Pharmacology and Drug Regulation

Definitions and Key Concepts

Pharmacology is the study of drugs and their effects on living organisms. Drugs are substances that produce a change in cellular or physiological function in humans.

• Pharmakon: Greek word for drug; refers to remedy, poison, or magical charm.

• Prescription drugs: Require a licensed health care provider's approval.

• Non-prescription drugs: Available to the public without a prescription.

• Approved use: Medication is used for a condition that is approved to treat by the FDA.

• Unapproved/off-label use: Medication is used for a condition that is not approved by the FDA.

Medication

Medications are substances requiring treatment, often prescribed for medical problems. Some medications are used for non-medical problems, such as difficulty in pronouncing specific types of sounds (e.g., ADHD).

Aspects of Drugs

• Manufacturers: Focus on a drug's therapeutic effect, aiming to optimize biochemical activity and limit negative effects.

• Healthcare providers: Concerned with the drug's therapeutic effect.

• Patients: Concerned with safety, adverse events, and costs.

Consumer's Perspective

• Side effects: Medications are taken when the benefits outweigh the risks and side effects are minimal.

Prescriber's Perspective

• Prescribers recommend lifestyle changes, physical therapy, or surgery before medication.

• Providing a sense of satisfaction to the patient includes education, coordination with other health care providers, and promotional activities by drug manufacturers.

Drug Regulation and Approval

Regulation of Pharmaceuticals

The Food & Drug Administration (FDA) determines which drugs are allowed to be sold and prescribed in the US, categorizing them into Rx and non-Rx drugs.

Food, Drug & Cosmetic Act (1938)

• Guides the FDA to regulate small molecules and hormones.

Public Health Service Act (1944)

• Regulates biologic drugs (large molecules); more complex.

Non-FDA Approved Off-Label Indications

• Uses of a product not yet approved by the FDA but shown to have value after approval based on post-marketing research.

Drug Development Process

• Discovery research

• Preclinical testing

• Clinical efficacy: Testing on humans, with three phases prior to approval:

  • PHASE 1: Determines safety, dosage range, and mechanism of absorption, distribution, and elimination. Healthy volunteers (more than 100). Lasts approximately 1-1.5 years.

  • PHASE 2: Safety and efficacy in patients with disease or symptoms. Volunteer with disease or symptoms (more than 300). Lasts approximately 2-3 years.

  • PHASE 3: Monitor adverse effects and efficacy in patients with disease or symptoms (more than 3000). Lasts approximately 3-5 years.

Approval of a New Drug (NDA)

• If approved for market, manufacturer continues to submit post-marketing information (Phase 4: most drugs are in phase 4).

• If changes are needed, a Supplemental NDA (sNDA) is submitted to the FDA.

Generics and Biologics

Generics & ANDA (Abbreviated New Drug Application)

• Pharmaceutical equivalence: Drugs have the same active ingredients, same dosage form, and same strength and color.

• Bioequivalence: Drugs have the same rate and extent of absorption into the bloodstream as the brand drug.

• Therapeutic equivalence: Drugs are therapeutically equivalent to the comparable brand when the FDA says the generic is safe and effective.

Drug Pricing

• Largest component is the drug cost (R&D and cost).

• Price is determined by the costs and profits of the supply chain.

Importation

• Importing from another country must be approved by FDA.

• It is generally illegal to purchase prescription drugs in another country for use in the US, with some exceptions.

Counterfeiting

• Fake medicines may contain wrong or no active ingredient and may be harmful.

Foreign Clinical Trials

• Clinical trials are often conducted outside the US (about 40-65% of trials).

• FDA is required to inspect many foreign clinical trial sites.

Intellectual Property Rights (IPRs)

• Laws and regulations protect ideas and products of innovators.

Hospitals and Healthcare Systems

Hospital Definition and Functions

• Institution with at least 6 beds; primary function is to deliver patient services, diagnostic & therapeutic for medical conditions.

• Must be licensed and governed by federal laws.

• Consume a large portion of national health care expenditures.

Modernization of Hospitals

• Medical education, more science-based approach.

• Changing medical education and research centers for medicine practice.

Financial Stability

• Health insurances provided financial stability; hospitals are no longer at financial risk.

Infrastructure

• There was a severe shortage of hospital beds.

• Hill Burton Act (Hospital survey & construction act of 1946) increased the number of hospitals.

• Shift from acute to chronic disease: Chronic conditions can be managed by a single hospital stay; treatment is continuous and includes ambulatory and long-term care.

Financing Hospital Care

• Payment mechanism: Diagnosis related group (DRGs).

• Hospitals are paid a fixed amount per admission according to the patient's principal diagnosis.

Value Based Purchasing (VBP)

• Hospitals receive incentive payments for their Medicare patients based on how well the hospitals perform and the quality of care provided.

Hospital Integration

• Horizontal integration: Affiliations with other hospitals to secure better efficiency.

• Vertical integration: Affiliations with other organizations (hospital to non-hospital).

Length of Stay

• Acute (short-term): Less than 30 days.

• Chronic (long-term): Average stay for 30 days.

Type of Service

• General hospitals: Provide a variety of services, including general medical and surgical services.

• Specialty hospitals: Concentrate on one disease process or one segment (e.g., cancer centers, children's hospitals).

Ownership

• Public hospitals: Federal, non-federal government.

• Private hospitals: Not for profit or for profit.

Community Hospitals

• Available to the public; all nonfederal, short-term general and specialty hospitals are available to the public.

Teaching Hospitals

• Serve as a training site for physicians.

Multihospital System

• Hospitals are part of a system with two or more hospitals owned, leased, sponsored, or contracted by a central organization.

Board of Directors (or Trustees)

• Board of directors for profit hospitals; board of trustees for non-profit hospitals.

• They determine the mission and goals of the hospital and develop policies.

Hospital Administration or CEO

• Either a physician or a person with an advanced degree in health administration or business.

Medical Staff

• Composed of staff physicians (salary employees) and community-based physicians (independent physicians).

• Licensure: Permission given by the government.

• Certification: Provides a hospital authority to participate in Medicare and Medicaid.

Ambulatory Care

Definition and Types

• Care for an individual presenting for personal health services, who is neither bedridden nor currently admitted to any health care institution.

• No need to stay at the hospital overnight.

• Includes physician offices, clinics, ambulatory care centers, urgent care centers, ambulatory surgery centers, dentist's offices, pharmacies, and schools.

Types of Medical Practices

• Private practice physicians: Independent doctor running their own business (solo or partnership).

• Managed care organizations (MCOs): Doctors work as part of a larger, insurance-managed healthcare system.

Physicians Affiliated with Managed Care Organizations

• Decides which providers you can see, how much they get paid, and what services are covered to control and improve quality.

• Use provider networks.

Summary

• This guide covers the basics of drug regulation, hospital systems, and ambulatory care, providing a foundation for understanding the structure and function of healthcare delivery in the United States.

Additional info: Some context and definitions were inferred to clarify fragmented points and ensure completeness.