Ultimate Texas MPJE 2022

Only pharmacies allowed to work with drug samples - ANSWER Pharmacy owned by charitable organization or government serving indigent population; Class D Three constituents of data required to be provided by manufacture ...

Only pharmacies allowed to work with drug samples - ANSWER Pharmacy owned by charitable organization or government serving indigent population; Class D Three constituents of data required to be provided by manufacturer for each product sold - ANSWER Transaction information, history, and statement Transaction Information - ANSWER Drug name strength dose and NDC, container size and count, transaction date, name and address of seller and buyer Transaction history - ANSWER Prior transaction information for each prior transaction Transaction Statement - ANSWER State's seller is authorized for transaction, information and history were provided and are correct, and product is legitimate and has processes to comply with verification requirements, previous seller was legitimate and provided true information Exceptions to distributing without a license - ANSWER Distributing between common ownership, patient specific basis, emergency medical reasons, or minimal quantities to a practitioner for office use Adulteration - ANSWER Actual contents of product is below standard or is unsafe 1. has filthy, putrid, decomposed substance 2. prepared or held under unsanitary conditions 3. do not conform with current GMP 4. manufactured, processed, packaged, or held in any factory, warehouse, or establishment and the owner/operator/agent of such factory delays, denies, limits inspection, or refuses to permit entry or inspection 5. poisonous or deleterious substance 6. unsafe color additive 7. strength differs from or its quality/purity falls below the compendium standard 8. it is not in compendium, and its strength differs from or its quality falls below what it represents 9. mixed or packed with any substance which reduces its strength/quality or the drug has been substituted in whole or in part Misbranding - ANSWER 1. labeling that is misleading or missing required information 2. prescription drug and manufacturer's label is missing any of the following: - name, address of manufacturer, packer or distributor - brand/generic of drug - net quantity (weight, qty, dosage unit) - weight of active ingredient per dosage unit - "Rx only" - if not taken orally, the specific routes of adm - special storage instructions if appropriate - manufacturer lot # - expiration date - adequate info for use 3. OTC drug and it fails to contain its label requirements 4. drug liable to deterioration unless packaged/labeled accordingly 5. container made, formed, filled as to be misleading 6. drug is *exact imitation of another drug*, or offered for sale under name of another drug 7. dangerous to health when used in the dosage or manner suggested in the labeling 8. packaged or labeled in violation of PPPA Examples of misbranding - ANSWER Dispensing a Rx w/o authorization (even if it labeled correctly by RPh) Misfilling a Rx with wrong drug, strength, or directions for use Drug that is NOT packaged in a child-resistant container Examples of both misbranding & adulteration - ANSWER If product strength is less than what is represented on the label Misfilled Rx with wrong strength of the drug prescribed Requirements for manufacturer's label - ANSWER 1. Manufacturer info - name, address, lot/control number 2. Drug info - name, net quantity, weight of active ingredient, route if other than oral, storage instruction, expiration 3. Federal legend "*Rx Only*" 4. Package inserts Requirements for OTC drug label - ANSWER Principal display panel, including statement of identity of product Manufacturer name and address Net qty of contents Cautions and Warnings Adequate *directions* for use "Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other info, inactive ingredients, questions followed by phone # Special warning requirement ingredients - ANSWER Yellow #5/6, aspartame, sulfites, mineral oil, wintergreen oil, sodium phosphates (90 mL max), isopreterenol, potassium salts, ipecac syrup, phenacetine, salicylates (max 36 tabs of 81mg), alcohol for analgesics/antipyretics, APAP, NSAIDs FDA Class I Recall - ANSWER Serious ADE or death possible the most serious FDA recall FDA Class II Recall - ANSWER Temporary/reversible ADE or serious ADE remote FDA Class III Recall - ANSWER Not likely to cause ADE When are package inserts required for institutionalized/hospitalized patients? - ANSWER *Prior to first administration* and *every 30 days* for OC, estrogen, and progesterone products. Misbranded without insert. Patient package inserts are required for which drugs? - ANSWER oral