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Download Lesson 3 Pharmacy Law - LaGuardia Community College Pharmacy
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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. 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. Family Law Penalties Misdemeanor is a crime punishable by a jail term of 1 year or less and/or a monetary fine Felony is a crime punishable by a jail term of greater than 1 year up to life or death. 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 FDA 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 drug Must include: established name of drug and quantity of each active ingredient. Statement of quantity Statement of usual dosage 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 Additional label elements added through later amendments National drug code FD&C yellow #5 (Tartazine) or yellow #6 if present (human allergens) If aspartame is present must declare phenylalanine and PKU warning If sulfites are present, must declare it If methysalicylate is present in concentration of over 5% must state toxicity warning Barcode label OTC label requirements Drug Manufacturer’s name and address Active ingredient(s) Inactive ingredients “Purposes” sections “Don’t use” section “Directions” “Questions” section provides an toll free number of questions These requirements were added through amendments to the FDCA over the years National Drug Code, NDC Labeling requirements by the FDCA Labeling 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 clinicians Description of the chemical nature of the drug including its generic name and chemical properties Pharmacology Indications for use Contraindications-situation where the drug should not be used Dose Warnings Side effect warnings Adverse reactions Drug Abuse potential, if applicable How drug is supplied Date 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 substances A product that is kept in unsanitary conditions A product that contains unapproved colorants Manufactured under conditions that are less than GMP’s Claims to be a drug of USP standards but is differing in quality FDCA defines misbranding as “false and misleading labeling” or dispensing or distributing a product in violation of its labeling Does not include the established name of the drug The name and/or address of the manufacturer is missing Failure to include Federal disclaimer or “Rx only” on legend drugs labels (see Durham Humphrey) or dispensing a legend drug without a prescription Sale of a drug under the name of another Failure to include “Warning –May be habit forming” if required on its label Products that are “dangerous to health when used in the dosage prescribed” In general, adulteration involves the composition of the drug products and misbranding involves misleading labeling Amendments to the FDCA Durham Humphrey Amendment of 1951 called the prescription drug amendment Established two classes of drugs: legend drugs that require a prescription and OTC with does not required that legend drugs must have the federal legend: “Caution: Federal law prohibits dispensing without a prescription”. Later in 1997, legend was shorten to “Rx only” Legend drugs not label with such are misbranded Allows prescribers to phone in Rx’s to pharmacies 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. Also called the “Drug efficacy amendment”. Drug needed to be safe and effective. Established marketing protocols for NDA’s GMPs for drug manufacturers 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 I to V. I having the highest potential for abuse and V the lowest. Established the Drug Enforcement Agency (DEA) under the US Dept of Justice 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, marijuana (weed), methaqualone (Luddes) “Crack” cocaine Crystal Methamphetamine Hashish Heroin Phencyclidine palmitate (PCP) (angel dust) Rohypnol (Roofies) Peyote Schedule II Drugs BRAND NAME GENERIC NAME Codeine ® Codeine Dolophine® Methadone Duragesic ® Fentanyl Astramorph, Duramorph ® Morphine Oxycontin ®, Roxicodone ® Oxycodone Adderall® Amphetamine/dextroamphetamine Amytal ® Amobarbital Cocaine 4% ® Cocaine Demerol ® Meperidine Percocet ® Oxycodone/Acetaminophen Dilaudid Hydromorphone Vicodin® Acetaminophen/Hydrocodone Schedule III Drugs BRAND NAME GENERIC NAME Bontril ® Phendimetrazine Soma® Carisoprodol Tylenol#3® Acetaminophen/Codeine Androgel® Testosterone gel Soma with Codeine® Carisoprolol/Codeine Schedule IV Drugs BRAND NAME GENERIC NAME Benzodiazepines (Ativan ®, Valium ®, Tranxene ®, Librium ®, Restoril®) Lorazepam, Diazepam, Chlorazepate, Chlordiazepoxide, Temazepam Fastin ® Phenermine Fioricet ® with Codeine Butalbital, APAP, Caffeine, Codeine Talwin ® Pentazocine Stadol ® Butorphanol Xanax ® Alprazolam Cylert ® Pemoline Schedule V Drugs BRAND NAME GENERIC NAME Acetaminophen/Codeine Elixir N/A Lomotil ® Diphenoxylate 2.5 mg/Atropine 0.025 mg Lyrica ® Pregabalin Phenergan with Codeine ® Promethazine