blood, Plasma, Urine & Feces Sample
Analysis for Drug and Metabolites
- To determine and analyze various
properties and effects of the drug and
its metabolites on humans.
 Patient Protection -GCP, HIPAA, &
Adverse Event Reporting
- Human patients must always be protected
during clinical trials
- Good Clinical Practices (GCP) and adverse
event reporting are applied.
 Bioanalytical Method Development and
Validation
- Bioanalytical methods detect analytes and
metabolites such as drug or biomarkers
in biological or human samples to
determine drug efficacy and safety.
4. CLINICAL TRIAL
 IND Application (Investigational New Drug)
- submitted to the FDA before starting clinical
trials
 Phase I -Healthy Volunteer Study (Humans)
- Less than 100 volunteers
- Assess the safety and pharmacokinetics,
absorption, metabolic, and elimination
effects on the body, as well as any side
effects for safe dosage ranges
• Phase II Studies in Patient Population
- 100-500 patients
- Assesses drug safety and efficacy may
receive a placebo or standard drug
previously used as treatment
- Analysis of optimal dose strength helps
create schedules while adverse events
and risks are recorded
 Phase III - Studies in Patient Population
- Enrolls 1,000-5,000 patients
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- Enabling medication labelling and
instructions for proper drug use
- Require extensive collaboration,
organization, and Independent Ethics
Committee (IEC) or Institutional
Review Board (IRB) coordination and
regulation in anticipation of full-scale
production following drug approval
 Phase IV - Post Marketing Surveillance
5. FDA REVIEW
- FDA reviews and approves, or does not approve,
the drug application submitted by the drug
development company.
 Regulatory Approval Timeline
- The new drug regulatory approval timeline
may be standard fast track, breakthrough,
accelerated approval, or priority review
depending on its applications and
necessity for patients
• NDA/ANDA (New Drug Application/
Abbreviated New Drug Application)
- Submit drug safety and efficacy to FDA after
clinical trials In ANDA, the applicant is claiming
that their drug is a duplicate of an already
approved drug
 Orphan Drug
- An orphan drug intended to treat disease is so
rare that financial sponsors are unwilling to
develop it under standard marketing
conditions.
- These drugs may not be approved quickly or not
at all.
 Accelerated Approval
- New drugs may be granted accelerated approval
if there is strong evidence of positive impact
on a surrogate endpoint instead of evidence
of impact on actual clinical benefits the drug
provides.
- Expedition of approval means the medication
can help treat severe or life-threatening
conditions.
REASONS FOR DRUG FAILURE
a) Toxicity: If the toxicity animal patients of a
new drug is too high in human or animal
patients
b) Efficacy: If a new drug's efficacy is not high
enough or evidence is inconclusive.
c) PK Properties or Bioavailability: PK
properties or poor bioavailability due to
low aqueous solubility, pass metabolism.
or high first-past metabolism
d) Inadequate Drug Performance: If the new
drug performs the desired function, but
only at a shallow level, the FDA may reject
the application in favour of a formulations
that performs better.
6. POST-MARKETING MONITORING
- FDA requires drug companies to monitor the
safety of its drug.
DRUG DOSAGE FORM
 DOSAGE FORMS
- Pharmaceutical drug products in the form in
which they are marketed for use, with a
specific mixture of active Ingredients and
inactive components (known as excipients)
in a particular configuration (such as tablet
or capsule) and apportioned into a
particular dose
- Can be given orally or parenterally and
available as solid, semisolid, liquid or
sterile dosage forms.
A. SOLID AND SEMISOLID DOSAGE FORMS
POWDERS AND GRANULES
 Oral Powder
- Generally supplied as finely divided
powder or as an effervescent
granules
- The finely divided powders are
intended to be suspended or
dissolved in water or mixed with
soft food prior administration
 Effervescent Powder
- For solution in water releases carbon
dioxide which makes for the taste
of salty or bitter medication
 Dentifrices
- May be prepared in the form of bulk
powder generally containing soap
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or detergent, mild abrasive and
anticaries effect
 Douche Powders
- Soluble powders intended to be
dissolved in water prior to use as
antiseptic or cleaning agent for a
body cavity
- Most commonly intended for vaginal
use
 Dusting powder
- Applied locally to various parts of the body
as adsorbents, antiseptics, antipruritic,
astringents and antiperspirants
 Insufflations
- Finely divided powders introduced into the
body cavities such as the ears, nose,
throat, tooth sockets, and vagina with
the use of insufflator (powder blower)
CAPSULES AND TABLETS
 Capsules
- Dosage forms in which unit doses of
powder, semisolid, or liquid drugs are
enclosed in a hard or soft, water-soluble
container or shell of gelatin
 Tablets
- Solid dosage forms containing drug
substance with or without suitable
diluents and are prepared either by
compression or molding method
COMPRESSED TABLETS
 Sugar Coated Tablet (SCT)
- Coated with a colored or uncolored sugar
layer
 Film-coated Tablet (FCT)
- Coated with a thin layer of polymer capable
of forming a skin like film
 Enteric-coated Tablet (ECT)
- Designed to pass unchanged through the
stomach to the intestines, where it
disintegrates, dissolves & absorbs.
 Multiple Compressed Tablet (MCT)
- Made by more than one compression cycle
- Usually prepared to separate physically or
chemically incompatible ingredients or to
produce repeat or prolong action of drug
 Controlled-release Tablet (CRT)
- Designed to release the drug's active
ingredient gradually over the day
Gelatin - coated tablet
- Geicap, a capsule shaped compressed tablet
that allows the coated product tablet to
be about, one-third smaller than a
capsule filled with an equivalent amount
of powder
Buccal tablets
- Involves placing the tablet between the
gums and the inner lining of the cheek
(buccal pouch)
 Sublingual tablets
- Involves placing a drug under the tongue to
dissolve and absorb into your blood
through the tissue there
 Effervescent Tablet
- Contain medicinal substances that dissolve
generally when added to water
 Chewable tablets
- Have a smooth disintegration when chewed
or allowed to dissolve in the mouth
 Immediate release tablet
- Designed to disintegrate and release their
medication with no special rate
controlling features such as special
coating and techniques
MOLDED TABLETS
- Very soft, soluble, and are designed for
rapid dissolution
 Tablet triturates
- Small, cylindrical tablets containing small
amounts of potent drugs
 Dispensing tablets (DT)
- Also known as compounding tablets
- Pharmacist used them to compound
prescription
 Hypodermic tablets (HT)
- Used in extemporaneous preparations of
parenteral solutions
- No longer available
 Lozenges/Troches/ Pastilles
- Are discoid shaped solid containing the
medicinal agent in a suitable flavored
base
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- Placed in the mouth where they slowly
dissolve
 Lollipops
- Are lozenges type of oral solid dosage form
with a short stick inserted into it which
produces local effect in the mouth
 Pills
- Small, round, solid dosage form containing
medicinal agents and intended for oral
administration.
 Cachets
- Related to capsules in as much as they
provide an edible containers for the oral
administration of solid drugs
 Pellets
- Small, sterile cylinders formed by
compression from medicated masses
SEMI SOLID AND TRANSDERMAL
 Ointments
- Semi solid preparations intended for
external application to the skin/mucous
membranes, usually contain medicinal
substances
 Creams
- Viscous liquid or semi-solid emulsions of
O/W or W/O type
- O/W type includes shaving creams, hand
creams, foundation cream
- W/O type creams include cold creams and
emollient creams
 Gels
- Semisolid systems consisting of dispersion
made up of either small inorganic
particles or large organic molecules
enclosing and interpenetrated by a liquid
 Transdermal preparations (transdermal
patches)
- Deliver drugs directly through the skin and
into the bloodstream
 Inserts
 Suppositories and Inserts
- Solid dosage form intended for insertion
into body orifices (rectum, vagina, or
urethra)
B. LIQUIDS AND DISPERSE SYSTEM DOSAGE
 Solutions
- Homogeneous mixtures of one or more
solutes dispersed in a dissolving medium
(solvent)
AQUEOUS SOLUTIONS
 Water
- Used mainly as a vehicle and as a solvent for
the desired flavoured of medicinal
ingredients
 Aromatic water (medicated water)
- Clear saturated aqueous solutions of
volatile oils used mainly as flavored or
perfumed vehicles
 Aqueous acids
- Inorganic acids and certain acids, of minor
significance as therapeutic agents but
are of greater importance in chemical
and pharmaceuticals manufacturing
 Douches
- Aqueous solutions directed against a part or
into a cavity of the body. They function
as a cleansing agent or antiseptic agent.
 Enemas
- Can be retention or evacuation enemas.
- Evacuation enemas are rectal preparations
employed to evacuate the bowel.
