MPJE EXAM PRACTICE QUESTIONS (PP. 306-624) WITH COMPLETE SOLUTIONS

MPJE EXAM PRACTICE QUESTIONS (PP. 306-624) WITH COMPLETE SOLUTIONS “Prior to dispensing, when is it not necessary for the pharmacist (or pharmacy employee) to OFFER to counsel? - CORRECT ANSWER - not "practicable" - person picking up is not the patient - pharmacist determine that offer should be make in writing (if in writing, should tell pt that counseling can be done in person or over the phone)" "When is emergency refill of a non-controlled prescription without prescriber authorization allowed? - CORRECT ANSWER - unable to contact prescriber after reasonable effort - failure to refill might result in interruption of therapeutic regimen or create patient suffering - patient/ representative informed that prescription is being dispensed without authorization - prescriber is informed at earliest reasonable time that authorization is required for future refills - unauthorized refill quantity must not exceed 72 hour supply" "Pharmacist may immediately prescribe and dispense /=30days of which diabetic products (under special circumstances)? - CORRECT ANSWER - diabetic ketoacidosis device - insulin drug - glucagon - diabetes device necessary to administer the insulin or glucagon" "What are the conditions in which pharmacist can prescribe and dispense diabetes products? - CORRECT ANSWER - patient claims to have 7day supply of the diabetes products AND - the pharmacist determines (using professional judgement) that pt will likely suffer significant physical harm within 7 days if the diabetes products is/are not obtained AND - the pharmacist that no pharmacist prescribed (and dispensed) the diabetes products in the preceding 12 months because the pharmacist: reviewed PDMP, contacted the pharmacy that most recently filled a prescription for diabetes, examined another prescription database, or reviewed a prescription label with the most recent prescription information AND - within 72 hours, provides notice to the practitioner who most recently prescribed the diabetes products AND - the pharmacy reports all such diabetes products "prescribed and dispensed" by the pharmacy to Connecticut's PDMP" "When can pharmacists add flavoring to a prescription product? - CORRECT ANSWER - if prescriber, patient, or patient's agent requests it - if acting on behalf of a hospital" "What are the requirements of a flavoring agent? - CORRECT ANSWER - must be used according to GMP and in minimum quantity to produce its intended effect - must be recognized as safe (e.g. USP, 21 CFR 172) - must produce no effect other than flavoring - not more than 5% of the total weight of the product" "In relation to generic substitution and interchangeable biologic products, what must the prescription RECORD document? - CORRECT ANSWER - brand name of drug substituted or, if not brand, generic brand and manufacturer - retail price of substituted drug at time of dispensing" "In relation to generic substitution and interchangeable biologic products, what must the prescription LABEL have? - CORRECT ANSWER - the name of the dispensed drug - if no brand name, must use generic name along with name of drug manufacturer or distributor, unless prescriber says no in writing, orally, or by electronic means" "In relation to generic substitution and interchangeable biologic products, what are the requirements of signage? - CORRECT ANSWER - sign must be easily seen - it must state: "This pharmacy may be able to substitute a less expensive drug product or interchageable biological product which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve"" "Unless the purchaser instructs otherwise, when can you substitute generic/IBP? - CORRECT ANSWER - generic drug/IBP to be substituted is the same strength, dose, dosage form, and is dispensed in same quantity - generic product/IBP is therapeutically equivalent ("Orange Book" for drugs and "Purple Book" for IBPs) - there is a cost savings and it is passed on to the purchaser" "What must a pharmacist do when substituting an Interchangeable Biological Product (IBP)? - CORRECT ANSWER - inform pt (or pt's representative) of substitution - within 48hrs of (or no later than 72hrs after) any dispensing (including refills unless prodcut dispensed is the same as prior filling), document name and manufacturer of specific product dispensed to pt and notify the prescriber using one of the following: interoperable EMR, e-prescribing technology, PBM system, pharmacy record, facsimile, telephone, or electronic transmission" "For delivery (e.g. mail order) of an interchangeable biologic product, what is the requirement? - CORRECT ANSWER patient may request that pharmacy deliver ONLY if patient (or patient's representative) is present to sign for the delivery" "What is the difference between a biosimilar product and an interchangeable product? - CORRECT ANSWER - Biosimilar product has "no clinically meaningful differences" from reference product for safety, purity, and potency as demonstrated through PK studies (exposure) and PD studies (response) - Interchangeable product is a biosimilar that has ALSO shown it is expect to produce the "same clinical result": if administered more than once, manufacturer must evaluate safety and efficacy of switching back and forth between reference product and interchangeable product" "According to FDA equivalency codes in the Orange Book, what are "A" rated products? - CORRECT ANSWER bioequivalent and "therapeutically equivalent" to brand name/reference product: - AA- conventional dosage forms - AN- solutions and powders for aerosolization - AO- injectable products with oil solvents - AP- injectable solutions - AT- tropical products (if same dosage form)" "According to FDA equivalency codes in the Orange Book, what are "AB" rated products? - CORRECT ANSWER product meets "necessary bioequivalence" requirements and may be substituted because equivalency problem resolved by in vivo and/or in vitro evidence" "According to FDA equivalency codes in the Orange Book, what are "B" rated products? - CORRECT ANSWER products are NOT bioequivalent" "What is the Biologics Price Competition and Innovation Act of 2009- 42 USC 262(k)? - CORRECT ANSWER - Part of the Affordable Care Act - created abbreviated licensure pathway for biologics shwon to be "biosimilar" (or interchangeable) - Section 351(k) of Public Health Service Act" "For FDA approval of same indications and conditions of use as a reference product, what is required for the biologic? - CORRECT ANSWER - same MOA - route(s) of administration - dosage forms - strengths" "What is a non-resident pharmacy? - CORRECT ANSWER - a pharmacy located outside of CT & ships, mails, or delivers legend drugs or devices into CT **MUST register with DCP before s ending drugs or medical devices into CT" "What are the non-resident pharmacy requirements? - CORRECT ANSWER - valid license where physically located - compliance with all home-state laws - submit last inspection report to DCP with application - after registration, submit annual report (locations, officers, pharmacists)" "What is a pharmacy rewards program? - CORRECT ANSWER when a retailer offers store credits, discounts, or other benefits in exchange for filling Rx's with the