Pharmacy Technicians Course. LaGuardia Community College

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 a jail term of 1 year or less and/or a monetary fineFelony is a crime punishable by a 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 drugsFDA is charged with protecting the public by enforcing FDCA

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 quantity Statement of usual dosageRoute 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)Additional label elements added through later amendmentsNational drug codeFD&C yellow #5 (Tartazine) or yellow #6 if present (human allergens)If aspartame is present must declare phenylalanine and PKU warningIf sulfites are present, must declare itIf methysalicylate is present in concentration of over 5% must state toxicity warningOTC label requirementsDrug Manufacturers name and addressActive ingredient(s)Inactive ingredientsPurposes sectionsDont use sectionDirectionsQuestions section provides an toll free number of questionsThese requirements were added through amendments to the FDCA over the years Labeling requirements by the FDCALabeling is the printed material that accompanies the medication container. This is called the Package Insert and is required by the FDA and is intended for use by healthcare cliniciansDescription of the chemical nature of the drug including its generic name and chemical propertiesPharmacologyIndications for useContraindications-situation where the drug should not be usedDoseWarningsSide effect warningsAdverse reactionsDrug Abuse potential, if applicableHow drug is suppliedDate of most recent revision to labeling

FDCA defines a drug FDCA defined a drug as: article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal FDCA defines adulteration as: A product that is combined with an ingredient that reduces its potency or quality, any putrid or decomposing substancesA product that is kept in unsanitary conditionsA product that contains unapproved colorantsManufactured under conditions that are less than GMPsClaims to be a drug of USP standards but is differing in qualitySee text for additional informationFDCA defines misbranding as false and misleading labeling or dispensing or distributing a product in violation of its labelingDoes not include the established name of the drugThe name and/or address of the manufacturer is missingFailure to include Federal disclaimer or Rx only on legend drugs labels (see Durham Humphrey) or dispensing a legend drug without a prescriptionSale of a drug under the name of anotherFailure to include Warning May be habit forming if required on its labelSee text for other provisionsIn general, adulteration involves the composition of the drug products and misbranding involves misleading labelingAmendments to the FDCADurham Humphrey Amendment of 1951 called the prescription drug amendmentEstablished two classes of drugs: legend drugs that require a prescription and OTC with does notrequired that legend drugs must have the federal legend: Caution: Federal law prohibits dispensing without a prescription. Later in 1997, legend was shorten to Rx onlyLegend drugs not label with such are misbrandedAllows prescribers to phone in Rxs to pharmaciesKefauver 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.Also called the Drug efficacy amendment. Drug needed to be safe and effective. Established marketing protocols for NDAsAlso regulate prescription drug advertisingThalidomide 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 it was used to treat morning sickness in 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 their husbands returning from WWII active duty in EuropeBirth 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 pharmacists for dispensing. Drug has approval from the FDA for use in Erythema Nodosum Leprosum and in multiple myeloma.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.Established the Drug Enforcement Agency (DEA) under the US Dept of JusticeStandards 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, marijuana (weed), methaqualone (Luddes)Crack cocaineCrystal MethamphetamineHashishHeroinPhencyclidine palmitate (PCP) (angel dust)Rohypnol (Roofies)Schedule II DrugsBRAND NAMEGENERIC NAMECodeine CodeineDolophineMethadoneDuragesic FentanylAstramorph, Duramorph MorphineOxycontin , Roxicodone OxycodoneAdderallAmphetamine/dextroamphetamineAmytal AmobarbitalCocaine 4% CocaineDemerol MeperidinePercocet Oxycodone/AcetaminophenDilaudidHydromorphoneSchedule III DrugsBRAND NAMEGENERIC NAMEBontril PhendimetrazineVicodin , Loricet , Anexsia Hydrocodone/APAPVicoprofenHydrocodone/ibuprofenTussionexHydrocodone/ChlorpheniramineSoma with CodeineCarisoprolol/CodeineSchedule IV DrugsBRAND NAMEGENERIC NAMEBenzodiazepines (Ativan , Valium , Tranxene , Librium , Restoril)Lorazepam, Diazepam, Chlorazepate, Chlordiazepoxide, TemazepamFastin PhenermineFioricet with CodeineButalbital, APAP, Caffeine, CodeineTalwin PentazocineStadol ButorphanolXanax AlprazolamCylert PemolineRobitussin AC Guaifensin and CodeineSchedule V DrugsBRAND NAMEGENERIC NAMEAcetaminophen/Codeine ElixirN/ALomotil