Law Exam 345 PDF

The ________ broadened the Medwatch reporting to include patient reporting. - FDAAA of 2007 What are some programs that address medication safety? - - MedWatch - REMS - Postmarket labeling - drug safety information website - sentinel initiative (means primarily important?) _______ is a proactive sur...

The ________ broadened the Medwatch reporting to include patient reporting. - FDAAA of 2007 What are some programs that address medication safety? - - MedWatch - REMS - Postmarket labeling - drug safety information website - sentinel initiative (means primarily important?) _______ is a proactive surveillance system designed to detect early signs of medication risk and safety problems. - Sentinel Initiative what are some examples of the restricted distribution programs? - - Thalomid REMS - iPledge program for Isotretinoin - Clozapine REMS What is the most serious classification of drug recalls? - Class I _______ product recalls mean that there is reasonable probability that the product will cause serious adverse health consequences or death. - Class I _____ product recalls mean that the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse health consequences is remote. - Class II ______ product recalls mean that the product is not likely to cause adverse health consequences (EX: mislabeling). - Class III Why do product recalls exist? - means for reming adulterated or misbranded drug products from the market Who is responsible for notifying sellers of drug recalls? - manufacturer What 3 things are classified as labeling, but are not printed directly on the outside of the product? - 1. package insert 2. Patient package insert 3. medgluide The _____ must be approved by the FDA before distribution. - Package insert Describe the Pregnancy and Lactation Labeling (drugs) final rule (PLLR) - 8.1 Pregnancy (includes labor and delivery) 8.2 Lactation (includes nursing mothers) 8.3 Females and males of reproductive potential (NEW) Any time that a drug is prescribed for an indication that is not FDA approved and thus not listed in the drugs labeling, that use is considered ______. - Off- Label What is an example of a potentially dangerous drug that must be dispensed with a patient package insert (PPI)? - oral contraceptives _____ must be provided to the patient by anyone dispensing potentially dangerous drugs, and failure to do so is considered ______. - - PPI's - misbranding t/f manufacturers must include a ppi for each package that it intends will be distributed to the patient and in turn pharmacists must include a ppi with each container dispensed regardless of wheter it is initally dispensed or refilled - true PPI for products dispensed in acute care hospitals or long term care facilities are considered to have been provided if given to the patient - -before first admin AND -every 30 days after In 1998, the FDA mandated the _______ program for drugs posing a "serious and significant concern." - Medication guide (MedGuide) MedGuides are required for a product if the FDA determines that one or more of what circumstances exist? - - labeling could prevent serious AE's - serious risk relative to benefits that pt should be aware of to decide risk vs benefit of using drug - pt adherence to directions is critical to drugs effectiveness True/False Failure to provide MedGuide or PPI to patient is considered misbranding. - True _______ and _______ are federally mandated (for certain drugs) and are considered labeling, therefore they require FDA approval before dissemination. - PPI's and MedGuides failing to provide PPIs and medguides is considered what - misbranding _______ is the written information provided by the pharmacy for all drugs. - Useful written consumer medication information (CMI) _______ does NOT replace the PPI or Medguide, it is NOT federally mandated, and does not require FDA approval before distribution. - Consumer medication information (CMI) federal law requires that the following info appear on manufactures containers of prescirption drug products - -name/adrdress of manufacturer, packager, distributor -name of drug (GENERIC) BRAND NAME NOT REQUIRED -net quantity in pack -weight of each active ingredient in each dose -rx only -route of admin if not an oral dose unit -special storage instructions if appropriate -manufacturers control or lot number -expiration date established by the manufacturer unit dose packaging and labeling requirements - 1. generic name of drug 2. quantity of active ingredient 3. expiration date 4. lot or control number 5. name of manufacturer, packer, or distributer 6. special characteristics Does the FDA require the hospital to use the bar codes on pharmaceutical products? no The FDA requires that the pharmaceutical product bar code includes _____. - Drugs NDC Who administered the Poison Prevention Packaging Act (PPPA)? - Consumer product Safety Commission (CPSC) _______ requires the use of child- resistant containers for nearly all prescription drugs, nonprescription drugs, and hazardous household products. - Poison Prevention and Packaging Act (PPPA) a package will fail the child resistant test if more than ______% of the children test panel can open the package in 10 min - 20 manufacturers may market _____ size of an otc product for the elderly/handicapped in noncompliant packaging thats not child resistant - one PPPA regulations related to dispensing - -must normally dispense oral drugs in child resistant packaging EXCEPT when the physican or patient request noncompliant packaging -request may be oral but always documented by pharmacist -patient may make a blanket request that all their meds be dispensed in noncompliant packaging (should be in writing, periodically check this with the patient ) t/f if a patient wants noncompliant packaging, physicans can make blanket request for all of the patients presciptions - false