Federal Requirements

  • DEA numbers

  DEA #s have 2 letters followed by 7 numbers

  

  1. The 1rst letter shows you the type of prescriber (A, B, F for MD; M for mid-level practitioners like FNP or PA)
  2. The 2nd letter should be the first letter of the doctor’s last name
  3. Add the 1st, 3rd, and 5th numbers
  4. Add the 2nd, 4th, and 6th numbers and multiply by 2
  5. Add the 2 sums of the numbers together
  6. The last digit in the total sum should match the last number in the DEA number

In order to prescribe schedule II-V drugs you need a DEA number

DEA number is required for all physicians prescribing medications

  • Schedules of controlled substances/refill allowances/transfer of prescriptions

  Schedule I (CI): high potential for abuse and are not accepted for medical purposes in the US. Ex: heroin

  Schedule II (CII): high potential for abuse but are accepted for medical purposes. Non-refillable without an MD order and must be locked up behind pharmacy counter. Ex: fentanyl

  Schedule III-V (CIII-CV): Less potential for abuse; may be refilled up to 5 times within 6 months of the date the prescription was first issued

  • Emergency or partial refill are acceptable for CIII-CV in certain circumstances
  • You can only transfer a prescription to another pharmacy once
    • Recall classifications

  Class 1: Products that could cause serious harm or prove \n fatal \n Class 2: Products found to cause a temporary health \n problem or pose a slight threat of serious harm \n Class 3: Products that may have a minor defect or other \n condition that would not harm the patient

  • 4 DEA forms

  DEA 222: purchasing and returning of outdated CII drugs

  DEA 41: the destruction of, or return of damaged controlled substances

  DEA 224: for a pharmacy to dispense controlled substances

  DEA 225: manufacture or distribute controlled substances

Top 10 Federal Laws

  1. 1906 Pure Food and Drug Act - Enacted to stop the sale of inaccurately labeled \n drugs/Manufacturers were required to: Provide truthful information on the label before a drug was sold and to prove the drug’s effectiveness
  2. 1938 Food, Drug, and Cosmetic Act - Added Cosmetics to the Food and Drug Act/Required drug companies to include directions to the consumer regarding use of a drug, and required package inserts/All addictive substances had to be labeled: “Warning: May be habit forming”
  3. 1951 Durham Humphrey Amendment - Distinguishes legend (prescription) drugs from OTC drugs/Requires: “Caution: Federal law prohibits dispensing without a prescription”
  4. 1962 Kefauver-Harris Amendment - For safety and effectiveness of all new drugs on the market/ Burden put on manufacturers to ensure “good manufacturing practice”(GMP)
  5. 1970 Comprehensive Drug Abuse Prevention and Control Act - The DEA was created and controlled substances placed into Schedules I-V based on abuse potential
  6. 1970 Poison Prevention Packaging Act - Requires Childproof packaging on drugs except drugs used in emergency situations such as sublingual nitroglycerin
  7. 1990 Omnibus Budget Reconciliation Act (OBRA) - Requires pharmacist to attempt or offer to counsel patients with Medicare or Medicaid on all new prescriptions, at time of purchase (elderly mostly affected)
  8. 1996 HIPAA - rules and regulations regarding the privacy and security of patient health information
  9. 2000 Drug Addiction Treatment Act - Physicians can prescribe controlled substances to persons suffering from opioid addiction
    1. 2006 Combat Methamphetamine Epidemic Act - Limits the purchase of pseudoephedrine. Only a licensed pharmacist or technician may dispense, sell, or distribute this drug and it is limited to 3.6 g per calendar day, 9g per 30 days from a retailer, 7.5 g per 30 days by mail order

Top 10 Pharmacy Reference Books

  1. Drug Facts and Comparison \n ◦ quick, accurate reference of drug facts and drug comparison \n ◦ •Most up-to-date reference available \n ◦ •Each drug listing in the F&C includes the following information: Indications, dosage strengths, dosage forms, sizes, and manufacturers
  2. Physician Desk Reference (PDR) \n ◦ Found in all prescribers’ offices and pharmacies \n ◦ Updated annually \n ◦ Provides a complete description of the drug, including its chemical structure and study results \n ◦ Only FDA-approved drugs \n ◦ •D manufacturer contact information, such as addresses and phone numbers
  3. Red Book \n ◦ Drug costs \n ◦ Retail setting \n ◦Includes tables showing pharmacy calculations and dosing instructions translated into Spanish
  4. Orange Book \n ◦ Lists all FDA-approved drug products with therapeutic equivalence \n ◦ Also includes discontinued drug products, orphan product designations, approvals list \n ◦ Updated annually
  5. United States Pharmacopoeia- National \n Formulary (USP-NF) \n ◦ Presents the official standards of the FDA \n ◦ Serves as a guide to the specifications that are required for \n pharmaceutical manufacturing and quality control (ex. tests, \n procedures, acceptance criteria)
  6. United States Pharmacopoeia (USP) \n ◦ Comprehensive source of information on compounding products, ingredients, their \n safety, and products used to treat specific medical conditions \n ◦ •Also includes most recent sterile preparation guidelines for USP
  7. American Hospital Formulary Service Drug Information \n ◦ Hospital setting; provides drug monographs that provide \n detailed information (ex. on-and off-label uses, specific dosage \n information, mechanism of action) except cost \n ◦ List of approved drugs stocked by a pharmacy (also a list \n of drugs covered by an insurance company)
  8. Ident-A-Drug \n ◦ Tablet and capsule identifications \n ◦ More than 7000 listings \n ◦ Listed by identifiable codes, shapes, and whether the tablet is scored
  9. Micromedex \n ◦ Online and mobile application that can be used by physicians, pharmacists and \n nurses \n ◦ Information is provided through several different software programs that can be \n purchased, including: comprehensive drug details: DRUGDEX \n ◦ FDA-approved drugs: PDR compilation of package inserts
    1. Trissel’s Handbook on Injectable Drugs \n ◦ Mostly used in the hospital setting \n ◦ Provides information on the compatibility of various agents given parenterally \n ◦ Monographs discuss products, administration, stability, and compatibility with infusion \n solutions and other drugs

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