with Codeine Exception to the CSA Drug Schedules Some drugs are typical narcotics but because they are combined with noxious drugs with more side effects they are de-scheduled from the CSA Additive are meant to discouraged abuse Examples Librax ® Donnatal ® (Chlordiazepoxide/Clidinium Bromide) (Phenobarbital, atropine, hyoscyamine, scopolamine) Remember Fiorinal ® (Butalbital/Caffeine/ASA) is a scheduled drug but Fioricet (Butalbital/Caffeine/APAP) is not Remember: BDZ are CIV federal, in NY they are CII Remember: Barbiturates are CIV except: Secobarbital (Seconal ®) and Amobarbital (Amytal ®) Schedule II Drugs- General Guidelines prescriptions may be written for a maximum of thirty day supply >>no refills. Have strong potential for abuse and have a medical purpose Must use DEA 222 to order Must use DEA 106 form to report loss or theft Can be written, or electronic Can’t be faxed Exception(s): for a terminal hospice patient in a Medicare XVIII certified hospice For a patient in a long term care facility For direct compounding into a parenteral dosage form Pharmacist must note this on fax copy Can’t be called in (except for: Emergency Verbal) Can’t be transferred between pharmacies Scheduled III & IV Drugs Prescriptions can be written, phone in, faxed, or sent electronically Can be filled for up to 5 refills within a 6 months whichever is first DEA 106 to report loss or theft Can be transferred to other pharmacy Schedule drugs continued Schedule V: includes cough preparation with codeine not more than 2 mg/ml. Can be phone in, written, faxed or electronically sent to a pharmacy Five refills within a 6 month period, whichever comes first DEA 106 is filed for theft or loss Can be filled with out a prescription only under the following conditions: Allowed by state law (NY does not do this) Sold by a pharmacist Log book must be kept with the following information: Name, address of patient Drug, quantity and price of the transaction Date purchased Signature of the pharmacist No more than 4 ounces or 24 solid dose forms in a 48 hour period to a single patient Patient must be 18 years old minimum 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. Drug name, dose, directions for use Quantity Refills (if not a CII) A pharmacist can’t alter the name of the patient, drug, dose, quantity and the prescriber’s signature. Under Federal law, other information can be altered with prescriber’s permission Fraudulent Prescriptions A huge problem in the United States Types of fake controlled substance prescriptions Stolen prescription blanks Altered quantity to obtain high amounts of drug Stolen prescription blanks with altered phone numbers Characteristics of a forged or manufactured prescription Prescription is “too neat” or too clean Quantities are higher than normal Directions written with no abbreviations Prescriptions issued for Illegitimate purposes Indicators Doctor may be running “prescription mills” A large number of people coming in with prescriptions from the same prescriber for the same drug in unusual doses Prescriptions seems scripted with the same directions just different patients Patients coming in that are not from the community Patients presenting prescriptions for other people (relatives) Patients returning for refills too early Security Requirements As per Federal Law, CII-CV drugs can be either locked up or dispersed. CII must be locked (key or combination) If CIII-CV are grouped together, they must be locked up in a cabinet If CIII-CV are not locked up, they must be scattered among the pharmacy’s entire inventory Record Keeping of Controlled Substances All invoices of controlled substances must be kept for two years DEA 222 must be attached to the corresponding invoice CII invoice must separate from other pharmacy invoices CIII-CV may be kept with other invoices but must have a red “C” stamped Biennial Inventory All scheduled controlled substances in house must be inventoried every two years Exact physically count of CII is required Estimated count of CIII-CV is ok if products are container s with less than 1,000 count Controlled Substance Prescriptions Maintained on file for 2 years Options for filing 1. Three files- CII, CIII-CV, other legend drugs 2. Two files- CII, CIII-CV + other drugs (CIII-CV must have red “C” in corner) All records must be made available to law enforcement while 72 hours To destroy controlled substances Must notify DEA office and state narcotic office (NYS DOH Bureau of Narcotic Enforcement) of Day and time of destruction DEA 41 is used to surrender drugs to the DEA directly or to destroy on premises. Retail pharmacy..only once a year. Institutions may have blanket authorization To report theft of controlled substances Notify local police Notify DEA office State narcotic office Fill out DEA 106 form To order CII drugs complete DEA 222 form To apply for a DEA registration DEA 224 DEA FORM 222 Required to order CII drugs from wholesalers Come in a triplicate form