MPJE – TN – Flashcard
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Anabolic steroids (C-?)
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III
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Methamphetamine max sales
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3.6 gm/day 9 gm/month
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Methamphetamine electronic record contents
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name and address of patient name and quantity of sudafed sold name (or identification) of pharmacist or pharmacy intern selling date and time of sale ID type and number
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sudafed may be kept where?
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behind counter or in a locked case within view of and within 25 ft of the counter
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stop sale alert override?
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Yes, pharmacist can override if imminent bodily harm. Override shall be logged by system
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methamphetamine registry - length of time
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7 years and patient cannot purchase any sudafed products during this time
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promotion of methamphatamine manufacture - amount possessed
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possession of more than 15 grams of precursor
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misbranded
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label must have all required items labeling is false or misleading in any particular contains habit forming drugs and is not labeled as "warning - may be habit forming" drug container of which bears a counterfeit, copy, or deceptive imitation of any trademark
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adulterated
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filthy, putrid or decomposed substance produced in unsanitary conditions it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch certified under the authority of the federal act it purports to be or is represented as a drug, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium
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Legend drug
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any item that federal law prohibits dispensing without a prescription form a licensed doctor, dentist, optometrist or veterinarian.
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amphetamine sale restriction
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no amphetamine classified as a CII shall be prescribed for purpose of assisting a patient to gain or lose weight.
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indication on label of container
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shall include on label if by request of prescriber, patient or patients caregiver and prescriber, patient or patients caregiver provides indication or indications to person dispensing legend drug
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prescriber has died, pharmacists may continue to dispense with following requirements:
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prescription is new that has not been previously dispensed, it may be dispensed within 90 days of date on which practitioner died; if prescription has been previously dispensed and can be refilled, refills may be dispensed but not for a period of more than 90 days for C III, IV, V and 180 for non-scheduled drugs from date on which practitioner died C II are not covered here
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affordable health care act of 2005 - reason for law
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put into action to lower cost of prescription drugs to citizens
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substitution authorization exemption
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prescriber determines medical necessity of brand name drug; generic not available; anti-epileptic drug - must notify prescriber and patient patient may request brand even if more expensive and can pay for it
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substitution requirements
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FDA approved production and given an "A" rating in orange book can be made in another country if FDA approved
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substitution of drugs not evaluated and rated for bioequivalency by FDA
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pharmacists are permitted to use professional judgement
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anti-epilepsy substitution
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must notify prescriber and patient
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controlled substance database - not required to report
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drug administered directly to patient drug dispensed by licensed health care facility, provided that the quantity does not exceed 48 hours of treatment drug sample dispensed narcotic treatment program
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information required to be in controlled substance database
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prescriber identifier dispensing date of controlled substance patient identifier controlled substance dispensed identifier quantity of controlled substance dispensed strength of controlled substance dispensed estimated days supply dispenser identifier other relevant information required by rule
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information submitted to controlled substance database - how often
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at least monthly within 10 days following last day of each calendar month
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controlled substance database info requests - what is documented
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identification of each person who requests or receives information the information provided date and time the information was requested or provided
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power to schedule drugs
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commissioner of mental health, upon agreement of commissioner of health
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Schedule I
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high potential for abuse no accepted medical use in treatment in US or lacks accepted safety for use in treatment under medical supervision
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Schedule II
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high potential for abuse currently accepted medical use in treatment in US, or currently accepted medical use with severe restrictions abuse of substance may lead to severe psychic or physical dependence
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Schedule III
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potential for abuse less than C I and II currently accepted medical use in treatment in the US abuse of substance may lead to moderate or low physical dependence or high psychological dependence
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Schedule IV
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low potential for abuse relative to C III currently accepted medical use in treatment in the US abuse of substance may lead to limited physical dependence or psychological dependence relative to C III
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Schedule V
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low potential for abuse relative to C IV currently accepted medical use in treatment in the US limited physical dependence or psychological dependence liability relative to C IV
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Schedule VI medications
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Marijuana Tetrahydrocannabinols synthetic cannabis
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Schedule VII medications
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butyl nitrate and any isomer of butyl nitrate
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counterfeit controlled substances
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offense to manufacture, sell, deliver or distribute a substance that is represented to be a controlled substance
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anabolic steroids - prohibited activities
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cannot distribute for enhancing performance in sports, increase muscle mass
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immediate methamphetamine precursors
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ephedrine, pseudoephedrine base or their salts, isomers or salts of isomers.
