Texas MPJE Exam Questions and Answers

What is the Food, Drug, and Cosmetic Act of 1938? - ANSWER Passed by Congress Requires new drugs to prove their safety prior to marketing (the primary federal law dealing with food, drug, cosmetic, and medical device sa ...

What is the Food, Drug, and Cosmetic Act of 1938? - ANSWER Passed by Congress Requires new drugs to prove their safety prior to marketing (the primary federal law dealing with food, drug, cosmetic, and medical device safety). Established the FDA. What is the Durham - Humphrey Amendment of 1951? - ANSWER Establishes 2 classes of drugs (Prescription and OTC). Allows for verbal prescriptions and prescription refills. What is the Kefauver-Harris Amendment of 1962? - ANSWER Requires drug companies to prove safety & efficacy for their claimed use Increases the safety requirements for drugs Establishes Good Manufacturing Practices (GMPs) Gave FDA jurisdiction over prescription drug advertising What is the Prescription Drug Marketing Act of 1987? - ANSWER Bans re-importation of prescription drugs and insulin products (except by the manufacturer). Bans sales/trade/purchase of prescription drug samples Mandates the storage/handling/recordkeeping requirements for prescription drug samples Prohibits resale of prescription drugs purchased by hospitals or healthcare facilities What is the Drug Quality and Security Act of 2013? - ANSWER Encompasses the Drug Compounding Quality Act (DCQA - large scale compounding) and the Drug Supply Chain Security Ac (DSCSA - track and trace system of prescription drugs throughout the supply chain) What is Section 503A? - ANSWER Regulation of State Licensed Compounding Pharmacies (compounds individual prescriptions/medical orders; has limited anticipatory compounding) Regulated by the state Follows USP <797> What requirements are section 503A pharmacies exempted from if they meet DCQA's requirements? - ANSWER 501(A)(2)(B): current GMP requirements 502(F)(1): labeling w/ adequate directions for use 505: new drug approval requirements What is Section 503B? - ANSWER Regulation of Outsourcing Facilities (compounds w/o pt-specific prescriptions/medical orders) Regulated by FDA Follows current GMP What requirements are section 503B pharmacies exempted from if they meet DCQA's requirements? - ANSWER 582: Drug Supply Chain Security Requirements (DSCSA) 502(F)(1): labeling w/ adequate directions for use 505: new drug approval requirements What is the Drug Supply Chain Security Act (DSCSA)? - ANSWER Uniform national framework for an electronic track and trace system for prescription drugs as they move through the supply chain. Sets national standards for states to license drug wholesaler distributors. What are Manufacturers required to provide according to DSCSA? - ANSWER Transaction Data (Transaction Information; Transaction History; Transaction Statement) for each product sold What is included as Transaction Information (as part of Transaction Data)? - ANSWER Product's Name, Strength, Dosage Form NDC Number Container Size and Number of Containers Date of Transaction Name/Address of distributor and receiver of ownership What is the Transaction History (as part of Transaction Data)? - ANSWER Paper/Electronic Statement including prior transaction information for each prior transaction back to the manufacturer What is the Transaction Statement (as part of Transaction Data)? - ANSWER Paper/Electronic statement by Seller that states they are an authorized seller, the product is from an authorized person, the seller received the transaction information and history from the prior owner, they have systems and processes that comply with verification requirements, and did not knowingly ship a suspect/illegitimate product or provide false transaction information What products are the exempted from DSCSA? - ANSWER Blood and Blood Components Sterile Water Irrigation Products Certain IV Fluids Certain Combination Products Radioactive drugs Imaging drugs Dialysis Solutions Medical Gases Medical Convenience Kits with drugs Compounded Drugs What are the requirements for "Distributing" pharmacies according the DSCSA? - ANSWER Must have a wholesale distribution license and pass DSCSA transaction data with that distribution What are the exemptions to the requirements of "Distributing" pharmacies? - ANSWER Distributing between entities of common ownership/affiliations Providing product on a patient specific basis Distributing under emergency medical reasons distributing "minimal quantities" to a licensed practitioner for office use Define Adulteration - ANSWER A drug is adultered if the composition/quality is compromised (i..e filthy, putrid, or decomposed substances, prepared/held in unsanitary