PHARMACEUTICAL DOSAGE FORMS, DRUG  Hypoglycemics

DELIVERY SYSTEMS AND

 Antidiarrheal
MEDICAL DEVICES

Through their use, many of the diseases that have

Introduction to Drugs and Pharmacy plagued humans throughout history, such as smallpox
and poliomyelitis, are now virtually extinct. Illnesses
such as diabetes, hypertension, and mental depression
Drug are effectively controlled with modern drugs. Today's
surgical procedures would be virtually impossible
- is defined as an agent intended for use in the without the benefit of anesthetics, analgesics,
diagnosis, mitigation, treatment, cure and prevention of antibiotics, blood transfusions, and intravenous fluids.
disease in human or in other animals (Food, Drug and
Cosmetic Act, 1938).
New drugs may be derived from plant or animal
sources, as by-products of microbial growth, or
One of the most astounding qualities of drugs is the through chemical synthesis, molecular modification, or
diversity of their actions and effects on the body. This biotechnology.
quality enables their selective use in the treatment of a
range of common and rare conditions involving
virtually every body organ, tissue and cell.
The process of drug discovery and development is
complex.

Some of the therapeutic classification of drugs:

 Mydriatics and Miotics It entails the collective contributions of many scientific
specialists, including organic, physical, and analytical
 Anticoagulants chemists; biochemists; molecular biologists;
 Emetics and Anti-emetics bacteriologists; physiologists; pharmacologists;
toxicologists; hematologists; immunologists;
 Diuretics endocrinologists; pathologists; bio-statisticians;
 Expectorants pharmaceutical scientists; clinical pharmacists;
physicians; and many others.
 Cathartics
 Antipyretics and Analgesics
After a potential new drug substance is discovered and
 NSAIDS undergoes definitive chemical and physical
 Antacid characterization, a great deal of biologic information
must be gathered. The basic pharmacology, or the
 Antihypertensives nature and mechanism of action of the drug on the
 Antidepressants biologic system, must be determined including
toxicologic features. The drug's site and rate of
 Anti-infectives absorption, its pattern of distribution and concentration
within the body, its duration of action, and the method
 Antidotes
and rate of its elimination or excretion must be studied.
 Antineoplastics
A comprehensive study of the short-term and long- Through professional interaction and communication
term effects of the drug on various body cells, tissues, with other health professionals, the pharmacist can
and organs must be made. Highly specific information, contribute greatly to patient care.
such as the effect of the drug on the fetus of a pregnant
animal or its ability to pass to a nursing baby through
the breast milk of its mother, may be obtained. Many a An intimate knowledge of drug actions,
promising new drug has been abandoned because of its pharmacotherapeutics, formulation and dosage form
potential to cause excessive or hazardous adverse design, available pharmaceutical products and drug
effects. information sources makes the pharmacist a vital
member of the health care team.

The most effective routes of administration (e.g., oral,

rectal, parenteral, topical) must be determined, and The pharmacist delivers pharmaceutical services in a
guidelines for the dosages recommended for persons of variety of community and institutional health care
varying ages (e.g., neonates, children, adults, the environments and effectively uses medication records,
elderly), weights, and states of illness must be patient monitoring, and assessment techniques in
established. safeguarding the public health.

It has been said that the only difference between a drug The Heritage of Pharmacy
and a poison is the dose.

Drugs, in the form of vegetation and minerals, have

Each particular pharmaceutical product is a existed as long as humans. Among many early races,
formulation unique unto itself. In addition to the active disease was believed to be caused by the entrance of
therapeutic ingredients, a pharmaceutical formulation demons or evil spirits into the body.
contains a number of non-therapeutic or
pharmaceutical ingredients.
From the earliest records, the primary methods of
removing spirits were through the use of spiritual
To ensure the stability of a drug in a formulation and incantations the application of noisome materials, and
the continued effectiveness of the drug product the administration of specific herbs or plant materials.
throughout its usual shelf life,the principles of
chemistry, physical pharmacy, microbiology, and
pharmaceutical technology must be applied. PLACEBO EFFECT
-more on psychologic rather than therapeutic
The pharmaceutical product must be properly
administered if the patient is to receive maximum
benefit. The medication must be taken in sufficient
quantity, at specified interval and for an indicated The First Apothecary
duration to achieve the desired therapeutic outcomes.