Diphenoxylate 2.5 mg/Atropine 0.025 mgLyrica PregabalinPhenergan with Codeine Promethazine with CodeinException to the CSA Drug SchedulesSome drugs are typical narcotics but because they are combined with other less potent dugs with more side effects they are de-scheduled from the CSAAdditive are meant to discouraged abuseExamplesPyridium Plus (Butabarbital)Librax (Chlordiazepoxide/Clidinium Bromide)Donnatal (Phenobarbital, atropine, hyoscyamine, scopolamine)Anaspaz PB(Hyoscyamine/Phenobarbital)Remember Fiorinal (Butalbital/Caffeine/ASA) is a scheduled drug but Fioricet (Butalbital/Caffeine/APAP) is notRemember: BDZ are CIII federal, in NY they are CIIRemember: Barbiturates are CIV except: Secobarbital (Seconal ) and Amobarbital (Amytal )Schedule II Drugs- General Guidelinesprescriptions may be written for a one month supply maximum with no refills.Have strong potential for abuse and have a medical purposeMust use DEA 222 to orderMust use DEA 106 form to report loss or theftCan be written, or electronic Cant be faxed (ok in only limited circumstances)Cant be called in (exemption Emergency Verbal)Scheduled III & IV DrugsPrescriptions can be written, phone in, faxed, or sent electronicallyCan be filled for up to 5 refills or up to 6 monthsDEA 106 to report loss or theftCan be transferred to other pharmacySchedule drugs continuedSchedule 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.Can be phone in, written, faxed or electronically sent to a pharmacyDEA 106 is filed for theft or lossCan be filled with out a prescription only under the following conditions:Sold by a pharmacistLog book must be keepNo more than 4 ounces or 24 solid dose forms in a 48 hour period to a single patientOther 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.Drug name, dose, directions for useQuantityRefills (if any)A pharmacist cant alter the name of the patient, drug, or the prescribers signature. Under Federal law, other information can be altered with prescribers permissionSecurity RequirementsAs per Federal Law, prescriptions for CII-CV can be either locked up or dispersed.If CII are grouped together, they must be locked up in a cabinetIf CIII-CV are grouped together, they must be locked up in a cabinetIf controlled substances are not locked up, they must be scattered among the pharmacys entire inventoryEither group and Lock or Separate and scatterRecord Keeping of Controlled SubstancesAll invoices of controlled substances must be kept for two yearsDEA 222 must be attached to the corresponding invoiceCII invoice must separate from other pharmacy invoicesBiennial InventoryAll scheduled controlled substances in house must be inventoried every two yearsExact physically count of CII is requiredEstimated count of CIII-CV is ok if products are container s with less than 1,000 countControlled Substance PrescriptionsMaintained on file for 2 yearsOptions for filing1. Three files- CII, CIII-CV, other legend drugs2. Two files- CII, CIII-CV + other drugs (CIII-CV must have red C in corner)3. Two files- CII-CV and other legend drugs (CIII-CV must have red C in corner)To destroy controlled substancesMust notify DEA office and state narcotic office (NYS DOH Bureau of Narcotic Enforcement) of Day and time of destructionDEA 41 is used to surrender drugs to the DEA directlyTo report theft of controlled substancesNotify local police Notify DEA office State narcotic officeFill out DEA 106 formTo order c2 drugs completeDEA 222 formTo apply for a DEA registrationDEA 224DEA numbersDEA numbers are issued by the US Dept of Justice to entities that prescriber, dispense, manufacturer, distribute or export scheduled controlled substancesContains 2 letters with a 7 digit number1 st letter signifies the type of DEA registrantA/B/F are doctors, dentists, hospitals, clinics, pharmaciesM are midlevel practitioners (PA, NP, etc)P/R are manufacturers, exporters, wholesalers, etc2 nd letter is part of the entitys name (most often the first initial of the last name)Six digits are the serial numberSeventh digit is a checksum digitDEA NumberTo verify if a DEA number is valid perform the checksum algorithmFirst Add the 1st,3rd,5th digits togetherSecond add 2nd,4th and 6th digits together and multiply by twoThird add the results of the two together and if it match the check digit the DEA is valid. If not, the DEA number is fraudulentPenalties 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 committing 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 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.50% 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 1984Result of a decade long dispute between generic drug manufacturers and brand drug manufacturersAllowed 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 efficacy and safety testing.Did not sit well with large brand drug companies. To help these drug manufacturers recoup their costs the term of brand drug patents were extended by an additional five yearsCalled generic drug actAlso called the Hatch Waxman actAnabolic 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) 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 medicaid patients. This requirement later extended to all patients depending on the state of residency.Required the pharmacist to perform a DUR, drug utilization review to screen for:Drug interactionsTherapeutic duplicatesDrug disease interactionsWrong dosingAbuse of medications (earlier refills)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 protected health information (PHI)be safeguarded by the healthcare industry.Medical records need to be safeguarded electronically which may involve encryption coding and password protection.