conditions, manufacturer did not conform to current GMPs, container is composed of poisonous substances, use of unsafe color additive, strength/quality/purity falls below standard unless the difference is clearly stated on the label, mixed/packed with any substance that reduces its strength or quality) Define Misbranded - ANSWER A drug is misbranded if there is a labeling issue or is thought to be misleading (i.e. fails manufacturer prescription or OTC labeling requirements, label/package does not indicate that the drug is liable to deterioration if applicable, container is made/formed/filled as to be misleading, drug is an imitation of another drug/offered for sale under another drug's name, dangerous to health when used in dose/manner suggested on label, violates Poison Prevention Packaging Act) What are the labeling requirements for the manufacturer's prescription container? - ANSWER The name/address of manufacturer/packer/distributor Brand +/ generic name Net quantity Weight of active ingredient per dosage unit "Rx Only" Specific routes of administration (other than oral) Special storage instructions (if appropriate) Manufacturer's control number (lot number) Expiration Date Adequate Information for use (package insert and medication guide or patient package insert if required) What are the labeling requirements for OTC drugs? - ANSWER The name/address of manufacturer/packer/distributor Principal Display Panel w/ statement of product identity Net quantity of contents Caution/warnings needed to protect user Adequate directions for safe and effective use (laymen's terms) Drug Facts Panel (Active Ingredients, Purpose, Use(s) - indications, Warnings, Directions, Other Information, Inactive Ingredients (alphabetical), Questions? (optional) followed by telephone number) What is the special labeling requirement for FD&C Yellow No. 5 (tartrazine) and No. 6? - ANSWER May cause ALLERGIC REACTIONS in certain susceptible persons (warning in "precautions" section) What is the special labeling requirement for Aspartame? - ANSWER PHENYLKETONURICS: Contains PHENYLALANINE ___mg per ____ dosage unit (warning in "precautions" section) What is the special labeling requirement for Sulfites? - ANSWER ALLERGY WARNING (in "warnings" section) Often used as a preservative What is the special labeling requirement for Mineral Oil? - ANSWER Only to be taken at BEDTIME and DO NOT USE IN INFANTS unless under the advice of a physician Cannot encourage use during pregnancy What is the special labeling requirement for Wintergreen Oil (methyl salicylate)? - ANSWER For drugs > 5% Use other than directed may be DANGEROUS Keep out of reach of CHILDREN Often used as a flavoring agent What is the special labeling requirement for Sodium Phosphates? - ANSWER NO MORE THAN 90ML/OTC oral solution container (also has specific warnings) What is the special labeling requirement for Isoproterenol? - ANSWER For Inhalation Preparations Do not exceed DOSE prescribed Contact physician if DIFFICULTY IN BREATHING PERSISTS What is the special labeling requirement for Potassium Salt Preparations for Oral Ingestions? - ANSWER Nonspecific SMALL-BOWEL LESIONS consisting of stenosis, with or without ulceration (associated with the administration of EC THIAZIDES w/ POTASSIUM SALTS) What is the special labeling requirement for Ipecac Syrup? - ANSWER "For EMERGENCY use to CAUSE VOMITING in POISONING. BEFORE USING, CALL physician, the poison prevention center, or hospital emergency room immediately for ADVICE" (boxed and in red letters) "Warning: keep out of reach of children. Do not use in UNCONSCIOUS persons." 1 TABLESPOON (15ml) dose in individuals > 1YO Only sold as 30ml (1oz) containers What is the special labeling requirement for Phenacetin (acetophenetidin)? - ANSWER Possible KIDNEY damage when taken in large amounts or for a long period of time What is the special labeling requirement for Salicylates? - ANSWER REYE'S SYNDROME warning 1 1/4 grain (pediatric) aspirin CANNOT be SOLD in containers > 36 TABLETS What is the special labeling requirement for Alcohol? - ANSWER For internal analgesics and antipyretics (APAP, ASA, NSAIDs) Warning for persons CONSUMING 3+ alcoholic BEVERAGES/DAY and to CONSULT with a doctor BEFORE taking What is the special labeling requirement for OTC Pain Relievers? - ANSWER Acetaminophen: prominent display of "acetaminophen", liver toxicity warning, not to use with other acetaminophen products warning, and to consult doctor/pharmacist before taking with warfarin NSAIDs: prominent display of "NSAID", "stomach bleeding" warning What are the exemption from tamper-evident packaging for OTC products? - ANSWER Dermatologic, Dentifrice (teeth cleaning), Insulin, or Lozenge products