- Retention enemas influences the general
system by absorption or to affect locally
the seat of disease
 Gargles
- Aqueous solutions used for treating the
nasopharynx by forcing air from the
lungs through gargle which is field in the
throat
 Mouthwashes
- Aqueous solutions which are most often
used for their deodorizing refreshing and
antiseptic effect
 Juices
- Prepared from fresh ripe fruits, aqueous in
character and used in making syrups
which are used as vehicles
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SWEET AND OTHER VISCID AQUEOUS
SOLUTIONS
 Syrups
- Concentrated solutions of sugar such as
sucrose in water or other aqueous liquid
- Used as flavored syrup or medicated syrup
 Honey
- Thick liquid preparations are somewhat
allied to the syrup and used as a base
instead of syrup.
 Mucilages
- Thick, viscid, adhesive liquids produced by
dispersing gum in water or by extracting
with water the mucilaginous principles
from vegetable substances
 Jellies
- Class of gel in which the structural coherent
matrix contains a light proportion of
liquid, usually water
- Used as lubricant for surgical gloves,
catheters, and rectal thermometer
NON-AQUEOUS SOLUTIONS
 Collodion
- Contains pyroxylin in a mixture of ethyl,
ether and ethanol
- Applied to the skin by a soft brush
applicator & when the ether & ethanol
have evaporated, they leave a film of
pyroxylin on the surface
 Elixirs
- Clear, pleasantly flavored sweetened
hydroalcoholic liquids intended for oral
use
- Used as flavors and vehicles
 Glycerin or glycerites
- Solution or mixture of medicinal substances
in not less than 50% by weight of
glycerin.
 Inhalations & inhalants
- Drugs administered by the nasal or oral
respiratory route for local or systemic
effect
- Nebulizers are used for the administration
of inhalation
 Liniments
- Solutions or mixtures of various substances
in oil, alcoholic solution of soap or
emulsion.
- Intended for external application
- Applied by being rubbed on the affected
area.
 Oleo vitamins
- Fish liver oils diluted with edible vegetable
oil or solution of volatile substances of
the indicated vitamins in vitamin
concentrates (vit. A and D) in fish liver oil
 Spirits (essence)
- Alcoholic hydro-alcohol solutions of volatile
substance used medicinally as inhalation
or as flavoring agent.
 Toothache drops
- Preparation used for temporary relief of
toothache by application of cotton
saturated with the product into the
tooth cavity
EXTRACT
- Concentrated preparations of vegetable or
animal drug obtained by removal of the
active constituents of the respective
drugs with suitable menstruum,
evaporation of all or nearly all of the
solvent and adjustment of the residual
masses or powders to the prescribed
standard
 Tinctures
- Alcoholic or hydroalcoholic solutions of
chemical or soluble constituent of
vegetable drugs
 Fluidextracts
- Liquid preparation of vegetable drugs
containing alcohol as a solvent or as a
preservative, or both, so made that each
ml contains the therapeutic constituents
of 1 gram of standard drug that it
represents
DISPERSE SYSTEMS
Suspensions
- Are dispersions of finely divided sold
particles of a drug in a liquid medium in
which the drug is not readily soluble
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 Emulsion
- A thermodynamically unstable system that
consists of two immiscible liquid phases-
dispersed as globules (dispersed phase)
and a liquid phase (continuous phase) -
that are stabilized by the presence of an
emulsifying agent
 Aerosols
- Pressurized dosage forms that upon
actuation emit a fine dispersion of liquid
and/or solid materials containing one or
more active ingredients of a gaseous
medium
C. STERILE TO NOVEL DOSAGE FORMS
STERILE DOSAGE FORMS
 Parental Preparation
- Sterile preparation intended to be
administered by injection under or
through one or more layers of skin
- Usually packed in ampules or vials
 Intravenous Admixture
- Combination of one or more sterile
products added to an IV fluid for
administration
 Intravenous fluids (IVF)
- Sterile, large volume solutions intended to
be administered via infusions
- Contain sugar, amino acids and electrolytes
 Total parenteral nutrition (TPN)
- Contains amino acids, carbohydrates, lipids
and other nutrients in sufficient
quantities
BIOLOGICS FOR ACTIVE IMMUNITY
 Vaccines
- A suspension of attenuated (live) or
inactivated (killed) microbes used to
stimulate the production of antibodies &
provide immunity against one or several
diseases
 Toxoids
- A chemically modified toxin from a
pathogenic microorganism, which is no
longer toxic but is still antigenic and can
be used as a vaccine
BIOLOGICS FOR PASSIVE IMMUNITY
 Human Immune sera
- Contain that specific antibodies obtained
from the blood of humans and produce
as a result of having had the specific
disease or having immunized against it
with a specific biologic product.
 Immunoglobulin
- A solution containing antibodies from the
pooled plasma of not less than 1,000
normal individuals
BIOLOGICS FOR PASSIVE IMMUNITY (ANIMAL
IMMUNE SERUM)
 Hyper immune serum
- A special preparation obtained from human
donor pools selected for high antibody
titer against a specific disease.
 Antitoxin
- A solution of antibodies derived from the
serum of animals immunized with
specific toxins (toxoids) used to achieve
passive immunity or to affect a
treatment
 Antiviral Serum
- Solution of antibodies derived from the
serum of animals immunized with
specific viral vaccines.
 Antivenin
- A preparation of antibodies derived from
the serum of animal immunized with
specific venom used to neutralize the
venoms produced by the specific
organism.
SPECIAL SOLUTIONS AND SUSPENSIONS
 Ophthalmic
- Sterile preparations to be used on the eyes
 Solutions
- Intended for the eye; clear, sterile solution
to be instilled into the eyes by the use of
dropper
 Suspensions
- Dispersion of finely divided relatively
insoluble drugs substances in a aqueous
vehicle containing suitable suspending
and dispersing agent
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 Ointments
- Contain medicinal agents added to the
ointment base either a solution or as
micronized powder. They are limited to
bedtime installation
LENS CARE PRODUCTS
 Wetting solutions
- Preparations designed to furnish hydrophilic
coating over the characteristically
hydrophilic surface of hard contact lens
surfaces
 Cleaning solutions
- Used to remove surface contaminants,
lipids, proteins and the like
 Disinfecting solution
- Isotonic, in an acceptable pH range non-
reactive with sterile solution which
exhibits disinfecting activity. lens
material and
 Soaking solutions
- Used to store and hydrate hard lenses and
to disinfect lenses
 Artificial tears
- Solution intended to rewet hard lenses
NASAL PREPARATIONS
 Inhalation solutions
- Drugs or solutions of drugs administered by
the nasal or oral respiratory route
 Otic Preparations
- Placed in the ear canal in small amounts for
removal of excess cerumen or for
treatment of ear infection, inflammation
or pain
NOVEL AND ADVANCED DOSAGE FORMS
 Radiopharmaceuticals
- Radioisotopes used in medicine for
therapeutic and diagnostic purposes
CATEGORY OF DRUGS IN THE MARKET
PRESCRIPTION/ETHICAL MEDICINE
- Refers to a medicine which can only be
dispensed by a pharmacist to a patient,
upon the presentation of a valid
prescription from a physician, dentist, or
veterinarian and for which a pharmacist's
advice is necessary
OTC (OVER THE COUNTER) DRUGS
- Refers to a medicine used for symptomatic
relief of minor ailments, and which may
be dispensed without a prescription
DANGEROUS DRUGS
 Prohibited Drug
 Opium and its active components and
derivatives, such as heroin and morphine;
 coca leaf and its derivatives, principally cocaine;
 alpha and beta eucaine;
 hallucinogenic drugs, such as mescaline, lysergic
acid diethylamide (LSD) and other substances
producing similar effects;
 Indian hemp and its derivate; all preparations
made from any of the foregoing;
 and other drugs, whether natural or synthetic,
with the physiological effects of a narcotic
drug
 Regulated Drug
- Self-inducing sedatives, such as
secobarbital, phenobarbital,
pentobarbital, barbital, amobarbital
- Any other drug which contains a salt or a
derivative of a salt of barbituric acid
- Any salt, isomer or salt of an isomer, of
amphetamine, such as benzedrine or
dexedrine, or any drug which produces a
physiological action similar to
amphetamine;
- Hypnotic drugs, such as methaqualone or
any other compound producing similar
physiological effects
PHARMACIST-ONLY OTC MEDICINE
- Over-the-counter medicine classified by
appropriate government agencies that
can be obtained only from a pharmacist,
with mandatory pharmacist's advice on
its selection and proper use
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THERAPEUTIC CLASSIFICATION OF DRUGS
A. DRUGS ACTING ON CENTRAL NERVOUS
SYSTEM
• Analgesic
- Relieves pain without inducing loss of
consciousness
• Local Anesthetic
- Eliminates pain perception in limited area by
local action on sensory nerves
• Anticonvulsant
- Medication used to control seizures
(convulsions) or stop an ongoing series of
seizures.
