State vs. Federal Pharmacy Law Laws may vary regarding pharmacy management from state to state. Because of this, only federal law will be covered in this class. When trying to decide which law to follow if state, federal and local differ… Always follow which ever law is strictest!

Terms What is an Act? A statutory plan passed by Congress or other legislature which is a “bill” until enacted and becomes law. What is an Amendment? A change in an original act or law.

1906 Federal Food and Drug Act One of first laws enacted to stop sale of unsafe products. Well intentioned but not effective – focused mostly on purity, not safety. Did not require listing of ingredients or prevent false claims.

1914 Harrison Narcotic Act Required a prescription for opium – until this time could be bought openly and there were many addicts.

1938 Food, Drug, and Cosmetic Act To replace the ineffective earlier Act adding medical devices & cosmetics. Came about after Tennessee company marketed a sulfa drug in an unsafe base compound that killed 100 people, most of them children. To prevent adulteration and misbranding. Drugs tested for safety prior to marketing. All ingredients listed, directions for safe use on label and all addictive substances had to be labeled “Warning: May be habit forming.” Gave rise to the FDA – Food and Drug Administration to enforce the regulations.

Terms Adulteration – The mishandling of medication that can lead to contamination or changes in strength or quality – potentially causing injury or illness to the consumer. Misbranding – Deceptive or misleading labeling of a product that may lead the consumer to believe that the product will cure illness.

1951 Durham-Humphrey Amendment Added more instructions for drug companies and required the labeling – “Caution: Federal law prohibits the dispensing without a prescription.” Currently “Rx Only” Made the original distinction between legend (prescription) and non-legend (OTC) drugs.

1962 Kefauver-Harris Amendments Enacted to ensure safety and effectiveness of all new drugs on the market. Burden placed on drug companies to test drugs. FDA oversaw and prevented such tragedies as thalidomide babies in the US– children born with birth defects to mothers who took this drug for nausea or sedation during pregnancy in Europe, Canada.

1970 Comprehensive Drug Abuse Prevention and Control Act (CSA- Controlled Substances Act) Formed the DEA - Drug Enforcement Administration to enforce laws regarding controlled substances. Part of the Dept. of Justice. Stair-step schedule of controlled substances rating - Schedule I-V with I being the most regulated and V being the least regulated. Controlled substances - substances such as narcotics, stimulants, hallucinogens, depressants and testosterone with potential for abuse and whose sale/possession is closely regulated.

1970 The Poison Prevention Packaging Act Requires manufacturers and pharmacies to place child proof caps on medications. Thought to have reduces child deaths from medication poisoning by 45%. The standard states that package should not be able to be opened by 80% of children under 5; can be opened by 90% of adults. Exceptions include certain legend medications, requests for no child proof caps by patient or MD, and hospitalized client medications.

1983 Orphan Drug Act Allows drug companies to bypass lengthy and expense testing of drugs when they are to be used for diseases that affect only a small part of population - <200,000 person in US. Also covered diseases that affect more than 200,000 if proved that cost of development can never be recovered in eventual sales.

Drug Price Competition and Patent- Term Restoration Act (Hatch-Waxman Amendment) This act streamlines the process for granting approval of generic drugs. It also give manufacturers incentives to develop new drugs by giving patent extensions. This act allows generic drug companies the ability to rely on safety and efficacy findings of an innovator's drug after the expiration of the patent.

1988 Prescription Drug Marketing Act - This act banned the sale, trade, or purchase of drug samples. Food and Drug Administration Act - This act established the FDA as an agency of the Department of Health and Human Services. Any adverse drug reactions and outcomes should be reported to the FDA

1990 Omnibus Budget Reconciliation Act (OBRA 90) Relates to persons covered by Government health care plans – Medicare and Medicaid. States that a pharmacist must review client medication profiles and offer to counsel (at the time of purchase) all clients who receive new prescriptions. This is to ensure client knowledge and safety. This may be done in writing or verbally. Resulted in all patients receiving this type of care. Fines can be given by Board of Pharmacy if pharmacist does not comply.

