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. After a few months , The Articles of Confederation, was drafted among the 13 founding states that established the United States of America as a confederation of sovereign states and served as its first constitution . • 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 (Congresational) 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: (1) • Criminal law: involves a crime against an individual specifically and to society in general. 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

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 • Only a licensed prescriber can write for drugs for certain conditions. However, the distinction between OTC and Legend drug were not distinct.

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. Label elements required on a dispensed prescription. • Names of prescriber, patient, and pharmacy (and address) • Serial number of prescription • Original Date of fill • Expiration date or number of refills • 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.

7. 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 animals” • FDCA defines adulteration: “a product that is combined with an ingredient that reduces its potentyor quality” (3) • FDCA defines misbranding as “false and misleading labeling” (4) • Penalties for violations of the FDCA include restraining orders and seizures of above products

8. 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”. This act established the difference between OTC and legend drugs. • 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.

9. 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 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.

10. Thalidomide syndrome

11. 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 ErythemaNodosumLeprosum and in multiple myeloma.

12. 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.

13. Other lesser known pharmacy laws • 1914: Harrison Narcotic Act : The possession of narcotics and coca became illegal without a prescription. • 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.

14. 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). • Schedule II: prescriptions may be written for a one month supply with no refills; must be written an a triple prescription in most states. Examples include morphine, fentanyl, hydromorphone, Percocet®, Codeine tablets, Demerol® (mepiridine), Ritalin ® (methylphenidate), Adderall ® (mixed amphetamine salts) • Schedule III: prescription may be written for five refills to be used in a 6 month period. Includes Vicodin®, Lorcet ®, and Tylenol ®

15. Schedule drugs continued • Schedule IV: same requirement as CIII’s. Includes benzodiazepines and barbiturates. In NYS, benzodiazepines are CII agents. Examples of benzodiazepines are Ativan® (lorazepam), Valium® (diazepam), Xanax ® (alprazolam), Restoril ® (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.

16. 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.

17. 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.

18. 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.

19. 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 neccessity of going through extensive clinical testing. • Allowed the influx of cheap drugs in the US marketplace.

20. 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).

21. 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. • Created a need for pharmacy technicians to assist pharmacists in the technical aspect of pharmacy to allow them to devoted more time to the clinical aspects of pharmacy practice.

22. The Health Insurance Portability and Accountability Act of 1996 • Known as “HIPAA” • Requires that personal medication information be safeguarded by the healthcare industry. • Medical records need to be safeguarded electronically and more importantly established that consent must be given by the patient to transmit this data from healthcare practitioner to a third party. • Consent must be given to fill a prescription by the person for whom the prescription is written.

23. 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