• Anti-gout
- Agents that work by correcting the
overproduction of uric acid which causes
intense inflammatory reaction
• Anti-migraine
- Intended to reduce the effects/ intensity of
migraine characterized by recurrent
headaches that are moderate to severe
headache
• Anti-Parkinsonism
- Drug that suppresses the neurologic
disturbances and symptoms of parkinsonism
• Antipyretic
- Drug that reduces fever by lowering the
body temperature.
• Hypnotic
- A CNS depressant used to induce sleep
• Anxiolytic
- Drug that suppresses symptom of anxiety
• Antidepressant
- A centrally acting drug that induces mood
elevation, useful in treating mental
depression
• Anti-psychotic
- Drug that suppresses symptoms of
psychoses of various diagnostic types
• Anti vertigo
- Drug that suppress dizziness
• Anti-motion sickness
- Drug that suppresses motion sickness like
nausea, vomiting ,and vertigo
B. DRUGS ACTING ON MUSCULOSKELETAL
SYSTEM
• Non-steroidal anti-inflammatory (NSAID)
- An analgesic, anti-inflammatory drug that
inhibits prostaglandin synthesis
• Muscle relaxant
- Works by causing the muscles to become
less tense or stiff, which in turn reduces pain
and discomfort
• Antirheumatic
- Anti-inflammatory drug used to treat
arthritis and rheumatoid disorder.
• Neuromuscular blocker
- Drug that paralyzes skeletal muscles by
preventing transmission of neural impulses
to them
C. ANTI-INFECTIVE
• Antileprosy
- Drug that kills or inhibits Mycobacterium
leprae, causative agent of leprosy
• Antiprotozoal
- Drug that kills or inhibits protozoa like in the
case of malaria
• Antiviral
- Drug that kills or inhibits virus
• Anti-schistosomal
- Drug that kills or inhibits pathogenic flukes
of genus Schistosoma
D. IMMUNOLOGICAL
• Vaccine
- An antigen containing drugs used to induce
active immunity against an infectious
disease
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• Immune sera
- A serum of an animal or human containing
antibodies against a specific disease
E. CARDIOVASCULAR DRUGS
• Adrenergic agent
- Are medicines that stimulate certain nerves
in your body
- Mimicking the action of the chemical
messenger's epinephrine & norepinephrine
or by stimulating their release
• Inotropic agent
- Agent that increases the contractile strength
of heart muscle, a cardiotonic
• Anti angina
- A coronary vasodilator useful in preventing
or treating attacks of angina pectoris (chest
pain).
• Antiarrhythmic
- Useful in suppressing rhythm irregularities of
the heart
• Antihyperlipidemic
- Drug that lowers lipids in the blood.
• Diuretic
- Drug that promotes renal excretion of water
& electrolytes useful in treating generalized
edema
F. RESPIRATORY DRUGS
• Anti-asthma
- Drugs that relieves asthma symptoms
• Antitussive
- Drug that suppresses coughing
• Mucolytic
- An agent which dissolves thick mucus and is
usually used to help relieve respiratory
difficulties.
• Nasal decongestant
- A drug used to relieve nasal congestion in
the upper respiratory tract
G. ANTIHISTAMINE AND
IMMUNOSUPPRESSANTS
• Antineoplastic
- Drug that attacks malignant cell in the body
• Immunosuppressants
- Drugs that inhibits immune response to
foreign materials, used to suppress rejection
of tissue graft
• Antihistamine
- Drug or other compound that inhibits the
physiological effects of histamine, used
especially in the treatment of allergies
I. BLOOD PRODUCTS AND BLOOD
SUBSTITUTES
• Plasma expander/substitute
- Used to treat patients who have suffered
hemorrhage or shock.
• Plasma protein fraction
- Sterile solution of proteins composed of
albumin & globulin from human plasma
- Used as a replacement therapy in patients
with complex deficiencies of coagulation
factors such as coagulopathy
J. ANTIDOTES
• General antidote
- Drug that reduces the effects of ingested
poisons by adsorbing toxic material
• Specific antidotes
- Drug that reduces the effects of a systemic
poison by a mechanism that relates to the
particular poison
K. GASTROINTESTINAL DRUGS
• Antacid
- Drug that neutralizes excess gastric acid
• H 2 antagonist
- Drug that inhibits histamine-induced gastric
acid secretion used to treat peptic and
duodenal ulcers
PERSPECTIVE PHARMACY (MODULE 6) FINALS
11 | P a g e
• Mucosal Protectant
- Given to protect the eroded ulcer sited in
the GIT from further damage by acid and
digestive enzymes.
• Antispasmodic drug
- Used to relieve spasm of involuntary muscle
like those of smooth muscle in the bowel
wall
• Antiemetic
- Drug that suppresses nausea and vomiting.
• Antimotility
- Drugs used to alleviate symptoms of
diarrhea
• Laxative, cathartic
- Drug that promotes defecation
L. HORMONES AND HORMONE
ANTAGONISTS
• Sex hormone
- Hormones ones produced by the sex organs
which play an important role in the
development of sexual characteristics
• Hormonal contraceptive
- Drug that prevents conception
• Thyroid hormone
- Hormone that maintains metabolic function
and normal metabolic rate.
• Anti Thyroid
- Drug that reduces thyroid hormone action
usually inhibiting hormone synthesis
• Anti-diabetic
- Drug that supplies insulin or stimulates the
secretion of insulin used in the treatment of
diabetes mellitus
M. DRUGS ACTING ON THE UTERUS
• Oxytocic or uterine stimulant
- A drug that induces labor by stimulating
contractions of the muscles of the uterus
• Tocolytic or uterine relaxant
- Drug used to suppress premature labor
N. SOLUTIONS CORRECTING WATER
ELECTROLYTE DISTURBANCES
• Oral rehydrating solution (ORS)
- A solution containing electrolytes,
carbohydrates & water used for
replacement of fluid and nutrients from the
body.
• Parenteral solution
- A solution given intravenously to maintain
adequate hydration restore blood volume,
re-establish loss electrolyte or partial
nutrition
• Peritoneal dialysis solution
- A solution used in peritoneal dialysis,
procedure which is used to correct
imbalance of fluid or of electrolytes in the
blood.
• Hemodialysis solution
- A solution used in hemodialysis, a procedure
in which the impurities are removed from
the blood
O. DERMATOLOGICAL AND MUCOUS
MEMBRANE
• Antibacterial
• Antifungal
• Antiviral
• Anti-inflammatory
- Drug that inhibits physiologic response to
cell damage (inflammation)
• Scabicide/anti-scabies
- A medication used to treat scabies - Itchy
skin disease caused by itch mite
• Pediculicide/anti-lice
- An agent that destroys lice
• Antipruritic
- Drug that reduces itching
• Keratolytic
- Drug that softens the superficial keratin
layer of the skin and promotes
desquamation (peeling)
PERSPECTIVE PHARMACY (MODULE 6) FINALS
12 | P a g e
• Astringent
- Agent used topically to toughen and shrink
tissue
• Antiseptic, disinfectant
- Agent that destroys microorganisms in
contact and is suitable for sterilizing animate
or inanimate object
P. OPHTHALMIC PREPARATIONS
• Antibacterial
• Antifungal
• Antiviral
• Local anesthetic
• Anti-inflammatory
• Mydriatic
- An adrenergic drug used to topically in the
eye to induce dilation of the pupil
• Miotic
- Cholinergic drug used topically in the eye to
induce constriction of the pupil
Q. EARS, NOSE, AND THROAT
PREPARATIONS
• Antibacterial
• Antifungal
• Anti-inflammatory
R. VITAMINS AND MINERALS
• Vitamin
- An organic chemical essential in small
amounts of normal metabolism used
therapeutically to supplement the vitamin
contents of foods
• Minerals
- An inorganic substance occurring naturally
which plays a vital role in regulating many
bodily functions
HEALTH PRODUCTS HANDLED BY
PHARMACISTS
Medications
- Plays a key role in:
o Treating diseases (chickenpox)
o Reducing symptoms (asthma attacks)
o Preventing disease (measles, mumps,
rubella)
o Slowing down the worsening of the
illness (parkinson's disease)
- Commonly used by doctors in treating their
patients
- Handled by pharmacists by law
Drug
- A pharmaceutical product that pertains to
chemical compound/s or biological
substance/s, other than food, intended for
use in the diagnosis, mitigation, treatment
or diagnosis of disease in humans or animals
Medicine
- Refers to a drug in their appropriate dosage
forms with assured quality safety and
efficacy for humans or animals, or both.
