PA MPJE FINAL EXAM Questions with 100% correct Answers Already Graded A+.., Exams of Nursing

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PA MPJE FINAL EXAM Questions with 100% correct Answers Already Graded A+. ________ ________ of cancer drug needs to be accounted for in record keeping for Cancer Drug Repository Program - ANSevery dose *Online pharmacies* have to report what to the DEA and how often? - ANSmonthly report of quantity of each CS dispensed and NDC if during the month in question the pharmacy has dispensed at least 100 prescriptions or at least 5000 dosage units 222 Order forms are requisitioned how? - ANSuse DEA 222a form and send to Registration Unit of DEA in Washington DC A _____________ ___________ must be establised by the medical staff to assure quality pharmaceuticals at reasonable costs - ANSformulary system2 A computerized system for recording and maintaining information concerning prescriptions must be designed so that it is capable of what? - ANS- providing immediate retrieval by means of monitor, hard copy printout, or transfer medium of patient information for all prescriptions filled within past 12 months - retrieval within 3 working days of all prescriptions dispensed from 12-24 months from the last activity date including information normally required to be on a prescription and identification of the pharmacist responsible for prescription information entered into the computer system A hard copy of a prescription that is transmitted electronically needs to be stored how long? - ANSat least 2 years from date of most recent filling A nonresident pharmacy may not engage in what with the commonwealth unless what? - ANSmay not engage in business of shipping, mailing or delivering legend devices or legend drugs unless has been issued certificate of registration by the board and has paid the fee established by the board A pharmacist who is employed by a physician under collaborative agreement for the purpose of management of drug therapy may not do what? - ANSengage in retail dispensing within the context of employment A pharmacy can at any time forward CS for destruction to who? - ANSreverse distributor A pharmacy can be held liable for who? Business associates may be held liable for who? - ANSpharmacy liable for business associates; business associates liable for subcontractors A pharmacy does not need to register as a distributor (if they distribute to another pharmacy or physician) of CS as long as what? - ANSsales amount to less than 5% of all controlled substances dispensed and distributed in a year A pharmacy must make reasonable effort to limit the use or disclosure of PHI by doing what? What is this called - ANSusing the minimum amount required to accomplish the purpose of the use or disclosure; called minimum necessary standard A prescription drug written for PRN or ad lib refills may be refilled how long from date of the prescription? - ANS1 year A prescription label must contain what information? - ANS- name, address, telephone number, and DEA number of pharmacy - name of patient and prescriber - full directions for use - serial number of the prescription and the date originally filled - trade or brand name of the drug, strength, dosage form, and quantity - if generic drug also need to include manufacturers name or suitable abbreviation A prescription written for a CS for an animal would not list what? What would it list on the script? - ANSwon't list animal's name; will list species of animal and name and address of the owner ABC-MAP contains information on CS in what schedules? - ANSCII-CV ABC-MAP is operated under who? - ANSauspices of the PA Dept of Health Ability to refuse, revoke, or suspend pharmacist license if what? - ANS- procured license through fraud, misrepresentation or deceit - found guilty, pleaded, guilty, entered plea of nolo contendere or has received probation without verdict, disposition in lieu of trail or an ARD in disposition of felony charges to any offense in connection with the practice of pharmacy or any offense involving moral turpitude - unfit to practice due to use of alcohol or drugs - unit to practice due to physical or mental disease or disability - has had license in any other state revoked or suspended - violated or knowingly permitted the violation of any provision of this act or regulation of the board - has knowingly allowed an unlicensed person to take charge of a pharmacy or engage in compounding or dispensing All patients on thalidomide must do what? - ANSagree to complete a confidential survey about their compliance with contraception, testing, and drug therapy All permit applicants must be of good _______ and _______________ _________________ - ANSmoral and professional character All pharmacists renewing license after January 1, 2015 need to have what specific CE requirement under Act 31? - ANSneed 2 hours of board approved CE in child abuse recognition and reporting All professional staff in hospital setting must have access to what? - ANSinformation related to drug interactions, drug therapy, side effects, toxicology, dosage, indications, and routes of administration All schedule III quantity limitations also come with what stipulation? - ANSmust also be with one or more active, non-narcotic ingredients in recognized therapeutic amounts All schedule V quantity limitations come with what stipulation? - ANShave to be with one or more active non narcotic active medicinal ingredients in sufficient portion to confer upon the mixture or compound valuable medicinal qualities other than possessed by the narcotic alone AMS itself should be inspected how often? For what? - ANSat least monthly for security and accountability An approved provider who makes a disclosure on treatment of an impaired professional will or will not be subject to civil liability for disclosure? - ANSwill not Any amendments, additions, deletions, or other changes to policies and procedures of operation for AMS need to be retained how long? - ANS2 years after then change is made Any applicant that intends to take the NAPLEX and MPJE needs to complete what? Also needs to provide what as part of this? - ANSneed to complete application and provide proof of graduation with BS or advanced degree in pharmacy from ACPE accredited school or college and affidavits of internship (proper hours) Any hospital, healthcare facility, peer, or colleague has cause to report to board (mandatory reporting) if there is evidence that a professional....? - ANS- has active addictive disease for which they are not receiving treatment - is diverting a controlled substance - is mentally or physically incompetent to carry out the duties of his or her license or certificate Any loss or disappearance of a SLCP must be reported to DEA how? - ANSorally ASAP and then followed up with a written report within 15 days Any OTC drugs that were previously available by prescription must have what kind of packaging? - ANSCRC Any patient communication that encourages the purchase or use of a product or service or any activity that involves the sale of PHI also requires what? - ANSpatient authorization (previously most written communications were considered treatment and didn't need authorization) Any person or facility who reports suspection of addiction or diversion by a professional shall be exempt from what? - ANSany civil or criminal liability arising from such report Any person who violates the unlawful acts (Section 8) is guilty of what? What are the penalties? - ANSmisdemeanor; imprisonment for not more than 1 year and fine of no more than $5000 Any renumeration from a drug company beyond the cost of providing refill reminders would require what? - ANSauthorization for release of PHI Any state law or regulation can be ____________ than it's federal counterpart as long as what? - ANSstricter; as long as it doesn't conflict Any subsequent unlawful acts committed after first may result in what penalties? - ANS- imprisonment of not more than 3 years or fine not more than $15000 or both Applicants for NAPLEX/MPJE should review what for the exams? - ANSRegistration bulletins for the two exams on the NABP website Approved program provider shall provide upon request what to the board in regards to an impaired professional? In what situations would this happen? - ANSdisclose consultant information; shall occur in case of impaired professionals who enter into agreement with the board, impaired professionals who are the subject of board investigation of disciplinary proceeding, impaired professionals who voluntarily enter a treatment program other than described above, but who fail to complete the program successfully or adhere to an after-care plan developed by program provider Are cancer drugs allowed to be distributed to other health care providers? If so, who? - ANSYes; can distribute to physicians office, pharmacy, hospital, health care facility, or health clinic for dispensing by pharmacist as allowed by federal or state law Are controlled substances inventories allowed to be stored as part of central record keeping? - ANSNO; maintain at the registered location Are drugs/devices that are prone to degradation from heat, cold fermentation, or prolonged agitation allowed to be mailed? - ANSYes if shipped in a manner which would preserve the integrity of the drug Are electronic orders on the DEA CSOS mandatory? - ANSNo; optional, registrants may continue to use paper DEA form 222 Are electronic prescriptions allowed to be written for CIIs? - ANSYES Are faxed CIII-CV scripts (and non-controls) allowed to serve as original prescriptions? - ANSYES Are interns currently allowed to administer injectables under supervision of a pharmacist? - ANSnot currently, but regulations are being developed Are LTCF residents allowed to purchase medications from pharmacy of choice? - ANSYes; resident must be notified at admission and through stay of right to use pharmacy of choice and of responsibility to comply with facility's policies and state and federal law regarding packaging and labeling Are optometrists allowed to prescribe CIIs? - ANSNO Are pharmacists required to register individually for controlled substance activity? - ANSNO Are pharmacy owners required to submit plans for changing location of a pharmacy to the Board? - ANSNO, but either way the new pharmacy will require inspection and approval by the board prior to opening for business Are refill reminders considered marketing? - ANSno if financial renumeration received is reasonably related to costs of making a refill reminder Are requests for e-z open containers required to be in writing? - ANSNO; but strongly encouraged by CPSC Are there age requirements for purchasing SLCP products? - ANSNot federally; some states impose an age requirement Are there requirements for counter length if multiple technicians or interns present? - ANSNO Are there specific timelines required to notify board if change in name or email (personal)?? - ANSno but should be reported promptly Are USP recommendations on unit dose packaging supported by FDA in law? - ANSFDA issued policy guide to reflect USP stance on unit dose packaging, but never finalized - holder fails to comply with all requirements after permit issued - upon suspension or revocation of a license of an employed pharmacist it is shown that the illegal acts of the pharmacist were within knowledge or should have been within knowledge of the permit holder, partner, or officer - pharmacist or pharmacy policy holder entered into agreement with medical practitioner who is licensed to diver patients to or from specific pharmacy - pharmacy's license, permit or registration to conduct a pharmacy or non-resident pharmacy issued by another licensing authority has been revoked or suspended or pharmacy was otherwise disciplined Board may defer or dismiss any type of corrective action against an impaired professional so long as what? - ANSthe professional is progressing satisfactorily in an approved treatment program Board of pharmacy has _____ ____________ to impose penalties on either pharmacist or permit holder. What does this mean? - ANSwide latitude; means no automatic link between specific infarction and specific penalty Board will only grant internship to pharmacy college internship program if what? - ANS- if the internship program is full-time - if there is no concurrent academic caseload - if the individual achieves a passing grade in the program Bulk prescription container labels must contain what? - ANS- name and address of the manufacturer, packer, or distributor - established name of the drug product - ingredient information, including the quantity and proportion of each active ingredient - if for other than oral use, the names of all inactive ingredients - quantity of the container in terms of weight or measure (like 100 mg) - net quantity or the container (like 1000 tablets) - statement of the recommended or usual dosage, or reference to the package insert - legend "Caution, federal law prohibits dispensing without a prescription" or "Rx only" - route of administration if it is not oral - identifying lot or control number - statement directed to the pharmacist specifying the type of container to be used in dispensing the drug (Dispense in tight, light-resistant container) - expiration date, unless exempted - labeling on or within the package must contain adequate information for use Buyer of a poisonous substance must be of what age? - ANS16 or older By 11/2023 what is required in terms of track and trace under PDMA? - ANSall partnerns (mfg, wholesaler, repackager) required to electronically track and trace all products using standardized numerical identification (SNI) NDC + 20 digit serial number By January 1, 2015 under PDMA all partners (mfg, wholesaler, repackagers) were required to have what? - ANSsystems in place to quarantine, investigate, and notify DEA of any suspect drug product Can a brick and mortar pharmacy still have website and not be considered online pharmacy? - ANSYES; if only do refills of CIII-V or request and fill new CIII-CV if patient has previously had CIII-CV filled Can an Administrative Inspection Warrant be refused? - ANSNO Can any DEA CS registration be transferred? - ANSYes, but need DEA's approval after submitting written request (don't confuse with transfer of business if pharmacy goes out of business) Can cancer drugs donated under the Cancer Drug Repository program be resold? - ANSNO Can CII scripts be faxed? - ANSYES Can CII scripts be partially filled? - ANSYES Can CIIs be refilled? - ANSNo Can drugs that were picked up be returned to stock? - ANSNO; grossly unprofessional conduct Can FDA order drug recalls? - ANSNO Can FDA require drug device recalls? - ANSYES; can require manufacturer to recall Can narcotic controlled substances be mailed? - ANSyes; law previously stated only non-narcotics, but has since been amended Can pharmacist delegate the administration of injectables to another person? - ANSNO; pharmacist is the only one who can administer Can pharmacist manager serve as manager for more than one pharmacy? - ANSnot usually, but can make a request in writing that the Board waive the rule Can pharmacist refuse inspection or withdraw consent during an inspection if only a Notice of Inspection is served? - ANSYes; only search warrant or AIW can't be refused Can pharmacy dispense CS before they are registered with DEA? - ANSNO; no person may engage in activity for which registration is required until application for registration is granted and certificate of registration is issued Can prescription vials be re-used? Why? - ANSas a general rule no because the wear on a plastic vial could compromise the effectiveness specifications Can refill information for CS be stored centrally? - ANSYES Can supplier choose not to accept DEA CSOS order? What are the requirements with this? - ANSyes; need to make statement that the order is not accepted and link the statement of nonacceptance to the original order and it must be retained 2 years Can the DEA show up unannounced to inspect central records? - ANSyes; without warrant of any kind Can you throw away DEA 222 forms completed in error? - ANSNO; need to store Cancer drug repository informed consent form must contain what information? - ANS- drug being dispensed has been donated and may have been previously dispensed - drug was unused even though it was previously dispensed - drug was