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drug-free school zone
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grounds or facilities of any school or within 1000 feet of the real property that comprises a public or private elementary school, middle school, secondary school, preschool, child care agency, or public library, recreational center or park
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selling, bartering, giving away or obtaining legend drugs
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unlawful to do any of those things without a valid written prescription
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abortion drugs - prohibited prescribers
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nurse practitioner or physicians assistant when the following are involved: writing or signing a prescription for any drug dispensing or administering of any prescribed or legend drug performing of any procedure that involves the use of a legend drug
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generic substitution
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if not deemed necessary for brand name, pharmacist shall dispense least expensive generic equivalent in stock
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use of brand name if less expensive
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if brand name is less expensive than generic, then pharmacist shall fill prescription with brand name drug
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contents of label - manufacturer, packager or distributor
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name and address of manufacturer, packager or distributor of the finished dosage form of the drug
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drugs in the controlled substance database
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CII - IV and C V identified by committee as demonstrating a potential for abuse
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law enforcement requesting information form controlled substance database
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must provide a case number that directly relates to an investigation involving controlled substances
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tamper-proof prescriptions - not required
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prescription written by veterinarians prescription for inpatients of a hospital or outpatients where patient does not have opportunity to handle written order
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Inspection of controlled substance records
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prescriptions, orders, records and stocks of controlled substances shall be open for inspection. not to extend to financial data, sales data, other than shipment data, or pricing data
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legend drug and controlled substance research - license
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no person shall manufacture, obtain, possess, administer or dispense a legend drug or controlled substance for the purpose of scientific research, chemical analysis, instruction or training of detection animals without having firs secured a license to do so from the director
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requirements for application for research use of legend drugs and controlled substances
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nature of proposed project qualifications of applicant to engage in project proposed quantity of each drug involved security measures to provide proper record keeping of drugs provisions for safe administration or dispensing of drugs to humans and method for selecting humans
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license to use legend drugs and controlled substances in research
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name and address of the licensees nature of authorized project(s) nature of legend drugs or controlled substances to be used in the project whether dispensing to humans is permitted license expires 1 year from date of issuance, or upon termination of project(s), whichever comes first no license shall be transferable, but may be renewed
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how long must licenses used in research with legend and controlled substances be kept
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2 years
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health insurance issuer and managed health insurance issuer may not:
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deny any licensed pharmacy from participating in any policy, contract or plan prevent any person from selecting a licensed pharmacy of person's choice
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pharmacy benefit card - required information
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benefit plan's name and issuer identifier processor control number insured's group number insured's identification number insured's name and all other persons on coverage American National Standards Institute Issuer Identification Number
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MTM counseling requirements
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insured who is prescribed and uses six or more types of medication may be entitled to receive two medication counseling sessions during first year with doctor or pharmacy
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MTM session shall consist of
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examination of patient's medical history number and types of medications the patient uses, including OTC meds types of interactions among medications recommended medication therapy and thorough analysis of the benefit of the medication therapy evaluation of cost savings gained as a result of changes made summary of expected outcomes and proposed follow-up exam dates
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who may prescribe
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Podiatrists Dentists - rational to the practice of dentistry physician/surgeon nurse practitioners optometrist - rational to the practice of optometry osteopathic physicians
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C II drugs on separate prescription
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C II drugs cannot be on the same prescription as other drugs
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nurse practitioners - notice to the board requirements
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name of nurse practitioner name of licensed physician having supervision, control and responsibility for prescriptive services formulary describing the categories of legend drugs to be prescribed and/or issued by the nurse practitioner
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nurse practitioners - prescriptive authority
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Legend drugs per formulary C II-V upon joint adoption of physician supervisory rules concerning controlled substances
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requirements on prescription for nurse practitioner under supervision and control of a supervising physician
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must have name, address and phone number of supervising physician and of nurse practitioner
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advanced practice nurse
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registered nurse with a master's degree or higher in a nursing specialty and national specialty certification as a nurse practitioner, nurse anesthetist, nurse midwife or clinical nurse specialist
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optometrist may treat conditions and disease of the eye - prescribing authority
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administration and prescribing of pharmaceutical agents rational to the diagnosis and treatment of conditions or diseases of the eye or eyelid
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sale of nonprescription drugs and devices
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may be sold in its original single package unless required by federal or state law to be dispensed or sold under supervision of pharmacist
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insulin storage and sale
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must be in an area not accessible to general public and must be dispensed under supervision of pharmacist
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emergency supply
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pharmacy may dispense without proper authorization number of doses not to exceed 72 hours this does not authorize the dispensing of controlled substances without proper authorization pharmacist may dispense another 72 hours worth of medication if proper authorization is still not obtained at that time
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registration fees for out-of-state pharmacy mailing into tennessee
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must pay licensure fee required of a tennessee pharmacy
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transfer of prescriptions to another prescription form
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pharmacists, pharmacy interns and pharmacy technicians may transfer from a prescription containing a C II any drug that is a non-scheduled drug
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board of pharmacy composition
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board shall consist of 7 members, one of whom shall be a consumer
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board of pharmacy appointment and term
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governor shall appoint members of board and should strive to have at least one member be at least 60 years of age and at least one minority no pharmacist may be eligible until practicing in the state for at least 5 years consumer must be a resident for at least 5 years term is 6 years and no one is eligible for reappointment
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power of board to suspend, revoke, or refuse to issue licenses
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may do these things of they find the person has: - been convicted of a crime - been convicted of violating any of the laws of this state or the US relating to drugs or to the practice of pharmacy - been addicted to the use of alcohol, narcotics or other drugs - engaged in conduct prohibited by any provisions of parts 2-5 of the chapter - exhibited an incapacity of a nature that prevents a pharmacist from engaging in the practice of pharmacy - been guilty of dishonorable, immoral, unethical or unprofessional conduct - had the license to practice revoked or suspended by another state - failed to comply with a lawful order or duly promulgated rule of the board
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license requirements - pharmacist
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must be at least 21 years of age
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board of pharmacy is under??