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.Portability refers to the ability to transfer insurance provision from one employer to anotherRequires pharmacy to appoint a HIPAA compliance officer

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.A prescriber can waive the requirement by only for one prescription at a time (no blanket authorization)Drug exceptions to the PPPA are sublingual nitroglycerin, oral contraceptives in the memory package dial, erythromycin ethylsuccinate tablets, Mebendazole Tablets, Pancrelipase preparations, among others see text on page 52Conditional Exceptionspatients in hospitalsFor OTC products with more than one strength, one strength can be marketed with out this package if the following is on the package: Not for households with young childrenUpon dispensing a refill, the pharmacist must used a new plastic vial and cap to refill the prescription due to the high wear and tear of Rx vialsPrescription Drug Marketing Act of 1987Passed to stop the passage of counterfeit drugs into the marketplace and to stop unfair monetary gain from illegally procured drugsMade it illegal for retail pharmacies to have in its possession Rx drug samples from the manufacturerHospital Pharmacies were not allowed to resale drug obtained through discounted pricing.Prevents the reimportation of drug into the US except by the drug manufacturerThink of it has the prescription drug samples actMedical 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 codeNDCs have three parts First set of five numbers-ManufacturerSecond set of four numbers-drug productThird set of two numbers-package sizeMedicare Prescription Drug, Improvement, and Modernization act of 2003Provides prescription drug coverage for medicare participantsProvides for medication therapy management (MTM) where pharmacist can receive compensation for thisAlso called the Medicare Modernization act (MMA)Medicaid Tamper Resistant Prescription Act of 2007Due to high federal cost of funding medicare and medicaid, the government mandated that doctors implement counterfeit proofing strategies of their prescription padsDoes not apply if an Rx is faxed, phoned or electronically sent directly to the pharmacyOnline Pharmacy Consumer Protection Act of 2007Also called the Ryan Haight ActRyan Haight was a 17 year old teen who died from an overdose of vicodin obtained from an internet based pharmacy. Ryan posed as a adult male with severe back painEstablished guidelines for online pharmaciesMust display compliance with this law on the sites homepageDefined that a Rx for a controlled substance must be for a legit medical reason AND involves at least one in person medical evaluationOccupational Safety and Health Act of 1970Created OSHA agencyAddresses workplace safety from hazardous substancesAddresses air quality, flammable and explosive chemicals, and hazardous drugsRequires a reporting system for job related injuriesRequires the use of SDS-Safety Data Sheets (also called MSDS M=Material)SDS are required to be distributed by manufacturers of hazardous chemicals or drugs to the purchaserSDS provides users of such with data on Hazards, fire aid measures of exposed, fire fighting methods, handling and storage, Physical and chemical properties, stability and reactivityResource Conservation and Recovery Act of 1976Known as the RCRAEstablished different classes of hazardous waste materialsF listed (industrial solvents)K listed (specific industrial wastes)P listed (finished commercial drug products that are acutely toxic) includes warfarin, nicotine, physostigmine, epinephrine (Adrenalin)U listed (finished commercial drug products that are subacutely toxic). Most chemotherapy drugsMost Pharmacies use a vendor that handles and disposes hazardous drugs for them in compliance with the RCRAFDA Modernization act of 1997 Changed the disclaimer of caution-Federal law prohibits dispensing without a prescription first established with the Durham Humphrey Act to simply Rx onlyDrug Addiction Treatment Act of 2000Referred to as DATA2000Before this law, only MDs licensed to prescribe methadone for opiate/Heroin addiction can write for methadone for this purpose and only in setting of a clinic licensed by the state and federal government as a detoxification maintenance providerWith this law, MDs can be licensed to prescribe Buprenorphine based products for office based treatment of addictionSuboxone (Buprenorphine) and Subutex (Buprenorphine/Naloxone)This MD have the DEA number of X+ 7 digits