donated to the approved, participating pharmacy in the drug's original unopened, sealed, and tamer evident packaging to be redistributed - visual inspection has been conducted by the pharmacist in a manner as to be able to reasonably determine that the drug has not expired, has not been adulterated or misbranded - CANNOT guarantee the safety of the drug being dispensed or administered, but the pharmacist as determined that the drug appears to be safe to dispense or administer based on accuracy of the donor form and the visual inspection required Cancer drugs shall only be dispensed by who? Pursuant to what? - ANSby licensed pharmacist pursuant to prescription issued by prescribing practitioner Candidate for authority to administer injectables, biologicals, or immunizations needs to meet what requirements? - ANS- active license to practice pharmacy in PA - completed 10 hours of instruction and experiential training - basic CPR certification Cannot dispense cancer drug to a patient who does not have what? - ANSsigned cancer drug repository informed consent form Central fill pharmacy may fulfill request to process, fill, or refill prescription from pharmacy or patient or prescriber and may deliver as long as what requirements are met? - ANS- the central fill pharmacy has a contract with or has the same owner as the originating pharmacy and the delivering pharmacy (including confidentiality of patient information) - prescription container must show name, address, telephone number and DEA number of the delivering pharmacy - share common electronic file with the pharmacies engaging in centralized prescription processing Copy of written policies and procedures on AMS needs to be kept where? - ANSin the pharmacy and at the long term care facility where the automated medication system is utilized Course on injectables/immunizations must include information on what? - ANS- basic immunology and human immune response - mechanics of immunity, adverse effects, dose and administration schedule of available vaccines - response to an emergency situation as result of the administration - administration of subQ, intradermal, and IM injections - disease epidemiology - standards for immunization practices - vaccine preventable diseases - recommended immunization schedules - vaccine storage and management - biohazard waste disposal and sterile techniques - informed consent - authority and recordkeeping requirements Course used to meet education requirements for authorization to administer injectables must contain what? - ANS- study material - hands on training and techniques for administration - testing with a passing score - minimum of 10 hours of instruction and experiential training - compliance with guidelines and recommendations from CDC, ACPE , or similar health authority or professional body Criminal sanctions can be imposed for HIPAAA if what occurs? - ANSif the disclosure was done intentionally or with knowledge that the information was protected, but was nevertheless disclosed. CRNP ability to prescribe is based on what? - ANScollaborative agreement between CRNP and physician CRNPs can prescribe CS under what restrictions? - ANS- CII drugs for up to 30 DS - CIII-CV substances for up to 90 days CS Collection events are reserved only for who? - ANSLaw enforcement (but pharmacy may partner with law enforcement to hold take back event) CS prescriptions need what additional information on the prescription on file? - ANS- DEA number of the prescriber - manual signature of the prescriber (unless it is an electronic script) CSOS digital certificate is valid until when? - ANSuntil DEA registration under which it is issued expires or until the CSOS CA is notified that the certificate should be revoked Currently, do Plan B and generic equivalents have an age requirement? - ANSNO; available OTC with no age restriction Currently, med guides are required for over how many products? - ANS300 Dangerous drugs include what? - ANSCS, sedatives, anticoagulants, antibiotics, oxytocics, and corticosteroids Data section in pregnancy/lactation provides what? - ANSall available data for the medication and it's use in pregnant women (human data takes precedence over animal data) - includes type of study, which animals used, dosage, types of adverse events, and relationship between drugs exposure in animals vs humans DEA 222 Order forms for __________________, __________________, and _____________________ shall contain only these substances - ANScarfentanil, etorphine hydrochloride, diprenorphine DEA CSOS uses what technology? What does this mean? - ANSPublic Key Infrastructure (PKI) which means users need to obtain CSOS digital certificate for electronic ordering DEA form 41 should NOT be used to record what? - ANStransfer of CS between pharmacy and reverse distributor who is disposing of drugs DEA recommends that the original signed agency agreement with agent to the prescriber be kept by prescriber how long? Copy should also be provided to who? - ANSduring the term of the agency relationship and for a reasonable period after termination or revocation; also provide to practitioner's designated agent, the agent's employer if it isn't the prescriber and any pharmacies that regularly receive communications from the agent pursuant to the agreement DEA requires what kind of computer updating if pharmacy is going to partially fill CII scripts? - ANSreal time updating of computer info and ability to readily retrieve original Rx info and listing of all partial fills Definition of pharmacy internship? - ANSsupervised practical experience required for licensure as a registered pharmacist Definition of treatment for HIPAA purposes? - ANS- all activities associated with filling prescriptions or medication orders including disclosures concerning the drug therapy with prescribers or other health care professionals, DUR activities, and dispensing the medication to the patient Dibucaine OTC must be in CRC if what amount? - ANSmore than 0.5 mg in a single package Do all manufacturers of clozapine have the same registry program? - ANSNO; but all are similar Do manufacturers need to get FDA pre-approval to make drug if a drug monograph is available? - ANSno as long as they simply follow the "recipe" Do patients pay for drugs during an investigational study? - ANSNO; sponsor needs to get special approval from FDA if they want to charge a patient for the investigational drug Do pharmacy supplies in institutional setting differ from those described for retail settings? How about space and sanitary requirements - ANSNo; outlined in PA pharmacy regulations Do practitioners need to be registered individually with the DEA to prescribe controlled substances? Exception? - ANSYES; but if individual practitioner is agent or employee of hospital or other institution the practitioner may, while in the normal course of business administer, dispense, and prescribe controlled substances under the registration of the hospital or institution Do you need to log sale of schedule A poison if it is pursuant to a prescription? - ANSNO Doctor of Dental Medicine abbreviation? - ANSD.M.D. Doctor of Dental Surgery abbreviation? - ANSD.D.S. Doctor of Medicine abbreviation? - ANSM.D. Doctor of Osteopathy abbreviation? - ANSD.O. Doctor of Podiatric Medicine abbreviation? - ANSD.P.M. Doctor of Veterinary Medicine abbreviation? - ANSD.V.M. Documentation of completion of maintenance on AMS should be kept on file where and how long? - ANSin pharmacy for at least 2 years documentation of pharmacist interventions during non-institutional MTM must occur when? - ANSas soon as practicable, but no later than 72 hours after the intervention - ordering lab tests and ordering and performing other diagnostic tests necessary in the management of drug therapy consistent with the testing standards of the institution Drugs and biologicals not specifically prescribed as to time or number of doses must be stopped when? - ANSafter a reasonable time that is predetermined by the medical staff Drugs received in Cancer Drug repository program need to be stored where? - ANSseparately from the rest of the participating pharmacy's stock Drugs that are not accepted under cancer repository program must be what? - ANSdestroyed or disposed of Each change to AMS policy/procedure needs to be what? - ANSsigned or initialed by the registered pharmacist manager and include the date on which the registered pharmacist manager approved the change Each commercial container of CS will have printed what on the bottle? - ANSsymbol on label designating what schedule the CS is listed Each month a patient is on isotretinoin they must have what type of pregnancy testing done? - ANSmust test negative on urine or blood test conducted by CLIA certified laboratory prior to receiving the prescription Each pharmacy requires it's own permit unless what? - ANSunless it is a satellite pharmacy Education requirements for authorization to administer injectables need to be administered in what time frame and using what? - ANScomplete within 2 years prior to application; complete using an evidence-based course Electronic order for controlled substances on CSOS may not be filled if what? - ANS- required data fields not completed - order not signed using a digital signature issued by DEA - digital certificate has expired or been revoked prior to signature - purchaser's public key will not validate the digital certificate - validation of the order shows that the order is invalid for any reason Electronic orders on DEA CSOS must be signed how? - ANSdigital signature issued by a Certification Authority (CA) run by the DEA Electronic transmission of a prescription means what? - ANScommunication of original prescription or refill authorization by electronic means to include computer to computer, computer to fax, or email transmission Electronically transmitting a prescription does not include sending it by what means? - ANSfax or phone Emergency dispensing of Schedule II drugs is allowed when? (3) - ANS- Immediate administration of schedule II substance is necessary - No alternative treatment is available (would a schedule III work?) - It is not reasonably possible for the prescriber to present a written prescription prior to dispensing Emergency kit should contain what? - ANSminimum quantity and categories based on immediate needs of the facility emergency kits should be available how? How should they be secured? - ANSreadily available to staff and have breakaway lock which shall be replaced after each use Emergency kits should be under control of who? - ANSpractitioner authorized to dispense or prescribe medications under the pharmacy act Erythromycin ethyl succinate granules for oral suspension and oral suspensions are exempt from PPPA in what amount? - ANSNMT 8 grams of the equivalent of erythromycin per package Erythromycin ethyl succinate tablets are exempt from PPPA in what amount? - ANSNMT 16 grams of drug per package Every pharmacy needs to post a sign stating what to notify patients of generic substitution? - ANS"PA LAW PERMITS PHARMACISTS TO SUBSTITUTE A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE." Expedited approval of drugs by FDA is for what? - ANSdrugs that treat serious life threatening illnesses and provide a meaningful therapeutic advantage over existing treatments (like AIDS drugs) Expedited approval of investigational drugs by FDA is conditional on what? - ANSneed to complete Phase IV post marketing studies Failure to comply with central record keeping requirements can result in what? - ANSspecial agent in charge of the Administration may cancel the central record keeping authorization without a hearing Failure to enter agreement where impaired professional is in approved treatment program means what for professional license? - ANSdisqualify professional from impaired professional program and activate immediate investigation and disciplinary proceeding by the board Failure to return license or registration after revocation or suspension can result in what? - ANSupon conviction, shall be a misdemeanor of the third degree FDA Amendments Act signed into law in 2007 did what? - ANSgranted FDA broad new authority related to safety of new and already approved drugs including power to require REMS programs FDA has adopted what as the preferred method of communicating information about a drug to a patient? - ANSMedication Guide FDA only needs to present what at time of regular inspection? - ANScredentials and Notice of Inspection Females of childbearing potential need to use what when using isotretinoin? - ANStwo forms of effective contraception simultaneously Final rule on electronic prescriptions for controlled substances became effective when? - ANSJune 1, 2010 First pregnancy test for iPLEDGE program can be done where? Where must the 2nd be done? - ANS- 1st screening test can be in prescribers office - 2nd test must be in CLIA-certified laboratory according to the package insert Fluoride OTC preparations must be in CRC if what amount? - ANScontaining more than 50 mg of elemental fluoride per package For addicts, treatment with methadone for detox/addiction can only be administered where? - ANSmethadone clinic For all dangerous drugs, what needs to be done in institutional setting? - ANS- policies and procedures need to be developed regarding administration - automatic stop orders shall be established for dangerous drugs not specifically prescribed as to time or number of doses For chain pharmacies, it may be more feasible to do what with controlled substance records? Is this allowed? - ANSstore them at a central location; is allowed by DEA if they are notified 14 days in advance, in triplicate by registered or certified mail, return receipt requested For each electronic order on DEA CSOS filled, supplier must forward copy to who, and in what time frame? - ANSforward copy of electronic order or an electronic report of the order in a format that DEA specifies to DEA within 2 business days For Impairment program, board will appoint what? - ANSprofessional consultant who is a licensee of the board with education and experience in identification, treatment, and Hospital regulations for pharmacy services are located where? - ANSTitle 28, Chapter 113 How are devices classified? - ANSaccording to function, premarket approval of certain devices, performance standards, conformance with cGMP regulations, and adherence to record/reporting requirements How are patients eligible to be a part of the cancer drug repository program? - ANS- diagnosed with cancer - doesn't possess or has limited prescription drug coverage related to the treatment of the patient's cancer so that the coverage limits prevent the patient from obtaining cancer drugs - patient doesn't meet the eligibility requirements for state medical assistance program that provides prescription drug coverage related to the treatment of cancer - PA resident meets income limits (prior year's family income not to exceed 350% of the prior year's Federal Poverty Income Guidelines) for the appropriate family size (income limits posted on the Board's web site) How are prescriptions deemed "readily retrievable"? - ANSIf when they are initially filled - the face of the script is stamped in red ink in the lower right corner with the letter C no less than 1 inch high - filed in the prescription file for controlled substances listed in schedule II - in the usual consecutively numbered prescription file for non-controlled substances How can a purchaser cancel part of a 222 order? - ANSnotify the supplier in writing; supplier can then indicate the cancellation on copies 1 and 2 by drawing a line and marking the item cancelled How can pharmacies limit who has access to PHI? - ANSlocked prescription files, shredding paper PHI records that are being discarded How do controlled drugs need to be stored? - ANSsecure, susbtantially constructed locked cabinet or may be dispersed through stock in such a way as to obstruct theft or diversion How do registrants become authorized to establish CS disposal program? - ANSmodify DEA registration How does institution need to meet storage of CS, alcohol and other prescribed drugs - ANSspecial locked storage space How does one need to certify compliance of liability insurance for collaborative agreement? - ANScertify on form available from board of pharmacy and submit the form along with the collaborative agreement and upon