No alterations, erasures, changes permitted Can be used to transfer drugs between DEA registrants Must be keep for two years (even voided ones) Attached to invoice DEA numbers DEA numbers are issued by the US Dept of Justice to entities that prescriber, dispense, manufacturer, distribute or export scheduled controlled substances Contains 2 letters with a 7 digit number 1 st letter signifies the type of DEA registrant A/B/F are doctors, dentists, hospitals, clinics, pharmacies M are midlevel practitioners (PA, NP, etc) P/R are manufacturers, exporters, wholesalers, etc 2 nd letter is part of the entity’s name (most often the first initial of the last name) Six digits are the serial number Seventh digit is a checksum digit DEA Number To verify if a DEA number is valid perform the checksum algorithm First Add the 1st,3rd,5th digits together Second add 2nd,4th and 6th digits together and multiply by two Third add the results of the two together and if it match the check digit the DEA is valid. If not, the DEA number is fraudulent Penalties involving violations of the CSA of 1970 Simple Posession of Controlled Substances (21 USC 844) Drug or Class Fine Imprisonment C II –C V(First offense) Not less than $1,000 Up to 1 year C II- CV (Second Offense) Not less than $2,500 15 days to 2 Years Any Offense (Flunitrazepam $250,000 Upto 3 years Marihuana (possession of a small amount) Not Less than $1,000 Up to 1 year Penalties for Violations of CSA of 1970 Drug Trafficking (Possession with intent to distribute) 21 USC 841,960,962 Drug or Drug Class Amount Fine Imprisonment Heroin 1 kilo or more $10,000,000 or more 10 years to life Cocaine or Coca leaves, Ecgonine 5 kilos or more >=$10,000,000 10 years to life PCP (Phencyclidine) 100 grams or more >=$10,000,000 10 years to life LSD (lysergic acid Diethylamide) 10 grams or more >=$10,000,000 10 years to life Methamphetamine 50 grams or more >=$10,000,000 10 years to life Fentanyl 400 grams or more >=$10,000,000 10 years to life Drug or Class Amount Fine Imprisonment C III Any weight $500,000 or more Up to 15 years C IV Any weight $250,000 or more Up to 5 years CV Any weight $100,000 or more Up to 1 year 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. 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 . 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 also have failing organs in particular the liver. The Drug Price Competition and Patent Term Restoration Act of 1984 Result of a decade long dispute between generic drug manufacturers and brand drug manufacturers 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 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 years Also called the Hatch Waxman act Anabolic Steroid Control Act of 2004 Placed anabolic steroids in the CIII category. Hormones that are pharmacological similar to testosterone 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 programs Required states to establish prospective drug utilization review ProDUR, retrospective DUR and educational programs States require the pharmacist to perform a proDUR, prospective drug utilization review to screen for: Drug interactions Therapeutic duplicates Drug disease interactions Wrong dosing Abuse of medications (earlier refills) States require the pharmacist to offer counseling to the patient with regards to medications Omnibus Budget Reconciliation act of 1990 (OBRA 90) Key counseling points Use of the medication Description of the dosage and how it is to be administered Common severe side effects or adverse effects Self monitoring of side effects and what to do if they occur Proper storage What to do if dose is missed Act also requires that pharmacies maintain patient profiles to include Patient’s name, address, DOB and other demographics History of illnesses Patient profile to include subprofile for medications (Med profile) Medication profile to include all medications current and past, OTC and information on patient allergies The Health Insurance Portability and Accountability Act of 1996 Known as “HIPAA” Requires 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. 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. Requires pharmacy to appoint a HIPAA compliance officer The Health Insurance Portability and Accountability Act of 1996 In addition to the security requirement of HIPPA, there are other area effected by the law including: Portability of insurance coverage to those changing jobs Address the use of HSA’s (Health Savings Accounts) Rules to combat waste, fraud and misuse of medicare and medicaid and health care delivery Administration rule of the act established rules for the electronic health record and electronic transactions involving PHI 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. A prescriber can waive the requirement for one prescription for a single dose(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 52 Conditional Exceptions patients in hospitals For 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 