US Pharmacy Law

1. US Pharmacy Law • American law preceded through many stages. • On July 4th, 1776 the 13 colonies declared independence from England’s King George. • On March 4, 1789, the Articles were replaced with the US Constitution, which provided for a stronger central government. It provided for a division of powers into executive (president), judicial (supreme court), and legislative branches. It also delineated rights to its citizens that are granted by their creator and can’t be taken away called the bill of rights (i.e. freedom of speech, freedom of religion, and due process)

2. US Constitution is the supreme law of the land and all proceeding laws and statutes (laws passed by congress or state senates) must conform to it. This is call constitutionality. • From the constitution, the US congress and state senates promulgate laws or statutes. Often these laws establish regulatory bodies to help enforce these laws. For example the Food and Drug Agency was established by the Food, Drug, and Cosmetic Act of 1938 to help enforce the regulations of the act.

3. US Law falls under several categories: • Criminal law: involves a crime against an individual specifically and to society in general. Examples are Murder, rape, sexual assault, burglary, grand larceny. It is brought to trial by a district attorney or prosecutor who seeks an indictment or a conviction of a crime by a jury to the offender. • Civil law (tort law): deals with dispute resolution between individuals and/or organizations. Emphasis is on compensation and not on punishment. Most cases of medical malpractice fall under this category. Medical cases that result in death can be heard here as “wrongful death” cases. • Family Law • Penalties • Misdemeanor is a crime punishable by jail term of 1 year or less and/or a monetary fine • Felony is a crime punishable by jail term of greater than 1 year up to life or death.

4. Important Milestones in Pharmacy law • Pure Food and Drug Act of 1906: forbade the manufacture, sale and distribution of adulterated medications as well as meat and poultry products. • Food, Drug, and Cosmetic Act of 1938 established the Food and Drug Administration which oversees the production of drugs, cosmetics and food products in terms of certain standards. Standards are: • Manufacturers of drugs are required to submitted safety data before they can market any drug. • Requirements for label and labeling of drugs • Established legend drugs and who may prescribed them

5. Label and Labeling requirements made by the FDCA. • Labels are on the immediate container of the drug • Must include: • established name of drug and quantity of each active ingredient. • Statement of new quantity • Statement of usual dosage • Federal legend (Durham Humphrey) • Route of administration • If habit forming, federal disclaimer • Name of all inactive ingredients if not for oral use • Name and address of manufacturer, packer or distributor • Lot number and expiration date • Specific container to be used by the pharmacist to dispense medication (i.e. dispense in an amber vial for light sensitive drugs)

6. Labeling requirements by the FDCA • Description of the chemical nature of the drug including its generic name • Pharmacology • Indications for use • Contraindications-situation where the drug should not be used • Dose • Side effect warnings • Adverse reactions • Drug Abuse potential, if applicable • How drug is supplied • Date of most recent revision to labeling The labeling is most often referred to as the package insert

7. Label elements required on a dispensed prescription as per the FDCA. • Names of prescriber, patient, and pharmacy (and address) • Serial number of prescription • Original Date of fill • Expiration date (of the drug) • Directions for use • Cautionary Statements (if needed) • Curiously, no mention is made of the name of the drug or its dosage or the pharmacist’s or technician’s name.

8. FDCA defines a drug • FDCA defined a drug as: “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal” • FDCA defines adulteration: “a product that is combined with an ingredient that reduces its potency or quality” • FDCA defines misbranding as “false and misleading labeling” • Penalties for violations of the FDCA include restraining orders and seizures of above products

9. Amendments to the FDCA • Durham Humphrey Amendment of 1951: required that legend drugs must have the legend: “Caution: Federal law prohibits dispensing without a prescription”. • Kefauver Harris Amendment of 1962: established that drugs be proven safe and effective before they are marketed to the public. • Act came about because of the thalidomide tragedy.

10. Thalidomide Scare of 1950’s and 1960’s • First used in Europe as a “wonder” drug for pain, and insomnia. It was reported to be effective for treating nausea and as a result used to treat morning sickness by pregnant women. • The US FDA never allowed the drug to be marketed in the US. Pregnant women obtained the drug from other sources like across border trade and from samples given to them by doctors in the US. • Birth defects have been linked to the drug even after only one dose. • This was proven by 1961. • The defect involved an absence/malformation of limbs in the fetus called phocomelia.

