1 History of Pharmacy Practice

State Standards 3) Compare and contrast the principles of pharmaceutical equivalents, generic equivalence, bioequivalence, pharmaceutical alternatives, and therapeutic equivalents as defined by the U.S Food and Drug Administration (FDA). Summarize the criteria for deeming a product therapeutically equivalent 7) Evaluate the Drug Enforcement Administration (DEA) rules and regulations surrounding the transfer of controlled substances, verification of a prescriber’s DEA number, and documentation requirements for receiving, ordering, returning, loss/theft, and destruction of controlled substances. Investigate the standards of practice of record keeping for repackaged and recalled products and supplies, including the FDA’s recall classification. Summarize findings in an oral, written, or digital presentation.

Objectives SWBAT… Identify key time periods in the development of modern pharmaceutical science Create a timeline showing the progression of pharmaceutical science from Ancient time-Modern time.

Figure 1-2 Ancient humans and medicine. (Images by Robert Thom Figure 1-2 Ancient humans and medicine. (Images by Robert Thom. Printed with permission of American Pharmacists Association Foundation. Copyright 2009 APhA Foundation.)

Ancient Mesopotamia Earliest known record of apothecary practice from Babylon, c. 2600 BCE Healers combined roles of priest, pharmacist, and physician. Clay tablets recorded symptoms of illness, prescriptions, and instructions for compounding remedies.

Mithradates VI Called Mithradates the Great King of Pontus and Armenia Minor (modern-day Turkey), 120–63 BCE Developed immunity to poisons by ingesting small, nonlethal doses Tested poisons on self and prisoners "Mithradates antidote" thought an antidote for any poison

Ancient China c. 2000 BCE: Legendary Emperor Shen Nung researched medicinal value of several hundred herbs, testing many of them on himself. Shen Nung wrote the first Pen T-Sao, or native herbal, recording 365 drugs. Today, Shen Nung is still worshipped as the patron god of Chinese drug guilds.

Ancient Egypt Two classifications of workers Echelons were gatherers and preparers of drugs, similar to modern pharmacy technicians. Chiefs of fabrication were the head pharmacists.

Papyrus Ebers Most important ancient Egyptian pharmaceutical record Written in 1500 BCE A collection of 800 prescriptions; specifically mentions 700 unique drugs

Ancient India The Charaka Samhita recorded more than 2,000 drugs. Written as early as 1000 BCE in Sanskrit Meaning "compendium of wandering physicians," the Charaka Samhita was the work of multiple authors.

Ancient Greece Terra Sigilata, or “sealed earth,” was the first therapeutic agent to bear a trademark. Originated in Greece before 500 BCE Composed of Lemnian clay that was blessed, refined, shaped into uniform tablets, impressed with an official seal, sun-dried, and then distributed commercially

Figure 1-4 Hippocrates of Cos Figure 1-4 Hippocrates of Cos. (Stock Montage/Hulton Archive/Getty Images.)

Hippocrates Greek physician who lived between 460 and 377 BCE Known as the father of medicine One of the most notable figures in medicine of all time Rejected the widely held view that illness was connected to mystic or demonic forces and positioned medicine as a branch of science

Hippocrates Published more than 70 writings related to the practice of medicine and apothecary Hippocratic Oath: physicians pledge to "do no harm" Theory of Humors Connects personal health to harmony among four bodily fluids, known as humors

Hippocrates Theory of humors Each humor related to a mood or personality characteristic Blood (happiness) Phlegm (lethargy) Yellow bile (irritability) Dark or "black" bile (anger)

Theophrastus One of the greatest early Greek philosophers and natural scientists Observed and wrote extensively on the medicinal qualities of herbs Known as the father of botany His unusually accurate observations and writings date to about 300 BCE.

Dioscorides Pedanios Dioscorides accompanied Roman armies throughout the known world to study medicinal treatments. His observations and rules for collecting, storing, and using drugs were collected into the five-volume De Materia Medica, precursor to all modern pharmacopeias.

Galen Practiced and taught pharmacy and medicine 130–200 CE His principles of preparing and compounding medicines reigned in the Western world for 1,500 years. His name still is associated with the class of pharmaceuticals compounded by mechanical means: galenicals.

The Middle Ages 500–1500 CE In the West, pharmacy and medicine were practiced and preserved in monasteries.

The Middle Ages Scientists were taught in cloisters as early as the 7th century. Monks gathered herbs in the wild and raised them in gardens; medicinal herb gardens are still found in monasteries.

Figure 1-8 The first apothecaries. (Images by Robert Thom Figure 1-8 The first apothecaries. (Images by Robert Thom. Printed with permission of American Pharmacists Association Foundation. Copyright 2009 APhA Foundation.)

Development of the Apothecary In 8th century, Arab practitioners separated the roles of the apothecary and physician. The first apothecaries, or privately owned drug stores, established in Baghdad.