The art of the apothecary has always been associated

with the mysterious, and its practitioners were
believed to have connection with the world of spirits
and thus performed as intermediaries between the seen Perhaps the most famous of these surviving artifacts is
and the unseen. the Ebers Papyrus, a continuous scroll some 60 feet
long and a foot wide dating to the 16th century B.C.
- Name after Georg Ebers
The compassion of a god, the observance of
ceremonies, the absence of evil spirits, and the healing Contains 800 prescriptions
intent of the dispenser were individually and
700 botanical drugs
collectively needed to make the drug therapeutically
effective. - Acacia and Fennel – Most common botanical
drugs that is used until now
- Minerals/Animals are also included
Throughout history, the knowledge of drugs and their
application to disease has always meant power. In the Minerals- Iron oxide, NaCl, Na Carbonate, Sulfur
Homeric epics, the term pharmakon (Gr.), from which Animal excrements
our word pharmacy was derived, connotes a charm or a
drug that can be used for good or for evil.

Many of the tribal apothecary's failures were doubtless Introduction of the Scientific Viewpoint
due to impotent or inappropriate medicines, Throughout history, many individuals have contributed
underdosage, overdosage, and even poisoning. to the advancement of the health sciences. Notable
Successes may be attributed to experience, mere among those whose genius and creativeness had a
coincidence of appropriate drug selection, natural revolutionary influence on the development of
healing, inconsequential effect of the drug, or placebo pharmacy and medicine were Hippocrates (ca. 460–
effects, that is, successful treatment due to psychologic 377 BC), Dioscorides (first century AD), Galen (ca.
rather than therapeutic effects. 130–200 AD), and Paracelsus (1493–1541 AD).

Hippocrates
Early Drugs - Father of Medicine
- a Greek physician, is credited with the introduction of
Numerous ancient tablets, scrolls, and other relics as scientific pharmacy and medicine.
early as 3000 B.C. have been uncovered and - his works included the descriptions of hundreds of
deciphered by archaeologic scholars to the gratitude of drugs, and it was during this period that the term
historians of both medicine and pharmacy. pharmakon came to mean a purifying remedy for good
only, transcending the previous connotation of a - he influenced the transformation of pharmacy from a
charm or drug for good or for evil purposes. profession based primarily on botanical science to one
based on chemical science.
- he believed it was possible to prepare a specific
Dioscorides
medicinal agent to combat each specific disease and
- a Greek physician and botanist, was the first to deal introduced a host of chemical substances to internal
with botany as an applied science of pharmacy. therapy.

- his work, De Materia Medica, is considered a

milestone in the development of pharmaceutical botany
Early Research
and in the study of naturally occurring medicinal
materials.
Karl Wilhelm Scheele (1742–1786)
De Materia Medica - the most famous of all pharmacists because of his
scientific genius and dramatic discoveries.
- contains naturally occurring plant drugs also
known as pharmacognosy. - among his discoveries were the chemicals lactic acid,
citric acid, oxalic acid, tartaric acid, and arsenic acid.
Drug came from the word
- he identified glycerin, invented new methods of
PHARMAKON – drug/charm
preparing calomel and benzoic acid, and discovered
Gnosis – Knowledge on Plant drug oxygen a year before Priestley.
Friedrich Sertürner (1783–1841)

Claudius Galen - a German pharmacist who isolated morphine from

opium in 1805.
- a Greek pharmacist–physician who attained Roman
citizenship, aimed to create a perfect system of Morphine (Analgesic)
physiology, pathology, and treatment. Galen
- opioids for point
formulated doctrines that were followed for 1,500
- being used by breast cancer patients
years.
Joseph Caventou (1795–1877) and Joseph Pelletier
- he originated so many preparations of vegetable
(1788–1842)
drugs by mixing or melting the individual ingredients
that the field of pharmaceutical preparations was once - combined their talents and isolated quinine and
commonly referred to as “Galenic pharmacy.” cinchonine from cinchona and strychnine and brucine
from nux vomica.
- Introduces Galenicals/Galenic Pharmacy by
mixing/melting individual vegetables. Joseph Pelletier and Pierre Robiquet (1780–1840)
- Galen’s Cerate – cold cream for inflammation - isolated caffeine, and Robiquet independently
separated codeine from opium.