What are the requirements for repackaging OTC products? - ANSWER Must follow CGMP requirements and tamper-evident packaging requirements if they are offered for sale to the public. If repackaged to be filled as a prescription, must follow prescription drug labeling requirements and instructions for refills and expiration dates would apply. What are the FDA Drug and Device Recall Classifications? - ANSWER Class 1 = serious adverse effects on health or death Class 2 = temporary or medically reversible ADE/remote probability of serious adverse effects Class 3 = not likely to cause adverse health consequences FDA does NOT have authority to order a recall but can to take other actions (i.e. seizing products) that most companies will comply with any recall requests. FDA DOES have recall authority for medical devices and other products. Who regulates the advertising/promotion of prescription products? - ANSWER FDA What is reminder advertising for prescription drugs and the requirements? - ANSWER Advertising of prices (by companies, pharmacists, etc.) with the only purpose to inform on pricing (not on drug's safety, efficacy, or indications). The advertisement must contain the proprietary name, generic name, strength, dosage form, the price charged for a specific quantity (should include all the charges to the customer; shipping fees may be stated separately). May advertise the availability of professional/other services as long as it is not misleading If these conditions are met, these advertisings are exempt from the FDA regulations Who regulates the advertising/promotion of OTC product? - ANSWER Federal Trade Commission (FTC) Who is required to receive a patient package insert (PPI)? - ANSWER Patients receiving Oral Contraceptives or Estrogen-Containing Products, and Hospitalized patients prior to the first administration of the product and every 30 days after. Failure to provide a PPI for these drugs is considered misbranded Who is required to receive a medication guide (MedGuide)? - ANSWER For drugs when information is necessary to prevent serious ADE, there are serious risks relative to benefits, or if adherence is critical for effectiveness Provided by manufacturers who must obtain FDA approval prior to distributing MedGuides (must provide sufficient number) What is are Risk Evaluation and Mitigation Strategies (REMS)? - ANSWER Strategies to manage a known/potential serious risk associated with a product. Includes: MedGuide, PPI, a communication plan, Elements to Assure Safe Use (training of HCP to prescribe, certifications of settings to dispense, allowing certain healthcare settings to dispense the drug, only dispensing to patients who've provided documentation for safe use, monitoring patients, enrolling patients into a registry), and an Implementation System. Must include a timetable for assessment of the REMS How can pharmacies register in the iPLEDGE program? - ANSWER must select a Responsible Site Pharmacist to obtain/submit iPLEDGE program information and registration materials. must attest to understanding the product's risks requirements of the iPLEDGE program Train/ensure other pharmacists will comply only obtaining the product from iPLEDGE wholesalers ensuring that any unused products will be returned to the manufacturer Only dispense the product to qualified iPLEDGE patients How to dispense an iPLEDGE product? What is the maximum day supply allowed to be dispensed? - ANSWER pharmacist must obtain authorization from iPLEDGE signifying the patient is registered, received counseling, and met their requirements. The maximum of a 30-day supply is allowed with no refills. What is the National Drug Code (NDC) number? - ANSWER identifies a particular manufacturer/packager (first 4-5 digits), product (next 3-4 digits), and package size (last 1 - 2 digits). Facilitates automated processing of drug data by government agencies, third-party payers, wholesalers, and manufacturers. It does not signify that the product is FDA approved What is the Orange Book? - ANSWER Generic Equivalent products of drugs (brand/generic equivalents) Available at http://www.fda.gov/cder/ob/ Describe how equivalency codes are written and what they mean - ANSWER First letter A = equivalent First letter B = Not equivalent AB = meets "necessary bioequivalence", may be substituted if scientific evidence has established equivalency AA = conventional dosage forms AN = aerosolize dosage forms AO = oil solutions for injection AP = aqueous solutions for Injection AT = topical products What is the Purple Book? - ANSWER Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations Only "interchangeable" products may be substituted by a pharmacist in Texas What is the Poison Prevention