retailer **to enroll consumer, retailer must provide "plain language summary" of terms and conditions" "If a consumer participates in a pharmacy rewards program that requires HIPAA authorization, what must the authorization form state? - CORRECT ANSWER - specific uses/disclosures of PHI is allowed - whether PHI will be disclosed to 3rd parties, and if it will no longer be protected after disclosure - which 3rd parties will have PHI - how authorization may be revoked - that consumer may have copy of signed authorization" "Who & what can pharmacists vaccinate? - CORRECT ANSWER They can administer to an adult ANY vaccine included on CDC's Adult Immunization Schedule **administration must be conducted pursuant to order of licensed healthcare provider (established by written protocol per regulations)" "What are the regulation requirements for pharmacist administration of vaccines? - CORRECT ANSWER - Pharmacist must complete an approved training program - Program must include pre‐administration education and screening, vaccine storage and handling, subcutaneous and intramuscular injections, recordkeeping, vaccine safety, cardiopulmonary resuscitation, basic cardiac life support and adverse event reporting - Program must be accredited by National Centers for Disease Control Prevention, the Accreditation Council for Pharmacy Education (ACPE) or other appropriate national accrediting body - A system of control and reporting must be established" "What are the requirements of the written protocol for pharmacist administration of vaccines? - CORRECT ANSWER Must address systems of control and reporting At a minimum, must include: - Name of healthcare provider authorized to order or prescribe drugs - Name of pharmacist(s) authorized to administer vaccines - Types of vaccines to be administered - Procedures, decisions criteria and plan to be followed by administering pharmacist, including when to refer patient to physician - Procedures for emergency situations - Recordkeeping/ documentation procedures - Administering pharmacist's name must be recorded" "What is a Collaborative Practice Agreement? - CORRECT ANSWER - formal relationship between pharmacist and medical provider (physician, APRN, other) - enabled by the statute/regulation, flexible by agreement - contains appropriate communication processes for coordination of care - may use patient-specific protocol or disease/condition of certain pt population" "What are the typical characteristics of a collaborative practice agreement? - CORRECT ANSWER - Post‐diagnosis initiation and monitoring of drug therapy - Usually addresses chronic disease states or conditions - Pharmacist's expertise may address polypharmacy issues" "What are the "statutory" elements of a collaborative practice agreement? - CORRECT ANSWER - Healthcare provider participants (e.g., Only physician prescribers; all prescribers) - Structure of relationship (e.g., 1:1 physician/pharmacist, or groups of physicians/pharmacists) - Populations served (e.g., single patient/agreement; populations/per agreement) - Authorized services (e.g., initiate, modify, terminate/deprescribe drug therapy; test ordering & interpretation; administration of meds) - Requirements & restrictions (e.g., reporting; documentation; limitations; licensing body oversight)" "What are the "contractual" elements and safeguards of a collaborative practice agreement? - CORRECT ANSWER - Pharmacist and physician determine (and document) scope of pharmacist services - List actual participants (prescriber/pharmacist) - Identify required training/competencies/continuing education - Identify specific patients or patient populations - Specify disease states, services, protocols/clinical guidelines, documentation processes - Specify term (period) of collaborative practice agreement (e.g., one year) - Address liability insurance issues" "How often must a pharmacist in a CDTM agreement report patient's drug therapy management to the physician? - CORRECT ANSWER every 30 days" "T/F: In a collaborative drug treatment management agreement, the patient MUST give consent to collaboration with pharmacist. - CORRECT ANSWER FALSE, however, they must have a physician-patient relationship with the physician" "When is a pharmacist allowed to prescribe an opioid antagonist? - CORRECT ANSWER - Pharmacist is trained and certified by DCP‐approved program - Prescribing is done in good faith - Pharmacist provides training in the administration of the opioid antagonist to the person to whom the drug is dispensed - Pharmacist maintains record of dispensing and training" "T/F: A pharmacist may NOT delegate or direct anyone else to prescribe or train on the administration of opioid antagonists - CORRECT ANSWER TRUE" "What is the difference in restriction between prescribing vs dispensing an opioid antagonist? - CORRECT ANSWER Prescribing: pharmacist can prescribe and dispense intranasal, auto-injection, and IM solution (and provide up to 10 syringes/needles for administration without prescribing) Dispensing: with a medical protocol standing order (where pharmacist is technically not prescribing), pharmacist is only allowed to dispense intranasal or auto-injection naloxone" "Are pharmacists allowed to prescribe and dispense opioid antagonist outside of pharmacy premises? - CORRECT ANSWER YES, but it requires: - advance notice to DCP with info on locations, dates, times, and pharmacists who will prescribe/dispense - there are other requirements for inventory, security, storage, labeling, record keeping, confidentiality, and reporting" "Who can a pharmacist (who is certified to prescribe naloxone) have an agreement with for distribution and administration of naloxone? - CORRECT ANSWER - Law enforcement agency - EMS provider - government agency - community health organization" "T/F: the certified prescribing pharmacist must provide training to those who will distribute or administer naloxone - CORRECT ANSWER True" "What must the agreement for distribution of naloxone address? - CORRECT ANSWER - storage - handling - labeling - recalls - record-keeping" "____________________ is defined as an act or omission of clinical significance relating to the dispensing of a drug that results in or may reasonably be expected to result in injury to or death of a patient - CORRECT ANSWER prescription error" "Pharmacy must display a sign (for concerns regarding Rx errors) that is at least _____(1)____ horizontal in a _____(2)_____ location - CORRECT ANSWER 1. 