US Pharmacy Law . American law preceded through many stages.
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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)
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.
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.
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.
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.
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 ®
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.
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.
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.
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.