Pharmacy Technicians Course. LaGuardia Community College

US Pharmacy Law American law preceded through many stages.On July 4th, 1776 the 13 colonies declared independence from Englands 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 cant be taken away called the bill of rights (i.e. freedom of speech, freedom of religion, and due process)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.

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 LawPenaltiesMisdemeanor is a crime punishable by jail term of 1 year or less and/or a monetary fineFelony is a crime punishable by jail term of greater than 1 year up to life or death.

Important Milestones in Pharmacy lawPure 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 drugsEstablished legend drugs and who may prescribed them

Label and Labeling requirements made by the FDCA.Labels are on the immediate container of the drugMust include: established name of drug and quantity of each active ingredient.Statement of new quantity Statement of usual dosageFederal legend (Durham Humphrey)Route of administrationIf habit forming, federal disclaimerName of all inactive ingredients if not for oral useName and address of manufacturer, packer or distributorLot number and expiration dateSpecific container to be used by the pharmacist to dispense medication (i.e. dispense in an amber vial for light sensitive drugs)Labeling requirements by the FDCADescription of the chemical nature of the drug including its generic namePharmacologyIndications for useContraindications-situation where the drug should not be usedDoseSide effect warningsAdverse reactionsDrug Abuse potential, if applicableHow drug is suppliedDate of most recent revision to labelingThe labeling is most often referred to as the package insert Label elements required on a dispensed prescription as per the FDCA.Names of prescriber, patient, and pharmacy (and address)Serial number of prescriptionOriginal Date of fillExpiration date (of the drug)Directions for useCautionary Statements (if needed)Curiously, no mention is made of the name of the drug or its dosage or the pharmacists or technicians name.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

Amendments to the FDCADurham 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.Thalidomide Scare of 1950s and 1960sFirst 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.

Thalidomide syndrome

Thalidomide TodayThalidomide 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.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.

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.The Comprehensive Drug Abuse Prevention and Control Act of 1970Established 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 :Morphinefentanyl HydromorphonePercocet 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 Schedule drugs continuedSchedule IV: same requirement as CIIIs. Examples: lorazepam Diazepamalprazolam temazepamSchedule 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.Other provision of the CSAAll 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 MDs, 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 writtenSignature 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. Controlled substances in NYStates, via their own laws, can make the CSA laws more strict, but cant 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.Penalties involving violations of the CSA of 1970Simple Posession of Controlled Substances (21 USC 844)Drug or ClassFineImprisonmentC II C V(First offense)Not less than $1,000Up to 1 yearC II- CV (Second Offense)Not less than $2,50015 days to 2 YearsAny Offense (Flunitrazepam$250,000Upto 3 yearsMarihuana (possession of a small amount)Not Less than $1,000Up to 1 yearPenalties for Violations of CSA of 1970Drug Trafficking (Possession with intent to distribute) 21 USC 841,960,962Drug or Drug ClassAmountFineImprisonmentHeroin1 kilo or more$10,000,000 or more10 years to lifeCocaine or Coca leaves, Ecgonine5 kilos or more>=$10,000,00010 years to lifePCP (Phencyclidine)100 grams or more>=$10,000,00010 years to lifeLSD (lysergic acid Diethylamide)10 grams or more>=$10,000,00010 years to lifeMethamphetamine50 grams or more>=$10,000,00010 years to lifeFentanyl400 grams or more>=$10,000,00010 years to lifeDrug or ClassAmountFineImprisonmentFlunitrazepam and GHB (see below)1 gram or moreGHB (any amount)$1,000,000Up to 20 yearsAny other C1 or CIIAny weight$1,000,000 or more Up to 20 yearsC IIIAny weight$500,000 or moreUp to 15 yearsC IVAny weight$250,000 or moreUp to 5 yearsCVAny weight$100,000 or moreUp to 1 yearThe 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 comiting sexual 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"

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 yearsAnyone 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 misdemeanorCriminal possession of prescription narcotics is still a felony in most cases in NYThe Orphan Drug Act of 1983Passed 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 exclusivity50% tax credit in the cost of conducting clinical trials.Research grantsWaive 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 Hurlers syndrome. People with Hurlers 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.

The Drug Price Competition and Patent Term Restoration Act of 1984Allowed 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.Anabolic Steroid Control Act of 1990Placed anabolic steroids in the CIII category.Hormones that are pharmacological similar to testosteroneResponded 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).Omnibus Budget Reconciliation act of 1990 (OBRA 90)Passed by congress to address the rising cost of the medicaid and medicare programsRequired 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.

The Health Insurance Portability and Accountability Act of 1996Known as HIPAARequires 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.Patients rights under HIPAA include:Access to their own health informationAbility to amended informationAbility to control to whom PHI is disclosedReceive written notification of how PHI may be used by the health provider also know as notice of privacy practicesWhen PHI is used by a provider for any reason other than treatment or payment, explicit authorization must be obtained from the patient.

Penalties for HIPAA violationsCivil Penalties: up to $25,000 fineCriminal 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 patients reputationAncillary LawsPoison Prevention Packaging Act of 1970Required childproof dispensing containers for all Rx drugsElderly people who desire non child resistant container must sign a waiver to such effect by the patients pharmacyExceptions to the PPPA are sublingual nitroglycerin, contraceptives, patients in hospitals, among others see text on page 52Medical Device Amendment of 1976Life saving medical devices were required to have premarket approval by the FDAExample is a cardiac pacemaker and defibrillatorsThe Drug Listing Act of 1972Amendment to FDCARequired all drugs to have an NDC code (cover later in the course)The Pharmacy Technicians Code of EthicsAdopted 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.comNational Pharmacy Technician Association can be reached at 1-888-247-8700 or at pharmacytechnician.org