t/f when preparing refills for patients, both the body and closure of plastic container units must be replaced - true _____ refers to the improper interference with the product for the purpose of making objectionable ro unauthorized changes. - Tampering _______ means that the packaging has an indicator or barrier to entry which, if breached or missing, can reasonable be expected to provide visible evidence to consumers that tampering has occurred. - Tamper- evident t/f regulations do not require tamper proof packaging - true for two piece hard geletin capsules, _____ tamper evident features must be used unless capsules are sealed then only 1 - 2 _____ refers to the date required on the manufacturers containers. - Expiration date ______ refers to the dating of drug products that are dispenses by pharmacists. Beyond use date manufacturers indicate expiration date how - month and year What does an expiration date of February 2022 indicate? - the it will expire on February 28, 2022 (the last date of the month) t/f pharmacists can continue to dispense a drug once its expiration date has passed false How should you assign a beyond use date to a unit dose package that has been prepared from a bulk container of a commercial drug product? - Drug products should have shorter of 2 potential dates: 1. 6 months maximum 2. 25% of the remaining time btw the date of repackaging and the manufacturers expiration date (divide time remaining by 4, and add that time to the repackaging date) assumea commercial bulk drug product has an expiration date of september 2024. A pharmacist repackages the product on january 1, 2024 and uses the FDA guideline of 6 months max of 25% of the time remaining on the original package of the commercial bulk product , whichever is least whats the 6 month maximum? whats the 25% time? - 6 month maximum= June 30 25% time = February 2024 or first week of march (wont be on test) What is the typical beyond use date for a prescription being dispensed by a pharmacist? - usually a max of 1 year multiple use containers dispensed by pharmacists have a BUD not longer than what the manufacturer's expiration date or one year from the date dispensed the expiration date of the medpak should not exceed ________ days from the date the med pack was prepared or EARLIER if the manufactuers expiration date of any drug in the package is actually earlier - 60 Describe the "7 point" label that is federally required for nonprescription products - 1. name of product 2. name and address of manufacturer, packer, or distributer 3. net contents of package 4. name of all active ingredients and certain inactive ingredients 5. name of any habit- forming drug present 6. cautions and warnings needed to protect the consumer 7. adequate directions for use if any of the seven point information is missing, the nonprescription product is considered - misbranded pharmacist may refill prescriptions written for nonprescription drugs without prescriber authority unless - -dose requested greater than recommended dose on commerical OTC produce -prescriber limited number of refills -schedule V controlled substance -individual state has set a time period limit for refills the dietary supplement and nonprescription drug consumer act made companies have to what - -include contact info on their labels to report ADE -companies have to notify FDA of any serious ADE within 15 business days What are 2 nonprescription labeling requirements for pregnancy and nursing mothers? 1. Nonrx drugs: "If pregnant or breast-feeding, ask a health professional before use." 2. Aspirin products: "It is important not to use this product during the last 3 mos of pregnancy unless specifically directed to do so by a doctor" a dietary supplementation is product thats intended for ingestion, intended to supplement diet and contains any one or more of the following - -vitamin -mineral -herb -AA -dietary substance -concentrate, metabolite, constituent, extract, combo describe the dietary supplement health and education act of 1994 - -created a category/defintion of dietary supplements legally -prohibited FDA from regulating dietary supplements as drugs t/f dietary supplements may be marketed without their efficacy or safety proven - true what claims are NOT allowed on dietary supplements by the DSHEA? - -disease claims are not allowed -can not say it prevents, treats, cures, mitagates, or diagnoses disease what claims ARE allowed for dietary supplements by DSHEA? - structure/function claims -claims it affects the normal structure or function of the human body (ex: healthy circulatory system, muscle enhancement, helps you relax, hot flashes) when a structure/function claim is on a dietary supplement label what statement must appear after? - this statement has not been evaluated by the FDA, this product is not intended to diagnose, treat, cure, or prevent any disease Under what circumstance is it federally required that the labeling for OTC products intended for PO use must indicate the sodium content per dosage unit? - if the amount present is > 5 mg per dose What does "sodium free" mean? - contains < 5 mg of Na per dosage unit What does "very low sodium" mean? - contains 35 mg or less of Na per dosage unit What does "low sodium" mean? - contains 140 mg or less of Na per dosage unit _______ prohibited the FDA from regulating dietary supplements as drugs. - Dietary Supplement Health and Education Act of 1994 (DSHEA) What kind of claims are NOT allowed on dietary supplements? - Disease claims: claims that explicitly or implicitly say that a product can be used to prevent, treat, cure, mitigate, or diagnose disease What kind of claims are allowed on dietary supplements? - Structure/function claims: claims that product effects the normal structure/function of the body what drug is waived from having child resistant packaging - nitroglycerin