PHARMACEUTICAL PRODUCT
• Drugs
• Medicines
• Biologicals
• Pharmaceutical & Biopharmaceutical Products
• Veterinary Products
• Veterinary Biologics And
• Veterinary Medicinal Products
HEALTH PRODUCTS IN THE MARKET
Products that may have an effect on health
which require regulations as determined by the
FDA
 Food
- Any processed substance which is intended for
human consumption and includes drink for
man, beverages, chewing gum and any
substances which have been used as an
ingredient in the manufacture, preparation
or treatment of food
PERSPECTIVE PHARMACY (MODULE 6) FINALS
13 | P a g e
 Drug
- (1) Articles recognized in official
pharmacopeias and formularies, including
official homeopathic pharmacopoeia, or any
documentary, supplement to any of them,
which are recognized and adopted by the FDA;
- (2) Articles intended for use in the diagnosis,
cure, migration, treatment, or prevention of
disease in man or other animals
- (3) Articles (other than food) intended to
affect the structure of any function of the
body of humans or animals;
- (4) Articles intended for use as a component
of any articles specified in clauses (1), (2), or
(3) but do not include devices or their
components, parts or accessories
 Cosmetics
- Articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body or any
part thereof for cleansing, beautifying,
promoting attractiveness, or altering the
appearance, and
- (2) Articles intended for use as a component of
any such articles
 Device
- Can be medical devices, radiation devices &
health- related devices
• Medical device
- Any instrument, apparatus, implement, machine,
appliance, implant, in-vitro reagent or
calibrator, software, material, or other similar
or related article intended by the
manufacturer to be used alone, or in
combination, for human beings for one or
more of the specific purpose
• Radiation device
- An electrical or electronic apparatus emitting any
ionizing or non-ionizing electromagnetic or
particulate radiation; or any sonic, infrasonic,
or ultrasonic wave. It includes ionizing
radiation emitting equipment, which is not
intentionally designed to produce radioactive
materials
•Health-related device
- Any device not used in health care but has been
determined by the FDA to adversely affect the
health of the people.
 Biologic or Biologic Product
- Any attenuated or inactivated virus or bacteria,
or subcomponents attached to adjuvants,
toxoids, hyperimmune serum, and analogous
products applicable to diagnosis, prevention,
treatment or cure of disease or injuries to
man, obtained or derived from living matter -
animals, plants or microorganisms, or parts
thereof
• In-Vitro Diagnostic Reagents
- Reagents and systems intended for use in the
diagnosis of disease or other conditions,
including a determination of the state of
health, in order to cure, mitigate, treat or
prevent disease or its sequel
• Household/Urban Hazardous Substance
- Any substance or mixture of substances intended
for individual or limited purposes, and which is
toxic, corrosive, an irritant, a strong sensitizer,
is flammable or combustible, or generates
pressure through decomposition, heat or
other means, if such substance or mixture of
substances may cause substantial injury or
substantial illness during or as a proximate
result of any customary or reasonably
foreseeable ingestion by children, but shall
not include agricultural fertilizer, pesticide,
and insecticide and other economic poisons,
radioactive substance, or substances intended
for use as fuels, coolants, refrigerants and the
like
- Any toy or other articles intended for use by
children which the FDA may determine to
pose an electrical, chemical, physical, or
thermal hazard
PHARMACISTS ROLE IN HANDLING
MEDICATION
Community Pharmacy
 Work with patient on general health
Processing of prescription
 Health promotion
PERSPECTIVE PHARMACY (MODULE 6) FINALS
14 | P a g e
 Dispense prescription
 Counsel and educate patients
 Ensure patients' medication safety
 Monitoring of drug utilization
 Manage staff
 Perform administrative tasks
 Communicate with prescribers
 Educate health provider colleagues
Hospital Pharmacy
 Serves as a member of policy-making,
committees (Pharmacy and Therapeutics
Committee), including those concerned with
drug selection, the use of antibiotics, and
hospital infections and thereby influences the
preparation and composition of an essential-
drug list or formulary
 Educate other health professionals about the
rational use of drugs
 Participates in studies to determine the
beneficial or adverse effects of drugs, and is
involved in the analysis of drugs in body fluids
 Control hospital manufacture and
procurement of drugs to ensure the supply of
high-quality products
 Planning and implementation of clinical trials.
 Review all medication orders
 Prepare all medication and endorse to the
nurse
 Educate health provider colleague
 Ensure patient medication adherence
 Provide pharmacist intervention when
necessary
Industrial Pharmacy
• Research and development
• Manufacture and quality assurance
• Drug Information
• Patent application and drug registration
• Clinical trials and post-marketing surveillance
• Sales and marketing
• Management
PHARMACISTS ROLE IN HEALTHCARE,
HEALTH PROMOTION, DRUG
INFORMATION DISSEMINATION, AND
MEDICATION THERAPY MANAGEMENT
Healthcare
• Pharmacists are an integral contributor to the
overall health care of patients
• The role of Pharmacists in health care
management include the distribution of drugs and
supplies, delivering drug related information and
consultation to meet needs of patients and health
team members
Health Promotion
• Refers to the process of enabling communities,
patients and clients to increase control over their
health and its determinants by engaging in healthy
behaviors to reduce the risk of developing diseases
and other comorbidities
• Health Promotion Activities in the Pharmacy
• Health Education by pharmacists
• Health screening
• Health Improvement Services
• Promoting Self Care
• Management of Prescribed Medicines
• Caregiver Education
Drug Information Service
• Refers to any activity in response to a drug
information request or query from healthcare
professionals, organizations, committees, patients
and other individuals with the goal of providing
carefully evaluated, evidence- based drug
information and recommendation to support
medication use practice, enhance quality of
patient care, improve patient outcomes and
ensure prudent use of resources
• Providing DI to patients, caregivers, and health
care professionals
PERSPECTIVE PHARMACY (MODULE 6) FINALS
15 | P a g e
• Creating and maintaining currency of a variety of
print and online educational resources for patients
(e.g., tip sheets, pamphlets) and health care
professionals (e.g., in-service documents,
newsletters) on topics such as optimal medication
use, general health, or select clinical questions
• Educating health care professionals on safe and
effective medication-use policies and processes,
including development of resources to
communicate this information.
• Leading or participating in continuing education
services for healthcare professionals.
• Leading or participating in continuing education
services for healthcare professionals.
• Precepting and educating pharmacy students.
Participating in quality improvement research
projects and drug cost analyses.
• Contributing to the biomedical literature and
providing peer review for other contributors
Medication Management
• Involves the patient-centered care provided by
the pharmacist to optimize safe, effective and
appropriate drug therapy by ensuring the proper
selection, procurement, storage, order,
transcription, preparation, dispensation,
administration of the drug and monitoring of the
drug utilization and effect
• Medication therapy reviews
• Pharmacotherapy consultation
• Disease management coach/support
• Anticoagulation management
• Medication safety surveillance
• Health, wellness, public health
• Immunization and other clinical services
ROLES OF A SUPERVISING PHARMACIST IN
RETAIL OUTLETS
Pharmacy Supervisor
• A pharmacy supervisor typically has a wide range
of responsibilities, which can include:
• Reviewing patient records to determine whether
they are eligible for medication therapy
management services
• Assisting pharmacists with drug ordering and
inventory management activities
• Providing data analysis and reporting on the
status of inventory levels and other pharmacy
department statistics
• Ensuring that all state and federal laws are
followed when dispensing medications to patients
• Maintaining an inventory of pharmaceutical
products by ordering supplies from suppliers and
distributors
• A pharmacy supervisor typically has a wide range
of responsibilities, which can include:
• Providing training to pharmacy technicians and
other staff members on topics such as inventory
control procedures and compounding drugs
• Assisting in maintaining the store’s appearance
by ensuring that shelves are stocked and neat and
clean
• Training staff on pharmacy policies and
procedures to ensure compliance with regulatory
standards
• Overseeing the hiring, training, scheduling, and
supervising of pharmacy technicians, pharmacists,
and other staff members in a retail setting

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  • 1. PERSPECTIVE PHARMACY (MODULE 6) FINALS 1 | P a g e PHARMACISTS ROLE IN HANDLING MEDICATION AND IT'S ROLE IN HEALTHCARE Coverage for Finals:  Drug Discovery and Development  Category and Therapeutic Classification of Drugs  Different Dosage forms  Health Products in the Market  Pharmacists Role in Healthcare, Health Promotion, Drug Information, Dissemination, and Medication Therapy  Management Roles of Pharmacists as a Supervising Pharmacist in Retail Outlets DRUG DISCOVERY AND DEVELOPMENT 1. DISCOVERY AND DEVELOPMENT Historically, drugs were mostly found by identifying active ingredients from traditional medicines or purely by chance. Afterward, classical pharmacology was used to investigate chemical libraries including small molecules natural products, or plant extracts and find those with therapeutic effects.  Target Identification & Validation - Finds a gene or protein that has therapeutic effect, characteristics are then recorded.  Hit Discovery Process - Compound screening assays are developed.  Assay Development & Screening - Evaluates the effects of the new drug candidate at the cellular, molecular, and biochemical levels.  High Throughput Screening - Uses data processing/control software, liquid handling devices, and sensitive detectors to rapidly conduct millions of pharmacological, chemical, and genetic tests identifying active compounds, genes, or antibodies that affect human molecules.  Hit to Lead - In the Hit to Lead (H2L) process, small molecule hits from an HTS are evaluated and optimized in a limited way into lead compounds.  Lead Optimization - In the lead optimization (LO) process, the lead compounds discovered in the H2L process are synthesized and modified to improve potency and reduce side effects. Lead optimization conducts experimental testing using animal efficacy models and ADMET tools, designing the drug candidate.  Active pharmaceutical ingredients (APIs) -are biologically active ingredients in a drug candidate that produce effects.  All drugs are made up of the API or APIs and excipients.  Excipients are inactive substances that deliver the drug into the human system. (Ex. binders, sweetening agents, colorants)  High Potency Active Pharmaceutical Ingredients (HP APIs) are molecules that are effective at much smaller dosage levels than standard APIs.  The drug discovery process ends when one lead compound is found for a drug candidate, and the process of drug development starts 2. PRECLINICAL RESEARCH Drug development begins with preclinical research to determine the efficacy and safety of the drug. Researchers determine the following about the drug:  Absorption, distribution, metabolization, and excretion  Potential benefits and mechanisms of action  Best dosage, and administration route  Side effects/adverse events  Effects on gender, race, or ethnicity groups  Interaction with other treatments  Effectiveness compared to similar drugs  In Vivo, In Vitro & Ex Vivo Assays - In vivo, preclinical research examples are the development of new drugs using mice, rat, and dog models. -In vitro is research conducted in a laboratory. Ex vivo uses animal cells or tissues from a non- living animal.  In Silico Assays -test systems or biological experiments performed on a computer or via computer simulation.