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the department of health
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nina norman prescription drug donation act of 2006
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charitable clinic pharmacy may accept for redispensing prescription drugs obtained from an institutional facility by the clinic pharmacy for relabeling and dispensing free of charge to indigent patients
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donation of controlled substances
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not allowed
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donations of prescription drugs must meet the following criteria
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drugs in dispensed, sealed and tamper-evident packaging. must not be misbranded or adulterated
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physicians assistants - supervision
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supervision by physician requires active and continuous overview of activities to ensure that physician's directions and advice are in fact implemented, but does not require the continuous and constant physical presence of supervising physician
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physicians assistant - authority to prescribe
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prescribe and/or issue legend drugs and controlled substances listed in C II-V
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application for licensure must be received how many days before date of examination
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40
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hours breakdown for licensure
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1,500 total hours 1,100 may be acquired in pharmacy programs 400 by pharmacy internship programs foreign graduates shall complete 500 hours in 6 consecutive months
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foreign graduates must also complete
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complete foreign pharmacy equivalency examination, test of spoken english and any other requirements established by NABP
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pharmacist may apply for an inactive license by
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completing biennial license renewal application form and paying biennial renewal fee for an inactive license
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pharmacist seeking active status for inactive license when license has been inactive for less than one year
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provide written notice requesting active license satisfy past due CE pay cumulative renewal fees and any penalty fees for period inactive
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pharmacist seeking active status for inactive license when license has been inactive for > 1 < 5
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same as 1 yr AND take jurisprudence exam complete pharmacy internship: > 1 3 < 5 - 320 hr within 180 days
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pharmacist seeking active status for inactive license when license has been inactive for > 5 yr
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same as 1 yr AND take jurisprudence and NAPLEX exams pharmacy internship of 320 hr within 180 days
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submission of application to operate as a pharmacy practice site, manufacturer or wholesaler must be submitted how many days prior to scheduled opening date
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30 days
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application for existing pharmacy site, manufacturer or wholesaler must be filed when
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pharmacy practice site, manufacturer or wholesaler changes name, location or ownership
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transactions constituting a change in ownership of practice site include, but are not limited to
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- sole proprietor becomes a member of a partnership or corporation which succeeds him as the new operator - a partnership dissolves - one partnership is replaced by another through removal, addition or substitution of a partner - 2 or more corporations merge and originally-licensed corporation dose not survive - transfers between levels of government
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how long is a license good before having to be renewed
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2 years
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pharmacists and pharmacy interns in active duty
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shall not be required to pay license or registration renewal fees during period of active duty and pharmacist shall not be required to complete CE during active duty
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renewal fee for active and inactive license
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$96 - active biennially $48 - inactive biennially
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fee for person, partnership, firm, corporation or agency owning or operating a pharmacy practice site
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$168 biennially
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fee for manufacturers and wholesalers in the state of TN
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$408 biennially
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standards for pharmacies
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shall occupy a space of not less than 180 square feet shall have hot and cold running water and immediate area refrigeration licenses and certificates of registration for a pharmacy practice site shall at all times be conspicuously displayed at the practice site
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functions performed by pharmacist or pharmacy intern
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certification of medical and prescription orders final verification of product prior to dispensing initial medical and prescription orders provide patient counseling provide drug information to patients, care givers, and health care providers supervision of compounding evaluation and establishment of criteria for selection of drug product(s) and supplier(s) daily opening and closing of a pharmacy practice site
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pharmacist convicted of any crime, including DUI shall report conviction to the board within __ days
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10
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pharmacy technicians may
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perform tasks associated with the preparation and dispensing process except those listed for pharmacist or pharmacy intern
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certified pharmacy technicians may
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receive new or transferred oral medical and prescription orders receive and transfer copies of oral medical and prescription orders between pharmacy practice sites verify contents of unit dose carts prepared by other registered technicians when an additional verification by use of bar code technology or a licensed health care professional is performed prior to administration to the patient
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pharmacy tech to pharmacist ratio
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2:1 but may be increased to 4:1 upon public safety considerations but only if the additional techs are certified
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patient counseling for new orders
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pharmacist shall personally counsel the patient or caregiver "face-to-face" if the patient or caregiver is present. If not present, a pharmacist shall make a reasonable effort to counsel through alternative means
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patient counseling shall cover
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name and description of medication dosage form, dose, route and duration of drug therapy special directions and precautions for preparation, administration and use by the patient common side effects or adverse effects and therapeutic contraindications techniques for self-monitoring proper storage prescription refill information action to be taken in event of missed dose
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patient counseling for refills
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may be offered by a person designated by pharmacist. counseling is not required unless requested by patient or deemed necessary in the professional judgement of pharmacist.