Paracelsus
USED UNTIL KNOW:
Philippus Aureolus Theophrastus Bombastus von
Hohenheim 1. Paclitaxel
Taxol ®
- a Swiss physician and chemist.
 - Antitumor activity a national pharmacopeia. Spalding's efforts were later
- Employed for metastatic carcinoma of the to result in his being recognized as the Father of the
ovary United States Pharmacopeia.
- Comes from Taxus baccata
Lyman Spalding
2. Vincaleukoblastine
- Anticancer/antineoplastic property - Father of USP
- Originated from Vinca rosea - First author of USP
3. Digoxin - Before 10 years then revised
- Cardiac Glycoside - Now 5 years then revised
- It has inotropic effect-main action will be in the
heart.
- Digitalis lanata
ASPIRIN
The United States Pharmacopeia and the National
- Pregnant
Formular
- Its low
y
BARBITURATES
USP
Syphilis – oral stones
- Mechanism of action, labeling, formulation,
A drug should be
pharmacologic activity
1. Pure – free from contamination
NF
2. Safe – shouldn’t be dangerous/hazardous to
- Preparations, structures, and formulas of all the health
drugs that conforms to the USP 3. Effective – renders if desired therapy
4. Quality - collectively
USP 20
NF 15

The first USP was published on December 15, 1820, in

Usp + Nf = published by United States English and Latin, then the international language of
Pharmacopeial Convention medicine, to render the book more intelligible to
The term pharmacopeia comes from the Greek physicians and pharmacists of any nationality. Within
pharmakon, meaning drug, and poiein, meaning make, its 272 pages were listed 217 drugs considered worthy
and the combination indicates any recipe or formula or of recognition; many of them were taken from the
other standards required to make or prepare a drug. Massachusetts Pharmacopeia, which is considered by
some to be the precursor to the USP.

The term was first used in 1580 in connection with a

local book of drug standards in Bergamo, Italy. In 1900, the Pharmacopeial Convention granted
authority to issue supplements to the USP whenever
necessary to maintain satisfactory standards. At the
On January 6, 1817, Lyman Spalding, a physician 1940 meeting of the convention, it was decided to
from New York City, submitted a plan to the Medical revise the USP every 5 years while maintain the use of
Society of the County of New York for the creation of periodic supplements.
 Thus the two publications became official compendia.
Among other things, the law required that whenever
In 1872, the synthesis of salicylic acid from phenol
the designation USP or NF was used or implied on
inaugurated the synthesis of a group of analgesic
drug labeling, the products must conform to the
compounds including acetylsalicylic acid (aspirin),
physical and chemical standards set forth in the
which was introduced into medicine in 1899.
compendium monograph.

Among other chemicals synthesized for the first time

The early editions of the NF served mainly as a
were sleep-producing derivatives of barbituric acid
convenience to practicing pharmacists by providing
called barbiturates. This new source of drugs—
uniform names of drugs and preparations and working
synthetic organic chemistry—welcomed the turn into
directions for the small-scale manufacture of popular
the 20th century.
pharmaceutical preparations prescribed by physicians.
Before 1940, the NF, like the USP, was revised every
10 years. After that date, new editions appeared every
Until this time, drugs created through the genius of the 5 years, with supplements issued periodically as
synthetic organic chemist relieved a host of maladies, necessary.
but none had been found to be curative—none,
that is, until 1910, when arsphenamine, a specific agent
against syphilis, was introduced to medical science.
In 1975, the United States Pharmacopeial Convention,
Inc. purchased the NF, unifying the official
compendia and providing the mechanism for a single
This was the start of an era of chemotherapy, an era in national compendium.
which the diseases of humans became curable through
the use of specific chemical agents. The concepts,
discoveries, and inspirational work that led mankind to
this glorious period are credited to Paul Ehrlich, the
German bacteriologist who together with a Japanese Drug Regulation and Control
colleague, Sahachiro Hata, discovered arsphenamine.