  • 2. PERSPECTIVE PHARMACY (MODULE 6) FINALS 2 | P a g e •Drug Delivery methods include oral, topical, membrane, intravenous, and inhalation. - Physiological barriers in animal or human bodies may prevent drugs from reaching the targeted area or releasing when they should. - The goal is to prevent the drug from interacting with healthy tissues while still being effective.  Formulation Optimization & Improving cabin - Formulation optimization is ongoing throughout preclinical and clinical stages. - It ensures drugs are delivered to the proper place at the right time and in the right concentration. 3. CLINICAL DEVELOPMENT  Complexity of Study Design, Associated Cost & Implementation Issues - Trials must be safe and efficacious and be completed under the drug development budget. - This rigorous process must be set up correctly and enroll many volunteers to be effective.  Clinical Trials - Dose Escalation, Single Ascending & Multiple Dose Studies - Proper dosing determines medication effectiveness.  Biological Samples Collection, Storage & Shipment - During clinical trials, biological samples are collected, stored, and shipped from testing sites according to global standards and regulations. - Transport containers of biological samples may include dry ice packs or other temperature stabilizing methods. - Different requirements apply to different types of biological samples.  Pharmacodynamic (PD) Biomarkers - "What drugs do on the body" - Drug's effects on the target human area, and link drug regimen and biological responses  Pharmacokinetic Analysis - "What the body does to a drug - Determines the theory of how a new drug behaves in the human body - Volume of distribution, clearance, and terminal half-life  Drug (Analyte) & Metabolite Stability in Biological Samples - Stability is important in determining human drug efficacy. - Drug and drug metabolites are susceptible to degradation, which can lower drug concentration over the life of the drug.  Blood, Plasma, Urine & Feces Sample Analysis for Drug and Metabolites - To determine and analyze various properties and effects of the drug and its metabolites on humans.  Patient Protection -GCP, HIPAA, & Adverse Event Reporting - Human patients must always be protected during clinical trials - Good Clinical Practices (GCP) and adverse event reporting are applied.  Bioanalytical Method Development and Validation - Bioanalytical methods detect analytes and metabolites such as drug or biomarkers in biological or human samples to determine drug efficacy and safety. 4. CLINICAL TRIAL  IND Application (Investigational New Drug) - submitted to the FDA before starting clinical trials  Phase I -Healthy Volunteer Study (Humans) - Less than 100 volunteers - Assess the safety and pharmacokinetics, absorption, metabolic, and elimination effects on the body, as well as any side effects for safe dosage ranges • Phase II Studies in Patient Population - 100-500 patients - Assesses drug safety and efficacy may receive a placebo or standard drug previously used as treatment - Analysis of optimal dose strength helps create schedules while adverse events and risks are recorded  Phase III - Studies in Patient Population - Enrolls 1,000-5,000 patients
  • 3. PERSPECTIVE PHARMACY (MODULE 6) FINALS 3 | P a g e - Enabling medication labelling and instructions for proper drug use - Require extensive collaboration, organization, and Independent Ethics Committee (IEC) or Institutional Review Board (IRB) coordination and regulation in anticipation of full-scale production following drug approval  Phase IV - Post Marketing Surveillance 5. FDA REVIEW - FDA reviews and approves, or does not approve, the drug application submitted by the drug development company.  Regulatory Approval Timeline - The new drug regulatory approval timeline may be standard fast track, breakthrough, accelerated approval, or priority review depending on its applications and necessity for patients • NDA/ANDA (New Drug Application/ Abbreviated New Drug Application) - Submit drug safety and efficacy to FDA after clinical trials In ANDA, the applicant is claiming that their drug is a duplicate of an already approved drug  Orphan Drug - An orphan drug intended to treat disease is so rare that financial sponsors are unwilling to develop it under standard marketing conditions. - These drugs may not be approved quickly or not at all.  Accelerated Approval - New drugs may be granted accelerated approval if there is strong evidence of positive impact on a surrogate endpoint instead of evidence of impact on actual clinical benefits the drug provides. - Expedition of approval means the medication can help treat severe or life-threatening conditions. REASONS FOR DRUG FAILURE a) Toxicity: If the toxicity animal patients of a new drug is too high in human or animal patients b) Efficacy: If a new drug's efficacy is not high enough or evidence is inconclusive. c) PK Properties or Bioavailability: PK properties or poor bioavailability due to low aqueous solubility, pass metabolism. or high first-past metabolism d) Inadequate Drug Performance: If the new drug performs the desired function, but only at a shallow level, the FDA may reject the application in favour of a formulations that performs better. 6. POST-MARKETING MONITORING - FDA requires drug companies to monitor the safety of its drug. DRUG DOSAGE FORM  DOSAGE FORMS - Pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active Ingredients and inactive components (known as excipients) in a particular configuration (such as tablet or capsule) and apportioned into a particular dose - Can be given orally or parenterally and available as solid, semisolid, liquid or sterile dosage forms. A. SOLID AND SEMISOLID DOSAGE FORMS POWDERS AND GRANULES  Oral Powder - Generally supplied as finely divided powder or as an effervescent granules - The finely divided powders are intended to be suspended or dissolved in water or mixed with soft food prior administration  Effervescent Powder - For solution in water releases carbon dioxide which makes for the taste of salty or bitter medication  Dentifrices - May be prepared in the form of bulk powder generally containing soap
  • 4. PERSPECTIVE PHARMACY (MODULE 6) FINALS 4 | P a g e or detergent, mild abrasive and anticaries effect  Douche Powders - Soluble powders intended to be dissolved in water prior to use as antiseptic or cleaning agent for a body cavity - Most commonly intended for vaginal use  Dusting powder - Applied locally to various parts of the body as adsorbents, antiseptics, antipruritic, astringents and antiperspirants  Insufflations - Finely divided powders introduced into the body cavities such as the ears, nose, throat, tooth sockets, and vagina with the use of insufflator (powder blower) CAPSULES AND TABLETS  Capsules - Dosage forms in which unit doses of powder, semisolid, or liquid drugs are enclosed in a hard or soft, water-soluble container or shell of gelatin  Tablets - Solid dosage forms containing drug substance with or without suitable diluents and are prepared either by compression or molding method COMPRESSED TABLETS  Sugar Coated Tablet (SCT) - Coated with a colored or uncolored sugar layer  Film-coated Tablet (FCT) - Coated with a thin layer of polymer capable of forming a skin like film  Enteric-coated Tablet (ECT) - Designed to pass unchanged through the stomach to the intestines, where it disintegrates, dissolves & absorbs.  Multiple Compressed Tablet (MCT) - Made by more than one compression cycle - Usually prepared to separate physically or chemically incompatible ingredients or to produce repeat or prolong action of drug  Controlled-release Tablet (CRT) - Designed to release the drug's active ingredient gradually over the day Gelatin - coated tablet - Geicap, a capsule shaped compressed tablet that allows the coated product tablet to be about, one-third smaller than a capsule filled with an equivalent amount of powder Buccal tablets - Involves placing the tablet between the gums and the inner lining of the cheek (buccal pouch)  Sublingual tablets - Involves placing a drug under the tongue to dissolve and absorb into your blood through the tissue there  Effervescent Tablet - Contain medicinal substances that dissolve generally when added to water  Chewable tablets - Have a smooth disintegration when chewed or allowed to dissolve in the mouth  Immediate release tablet - Designed to disintegrate and release their medication with no special rate controlling features such as special coating and techniques MOLDED TABLETS - Very soft, soluble, and are designed for rapid dissolution  Tablet triturates - Small, cylindrical tablets containing small amounts of potent drugs  Dispensing tablets (DT) - Also known as compounding tablets - Pharmacist used them to compound prescription  Hypodermic tablets (HT) - Used in extemporaneous preparations of parenteral solutions - No longer available  Lozenges/Troches/ Pastilles - Are discoid shaped solid containing the medicinal agent in a suitable flavored base