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counseling if patient or caregiver refuses
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pharmacist shall not be required to do so if patient refuses
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patient profile information
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make a reasonable effort to obtain: name, address, telephone number date of birth (age), gender individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices pharmacist's comments as deemed relevant
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drug regimen review
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pharmacist shall review a patients record prior to dispensing each medical or prescription order, including: over-utilization or under-utilization therapeutic duplication drug-disease contraindication drug-drug interactions incorrect drug dosage or duration of drug treatment drug-allergy interactions clinical abuse/misuse
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each medical and prescription order when dispensed shall be:
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serially numbered filed numerically maintained so as to be readily retrievable at the pharmacy practice site for at least 2 years from the date last dispensed
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upon initial dispensing of a medical or prescription order, the pharmacist shall record on the order
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date dispensed pharmacist initials amount dispensed if simply initialed and dated, pharmacist shall be deemed to have dispensed the full face amount of order
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upon refilling a medical or prescription order, the pharmacist shall enter on the back of the order
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date refilled pharmacist initials amount dispensed on that refill if simply initialed and dated, pharmacist shall be deemed to have dispensed the full face amount of order
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upon transferring medical and prescription orders, the transferee must record:
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name, address and original medical or prescription order serial number at the pharmacy from which order was transferred name of transferor all information constituting a medical or prescription order including: - date of original dispensing - original number of refills authorized - date of last dispensing - valid number of refills remaining
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transfer of C III - V
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transfer is allowed on a on-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescribers authorization (more info on federal section)
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electronic order transmission shall include
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- telephone number of the authorized prescriber to allow verbal confirmation of the validity and accuracy of the order - correct time and date of transmission - name of pharmacy to which order is being transmitted - prescribing practitioner's E-signature - identity of agent if transmission is delegated by prescriber to said agent
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areas of receipt and dispensing
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non-mobile in nature
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labeling requirements
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- name, address and telephone number of pharmacy practice site - medical or prescription order serial number - name of prescriber - name of patient - directions for use - date medical or prescription order originally dispensed and/or refill date - advisory label - name of product - expiration date NOT QUANTITY DISPENSED NOT STRENGTH OF PRODUCT NOT FORM (TABLET, CAPSULE, LIQUID, ETC) NOT NDC NUMBER NOT IF CAN BE REFILLED
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temporary absence of pharmacist
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- pharmacist is allowed one temporary absence for a period not exceeding 1 hour per day. - during absence a sign saying "pharmacist not on duty" must be conspicuously displayed in the pharmacy practice site. - must be closed by physical barrier from floor to ceiling - no prescription order may be compounded or dispensed during absence
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repackaging for institutional pharmacy shall be labeled to include
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- name, strength, and quantity of prescription drug or device or related material, if larger than one in the container - manufacturer's name and lot or control number - expiration date of prescription being repackaged - cautionary notations if applicable
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loss of prescription drugs, devices and related materials
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pharmacist in charge shall immediately report to the board any robbery, embezzlement, theft, burglary, or fire or disaster resulting in a loss of prescription drugs, or controlled substances.