The first federal law in the United States designed to

The advancement of science, both basic and applied, regulate drug products manufactured domestically was
led to drugs of a more complex nature and to more of the Food and Drug Act of 1906.
them. The standards advanced by the USP were more
than ever needed to protect the public by ensuring the
purity and uniformity of drugs. The law required drugs marketed interstate to comply
with their claimed standards for strength, purity, and
quality. Manufacturers' claims of therapeutic
The National Formulary (NF) was officially named on benefit were not regulated until 1912, when the
June 30, 1906, when President Theodore Roosevelt passage of the Sherley Amendment specifically
signed into law the first federal Pure Food and Drug prohibited false claims of therapeutic effects,
Act, designating both the USP and NF as establishing declaring such products misbranded.
legal standards for medicinal and pharmaceutical
substances.
The Federal Food, Drug and Cosmetic Act of 1938
The need for additional drug standards was tragically Prescription drugs must bear the symbol “Rx Only” or
demonstrated in 1938. The then new wonder drug the legend “Caution: Federal Law Prohibits Dispensing
sulfanilamide, which was not soluble in most common Without Prescription.”
pharmaceutical solvents of the day, was prepared and
distributed by an otherwise reputable manufacturer as
an elixir using as the solvent diethylene glycol, a According to the Durham-Humphrey Amendment,
highly toxic agent used in antifreeze solutions. Before prescriptions for legend drugs may not be refilled
the product could be removed from the market, more (dispensed again after the initial filling of the
than 100 persons died of diethylene glycol poisoning. prescription) without the express consent of the
prescriber. The refill status of prescriptions for certain
legend drugs known to be subject to public abuse was
The necessity for proper product formulation and further regulated with the passage of the Drug Abuse
thorough pharmacologic and toxicologic testing of the Control Amendments of 1965 and then by the
therapeutic agent, pharmaceutical ingredients, and the Comprehensive Drug Abuse Prevention and Control
completed product was painfully recognized. Act of 1970.

Congress responded with the passage of the Federal

Food, Drug, and Cosmetic Act of 1938 and the creation
of the FDA to administer and enforce it.

Kefauver-Harris Amendments of 1962

The 1938 Act prohibits the distribution and use of any
new drug or drug product without the prior filing of a
New Drug Application (NDA) and approval of the
FDA. A tragedy in 1960 led to the passage of the Kefauver-
Harris Amendments to the Federal Food Drug and
Cosmetic Act of 1938. A new synthetic drug,
thalidomide, recommended as a sedative and
Durham-Humphrey Amendment of 1951
tranquilizer, was being sold OTC in Europe.

The Durham-Humphrey Amendment of the Federal

A pharmaceutical company was awaiting FDA
Food Drug and Cosmetic Act established a legal
approval for marketing in the United States when
distinction between prescription and over-the-counter
reports of a toxic effect of the drug's use in Europe
(OTC) or non-prescription drugs.
began to appear.

Medications deemed safe enough by the FDA for self-

Thalidomide given to women during pregnancy
treatment are made available to consumers for direct
produced birth defects, most notably phocomelia, an
purchase whereas medications requiring
arrested development of the limbs of the affected
professional diagnosis for their safe and effective use
newborn. Thousands of children were affected to
must be dispensed only upon a valid prescription or
various extents.
institutional medication order.
Some were born without arms or legs and others, with decreasing levels of control, from schedule I to
partially formed limbs. The more fortunate were born schedule V. The drugs in the five schedules may be
with only disfigurations of the nose, eyes, and ears. described as follows:
The most severely afflicted died of malformation of the
heart or gastrointestinal tract.

This drug catastrophe spurred the Congress to

strengthen the existing laws regarding new drugs.
Without dissent, on October 10, 1962, the
Kefauver Harris Drug Amendments to the Food, Drug,
and Cosmetic Act of 1938 were passed by both houses
of Congress.

The purpose of the enactment was to ensure a greater

degree of safety for approved drugs, and manufacturers
were now required to prove a drug both safe and
effective before it would be granted FDA approval for
marketing.
FDA Pregnancy Categories

Comprehensive Drug Abuse Prevention and

Control Act of 1970 Appropriate prescribing and use of medications
requires a risk-versus-benefit assessment of the
medication for a specific patient.
The Comprehensive Drug Abuse Prevention and
Control Act of 1970 (now referred to as the Controlled
Substances Act [CSA]) served to consolidate and There are many risk factors that must be evaluated,
codify control authority over drugs of abuse into a including pregnancy. In 1979, the United States FDA
single statute. introduced a classification of fetal risks due to
pharmaceuticals. This was based on a similar system
that was introduced in Sweden just 1 year earlier.
Under its provisions, the Drug Abuse Control
Amendments of 1965, the Harrison Narcotic Act of
1914, and other related laws governing stimulants, The FDA has established five categories that can be
depressants, narcotics, and hallucinogens were used to estimate the potential of a systemically
repealed and replaced by regulatory framework now absorbed drug for causing birth defects. The reliability
administered by the Drug Enforcement Administration of the documentation is the key differentiation factor
(DEA) in the Department of Justice. among the categories for determining the risk-versus
benefit ratio.

