History of Pharmacy in the United States

1729

1729

First US pharmacy opened by Christopher Marshall in Philadelphia

1770

Franco-Spanish Louisiana separates the practice of medicine, surgery, and pharmacy in the United States

1775

Apothecary Andrew Craigie fights at the Battle of Bunker Hill and is later named the first Apothecary General of the Army Medical Department in 1777

1796

Smallpox vaccine discovered by Edward Jenner

• Let the Vaccine Act of 1822 - federal control of vaccine distribution.

1820

United States Pharmacopeia (USP) founded to develop guidelines and standards of practice

1821

Philadelphia College of Pharmacy was established becoming America’s first pharmacy organization

• Graduates called themselves “pharmaceutists” instead of apothecaries

1848

Drug Importation Act

• Required imported drugs to meet USP standards of strength and purity

1852

American Pharmacist Association (APhA) established

1881

North Carolina Board of Pharmacy (NCBOP) established

1898

National Community Pharmacists Association (NCAP) founded

1893

NC Pharmacist invents Pepsi

1904

National Association of Boards of Pharmacy (NABP) is established

1928

Alexander Fleming developed the first antibiotic, penicillin from fungus (Scotland)

1932

Accreditation Council for Pharmacy Education established

1929 - 1949

“Soda pop era” of retail pharmacies

1906

Pure Food and Drug Act

• Prohibited misbranding, defined as misleading and fraudulent labeling of foods and drugs (did not prohibit false therapeutic statements, only misleading ones)

• Created the Food and Drug Administration (FDA)

• Created the terms adulterated and misbranded

1938

Food, Drug, and Cosmetic Act

• Replaced the Pure Food and Drug Act

• Prohibited false therapeutic claims

• Required new drugs to undergo pre-market approval by the FDA

• Mandated that drugs be labeled with adequate directions for safe use

1942

American Society of Health-System Pharmacists (ASHP) established

1946

Centers for Disease Control and Prevention (CDC) established

1953

US Department of Health and Human Services (DHHS) established

• FDA later re-established as an agency under DHHS (1988)

1951

Durham-Humphrey Amendment

• Amendment to the Federal Food, Drug and Cosmetic Act of 1938

• Distinguished between Rx (“legend”) and OTC drugs

  • First full distinction, although the 1914 Harrison Narcotics Act did this with narcotic drugs

• Required pharmacist to have a valid prescription before filling a prescription only drug

  • Decision to make a drug Rx or OTC was left up to the manufacturer at this time

1962

Kefauver-Harris Amendment

• Thalidomide was used for the treatment of nausea in pregnant women in the 1950s and 60s

  • Resulted in over 10,000 children born with severe deformities (phocomelia)

• Required drug manufacturers to prove the effectiveness of drugs to the FDA before going on the market and report any serious side effects

• Provides modern framework for pharmaceutical approvals

1965

Medicare and Medicaid

• Social Security Amendments of 1965 signed into law by President Lyndon B. Johnson

Medicare

• Hospital (Part A) and Medical (Part B) coverage to those over 65

Medicaid (launched 1970)

• Funded by both the federal government and the state

• Low-income families, pregnant women, people with disabilities, people requiring long term care

1972

FDA forms OTC Drug Review

• Gave FDA authority to review drugs for OTC vs RX use

• New drugs now either submit New Drug Application (NDA) or go through OTC monograph process via the FDA

1976

Board of Pharmacy Specialties (BPS) established

1977

Centers for Medicare and Medicaid Services (CMS) established under DHHS

1979

American College of Clinical Pharmacology (ACCP) re-established to advance the practice of clinical pharmacy

1985

Campbell University Pharmacy School opens

• First new pharmacy school since the 1940s

1983

Federal Anti-Tampering Act

• Required all OTC drugs be packed in tamper-resistant packaging (TRP)

• Criminalizes tampering with packaged consumer products

1982 Tylenol murders

• Deaths due to cyanide placed in bottles of Tylenol capsules

1988

• Amendment to the 1938 Food, Drug, and Cosmetic Act

• Established legal framework for the safe and effective distribution of prescription drugs

• Drugs made in the US and exported cannot be reimported into the US unless deemed appropriate by the manufacturer

1994

Washington State Pharmacists Association initiated the first ongoing formalized training of pharmacists in vaccine administration

1996

APhA began national program for pharmacist immunization delivery

2000

RPh to PharmD switch

• AACP

  • Switched from a Bachelor in Science in Pharmacy to a Doctorate of Pharmacy Degree beginning with the class of 2006

    • Switch from RPh to PharmD

2000

North Carolina Association of Pharmacists (NCAP) established

2003

Medicare Prescription Drug, Improvement, and Modernization Act

• Created a prescription drug benefit available for those covered by Medicare

  • Added on Medicare “parts” to original Medicare (Part A and B)

  • Part D – Medicare prescription drug plan (PDP)

2005

Combat Methamphetamine Epidemic Act (Title VII of the Patriot Act)

• This law placed strict regulations on the storage and sale of OTC medications that are used in the production of the illegal street drug methamphetamine

  • Stored behind the counter and must verify consumer ID in a log

  • Any OTC drugs that contain ephedrine, pseudoephedrine, or phenylpropanolamine

  • Limits consumer to purchasing no more than 3.6 grams without a prescription at one time (or no more than 9 grams in 30 days)

2010

Affordable Care Act

• Aka “Obamacare”

• Goal was to make affordable health insurance available to more people

• Brought about the Health Insurance Marketplace, a single place where consumers can enroll in private health plans

2013

Drug Quality and Security Act

• Amendment to the Food, Drug, and Cosmetic Act

• Created the Compounding Quality Act (CQA)

  • Gave the FDA more authority to regulate compounded drugs

    • Came in response to the New England Compounding Center meningitis outbreak

• Also created the Drug Supply Chain Service Act (DSCSA)

  • Requirements on tracing prescriptions through supply and distribution chain

2023

Pharmacy Benefit Manger Transparency Act of 2023

• Pharmacy benefit manager (PBM) - middleman of the pharmacy reimbursement model

• Act has been introduced but not passed

• Prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy

2005, 2023

Public Readiness and Emergency Preparedness (PREP) Act

• DHHS can issue a declaration in response to a public health emergency

  • Provides immunity from tort liability claims (except willful misconduct) to individuals or organizations involved in the manufacture, distribution, or dispensing of medical countermeasures

• 11th Amendment added in 2023 in response to COVID-19 with specific mention of pharmacist’s contribution to public safety

2022

Inflation Reduction Act

• Made major changes to Medicare Parts A&B (1965) and
  D (2003)

  • Changes to Medicare Part D:

    • Eliminates the coverage gap (donut hole) in 2025

And many other changes
• Also includes changes to Medicare Part B

How does the US Healthcare System compare to other developed countries?

• Shorter hospital stays and fewer physician visits on average per capita

  • US spends more money per capita and a larger portion of GDP on healthcare than any other country

  • More uninsured people compared to others

• Multi-payer system versus single payer system

  • Private, state, and federal “payers” can provide medical care

  • Universal healthcare - original Medicare/Medicaid - federal government provided all care