8"x10" 2. conspicuous" "Compare and contrast: Connecticut vs NABP Model for quality assurance program - CORRECT ANSWER Connecticut: 1. Written QA program on premises 2. Report error to patient/caregiver and prescriber (unless patient/caregiver/prescriber reported error to the pharmacy) 3. Perform QA review within two business days of discovering error 4. Silent regarding protection from discovery or use in civil litigation 5. No express requirement to train pharmacy personnel NABP Model: 1. Written policies and procedures, with individual(s) designated as responsible for program 2. No mandated reporting to outside entities - but "blinded" incidents to be reported to "nationally recognized error reporting program" (e.g., a patient safety organization) 3. Initiate documentation of incident within three calendar days 4. CQI program treated as privileged and confidential, protected from discovery 5. Annual CQI education for pharmacy staff; quarterly self‐audit" "Greater than ____ needles requires a prescription - CORRECT ANSWER 10" "Less than or equal to ____ needles does not require a prescription and may be provided - CORRECT ANSWER 10" "A prescription for needles is valid for __(1)__ year but seller must confirm continued need with prescriber every __(2)__ months and Rx must be kept on file for __(3)__ years. - CORRECT ANSWER 1. one 2. six 3. three" "A quantity of needles that does not require a prescription may be provided or sold at retail only by _______? - CORRECT ANSWER - pharmacy (by licensed pharmacist or under pharmacist's direct supervision) - needle services program - healthcare facility or licensed practitioner for use by the provider's own patients" "The ______ requires registered drug establishments to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution - CORRECT ANSWER Drug Listing Act of 1972" "How often must registrants update their list of all drugs manufactured, prepared, propagated, compounded or processed for distribution? - CORRECT ANSWER every June and December *the FDA publishes this info as the NDC directory and only includes drugs in final marketed form" "What are the 3 segments of an NDC number? - CORRECT ANSWER - manufacturer/ packager - product - package size" "Distributors MUST register with DCP to operate in CT. What is the exception to this? - CORRECT ANSWER A manufacturer that is not in Connecticut ‐‐ but is registered with FDA ‐‐ only needs to file a copy of FDA registration with DCP to operate (sterile compounding pharmacies are NOT included in this exception)" "Where can manufacturers and wholesalers distribute to? - CORRECT ANSWER - Manufacturers - Wholesalers/ distributors - Hospitals - Prescribing practitioners - Pharmacies - Government agencies - Clinics - Or as otherwise permitted by statute (e.g., non-legend drug permit holders; "epinephrine cartridge injectors" to "authorized entity")" "Generally, there are NO retail sales by manufacturers or wholesalers with the exception of _______. - CORRECT ANSWER flea markets" "In reference to drug wholesalers and manufacturers, what is classified as a suspicious order? - CORRECT ANSWER unusual size, deviating substantially from a normal pattern, or unusual frequency *must report to DCP any orders reported to the DEA" "In reference to wholesalers and manufacturers, you must report to DCP (within ______ business days) any practitioner/pharmacy that, because of potential diversion concerns, wholesaler/manufacturer ceases or declines to distribute any CII‐CV - CORRECT ANSWER 5" "What is defined as a wholesaler? - CORRECT ANSWER An entity that sells or supplies to other wholesalers, manufacturers, distributors, hospitals, prescribers, pharmacies, government agencies, clinics or other authorized entities *includes medical device and oxygen providers, third‐party logistics providers, virtual manufacturer/wholesale distributor" "What is defined as a manufacturer? - CORRECT ANSWER - an entity that prepares, synthesizes, compounds, packages, repackages, or labels under a trademark any drug, device, or cosmetic - Or is a sterile compounding pharmacy that dispenses CSPs without a prescription or patient‐specific order" "What are the characteristics of a third-party logistics provider? - CORRECT ANSWER - distributes drugs/devices/cosmetics by taking possession (but not title) - usually integrates warehousing and shipping functions ("pick and pack") on contract with manufacturer and integrated with the manufacturer's systems (does not "own" the product)" "What are the characteristics of a virtual manufacturer? - CORRECT ANSWER - owns NDA or ANDA (if drug) or unique device ID number (if Rx device) - contracts with manufacturing organization for physical manufacture of drug/device/cosmetic - is not involved with physical manufacture of product - does not take possession of, or store, product" "What is NOT a covered product under the Drug Supply Chain Safety Act? - CORRECT ANSWER - blood or blood components intended for infusion - radioactive drugs or biologics - imaging drugs - certain IV products - medical gas - homeopathic drugs - lawfully compounded drugs" "What is defined as a transaction under the Drug Supply Chain Safety Act? - CORRECT ANSWER a transaction that involves transfers of product where change of ownership occurs" "What is excluded as a transaction under the Drug Supply Chain Safety Act? - CORRECT ANSWER - intracompany distributions - distribution among hospitals under common control - public health emergencies - dispensed pursuant to a prescription - product sample distribution - blood and blood components for transfusion - minimal quantities by a licensed pharmacy to a licensed practitioner - certain activities by charitable organizations - distributions pursuant to a merger or sale - certain combination products - certain medical kits - certain IV products - medical gas distribution - approved animal drugs" "What are some examples of suspect products? - CORRECT ANSWER - altered product info - missing info on label - looks different than product on shelf - no "Rx only" symbol - bubbling on the label - foreign language - lot numbers or expiration dates do not match the outer/inner container - missing or wrong package inserts - damaged, broken, seal, open package - different product name than FDA approved version" "What are the steps to take if you determine that you have an illegitimate product? - CORRECT ANSWER - notify FDA within 24hrs using form FDA 3911 - notify other trading partners within 24hrs - request notification termination using form FDA 3911" "Per DSCSA requirements, dispensers must accept only prescription drugs that have __(1)__, __(2)__, and __(3)__, - CORRECT ANSWER 1. transaction info 2. transaction history 3. transaction statement" "Per DSCSA requirements, dispensers may transfer (with transaction info, transaction history, and transaction statement) with what exception? - CORRECT ANSWER except when dispensing to patients, making returns, or selling to another dispenser for a "specific patient need" (i.e. an identified patient)" "T/F: Upon requests, provide regulators with transaction info, transaction history, and transaction statements for recalls & investigations of suspect products - CORRECT ANSWER True" "Per the DSCSA, which products are excluded from the track and trace requirements? - CORRECT ANSWER - samples - veterinary drugs - OTC drugs" "What are the product identifier requirements? - CORRECT ANSWER - national drug code (NDC) - serial number - lot number - expiration date" "What are the packages without product identifiers? - CORRECT ANSWER - excluded products - grandfathered (products in the chain before the requirements) - waiver, exception, or exemption" "When did the DSCSA become effective? - CORRECT ANSWER 1/1/2015 and preempts any state law in conflict with it" "When can a controlled substance be mailed? - CORRECT ANSWER - the mailer or addressee is a DEA registrant OR - the mailer or addressee is exempt from DEA registration" "What are the packaging standards for