children” Upon 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 vials Prescription Drug Marketing Act of 1987 Passed to stop the passage of counterfeit drugs into the marketplace and to stop unfair monetary gain from illegally procured drugs Made it illegal for retail pharmacies to have in its possession Rx drug samples from the manufacturer Prevents distribution of drug samples except to licensed prescribers Prevents the reimportation of drug into the US except by the drug manufacturer Requires that medications produced for animals have the following: “Federal Law restricts this drug to be used under the order of a licensed veterinarian” 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 NDC’s have three parts First set of five numbers-Manufacturer Second set of four numbers-drug product Third set of two numbers-package size Medicare Prescription Drug, Improvement, and Modernization act of 2003 Provides prescription drug coverage for medicare participants Provides for medication therapy management (MTM) where pharmacist can receive compensation for this Reduces medicare reimbursement for durable medical equipment Medicaid Tamper Resistant Prescription Act of 2007 Due to high federal cost of funding medicare and medicaid, the government mandated that doctors implement counterfeit proofing strategies of their prescription pads Does not apply if an Rx is faxed, phoned or electronically sent directly to the pharmacy Combat Methamphetamine epidemic act of 2005 Federal government placed the following drugs under the CSA of 1970 under the “scheduled listed chemicals” Ephedrine, pseudoephedrine , and phenylpropanolamine This chemicals have been used by “meth kitchens” to make methamphetamine Requires the removal of all products that contain these chemical from the OTC area Sales for products with these chemicals must be documented as follows: Logbook kept with name, address, date and time, drug and quantity Pharmacist signature Sale limits include: No more than 3.6 grams of drug per day to any one person No more than 9 grams of drug per 30 days to any one person Occupational Safety and Health Act of 1970 Created OSHA agency Addresses workplace safety from hazardous substances Addresses air quality, flammable and explosive chemicals, and hazardous drugs Requires a reporting system for job related injuries Requires 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 purchaser SDS provides users of such with data on Hazards, first aid measures if exposed, fire fighting methods, handling and storage, Physical and chemical properties, stability and reactivity There are a total of 16 sections to the SDS Pharmacy that handle hazardous substances must have a “spill kit” Kit has disposal bags, eye goggle, latex gloves, absorbable spill sponges Resource Conservation and Recovery Act of 1976 Known as the RCRA Established the EPA Established different classes of hazardous waste materials F listed K listed P listed (finished commercial drug products that are acutely toxic) Examples: Warfarin, arsenic trioxide, Nicotine, Epinephrine and Nitroglycerin U listed (finished commercial drug products that are subacutely toxic). Most chemotherapy drugs like Mitomycin, Chlorambucil, cyclophosphamide and some chemicals like lindane, phenol and mercury Most Pharmacies use a vendor that handles and disposes hazardous drugs for them in compliance with the RCRA FDA 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 only” Drug Addiction Treatment Act of 2000 Referred to as DATA2000 Before this law, only MDs licensed to prescribe methadone for opioid/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 provider With this law, MD’s can be licensed to prescribe Buprenorphine based products for office based treatment of addiction Suboxone (Buprenorphine/Naloxone) and Subutex ( (Buprenorphine) This MD have the DEA number of X+ 7 digits State Boards of Pharmacy SBOP makes most of the laws pertaining to the practice of pharmacy in a given state. Federal laws pertain to drugs that cross state borders (Interstate commerce clause of constitution) Most SBOPs in the US have the following mandates in their state: A licensed pharmacist is on duty whenever the pharmacy is open An alarm is operational when pharmacy is closed All pharmacies must have a Class A balance with metric weights All pharmacies must have a sink with hot/cold water Minimum amount of counterspace A safe for CII drugs Required references that all pharmacies must have: A copy of the CSA of 1970 A copy of the USP/NF United States Pharmacopeia USP was established during the 19th century and was later combined with the National Formulary into the USP/NF Provides standards for purity, quality and consistency to all manufacturer drug and OTC products USP/NF standards are used by drug manufacturers across the globe in the manufacture of drug products If a product is in compliance with the USP/NF standard it will state it on the label Lisinopril 10 mg tablet, USP
