Health care systems lecture 10 and 11

Historical Periods Related to Pharmacy

Ancient Through Early Modern Era (Prehistory to AD 1500)

Empiric Era (1600 to 1940)

Industrialization Era (1940 to 1980)

Patient Care Era (1990 to present)

Biotechnology and Genetic Engineering (The new horizon)

What Was Unique About the Industrial Period

High numbers of war injuries created a need for mass-produced pharmaceutical products.

Manufacturing shifted away from individual pharmacies to centralized industrial firms

What Is Unique About the Patient Care Period

A shift toward patient-focused drug therapy centered on controlling and monitoring drug treatment.

Developed in response to adverse reactions, interactions, and unexpected outcomes caused by multiple drug therapies.

Established the formal concept of pharmaceutical care (by Hepler & Strand).

Pharmacy education expanded to include human behavior related to patient care

Basic Pharmacist Demographic Trends

Gender: More practicing pharmacists are female (68.1% in 2024 vs. 58.9% in 2014).

Racial Diversity: The percentage of non-white pharmacists increased (21.1% in 2024 vs. 16.5% in 2014).

Education: More pharmacists hold a PharmD degree (47.5% in 2024 vs. 37.8% in 2014).

Practice Setting: Practice settings shifted heavily toward community pharmacy (59.1% in 2024 vs. 48.1% in 2014), while hospital/health-system practice decreased (21.7% in 2024 vs. 29.4% in 2014).

Important Findings of the 2024 AACP Pharmacist Workforce Report

Employment Status: 73.5% of respondents are actively practicing.

Workload & Hours: Workload increased (73% rated workload high or excessively high) even though average weekly hours dropped from 44.4 to 42.2. Workload was highest in chain (91%) and mass-merchandiser settings (88%).

Pay & Debt: Average salary was $145,000, but 53.8% felt worried about repaying student loans (which averaged $170K for 2011–2020 grads).

Work Environment: Community pharmacists reported the lowest job satisfaction (61%), lowest autonomy (49.4%), highest time pressure (76.1%), and highest rates of workplace harassment (33.2%).

Career Outlook: While 87.2% are proud to be pharmacists, only 48.7% would recommend the career, and 36.1% are likely to search for a new job in the coming year

Understand the Mission of the FDA

Purity, Safety, and Efficacy: Ensure drugs, medical devices, and other regulated products are pure, safe, effective, and bear truthful labeling

Identify the Scope of FDA Regulation

Regulated Categories: The FDA regulates food (jointly with the Department of Agriculture), drugs, biologics, medical devices, cosmetics, and radiation-emitting electronic products—representing 20% of consumer spending

Understand the relationship between the FDA and the Federal Government

Executive Branch: The FDA is part of the Department of Health and Human Services (HHS); its Commissioner is appointed by the President and confirmed by the Senate, reporting directly to the HHS Secretary.

Legislative Branch: The FDA is not an independent agency and does not receive deference from Congress, which routinely reviews it through committee oversight due to large financial and special interests

Explain why there are multiple definitions of “drug”

Official listings: Articles recognized in official pharmacopoeias (e.g., USP, NF).

Intended therapeutic use: Articles intended to diagnose, cure, mitigate, treat, or prevent disease in humans or animals (determined by seller claims or consumer expectations).

Structure/Function: Articles (other than food) intended to affect the structure or function of the body.

Components: Articles intended for use as a component of any item in the above categories

Provide examples of adulteration

Adulteration: Selling contaminated, unsafe, or impure dietary supplements or foods that cause harm post-marketing

Provide examples of misbranding

Selling a product with false or misleading labeling.

Selling a drug without "adequate directions for use" or using unapproved labeling.

Promoting a common product with disease-curing claims (e.g., labeling apple cider vinegar with claims that it cures cancer makes it a drug subject to misbranding laws if unapproved).

Understand the FDA's requirements for direct-to-consumer (DTC) advertisements

Requirements: DTC ads must be truthful, non-misleading, present a fair balance of risks/benefits, and state at least one FDA-approved use.

Broadcast Ads: Must include a major statement covering key risks and provide access to full risk information.

Print Ads: Must include a brief summary or patient labeling detailing major risks and contraindications

Discuss Post-Market Surveillance

Why it is needed: Clinical trials are limited in time/scope and usually exclude pregnant women, meaning serious side effects or teratogenic risks often go undetected before approval

Discuss Post-Market Challenges

Challenges:

Post-market adverse event reporting by healthcare professionals is largely voluntary.

Large post-market studies are costly, and drug companies may lack the incentive to fund research that could undermine their products.