The Comprehensive Drug Abuse Prevention and

Control Act of 1970 established five “schedules” for The Pregnancy Category “X” is the strongest and states
the classification and control of drug substances that that if any data exist that a drug may be implicated as a
are subject to abuse. These schedules provide for teratogen and the risk-versus-benefit ratio does not
support the use of the drug, then the drug is marketed drugs to assist in the enforcement of federal
contraindicated during pregnancy.The FDA-assigned laws requiring that drugs be safe and effective and not
pregnancy categories are as follows: adulterated or misbranded. Under the regulations of
the act, each firm that manufactures or repackages
drugs for ultimate sale or distribution to patients or
Medication Exposures During Pregnancy and consumers must register with the FDA and submit
Lactation appropriate information for listing.

Every woman in the general population has a 3% to Orphan Drug Act of 1983
5% risk of having a child with a birth defect or mental
retardation. Birth defects are the leading cause of infant
mortality in the United States. Drugs intended for the treatment of “rare diseases and
conditions” may be designated orphan drugs to help
promote research on rare diseases. “Rare” diseases are
Two important factors to consider when assessing the defined as diseases affecting fewer than 200,000
teratogenic potential of a medication are the stage of people or diseases that affect more than 200,000
pregnancy at which the exposure occurred and people but where circumstances are such that a
the amount of medication taken. company is unlikely to recover its research and
development costs.

Black Box Warnings

Drug Price Competition and Patent Term
Restoration Act of 1984
A black box warning in prescription drug labeling is
used to call attention to one of the following situations:
Changes to speed FDA approval of generic drugs and
the extension of patent life for innovative new drugs
(a) there is an adverse reaction so serious in proportion were the major components of the Drug Price
to the potential benefit that it be considered in Competition and Patent Restoration Act of 1984.
assessing the risks and benefits of using the drug,

Under the provisions of the legislation, applications for

(b) the risk of a serious adverse reaction can be generic copies of an originally approved new drug can
prevented or reduced in severity by careful use of the be filed through an abbreviated new drug application
drug (e.g., patient selection, special monitoring, certain (ANDA), and the extensive animal and human studies
concomitant therapy), or (c) the FDA has approved the of an NDA are not required.
drug with restrictions to prescribing/distribution to
ensure its safe use.
The FDA evaluates the chemistry, manufacturing,
control (CMC) standards, and the drug's bioavailability
Drug Listing Act of 1972 in determining that the generic version is equivalent to
the originally approved drug.

The Drug Listing Act was enacted to provide the FDA

with the legislative authority to compile a list of
Since 1984, over 10,000 generic drug products have 3. Distribution of samples: Samples may be distributed
entered the market, and generic drugs now account for only to (a) practitioners licensed to prescribe such
about 70% of prescriptions dispensed. drugs and (b) at the written request of the practitioner,
to pharmacies of hospitals or other health care
institutions.
For holders of patented drugs, the legislation provides
an extension of patent life equal to the time required
for FDA review of the NDA plus half the time spent in 4. Wholesale distributors: Manufacturers are required
the testing phase, up to a maximum of 5 years and not to maintain a list of their authorized distributors.
to exceed the usual 20-year patent term. This extends
the effective patent life and exclusive marketing period
for innovative new drug products, thereby encouraging Prescription Drug User Fee Act of 1992
pioneering research and development.

The Prescription Drug User Fee Act, first passed in

1992 and subsequently renewed, allows the FDA to
accept user fees from drug and biologic companies in
Prescription Drug Marketing Act of 1987 and
return for committing to review new drug and biologic
Prescription Drug Amendments of 1992
applications within certain time frames.

