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Pharmacy in Public Health: Law in Public Health

Pharmacy in Public Health: Law in Public Health. Course, date, etc. info. Introduction. Public health differs from pharmacy practice in that it can enforce behaviors via law Public health laws address a variety of issues related to determinants of health and health risks

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Pharmacy in Public Health: Law in Public Health

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  1. Pharmacy in Public Health:Law in Public Health Course, date, etc. info

  2. Introduction • Public health differs from pharmacy practice in that it can enforce behaviors via law • Public health laws address a variety of issues related to determinants of health and health risks • Inspirations for many pharmacy laws can be traced back to a public health issue

  3. Learning Outcomes • Describe the source of authority for federal and state governments to pass public health laws • Describe public health problems that inspired the passage of pharmacy laws • Explain how international approaches to public health issues can be addressed • List and describe ongoing or emerging public health issues that may inspire future laws or regulations

  4. Source of Authority • States have “police power” • State government has power to act on behalf of its citizens to protect or benefit them • Unless that power is explicitly given to the federal government • State authority reiterated in the 10th Amendment • Police power may be delegated to local governments • Police power gives states the ability to create and enforce laws that restrict or mandate behaviors • This leads to a constant effort to ensure laws are not unduly restrictive of individual freedom

  5. Areas of Public Health Law • Change behavior • Modifying high-risk behaviors • Requiring behaviors • Prohibiting behaviors • Regulate products or services • Licensure • Manufacturing • Distribution and advertising • Protect vulnerable populations or places • Access to services including healthcare • Clean and safe environment • Human rights protection

  6. Examples of Historically Important Public Health Laws and Court Decisions Table 4.1, pg 78

  7. Faulty Products • There are many ways a product can cause harm: • Fails to work (ineffective, sub-therapeutic, false claims) • Causes harm (unsafe ingredients, tampered) • Intentionally altered (counterfeit, adulterated)

  8. Example: Fraudulent Products 1905-06 Expose’ on Quack Medicines • Situation: • No legal requirement to list any ingredients on label • Post- civil war era explosion in use of patent medicines Problem: • Fraudulent products marketed • Deaths and disability with no accountability • Resolution: • 1906 Food and Drug Act

  9. Example: Unsafe ingredients 1937 Elixir Sulfanilamide tragedy • Situation: • No legal requirement to list inactive ingredients on label • Needed a liquid form of new sulfa antibiotic for children • Problem: • DEG used as diluent – it is toxic. • Over 100 people, mostly children die • Resolution: • Federal Food, Drug &Cosmetics Act of 1938 Photo source U.S. FDA, Center for Drug Evaluation and Research

  10. Example: No Efficacy Standards 1950s European Thalidomide Tragedy • Situation: • Product approved in Europe; under review in U.S. • Approval delayed because of neurological studies results • Voluntary standards for new products • Problem: • Teratogenic effects appear in Europe • Need more stringent requirements for new product approval • Resolution: • 1962 Kefauver-Harris Drug Amendment

  11. Example: Product Tampering 1980s Cyanide-laced Tylenol Capsules • Situation: • Extra-strength Tylenol capsules could be opened • No seals or tamper-evident packaging • Problem: • Person opened capsules, added cyanide, replaced products on store shelves • Seven people were poisoned and died • Resolution: • 1982 Tamper-resistant packaging regulations • Manufacturer switched to a caplet dosage form

  12. Some of the Federal Pharmacy Laws Inspired by Faulty or Dangerous Medications Table 4.2, pg 83

  13. Evolution of the Medicine Bottle and Label Figure 4.5, pg 81

  14. Mutual Recognition Agreements • Issue: medication made in other countries for sale to the U.S. may not be of the same quality • Some may have higher standards; some lower • International agreements (contracts not laws) used to set minimum standards for a product • Between governments or agencies • Equivalence of processes or products must be shown • FDA is moving toward MRAs

  15. Distribution Regulations • Issue: once a product leaves the manufacturer, it may be altered or tampered with before it reaches the pharmacy • Primary wholesalers (authorized distributors) • Buy directly from manufacturer • Secondary wholesalers (unauthorized) • Do not receive product directly from manufacturer • May re-distribute products from end-users • Often the point where bogus products enter the market • Pedigrees - track products from manufacturer to purchaser

  16. Unsafe Use • Unsupervised use of potent medications • Medication errors • Abuse of clinically used medications

  17. Issue: Access to medications • Issue: Uninsured or underinsured populations and healthcare costs that will bankrupt most people if not insured for catastrophic event • Out-of-pocket expense • Rapid rise in cost often outstrips the financial resources of a retired or minimum wage worker • Creation of Medicare and Medicaid

  18. Federal Pharmacy Laws Inspired by Unsafe Use and Access Issues Table 4.3, pg 85

  19. Issue: Inappropriate disposal practices • Issue: unregulated disposal of industrial, healthcare, and home medical wastes • Contamination of water, soil, and air is a health hazard to humans and animals • 1976 Resource Conservation Recovery Act (RCRA) • Non-hazardous wastes • Biological or medical wastes • Hazardous wastes • Ignitable, corrosive, reactive, or toxic

  20. Examples of state-level laws • Practice Acts • Define scope of practice for professionals • Prescriptive authority • Dispensing versus administration • Professional Boards • Professional licensure • Practice site licensure • Respond to complaints • Public health insurance programs • Medical waste disposal

  21. Issue: (Re-)Emerging Issues • Growth of law and regulation • Product safety • Product effectiveness • Safe use of products • Access to safe products and care • Proper disposal

  22. Issue: (Re-)Emerging Issues • Same issues persist today- often in new ways • Global influences and travel • Technological advances • Internet and information sharing • Human nature (both the good and the bad)

  23. Summary • Police power allows state and local governments to pass laws that support public health efforts • Most pharmacy laws have their origins as a response to a public health issue • Old problems are re-emerging with the advent of technology, global trade, and will require new or amended laws to address them

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