request make certificate of insurance available to the board regarding the the licensees maintenance of professional liability insurance How does the FD&C Act define the term drug? - ANS- articles recognized in the official USP, Homeopathic Pharmacopoeia of the US, or the NF, or any supplement to them - articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, in man or other animals - articles (other than food) intended to affect the structure or any function of the body of man or other animals - articles intended for use as a component of any article specified in the above clauses, but does not include devices or their components, parts, or accessories How does VA patient in LTCF get their meds? What rules does this have to be in compliance with? - ANSpharmacy within LTCF or who is contracted with LTCF receives the drugs directly from VA drug benefit program in the patient's name and repackage and relabel those drugs so they may be dispensed in unit doses in compliance with the FDA, USP and LTCF policies and procedures How is dietary supplement defined under FD&C Act? - ANSany product that is intended for ingestion, intended to supplement the diet and that contains vitamins, minerals, herbs or other botanicals, amino acids, concentrate, metabolite, constitutent, extract, or combination of the above; or dietary substance for use by man to supplement the diet by increasing the dietary intake How is protected health information (PHI) defined under HIPAA? - ANS- information created or received by a covered entity - relates to an individuals past, present, or future physical or mental health condition - identifies the individual or creates a reasonable basis to believe that the information can be used to identify the individual How is tamper evident packaging defined? - ANShaving one or more indicators or barriers to entry, which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred How long do records on the CSOS have to be maintained? - ANSelectronically for 2 years How long is a pharmacy internship valid? - ANS6 years from the date of issue, but is invalid if enrollment at school of pharmacy ceases How long must female be on 2 forms of contraception before receiving an initial isotretinoin prescription? How long after does she need to stay on these 2 forms of contraception? - ANS1 month before use, during use of isotretinoin, and for one month after stopping isotretinoin How long must inventory records of controlled substances be maintained? - ANS2 years How many negative pregnancy tests must a female of childbearing potential have before receiving isotretinoin? - ANS2 negative urine or blood pregnancy tests How many tablets of Sudafed 30 mg (Pseudoephedrine HCl) can be purchased? - ANS146 How much base is in 25 mg ephedrine? - ANS20.57 mg How much base is in 30 mg pseudoephedrine HCl? - ANS24.65 mg How much base is in 30 mg pseudoephedrine SO4? - ANS23.22 mg How often are pharmacies required to register for controlled substance activity? With who? - ANSevery 3 years (triennially) with Attorney General How often does P&T committee need to meet? What should be done at these meetings? - ANSat least quarterly; record its proceedings and report to the medical staff How often does training need to be updated for sale of SLCP? - ANSannually How should the numbers in DEA number add up? - ANS- add 2nd, 4th, 6th digits and double that about - then to that amount add first, third and 5th digits - last digit of total should correspond with the last digit in the DEA number How soon before change in personal address does the pharmacy need to notify the board? Why is this limited? - ANSwithin 10 days of the change; because address on file is the official address for serving notices to you (i.e. if board has to notify you that a complaint has been lodged against you and you have limited time frame to respond and don't board will consider it failure to respond if it is due to an address change) How soon do drug therapy management interventions need to be documented? - ANSASAP, but no later than 72 hours after If a CS is filled at a central fill pharmacy prescription label must show what? Who sets these requirements? - ANS- must have retail pharmacy name and address, unique identifier (like DEA registration) and indication that it was filled at a central fill pharmacy - DEA pharmacists manual makes these requirements If a DEA CS registrant is regularly required to dispose of controlled substances (like a hospital), what can be issued? What is the condition? - ANS- Special Agent in Charge can issue authorization for registrant to dispose of the substances without prior approval of the DEA in each instance - condition is that the registrant keep records of such disposals and file periodic reports with the special agent in charge summarizing the disposals If balance of partially filled CII script is not filled within ______ hours, the pharmacist must do what? - ANS72 hours; notify prescriber either to get a new prescription for the balanced owed or to let him/her know that the Rx was not completely filled (i.e. if patient indicates they don't need the balance) If barcode is required for a drug product must contain what? - ANSat minimum the NDC number in a linear bar code which must be included on the drug label If board has probably cause, they have the authority to compel pharmacist to submit to what? - ANSmental or physical examination by physicians or psychologists approved by the board If central fill pharmacy is contracted with private, common, or contract carriers to transport filled prescriptions to retail pharmacy if loss occurs, who is responsible for reporting? What form? - ANScentral fill pharmacy is responsible; DEA form 106 If CII is dispensed in an institution and the patient received, how long do records of this need to be kept? - ANS2 years If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers can do what with the outsourcing facility? - ANShospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight If computer does not have capability to print out each day's CS prescription refill data, what must pharmacist do each day to document any refill information entered into the computer is correct? - ANSsign a logbook or separate file each day, verifying the accuracy of the refill information by the pharmacist If computer is down and information from prescriptions cannot be entered in, it must be entered into computerized record keeping system when? - ANSas soon as it is available for use If computer system is capable, what is required (what must pharmacist do) to show documentation that any CS refill information entered in the computer is correct? - ANSpharmacist must generate printout of each day's CS prescription refill data, verify, date, and sign it within 72 hours of the time the refill was dispensed If covered entity uses PHI for "commercial advantage, personal gain, or malicious harm" what could the penalties be? - ANSup to $250,000 and/or 10 years in prison If CS prescription is filled at a central fill pharmacy, what label must be attached? - ANS- retail pharmacy name and address - unique identifier (like central fill pharmacy DEA number indicating that the prescription was filled at the central fill pharmacy If CS registrant has license suspended or revoked what must they do? - ANSdeliver the Certificate of Registration and all 222 forms to the DEA and at the direction of the DEA either deliver all controlled substances to the DEA or keep them under seal If CSA Notice of Inspection is issued can the pharmacy owner refuse? - ANSYES If DEA 222 order form is filled out and lost and new one is properly executed, where do all the copies go? - ANScopy of the statement is attached to copies 1 and 2 and those are sent to supplier, copy 3 is retained in the pharmacy If DEA 222 order form that was filled out and then lost is subsequently receive by the supplier, what should be done with it? - ANSsupplier shall mark upon the face "not accepted" and return copies 1 and 2 to the pharmacy which attaches it to copy 3 and the statement If DEA approves modifications to CS registration, what will happen? - ANSwill issue a new certificate, which must be maintained with the old certificate If DEA CS registration needs to be modified (change of address, addition of schedules), what needs to happen? - ANSnotify DEA in writing If DEA CS registration renewal form is not received by 30th day before expiration date of current registration, what happens? - ANSpharmacy should contact the local DEA registration specialist or DEA headquarters IF DEA CSOS order is defective can it be corrected? - ANSno neither purchase or supplier can correct, will need to issue new order to be filled If DEA CSOS order is not filled, who has to maintain record? - ANSsupplier does not have to, purchaser must retain electronic copy of the voided order If DEA doesn't say no to transfer of business to another individual, what can occur on the day of transfer? - ANStransfer can occur as long as they don't say no, must complete CS inventory on day of transfer (transfer of CIIs through DEA 222 form) and CS records must be transferred If dispensing emergency CII, quantity dispensed should be how much? - ANSshould only be enough to get the patient through the emergency period If doing mail order and pharmacist substitutes generic drug for brand name, how is communication made? - ANSin communications to mail order customer should include statement saying "PA LAW PERMITS PHARMACISTS TO SUBSTITUTE LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE. CHECK HERE IF YOU DO NOT WISH A LESS EXPENSIVE BRAND OR GENERIC DRUG PRODUCT" If drug cannot be returned to stock bottle, what can be done? - ANSkeep in the vial or container in which they have been repackaged If drug is exposed to conditions of fire, water, or extreme temperature in instances it is also classified as what? Under what Act is this done? - ANSconsidered adulterated if exposed to extremes; under the Controlled Drug Device and Cosmetic Act if drug is rated B it means what? - ANSit cannot be substituted either with an A drug or another B drug If drug is returned to stock, it shouldn't be mixed with what? - ANSdon't mix with stock bottles of different lot numbers or with different expiration dates If drug recall is ordered and there is no lot number (i.e. if it is a RTS bottle, or repackaged) what should be assumed? - ANSthat it is included in the recall If emergency CII script, the script be reduced to writing within what time frame? - ANSimmediately If executing another order form after losing filled out DEA 222 order form, what info must be on the order form? - ANSserial number, date of the lost form, statement stating that the goods covered by the first order form were not received through loss of that order form If expiration date says December 2016, what day does it expire? - ANSthe last day of the month; i.e. December 31st If giving vaccine to child <18 need what? - ANSparenteral consent If going to do drug therapy management need to identify who? - ANSphysician responsible for authorizing drug therapy and pharmacist authorized to perform the drug therapy management If having trouble finding new pharmacy manager, can request extension of how long? - ANS30 days; have to make request in writing If impaired professional enrolls into approved treatment program and enters into an agreement with the board, what can happen to license? - ANSshall be suspended or revoked but enforcement of suspension or revocation shall be stayed for the length of time the professional remains in the program and makes satisfactory progress, complies with terms of agreement and adheres to any limitations on his practice imposed by the board to protect the public If in the opinion of the consultant (after consulting with provider), an impaired professional has not made satisfactory progress in treatment program, then what? - If patient refuses to sign acknowledgement of NOPP, what must the pharmacy do? - ANSpharmacy must make record of this fact and maintain that record for a period of 6 years If patient refuses to sign authorization to release PHI then pharmacy is prohibited from what? - ANSusing or disclosing the information, and the pharmacy may not condition treatment on the receipt of an authorization (can't refuse treatment) If patient requests amendment to their records, pharmacy must respond in what time frame? Example? - ANSwithin 60 days; Ex: if pharmacist inadvertently put someone else's prescription information on your patient profile and once you become aware of it, and you ask the pharmacist to change the records If permit holder in pharmacy fails to renew in time, what must happen? - ANSpharmacy must cease operation until renewal is obtained If pharmacist allows license to lapse for 1 year or more and wishes to reactivate, what must they do? - ANSshow current proficiency to practice pharmacy (can be through full- time practice of pharmacy in another state) If pharmacist dispenses drug that has been recalled, what can happen? - ANScharged with violation of the Food Drug and Cosmetic Act If pharmacist does not notify DEA after physician fails to deliver emergency CII script hard copy, what can happen? - ANSvoids the authority of the pharmacy to accept emergency oral orders for schedule II substances If pharmacist fails to renew license in time, what must happen? - ANSmust cease practice until renewal is obtained If pharmacist fills electronic controlled script, do they have to print out and notate on the script if it is required? - ANSNO; can make the notation electronically and retain annotation electronically in the prescription record or linked to files If pharmacist has license suspended or revoked, need to still do what if they want to have their license reinstated? - ANScomply with CE requirements during period of suspension or revocation If pharmacist holds license in another state, and has disciplinary action taken in another state, need to do what? - ANSreport this on biennial registration, application, or within 90 days of final disposition, whichever is sooner If pharmacist is changing dosing, duration, or frequency of medication prescribed during drug therapy management, how soon does physician need to be notified? - ANSno longer than 72 hours after the change If pharmacist is licensed in multiple states, must report this to who? - ANSBoard of pharmacy on biennial registration application If pharmacist is licensed in multiple states/territories board will also notify these other states/territories if what? - ANSif there is disciplinary actions taken against the pharmacist in PA If pharmacist receives a prescription for Medicaid that is non-compliant with requirements, pharmacy should do what? - ANScorrect it by calling the prescriber for a phoned in, electronic, or faxed prescription If pharmacist receives paper copy of a script that indicates it was previously sent electronically, the pharmacist must do what? - ANScheck records to ensure the electronic version was not received and the prescription dispensed; if both received, need to mark one as void If pharmacist receives paper prescription that indicates electronic script was previously sent to different pharmacy, what should pharmacist do? - ANScheck with that pharmacy to determine whether prescription was received and dispensed - if not then other pharmacy must mark electronic copy void - if was filled, then pharmacist should make paper copy void and not dispense If pharmacist substitutes less expensive generic for brand name drug, need to do what? - ANSnotify the patient or person presenting the prescription or have intern or other person under supervision of pharmacist do it (just need to notify them that generic substitution is possible, advise on price, and informing that they may refuse the substitution either orally or in written statement If pharmacist wishes to dispense/order clozaril, what must they do? - ANShave facility/store registered with clozaril national registry in order to purchase Clozaril from a wholesaler If pharmacists have access to the same database, what are teh recording requirements? - ANSnone provided that both pharmacists have access to the same computerized prescription system which contains the prescription and refill records and incorporate procedures to prevent unauthorized refills If pharmacy closing occurs, what must be done? - ANS- immediately return