Chapter 3 Flashcards
Evolution of the Pharmacy Profession: Before the 1940s
Standards and Laws:
Before 1940s, no credible standards or enforceable laws regarding the safety of therapeutic agents.
Pure Food and Drug Act (1906):
First major legislation addressing drug safety.
Not comprehensive, contained loopholes, and didn’t address efficacy.
Elixir Sulfanilamide Scandal (1937):
Sulfa antibacterial, generally safe, had been in use for years.
New oral preparation contained diethylene glycol (antifreeze).
Resulted in 73-107 deaths, including children.
Food, Drug, and Cosmetic Act (1938):
Enacted in response to the Elixir Sulfanilamide incident.
Addressed gaps in the Pure Food and Drug Act.
Represented a significant step towards drug safety regulation.
Evolution of the Pharmacy Profession: 1940s–1970s
Section title
FDA Authority Expansion (post 1938)
The Food, Drug, and Cosmetic Act (FDCA) (post-1938) granted more enforcement authority to the FDA.
FDA gained power in approving new drugs, establishing safety and efficacy standards.
Drug Categorization (1940s-1970s)
During this period, drugs were not yet classified into prescription and non-prescription categories.
Pharmacist Role: 1940s-1970s
Pharmacists often served as the primary source of health care advice and medication recommendations.
Pharmacists had indirect prescribing authority, contributing to patient care.
Medication Use Systems: 1940s–1970s
Era of Expansion:
This period marked an “era of expansion” in health care, with significant changes in organization, delivery, and financing.
Hill-Burton Act (1946):
The Hospital Survey and Construction (Hill-Burton) Act of 1946 allocated funds for hospital construction and renovation, enhancing healthcare infrastructure.
Durham-Humphrey Amendment (1951):
Amendment to the FDCA in 1951 created the distinction between prescription and non-prescription drugs.
Medicare and Medicaid (1965):
Titles XVIII and XIX were added to the 1935 Social Security Act in 1965, establishing Medicare and Medicaid, respectively.
Significantly influenced healthcare accessibility and affordability.
Changes in Pharmacy Curriculum 1940s-1970s:
B.S. degree duration increased from 4 to 5 years.
Expansion of didactic scientific curriculum
Includes classes like the ones we take now: med chem, pharmacology, etc.
Mirror to Hospital Pharmacy (ASHP) 1970s-Present
This was a report that raised concerns about the profession’s direction and the production of professionals.
Impact on student satisfaction and the perception of pharmacy.
ASHP is the Americans Society of Health-System Pharmacists
Dichter Institute Study (APhA):
More respondents viewed pharmacists as businessmen rather than healthcare providers.
APhA is the American Pharmacists Association
Millis Commission’s Report (1975) -
Identified inadequacies in pharmacist preparation, particularly in systems analysis, management, and communication skills.
Pharmacy’s Self-Reflection:
The profession blamed itself because of large, multiservice
pharmacies, which de-emphasized training, expertise, and
patient care. Ex: CVS
Clinical Pharmacy Movement:
Rebranded the profession as therapeutic advisors.
Increased post-B.S. Pharm.D. programs for clinical pharmacists, primarily in hospitals.
Pharm.D. as Entry-Level Degree
Pharm.D. later became the entry-level degree for pharmacists
Health Maintenance Organization (HMO) Act of 1973:
The primary goal of the HMO Act was to encourage the development and growth of Health Maintenance Organizations (HMOs) as a form of managed care. HMOs are a type of health insurance plan that provides a range of healthcare services through a network of healthcare providers
What is a DRG?
Diagnosis related group
Diagnosis-Related Groups (DRGs):
Created a reimbursement schedule for Medicare patients based on disease states, irrespective of care length.
Encouraged hospitals to discharge patients “sicker and quicker.”
Clinical Pharmacy Evolution:
Initial focus on products and services, less emphasis on the patient.
Adverse effects of medicalization and increased drug reliance (adverse reactions, hospitalizations, non-compliance, deaths).
Effects of Medicalization:
The increased medicalization and reliance on drug therapies have both positive and negative effects, referred to as “drug misadventures.”
Adverse effects include adverse drug reactions, hospitalizations, patient non-compliance, and even deaths.