1990 Anabolic Steroids Control Act Stiffer regulations on testosterone based products due to abuse by athletes. Made Schedule III controlled substance.

Why Abuse Anabolic Steroids? Anabolic steroids are used because of their ability to improve performance by increasing muscle mass and decreasing body fat. They are also used, especially by men, to change their body shape towards more muscular physique.

Do anabolic steroids have legitimate uses? Steroids are used for treating delayed puberty some types of impotence wasting of the body due to such conditions as HIV some types of anemia osteoporosis (brittle bones in menopausal women)

2005 Combat Methamphetamine Epidemic Act Limited sale of the decongestant drug pseudo ephedrine and the stimulant ephedrine because of their use as base ingredients in making methamphetamine. Must be kept in secured location behind the counter. Must be sold only by pharmacist or technician. Quantity of purchase is limited to (3.5g/day or 7.5g/month) Requires photo ID and log signature for purchase, records of sale kept for 2 years.

2005 Combat Methamphetamine Epidemic Act Did not completely solve problem because no linked data base exists in all states so “store hopping” or crossing of state lines occurs to get supply. Some states such as Missouri and Kentucky are requiring linked logs. Some states are making these drugs prescription – Oregon and Missouri

Why is Meth Abused? What are the legitimate uses of Meth? Causes release of neurotransmitter Dopamine that stimulates pleasure center of brain causing euphoria “high”, increases energy and wakefulness. May be given legitimately for weight loss or as stimulant for narcolepsy.

What are side effects of Meth abuse? Extreme weight loss Tooth decay and gum deterioration “Meth Mouth” Mood swings, paranoia, psychotic - often violent behavior Itching, crawling sensation under skin leading to open sores Long term damage to blood vessels, heart, liver and lungs

BTC Drugs There is officially no class called BTC drugs or Behind the Counter Drugs However, drugs such as pseudoephedrine that are not legend but have restrictions on their sale and must be dispensed by pharmacy staff are often called “BTC drugs” Plan B emergency contraception is a “dual marketing” status drug in that it must have script for under 17 but is dispensed by pharmacist as a BTC drug upon request to women over age 17 and over. Other BTC products include insulin and syringes

1996 HIPAA Health Insurance Portability and Accountability Act Title I: It limits what is considered a pre-existing condition and limits time insurance can deny you coverage due to this.. It gives certain people the right to buy individual health insurance if no group health plan coverage is available. It does not allow employers or their health insurers to discriminate or act unfairly against employees and their dependents based on their health status or genetic information.

HIPAA Title II: Standardized all forms used in connection with electronic health information from lab reports, and medical bills to insurance forms Sets boundaries and provides security for use of protected health information and requires patients to be informed of how this information will be used.

HIPAA-1996 What is protected information? Any information related to past, present or future physical or mental health or care Payment records Any information that would identify the person receiving care All this must be kept confidential and written consent is required by patient to release this information!

HIPAA 1996 What is not protected? Statistical data without patient identifiers CDC requirements for reporting of communicable/infectious diseases to protect public health Information requested under subpoena or court order by legal entity This information may be released without consent of patient.

HIPAA Provides rights to patients Right to written copy of privacy practices Right to written copy of health information record Right to amend health record Right to full disclosure of how all their health information has been used Right to file a complaint about how it has been used Right to authorize release of information for purposes other than treatment, payment or health care operation. May designate someone to receive their information.

HIPAA Written consent for release of information to third party billing must be obtained only once. Form must be in plain language, signed and dated by patient. In pharmacy, considerations include client counseling, prescription logs, disposal of medication bottles, paper and electronic records, and third party payers.

Health Information Technology for Economic and Clinical Health Act (HITECH) Health Care Providers must begin move to “meaningful use” of Electronic Health Records (EHR’s) or suffer financial penalties. Modified HIPAA Further restrictions on using PHI for marketing, fundraising & makes all business associates responsible for being HIPAA compliant Tightened definition of what is a “breach” and increased fines Protects genetic information by prohibiting most insurance plans from using or disclosing genetic information for underwriting purposes. This is to be compliant with GINA – Genetic Information Nondiscrimination Act of 2008