Texas Pharmacy Law Exam Q&A Verified A+

Texas Pharmacy Law Exam Q&A Verified A+ Pure Food and Drug Act 1906 - -Purity Standards (Misbranded, Adulterated) Food, Drug, and Cosmetic Act (1938) - -Created FDA -Required drug to be SAFE when used according to labeled direction Durham-Humphrey Amendment (1951) - -Created OTC and RX distinction: Manufacturers of prescription drugs must provide a warning on the label stating, "Federal law prohibits dispensing without a prescription" -Allowed the authorization of oral prescriptions and refilling Kefauver-Harris Amendment (1962) - -Requires "PROOF-OF-EFFICACY" (passed in response to thalidomide) -Provides the authority to the FDA to regulate prescription drug advertisements, must disclose SE (Note that the FTC regulates OTC advertising, not the FDA) -Provides good manufacturing practices (GMP) guidelines for drug manufacturers Medical Device Act (1976) - -Passed to protect public from dangerous and useless devices -Sets GMP standard manufacturing for medical devices Orphan Drug Act (1983) - -Extended patent life of drugs to treat rare disorders in order to encourage pharmaceutical companies to develop drugs for diseases that have a small market Hatch-Waxman Act (1984) - -A.K.A. Drug Price Competition and Patent Restoration Act -ANDA: Abbreviated new drug application for generic drugs, generic manufacturing drug companies only have to show bioequivalence, no duplicate clinical testing -Increases the patanet term for newly dveloped drugs. Encourages innovation Prescription Drug Marketing Act (Dingle Bill Act of 1987) - -Requires states to license wholesale distributors under federal guidelines -Provides a minimum standard for prescription drug storage, handling, and record keeping -Bans re-importation of prescription drugs produced in the US -Bans sale, trade, or purchase of drug samples -Mandates storage, handling, and recordkeeping requirements for drug samples -Prohibits the resale of prescription drugs purchased by hospitals or healthcare facilities (certain exceptions) Omnibus Reconciliation Act of 1990 (OBRA-90) - -Prospective Drug Utilization Review -Patient Counseling Standards: Dispensing pharmacist must offer counseling (In Texas required to counsel, not just offer, must document later) FDA Modernization Act (1997) - -Replaced the prescription legend "Caution: Federal law prohibits dispensing without a prescription" with "Rx Only". -Clarified when a pharmacist may compound prescription drugs FDA Rule: OTC Labeling Requirments (1999) - -Standard, easy to read format making it easier for self-administration easier and safer Define an "Adulterated" drug - -"It's dirty" -Contaminated, filthy, putrid, decomposed -The manufacturing does not comply with GMP -Unsafe color additive -Labeled as "USP" but is not -Strength differs from what the label says -If it is mixed or packed with any substance with reduces its strength or quality or the drug has been substituted wholly or in part Define a "Misbranded" drug - -"It's a lie" -Label is false or misleading -The manufacture does not include one of the following: 1) Name and address of the manufacturer, packer or distributor 2) Quantity 3) Name of the drug 4) Strength per dosage unit 5) Adequate directions for use 6) The Federal legend: either "Caution: Federal law prohibits dispensing without a prescription" or "Rx Only" 7) Storage directions 8) Expiration date -A pharmacist dispenses a prescription without authorization of the practitioner -If it is an imitation of another drug or offered for sale under the name of another drug -If it violates the Poison Prevention Act it is misbranded -OTC products must include the following or it is misbranded: (monitored by FTC) 1) A principal display panel including a statement of identity of the product 2) The name and address of the manufacturer, packer or distributor 3) Net quantity of the contents 4) Cautions and warnings needed to protect the user 5) Adequate directions for safe and effective use for a layperson 6) "Drug facts" panel What must be included on an OTC "Drug facts" panel? - -Active ingredients -Purpose -Use or indication -Warnings -Directions -Other information -Inactive ingredients Describe a Class I drug recall - Generally issued when the drug is believed to cause serious adverse health problems including death Describe a Class II drug recall - Issued when the drug causes temporary or reversible medical consequences and adverse reactions Describe a Class III drug recall - Issued when the drug is not likely to cause any health problems Which government entity regulates prescription drug advertising? - FDA What information does the FDA require all "Direct to consumer" advertising to contain? - -Accurate and not misleading -Make claims only when supported by substantial evidence -Reflect the balance between risks and benefits -Be consistent with the FDA approved labeling Which government entity regulates