Packaging Act (PPPA) of 1970? - ANSWER Administered by Consumer Product Safety Commission Requires all prescription and certain non-prescription drugs be in child-resistant containers What are the exemptions from child-resistant containers according to the PPPA? - ANSWER For patients or providers who request otherwise, Bulk containers that are not for household use, Medications distributed to hospitalized patients, and only one size container of an OTC product that is allowed to not be child-proof and must have a warning "This Package for Households without Young Children" What dose of Sublingual/Chewable Isosorbide Dinitrate is exempted from PPPA child-resistant? - ANSWER <10mg What dose/package of Erythromycin oral solution (granules) is exempted from PPPA child-resistant? - ANSWER <8g What dose/package of Erythromycin tablets is exempted from PPPA child-resistant? - ANSWER <16g What dose/package of Sodium Fluoride is exempted from PPPA child-resistant? - ANSWER <264mg What dose/package of Prednisone is exempted from PPPA child-resistant? - ANSWER <105mg What dose/package of Methylprednisone is exempted from PPPA child-resistant? - ANSWER <84mg What dose/package of Betamethasone is exempted from PPPA child-resistant? - ANSWER <12.6mg What dose/package of Mebendazole is exempted from PPPA child-resistant? - ANSWER <600mg What is the Federal Hazardous Substances Act of 1966? - ANSWER Administered and Enforced by Consumer Product Safety Commission Intends to protect consumers from hazardous and toxic substances What are the label requirements of hazardous products? - ANSWER Label on immediate and any outer package or on a with the name and business address of manufacturer/packer/distributor/seller, common/usual/chemical name of each hazardous ingredient, "Caution or Warning" or "Danger" for corrosive/flammable and "Poison" if highly toxic, an Affirmative Statement of presented hazards, Precautionary Statements of how consumers can protect themselves, "Keep out of the reach of children", and (if appropriate) First Aid treatment instructions, Special Care in Handling/Storage If a plant, requires a hang tag and accompanying printed literature with required precautionary info What is the Federal Hazard Communication Standard? - ANSWER Administered and Enforced by the Occupational and Safety Health Administration (OSHA) Requires employers (and pharmacies) to meet the Hazard Communication Standard What is the Hazard Communication Standard Requirements? - ANSWER Manufacturers and importers: must classify and prepare appropriate labels and Safety Data Sheets (SDS) for their products Pharmacies: must have a written Hazard Communication Plan (list of hazardous products in the workplace, ensure they are all appropriately labeled and have SDS, training for all workers: appropriate protective measures and know where/how to obtain additional information) What are the Centers for Medicare and Medicaid Services (CMS) requirements? - ANSWER All written prescriptions must meet Tamper-Resistant requirements A consultant pharmacist must perform a medication regimen review for all long term care patients every 30 days What are the requirements for Mail Delivery Prescriptions? - ANSWER Noncontrolled: may be mailed as long as medications are not alcoholic beverages, poisons or flammable Controlled: container must be labeled according to prescription labeling requirements, the outer container must be free of markings indicating nature of contents (includes name of pharmacy as part of return address). If between DEA registrants, must be in a plain outer container with all required record keeping met Prescriptions delivered by UPS or FedEx (common carriers) are not subjected to postal regulations and can deliver any prescription drugs Who regulates the Federal Tax-Free Alcohol laws? - ANSWER Alcohol and Tobacco Tax and Trade Bureau (TTB) and the federal Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATFE) User permits must be acquired from TTB and there are specific recordkeeping requirements Who enforces the Federal Tax-Free Alcohol laws? - ANSWER the federal Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATFE) What are the HIPAA Notice and Acknowledgement Requirements? - ANSWER Pharmacies must provide patients with a "Notice of Privacy Practices" and make good faith effort to obtain a written acknowledgement of receipt of Notice from patient Notice must be provided upon first service delivery The HIPAA privacy rule requires Mandatory provisions in the notice When can pharmacies use and disclose Protected Health Information (PHI) without patient authorization? - ANSWER To provide treatment for patient and for healthcare operations For certain governmental