Development of the Apothecary Arab apothecaries developed new medicines. Traveling Muslims brought the new system of pharmacy to Europe and Africa. Italy was the first European country to separate pharmacy from medicine, thus establishing separate professions, in 1240 CE.

Figure 1-9 The first pharmacopoeia. (Images by Robert Thom Figure 1-9 The first pharmacopoeia. (Images by Robert Thom. Printed with permission of American Pharmacists Association Foundation. Copyright 2009 APhA Foundation.)

The First Pharmacopeia The first pharmacopeia, the Nuovo Receptario, was published in Florence (now in Italy) in 1498. Collaborations between the Guild of Apothecaries and the Medical Society; one of the earliest interprofessional collaborations

The Renaissance 1500–1600 CE Many scientific advancements, renewed interest in culture and the arts, and expanded exploration, including the European exploration of the Americas

The First Anglo-Saxon Organization for Pharmacists The Guild of Grocers monopolized the lucrative trade in drugs and spices. In 1617, King James I formed a separate company for apothecaries: Master, Wardens and Society of the Art and Mystery of the Apothecaries of the City of London.

The First Apothecary in the American Colonies John Winthrop, first Governor of Massachusetts Bay Colony and founder of Boston, sought advice from English apothecaries and physicians (who were unwilling to move to the colonies). 1640: Winthrop began selling apothecary products, both imported and native to New England.

The First Apothecary in the American Colonies In 1640, Winthrop began selling imported European medicines and medicines derived from native New England plants.

The 18th Century Revolutionary war gave U.S. independence from England. Notable advancements in pharmacy and medicine were happening on both sides of the Atlantic Ocean.

The 18th Century America's first female pharmacist, Elizabeth Marshall America's first hospital, Philadelphia, 1751 Founded by Benjamin Franklin The hospital's pharmacy began operations in 1752 under Jonathan Roberts

The 18th Century John Morgan, pharmacist and physician Successor to Jonathan Roberts Advocated written prescriptions Advocated for the independent practice of the pharmacy and medicine

The 18th Century America's first Apothecary General, Andrew Craigie Appointed 1777 when Congress reorganized the Medical Department of the U.S. Army

The 18th Century America's first Apothecary General, Andrew Craigie Duties included procurement, storage, manufacture, and distribution of the Army’s drugs Developed an early pharmaceutical wholesaling and manufacturing business

The 19th Century America's first college of pharmacy, the Philadelphia College of Pharmacy The American Pharmaceutical Association Founded to meet the needs for better communication among pharmacists Set standards for education and apprenticeship Quality control over imported drugs

Figure 1-11 The father of American pharmacy, William Procter, Jr Figure 1-11 The father of American pharmacy, William Procter, Jr. (Images by Robert Thom. Printed with permission of American Pharmacists Association Foundation. Copyright 2009 APhA Foundation.)

Activity Create a timeline showing the progression of pharmaceutical science from Ancient time-Modern time. Your time line must include… What you believe are the 10 top achievements that led to modern pharmacy (briefly explain what happened in each, and why you chose this achievement) The top 10 people that contributed to modern pharmacy and their role. (briefly explain what each contributed and why you chose them as important) Presentations must be creative and legible. You will present these to the class You may choose how you present your material. Prezi Poster

Chapter 1 History of Pharmacy 19th Century- Modern Times

State Standards 3) Compare and contrast the principles of pharmaceutical equivalents, generic equivalence, bioequivalence, pharmaceutical alternatives, and therapeutic equivalents as defined by the U.S Food and Drug Administration (FDA). Summarize the criteria for deeming a product therapeutically equivalent 7) Evaluate the Drug Enforcement Administration (DEA) rules and regulations surrounding the transfer of controlled substances, verification of a prescriber’s DEA number, and documentation requirements for receiving, ordering, returning, loss/theft, and destruction of controlled substances. Investigate the standards of practice of record keeping for repackaged and recalled products and supplies, including the FDA’s recall classification. Summarize findings in an oral, written, or digital presentation.

Objectives SWBAT… Identify key time periods in the development of modern pharmaceutical science Create a timeline showing the progression of pharmaceutical science from Ancient time-Modern time.

The 19th Century William Procter, Jr. Called "the father of American pharmacy" Graduated from the Philadelphia College of Pharmacy in 1837 Operated a retail pharmacy

The 19th Century William Procter, Jr. Served as professor of pharmacy for 20 years A founder of the American Pharmaceutical Association Editor of the American Journal of Pharmacy for 22 years

The 19th Century The United States Pharmacopoeia (USP) Published in 1820 First book of drug standards to achieve national acceptance

The 19th Century The United States Pharmacopoeia (USP) In 1877, Edward R. Squibb pushed for the USP to be updated by the American Pharmaceutical Association. Publication regained its authoritative stature

The 19th Century The United States Pharmacopoeia (USP) Today, the USP is considered the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other health care products manufactured and sold in the United States.