contraceptives; estrogen-containing products Misbranded without insert iPLEDGE requirements - ANSWER Doctor, pharmacy, and patient are registered, negative pregnancy test, contraceptive use and pregnancy testing, dispensed as blister packs of no more than 30 day supply, no refills Requirements to be considered compounding vs manufacturing - ANSWER Patient specific, done by pharmacist or physician, USP compliance, manufacturer of drug is registered and has certificate of analysis, excipients comply with USP/NF monograph, not a replica of an existing product, drug not withdrawn from market due to safety, no statement from FDA stating difficulty for compounding demonstrating an ADE, 5% rule FDA Orange book - ANSWER Generic equivalency book official name: Approved Drug Products with Therapeutic Equivalence Evaluations A# are drug products the FDA considers to be _______ equivalent and _______ equivalent - ANSWER pharmaceutical and therapeutically B# are drug products the FDA considers to ____ be _______ equivalent and _______ equivalent - ANSWER NOT, pharmaceutical, therapeutically What does "AB" stand for (Orange Book)? - ANSWER Actual or potential bioeq issues but enough evidence to show bioeq - APPROVED for substitution Other ratings from Orange Book - ANSWER AA = equivalent, conventional dosage forms AN = equivalent, sol'n & powders for aerosolization AO = equivalent, injectable OIL sol'n AP = equivalent, injectable aqueous sol'n AT = equivalent, TOPICAL products FDA Purple book - ANSWER Biologic interchangablity book official name: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations In Texas, which products may be substituted? - ANSWER generically equivalent or interchangeable products What does it mean to be biosimilar? - ANSWER Highly similar, no clinically meaningful differences (does NOT mean they can be interchanged though) Requirements for a biologic to be considered interchangeable? - ANSWER Shown to be biosimilar and can be expected to produce the same clinical result Does biosimilar mean that it's interchangeable? - ANSWER No Poison Prevention Packaging Act (PPPA) of 1970 - ANSWER Regulated by Consumer Product Safety Commission Requires child-resistant containers for all prescriptions and certain OTC drugs Which OTC medications requires child safety caps under PPPA? - ANSWER Ketoprofen Ibuprofen Loperamide Lidocaine Methyl alcohol Aspirin Diphenhydramine APAP Minoxidil Wintergreen oil (methyl salicylate) Iron Naproxen Dibucaine Fluoride Imidazolines (oxymetazoline, naphazoline, tetrahydrozoline, xylometazoline) Controlled drugs Any drug ∆ Rx --> OTC PPPA exemption request from patient/prescriber - ANSWER Only patient can provide blanket request for all future prescriptions. Provider can only request for single prescription PPPA exemptions (know all strength and dosage forms) - ANSWER Bulk containers, drugs distribution to institutionalized patients, OC/estrogens/northindrone in manufacturers package, medroxyprogesterone tablets, nitroglycerin SL, isosorbide chewable up to 10mg, ASA/APAP effervescents, Unit dose potassium supplements, sodium fluoride up to 264mg, anhydrous chloestyramine/colestipol packets, erythromycin granules for PO suspension, erythromycin suspension up to 8g, erythromycin tablets up to 16g, prednisone tabs up to 105mg, methylprednisolone tabs up to 84mg, mebendazole tabs up to 600mg, betamethasone tabs up to 12.6mg, inhalants, pancrelipase, sucrose in glycerol and water What is Federal Hazardous Communications Standard and who enforces it? - ANSWER Protect employees from hazardous materials Manufacturers need to classify hazards of chemicals and have Safety Data Sheets for each Requires pharmacies to have a written Hazard Communication Plan OSHA What is Federal Hazardous Substances Act (1966) and who enforces it? - ANSWER Requires labeling of hazardous materials including name/address of manufacturer, common/chemical name of each ingredient, type of danger, "Keep out of reach of children", handling and storage instructions, (how to protect, first aid, language informing of burn risk) Consumer Product Safety Commission administers & enforces it - protect consumers from hazardous and toxic substances note: does not apply to drugs Which substances are exempt from Federal Hazard Communication Standard? - ANSWER Drugs in solid, final dosage form for admin How often does CMS require a pharmacist to perform Medication Regimen Review in LTCF? - ANSWER Every 30 days; pharmacist reports to 3 ppl (Attending physician, Director of Nursing, Medical Director) PRN orders of psychotropic drugs for LTCF patients (CMS limit) - ANSWER 14 days, unless doctor documents rationale for longer Alcohol and Tobacco Tax Trade Bureau (TTB) - ANSWER Issues