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outdated and deteriorated drugs
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owner or pharmacist in charge shall immediately return or destroy all outdated, defective, or deteriorated prescription drugs except THAT DESTRUCTION OF CONTROLLED SUBSTANCES SHALL BE PERFORMED BY A BOARD APPROVED AGENT OR VENDOR
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use and operation of automated dispensing
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- lot number of each drug contained must be listed or posted - after each lot number is used, container must be cleaned to remove all residue before refilling - lot numbers may not be mixed
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pharmacist in charge - notification of changes
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notify the board immediately of: - resignation, removal or death of the PIC named in the application for license - the disability for a period exceeding 30 days of the pharmacist in charge named in the application for license
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notice of change for PIC must contain
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- name and signature of outgoing PIC - effective date of appointment of new PIC - name and signature of new PIC - name and address of pharmacy
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pharmacist in charge - inventory of controlled substances
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must occur on change of PIC shall include and must be kept for 2yr: - name and address of pharmacy - name, strength, dosage form, and quantity of each controlled substance on hand - date of inventory - whether inventory was taken as of the opening or close of business on that date
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pharmacist in charge - duties
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- inventory of controlled substances in various situations - maintain a registry of pharmacy technicians - no PIC shall be PIC of more than 1 pharmacy - shall be on duty a minimum of 50% of hours that pharmacy is in operation - notify board of any situation in which order has caused serious personal injury or death
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centralized prescription processing - criteria
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- both pharmacies shall be licensed by TN - both pharmacies shall share a common electronic file or have the technology to allow each other to access information necessary to fill or refill a prescription - both pharmacies shall have the same owner or have a contract stating the services provided by each pharmacy
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institutional pharmacy - physical requirements
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- sufficient floor space (different than 180 for retail) - hot and cold running water - refrigerated storage space - frozen storage - adequate information systems
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institutional pharmacy - prescription orders maintained for how many years
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2 years from date of issuance
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institutional pharmacy - controlled substances issued as floorstock documentation
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- drug name, strength, and dosage form - date and time of administration - quantity/dose administered - identification of patient - identification of prescriber - identification of authorized personnel administering
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institutional pharmacy - destruction of controlled substances
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kept for 2 years and document - identification of patient - drug name, strength, dosage form, and quantity - date and method of destruction - identification of authorized personnel witnessing the destruction and its record
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institutional pharmacy - C II storage
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substantially constructed cabinet, safe, or other structure which provides a double locked secured system
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home care kits - may contain
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- sodium chloride for injection 0.9% bacteriostatic - sterile water for injection bacteriostatic or preservative free - epi 1mg/ml - diphenhydramine - heparin flush < or = 100 units/ml - naloxone - sodium chloride for irrigation - sterile water for irrigation - dextrose 50% - urokinase 5000 units - any other legend drug as approved by the board
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institutional pharmacy - pharmacist on call
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must be on call 24/7
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institutional pharmacy - after hours drug provision
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when pharmacy is closed, drugs shall be in locked cabinets, automated dispensing machines or other enclosures outside the pharmacy
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institutional pharmacy - after hours drug "log"
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must be kept for 2 years and contain: - date and time of removal of drug - patient's name and location - name, strength, dosage form and quantity - identification of personell removing drug
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institutional pharmacy - access after hours to pharmacy
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authorized personell accompanied by security guard may have access to pharmacy after hours to remove required drug
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institutional pharmacy - access after hours to pharmacy "log"
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must be kept for 2 years and contain: - date and time of removal of drug - patient identification and location - name, strength, dosage form and quantity - signatures of authorized personnel and accompanying witness - quantity may not exceed amount needed plus 1 dose until pharmacy reopens
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emergency room drugs not dispensed directly dispensed by physician
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drugs must be packaged in amounts not to exceed a 12 hour period or with products commercially prepared for multiple dose therapy
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institutional pharmacy - monthly inspections
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must be performed monthly and kept for 2 years - normal drug stuff AND - telephone number of poison control centers - metric-apothecaries' conversion - adequate pharmaceutical references for drugs administered in location
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CE credits
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30 hours every 2 years 15 hours must be live contract programs - not required if pursuing some form of medical degree or in residency or fellowship
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OUTER CONTAINER of radioactive drug label requirements in addition to regular label requirements
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- standard radiation symbol - "caution - radioactive material" - the radionuclide - the chemical form - amount of radioactive material, in millicuries or microcuries - if a liquid, the volume - calibration time for amount of radioactivity contained - expiration time - name, address, and telephone number of nuclear pharmacy
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INNER CONTAINER of radioactive drug label requirements
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- standard radiation symbol - "caution - radioactive material" - name of the drug - medical or prescription order number
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nuclear pharmacy equipment
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- vertical laminar flow hood - dose calibrator - refrigerator - room monitor - portable survey meter - single or multiple channel scintillation counter - microscope - radiochemical exhaust hood and filter system (if required by state board of radiological health) - other equipment required by state board of radiological health
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sterile compounding hood requirements
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any of the following: - class 100 laminar flow hood - biologic-safety cabinet (Class II, Type A) - class 100 clean room
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prefilters in laminar flow hoods shall be changed
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at least quarterly and written record maintained of such change
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how long must laminar flow hoods be running if turned off
