HISTORICAL DEVELOPMENT

PROFESSION OF PHARMACY

AND PHARMACUTICAL

INDUSTRY

Ancient Origins

• Pharmacy comes from the Greek word pharmakon,

meaning drug

• Scientific approach to medicine began with the

ancient Greeks

• Hippocrates

• Proposed that disease came from natural, not

supernatural causes

• Established the theory of humors (blood,

phlegm, black bile, yellow bile)

•Galen

• Conducted animal experiments

• Produced a systematic classification of drugs for treatment of disease

• Galenical pharmacy described the process of creating extracts of active medicinals from plants

•Diascorides

• First century A.D.

• De Materia Medica (standard text on drugs for 1500 years)

• Dr. John Morgan

• Eighteenth Century

• Supported the separation of the professions ofpharmacy and medicine

Pharmacist

• The profession of pharmacy exists to safeguardthe health of the public

• The pharmacist is one who is licensed toprepare and dispense medications, counselpatients, and monitor outcomes pursuant to aprescription from a licensed healthprofessional

Traditional Era

• Early twentieth century

• Formulation and dispensing of drugs from

natural sources

– Pharmacognosy

• The study of the medicinal properties of natural

products of animal, plant, and mineral origins

– Galenical pharmacy

• Techniques for preparing medications

Scientific Era• Began after World War II

• Emergence of the pharmaceutical industry

– Drugs made in factories, not apothecary shop

• Pharmacy education emphasized sciences

– Pharmacology

• The scientific study of drugs and their mechanism of

action including side effects

– Pharmaceutics

• Release characteristics of drug dose forms

Clinical Era

• 1975: Millis Report, Pharmacists for the Future

• New educational emphasis on clinical (patient-

oriented) pharmacy

– Pharmacokinetics

• the activity of a drug within the body over a period of

time; includes absorption, distribution, metabolism, and

elimination

– Pathophysiology

• the study of disease and illnesses affecting the normal

function of the body

Pharmaceutical-Care Era

• 1990: Hepler and Strand defined

• Pharmaceutical care

– a philosophy that expanded the pharmacist’s role to

include appropriate medication use to achieve positive

outcomes with prescribed drug therapy

– includes

• Monitoring response to therapy

• Educating patients and dispensing prescriptions

• The earliest traditional systems of medicine

practiced in India have been Ayurveda and

Siddha.

• The colonial period brought the new western

system of medicine and paved the way to

emerge pharmacy houses in India.

• Though pharmacy was practiced since ages in

India, it is recognized as a profession from

18th century only.

• Growth of Pharmacy Education

• In1980s, the growth of publicly funded

institutions of higher education (including

pharmacy institutions) was very slow. Until

early 1980s, there were 11 universities and 26

colleges offering pharmacy education at the

bachelor's and master's levels. Addition, there

was at least 1 government school in every

Indian state offering the DPharm program.

• Since the late 1980s, due to rapid indu-strialization inthe pharmaceutical sector, privatization, and economicgrowth, pharmacy education has been developing fasterin India than anywhere in the world.

• In 2007, there were 854 institutions that admitted morethan 52,000 students to the BPharm degree programand 583 institutions that trained more than 34,000students in the DPharm degree program.

• Most of the institutions, however, are privately fundedcolleges or privately funded universities. The privatesector, which accounted for about 10% of the studentsadmitted in the 1980s, now accounts for 91% of allpharmacy students admitted .

• The origin of pharmacy institutions in India

dates back to 1899 in Madras for training of

pharmacists followed by the state medical

faculty of Bengal in 1928.

• Prof. M.L. Schroff, father of pharmacy educa-

tion in India, started UG program in pharmacy

at BHU in the year 1932, later, Andhra

University in 1937, Madras University in

1938, Bombay University in 1943, Punjab

University in 1944 and L.M. College in 1947

started degree programme.

• The statutory regulation of pharmacy

institutions in India was established with the

enactment of the Pharmacy Act 1948, and The

Pharmacy Council of India was established in

the year 1949 and the first education

regulations (ER) framed in 1953, which were

subsequently amended in 1972, 1981 and

1991.

• The PCI regulates the pharmacy education andprofession in India At present there are more than 1500institutions offering various pharmacy programmes ofDiploma, UG, PG and Pharm.D with an annual intakeof more than 1,00,000 students.

• The syllabus is more industry oriented and mainlyfocused to cater the needs of the PharmaceuticalIndustry.

• The Pharmacists with UG and PG qualificationpreferred working in Industry rather than CommunityPharmacy due to lucrative job opportunities and mostof the commu-nity pharmacists engaged are Diplomaholders in India.