OTC advertising? - FTC A "Med guide" written in lay language that includes an explanation of how to safely use a drug must be provided or the prescription is considered....? - Misbranded When may the FDA require a Medguide - -It could prevent serous adverse effects -The drug has serious risks that could influence patients' decision to use it -Patient adherence to directions is crucial Describe the different parts of the NDC - The NDC is a 10 or 11 digit code divided into 3 segements 1) Labeler code--first 4 to 5 digits 2) Drug product code--middle 4 digits 3) Pack size code--last 2 digits Describe pregnancy category A - Adequate and well controlled studies have failed to demonstrated a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters) Describe pregnancy category B - Animal or reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate risk to the fetus in any trimester Describe pregnancy category C - Animal reproductions studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks Describe pregnancy category D - There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks Describe pregnancy category X - Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits Poison Prevention Packaging Act - -Requires child-resistant containers for prescription and non-prescription drugs -The physician or the patient may request non-child resistant containers (the PATIENT may sign a blanket waiver to child resistant caps) -Manufacturers of OTC products may designate ONE size to be easy open for the elderly What does the acronym "HIPPAA" mean? - Health Insurance Portability and Accountability Act With regard to HIPPAA, PHI is information relating to what? - A patient's health status, health care, or payment for patient's health care With regard to HIPPAA, what are the 2 stipulations that go along with the requirement that providers must obtain the patient's consent prior to disclosing PHI for treatment, payment, or health care operations? - Consent must be signed by the patient, and record of consent must be kept on file for 6 years Under HIPPAA, a healthcare provider may not disclose medication records or the history of patients without prior approval of the patient. What is the only exception? - The only exception under the law is when the patient is a minor According to the Combat Methamphetamine Epidemic Act (PSE act), the seller must keep a written or electronic logbook of sales that identifies what? - Products sold by name, quantity, name and address of purchaser, and date & time of sale According to the Combat Methamphetamine Epidemic Act, the purchaser must provide what? What is the responsibility of the seller? - A government issued photo identification. The seller must be "self-certified" before selling these products According to the Combat Methamphetamine Epidemic Act, the purchaser is limited to what? - 2 packages, 3.6 grams/day, 9 grams/30 days According to the Combat Methamphetamine Epidemic Act, the logbook of sales must be kept for how long? - 2 years According to the Combat Methamphetamine Epidemic Act, what is the the age requirement for PSE products - 16 years old Define a Schedule I controlled substance - No current accepted medical use in the USA Define a Schedule II controlled substance - -High potential for abuse which may lead to severe physical or psychological dependence -Accepted medical use with severe restrictions -Requires use of Official Prescription Form Pure forms of codeine and hydrocodone are what Schedule? - Schedule II When mixed with other non-narcotic agents, which drugs may be classified as Schedule III, so long as they do not maximum allowable limits? - Codeine, Dihydrocodeine, Morphine, Opium, Ethymorphine, and Hydrocodone What are the maxim allowable limits for Codeine to be classified as a Schedule III? - Max concentration: 1.8gm/100ml Max dosage per unit: 90mg What are the maximum allowable limits for Dihydrocodeine to be classified as a Schedule III? - Max concentration: 1.8gm/100ml Max dosage per unit: 90mg What is the maximum allowable limit for Morphine to be classified as Schedule III? - Max concentration: 50mg/100ml What are the maximum allowable limits for Opium to be classified as Schedule III? - Max concentration: 500mg/100ml Max dosage per unit: 25mg What are the maximum allowable limits for Ethylmorphine to be classified as Schedule III? - Max concentration: 300mg/100ml Max dosage per unit: 15mg What are the maximum allowable limits for Hyrdocodone to be classified as Schedule III? - Max concentration: 300mg/100ml Max dosage per unit: 15mg Define a Schedule IV drug - Low potential for abuse (Examples: alprazolam, diazepam, phenobarbital, and phentermine) What is the maximum allowable limit for Codeine to be classified as a Schedule V drug? - Max concentration: 200mg/100ml What is the maximum allowable limit for Dihydrocodeine to be classified as a Schedule V drug? - Max concentration: 100mg/100ml