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continuously for 30 minutes before being used to compound
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labeling of sterile product
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- patient's name (if for outpatient) - prescriber(s) name (if for outpatient) - pharmacy practice site name, address and phone number (if for outpatient) - identification of pharmacist who compounded - when applicable, identification of pharmacy intern or tech who assisted in compounding - name and amount of drug added - expiration date and, when applicable, expiration time - date of compounding - appropriate auxiliary labels - directions for use (if for outpatient)
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hazardous products - hood requirement
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dedicated class II, type A contained vertical flow biohazard cabinet
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attire for hazardous products
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gloves and gown - gloves should be rinsed frequently with 70% isopropyl alcohol - gown made of lint-free low permeability fabric with a closed front, long sleeves and elastic or knit closed cuffs with cuffs tucked under gloves
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attire for sterile product compounding
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- upon entering sterile compounding area, an outer garment that generates a low level of particulate must be donned and removed before exiting area - if scrubs or site specific clothing are donned to work in sterile compounding area, lab jacket or outer covering shall be worn while outside the compounding area and this garment removed upon entering sterile compounding area - gloves are required if preparation occurs greater than 28 hours from anticipated time of dispensing
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attire for using class 100 clean room without a laminar flow hood
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- jumpsuit or surgical scrubs - head covering - mask - shoe covers - gloves
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facilities at which prescription drugs and prescription devices are stored, warehoused, handled, held, offered, marketed, or displayed shall:
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- be of suitable size and construction to facilitate cleaning, maintenance, and proper operations - have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space equipment and security conditions - quarantine for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated or that are in immediate or sealed, secondary containers that have been opened - be maintained in a clean and orderly condition - be free from infestation by insects, rodents, birds or vermin of any kind
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record keeping for manufacturers and wholesalers shall establish and maintain inventories and records of all transactions regarding receipt and distribution or other disposition or prescriptions drugs. Including:
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- source of prescription drugs including name and principal address of seller or transferor and address of location from which prescription drugs were shipped - identity and quantity of prescription drugs and prescription devices received and distributed or disposed of - dates of receipt and distribution or other disposition of the prescription drugs or devices - must keep records for 2 years - records kept off site must be made available within 2 days of a request
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access to controlled substance database
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- prescriber who is currently issuing or who anticipates issuing a controlled substance(s) to the patient - dispenser who is currently dispensing or who anticipates dispensing a controlled substance(s) to the patient - person who has patient's written permission to have access to the database - manager of any investigations or prosecution unit of a health-related board - district attorney who obtains an order from circuit or criminal court
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alternative identification of patients
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- no social or refuses to provide it, may use drivers license number or telephone number - if none of the above are options then "000-00-0000" may be used - if patient refuses the above then "999-99-9999" -if pt's social is not available, board shall use information from person obtaining controlled substance on behalf of the patient or the "0's or 9's" - child who does not have a social, then board shall use information from parent or guardian or the "0's or 9's" - if pt is animal, then board shall use information from owner or the "0's or 9's"
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fee for license of a charitable clinic pharmacy
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$168
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charitable clinic pharmacy - if received drugs do not contain drug name, strength, lot number and expiration date
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drug shall not be dispensed and they shall be destroyed
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charitable clinic pharmacy - if controlled substances are received
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pharmacist shall send controlled substances back to institutional facility NO CONTROLLED SUBSTANCES shall be possessed, purchased, traded or distributed from the charitable clinic pharmacy
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charitable clinic pharmacy - labeling
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indigent patient's identifying information, dosage instructions, auxiliary labels and drug expiration date
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charitable clinic pharmacy - if donor patient donation form is not received
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pharmacist shall not dispense the drugs
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charitable clinic pharmacy - donor patient form
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- name of patient to whom medication was originally dispensed - name of institutional facility authorized to deliver - name of drug, quantity, prescription number, date of prescription and name of pharmacy where it was originally dispensed - name of charitable clinic pharmacy - date drug was donated - authorization to donate the drug voluntarily - signature for donor or representative if donor is dead or not competent - statement that no one is liable for anything
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charitable clinic pharmacy - waiver form
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- name of indigent patient - name of drug, quantity, prescription number, date of prescription, name of charitable clinic pharmacy dispensing drug - signature line for indigent patient - waiver releasing all from liability
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telepharmacy - minimal operating requirements for central pharmacy
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- shall be connected to the satellite clinic through computer link, videolink and audiolink - shall have a computer system that is connected to the satellite clinic's computer system that shares common electronic files - shall have it's own computer(s) that is/are not accessed by others employed by the federally qualified health center, scanner(s), printer(s), and fax machine(s) - shall have a licensed pharmacist at the central pharmacy location
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telepharmacy - dispensing of controlled substances
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- no C I-IV shall be dispensed from satellite clinic
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board of pharmacy duty to enforce all pharmacy laws by employing -
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staff and investigators who are pharmacists to carry out enforcing law
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Information given during a peer review is considered to be:
answer
All information, interviews, reports, statements, memoranda or other data furnished to any peer review committee, association board, or other entity, and any findings, conclusions or recommendations resulting from the proceedings of such committee, board or entity are privileged. Privileged means that the disclosure of the information cannot be compelled, even by a court of law. It is also testimonial privilege
question
ineligible for inactive license if:
answer
A pharmacist maintaining an active license to practice pharmacy in another state or jurisdiction is ineligible for inactive license status in Tennessee.