mailing a controlled substance? - CORRECT ANSWER - The inner container is marked and sealed and placed in a plain outer container or securely wrapped in plain paper - If the controlled substance consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescription - The outside wrapper or container is free of markings that would indicate the nature of the contents" "Registered pharmacy may distribute controlled substances (without being registered as a distributer) to another pharmacy or registered practitioner for the purpose of general dispensing to patients ONLY IF: - CORRECT ANSWER - The pharmacy/ practitioner receiving controlled substances is registered with the DEA to dispense - The distribution and receipt are recorded on both ends - The distributing pharmacy documents transfer on DEA Form 222 (or electronic equivalent) if it is for CI or CII - The total number of dosage units of all controlled substances distributed does not exceed 5% of all controlled substances dispensed in a calendar year (if 5%, must register as a distributor)" "What is the 20% rule? - CORRECT ANSWER A pharmacist is permitted to compound CII‐V aqueous, oleaginous or solid dosage form containing a narcotic controlled substance up to 20% of complete solution, compound, or mixture *must be for a specific patient/order and must be written if CII" "What does the Governor's Declaration of Emergency allow? - CORRECT ANSWER - the declaration allows hospital pharmacies, pharmacies, & DCP registrants - with prior DCP approval - to transfer controlled drugs to another pharmacy, registrant, or DCP authorized location. Gives DCP authority: - To develop (in consultation with DPH) biannual list of "strategic prescription drugs" (e.g., vaccines, antibiotics) for public health preparedness, or bio‐terrorism prevention/treatment - To require wholesalers and repackagers to provide DCP with on‐hand inventory report of specifically identified prescription drugs" "What are the requirements for a CT "non-sterile compounding pharmacy"? - CORRECT ANSWER - Must have policy and procedure manual that addresses: compounding, dispensing, delivery, administration, storage, and use of (non‐sterile) compounded products - Must comply with USP Chapter 795 - May provide compounded (non‐sterile) drugs to prescribers for administration to prescriber's patients by prescriber or under supervision of prescriber, but limited to 30‐day supply [RCSA 20‐576‐71(c)] or the limitations in 21 USC 353a(2)(B) - Generally, should be open at least 35 hours per week, but may be granted a waiver to be open fewer hours" "What are the requirements for a CT "sterile compounding pharmacy"? - CORRECT ANSWER - Must have policy and procedure manual - Must follow "USP chapters" 797,800and825, and referenced documents (such as sterility testing for all high‐risk level CSPs) - May provide to prescribers for administration to prescriber's patients, but limited to two‐week supply [RCSA 20‐576‐66(c)]" "A sterile compounding pharmacy that dispenses CSPs without a prescription of patient-specific medical order is considered at _____ in the state of CT. - CORRECT ANSWER Manufacturer" "T/F: Sterile compounding pharmacies in the retail and hospital setting are both 503A pharmacies. - CORRECT ANSWER True" "Effective 1/1/2020, what is required regarding sterile compounding oversight in both retail and institutional pharmacies? - CORRECT ANSWER - must have a designated pharmacist responsible for sterile compounding oversight - designated pharmacist can oversee more than one location - DCP must be notified of designated pharmacist - designated pharmacist must provide DCP with proof of competence in sterile compounding - designated pharmacist must notify DCP if no longer acting as such" "What are the requirements of a new SCP or if a pharmacy starts compounding on or after 7/1/2014? - CORRECT ANSWER - file an addendum to pharmacy license application with DCP - no compounding until DCP inspects and gives approval" "What are the requirements for a non-resident SCP pharmacy? - CORRECT ANSWER - File addendum with DCP that includes sterile compounding - Provide written proof of "passed" state agency inspection where non-resident pharmacy is located - Every two years, must also provide to DCP copy of most recent inspection report - If state does not conduct inspections, must provide satisfactory proof of compliance with USP 797 - No compounding for sale/delivery into Connecticut until receipt of approval from DCP" "Who can SCPs supply "patient-specific" CSPs to? - CORRECT ANSWER - Patients - Practitioners (MD/DO,DPM,DDS/DMD,APRN,DVM) - Hospital or health care facility licensed by DPH" "If SCP supplies CSPs without patient‐specific prescription/order, what must they also do? - CORRECT ANSWER they must also register as a manufacturer with DCP" "SCP on‐site inventory of CSPs may not exceed ____‐day supply (calculated from completion of compounding) - CORRECT ANSWER 30" "T/F: compounded drugs are not FDA approved - CORRECT ANSWER True, the FDA does not review these drugs to evaluate their safety, effectiveness, or quality before they reach patients" "What is Section 503A? - CORRECT ANSWER - describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. - One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions" "What is Section 503B? - CORRECT ANSWER - established a new, voluntary category of compounders known as outsourcing facilities. - Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements, and they may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient (e.g., for office stock)" "Define compounding according to the FDCA Section 503A. - CORRECT ANSWER does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling." "Drugs compounded in accordance with all conditions of section 503A are exempt from: - CORRECT ANSWER - Section 501(a)(2)(B) (current good manufacturing practice requirements) - Section 502(f)(1) (labeling with adequate directions for use) - Section 505 (new drug approval requirements)" "In Section 503A, who is compounding done by? - CORRECT ANSWER - Licensed pharmacist in a state-licensed pharmacy or federal facility, or licensed physician" "What are the patient-specific requirements in a Section 503A? - CORRECT ANSWER - Compounding must be based on the receipt of a valid prescription for an identified individual patient. - It can occur after the receipt of the prescription, or in limited quantities before the receipt of such a prescription" "Drugs compounded in accordance with all conditions of section 503B are exempt from: - CORRECT ANSWER - Section 502(f)(1) (labeling with adequate directions for use), Section 503A(a) - Section 505 (new drug approval requirements), and - Section 582 (drug supply chain security requirements)" "In Section 503B, who is compounding done by? - CORRECT ANSWER Compounding is by or under the direct supervision of a licensed pharmacist in an outsourcing facility (which is not required to be a licensed pharmacy)." "What is the definition of an ultimate user? - CORRECT ANSWER a person who has lawfully obtained, and who possesses a controlled substance for any of the following: - The individual's own use - The use of a member of the same household - An animal owned by an individual or a