The Prescription Drug Marketing Act of 1987

The Act is credited with a more rapid application
established new safeguards on the integrity of the
review process and the speedier approval of new drug
nation's supply of prescription drugs. The act is
products.
intended to reduce the risks of adulterated, misbranded,
repackaged, or mislabeled drugs entering the
legitimate marketplace through “secondary sources.”
The primary sections of the Act are summarized as The third enactment, passed as part of the “Public
follows: Health Security and Bioterrorism Preparedness and
Response Act of 2002,” included designated resources
for postmarketing studies to monitor the continuing
safety and efficacy of new drug products.
1. Reimportation: Prohibits the reimportation of drug
products manufactured in the United States except by
the manufacturer of the product.
Dietary Supplement Health and Education Act of
1994 and the Dietary Supplement and
Nonprescription Drug Consumer Protection Act of
2. Sales restrictions: Prohibits selling, trading,
2006
purchasing, or the offer to sell, trade, or purchase a
drug sample. It also prohibits resale by health care
institutions of pharmaceuticals purchased explicitly for
the use of the institution. Charitable institutions that In passing the Dietary Supplement Health and
receive drugs at reduced prices or no cost cannot Education Act (DSHEA) of 1994, Congress recognized
resell the drugs. the growing interest in the use of various herbs and
dietary supplements and addressed the need to regulate
the labeling claims made for these products.
These products, which include vitamins, minerals, Prescription Drugs/Ethical Drugs/Ethical Drugs
amino acids, and botanicals, legally are not considered
- cannot be dispensed without prescriptions
drugs if they have not been submitted for review on
NDAs and thus have not been evaluated for safety and Ex) Ibuprofen 400 mg
efficacy by the FDA.
OTC DRUGS /Non-ethical/non-elicit
Ex) Ibuprofen 200 mg
However, as with drugs, their safe use is a concern to
the FDA. PACKAGING
PRIMARY PACKAGING

The act forbids manufacturers or distributors of these

products to make any advertising or labeling claims
that indicate that the use of the product can prevent or
cure a specific disease. In fact, a disclaimer must IMMEDIATE PACKAGING
appear on the product: “This product is not
intended to diagnose, treat, cure, or prevent any
disease.” SECONDARY PACKAGING
The FDA and The Food and Drug Administration
Modernization Act of 1997 and The Food and Drug
However, the law does permit claims of benefit as they Administration Amendments Act of 2007
may properly relate to a nutrient deficiency disease or,
based on scientific evidence, how an ingredient may
affect the body's “structure or function” (e.g., increase As noted previously, the FDA was established in 1938
circulation or lower cholesterol) or how use of to administer and enforce the Federal Food Drug and
the product can affect a person's general well-being. Cosmetic Act. Starting with this initial authority, today
the FDA is responsible for enforcing many additional
pieces of legislation.
But before any promotional or labeling claims may be
made, they first must be submitted to the FDA as being
truthful and not misleading. The mission of the FDA is to protect the public health
against risks associated with the production,
distribution, and sale of food and food additives,
The “Dietary Supplement and Nonprescription Drug human drugs and biologicals, radiologic and medical
Consumer Protection Act of 2006” enabled the FDA to devices, animal drugs and feeds, and cosmetics.
implement a policy of GMPs for dietary supplements
similar to those in place for pharmaceutical products.
In carrying out the intent of legislation it is mandated
to enforce, the FDA :
This requires that dietary supplements are
manufactured according to quality standards, that all
ingredients listed are in the declared amounts, that they  Sets policies, establishes standards, issues
are properly packaged and accurately labeled, and that guidelines, and promulgates and enforces rules and
complete manufacturing and QC records are regulations governing the affected industries and
maintained along with a system for the identification their products
and reporting of serious adverse events.
 Monitors for regulatory compliance through Class II: The use of or exposure to a violative product
reporting requirements, product sampling and may cause temporary or medically reversible adverse
testing, and establishment inspections health consequences or the probability of serious
adverse health consequences is remote.
 Establishes product labeling requirements,
disseminates product use and safety information,
issues product warnings, and directs product
Class III: The use of or exposure to a violative product
recalls
is not likely to cause adverse health consequences.
 Acts as the government's gatekeeper in making
safe and effective new drugs, clinical laboratory
tests, and medical devices available through a The depth of recall, or the level of market removal or
carefully conducted application and review correction (e.g., wholesaler, retailer,consumer),
process depends on the nature of the product, the urgency of
the situation, and depth to which the product has been
distributed. The lot numbers of packaging control
numbers on the containers or labels of the products
help in identifying the product to be recalled.