question
learned intermediary - manufacturer
answer
manufacturers are only obligated to warn the prescribing physician.
question
pharmacists must do the following in addition to patient counseling, patient profiling, drug regimen review:
answer
- Developing relationships with licensed practitioners to enable the pharmacist to accomplish comprehensive management of a patient's pharmacy related care and to enhance a patient's wellness, quality of life and optimize outcomes; and - Communicating to the health care provider any knowledge of unexpected or adverse response to drug therapy, or resolving unexpected or adverse response; and -Having a pharmacist accessible at all times to patients and healthcare providers to respond to their questions and needs.
question
As an alternative to recording refill information on the back of medical and prescription orders,
answer
- an automated data processing system may be used for the storage and retrieval of refill information for medical and prescription orders, subject to certain conditions. - A pharmacist may dispense an appropriately authorized refill of a medical or prescription order by referral to a patient profile (medication record) instead of the original medical or prescription order on file at that pharmacy practice site, subject to certain conditions.
question
Any such computerized system must provide on-line retrieval (via CRT display or hard-copy printout) of the original medical or prescription order information and the complete refill history of all medical and prescription orders which are currently authorized for refilling. This shall include all the information contained in and required to be entered on each such medical or prescription order. This data must include at least:
answer
the medical or prescription order serial number; date of issuance of the medical or prescription order; patient's name (AND ADDRESS ON CONTROLLED SUBSTANCE MEDICAL AND PRESCRIPTION ORDERS); prescriber's name (AND ADDRESS AND DEA REGISTRATION NUMBER ON CONTROLLED SUBSTANCE MEDICAL AND PRESCRIPTION ORDERS); product name, strength, dosage form, and quantity prescribed; directions for use, and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and identity (name, initials, or identification code) of the dispensing pharmacist for the original dispensing and each refill.
question
refills utilizing patient profile instead of original prescription
answer
A pharmacist may dispense an appropriately authorized refill of a medical or prescription order by referral to a patient profile (medication record) instead of the original medical or prescription order on file at that pharmacy practice site, subject to certain conditions
question
who is responsible for notifying the board of a change in PIC
answer
It is the responsibility of the person, partnership, firm, or corporation holding a pharmacy practice site license to notify the board immediately of the resignation, removal, disability (exceeding 30 days), or death of the pharmacist in charge named in the application for license (or successor pharmacist in charge)
question
does state or federal law require expiration date on label?
answer
State law is determinate as to how to calculate an expiration date for a prescription. However, if state law is silent on the subject, it is advisable to follow the USP guidelines. The reason that the answer "Both state and federal law" is not correct is because federal law does not require an expiration date on a prescription label
question
can a pharmacist give an officer the original prescription for a case
answer
Yes, but maintain a copy for the records of the pharmacy
question
compounding in advance
answer
only in the quantity expected that day NOT MORE
question
statute of limitations
answer
The statute of limitations begins to run one year from the date that the alleged injury is discovered In no event shall a cause of action be brought more than three years after the date on which the negligent act or omission occurred, except where there is a fraudulent concealment on the part of the defendant, in which case the action shall be commenced within one year after discovery that the cause of action exists
question
expert witness qualifications
answer
To qualify as an expert witness in Tennessee, the expert must have practiced in Tennessee or a contiguous bordering state during the year preceding the date of the alleged injury or wrong. The expert must demonstrate that he or she is familiar with the standard of care expected of a professional in the same or similar community as the defendant practices
question
amount of radioactivity in nuclear medicines must be determined
answer
- immediately prior to dispensing
question
pharmacist gets DUI - when should he report to board
answer
within 10 days OF CONVICTION
question
health care liability action is
answer
defined as any civil action . . . alleging that a health care provider or providers have caused an injury related to the provision of, or failure to provide, health care services to a person, regardless of the theory of liability on which the action is based
question
professions with limited prescriptive authority
answer
dentists, optometrists, podiatrists, and veterinarians
question
pharmacist substitutes generic - what is required
answer
notify patient by noting the substitution on the prescription label
question
tamper resistant paper from out of state physicians
answer
fill it as there is no law agains out of state prescriptions being on tamper resistant paper
question
transfer of controlled substances on prescription with C II
answer
needs oral order from physician - pharmacist CAN ONLY TRANSFER NON CONTROLLED SUBSTANCES
question
a prescription is fictitious if:
answer
the prescriber does not exist
question
a prescription is forged if:
answer
signature is forged or prescription has been altered
question
first letter of DEA number
answer
can be an "F" for type "A" practitioners now
question
Before revoking a registration to dispense controlled substances, the board of pharmacy and professional licensing board must first:
answer
Before denying, suspending or revoking a registration, or refusing a renewal of registration, the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended, or why the renewal should not be refused
question
schedule III & IV refills
answer
up to a max of 5 times in 6 months
question
pharmacist dispensing controlled substances must:
answer
register with the board of pharmacy
question
Under the Tennessee Prescription Safety Act of 2012, how often must reports be submitted to the Tennessee Controlled Substance Database?