functions (i.e. public health activities - reporting ADEs to FDA, Health Oversight Agencies - Boards of Pharmacies, Drug Monitoring Programs, Law Enforcement Agencies) What must pharmacies establish for dealing with PHI? - ANSWER Pharmacies must establish policies/procedures protecting from accidental/intentional uses and disclosures of PHI using appropriate safeguards to protect PHI privacy and must train all employees on policies/sanctions for any violations Pharmacies must designate a Privacy Official to develop/implement HIPAA related policies, procedures, and compliance, as well as a contact person to receive complaints When can PHI uses and disclosures allowed? - ANSWER With a signed authorization from the patient If used for marketing purposes and covered entity receives payment, the authorization form must expressly inform the patient of such face-to-face communications about alternatives are considered part of treatment (not marketing) Refill reminders are not considered marketing as long as payment made to pharmacy is reasonable and related the pharmacy's cost of making the communication. How long does a pharmacist have to comply to a patient's request for a copy of the PHI? What about for emergencies? - ANSWER Patients have the right to access/obtain a copy of their PHI Pharmacies must comply within 30days (15 days, w/in 24 - 72hrs in emergencies in Texas) but may extend by no more than 30 additional days if they notify the patient the reason for delay How long does a pharmacist have to comply to a patient's request to amend their PHI record and request an accounting of disclosure? - ANSWER Patients have right to amend their PHI records and request an accounting of disclosures of their PHI made by a pharmacy under certain circumstances Pharmacies must comply within 60 days, but may extend by no more than 30 additional days if they notify the patient the reason for delay What is the HITECH Act? - ANSWER adds breach notification requirements to HIPAA Covered Entities (pharmacies) must notify individuals of breach within 60 days of discovery If <500pts affected, must maintain a log and notify HHS annually If >500pts affected, must notify the security of HHS and Prominent Local Media within 60 days Define "breach" - ANSWER Unauthorized acquisition, access, use, or disclosure of PHI that compromises its security/privacy does not include instances where inadvertent disclosure between authorized individuals the covered entity or Business Associate has good faith belief that the PHI is not further acquired, accessed, retained, used, or disclosed Marijuana Schedule - ANSWER CI Dihydromorphine Schedule - ANSWER CI Mescaline Schedule - ANSWER CI (Peyote Cactus) Methaqualone Schedule and brand - ANSWER CI; Quaalude Codeine Schedule - ANSWER CII Dihydrocodeine Schedule - ANSWER CII Vicodin Schedule and generic - ANSWER CII; Hydrocodone/Acetaminophen Percocet Schedule and generic - ANSWER CII; Oxycodone/Acetaminophen Dolophine Schedule and generic - ANSWER CII; Methadone Duragesic Schedule and generic - ANSWER CII; Fentanyl Demerol Schedule and generic - ANSWER CII; Meperidine Dilaudid Schedule and generic - ANSWER CII; Hydromorphone Cocaine Topical Schedule - ANSWER CII Amphetamine Schedule - ANSWER CII Methamphetamine Schedule and brand - ANSWER CII; Desoxyn Phenmetrazine Schedule and brand - ANSWER CII; Preludin Methylphenidate Schedule and brand - ANSWER CII; Ritalin Pentobarbital Schedule and brand - ANSWER CII; Nembutal Sodium Secobarbital Schedule and brand - ANSWER CII; Seconal Amytal Schedule and generic - ANSWER CII; Amobarbital Glutethimide Schedule and brand - ANSWER CII; Doriden, Dorimide Phencyclidine Schedule and brand - ANSWER CII; PCP, Angel Dust Morphine Schedule and brand - ANSWER CII (oral) Kadian, MS Contin (injection) Duramorph, Infumorph What are the dose/unit limits of codeine to classify as CIII? - ANSWER no more than 1.8g/100mL or 90mg/dosage unit What are the dose/unit limits of opium to classify as CIII? - ANSWER no more than 500mg/100mL or 25mg/dosage unit Acetaminophen/Codeine Schedule and brand - ANSWER CIII; Tylenol #3 Amobarbital suppository Schedule and brand - ANSWER CIII; Amytal Sodium Secobarbital suppository schedule and brand - ANSWER CIII; Seconal Pentobarbital suppository schedule and brand - ANSWER CIII; Nembutal Chlorphentermine schedule and brand - ANSWER CIII; Apsedon, Desopimon, Lucofen Phendimetrazine schedule and brand - ANSWER CIII; Bontril Benzphetamine schedule and brand - ANSWER CIII; Didrex tesosterone schedule and brand - ANSWER CIII; Androgel Ketamine schedule - ANSWER CIII Marinol schedule and generic - ANSWER CIII Dronabinol Paregoric Schedule and generic - ANSWER CIII Camphorated Opium Tincture