permits for tax free alcohol for pharmacies that use 95% ethanol for compounding Who enforces the Tax Free Alcohol Regulations? - ANSWER Alcohol, Tobacco, Firearms, and Explosives (ATF) Tobacco Tax and Trade Bureau (TTB) ________ tax free alcohol for pharmacies - ANSWER regulates Requirement for 95% ethanol to be considered "tax free"? - ANSWER When used for scientific, medicinal or mechanical purposes HIPAA requirement for new patients - ANSWER Obtain written acknowledgement of receipt of Notice of Privacy Practices Allowed PHI disclosures - ANSWER Providing treatment, receiving payment, health care operations, government functions including FAERs, reporting to TSBP, reporting drug monitoring programs, ADE reporting, law enforcement Marketing purposes must have signed authorization from patient Are Incidental / Unintended Disclosures of PHI a violation of the Privacy Rule? - ANSWER No Time limit to respond to patient's PHI request - ANSWER DEA: Must respond within 30 days, may extend by no more than 30 additional days TX: 15 days Time limit for patient request to amend PHI - ANSWER 60 days, may extend by no more than 30 additional days HIPAA's required pharmacy personnel - ANSWER Privacy Official and contact person for complaints Under HITECH Act, time limit to notify individuals of PHI breach - ANSWER 60 days after discovering Requirement for PHI breach of <500 individuals - ANSWER maintain log of breaches and notify HHS *annually* Requirement for PHI breach of >500 individuals - ANSWER Report to HHS and local media within 60 days C-I list - ANSWER HIGH potential for abuse and SEVERE potential for dependence. Opiate derivatives (heroin, dihydromorphine), marijuana, LSD, peyote, mescaline, methaqualone C-II list - ANSWER HIGH potential for abuse which may lead to SEVERE dependence. Narcotics, cocaine, stimulants, amobarbital, secobarbital, pentobarbital C-III list - ANSWER LOWER potential for abuse than CII and may lead to MODERATE or LOW physical dependence or HIGH psychological dependence. Anabolic steroids, ketamine, C-II barbituate suppositories, buprenorphine, codeine up to 90mg/dose, opium combo up to 25mg/dose C-IV list - ANSWER BZDs, carisoprodol, modafinil, phentermine, phenobarbital, tramadol C-V list - ANSWER Codeine up to 200mg/100ml, opium less than 50mg/100ml, pregabalin, lacosamide US Attorney General - ANSWER Head of Department of Justice (DOJ) Federal level: Able to reschedule substances; Must obtain FDA scientific and medical recommendations Commissioner of the Texas Department of State Health Services - ANSWER State level: able to reschedule substances Cannot override actions by the legislature DEA 224 - ANSWER Registration for dispensing controlled substances (i.e: pharmacies) DEA 224a - ANSWER Renewal of registration for dispensing CS (i.e: pharmacies) Distributing - ANSWER No RX - Just selling drugs Dispensing - ANSWER RX is needed and it's for a specific person Verifying a DEA # - ANSWER Start with A,B,F,G,M - G: Dept of Defense contractors - M: mid-level practitioners Second letter is first letter of last name (or pharmacy/hospital name) Step 1: Add 1st, 3rd, and 5th digit Step 2: Add 2nd, 4th, and 6th digit, multiply by 2 Step 3: Add step 1 and 2 Last digit of sum will be last digit of DEA number Mid-level practitioners - ANSWER APRN, PA, Ambulance Services, Animal Shelters, Veterinary Euthanasia Technicians Time limit to obtain DEA permit upon sale of pharmacy - ANSWER Previous owner can let pharmacy float on their DEA # for 45 days Concentration limit for compounded narcotics - ANSWER 20%, with non-narcotic therapeutic ingredient What pharmacists need for immunization status - ANSWER 20 hours CDC training Basic Cardiac Life Support Certification 3 hrs CE *Q2 years* related to vaccinations After administering vaccine on protocol - ANSWER Notify protocol physician within 24 hours Notify PCP within 14 days Requirements for pharmacists who participate in drug therapy management (DTM; clinical pharmacists) - ANSWER Notify TSBP prior to engaging in DTM 6 hrs of CE *annually* related to drug therapy Inventories must include expired drugs (true/false) - ANSWER True Concentration limits for codeine - ANSWER C-V: 200mg/100ml C-III: 1.8g/100mL or 90mg/dosage unit note: compounded narcotic Rx will never be C-IV Concentration limits for opium - ANSWER Federal C-V: 100 mg/mL Texas C-V: 50mg/100mL C-III: 500mg/100mL or 25mg/dosage unit note: compounded narcotic Rx will never be C-IV Any straight narcotic, regardless of concentration, will always be - ANSWER C2 DEA 222 - ANSWER Ordering/transferring C2 Purchaser submits copy 1 & 2 goes to supplier Purchaser keeps copy 3 Supplier records number of containers supplied/date shipped to purchaser on Copies 1