member of the individual's household" "T/F: An ultimate user may NOT use "take-back" program to dispose of illicit drugs - CORRECT ANSWER True" "What may an authorized collector collect and mingle? - CORRECT ANSWER - controlled substances - non-controlled substances" "An authorized collector may NOT: - CORRECT ANSWER - Co‐mingle drugs collected from ultimate users with collector's inventory/stock - Dispose of its own inventory/stock in a collection receptacle or mail‐back package - Take drugs for destruction from other DEA registrants - Require any person to provide personally identifying information (i.e., no ID required from ultimate user to make disposal)" "What are the aspects of the CT drug take-back program by DCP licensed pharmacies initiated in July of 2019 ? - CORRECT ANSWER - The program complies with federal laws on collection and disposal of controlled substances - Regulations establish tracking and monitoring requirements - A participating pharmacy ("Authorized Collector") must specify locations where take-back drugs will be accepted and stored - The program allows for 50 pharmacies to participate in first year (2019), and an additional 50 pharmacies each following year - The program is voluntary" "What are the DCP requirements for anonymous drop-off of unwanted pharmaceuticals at police stations in CT? - CORRECT ANSWER - Secure locked box available 24 hours daily - Transported to facility for "witnessed incineration"" "What is the CT drug drop box program? - CORRECT ANSWER - a program that allows for safe disposal locations to discard unused household medications - located only within police departments or DCP-approved retail pharmacies - environmentally safe disposal - "commercial disposal" is prohibited (i.e. take-back from nursing homes, medical offices) - medications are incinerated in an authorized facility - no cost for retail pharmacy to participate but applications must be renewed annually" "What are the requirements to be an authorized collector in CT? - CORRECT ANSWER - must be a retail pharmacy - Have modified DEA registration to act as authorized collector - Submit application to DCP - DCP will conduct an inspection of premises and collection receptable prior to issuing certificate or registration to be a collector" "CT authorized collectors may NOT: - CORRECT ANSWER - Participate in a take-back event within same building where receptacle is located - Participate in mail back program as would otherwise be permitted under federal law - Dispose of its inventory/stock in the collection receptacle - Handle, count, sort, or inventory drugs to be deposited in collection receptacle" "What must a CT authorized collector do in regards to the CT drug take-back program? - CORRECT ANSWER - maintain confidentially of ultimate user making deposit for disposal - provide 30days advance written notice if discontinuing collection" "What are the requirements of CT collection receptacles in retail pharmacies? - CORRECT ANSWER - Be securely fixed to the premises at the registered location - Have two (2) locking mechanisms, with different keys by two different employees, to unlock and view or access inner liner - At least one of the two employees must be a pharmacist - Have one‐way access point for deposits by ultimate users that can be locked to prevent deposits when pharmacy is closed or the inner liner is full - Be located immediate proximity to controlled substance storage area - Be visible to authorized (and present) employee - Have signage indicating (1) drug types accepted for deposit; (2) prohibited items; (3) drugs for deposit are not to be left in the vicinity of the collection receptacle at any time - continuously monitored by video camera with 14days storage - if store closed or authorized employee not present, no deposits are permitted" "In CT, collectors must report to DCP within_____ hours of any loss, theft, serious damage, or destruction to collection receptacle for its contents - CORRECT ANSWER 72" "What are the requirements in CT for destruction of drugs from collectors? - CORRECT ANSWER - Must be by DCP registered reverse distributor only - Reverse distributor must be present to receive inner liner, and must sign the Authorized Collector's log book - 2 employees of Authorized Collector (at least 1 RPh) must be present to: remove/replace the rigid container and inner liner; seal inner liner, then seal rigid container with tamper evident tape, but inner liner ID must be displayed (rigid container may not have any outer markings that indicate nature of the contents); make required entries in log book - Process of removal and transfer of containers to reverse distributor for destruction, and placement of new containers in collection receptacle must be recorded by video camera - No on‐site destruction is permitted by Authorized Collector" "What are the requirements for the log book of authorized collector's container and liner records? - CORRECT ANSWER Log book records for each transaction must record: - date container/liner were placed in collection receptacle - inner liner unique ID - date container/liner is taken from the collection receptacle, sealed and provided to reverse distributor - names and signatures of the two authorized employees witnessing/ performing removal and replacement of container/liner - name, registration number, and address of the reverse distributor. **Authorized collector must retain container/liner record logs for 3 years and make them available for inspection at DCP's request" "What does Connecticut Law require for a valid controlled substance prescription? - CORRECT ANSWER - A documented patient evaluation that includes a physical examination - A request for controlled substances based SOLELY on electronic questionnaire results does not constitute a valid practitioner‐patient relationship" "What does Federal Law require for a valid controlled substance prescription? - CORRECT ANSWER To dispense using the internet, must have "valid prescription": - Issued for legitimate purpose in usual course of professional practice - By prescriber who has done in‐person evaluation of patient (or covering prescriber) The federal requirement of in‐person examination does not apply to telemedicine - BUT the prescribing practitioner must have a special registration for telemedicine" "Telehealth providers are prohibited (unless for hospital inpatient) from prescribing CI, CII, or CIIIs via telehealth (without in-person examination). What is the exception to this rule? - CORRECT ANSWER - May prescribe via telehealth a CII or CIII (other than an opioid) for the treatment of a psychiatric disability or substance use disorder (including medication‐assisted treatment) in accordance with Ryan Haight Online Pharmacy Consumer Protection Act (21 USC 829(e)) - If prescribing under the exception, practitioner MUST use electronic prescribing (no waiver permitted)" "T/F: Pharmacists cannot be telehealth providers - CORRECT ANSWER False; they can" "What is the Ryan Haight Online Pharmacy Consumer Protection Act? - CORRECT ANSWER - defines a calid prescription for online dispensing of controlled substances (must have at least 1 in-person medical evaluation of pt) - forming definitions, creating new DEA registration/reporting