  • 5. PERSPECTIVE PHARMACY (MODULE 6) FINALS 5 | P a g e - Placed in the mouth where they slowly dissolve  Lollipops - Are lozenges type of oral solid dosage form with a short stick inserted into it which produces local effect in the mouth  Pills - Small, round, solid dosage form containing medicinal agents and intended for oral administration.  Cachets - Related to capsules in as much as they provide an edible containers for the oral administration of solid drugs  Pellets - Small, sterile cylinders formed by compression from medicated masses SEMI SOLID AND TRANSDERMAL  Ointments - Semi solid preparations intended for external application to the skin/mucous membranes, usually contain medicinal substances  Creams - Viscous liquid or semi-solid emulsions of O/W or W/O type - O/W type includes shaving creams, hand creams, foundation cream - W/O type creams include cold creams and emollient creams  Gels - Semisolid systems consisting of dispersion made up of either small inorganic particles or large organic molecules enclosing and interpenetrated by a liquid  Transdermal preparations (transdermal patches) - Deliver drugs directly through the skin and into the bloodstream  Inserts  Suppositories and Inserts - Solid dosage form intended for insertion into body orifices (rectum, vagina, or urethra) B. LIQUIDS AND DISPERSE SYSTEM DOSAGE  Solutions - Homogeneous mixtures of one or more solutes dispersed in a dissolving medium (solvent) AQUEOUS SOLUTIONS  Water - Used mainly as a vehicle and as a solvent for the desired flavoured of medicinal ingredients  Aromatic water (medicated water) - Clear saturated aqueous solutions of volatile oils used mainly as flavored or perfumed vehicles  Aqueous acids - Inorganic acids and certain acids, of minor significance as therapeutic agents but are of greater importance in chemical and pharmaceuticals manufacturing  Douches - Aqueous solutions directed against a part or into a cavity of the body. They function as a cleansing agent or antiseptic agent.  Enemas - Can be retention or evacuation enemas. - Evacuation enemas are rectal preparations employed to evacuate the bowel. - Retention enemas influences the general system by absorption or to affect locally the seat of disease  Gargles - Aqueous solutions used for treating the nasopharynx by forcing air from the lungs through gargle which is field in the throat  Mouthwashes - Aqueous solutions which are most often used for their deodorizing refreshing and antiseptic effect  Juices - Prepared from fresh ripe fruits, aqueous in character and used in making syrups which are used as vehicles
  • 6. PERSPECTIVE PHARMACY (MODULE 6) FINALS 6 | P a g e SWEET AND OTHER VISCID AQUEOUS SOLUTIONS  Syrups - Concentrated solutions of sugar such as sucrose in water or other aqueous liquid - Used as flavored syrup or medicated syrup  Honey - Thick liquid preparations are somewhat allied to the syrup and used as a base instead of syrup.  Mucilages - Thick, viscid, adhesive liquids produced by dispersing gum in water or by extracting with water the mucilaginous principles from vegetable substances  Jellies - Class of gel in which the structural coherent matrix contains a light proportion of liquid, usually water - Used as lubricant for surgical gloves, catheters, and rectal thermometer NON-AQUEOUS SOLUTIONS  Collodion - Contains pyroxylin in a mixture of ethyl, ether and ethanol - Applied to the skin by a soft brush applicator & when the ether & ethanol have evaporated, they leave a film of pyroxylin on the surface  Elixirs - Clear, pleasantly flavored sweetened hydroalcoholic liquids intended for oral use - Used as flavors and vehicles  Glycerin or glycerites - Solution or mixture of medicinal substances in not less than 50% by weight of glycerin.  Inhalations & inhalants - Drugs administered by the nasal or oral respiratory route for local or systemic effect - Nebulizers are used for the administration of inhalation  Liniments - Solutions or mixtures of various substances in oil, alcoholic solution of soap or emulsion. - Intended for external application - Applied by being rubbed on the affected area.  Oleo vitamins - Fish liver oils diluted with edible vegetable oil or solution of volatile substances of the indicated vitamins in vitamin concentrates (vit. A and D) in fish liver oil  Spirits (essence) - Alcoholic hydro-alcohol solutions of volatile substance used medicinally as inhalation or as flavoring agent.  Toothache drops - Preparation used for temporary relief of toothache by application of cotton saturated with the product into the tooth cavity EXTRACT - Concentrated preparations of vegetable or animal drug obtained by removal of the active constituents of the respective drugs with suitable menstruum, evaporation of all or nearly all of the solvent and adjustment of the residual masses or powders to the prescribed standard  Tinctures - Alcoholic or hydroalcoholic solutions of chemical or soluble constituent of vegetable drugs  Fluidextracts - Liquid preparation of vegetable drugs containing alcohol as a solvent or as a preservative, or both, so made that each ml contains the therapeutic constituents of 1 gram of standard drug that it represents DISPERSE SYSTEMS Suspensions - Are dispersions of finely divided sold particles of a drug in a liquid medium in which the drug is not readily soluble
  • 7. PERSPECTIVE PHARMACY (MODULE 6) FINALS 7 | P a g e  Emulsion - A thermodynamically unstable system that consists of two immiscible liquid phases- dispersed as globules (dispersed phase) and a liquid phase (continuous phase) - that are stabilized by the presence of an emulsifying agent  Aerosols - Pressurized dosage forms that upon actuation emit a fine dispersion of liquid and/or solid materials containing one or more active ingredients of a gaseous medium C. STERILE TO NOVEL DOSAGE FORMS STERILE DOSAGE FORMS  Parental Preparation - Sterile preparation intended to be administered by injection under or through one or more layers of skin - Usually packed in ampules or vials  Intravenous Admixture - Combination of one or more sterile products added to an IV fluid for administration  Intravenous fluids (IVF) - Sterile, large volume solutions intended to be administered via infusions - Contain sugar, amino acids and electrolytes  Total parenteral nutrition (TPN) - Contains amino acids, carbohydrates, lipids and other nutrients in sufficient quantities BIOLOGICS FOR ACTIVE IMMUNITY  Vaccines - A suspension of attenuated (live) or inactivated (killed) microbes used to stimulate the production of antibodies & provide immunity against one or several diseases  Toxoids - A chemically modified toxin from a pathogenic microorganism, which is no longer toxic but is still antigenic and can be used as a vaccine BIOLOGICS FOR PASSIVE IMMUNITY  Human Immune sera - Contain that specific antibodies obtained from the blood of humans and produce as a result of having had the specific disease or having immunized against it with a specific biologic product.  Immunoglobulin - A solution containing antibodies from the pooled plasma of not less than 1,000 normal individuals BIOLOGICS FOR PASSIVE IMMUNITY (ANIMAL IMMUNE SERUM)  Hyper immune serum - A special preparation obtained from human donor pools selected for high antibody titer against a specific disease.  Antitoxin - A solution of antibodies derived from the serum of animals immunized with specific toxins (toxoids) used to achieve passive immunity or to affect a treatment  Antiviral Serum - Solution of antibodies derived from the serum of animals immunized with specific viral vaccines.  Antivenin - A preparation of antibodies derived from the serum of animal immunized with specific venom used to neutralize the venoms produced by the specific organism. SPECIAL SOLUTIONS AND SUSPENSIONS  Ophthalmic - Sterile preparations to be used on the eyes  Solutions - Intended for the eye; clear, sterile solution to be instilled into the eyes by the use of dropper  Suspensions - Dispersion of finely divided relatively insoluble drugs substances in a aqueous vehicle containing suitable suspending and dispersing agent