Permit to the Board of Pharmacy - notify the Board of the disposition of the files and prescription drugs (unless 30 days beyond closing, then need Board permission to sell, transfer, or dispose of files and drugs) - remove pharmacy signs/symbols from the interior and exterior If pharmacy determines that an unfilled (but completed) DEA 222 order form is lost, what happens? - ANSpharmacy executes another order form If pharmacy engages with central fill pharmacy, who is responsible for making the offer to counsel? - ANSthe delivering pharmacy If pharmacy has retail pharmacy operating out of it, do they need a separate DEA registration for CS activity for this pharmacy? - ANSYES If pharmacy has to use or disclose PHI for any purpose other than TPO, what needs to be done? - ANSneed to obtain written authorization from the patient before PHI is used or disclosed If pharmacy is located in a retail establishment, but has different hours, what are the requirements? - ANS- needs to be securely sealed off from the remainder of the retail establishment by an impenetrable floor to ceiling barrier - needs to be securely locked whenever a pharmacist is not present and on duty and shall be closed whenever a licensed pharmacist is not present and on duty - safes, electrical equipment, etc. of the retail establishment may not be located in, or approached through the pharmacy unless a pharmacist is on duty when individuals from the retail establishment need access - hours of pharmacy shall be posted at all points of public access - protocols for access to the pharmacy for bona fide emergencies when its closed shall include notification to the pharmacist manager If pharmacy is to work with LTCF and medicare is to participate, what services must the pharmacist provide for the facility? - ANS- provide consultation on aspects of the provision of pharmacy services in the facility - establish a system of records of receipt and disposition of all CS in sufficient detail to enable an accurate reconciliation - determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled If pharmacy is undergoing alterations, the only way they don't have to close is if what? - ANS- pharmacy takes adequate precautions to protect the health and safety of individuals during the alteration period - plans for the alterations and precautions are submitted to the board at least 30 days prior to the beginning of alteration work and the board raises no objection during that time If pharmacy manager is lost, must notify Board how and in what time frame? - ANSin writing with name f new pharmacist manager within 15 days If pharmacy needs to request assistance from the Special Agent in Charge in regards to destroying CS, what form do they submit? - ANSDEA form 41 If pharmacy permit applicant is a corporation what requirements must be met? - ANS- no director or officer or person having a beneficial interest of more than 10% of the If retail pharmacy installs and operates automated dispensing system at a LTCF what do they need to have? - ANSseparate registration at the location of each LTCF at which automated dispensing systems are located If sales person violates sales, training, certification requirements when it comes to SLCPs, who can do what? - ANSAttorney General can prohibit further selling by this individual If schedule II substances are in what form they become schedule III? - ANSsuppository form If Special agent in charge authorizes blanket approval for destruction of CS, what may also go with this? - ANSSAC may place such conditions as he deems proper on the disposal of CS including method and frequency and detail of reports If strength, quality, or purity of a drug is affected it may be considered what? - ANSadulteration AND misbranding If subsequent investigation of CS determines that nothing was lost or stolen, then what needs to be done? - ANSpharmacist doesn't need to complete DEA form 106, but does need to notify DEA in writing of this fact in order to resolve the initial report and explain why no DEA form 106 was filed regarding the incident If substituting less expensive interchangeable biological, need to ensure that what? - ANScharging regular and customary retail price for the interchangeable product; and recording the substitution If supplier does not have item ordered in stock on DEA 222 form, they can also do what? - ANSendorse the reverse side of the DEA 222 order form to another supplier if they don't have it If tax free alcohol is used in preparation of a compound for patient (in the hospital setting), can the patient be charged for the alcohol? What can they be charged for? - ANScannot charge for the alcohol; can charge for any medicines compounded on the premises and dispensed to patients for use on the premises If the supplier to whom a DEA CSOS lost order was directed subsequently receives the first order, the supplier must then indicate what? - ANSthat it is not accepted and return it to the purchaser; purchaser must link the returned order to the record of that order and the statement If theft or loss of DEA 222 order forms occurs and supplier can't state the serial numbers of the lost/stolen order forms, what do they have to report to DEA? - ANSdate or approximate date of receipt thereof and the names and addresses of the purchasers If there are substantial alterations to layouts or fixtures in an existing pharmacy then what? - ANSpharmacy must close If there is a suspicion of addiction/diversion by another professional and you fail to report it (or fail to report in reasonable time frame), what could the penalties be? - ANS- fine not to exceed $1,000 If there is an error on made on DEA 222 form, what does the purchaser have to do? - ANSNO white out, alterations, erasures are permitted; need to write VOID on all copies and keep stored; use new order form If there was a confirmed theft or loss of CS, pharmacist should do what? - ANScomplete DEA form 106 related to the theft or loss If third party auditor finds that pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions, the pharmacy must not do what? - ANSmust not accept electronic prescriptions that only include subset of the information (i.e. if only hospital DEA on script, application needs to be able to import, store, and display hospital DEA and individual practitioners DEA extension) *pharmacy can continue to process other controlled prescriptions if pharmacy application meets all other requirements* If third party auditor finds that pharmacy application doesn't meet requirements for electronic prescribing of controlled substances, then what? - ANSpharmacy must not accept electronic prescriptions for controlled substances that are subject to the additional information requirements If use different distributor/manufacturer drug to fill refill medication and it is not identical to first fill, when does prescriber need to be notified? - ANSin advance, but if not possible to do in advance then do ASAP thereafter If using a manual system, pharmacist must record what when refilling CIII-CV presciptions? - ANSinitial and date the back of the prescription for each refill If waiver is approved to allow pharmacist to manage more than 1 store at a time, how long is this waiver good for? - ANS60 days in addition to the 15 days that are normally allowed to find a replacement If you are going to advertise 20% of sales of drugs, myst do what? - ANSshow a price list from which derived If you are newly licensed pharmacist do you have to meet CE credits right away? - ANSno, exempt from completing CE hours for the license renewal immediately following licensure If you complete excess hours of CE will they carry over to the next renewal period? - ANSNO Impairment program does not apply to who? - ANSany professional convicted of, pleaded guilty to, or entered a plea of nolo contendere to a felonious act prohibited by the CSDDCA or the conviction of a felony relating to a CS in another jurisdiction In 2009 the age for purchasing Plan B changed to what? - ANSfrom 18 to 17 In 2013, what happened with Plan B sales? - ANSwere allowed to be OTC; generics were allowed OTC shortly thereafter with NO AGE REQUIREMENT In addition to being registered 30 days prior, pharmacies must do what before engaging in internet pharmacy? - ANScontact respective boards of pharmacy for all states they wish to do business in at least 30 days prior In addition to notification that generic substitution is allowed, also need to post what outside pharmacy? - ANSlist of commonly used generically equivalent drugs and interchangeable biological products containing brand names, list of manufacturers, and generic names, alphabetized and in boldface type In addition to requirements to be a qualified physician for buprenorphine requirements, practitioners also need to request what? - ANSwaiver from CSAT, which notifies DEA of all waiver requests to become DATA waived practitioners In an applicant for pharmacy permit is an association, what are the requirements? - ANS- no director or officer has pled guilty or nolo contendere related to practice of pharmacy or moral turpitude - no directed or officer has had a pharmacy or pharmacists license revoked or renewal refused for cause In conjunction with logbook, retailers are required to ask for what during sale of SLCP? - ANSphoto ID issued by either state or federal government or other appropriate ID (list of forms of ID available in CFR; even report card is listed as acceptable ID) In contrast with traditional compunding pharmacies, large batch sterile compounders must follow what rules? - ANSUnder DQSA should become outsourcing facilities and are under more FDA scrutiny to allow for hospital pharmacies and doctors offices to legally buy sterile compounded products from outsourcing facilities In December 2014, FDA changed what in prescription drug labeling in regards to pregnancy and breastfeeding? - ANSeliminated pregnancy categories A, B, C, D, and X and revised so that more complete information about the effects of medicines in pregnancy and breast feeding In PA, pharmacy would be required to be licensed as a wholesaler if what? - ANSif sales to licensed practitioners exceeded 5% of the retail pharmacy's total annual prescription drug sales in PA, what is the rule with prescription refills and therapeutic equivalence? - ANS- refills shall be completed using identical product (same distributor and manufacturer) as dispensed on the original, unless the person presenting the prescription and the practitioner authorize in advance a different manufacturers generic equivalent product In the absence of pharmacist, dispensing of drugs in an institution is limited to what? - ANSlimited to emergencies and shall be performed only under the direct supervision of a practitioner licensed under the state to prescribe and dispense drugs In the context of HIPAA regulations, what is marketing defined as? - ANSto make a communication about a product or service that encourages recipients to purchase or use the product or service In the event a patient experiences an adverse event or reaction under order or protocol, pharmacist must notify physician when? - ANSas soon as practicable and in NO EVENT later than 24 hours after learning of the adverse event or reaction In what situations does an already approved drug become a "new drug" and have to go through NDA approval process? - ANS- if drug contains a new substance (either active, carrier, excipient, or coating, etc.) - when there is a new combination of approved drugs - when the proportion of ingredients in combination is changed - when the dosage, method, duration of administration, or application is changed - when new use for a drug is claimed even though the drug isn't new (new indication) In what situations will board consider non-traditional internship? - ANS- if it is submitted to the Board 90 days in advance - the intern still needs to earn 500 hours in a pharmacy Individual practitioner may issue multiple CS prescriptions authorizing the patient receive total of what day supply? - ANS90 day supply (provided conditions are met) Individuals applying for initial license need how many hours in child abuse recognition training and reporting requirements? - ANS3 hours Individuals applying for initial licensure must do what no later than 12 months after obtaining initial license? - ANSdocument at least 2 hours of CE in pain management, identification of addiction, and at least 2 hours of education in practices of prescribing or dispensing opioids (these can be part of individuals education program or CE program) Individuals who prescribe CS should also register with who? - ANSDEA Information about a patient acquired under OBRA may only be revealed when? - ANS- patient consent - if the Board requires the information - State or Federal law requires it - Court order Initial written orders and countersignature for LTCF may be received how? - ANSby fax which includes the practitioner's signature Inspections from State Board of pharmacy and DOH can or cannot be refused? - ANSCannot Instead of tamper evident packaging, what can the package have? - ANSdistinctive by design (i.e. the packaging cannot be duplicated with commonly available materials or processes; like an OTC inhaler) Institution may not be considered for a pharmacy permit unless what? - ANSunless the pharmacy in that institution is open a minimum of 20 hours per week under the supervision of a registered manager Institutional Medical staff by laws need to specify what? - ANSstaff who are qualified to accept oral orders, to include the ability of pharmacists to accept and transcribe oral orders pertaining to drugs Inventory must also be taken of controlled substances when? - ANSchange in ownership Inventory must be taken at what time of the day? - ANSbeginning or close of business and the time must be recorded in the inventory record Inventory must contain what? - ANScomplete and accurate count of all controlled substances "on hand" (i.e. in the possession of or under the control of the registrant Inventory records for CII must be _______ _______________ - ANSkept separately Inventory records for CIII-CV must be ____________ _______________ - ANSreadily retrievable Investigational drugs can be approved for patients in the general population provided what? - ANS- it is pursuant to treatment protocol that has been submitted to the FDA - the drug is used to treat a serious or immediately life threatening disease - there is no comparable or satisfactory alternative drug or other therapy available - the drug is an approved investigational new drug being used in a controlled clinical trial, or all clinical trials have been completed and the sponsor of the clinical trial is actively pursuing market approval Ipecac syrup can be available without prescription if in what quantity ? - ANSpackaged in quantity of 1 fluid ounce (30 milliliters) iPLEDGE designed to create link between what? - ANSnegative pregnancy test and the dispensing of the prescription for the female patient of childbearing potential iPLEDGE requires registration of who? - ANSwholesalers distributing isotretinoin, healthcare professionals prescribing isotretinoin, pharmacies dispensing isotretinoin and all male and female patients prescribed isotretinoin Is a pedigree required under FDA? - ANSNo; PDMA now doesn't allow because a court ruled it had an unfair economic impact on secondary wholesalers Is a pharmacist required to counsel on refill prescriptions? - ANSNO (surprisingly) Is faxing of CII scripts allowed? - ANSYES, but generally before dispensing a faxed CII order pharmacist must receive the original signed Rx for review Is it a federal or state law to lock up schedule II drugs? - ANSNO; but is legitimate precaution Is it legal for a practitioner to write a script for a drug for an off-label use and for a pharmacist to fill it? - ANSYES; just must use professional judgement (manufacturer may distribute peer reviewed literature that describes off label use) Is it mandatory to use 222 forms in sequential order? - ANSno; but makes sense to do so considering reporting requirements for lost/stolen forms Is it required to record the signature of those taking inventory? - ANSNO; not required, but recommended Is name of collaborating physician required on a prescription from nurse midwife? - ANSno Is NDC number required on bulk prescription container labels? - ANSNO (suprisingly); but it is