requirements - gives states the power to take enforcement actions against online pharmacies to protect the State's citizens" "According to Ryan Haight Federal Law, what are the requirements for operating legally as an online pharmacy? - CORRECT ANSWER - Register with DEA as a pharmacy - Obtain DEA registration modification - Have website with specific language - Comply with all requirements for licensure as a pharmacy in each state from and to which it dispenses, delivers or distributes (or offers to dispense, deliver or distribute) controlled substances via the internet - Report monthly to DEA (by 15th) the total amount of controlled substances dispensed - by any means - in the preceding month (actual numbers if 100 Rx's filled or ≥5,000 dosage units dispensed, report negative if below threshold)" "What are the website requirements for online pharmacies under Ryan Haight Federal Law? - CORRECT ANSWER Declaration statement Disclosure info on homepage of website: - pharmacy name and address as it appears on DEA registration - pharmacy phone number and email - name of pharmacist in charge, professional degree, state of licensure and phone number - lost of state(s) where pharmacy is licensed to dispense controlled substances - The name, address, telephone number, professional degree, and States of licensure of any practitioner contracted to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof" "Online pharmacies must give ___days' prior notice to DEA if pharmacy changes its internet website address - CORRECT ANSWER 30" "A DEA registered pharmacy using the internet to facilitate dispensing of controlled substances is not considered an "online pharmacy" if: - CORRECT ANSWER - dispensing consists solely of filling new, or refilling, prescriptions for CIII, CIV, or CV (no CII) - delivery, distribution, or dispensing consists solely of filling prescriptions that were electronically prescribed in a manner authorized by CSA (includes electronically prescribed CIIs) - delivery, distribution, or dispensing consists solely of: transmission of Rx info between pharmacy and automatic dispensing system (ADS) in LTC facility, the pharmacy hold DEA registration of the ADS, and the pharmacy otherwise complies with DEA regulations" "What is PHI? - CORRECT ANSWER - anything a Covered Entity (CE) or Business Associate (BA) knows about a patient because of the Covered Entity's relationship with the patient - PHI includes "limited data sets" - does not have to be healthcare specific - PHI does not include "de‐identified" information" "What must be removed in order to de-identify PHI? - CORRECT ANSWER - names, phone numbers, fax numbers - all geographic info smaller than a state (except initial 3 digits of zip code) - all dates (except year) related to patient (birth date, admission, discharge, date of death, and all dates for those over 89 (including year) - email, URLs, IP address - SSN, MRN, health plan beneficiary numbers, account numbers, certificate/license number, vehicle identifiers and serial numbers, license plates - biometric identifiers (fingerprints, voice prints, photos, and any comparable images) - any other unique identifying number, characteristic, or code" "What is the HIPPA definition of a limited data set? - CORRECT ANSWER Cut‐down of de‐identification, allowing a little more disclosure of PHI (with a written data use agreement) for research, public health, and health care operations, for elements of date and geographic data (to level of city or zip code but no street address - limited data sharing requires a data use agreement that complies with the privacy rile" "In regards to neglect, pharmacists are mandatory reporters for whom? - CORRECT ANSWER Child (18) abuse or neglect - Oral report within 12 hours; written report within 48 hours to DCF Elderly (≥60) abuse or neglect - Report to DSS within 72 hours Abuse or neglect of person with Intellectual disability (or ward of DSS) - Report to DSS within 72 hours" "What must a Notice of Privacy Practices (NoPP) include? - CORRECT ANSWER - How the CE may use and disclose an individual's PHI - The patient's rights regarding PHI (e.g., access, amendment, accounting) and how the patient may make a complaint - The CE's duties regarding the PHI, including a statement that the CE is required by law to maintain the privacy of PHI - Whom the patient may contact for more information about the CE's policies *NoPP is only for treatment, payment, and health care operations" "How must the provider-CE Notice of Privacy Practices be provided? - CORRECT ANSWER - Posted in "clear and prominent location" at site of service (a/k/a "affixed to the wall") - If a summary is posted, the full NOPP needs to be right there to pick up (not acceptable for patient to have to ask for a NOPP) - On CE's website - NOPP must comply with all Limited English Proficiency (LEP), Americans with Disability Act (ADA), and Rehab Act requirements" "Healthcare provider CEs must make sure that NOPP is made available to patient __(1)__, and attempt is made to obtain __(2)__ (and, if unsuccessful, provider signs the form to prove attempt was made) - CORRECT ANSWER 1. on or before first visit 2. an acknowledgement" "T/F: Provider‐CE is required to redistribute a NoPP after revisions and must change the NoPPs that are posted and on the website - CORRECT ANSWER False; they are not require to redistribute a NoPP after revisions BUT must change NoPPs that are posted and on the website" "What must the CE maintain/retain for 6 years after last effective date or creation? - CORRECT ANSWER - HIPAA privacy policies and procedures - Notice of Privacy Practices (NoPP) - Disposition of complaints - Any other: actions (e.g., acknowledgment of NoPP), activities (e.g., disclosure persuant to authorization), designations (e.g., Privacy Officer) that the Privacy Rule requires to be documented" "What is the HIPAA Minimum Necessary Rule? - CORRECT ANSWER HIPAA requires use or disclosure of PHI to be the least amount of information needed to get the job done - applies to internal and external uses and disclosures" "When is sharing info on a common patient allowed between CEs and BAs? - CORRECT ANSWER - treatment - minimum necessary rule for business operations, or payment - A CE/BA is permitted to reasonably rely on the requesting CE/BA as to whether the scope of the PHI requested meets the minimum necessary rule" "HIPAA allows PHI to be disclosed to friends and family only when: - CORRECT ANSWER - consent of individual and family/friend is assisting the individual with healthcare, health insurance, or payment issues - patient has dies and person has access prior to pt death and was involved in care or payment (unless expressly against known wishes of the pt)" "A patient authorization with specific content is required under HIPAA for: - CORRECT ANSWER - psychotherapy notes - marketing activities - sale of PHI - research" "HIPAA Compliant Authorization to use/disclose PHI must contain what items? - CORRECT ANSWER - Description of the information to be used/disclosed - Name of CE authorized to make disclosure/use - Name or identification of person (entity) to whom requested disclosure/use is to be made - Purpose of the use/disclosure - Expiration