answer
shall be submitted by a procedure and in a format established by the committee, at least once every seven (7) days for all the controlled substances dispensed during the preceding seven (7) day period.
question
Who is not required to register with the Tennessee Controlled Substance Monitoring Database under the Tennessee Prescription Safety Act of 2012?
answer
All prescribers with DEA numbers who prescribe controlled substances and dispensers in practice providing direct care to patients in Tennessee for more than fifteen ( 15) calendar days per year shall be registered in the controlled substance database. New licensees shall have up to thirty (30) calendar days after notification of licensure to register in the database. Licensed veterinarians who never prescribe a controlled substance in an amount intended to treat a non-human patient for more than forty-eight (48) hours shall not be required to register in the database. There are no other provisions for an exemption from registration under the law. Pharmacies may get a 2-year exemption from electronic reporting upon showing of undue hardship and ratification of the waiver by the committee.
question
Under the Tennessee Prescription Safety Act of 2012, how many unlicensed health care extenders may a dispenser designate to serve as the dispenser's agent(s) in accessing the controlled substance database?
answer
"Healthcare practitioner extender" means any registered or licensed healthcare professional, and up to two (2) unlicensed persons designated by the prescriber or dispenser, who act as agents of that prescriber or dispenser. The prescriber or dispenser shall be responsible for all actions taken by their agents pursuant to this act.
question
It is January 2013, and Pharmacist has not registered as a handler of controlled substances with the Tennessee Board of Pharmacy. Pharmacist is actively involved in the care of Patient and is conducting a medication history review. May Pharmacist access the controlled substance database as part of this review?
answer
Tennessee Code Annotated, Section 53-10-306(a) Information sent to, contained in, and reported from the database in any format is confidential and not subject to title 10, chapter 7, regarding public records, and not subject to subpoena from any court and shall be made available only as provided for in § 53-10-308 and to the following persons, and in accordance with the limitations stated and rules promulgated pursuant to this part: . . . . (4) A dispenser or pharmacist not authorized to dispense controlled substances conducting drug utilization or medication history reviews who is actively involved in the care of the patient; or a dispenser having authority to dispense controlled substances to the extent the information relates specifically to a current or a bona fide prospective patient to whom that dispenser has dispensed, is dispensing, or considering dispensing any controlled substance. Each authorized individual referenced under this subdivision shall have a separate identifiable authentication for access
question
It is January 2, 2013, and pharmacist is presented with a prescription for 50 doses of hydrocodone. Pharmacist checks the controlled substance database and sees that Patient has obtained more than 500 doses of hydrocodone within the past 30 days from 10 different prescribers and pharmacies. Pharmacist calls the prescriber and asks if Patient told him whether he had obtained hydrocodone within the past 30 days. Prescriber replies, "No, I asked Patient, but he swore he had not." Pharmacist asks Patient who denies that he has had any prescriptions filled for hydrocodone within the past 30 days. Under the Tennessee Prescription Safety Act of 2012, what is Pharmacist legally obligated to do, if anything?
answer
Any physician, dentist, optometrist, podiatrist, veterinarian, pharmacist, advanced practice nurse with a certificate of fitness issued under title 63, chapter 7, or physician assistant, hereinafter referred to collectively as "health care providers", who has actual knowledge that a person has knowingly, willfully and with intent to deceive, obtained or attempted to obtain controlled substances in the manner prohibited by § 53-11-402(a)(6) shall cause a report to be submitted regarding such activity within five (5) business days of obtaining such knowledge. The report should be submitted to the local law enforcement agency where the health care provider is located or, where one exists, to a judicial district or multi-judicial district drug task force
question
After receiving a "clean claim" from a pharmacy, a third party prescription plan must pay the claim within what time frame?
answer
(1) (A) Not later than thirty (30) calendar days after the date that a health insurance entity actually receives a claim submitted on paper from a provider, a health insurance entity shall: (i) If the claim is clean, pay the total covered amount of the claim; (ii) Pay the portion of the claim that is clean and not in dispute and notify the provider in writing why the remaining portion of the claim will not be paid; or (iii) Notify the provider in writing of all reasons why the claim is not clean and will not be paid and what substantiating documentation and information is required to adjudicate the claim as clean. (B) Not later than twenty-one (21) calendar days after receiving a claim by electronic submission, a health insurance entity shall: (i) If the claim is clean, pay the total covered amount of the claim; (ii) Pay the portion of the claim that is clean and not in dispute and notify the provider why the remaining portion of the claim will not be paid; or (iii) Notify the provider of the reason why the claim is not clean and will not be paid and what substantiating documentation or information is required to adjudicate the claim.