requested on all prescription and OTC drug labels and labeling Is orange book federal law? - ANSNO; only used as a guide to states as they enact their own substitution laws and regulations Is PA law in agreement with USP guidelines on beyond use date for multiple use containers? - ANSYES; use manufacturers expiration date if it is less than 1 year, otherwise use 1 year Is promoting the sale of CS okay? - ANSNO Med guides are applicable to both ____ and ____________ prescriptions - ANSnew and refill Medicaid prescriptions are required to be tamper resistant which means it must have what characteristics? - ANS- prevent unauthorized copying of completed or blank prescription forms - prevent erasure or modification of information written on the prescription - prevent the use of counterfeit prescription forms Medical records for a resident of LTCF need to be retained how long? - ANS7 years following resident's discharge or death Medications in LTCF need to be administered under written orders of who? - ANSattending physician Medications in LTCF shall be administered by the same licensed person who did what? When does it need to be given? - ANSprepared the dose for administration;l ASAP after dose is prepared Medications shall be administered to LTCF patient by who? - ANSauthorized personnel including doctor, dentist, RN, LPN, CRNP, PA, etc. Meds in AMS should be inspected how often? For what? - ANSat least monthly for expiration date, misbranding, physical integrity Meds that have been returned to stock and lack original lot numbers or expiration dates should only be dispensed in what time frame? - ANSup to 6 months from the date they were first prepared for dispensing members of the state board of pharmacy serve lasting how long? How many terms are allowed? - ANS6 year terms with no more than 2 consecutive terms Methadone may only be dispensed in retail setting for what? Methadone cannot be dispensed in retail setting for what use? - ANSonly dispense for analgesia; cannot dispense for detoxification or maintenance of detox Methylprednisolone tablets are exempt from PPPA in what amount? - ANSNMT 84 mg of drug per package Mid level practitioner DEA numbers begin with what letter? - ANSM Midwife abbreviation? - ANSC.N.M. Midwife prescribing is based on what? - ANScollaborative agreement with a physician Midwives may only prescribe what medications after consulting with a physician? - ANSpsychotropic drugs minimum necessary standard with PHI does not apply to what? - ANSdisclosures for treatment purposes, disclosures to the patient themselves, or to disclosures made pursuant to a written authorization from the patient Minimum size of a prescription area must be how large? - ANS250 square feet Minoxidil OTC preparations must be in CRC if what amount? - ANSContaining more than 14 mg in a single retail package Most CV substances are what? - ANScough suppressants or antidiarrheals Mouthwashes OTC must be in CRC if what amount? - ANS3 grams or more of ethanol in a single package MTM agreement may be terminated when? By who? - ANSat any time at the request of any party to it MTM requirements in non-institutional setting are similar to institutional, but instead of protocol, MTM in non-instutional setting is pursuant to what? - ANScollaborative agreement Multiple CII prescriptions may only be issued if the practitioner concludes what? And if practitioner does what? - ANS- concludes that providing the patient with multiple prescriptions in this manner does not create undue risk of diversion or abuse - and if practitioner complies with all other requirements under the Act and these regulations as well as any additional requirements under state law Must document what in regards to cancer drug repository program (4 Ds)? - ANSDonation, Dispensing, Distribution, Destruction Must record dispensing of cancer drug on what? - ANSrepository dispensing form Must record receipt of cancer drug on what? - ANSrepository donor form Naproxen OTC preparations must be in CRC if what amount? - ANScontaining the equivalent of 250 mg in a retail package Need to administer injectables/immunizations in accordance with guidelines from who? - ANSCDC Need to ensure prescription is written by a prescriber acting within what? - ANSscope of practice (i.e. dentist can't write for birth control) Need to notify PCP if injectable is given within what time frame? - ANSwithin 48 hours upon administration (for any age) Need to provide what information after giving injectable pursuant to protocol to physician/PCP? - ANS- identity of patient - identity of the medication, biological, or immunization - site of administration - dose administered - date of administration need to record what relative to VIS? - ANSdate of publication of the VIS and the date and to whom it was provided New DEA policy on agents of prescribers for CS does what what? - ANScreates a vehicle (written agent agreement) for individuals acting outside of employee/employer relationship to be considered agents of the prescriber New permit is required and filed for within 30 days of changes to what? - ANS- name - ownership - controlling interest Newly scheduled drugs must be inventoried when? - ANSthe day they become scheduled and then again with the next scheduled biennial inventory No DEA registrant may employ an individual who has access to CS if that individual has previously had what? - ANSprevious conviction of felony offense related to CS or who at any time had an application for CS registration denied, revoked, or surrendered for any cause (individuals who find themselves in this situation can request a waiver from the DEA from this prohibition) Non-resident pharmacies must meet what operational requirements? - ANS- regular hours of operation but not less than 6 days per week and minimum 40 hours per week - provide toll-free telephone number to facilitate communication with patients in the commonwealth - toll-free number disclosed on label affixed to each container of drugs dispensed to patients in PA NOPP must contain what statement on the face of the document? - ANS"This notice describes how medical information about you may be used and disclosed and how you can get access to this information, please review it carefully" NOPP must convey what information to the patient? - ANS- description and at least one example of how pharmacy will use patient's PHI - statement of the types of uses and disclosures that require prior authorization from the patient Order from a prescriber for injectable can come in what format? - ANSwritten, oral, or electronic Original prescriptions need to be kept how long? - ANS2 years (if refilled, need to keep 2 years from the date of last refill) OTC drug monographs can be like what? In what way? - ANSa recipe; manufacturer adheres to the acceptable ingredients, doses, formulations, and labeling in the OTC monograph OTC monographs also define what? - ANSsafety, effectiveness, and labeling of all marketing OTC active ingredients OTC products can seek approval/marketing through what methods? - ANSNew Drug Application, Abbreviated New Drug Application (ANDA), or under an OTC monograph Out of the two parties exchanging CII drugs, which party completes the DEA 222 form? - ANSwhoever is RECEIVING the CS Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for ______________ _______ - ANSpatient use Outsourcing facilities must follow what rules? - ANS- must comply with CGMP - will be inspected by FDA according to risk-based schedule - must meet certain other conditions like reporting adverse events and providing FDA with certain information about the products they compound Oversight of pharmaceutical services in LTCF will be responsibility of who? What needs to be developed? - ANSquality assurance committee; will develop written polices and procedures for drug therapy, distribution, administration, control, and accountability and use with input from pharmacist PA board of pharmacy may revoke, suspend the certificate of registration for non- resident pharmacy in what situations? - ANS- conduct which causes serious bodily injury or psychological injury to a resident of the commonwealth provided the board has referred the matter to the regulatory or licensing agency in the state in which the non- resident pharmacy is located - upon proof satisfactory to the board that the nonresident pharmacy's permit to conduct a pharmacy was suspended or revoked or the nonresident pharmacy was otherwise disciplined by the proper licensing authority of another state PA law requires that anyone in possession of distressed drugs do what? - ANSnotify the Dept of Health so that items may be inspected to determine their fitness for use or consumption PA regulations place what time limit in which CII script must be filled from the date of issue? - ANS6 months Participation in cancer drug repository program requires _______________ _______________________ - ANSelaborate recordkeeping Participation of pharmacist and physician in collaborative agreement is ______________ - ANSvoluntary Patient package inserts are required for which drugs? - ANSoral contraceptives and estrogens Patient profile needs to be maintained for how long? - ANS2 years after last entry Patient should be given a right to do what when it comes to drug therapy management? - ANSrefuse the DTM/MTM Patient's healthcare information can only be disclosed for what reasons? - ANS- to provide health care to the patient - obtain payment for the health care services provided - or in connection with the day to day operations of the pharmacy Patients also have the right to restrict disclosures about their treatment to a health plan if they have done what? - ANSpaid in full out of pocket Patients can receive copies of their health information in what format? - ANSelectronic or paper (whatever the request) Patients who may take TIRF need to do what? - ANSrequired to sign patient-prescriber agreement form Patients will receive what as part of the STEPS program? - ANSvisual aids including a videotape, written material, verbal counseling about benefits and risks and the importance of not becoming pregnant during therapy PDMA bans trade, sale, or purchase of what? - ANS- drug samples - prescription drugs that have been purchased by a hospital, health care entity, or charitable organization PDMA requires that requests for drug samples be initiated by who? How is request initiated? And where do drug samples need to be stored? - ANSphysician must request in writing; have to store in hospital pharmacy, NOT retail and receipt must be issued Per PA regulations are there quantity limits on CII scripts? - ANSNo; but pharmacist is responsible as part of corresponding responsibility to ensure any quantity written for is reasonable Person receiving order from prescriber in LTCF needs to do what after receiving order? - ANSimmediately record the order in the patient's clinical record and sign and date the entry Personal Address change form on board website requires what? - ANSinclude both old address and new address, license number, SSN, date of birth Personal Name change form on board website requires what? - ANSnew name, former name, and official documentation that legalized the name change (like marriage license, or court document), license number, SSN, date of birth Persons who wish to dispense controlled substances using an electronic prescription must have what? - ANSsoftware that meets requirements of the rule Pharmaceutical service in a hospital needs to be directed by who? - ANSpharmacist Pharmacies are required to enter what info in ABC-MAP? WHen does it have to be entered? - ANS- name of prescriber - prescribers DEA number - date Rx was written - date Rx was filled - name, date of birth, gender, address of patient - NDC number of the drug dispensed, quantity, days supply - DEA and NPI numbers of the pharmacy - payment method the patient used enter within 1 business day of dispensing Pharmacies electronically sharing a real time, online database may transfer CS prescriptions how many time? - ANSas many times as needed up to the maximum refills allowed by law Pharmacies may only participate in what kind of CS disposal programs? - ANScollection receptacles Pharmacies must submit what to PDMP if they did not dispense any CS on a given business days? What is the exception? - ANSmust submit zero-report; can request waiver from submitting zero reports if the pharmacy never dispenses CS or dispenses less than 5 CS per month Pharmacies that utilize or act as central fill pharmacy or central processing center myst have what? - ANSoperating policies and procedures to include audit trail that records and documents the central prescription process and the individuals accountable at each step in the process for complying with applicable law and regulations including those applicable to recordkeeping Pharmacist requirements, drug regimen reviews, labeling of drugs and biologics, and storage of drugs and biologicals are all requirements for what? - ANSfor medicare to participate Pharmacist should ensure what if getting emergency CII script? - ANSreasonable effort must be made to ascertain that the oral authorization came from a registered individual practitioner Pharmacist transferring a prescription out does what? - ANS- cancels the original prescription in his/her records - indicates on the prescription records to whom the prescription was tranferred, including name of pharmacy - indicates date of transfer and his/her name or initials as the transferring pharmacist Pharmacist who allows license to lapse must also do what in terms of CE? - ANSearn required number of CE credits he/she would have been required to earn had he/she held an active license Pharmacist who is receiving a transferred prescription needs to record what? - ANS- note that it is a transferred prescription on the script - date of issuance of original script - date of original filling - original number of refills authorized - complete refill record from original prescription - number of valid refills remaining - location and file number of the original prescription - name of the pharmacy and pharmacist from whom the prescription was tranferred Pharmacists are equally responsible/liable as prescribing practitioner when filling CS prescription. What is this called? - ANSCorresponding Responsibility Doctrine Pharmacists may inquire if a physician is qualified to write for buprenorphine by doing what? - ANS- call 1-866-BUP-CSAT - email [email protected] - check SAMHSA web site Pharmacists may query ABC-MAP for any patient they consider filling CS for, but they MUST check ABC-MAP before filling CS for opioid or benzo for which patients? - ANS- patient is a new patient - patient pays cash when they have insurance - patient requests an early refill - patient is getting opioids or benzos from more than one prescriber Pharmacists need to look for what before dispensing Lotronex prescription? How can prescriptions be accepted? - ANSNeed to look for PPL sticker which provides verification to the pharmacist that the prescription is written by a certified prescriber enrolled in PPL; Cannot accept telephone, fax, or computerized scripts for Lotronex, NEEDS TO BE HARD COPY Pharmacy also needs to take steps to ensure that PHI is limited to which persons? - ANSonly those who have a right to access PHI Pharmacy cannot process electronic prescriptions for controlled substances until what? - ANS- pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEAs requirements - and application provider provides the audit/certification report to the pharmacy Pharmacy is required to make a _________ ___________ effort to obtain a patient's written acknoledgement of receipt of NOPP - ANSgood faith Pharmacy may not contribute in any way to the installation of a fax machine where? - ANSin prescriber office or institution Pharmacy may place an ____________ ______ with CS in a non-DEA registered LTCF if what? - ANSemergency kit; if state agency or regulatory authority specifically approves the placement Pharmacy may use what to keep track of telephone prescriptions, refills, counseling, etc? - ANScomputerized recordkeeping system Pharmacy must maintain an inventory worth how much? - ANS$5000 of non-proprietary (prescription) drugs and devices at cost Pharmacy needs to be classified as what to perform on site destruction of CS? - ANScollector (and be DEA registered) Pharmacy permit should