  • 8. PERSPECTIVE PHARMACY (MODULE 6) FINALS 8 | P a g e  Ointments - Contain medicinal agents added to the ointment base either a solution or as micronized powder. They are limited to bedtime installation LENS CARE PRODUCTS  Wetting solutions - Preparations designed to furnish hydrophilic coating over the characteristically hydrophilic surface of hard contact lens surfaces  Cleaning solutions - Used to remove surface contaminants, lipids, proteins and the like  Disinfecting solution - Isotonic, in an acceptable pH range non- reactive with sterile solution which exhibits disinfecting activity. lens material and  Soaking solutions - Used to store and hydrate hard lenses and to disinfect lenses  Artificial tears - Solution intended to rewet hard lenses NASAL PREPARATIONS  Inhalation solutions - Drugs or solutions of drugs administered by the nasal or oral respiratory route  Otic Preparations - Placed in the ear canal in small amounts for removal of excess cerumen or for treatment of ear infection, inflammation or pain NOVEL AND ADVANCED DOSAGE FORMS  Radiopharmaceuticals - Radioisotopes used in medicine for therapeutic and diagnostic purposes CATEGORY OF DRUGS IN THE MARKET PRESCRIPTION/ETHICAL MEDICINE - Refers to a medicine which can only be dispensed by a pharmacist to a patient, upon the presentation of a valid prescription from a physician, dentist, or veterinarian and for which a pharmacist's advice is necessary OTC (OVER THE COUNTER) DRUGS - Refers to a medicine used for symptomatic relief of minor ailments, and which may be dispensed without a prescription DANGEROUS DRUGS  Prohibited Drug  Opium and its active components and derivatives, such as heroin and morphine;  coca leaf and its derivatives, principally cocaine;  alpha and beta eucaine;  hallucinogenic drugs, such as mescaline, lysergic acid diethylamide (LSD) and other substances producing similar effects;  Indian hemp and its derivate; all preparations made from any of the foregoing;  and other drugs, whether natural or synthetic, with the physiological effects of a narcotic drug  Regulated Drug - Self-inducing sedatives, such as secobarbital, phenobarbital, pentobarbital, barbital, amobarbital - Any other drug which contains a salt or a derivative of a salt of barbituric acid - Any salt, isomer or salt of an isomer, of amphetamine, such as benzedrine or dexedrine, or any drug which produces a physiological action similar to amphetamine; - Hypnotic drugs, such as methaqualone or any other compound producing similar physiological effects PHARMACIST-ONLY OTC MEDICINE - Over-the-counter medicine classified by appropriate government agencies that can be obtained only from a pharmacist, with mandatory pharmacist's advice on its selection and proper use
  • 9. PERSPECTIVE PHARMACY (MODULE 6) FINALS 9 | P a g e THERAPEUTIC CLASSIFICATION OF DRUGS A. DRUGS ACTING ON CENTRAL NERVOUS SYSTEM • Analgesic - Relieves pain without inducing loss of consciousness • Local Anesthetic - Eliminates pain perception in limited area by local action on sensory nerves • Anticonvulsant - Medication used to control seizures (convulsions) or stop an ongoing series of seizures. • Anti-gout - Agents that work by correcting the overproduction of uric acid which causes intense inflammatory reaction • Anti-migraine - Intended to reduce the effects/ intensity of migraine characterized by recurrent headaches that are moderate to severe headache • Anti-Parkinsonism - Drug that suppresses the neurologic disturbances and symptoms of parkinsonism • Antipyretic - Drug that reduces fever by lowering the body temperature. • Hypnotic - A CNS depressant used to induce sleep • Anxiolytic - Drug that suppresses symptom of anxiety • Antidepressant - A centrally acting drug that induces mood elevation, useful in treating mental depression • Anti-psychotic - Drug that suppresses symptoms of psychoses of various diagnostic types • Anti vertigo - Drug that suppress dizziness • Anti-motion sickness - Drug that suppresses motion sickness like nausea, vomiting ,and vertigo B. DRUGS ACTING ON MUSCULOSKELETAL SYSTEM • Non-steroidal anti-inflammatory (NSAID) - An analgesic, anti-inflammatory drug that inhibits prostaglandin synthesis • Muscle relaxant - Works by causing the muscles to become less tense or stiff, which in turn reduces pain and discomfort • Antirheumatic - Anti-inflammatory drug used to treat arthritis and rheumatoid disorder. • Neuromuscular blocker - Drug that paralyzes skeletal muscles by preventing transmission of neural impulses to them C. ANTI-INFECTIVE • Antileprosy - Drug that kills or inhibits Mycobacterium leprae, causative agent of leprosy • Antiprotozoal - Drug that kills or inhibits protozoa like in the case of malaria • Antiviral - Drug that kills or inhibits virus • Anti-schistosomal - Drug that kills or inhibits pathogenic flukes of genus Schistosoma D. IMMUNOLOGICAL • Vaccine - An antigen containing drugs used to induce active immunity against an infectious disease
  • 10. PERSPECTIVE PHARMACY (MODULE 6) FINALS 10 | P a g e • Immune sera - A serum of an animal or human containing antibodies against a specific disease E. CARDIOVASCULAR DRUGS • Adrenergic agent - Are medicines that stimulate certain nerves in your body - Mimicking the action of the chemical messenger's epinephrine & norepinephrine or by stimulating their release • Inotropic agent - Agent that increases the contractile strength of heart muscle, a cardiotonic • Anti angina - A coronary vasodilator useful in preventing or treating attacks of angina pectoris (chest pain). • Antiarrhythmic - Useful in suppressing rhythm irregularities of the heart • Antihyperlipidemic - Drug that lowers lipids in the blood. • Diuretic - Drug that promotes renal excretion of water & electrolytes useful in treating generalized edema F. RESPIRATORY DRUGS • Anti-asthma - Drugs that relieves asthma symptoms • Antitussive - Drug that suppresses coughing • Mucolytic - An agent which dissolves thick mucus and is usually used to help relieve respiratory difficulties. • Nasal decongestant - A drug used to relieve nasal congestion in the upper respiratory tract G. ANTIHISTAMINE AND IMMUNOSUPPRESSANTS • Antineoplastic - Drug that attacks malignant cell in the body • Immunosuppressants - Drugs that inhibits immune response to foreign materials, used to suppress rejection of tissue graft • Antihistamine - Drug or other compound that inhibits the physiological effects of histamine, used especially in the treatment of allergies I. BLOOD PRODUCTS AND BLOOD SUBSTITUTES • Plasma expander/substitute - Used to treat patients who have suffered hemorrhage or shock. • Plasma protein fraction - Sterile solution of proteins composed of albumin & globulin from human plasma - Used as a replacement therapy in patients with complex deficiencies of coagulation factors such as coagulopathy J. ANTIDOTES • General antidote - Drug that reduces the effects of ingested poisons by adsorbing toxic material • Specific antidotes - Drug that reduces the effects of a systemic poison by a mechanism that relates to the particular poison K. GASTROINTESTINAL DRUGS • Antacid - Drug that neutralizes excess gastric acid • H 2 antagonist - Drug that inhibits histamine-induced gastric acid secretion used to treat peptic and duodenal ulcers
  • 11. PERSPECTIVE PHARMACY (MODULE 6) FINALS 11 | P a g e • Mucosal Protectant - Given to protect the eroded ulcer sited in the GIT from further damage by acid and digestive enzymes. • Antispasmodic drug - Used to relieve spasm of involuntary muscle like those of smooth muscle in the bowel wall • Antiemetic - Drug that suppresses nausea and vomiting. • Antimotility - Drugs used to alleviate symptoms of diarrhea • Laxative, cathartic - Drug that promotes defecation L. HORMONES AND HORMONE ANTAGONISTS • Sex hormone - Hormones ones produced by the sex organs which play an important role in the development of sexual characteristics • Hormonal contraceptive - Drug that prevents conception • Thyroid hormone - Hormone that maintains metabolic function and normal metabolic rate. • Anti Thyroid - Drug that reduces thyroid hormone action usually inhibiting hormone synthesis • Anti-diabetic - Drug that supplies insulin or stimulates the secretion of insulin used in the treatment of diabetes mellitus M. DRUGS ACTING ON THE UTERUS • Oxytocic or uterine stimulant - A drug that induces labor by stimulating contractions of the muscles of the uterus • Tocolytic or uterine relaxant - Drug used to suppress premature labor N. SOLUTIONS CORRECTING WATER ELECTROLYTE DISTURBANCES • Oral rehydrating solution (ORS) - A solution containing electrolytes, carbohydrates & water used for replacement of fluid and nutrients from the body. • Parenteral solution - A solution given intravenously to maintain adequate hydration restore blood volume, re-establish loss electrolyte or partial nutrition • Peritoneal dialysis solution - A solution used in peritoneal dialysis, procedure which is used to correct imbalance of fluid or of electrolytes in the blood. • Hemodialysis solution - A solution used in hemodialysis, a procedure in which the impurities are removed from the blood O. DERMATOLOGICAL AND MUCOUS MEMBRANE • Antibacterial • Antifungal • Antiviral • Anti-inflammatory - Drug that inhibits physiologic response to cell damage (inflammation) • Scabicide/anti-scabies - A medication used to treat scabies - Itchy skin disease caused by itch mite • Pediculicide/anti-lice - An agent that destroys lice • Antipruritic - Drug that reduces itching • Keratolytic - Drug that softens the superficial keratin layer of the skin and promotes desquamation (peeling)