11. Thalidomide syndrome

12. Thalidomide Today • Thalidomide was removed from the worldwide market in 1962-1963. • Today however the drug is market in the US under the brand name Thalomid® under very strict conditions and requires registration with the STEPS program (system for thalidomide education and prescribing safety). The program is monitored by the FDA and requires registration by doctors, patients and pharmacist for dispensing. • Drug has approval from the FDA for use in Erythema Nodosum Leprosum and in multiple myeloma.

13. Thalidomide is an example of a drug where the labeling includes US black box warnings. • These warnings are encircled with a black outlined box and contains very important information that must be made to health care professionals.

14. Other lesser known pharmacy laws • 1914: Harrison Narcotic Act : The possession of narcotics and coca became illegal. • 1924: Heroin Act: The manufacture and the possession of heroin became illegal. • 1927: Bureau of Prohibition: enforces the 18th amendment to the US constitution. • 1937: Marijuana Tax Act: requires payment of a tax to buy cannabis. Illegal to do so without payment.

15. The Comprehensive Drug Abuse Prevention and Control Act of 1970 • Established five schedules of drugs that have high potential for abuse. Listed with symbol “C” followed by a number from 1 to 5. 1 having the highest potential for abuse and 5 the lowest. • Standards are set in each class that helps law enforcement prevent diversion and to protect the public. • Schedule I: have no accepted medical use in the US. Includes Heroin (smack), LSD (angel dust), marijuana (weed), methaqualone (Luddes) • Schedule II: prescriptions may be written for a one month supply with no refills; must be written an a triplicate prescription in most states. Examples include : • Morphine • fentanyl • Hydromorphone • Percocet® • Demerol® (mepiridine) • Ritalin ® (methylphenidate) • Schedule III: prescription may be written for five refills to be used in a 6 month period. Includes Vicodin®, Lorcet ®, and Tylenol ®

16. Schedule drugs continued • Schedule IV: same requirement as CIII’s. Examples: • lorazepam • Diazepam • alprazolam • temazepam • Schedule V: includes cough preparation with codeine. Example is Tussin C® (Guaifenesin with Codeine). Up to 11 refills are allowed like a regular prescription and is valid for one year.

17. Other provision of the CSA • All individuals handling controlled substance are required to register with the DEA (Drug Enforcement Agency which is a branch of the US Dept. of Justice). This includes MD’s, drug companies, distributors, pharmacies (not individual pharmacists). • A prescription for a controlled substance must have the following to be dispensed: • The full name and address of both prescriber and patient. • DEA of the prescriber • Date prescription was written • Signature of the prescriber. • If any of the following are missing, the prescription can not be filled. • Corrections can be made the pharmacist in consultation with the prescriber but the above elements can not be altered.

18. Controlled substances in NY • States, via their own laws, can make the CSA laws more strict, but can’t make them more loose. • According to the CSA, benzodiazepines are CIV agents but in NY they are treated like a CII agent. • In NY, a prescriber is allowed to phone in a verbal prescription to the pharmacy for a controlled substance; however, the following apply: • Only a five day supply of the medication can be supplied in the case of CII and CIII. • The prescriber must submitted a written prescription to the pharmacy in that period of time. • No refill are allowed.

19. Penalties involving violations of the CSA of 1970

20. Penalties for Violations of CSA of 1970

21. The above table contains that maximum penalty for jail time or amounts that are less than the one above the fine and penalties are less. These listed offenses are for first time offenses Flunitrazepam (Rohypnol® or street name of “Roofies” is a benzodiazepine that produces powerful sedation and anterograde amnesia. It is a “date rape drug” and has been used in comitingsexual assault in the US and other countries. GHB (gamma hydroxybutyrate) is similar to flunitrazepam and is a date rape drug also known as “Georgia Home Boy","Lollipops"