The Pharmacist's Contemporary Role

Drug Product Recall

Pharmacy graduates holding the Bachelor of Science
(BS) in Pharmacy degree or the Doctor of Pharmacy
If the FDA or a manufacturer finds that a marketed (PharmD) degree practice in a variety of settings,
product presents a threat or a potential threat to applying the basic pharmaceutical sciences, the clinical
consumer safety, that product may be recalled or sciences, and professional training and experience.
sought for return to the manufacturer from its depth of
distribution. The pharmaceutical manufacturer is
legally bound to report serious unlabeled adverse
reactions to the FDA through the FDA MedWatch
Program.

This includes practice in community pharmacies,

A drug product recall may be initiated by the FDA or
patient care institutions, managed care, home health
by the manufacturer, the latter being termed a
care, military and government service, academic
voluntary recall. A numerical classification, as follows,
settings, professional associations, and the
indicates the degree of hazard associated with the
pharmaceutical research and manufacturing industry,
product being recalled:
as well as in other positions requiring the pharmacist's
expertise.
Class I: There is a reasonable probability that the use
of or exposure to a violative product will cause serious
Historically, the abbreviation RPh (registered
adverse health consequences or death.
pharmacist) has been used as the professional
designation of a pharmacist licensed by a state board of
pharmacy to practice in that state. Doctors of Pharmacy The emergence of practice differentiation was in the
use the PharmD after their name in place of RPh. late 1960s and early 1970s with the professional
literature describing hospital pharmacists who had
developed unique roles that were distinctive from the
Most pharmacists practice within an ambulatory care traditional dispensing roles of the pharmacist.
or community pharmacy setting:

These pioneering “clinical pharmacists” participated

 develops and maintains individual patient with physicians in therapeutic decision making, and it
medication profiles was suggested that their level of knowledge and
practice skills required special educational and
 compounds drug preparations experiential preparation.
 dispenses drug products
 issues patient information leaflets
 counsels patients on their health status
 provides information on the use of drug and non- Pharmacists working for pharmaceutical research,
drug measures development, and manufacturing firms can participate
 serve as an expert source of drug information and in a range of activities:
participate in the selection, monitoring, and
assessment of drug therapy
 drug discovery
 drug analysis and QC
A substantial number of pharmacists practice in
institutional settings, such as hospitals, clinics,  product development and production
extended care facilities, and health maintenance
 clinical studies and drug evaluation
organizations (HMOs):
 labeling and drug literature
 marketing and sales, regulatory affairs, and
 manage drug distribution and control systems
management
 provide a variety of clinical services
 drug utilization reviews (DURs)
Schools of pharmacy enlist pharmacists, some with and
 drug use evaluations some without advanced degrees (MS, PhD):

 therapeutic drug monitoring

 intravenous admixture programs  serve as preceptors within the practice setting

 pharmacokinetic consulting services  teach specific courses and/or laboratories within

the academic institution
 investigational drug supplies
 participate in extramural research
 poison control and drug information
 contribute to the service and continuing education
mission of the school
 following statement on pharmaceutical care
in 1993:
The Mission of Pharmacy

The mission of the pharmacist is to provide

In 1991, the House of Delegates of the APhA adopted
pharmaceutical care. Pharmaceutical care is the
the following mission statement for pharmacy practice:
direct, responsible provision of medication-related
care for the purpose of achieving definite outcomes
that improve a patient's quality of life.

“To serve society as the profession responsible for the

appropriate use of medications, devices, and services
to achieve optimal therapeutic outcomes”.
The APhA in 1996 issued its Principles of Practice for
Pharmaceutical Care, including the following general
statement:

And, in 2011, APhA's Board of Trustees adopted the

following vision statement for the profession of Pharmaceutical care is a patient-centered, outcomes-
pharmacy: oriented pharmacy practice that requires the
pharmacist to work in concert with the patient and the
patient's other healthcare providers to promote health,
“Pharmacists are essential for optimizing medication to prevent disease, and to assess, monitor, initiate, and
use and improving health care”. modify medication use to assure that drug therapy
regimens are safe and effective.
Pharmaceutical Care

