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
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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.
Pharmaceutical Care Mandate:
in recognizing the complexities and possibilities associated with drug therapies, the field of pharmacy has acknowledged the importance of shifting towards a patient-centered model. This change is encapsulated in the concept of “pharmaceutical care.”
“The responsible provision of drug therapy for the purpose
of achieving definite outcomes that improve a patient’s
quality of life.” - What does this quote define?
Definition of Pharmaceutical Care
Outcomes of Pharmaceutical Care:
The desired outcomes of pharmaceutical care include the cure of disease, elimination or reduction in symptomatology, arresting or slowing the disease process, and preventing disease or symptoms
Basic Functions of Pharmaceutical Care:
Identifying potential or actual drug-related problems.
Resolving actual drug-related problems.
Preventing potential drug-related problems.
Medication Therapy Management (MTM):
Emphasizes the importance of medications in public health and safety.
Recognizes the collaborative nature among pharmacists and other healthcare professionals to achieve public health and safety goals
Implementation Models:
Improved clarity compared to the previous model of pharmaceutical care.
Pharmaceutical Care: Barriers:
There are barriers associated with this model of patient care
Drug Focus: Pharmaceutical Care:
Dispensing function is primary in the pharmaceutical care model.
Service Focus: Pharmaceutical Care
Services provided are distant from the patient and lack consideration for outcomes.
Healthcare Professionals Interactions: Pharmaceutical Care
Infringement on others’ “turf” leads to political challenges.
Incentives in Pharmaceutical Care
Compensation is often based on dispensing productivity rather than patient care.
Logistical Challenges: Pharmaceutical care
Pharmacies are not designed for consultations, disease monitoring, and providing drug information.
Medicare Prescription Drug Improvement and Modernization Act of 2003 & Pharmacy
This act positions pharmacy as the natural choice for providing pharmaceutical care services.
Although envisioned, these services are not mandated and currently not reimbursed.
The Asheville Project:
This is an ongoing project.
Pharmacists are reimbursed for pharmaceutical care services, initially focusing on diabetes.
Proven to improve outcomes and save money.
APhA, ASHP, AMCP
American Pharmacists Association (APhA)
American Society of Health-System Pharmacists (ASHP).
Academy of Managed Care Pharmacy (AMCP).
Benefits and Services of Professional Pharmacy Organizations:
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Information Dissemination:
These orgs will include publications, research, and professional updates.
Maintain Competency:
Offers continuing education and participation in professional meetings to ensure members stay current in their field.
Career Planning Assistance:
Provides resources such as job postings and workshops to assist members in career development.
Financial Benefits:
Offers financial benefits such as discounts, insurance, and other perks to its members.
Participation in Governance:
Allows members to actively engage in the governance of the profession and participate in lobbying efforts.
ISMP
Institute for Safe Medication Practices:
A non-profit organization dedicated to promoting safe medication practices.
NACDS
National Association of Chain Drug Stores:
Definition: A trade association representing the interests of chain drug stores and pharmacies.
PhRMA
Pharmaceutical Researchers and Manufacturers Association:
A trade group representing research-based pharmaceutical and biotechnology companies.
GPhA
Generic Pharmaceutical Industry Association:
Definition: An association representing the generic pharmaceutical industry.
NABP
National Association of Boards of Pharmacy:
NABP plays a crucial role in ensuring the quality and safety of pharmacy practices. It develops the NAPLEX (North American Pharmacist Licensure Examination) and operates the Verified Internet Pharmacy Practice Sites (VIPPS) program.
ACPE
American Council for Pharmacy Education:
ACPE ensures the quality of pharmacy education by accrediting pharmacy schools and continuing education providers. It sets standards and guidelines to maintain the excellence of pharmacy education.
AACP
American Association of Colleges of Pharmacy:
AACP advocates for pharmacy education and supports pharmacy schools. It promotes collaboration among educators, advances research in pharmaceutical sciences, and contributes to the development of pharmacy curricula
AFPE
American Foundation for Pharmaceutical Education:
AFPE aims to advance pharmaceutical education by offering financial support to students, researchers, and educators. It plays a role in fostering innovation and excellence in the pharmaceutical field.
Pharmacy Technicians:
Expanded Role
Assist the pharmacist in serving patients.
Maintain medication and inventory control systems.
Participate in the administration and management of a pharmacy practice.
Certification (CPhT):
Training involves 600 contact hours over 15 weeks.
Completion of the Pharmacy Technician Certification Examination (PTCE).
E-Pharmacy
Mail-order Model (Full-Service):
Prescription from an unaffiliated physician filled and mailed to the patient.
Other services and products available on the website.
Information and Counseling:
E-pharmacy
Offers services other than dispensing for a fee.
Provides information and counseling.
Prescribing and dispensing:
E-pharmacy
Patient” completes a medical survey online.
“Physician” reviews the survey, prescribes the desired medication.
Fees cover the survey, physician services, prescription, and shipping.
Associated with fraud, ethical, and safety concerns, often outside the U.S.
VIPPS
Verified Internet Pharmacy Practice Site:
What does VIPPS do?
Voluntary program of the National Association of Boards of Pharmacy (NABP).
Certifies Internet pharmacies based on 19 criteria.
VIPPS seal displayed on the pharmacy’s home page, linking to VIPPS information about that pharmacy.
State Requirements for E-Pharmacies
Some states mandate that the dispensing pharmacist be licensed in the same state as the patient.
Federal Legislation:
There is no federal legislation addressing E-Pharmacy and Internet Pharmacy as of yet