22. Rockefeller Drug Laws • In 1973, NYS governor Nelson Rockefeller signed in law one of the most draconian state drug laws in the US. • Anyone with illegal possession with intent to sell 57 grams or more of heroin, cocaine, marihuana, morphine would sentenced to a minimum of 15 years • Anyone with illegal possession of 113 grams or more of the above drugs would serve a 15 years to life. • Due to political pressures, governors George Pataki and David Patterson greatly reduced these minimum sentences to class D felonies and for marihuana a misdemeanor • Criminal possession of prescription narcotics is still a felony in most cases in NY

23. The Orphan Drug Act of 1983 • Passed by congress to provide incentives for drug companies to create drugs for rare diseases in which the profit motivation is not there. • Seven year market exclusivity • 50% tax credit in the cost of conducting clinical trials. • Research grants • Waive the costs of submitting fees to the FDA. • Example is a drug called Aldurazyme® made by BioMarin Pharmaceuticals (California based company with the ticker symbol: Nasdaq: BMRN). It is an enzyme that is lacking in a genetic disease called Hurler’s syndrome. People with Hurler’s are often disfigured with gargoyle like features. They are often mentally retarded with other neurological features. They also have failing organs in particular the liver. They often will die by about 10 years of age because of liver disease.

24. The Drug Price Competition and Patent Term Restoration Act of 1984 • Allowed manufacturers of generic drugs to file an Abbreviated New Drug Applications (ANDA) with the FDA. • Allowed these companies to show that their generic drugs where therapeutically equivalent to their brand competitors without the necessity of going through extensive clinical testing. • Allowed the influx of cheap drugs in the US marketplace.

25. Anabolic Steroid Control Act of 1990 • Placed anabolic steroids in the CIII category. • Hormones that are pharmacological similar to testosterone • Responded to high rate of steroid abuse in young teens and athletes (Mark McGuire and Barry Bonds). • Example of such drugs: Anadrol® (oxymetholone), Decadurabolin® (nandrolone), and Winstrol ® (stanozolol).

26. Omnibus Budget Reconciliation act of 1990 (OBRA 90) • Passed by congress to address the rising cost of the medicaid and medicare programs • Required pharmacist to counsel all medicare and medicaid patients. This requirement later extended to all patients depending on the state of residency. • Created a need for pharmacy technicians to assist pharmacists in the technical aspects of pharmacy to allow them to devoted more time to the clinical aspects of pharmacy practice.

27. The Health Insurance Portability and Accountability Act of 1996 • Known as “HIPAA” • Requires that personal health information (PHI)be safeguarded by the healthcare industry. • Medical records need to be safeguarded electronically which may involve encryption coding and password pertection. • Patient’s rights under HIPAA include: • Access to their own health information • Ability to amended information • Ability to control to whom PHI is disclosed • Receive written notification of how PHI may be used by the health provider also know as “notice of privacy practices” • When PHI is used by a provider for any reason other than treatment or payment, explicit authorization must be obtained from the patient.

28. Penalties for HIPAA violations • Civil Penalties: up to $25,000 fine • Criminal Penalties are incurred if the entity knowingly using PHI unlawfully • $50,000 and 1 year in prison • $100,000 and 5 years in prison if entity obtains PHI under false pretenses • $250,000 and 10 years in prison if entity sells PHI for personal gain or for malicious harm to patient’s reputation

29. Ancillary Laws • Poison Prevention Packaging Act of 1970 • Required childproof dispensing containers for all Rx drugs • Elderly people who desire non child resistant container must sign a waiver to such effect by the patient’s pharmacy • Exceptions to the PPPA are sublingual nitroglycerin, contraceptives, patients in hospitals, among others see text on page 52

30. Medical Device Amendment of 1976 • Life saving medical devices were required to have premarket approval by the FDA • Example is a cardiac pacemaker and defibrillators • The Drug Listing Act of 1972 • Amendment to FDCA • Required all drugs to have an NDC code (cover later in the course)

31. The Pharmacy Technician’s Code of Ethics • Adopted by the American Association of Pharmacy Technicians and the National Pharmacy Technician Association. • American Association of Pharmacy technicians can be reached at 1-877-368-4771. or at pharmacytechnician.com • National Pharmacy Technician Association can be reached at 1-888-247-8700 or at pharmacytechnician.org