The Omnibus Budget Reconciliation Act of 1990

Today, the role of the pharmacist in contemporary
practice is the delivery of pharmaceutical care, which
was first proposed in 1975 by Mikeal and others as The Omnibus Budget Reconciliation Act of 1990
“the care that a given patient requires and receives (OBRA 90), which became effective on January 1,
which assures rational drug usage”. Since then, the 1993, established a requirement for each state to
term has been redefined by many authors, including develop and mandate DUR programs to improve the
Strand and others who in 1992 stated: quality of pharmaceutical care provided to patients
covered by the federal medical assistance (Medicaid)
program.
Pharmaceutical care is that component of pharmacy
practice which entails the direct interaction of the
pharmacist with the patient for the purpose of caring The statute was designed to ensure that prescriptions
for that patient's drug-related needs. are appropriate, medically necessary, and not likely to
result in adverse medical effects. The statute required
that each state's plan provide for a review of drug
The ASHP, a national organization that represents therapy before each prescription is dispensed and
pharmacists who practice in hospitals, HMOs, long- delivered to an eligible patient.
term care facilities, home care agencies, and other
components of health care systems, advanced the
The regulations required patient medication monitoring fundamental basis of the roles and responsibilities of
for therapeutic appropriateness, therapeutic pharmacists. These principles, based on moral
duplication, overuse, underuse, drug–disease obligations and virtues, are established to guide
contraindications, drug–drug interactions with other pharmacists in relationships with patients, health
prescribed and OTC medications, drug–allergy professionals, and society.
interactions, correct drug dosage, duration of
treatment, and clinical abuse or misuse.
I. A pharmacist respects the covenantal relationship
between the patient and pharmacist.
They also required that pharmacists offer therapeutic
counseling to each recipient of a prescription or the
recipient's caregiver regarding the drug, dosage and Considering the patient-pharmacist relationship as a
duration of use, route of administration, side effects, covenant means that a pharmacist has moral
contraindications, techniques for self-monitoring drug obligations in response to the gift of trust received
therapy, proper storage, refill information, and action from society. In return for this gift, a pharmacist
to be taken in the event of a missed dose. Pharmacists promises to help individuals achieve optimum benefit
are to maintain patient medication profiles and from their medications, to be committed to their
therapeutic counseling records. welfare, and to maintain their trust.

II. A pharmacist promotes the good of every patient

in a caring, compassionate, and confidential
manner.
Patient Protection and Affordable Care Act of 2010

A pharmacist places concern for the well-being of the

The Patient Protection and Affordable Care Act patient at the center of professional practice. In doing
(PPACA) was enacted to decrease the number of so, a pharmacist considers needs stated by the patient
medically uninsured while improving the quality and as well as those defined by health science. A
reducing the overall costs of health care in the United pharmacist is dedicated to protecting the dignity of the
States. Among its many provisions are expanded patient. With a caring attitude and a
prescription drug coverage for Medicare and Medicaid compassionate spirit, a pharmacist focuses on serving
patients, programs for innovative methods of health the patient in a private and confidential manner.
care delivery, and a pathway for the approval of
biosimilars (generic biological products).
III. A pharmacist respects the autonomy and
dignity of each patient.
Code of Ethics for Pharmacists

A pharmacist promotes the right of self-determination

PREAMBLE and recognizes individual self-worth by encouraging
patients to participate in decisions about their health. A
Pharmacists are health professionals who assist
pharmacist communicates with patients in terms that
individuals in making the best use of medications. This
are understandable. In all cases, a pharmacist respects
Code, prepared and supported by pharmacists, is
personal and cultural differences among patients.
intended to state publicly the principles that form the
 VIII. A pharmacist seeks justice in the distribution
of health resources.
IV . A pharmacist acts with honesty and integrity in
professional relationships.
When health resources are allocated, a pharmacist is
fair and equitable, balancing the needs of patients and
A pharmacist has a duty to tell the truth and to act with
society.
conviction of conscience. A pharmacist avoids
discriminatory practices, behavior or work conditions
that impair professional judgment, and actions that
compromise dedication to the best interests of patients.

V. A pharmacist maintains professional

competence.

A pharmacist has a duty to maintain knowledge and

abilities as new medications, devices, and technologies
become available and as health information advances.

VI. A pharmacist respects the values and abilities of

colleagues and other health professionals.

When appropriate, a pharmacist asks for the

consultation of colleagues or other health professionals
or refers the patient. A pharmacist acknowledges that
colleagues and other health professionals may differ in
the beliefs and values they apply to the care of the
patient.

VII. A pharmacist serves individual, community,

and societal needs.

The primary obligation of a pharmacist is to individual

patients. However, the obligations of a pharmacist may
at times extend beyond the individual to the
community and society. In these situations, the
pharmacist recognizes the responsibilities that
accompany these obligations and acts accordingly.