The 19th Century Gregor Mendel 1822–1884 Called the father of modern genetics Austrian priest and scientist Studied inherited traits in pea plants Significance of his work not recognized until his research was rediscovered in the 20th century

Figure 1-12 Gregor Mendel. (Image from the National Library of Medicine.)

The 20th Century Period of impressive scientific discovery and advancement Federal government began regulating the practice of pharmacy. Penicillin discovered by Scottish physician Alexander Fleming Mass production of world's first antibiotic began during World War II.

The 20th Century The American Council on Pharmaceutical Education Founded in 1932 to establish standards for pharmacy education Established standards for baccalaureate degree in pharmacy; added the doctor of pharmacy standards as an alternative

The 20th Century The American Council on Pharmaceutical Education 2000 Conversion to doctor of pharmacy (PharmD) sole entry-level degree for profession of pharmacy 2003 Name changed to Accreditation Council for Pharmacy Education

The 20th Century Polio vaccine developed by Jonas Salk in the late 1940s and tested on nearly 2 million school children Successful trials results and vaccine announced in 1955

Biotechnology Drugs produced using living organisms such as yeast, bacteria, or mammalian cells The majority are manufactured through recombinant DNA technology. A human gene capable of triggering specific protein production is inserted into a living organism and cultured in a laboratory.

Biotechnology The majority are manufactured through recombinant DNA technology. The organism incorporates the gene into its cell structure, and begins producing the desired protein (drug).

Biotechnology Fragile proteins means drugs administered only by intravenous or subcutaneous injection. The majority of biotechnology drugs are tested for use in the treatment of cancer or cancer-related conditions.

Figure 1-14 DNA sequencing. Source: SPL/Custom Medical Stock Photo

Pharmacogenomics Study of individual genetic differences in response to drug therapy Predicts whether a patient will have a severe, negative reaction to a prescribed medication

Pharmacogenomics Simple, rapid DNA test used May aid in selection of better medications for patient Still in development

Evolution of the Pharmacist’s Role Traditional Era (1900–1930) Formulating and dispensing drugs derived from natural sources Scientific Era (1930–1960) Development of new drugs; scientific testing; new regulations on efficacy of medications, mass production of synthetic drugs and antibiotics

Evolution of the Pharmacist’s Role Clinical Era (1960–1990) Pharmacists expected to dispense drug information, warnings, advice, and suggestions to patients

Evolution of the Pharmacist's Role Pharmaceutical Care Era (today) Practice of pharmacy focused on ensuring positive outcomes for drug-related therapies Philosophy of pharmaceutical care incorporates all three previous eras.

Evolution of the Pharmacy Technician Role can be traced to echelons of ancient Egypt. In early and mid-1900s, pharmacy technicians were: Called assistants, aides, or support personnel Mostly children of pharmacists working at family pharmacies Only informal and on-the-job training

Evolution of the Pharmacy Technician Military pharmacy technicians U.S. military pioneered this role by developing standardized training and competency requirements. Move for standardization 1990s: national certification examination, model curriculum for training, and specific mention of technicians in state pharmacy practice acts

Evolution of the Pharmacy Technician National certification Since 1995, the Pharmacy Technician Certification Board (PTCB) has certified over 425,000 pharmacy technicians through their certification exam and transfer process.

Evolution of the Pharmacy Technician National certification ExCPT Pharmacy Technician Exam, administered by the National Healthcareer Association (NHA) Certification requirements vary by state.

Evolution of the Pharmacy Technician Where we are today Since January 2012, all but six states regulate practice of pharmacy technicians (Not CO, HI, MI, NY, PA, WI).

Evolution of the Pharmacy Technician Where we are today Some states require mandatory, accredited formal education and training, while others require certification (either national or state) and many states now require registration, licensure, or a combination of all three

Evolution of the Pharmacy Technician Future of pharmacy and the pharmacy technician Poised for the greatest and most significant advancements to date

Evolution of the Pharmacy Technician Occupational outlook for pharmacy technicians Bureau of Labor Statistics predicts 25–31% growth in pharmacy technician employment from 2008 to 2018.

Medication Therapy Management (MTM) and Pharmacists Service that optimizes therapeutic outcomes for individual patients Through MTM, pharmacists provide medication therapy review, pharmacotherapy consultations, immunizations, and disease-state management and health and wellness programs

Activity Once you finish your timeline… Create a timeline showing the progression of pharmaceutical science from Ancient time-Modern time. Your time line must include… What you believe are the 10 top achievements that led to modern pharmacy The top 10 people that contributed to modern pharmacy and their role. Presentations must be creative and legible. You will present these to the class You may choose how you present your material. Prezi Poster Once you finish your timeline… Write 2 paragraphs over what you think pharmacy will do next. You can be creative. Include a product/method/or idea that you think would help the Pharmacy field. Attach this to your presentation

Summary The need for pharmaceutical products, services, and knowledge has existed since prehistoric times. As the profession gains new information and technology, pharmacy continues to evolve to better serve patients.