date/event - Signed & dated by patient (or personal representative, with description of authority to act for patient) - Required statements : right to revoke; potential for re-disclosure that is no longer protected; CE may not condition treatment, enrollment, or eligibility upon signage (except in limited circumstances)" "Generally, in Connecticut, a minor (less than 18 y.o.) does not control his/her own health decisions or records, the minor's parents/guardians control. What are the common exceptions to this? - CORRECT ANSWER - HIV & STDs testing and care - Abortion counseling - Family planning/mature adolescent - Inpatient psych care 16 & 17 years old - Outpatient counseling under special circumstances - Substance abuse treatment - if emancipated (qualified as an adult)" "T/F: HIPAA Privacy Rule allows (but does not require) a CE to release childhood immunization information to school on parent's verbal okay - CORRECT ANSWER True; verbal okay supersedes written authorization and must documented" "What is considered marketing based on HIPAA? - CORRECT ANSWER Any time a CE (or BA) receives "financial remuneration" from a third party (directly or indirectly) in exchange for making a communication to a patient about the third party's product or service *not permitted without pt authorization" "What are the exceptions to the HIPAA marketing rule? - CORRECT ANSWER - Refill reminders (should not be a new formulation or encourage pt to switch or add adjunctive meds) - Communications that promote health (not a particular product or service) - In‐person face‐to‐face communications (not email or phone calls) - Communications about government sponsored programs (e.g., communicating about Medicare or Medicaid eligibility)" "What is the Telephone Consumer Protection Act? - CORRECT ANSWER Regulations that prohibit automated/recorded telephone calls to consumer cell phones absent express written permission *exceptions: emergencies, healthcare messages made by/on behalf of a HIPAA CE or BA" "The sale of PHI for anything of value is prohibited. What are the exceptions to this rule? - CORRECT ANSWER - Public health activities and research purposes (only to extent the price charged for the PHI reflects the cost of preparation and transmittal) - Treatment - Payment - Sale, transfer, merger or consolidation of all or part of CE and for related due diligence (within definition of health care operation) - To an individual per 45 CFR 164.524 and 164.528 (e.g., copy of record) - As "required by law" per 45 CFR 164.512 - Catch all: any purpose permitted by and in accordance with the Privacy Rule, but limited to cost‐based fees or as otherwise expressly permitted by law" "If a CE/BA receives a subpoena for medical records that is signed by a lawyer, the CE/BA should not produce the records unless: - CORRECT ANSWER - a court order requiring production, OR - a HIPAA "qualified protective order" that's been entered in the lawsuit, OR - a HIPAA compliant authorization from the patient that authorizes the disclosure demanded by the subpoena, OR - the CE/BA takes certain additional actions required by HIPAA's rule for subpoenas" "T/F: Lawyers can subpoena records but that does not mean a CE/BA is legally able to comply under HIPAA and state law - CORRECT ANSWER True; pt authorization, court order, or "satisfactory assurances" are needed *DO NOT simply mail records to a court in response to a subpoena" "What are the safety assurances under HIPAA? - CORRECT ANSWER A written statement with documentation demonstrating that: - The time for the individual to raise objections to the court or administrative tribunal has elapsed; AND - The party requesting such information has made a good faith attempt to provide written notice to the individual (or, if the individual's location is unknown, to mail a notice to the individual's last known address) AND - The notice included sufficient information about the litigation or proceeding in which the protected health information is requested to permit the individual to raise an objection to the court or administrative tribunal The time for the individual to raise objections to the court or administrative tribunal has elapsed: - No objections were filed; OR - All objections filed by the individual have been resolved by the court or the administrative tribunal and the disclosures being sought are consistent with such resolution." "How are substance abuse treatment records treated differently involving supoenas? - CORRECT ANSWER 42 CFR Part 2 (federal law) is significantly more restrictive on disclosure of substance use treatment records than HIPAA - applies only to programs that provide SUD treatment or referrals - requires authorization to disclose to another provider for treatment, payment, and health care operations - minor must ALWAYS be asked for authorization (cant disclose to parent unless minor authorizes or lacks capacity to be rational or poses a threat to self/others)" "Why must you complete the application for an Investigational New Drug (IND)? - CORRECT ANSWER - Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. - A sponsor will probably want to ship the investigational drug to clinical investigators in many states, so it MUST seek an exemption from that legal requirement. - The IND is the means through which the sponsor technically obtains this exemption from the FDA" "When is a New Drug Application (NDA) completed? - CORRECT ANSWER - When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval - The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. - all NDA's are assigned an NDA number" "What is an Abbreviated New Drug Application (ANDA)? - CORRECT ANSWER - contains data that provides for the review and ultimate approval of a generic drug product. - generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. - must scientifically demonstrate that its product is bioequivalent" "Compare FDA approval requirements of NDA vs ANDA. - CORRECT ANSWER NDA: - chemistry - manufacturing - controls - labeling - testing - animal studies* - clinical studies* - bioavailability* ANDA: - chemistry - manufacturing - controls - labeling - testing - bioequivalence*" "What is bioequivalence? - CORRECT ANSWER the absence of a significant difference in the rate and extent to which the active ingredient/moiety in pharmaceutical equivalents/ alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study" "What are the 2 regulatory pathways in which a nonprescription drug can be brought to the market? - CORRECT ANSWER - drug application process - OTC drug review (OTC monograph) process" "What is an OTC monograph? - CORRECT ANSWER A "rule book" for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application (NDA) and FDA pre‐market approval" "What is a Biologic License Application? - CORRECT ANSWER - a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. - If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product under the provisions of the Public Health Service (PHS) Act." "FDA Expedited Review Programs - CORRECT ANSWER - priority review: drug shows significant improvement over current standards (FDA acts on request within 60days) - Fast track: drug fills unmet need or advantage over current therapy (FDA acts on request within 