  • 12. PERSPECTIVE PHARMACY (MODULE 6) FINALS 12 | P a g e • Astringent - Agent used topically to toughen and shrink tissue • Antiseptic, disinfectant - Agent that destroys microorganisms in contact and is suitable for sterilizing animate or inanimate object P. OPHTHALMIC PREPARATIONS • Antibacterial • Antifungal • Antiviral • Local anesthetic • Anti-inflammatory • Mydriatic - An adrenergic drug used to topically in the eye to induce dilation of the pupil • Miotic - Cholinergic drug used topically in the eye to induce constriction of the pupil Q. EARS, NOSE, AND THROAT PREPARATIONS • Antibacterial • Antifungal • Anti-inflammatory R. VITAMINS AND MINERALS • Vitamin - An organic chemical essential in small amounts of normal metabolism used therapeutically to supplement the vitamin contents of foods • Minerals - An inorganic substance occurring naturally which plays a vital role in regulating many bodily functions HEALTH PRODUCTS HANDLED BY PHARMACISTS Medications - Plays a key role in: o Treating diseases (chickenpox) o Reducing symptoms (asthma attacks) o Preventing disease (measles, mumps, rubella) o Slowing down the worsening of the illness (parkinson's disease) - Commonly used by doctors in treating their patients - Handled by pharmacists by law Drug - A pharmaceutical product that pertains to chemical compound/s or biological substance/s, other than food, intended for use in the diagnosis, mitigation, treatment or diagnosis of disease in humans or animals Medicine - Refers to a drug in their appropriate dosage forms with assured quality safety and efficacy for humans or animals, or both. PHARMACEUTICAL PRODUCT • Drugs • Medicines • Biologicals • Pharmaceutical & Biopharmaceutical Products • Veterinary Products • Veterinary Biologics And • Veterinary Medicinal Products HEALTH PRODUCTS IN THE MARKET Products that may have an effect on health which require regulations as determined by the FDA  Food - Any processed substance which is intended for human consumption and includes drink for man, beverages, chewing gum and any substances which have been used as an ingredient in the manufacture, preparation or treatment of food
  • 13. PERSPECTIVE PHARMACY (MODULE 6) FINALS 13 | P a g e  Drug - (1) Articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopoeia, or any documentary, supplement to any of them, which are recognized and adopted by the FDA; - (2) Articles intended for use in the diagnosis, cure, migration, treatment, or prevention of disease in man or other animals - (3) Articles (other than food) intended to affect the structure of any function of the body of humans or animals; - (4) Articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories  Cosmetics - Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and - (2) Articles intended for use as a component of any such articles  Device - Can be medical devices, radiation devices & health- related devices • Medical device - Any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings for one or more of the specific purpose • Radiation device - An electrical or electronic apparatus emitting any ionizing or non-ionizing electromagnetic or particulate radiation; or any sonic, infrasonic, or ultrasonic wave. It includes ionizing radiation emitting equipment, which is not intentionally designed to produce radioactive materials •Health-related device - Any device not used in health care but has been determined by the FDA to adversely affect the health of the people.  Biologic or Biologic Product - Any attenuated or inactivated virus or bacteria, or subcomponents attached to adjuvants, toxoids, hyperimmune serum, and analogous products applicable to diagnosis, prevention, treatment or cure of disease or injuries to man, obtained or derived from living matter - animals, plants or microorganisms, or parts thereof • In-Vitro Diagnostic Reagents - Reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its sequel • Household/Urban Hazardous Substance - Any substance or mixture of substances intended for individual or limited purposes, and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizer, pesticide, and insecticide and other economic poisons, radioactive substance, or substances intended for use as fuels, coolants, refrigerants and the like - Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard PHARMACISTS ROLE IN HANDLING MEDICATION Community Pharmacy  Work with patient on general health Processing of prescription  Health promotion
  • 14. PERSPECTIVE PHARMACY (MODULE 6) FINALS 14 | P a g e  Dispense prescription  Counsel and educate patients  Ensure patients' medication safety  Monitoring of drug utilization  Manage staff  Perform administrative tasks  Communicate with prescribers  Educate health provider colleagues Hospital Pharmacy  Serves as a member of policy-making, committees (Pharmacy and Therapeutics Committee), including those concerned with drug selection, the use of antibiotics, and hospital infections and thereby influences the preparation and composition of an essential- drug list or formulary  Educate other health professionals about the rational use of drugs  Participates in studies to determine the beneficial or adverse effects of drugs, and is involved in the analysis of drugs in body fluids  Control hospital manufacture and procurement of drugs to ensure the supply of high-quality products  Planning and implementation of clinical trials.  Review all medication orders  Prepare all medication and endorse to the nurse  Educate health provider colleague  Ensure patient medication adherence  Provide pharmacist intervention when necessary Industrial Pharmacy • Research and development • Manufacture and quality assurance • Drug Information • Patent application and drug registration • Clinical trials and post-marketing surveillance • Sales and marketing • Management PHARMACISTS ROLE IN HEALTHCARE, HEALTH PROMOTION, DRUG INFORMATION DISSEMINATION, AND MEDICATION THERAPY MANAGEMENT Healthcare • Pharmacists are an integral contributor to the overall health care of patients • The role of Pharmacists in health care management include the distribution of drugs and supplies, delivering drug related information and consultation to meet needs of patients and health team members Health Promotion • Refers to the process of enabling communities, patients and clients to increase control over their health and its determinants by engaging in healthy behaviors to reduce the risk of developing diseases and other comorbidities • Health Promotion Activities in the Pharmacy • Health Education by pharmacists • Health screening • Health Improvement Services • Promoting Self Care • Management of Prescribed Medicines • Caregiver Education Drug Information Service • Refers to any activity in response to a drug information request or query from healthcare professionals, organizations, committees, patients and other individuals with the goal of providing carefully evaluated, evidence- based drug information and recommendation to support medication use practice, enhance quality of patient care, improve patient outcomes and ensure prudent use of resources • Providing DI to patients, caregivers, and health care professionals
  • 15. PERSPECTIVE PHARMACY (MODULE 6) FINALS 15 | P a g e • Creating and maintaining currency of a variety of print and online educational resources for patients (e.g., tip sheets, pamphlets) and health care professionals (e.g., in-service documents, newsletters) on topics such as optimal medication use, general health, or select clinical questions • Educating health care professionals on safe and effective medication-use policies and processes, including development of resources to communicate this information. • Leading or participating in continuing education services for healthcare professionals. • Leading or participating in continuing education services for healthcare professionals. • Precepting and educating pharmacy students. Participating in quality improvement research projects and drug cost analyses. • Contributing to the biomedical literature and providing peer review for other contributors Medication Management • Involves the patient-centered care provided by the pharmacist to optimize safe, effective and appropriate drug therapy by ensuring the proper selection, procurement, storage, order, transcription, preparation, dispensation, administration of the drug and monitoring of the drug utilization and effect • Medication therapy reviews • Pharmacotherapy consultation • Disease management coach/support • Anticoagulation management • Medication safety surveillance • Health, wellness, public health • Immunization and other clinical services ROLES OF A SUPERVISING PHARMACIST IN RETAIL OUTLETS Pharmacy Supervisor • A pharmacy supervisor typically has a wide range of responsibilities, which can include: • Reviewing patient records to determine whether they are eligible for medication therapy management services • Assisting pharmacists with drug ordering and inventory management activities • Providing data analysis and reporting on the status of inventory levels and other pharmacy department statistics • Ensuring that all state and federal laws are followed when dispensing medications to patients • Maintaining an inventory of pharmaceutical products by ordering supplies from suppliers and distributors • A pharmacy supervisor typically has a wide range of responsibilities, which can include: • Providing training to pharmacy technicians and other staff members on topics such as inventory control procedures and compounding drugs • Assisting in maintaining the store’s appearance by ensuring that shelves are stocked and neat and clean • Training staff on pharmacy policies and procedures to ensure compliance with regulatory standards • Overseeing the hiring, training, scheduling, and supervising of pharmacy technicians, pharmacists, and other staff members in a retail setting