contain what information? - ANS- name and address of pharmacy (can only display name under which it is registered) - name of current owner - name of current pharmacist manager Pharmacy permits are renewed when? - ANSevery 2 years in odd-numbered years Pharmacy records what for any CIII-CV drugs that are being sent to reverse distributor? - ANS- name of drug - strength - quantity - date of transfer Pharmacy that uses AMS to fill prescriptions or med orders needs to have what in case of emergency? - ANSplan for recovery of disaster that interrupts the ability of the pharmacy to provide services Physical copy of emergency CII script needs to be delivered to the pharmacy within what time frame? What does it need to have on it? HOw does PA law differ on this issue? - ANS- prescriber must deliver or postmark prescription to the pharmacy within 7 days - with the words "Authorization for emergency dispensing." - PA law says delivery of hard copy cover must be within 72 hours Physician Assistant abbreviation? - ANSP.A. or PA-C Physician can delegate prescribing, dispensing, and administration of drugs and therapeutic devices to the physician assistant if what? - ANSif drug/device is permitted under the written agreement Physician should do what as part of drug therapy management? - ANS- authorize pharmacist - supervise - notify patients of role of pharmacist whose drug therapy management may be affected by the pharmacist through drug therapy management Physician telephone and oral orders for medications in LTCF need to be dated and signed when? - ANSsign by prescribing practitioner within 48 hours Physicians must countersign and date verbal orders to physicians assistants or CRNPs within what time frame? - ANS7 days Physicians prescribing buprenorphine are initially limited how? When are these limitations lifted (and what are the new regulations)? - ANSlimited to 30 patients initially; can request to treat up to 100 patients after 1 year; and new regs say if physician has prescribed buprenorphine to 100 patients for at least 1 year they can now apply to increase their patient limits to 275 Physicians prescribing buprenorphine must also have capacity to do what? - ANSrefer patient's for necessary ancillary services (like psychosocial therapy) Poisons are divided into what schedules? - ANSA and B Policies and procedures on the operation of AMS created or adopted by pharmacy must contain what? - ANS- tablet of contents - description of all procedures of operation - identification of the circumstances under which medications may be removed from the AMS by a licensed medical practitioner for distribution to a patient without prior order review by a licensed pharmacist Policies for receiving oral orders in LTCF shall include what? - ANS- identification of all medications and treatments which may not be prescribed and dispensed pursuant to an oral order - sales pursuant to an outpatient prescription in the hospital Prescription for CS must be issued for ___________ _____________ ________________ by a practitioner acting in ______________ ______________ __ __________ __________________ ______________ - ANSlegitimate medical purpose; usual course of higher professional practice Prescription monitoring law created what? - ANScontrolled substance database called the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Prescription Monitoring Law was signed into law and became effective when? - ANSJune 30, 2015 effective and was operational August 2016 Prescription monitoring program laws also have liability built in for what? However, also notes what? - ANSto protect pharmacists for submitting information or not seeking information from the program prior to dispensing (however criminal and civil penalties are built in if one is using database for fraudulent or criminal purposes) Prescription sent electronically must have what protection? - ANSbe electronically encrypted or transmitted by other technological means designed to protect and prevent access, alteration, manipulation, or use by any unauthorized person Prescriptions for CII substances shall be maintained where? - ANSin a separate prescription file Prescriptions for CIII-CV substances shall be maintained how? - ANSin a separate file or in such form that they are readily retrievable from other prescriptions in the pharmacy Prescriptions kept on file in a pharmacy need to include what? - ANS- name and address of the patient - name and address or other identifier of the prescriber - date the prescription was issued - name and quantity of the drug prescribed - directions for use; including cautions communicated to consumer - date the prescription was compounded and dispensed - name or initials of the dispensing pharmacist Prescriptions may be refilled how long from the date of the prescription if refills have been authorized? - ANS1 year Prescriptions that have not been picked up or delivered to the patient should be assess for RTS when? - ANSperiodically by the pharmacist Presence of NDC number does not indicate what? - ANSthat a drug has received an NDA approval Previously breaches only needed to be reported if what? - ANSif they posed risk of financial, reputational, or other harm to the affected individuals Print out of refill information for a CS must include what for refill by refill audit trail? - ANS- name of prescribing practitioner - name and address of patient - quantity dispensed on each refill - date of dispensing for each refill - name or ID code of dispensing pharmacist - number of the original prescription order Prior to dispensing donated cancer drug, need to do what? - ANSinform the patient that the drug was previously dispensed, but was unused and then donated in original, unopened, sealed, and tamper evident unit dose packaging to be restocked and redistributed Prior to Durham Humphrey who determined if drug was prescription or OTC? - ANSmanufacturer Prior to performing any services in connection with AMS, pharmacy manager must ensure what? - ANSall licensed practitioners and supportive personnel are trained in pharmacy's SOP in regard to AMS as set forth in the written policies and procedures; training needs to be documented and available for inspection Protocol for MTM needs to be signed by who? - ANSlicensed physicians and pharmacists who are entering into the protocol and the dates signed Protocol for physician/pharmacist agreement to administer injectables must include what? - ANS- participating pharmacist and prescriber or institution - medication, biological, or immunizations that may be administered - patient or groups of patients to receive the injectables - authorized routes and sites of administration allowed -course of action to follow in emergency situations (like adverse reactions) - length of time the pharmaicst shall observe the individual after injection - location at which pharmacist may administer - recordkeeping requirements and procedures for notification of administration - allowance for termination of the protocol upon request at any time QA program for AMS requires what? - ANS- monitoring of AMS - establishes mechanisms and procedures to test the accuracy of the automated medication system at least every 6 months and whenever any upgrade or change is made to the system - requires the pharmacy to maintain all documentation relating to the written program for QA for at least 2 years and upon request provide information to the Board regarding quality assurance program Re-use of prescription vials may be allowed if what? Why? - ANSif the container is glass due to negligible wear/damage and provided a new child-resistant closure is used (this also can apply to any other package type that is not prone to wear) Reciprocally licensed pharmacists need to start accumulating contact hours when? How many? - ANSneed to start at the beginning of the next quarter following licensure and will be required to earn 3.75 contact hours each quarter thereafter until the end of the licensure period Recommendation from the Secretary of Dept of HHS is ______________ on the Attorney General - ANSbinding Record of destruction or disposal of cancer drugs that are not accepted for donation may include what? - ANS- date of destruction - name, strength, quantity of cancer drug destroyed - name of person or firm that destroyed the drug - source of drugs destroyed Record of disclosures must be maintained for how long? - ANS6 years Records for drugs dispensed from the pharmacy should be maintained where? - ANSin the pharmacy Records related to administration of immunizations/injectables needs to be maintained how long? - ANS2 years minimum Registrant can renew CS registration application when? WHat form needs to be completed? - ANSno more than 60 days prior to current expiration date; complete DEA 224a appication REMS programs may include what components? - ANSmed guides, communication plans, and/or elements to assure safe use (ETASU) Renewal applications for authority to administer injectables needs to show what? - ANSthat pharmacist has completed a minimum of 2 of the 30 required hours of continuing education in this area of practice and current CPR certification Residents of LTCF need written physician order for each medication received including what? - ANSOTC meds Responsibility for proper prescribing and dispensing of CS is upon who? - ANSprescribing practitioner Retail pharmacies are typically inspected by who? - ANSBoard of Pharmacy Seller of dietary supplements must have substantiation that what? - ANSnutritional support statements are truthful and not misleading Separate controlled substance registrations are required for what activities normally? - ANS- manufacturing - distributing - reverse distributing - dispensing/instructing - research - importing - exporting - narcotic treatment program - chemical analyses Separate registrations are required for ________ pharmacy owned or operated by the same firm - ANSeach SLCP logbook entries must be maintained how long? - ANS2 years following the date of entry SLCP logbook must also include what? - ANS- Notice stating "WARNING: Section 1001 of Title 18, USC states that woever with respect to the logbook knowingly and willingly falsifies, conceals, or covers up by any trick, scheme or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than 5 years, or both So what are the 3-2-2 filing method options? What does PA law say about these? - ANS- II, III-V, non-controls (3 files) - II, III-V and non-controls (2 files) - II and III-V, and non-controls (2 files) *PA law says can only use first 2 methods* (CII scripts need to be separate) Sodium fluoride products are exempt from PPPA in what amount? - ANSNMT 110 mg of sodium fluoride per package (equivalent of 50 mg of elemental fluoride per package) Sole pharmacist may take a 30 minute break as long as what? - ANS- stay in immediate building - still be available for counseling emergencies - pharmacy can remain open during break to receive new scripts, prepare Rxs for final verifiation, deliver Rxs already verified Spilled or damaged controlled substances that are NON-recoverable are required to be destroyed how and reported how? - ANSwill already be non-recoverable (duh); simply record in CS records (with 2 witnesses needed), but NO DEA 41 form Spilled or damaged controlled substances that are recoverable are required to be destroyed how and reported how? - ANSdestroy using accepted destruction method, report on DEA 41 form Staff involved in administration of resident care in LTCF need to be knowledgeable in what? - ANSP&P regarding pharmacy services including med administration Standing order for naloxone strongly encourages what? - ANSfor those obtaining naloxone to complete a training program and provide link to approved program Substitution is only allowed if drugs are _______________ __________________ - ANStherapeutically equivalent (A drugs can be substituted for each other) Subutex and Suboxone are what schedule CS? - ANSCIII Subutex is typically used for ___________ _________________ and Suboxone is used for ________________ _______________ - ANSsubutex for initial treatment, suboxone for maintenance treatment Supplier may void part or all of an order on a DEA 222 form how? - ANSnotify the purchaser in writing, indicate the voiding on copies 1 and 2 by drawing a line through the cancelled items and printing void in the space provided for the number of items shipped Symbol with CS schedule has to be printed how on bottle? - ANSprominently located on the label or the labeling of the commercial container and shall be large enough to afford easy identification of the schedule of the CS upon inspection without removal from the dispenser's shelf (there were formerly height requirements for the lettering, but now as long as it can be seen when walking by its okay) Syringes and needles are permitted to be sold with or without script? - ANSeither with or without Syringes and needles for sale must be kept where? - ANSin the prescription area Tamper Evident Packaging Act was enacted in response to what? - ANScontamination of Tylenol capsules with cyanide in 1982 Tax free alcohol can be used for what? - ANSscientific, medicinal and mechanical purposes, and in the treatment of patients The 2 year retention rule for DEA records is based on what date? - ANSlast entry made (i.e. for 222 forms it's not from the date of order, but from the date that the packages were received and the date received on copy 3) The AMS must electronically record what? - ANSacitivity of each pharmacist, tech, or other authorized personnel with the time, date, and initials or other identifier so that a clear, readily retrievable audit trail is established The Final Rule for Disposal of CS does what? - ANSsets requirements for DEA registrants that voluntarily decide to establish disposal programs to collect unwanted CS from ultimate users; allows numerous DEA registrants to become authorized to establish disposal programs including manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics, and retail pharmacies The letter "L" in an optometrist's license indicates what? - ANSthat the optometrist may not prescribe drugs The most important thing to remember with release of PHI is what? - ANSit's okay to do as long as there is signed patient authorization; NEVER share PHI without signed authorization The offer to counsel shall be made to each patient when? - ANSfor each NEW retail or outpatient prescription The only setting where tax free alcohol can be used is where? - ANSin the hospital setting; may not be used in retail setting The pharmacy may not cancel an item on its own by doing what? - ANSdrawing a line and marking the item cancelled Therapeutically Ceritifed Optometrists will have what in license number? - ANSletter "T" Therapeutically certified optometrists can prescribe what? - ANS- topical anesthetics - topical ocular lubricants - topical ophthalmic dyes and stains - topical hyper-osmotic agents - topical autonomic drugs - topical NSAIDs - topical antimicrobials - topical and oral analgesics - topical anti-allergy (antihistamines and mast cell stabilizers) - topical steroids and oral steroids (prednisone and methylprednisolone) - topical immunomodulators Therapeutically certified optometrists may not prescribe what? - ANS- any parenteral drug - beta blockers - drugs for systemic conditions except as an adjunctive therapy and shall be limited to anterior eye structures - drugs for glaucoma - provide a written notice of inspection Under the CSAT/SAMHSA program, what are the requirements? - ANS-practitioners intending to treat opioid addiction must apply for certification by CSAT and applicable state methadone authority - certification determined by accreditation body that evaluates whether the OTP meets the required standards Under the LTC patient access to pharmaceuticals act, what kind of immunity is described? - ANSpharmacy serving the LTCF is immune from civil liability arising from dispensation of repackaged drugs as long as pharmacy properly repackages and relabels the drug Under Waxman Hatch what was not required for generic drug approval? What does generic manufacturer have to do? - ANSgeneric manufacturer was not required to prove safety and efficacy of the drug through clinical studies, but only had to show the drug was bioavailable and bioequivalent to innovator drug Unit dose test failure occurs if what? - ANSif child can access