• The patent regime triggered the growth of IndianPharma Industry as innovative Industry.

• As a major break-through in the history of

Pharmacy education in India, The Pharm.D

regulations u/s 10 of the Pharmacy Act 1948,

have been notified in the Gazette of India

on10thMay, 2008 with an aim to equip the

future pharmacist of India with skills of not

only dispensing medicines but also to serve as

counselor of medicines with focus towards

patients and prescriber of drugs.

• A variety of pharmacy degree programs are

offered in India: diploma in pharmacy

(DPharm), bachelor of pharmacy (BPharm),

master of pharmacy (MPharm), master of

science in pharmacy [MS(Pharm)] and master

of technology in pharmacy [MTech (Pharm)],

doctor of pharmacy (PharmD), and doctor of

philosophy in pharmacy (PhD).

Pharmaceutical industry

• The roots of the pharmaceutical industry lie

back with the apothecaries and pharmacies that

offered traditional remedies.

• Originating as a pharmacy founded in

Darmstadt in 1668, it was in 1827 that

Heinrich Emanuel Merck began the transition

towards an industrial and scientific concern, by

manufacturing and selling alkaloids.

• only in the middle of the 19th century that the

industrial production of medicine, producing

patented medicine from 1842.

• Pfizer was founded in 1849, by two German

immigrants, initially as a fine chemicals

business.

• Eli Lilly was a pioneer of new methods in the

industry, being one of the first to focus on

R&D as well as manufacturing.

• “The Thalidomide scandal of 1961 prompted anincrease in the regulation and testing of drugs beforelicensing…”

UK’s National Health Service (NHS) in Europe created amuch more structured system; both for prescription ofdrugs and their reimbursement. In 1957, the NHSbrought in what was essentially a price fixing schemeto allow reasonable return on investment for drugmanufacturers, solidifying the incentive to invest innew medicines.

Increase in the regulation and testing of drugs beforelicensing, with a new amendment to US Food and DrugAdministration (FDA) rules demanding proof ofefficacy and accurate disclosure of side-effects for newmedications being implemented in 1962.

The Father of American Pharmacy—William Procter Jr. (1817–1874).Community

pharmacist, pharmaceutical educator, pharmaceutical scientist, and association

executive are all titles appropriate for William Procter Jr.; he is seen here in his office

as editor of the American Journal of Pharmacy. As Gregory Higby describes, “for

American Pharmacy, Procter has served as a symbol of identity and pride.”

The Marshall Apothecary (1729–1825). Irish immigrant Christopher Marshall (1709

1797) established a Philadelphia apothecary shop in 1729. He is depicted here in 1754

demonstrating the use of a pill machine for his two sons, Christopher Jr. (1740–1806)

and Charles (1744–1825) who, with the founder’s granddaughter, Elizabeth, continued to

operate the pharmacy until 1825.

The First Hospital Pharmacy in Colonial America (circa 1755–1756). John Morgan

(1735 1789), is shown here at the Pennsylvania Hospital as staff apothecary. Morgan

subsequently obtained a medical degree and served as physician-in-chief for the

Continental Army in 1776, while advocating the importance of the separation of the

practice of pharmacy from the practice of medicine.

Craigie—America’s First Apothecary General (circa 1755). Bostonian Andrew

Craigie (1754 1819) was appointed commissary of medical stores on April 30, 1775; in

less than 2 months Craigie was caring for the wounded at the Battle of Bunker Hill, as

shown here. Two years later, the Continental Congress created the position of

Apothecary General, and Craigie was the first to be appointed.

The Shakers and Medicinal Herbs (circa 1830). The first U.S. industry in medicinal

herbs was established by the United Society of Shakers. Commencing cultivating herbs

in 1820, the Shakers of Mount Lebanon, N.Y., gained wide recognition in the 1850s by

compressing powdered herbs into “bricks” as shown here. The business was purchased

by the Tilden Company in 1893.

The Founding of the American Pharmaceutical Association (1852). Twenty

pharmacists from eight states gathered around a table at the Philadelphia College of

Pharmacy to sign the Code of Ethics. Seated at table (left to right) are Edward Parrish;

Daniel B. Smith, president; William Procter Jr; corresponding secretary; George

Coggeshall, recording secretary; Alfred B. Taylor, treasurer; and Joseph Laidley.

The Standardization of Pharmaceuticals (circa 1883). Parke-Davis was one of the first

American firms to produce standardized pharmaceuticals. At work on the left is Albert

B. Lyons (1841–1926), founding secretary of the APhA Scientific Section, who

developed assay procedures permitting Parke-Davis in 1883 to introduce for the first

time chemically assayed fluid extracts.