60days) - Breakthrough therapy: treats serious condition with clinically significant endpoint and advantage over current therapy (FDA acts on request within 60days) - accelerated approval: uses surrogate or intermediate endpoints to show therapy has promise of clinical benefit" "What is "off label" prescribing? - CORRECT ANSWER any time a patient takes a medication in a manner other than the manufacturer's recommendation *manufacturers may NOT promote off-label uses per FDA but practitioners can prescribe for off-label uses" "A manufacturer's container for a drug must state: - CORRECT ANSWER - name & address of manufacturer/packer/distributor - established name of drug/drug product - net quantity - weight of API per dosage unit (mEq if electrolyte) - inactive ingredients in alphabet order - if Rx only, must say: "Caution: Federal law prohibits dispensing without a prescription" or "Rx only" or "Solamente Rx" - routes of admin - special storage instructions - manufacturers control/ lot number - manufacturer's exp date - bar code (unless sold directly to pt) - if OTC, must have adequate directions for use" "What is the 2006 Physician Labeling Rule? - CORRECT ANSWER **FDA must approve package insert** - highlights, TOC, date FDA initially approved drug, MedWatch info - applies to all drugs approved by NDA or BLA since 6/30/2001 - purpose is to give healthcare professionals info needed for appropriate prescribing" "A prescription is exempt from labeling requirements of FDCA/CT-UFDCA is drug is dispensed "on a written or oral prescription) of an authorized prescriber IF the drug's label contains what elements? - CORRECT ANSWER - Dispenser's name and business address - Serial number - Date of fill/refill - Prescriber's name - Patient's name - Directions for use - Required cautionary statements (if controlled substance: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed") **other requirements apply id dispensed by retail pharmacies and institutional pharmacies for outpatients" "T/F: Effective June 30, 2015, there are no more pregnancy categories (A, B, C, D, X) on prescription drug and biological product labeling - CORRECT ANSWER True; now use subsections for pregnancy, lactation, and female/male reproductive potential" "What are the requirements for the pregnancy subsection labeling? - CORRECT ANSWER - Summary of risks of all relevant data sources (or statement that drug is not absorbed systemically) - If "pregnancy exposure registry" exists, statement of such existence with contact information on how to enroll" "What are the requirements for the lactation subsection labeling? - CORRECT ANSWER - Summary of risks of all relevant data sources (or statement that drug is not absorbed systemically) - Relevant ways to minimize drug exposure when breast feeding, and available interventions for monitoring/mitigating adverse reactions" "What are the requirements for the female/male reproductive potential subsection labeling? - CORRECT ANSWER - Relevant information on pregnancy testing/contraception, and if required/recommended before, during, after use - Any human or animal data that suggests drug‐associated fertility effects" "When does the FDA require Medication Guides to be issued? - CORRECT ANSWER - certain information is necessary to prevent serious adverse effects - patient decision‐making should be informed by information about a known serious side effect with a product, OR - patient adherence to directions for the use of a product are essential to its effectiveness" "What is the exception to providing a Medication Guide when product is dispensed? - CORRECT ANSWER - prescriber may (using clinical judgement) instruct dispenser NOT to provide medication guide *but if pt asks for information, the dispenser MUST provide the medication guide despite prescriber instruction" "What 6 factors are considered when determining whether a REMS should be required? - CORRECT ANSWER - The seriousness and nature of known or potential adverse events and the background incidence - The expected benefit of the drug with respect to the disease or condition. - The seriousness of the disease or condition to be treated. - Whether the drug is a new molecular entity. - The expected or actual duration of treatment with the drug. - The estimated size of the population likely to use the drug." "What are the goals of the MedWatch Program? - CORRECT ANSWER - Increase awareness of drug & device induced disease - Easier process for professionals to report adverse events and product problems to FDA - Provide regular feedback to the healthcare community about safety issues involving medical products" "Who is MedWatch reporting MANDATORY for? - CORRECT ANSWER IND Reporters, manufacturers, distributors, importers, and user facilities (devices) **voluntary for healthcare professionals and consumers" "In a voluntary recall initiated by the manufacturer/distributor, what is required? - CORRECT ANSWER It is the manufacturer's responsibility to send written notices to all wholesalers and pharmacies for recalls in Class I & II categories; some Class III recalls are handled with written notices" "What is a Class I recall? - CORRECT ANSWER Drug product may cause serious adverse health consequences including death, the recall should include stocks in pharmacies and notification of patients to whom drug has been dispensed" "What is a Class II recall? - CORRECT ANSWER Drug product may cause temporary or reversible effects but probability of serious adverse effects is remote - recall usually includes stock in pharmacies" "What is a Class III recall? - CORRECT ANSWER The drug product is unlikely to cause any adverse health consequences" "What are the important elements for a recall communication? - CORRECT ANSWER - should be brief and to the point - clearly identify the product, size, lot number, code, serial number and any other pertinent descriptive information - explain the reason for the recall and any hazard involved - provide specific instructions on what should be done with the recalled product - provide a way for the recipient of the recall communication to report whether it has any product - should NOT contain irrelevant or promotional statements/materials" "T/F: It is the manufacturer/distributor's responsibility to carry our the instructions in the recall communication. - CORRECT ANSWER False; it is the recipient's responsibility" "In a Class I recall of a prescription drug, what does the FDA expect retail, hospital, and nursing home pharmacists to do? - CORRECT ANSWER - review their records to identify all patients to whom the drug was dispensed - notify the patients' prescribers of the recall (prescriber will decide whether patients are to be contacted)" "What is the difference between federal and CT scheduling of marijuana? - CORRECT ANSWER Federal: marijuana is Schedule I (except FDA approved formulations of cannabidiol - CV) CT: changed marijuana from schedule I to schedule II" "Which healthcare professional(s) can apply for and receive a dispensary license? - CORRECT ANSWER only a pharmacist" "What is the maximum number of dispensaries that may be employed by a single dispensary facility? - CORRECT ANSWER 15 unless the DCP approves for more" "What are the requirements for a