more than 8 individual doses or a toxic amount, whichever is less Upon receipt of cancer drug from donation, must do what? - ANSvisually inspect to determine if they were previously adulterated or misbranded Upon request, pharmacy must provide written policies and procedures on AMS to who? - ANSBoard of pharmacy for inspection and review Upon written request from the DEA, the registrant must supply central records to the registered location within what time frame? - ANS2 days Waxman Hatch Amendment also did what for brand name drug manufacturers? - ANSextended the patent life for the time of the FDA approval process for the brand name drug and granted exclusivity rights in certain cases for brand name manufacturers (ie 3 year exclusivity is granted for any new uses developed by the pioneer brand name manufacturer for an existing drug whose patent is expiring) Waxman Hatch Amendment did what? - ANSmade it easier for generic drugs to get FDA approval Waxman Hatch Amendment is also known as what? - ANSDrug Price Competition and Patent Term Restoration Act of 1984 What absolutely has to be discussed during counseling? - ANSno absolute guidelines; it is at discretion of the pharmacist What act states that persons applying for licensure need to complete 3 hours of child abuse training? Who regulates this? - ANSAct 31 of 2014; states that BPOA and DHS are required to ensure this happens What additional wording must be on the label of dietary supplements besides the structure/function claims? - ANS- "this product has not been evaluated by the FDA" - "this product is not intended to diagnose, treat, cure, or prevent any disease" What agency is responsible for Controlled Substance Act? What regulation is this under? - ANSDEA; 21 CFR, Chapter 1300 What agency is responsible for Controlled Substances Drug Device and Cosmetic Act? What regulation is this under? - ANSPA Dept of Health; Title 28, Chapter 25 What agency is responsible for Food Drug & Cosmetic Act? What regulation is this under? - ANSFDA; 21 CFR What agency is responsible for Pharmacy Act? What regulation is this under? - ANSPA Board of Pharmacy; Title 49, Chapter 27 What are exceptions to the tamper resistant packaging requirements? - ANSdermatologicals, dentifrices, insulin and lozenges What are Good Manufacturing Practices? - ANSset of regulations that establish minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product What are penalties if a dangerous weapon was used to carry out the crime against the pharmacy? - ANSmaximum $35,000 fine and/or 25 years imprisonment; if death resulted from the crime maximum $50,000 fine and/or life imprisonment What are penalties upon conviction for burglary or robbery of pharmacy? - ANSmaximum $25,000 fine and/or 20 years imprisonment What are prescription medications that are exempt from PPPA with no quantity limits? - ANS- nitroglycerin SL dosage forms - anhydrous cholestyramine powder form - any preparations in aerosol containers intended for inhalation therapy - pancrelipase preparations - oral contraceptives (cyclically administered in manufacturer's memory aid dispenser packages) - medroxyprogesterone acetate tablets - sacrosidase (sucrase) preparations in a solution of glycerol and water - hormone replacement therapy products that rely solely upon the activity of one or more progestogen or estrogen substances What are reasons for the Attorney general to revoke CS registration? - ANS- materially falsified the application - has been convicted of a felony relative to controlled substances - has had a state license or registration suspended, revoked, or denied What are satellite pharmacies? - ANSpharmacies that provide specialized services for the patients of an institution and which is dependent on the central pharmacy for administrative control, staffing, and drug procurement What are schedule A poisons? - ANS- arsenic - cyanides - mercury compounds - thalium - etc. What are schedule B poisons? - ANS- HCl acid - nitric acid - sulfuric acid - acetic acid - potassium and sodium hydroxide - chloroform - ether - formaldehyde - etc. What are some common OTC drugs that are *subject* to the requirements of the PPPA (with amounts)? - ANS- aspirin in any dosage form/amount - iron containing drugs with elemental iron of 250 mg or more - Iron containing dietary supplements with elemental iron of 250 mg/package - acetaminophen more than 1 gram in a single package - diphenhydramine more than 66 mg of diphenhydramine base in a single package - ibuprofen in oral dosage form with 1 gram or more in a single package What are some examples of acceptable structure/function claims for dietary supplements? - ANS- helps improve mood (but can't say reduces depression) - maintains a healthy circulatory system (but can't say prevents cardiovascular disease) - maintains cholesterol in a healthy range (but not lowers cholesterol) - supports the immune system (but not helps prevent colds and flu) What are some examples of AMS? - ANS- Parata Max - Pharmacy Automation systems - Pyxis - Omnicell - Script Pro What are the current FDA rule on unit dose packaging expiration date? Example? - ANS- expiration date is not to exceed 6 months and the 6 month period cannot exceed 25% of the remaining time between the date of repackaging and the expiration date on the unopened original manufacturers container - Ex: in order to repack on 1/1/16 with a 6 month expiration date, the manufacturers container must have an expiration date of 1/1/18 or later What are the DEA requirements for Central fill pharmacies taking part in central filling? - ANS- must keep copy of the prescription if sent by fax or electronic record of info including name, address, DEA number of transmitting pharmacy - record of the date of receipt of the transmitted prescription - record name of pharmacist filling prescription and date of filling - record of date delivered to retail pharmacy and method of delivery What are the DEA requirements for TRANSMITTING pharmacies taking part in central filling? - ANS- prescription can be transmitted electronically to central fill pharmacy - must write central fill pharmacy on face of prescription and record the name, address, and DEA number of the central fill pharmacy - record name of transmitting pharmacist - record date of transmission - transmitting pharmacy must keep record of receipt of the filled prescription, including date of receipt, method of delivery, name of employee accepting delivery What are the duties of a pharmacy intern? - ANS- CANNOT be in a pharmacy if pharmacist is not on duty - may perform procedures which require professional skill and training (like compounding) when working under direct, immediate, and personal supervision of a pharmacist - may accept telephoned prescriptions from physician offices What are the duties of a pharmacy technician, and what may they not do? - ANS- cannot accept or transcibe an oral or telephoned prescription - may not enter or be in pharmacy if pharmacist is not on duty - cannot perform any act within the practice of pharmacy that involves discretion or professional judgement - may assist in reconstituting parenterals, etc. after which pharmacist initials the product to accept full responsibility - may not perform a duty until trained in that duty and the duty is specified in written protocol What are the exceptions for marketing under HIPAA? - ANSnot considered marketing if it is for the treatment of the individual, face to face communications, for case management or care coordination, direction or recommendation on alternative treatments, therapies, health care providers, or settings of care, health related services offered by pharmacy or health plan What are the exceptions permitting methadone use outside a clinic? - ANS- dispensing by a physician over 3 day period while in the process of enrolling a patient in a clinic; would need to be in physician office, no prescription - administering to a patient while hospitalized for a condition unrelated to the addiction - for intractable pain (like terminal cancer patient) What are the exceptions to needing the original Rx for faxed CII scripts? - ANS- schedule II to be compounded for direct administration to a patient by parenteral, IV, IM, SC, or intra-spinal infusion - schedule II narcotic for hospice patient - schedule II substance for patient in LTCF What are the exceptions to the 72 hour rule for partial filling of CII scripts? What does pharmacist need to do in these instances? - ANS- long term care facility may dispense partial quantities of schedule II up to 60 days - pharmacist may dispense partial of CII up to 60 days to patients with a medical diagnosis documenting a terminal illness - NOTE if patient is terminally ill or LTCF patient on prescription What are the HIPAA requirements? - ANS- notify patients about their privacy rights, and about how their information can be used by the pharmacy, which is detailed in the Notice of Privacy Practices - Ensure that pharmacy personnel comply with HIPAA by adopting and implementing procedures for its pharmacy practice and training employees - designating a privacy officer - securing patient records that contain individually identifiable health information and ensuring that they are only available to those who need access to them What are the labeling requirements for a medication filled in an institution that is not in unit dose packaging? - ANS- patient name - drug name - drug strength - dosing instructions - lot number What are the labeling requirements under tamper evident packaging act? - ANSneed to label to alert consumer to tamper resistant features used; placed so that it will be unaffected if a tamper resistant packaging feature is breached or missing What are the limits on prescribing of opiates for ER patients/urgent care patients/those in observation status in a hospital? What are the exceptions? - ANS- practitioner may not prescribe more than 7 days supply of opioid and is not permitted to prescribe refills - exception if prescriber thinks it is necessary with professional judgement or is treating pain associated with a cancer diagnosis, palliative care - can issue quantity needed in these situations as long as documented in medical record and note that a non-opioid was inadequate treatment What are the mail order limits on SLCPs? Mail order sales are also not subject to what? - ANSno more than 7.5 grams within a 30 day period; not subject to logbook, training, or certification requirements (only have to request identification) What are the only medications approved for treatment of narcotic addiction in treatment programs? - ANS- methadone - levo alpha acetyl methadol (LAAM) - buprenorphine sublingual - buprenorphine-naloxone What are the options for disposal programs allowed under the Final Rule on CS? - ANSmail back, collection receptacles, collection events What are the options for ETASU? - ANS- special training and/or certification requirements for prescribers or dispensers of the drug - restricting distribution of the drug to particular care settings - dispensing a drug based on evidence or documentation of safe use conditions (like patient counseling and acknowledgement using informed consent form) - patient monitoring and follow-up (lab testing) - patient registries What are the penalties for a person who knowingly permits or uses or discloses PHI improperly? - ANSup to $50,000 fine and up to 1 year in jail What are the potential drug therapy problems a PDR is used to catch? - ANS- therapeutic duplication - drug-drug interactions - incorrect dosage - incorrect duration of treatment - drug-allergy interactions - clinical abuse or misuse What are the potential toxicities from hazardous drugs? - ANScarcinogenicity, teratogenicity, developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity What are the provisions for partial filling of CIII-CV scripts? (3) - ANS- all partial fills are recorded in same manner as a refill - total quantity prescribed in all partial fillings doesn't exceed the total quantity prescribed - no dispensing occurs beyond 6 months after prescription is issued What are the refill limits on CIII-CV prescriptions? - ANSmaximum 5 refills or over a period of 6 months, whichever comes first to the extent allowed by the physician - a pharmacist dispenses a drug to a medical practitioner which the practitioner will administer to a patient What are the specific areas and credits required out of the 30 CE credit hours? - ANS- 2/30 in patient safety - 2/30 in administration of injectables, biologicals, immunizations (if have authority to administer injectables, biologicals, or immunizations) - 2/30 credits required in child abuse recognition and reporting - 2/30 credits in pain management, identification of addiction, or dispensing opioids What are the specific functions of the P&T committee? - ANS- serve as an advisory group to medical staff and pharmacists on the choice of drugs - develop and review periodically a formulary or drug list - recommend standards regarding the use and control of investigational drugs - recommend standards concerning research in the use of recognized drugs - evaluate clinical data concerning new drugs or preparations requested - make recommendations on drugs stocked on the nursing unit floors - establish procedures which will prevent unnecessary duplication in stocking drugs having identical amounts of the same therapeutic ingredients - make recommendations concerning drugs that need automatic stop orders - make recommendations regarding proper P&P on the administration of drugs What are the specific requirements for a collaborative agreement? - ANS- need to identify pharmacist and physician - require the regimens for management of drug therapy be initiated by physician - identify the types of decisions regarding the management of drug therapy that the pharmacist is authorized to make within scope of practice and types of management of drug therapy authorized - identify terms under which pharmacist is permitted to engage in drug therapy management without consent by collaborating physician - specify functions and tasks the pharmacist shall follow including method for documenting decisions made and plan for communication of feedback to the authorizing physician concerning specific decisions made - provide for execution of the agreement when the participating physician or pharmacist is temporarily unavailable - notify the patient of the collaborative agreement, and provide opportunity for the patient to refuse management of drug therapy by a pharmacist - signatures of both physician and pharmacist, date and allowance of the termination of the collaborative agreement at the request of either party at any time What are the stipulations to an individual practitioner prescribing CS under a hospital's DEA? - ANS- dispensing/administering/prescribing is done in the usual course of professional practice - practitioner is authorized to do so by the jurisdiction in which he is practicing - hospital/institution by which practitioner is employed has verified that the practitioner is permitted to dispense, administer, or prescribe drugs within the jurisdiction - individual practitioner is acting only within the scope of his employment in the hospital/institution - hospital authorizes the intern/resident/foreign trained physician to prescribe under the hospital registration with individual code - DEA registration code will consist of numbers, letters, or combination and will be suffix to the institutions DEA number, preceded by a hyphen - list of codes and respective practitioners is made available to other registrants and law enforcement agencies What are the three subsections now listed under pregnancy and breastfeeding? - ANS- risk summary - clinical considerations - data section What are the two contexts that Phase IV clinical studies would be completed? - ANS- if the FDA had performed and expedited approval of the drug and wanted manufacturer to complete more clinical studies - if the manufacturer wanted the FDA to approve an additional indication for a drug and was performing clinical studies to support that request What are the two major violations of the FD&C Act recognized by the FDA? - ANSadulteration and misbranding What are the unlawful acts under section 8 of Pharmacy Act? - ANS- procure or attempt to procure license permit or certificate for himself or any other person under false representations - any person not duly licensed as a pharmacist to engage in practice of pharmacy - pharmacist that doesn't dispense emergency prescription proeprly - unlicensed person operating or conducting or taking charge or supervising pharmacy (owner liable as well) - any person representing themself to be licensed when they are not - any person knowingly preventing or refusing to permit any member of board or its agents from entering a pharmacy for inspection - any person who's license, permit, or certificate has been revoked, suspended, or refused renewal to fail to deliver same to board upon demand - any person to sell at auction drugs or devices unless sale has been approved in advance by board and and sale is under supervision of pharmacist - any person, firm, or corporation using the title "pharmacist" (or similar) or "pharmacy" (or similar) unless pharmacy duly issued a permit - buying, selling, or offering to sell sample or drug/device labeled as not for resale or investigational - any person using to own advantage or reselling trade secrets to anyone other than board, representatives, or courts - advertising or promoting prices for drugs and pharmaceutical services to public that don't conform to federal laws or regs - any person counterfeiting goods or keeping in possession with intent to defraud purchasers or manufacturers - any person by himself or another attempting to procure any drug by fraud, deceit, misrepresentation, forgery or alteration of script, concealment of material fact, use of false statement in any prescription order or report - any person to advertise filling or refilling of scripts if person is not licensed in PA or pharmacy not licensed by board - one or more medical practitione What are the USP guidelines on beyond use dates for multiple unit containers (typical prescription vial)? - ANSno later than the expiration date on the manufacturers container or one year from the date the drug is dispensed, whichever is earlier What are the ways that a registered pharmacy can dispose of CS? - ANS- destroy the CS using on site method of destruction (only available if pharmacy is DEA registered as a collector) - deliver to a reverse distributor's registered location by common or contract carrier pick up, or by reverse distributor pick up at the registrant's location - for return or recall deliver CS by common or contract carrier pick up to registered person from which it was obtained, manufacturer, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf - request assistance from the Special Agent in Charge of the Administration in the area where the practitioner is located What can reverse distributor do? - ANSat any time return CS to manufacturer or dispose of them What changes can pharmacist make to CII prescription? - ANSunclear; state law is in charge of this, but PA law is silent on this issue What claims does the Dietary Supplement Health and Education Act NOT allow manufacturers of dietary supplements to make? - ANSthat the dietary supplements diagnose, treat, cure, or prevent disease What claims does the DSHEA allow manufacturers of dietary supplements to make? - ANSpromote substantiated structure/function claims which would normally classify the product as a drug (this is one of the claims under the FD&C Act definition of drug) What classes of medications may be prescribed by CRNP? - ANS- antihistamines - anti-infective agents - antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids - autonomic drugs - blood formation, coagulation, and anticoag drugs and thrombolytic and antithrombolytic agents - CV drugs What did the Safe Medical Device Act of 1990 do? - ANS- required device user facilities like hospitals to report deaths or serious injuries or illnesses caused by a device within 10 working days to the manufacturer or the FDA if the manufacturer is unknown (if death need to report to both FDA and manufacturer definitely) What do CS prescriptions need to contain? - ANS- date and signature, both completed on day they were issued - full name and address of patient (if animal use name and address of owner and species of animal) - drug name, strength, dosage form, quantity prescribed, directions for use - name, address, DEA number of prescriber - manual signature of the physician, no signature stamps What do pharmacies have to do as part of ER/LA Opioid REMS program? - ANSprovide updated one-page med guide with prescription including info on safe disposal of ER/LA opioids and instructions for when to contact the prescriber before changing dose, signs of potential overdose, and emergency instructions, and safe storage to prevent exposure to family members What does an Order to Show Cause mean? - ANSDEA is required to provide you an opportunity to defend yourself and with the Order is asking you to give a good reason why the DEA should not revoke/suspend your license What does biosimilar subsitution bill do? - ANSallows pharmacists to substitute a biological product for a prescribed biological product What does DEA CSOS allow for? - ANSsecure electronic transmission of controlled substance orders without supporting DEA form 222 What does emergency prescription mean? - ANSrefill of a prescription which is essential to the continuation of therapy in a chronic condition for which the refill has not been authorized and for which the pharmacist notifies the prescriber within 72 hours that an emergency prescription has been dispensed What does supplier do with copies 1 and 2 of DEA 222 order form? - ANSsupplier keeps copy 1 and sends copy 2 to DEA What does the "no blood, no drug" program mandate? - ANSall patients must have weekly CBC done; once weekly for 6 months, then once every 2 weeks for 6 months, then after 1 year can step down to once every 4 weeks What does the attorney general have to do before setting the schedule of a medication? - ANSrequest a scientific and medical evaluation of the drug from the Secretary of the Department of Health and Human Services What does the Comprehensive Addiction and Recovery Act allow? What is a provision with this? - ANS- Allows a pharmacist to partially fill CII for patients who are not terminally ill or residents of LTCF as long as the practice is not prohibited by state law IF partial is requested by patient or prescriber - any remaining portion must be filled within 30 days that the prescription was issued What does the Dietary Supplement Health and Education Act mandate? - ANSthat the FDA regulate dietary supplements as a special type of food, rather than a drug What does the Final Rule for DIsposal of CS implement? - ANSSecure and Responsible Drug Disposal Act of 2010 What does the Food Drug and Cosmetic Act regulate? - ANSdrug quality (no new drug can be marketed until proven safe and approved by FDA; also requires labels to have adequate directions for use) What does the Matters of Conscience Statement of policy state? - ANSreflects a common sense approach by the board to balance the religious, moral, or ethical objections of a pharmacist with the needs of the patient What does the P&T committee do (broadly)? - ANSassist in formulation of broad professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use and safety procedures relating to the use of drugs in the hospital What does the Ryan Haight Online Pharmacy Consumer Protection Act do? What does it mean for pharmacies? - ANSamends the CSA to prevent the illegal distribution of CS on the internet; pharmacies must get a modification of existing DEA registration to allow operation of an online pharmacy and adds reporting and disclosure requirements What does the S.T.E.P.S program entail? - ANSregistration of thalidomide prescribers and pharmacies, extenstive patient education about the risks associated with thalidomide, registry of all patients receiving thalidomide What does the Secure and Responsible Drug Disposal Act of 2010 do? - ANSLegal provisions for patients to dispose of unwanted pharmaceutical controlled substances (prior to this could only give them to law enforcement and pharmacies, doctor's offices, and hospitals were not allowed to accept them) What does the term "detoxification treatment" mean? - ANSdispensing of an opioid agonist treatment medication in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of an opioid drug and as a method of bringing the individual to a narcotic drug free state within such period What drug categories cannot be prescribed by CRNP? - ANS- gold compounds - heavy metal antagonists - radioactive agents - oxytocics What drug products are subject to labeling requirements? - ANS- prescription drug products that are sold to or used in hospitals - biological products - OTC drug products that are dispensed pursuant to an order and are packaged or labeled for hospital use or marketed, promoted, or sold to hospitals What ETASU does the isotretinoin REMS program employ? - ANSrestricted distribution What form is required for schedule II controlled substances? - ANSDEA form 222 What form is used to fill out for initial registration of CS activity with DEA? - ANSDEA 224 application form What form needs to be filled out by *reverse distributor* if CS are being destroyed? - ANSDEA 222 form when getting from pharmacy; DEA form 41 once drugs are destroyed What information must an order for an injectable contain? - ANS- identity of the prescriber issuing - identity of the patient to receive the injection - identity of the medication, immunization or vaccine, and dose - date of the original order and date or schedule of any subsequent administration What information needs to be recorded for every cancer drug received, dispensed, distributed, or disposed of in the Cancer drug repository program? - ANS- name and strength - quantity of drug - expiration date - lot number - name of pharmacy that originally dispensed the cancer drug - name of donor - name of person to whom it was originally prescribed - name of person to whom it was dispensed - date it was dispensed - name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the Cancer Drug Repository program - date the cancer drug was disposed of or destroyed - whether a handling fee was charged and the amount of the fee What information needs to be submitted to the Board in order to become a Cancer Drug Repository Program? - ANS- name, address, telephone number of pharmacy - identification and background of pharmacy's ownership What is iPLEDGE? - ANSsingle pregnancy risk management program for prescribing and dispensing of all isotretinoin products What is it called when pharmacist has protocol with physician to administer injectables? - ANSstanding order What is Lazanda? - ANSfentanyl nasal spray what is long term detoxification treatment? - ANStreatment for period more than 30 days, but not in excess of 180 days What is maintenance treatment of detoxification? - ANSdisepensing of an opioid agonist treatment medication at stable dosage levels for a period in excess of 21 days in the treatment of an individual for opioid addiction What is microprinting? - ANSsmall print which will be shown with magnification, but not upon copying What is naloxone? - ANSopioid antagonist used for patients that overdose and restore breathing by blocking the effects of opioids on the brain What is Onsolis? - ANSfentanyl buccal soluble film What is Phase I of clinical testing in humans? - ANS- studies performed on small number of healthy persons (20-80) and used to determine the pharmacology of the drug and it's toxicology, NOT efficacy What is Phase II of clinical testing in humans? - ANSstudies performed on a limited number of people (100-300) who actually have the disease to determine efficacy What is Phase III of clinical testing in humans? - ANSstudies performed on larger scale of affected individuals (1000-3000) What is Phase IV of clinical testing in humans? - ANSstudies performed after a drug has been granted FDA approval What is Ryzodeg? - ANSDegludec + aspart insulin What is short term detoxification treatment? - ANStreatment for a period not in excess of 30 days What is some info that is on the DEA form 106? - ANS- name and address of firm - DEA registration number - date of theft or loss - if police were notified or not - type of theft or loss - items taking or lost including estimated value - any identifying symbols or cost codes on the containers - list of missing items - name and title of person completing the report What is specifically listed as not allowed in a pharmacy? - ANS- television within view of prescription area - no pets (except guard dog for security) - no storage in the prescription area of merchandise other than that used in the preparation, dispensing, or delivery of drugs and no access for unauthorized personnel What is Subsys? - ANSfentanyl sublingual spray What is the 3 pronged approach of the S.T.E.P.S. program? - ANS- controlling access to the drug - educating prescribers, pharmacists, and patients - monitoring compliance What is the 30 day purchase limit on SLCPs? - ANSno more than 9 grams in 30 day period What is the additional online statement that must be posted on online pharmacy's home page? - ANS"online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regulations. As part of the this obligation, this online pharmacy has obtained modified DEA registration authorizing it to operate as online pharmacy. In addition, this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance with section 309 of the CSA (21 USC 829), or a medical evaluation vial telemedicine in accordance with section 102 (54) of the CSA)" What is the application procedure for authorization to administer injectables? - ANS- submit application and applicable fee - certification of having completed required education and training - certification of holding current CPR certificate What is the clozapine REMS program called? - ANS"No blood, no drug" program What is the Controlled Substance Registration Protection Act? - ANSEnacted to protect DEA registrants like pharmacies What is the daily sales limit of SLCPs? - ANS3.6 grams (base) per day per purchaser regardless of the number of transactions What is the definition of health care operations under HIPAA? - ANSactivities required for the day to day operations of the pharmacy, including record keeping, preparation, and review of quality assurance reports and risk management activities, etc. What is the definition of label? What is the difference with this and labeling? - ANSdisplay of written, printed, or graphic matter upon the *immediate container* of any article; labeling means all labels, and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article (including package insert) What is the definition of payment for HIPAA purposes? - ANSall communications required to obtain payment or reimbursement for the dispensing activities, including obtaining prior authorization from third party payers, claims submissions, and providing information to payers concerning the patient's diagnosis and the use of the drug or the need for drug therapy What is the electronic system to order controlled substances? - ANSDEA Controlled substances ordering system (CSOS) What is the exception to the red C rule if filing controlled scripts? Does PA law follow this? - ANSfederal law says can go without red C if pharmacy employs a computer system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled - YES PA law follows for electronic CS scripts, but silent on paper prescriptions What is the inventory requirement for controlled substances? - ANSbiennial (every 2 years); must be within that two year period What is the isotretinoin REMS computer program? - ANSiPLEDGE What is the minimum amount of liability insurance a licensee who engages in MTM will need? - ANS$1,000,000 *per occurrence or claims made* What is the National Precursor Log Exchange (NPLEx)? What act is it in compliance with? - ANSrequires that all retailers that sell PSE over the counter must submit electronic transactions to NPLEx by April 5th 2014; HB 602 Act 53 What is the new CE requirement when it comes to opioids? - ANSpharmacists must obtain 2 of the 30 hours of CE in the area of pain management, ID of addiction, or prescribing or dispensing of opioids What is the only exception to the time the Attorney General doesn't have to consult the Secretary of the Dept of HHS on scheduling a drug? - ANSIf the drug must be placed into schedule I to avoid an "imminent hazard to public safety"