NEBRASKA MPJE EXAM 2024 WITH ACTUAL CORRECT QUESTIONS AND VERIFIED DETAILED ANSWERS, Exams of Nursing

Download NEBRASKA MPJE EXAM 2024 WITH ACTUAL CORRECT QUESTIONS AND VERIFIED DETAILED ANSWERS and more Exams Nursing in PDF only on Docsity! 1 | P a g e NEBRASKA MPJE EXAM 2024 WITH ACTUAL CORRECT QUESTIONS AND VERIFIED DETAILED ANSWERS |FREQUENTLY TESTED QUESTIONS AND SOLUTIONS |ALREADY GRADED A+|NEWEST|GUARANTEED PASS |LATEST UPDATE Q1: Samples of prescription drugs received by a physician from medical representatives can be: (Select ALL that apply.) A) Given to patients B) Sold to a chain pharmacy store C) Sold to another physician D) Sold to a hospital pharmacy E) Sold at a discount to public health clinics A Q2: A pharmacy must register as a wholesale drug distributor if it distributes more than: A) 2% of gross dollar value of the total prescription drug sales revenue in a 12-month period B) 5% of gross dollar value of the total prescription drug sales revenue in a 12-month period C) 3% of gross dollar value of the total prescription drug sales revenue in a 24-month period D) 4% of gross dollar value of the total prescription drug sales revenue in a 6-month period 2 | P a g e E) 5% of gross dollar value of the total prescription drug sales revenue in a 6-month period B Q3: Drugs, devices, and biologicals requiring refrigeration must be stored between: A) -4 and 14 degrees Fahrenheit B) 46 and 59 degrees Fahrenheit C) 36 and 46 degrees Fahrenheit D) 32 and 55 degrees Fahrenheit E) 26 and 36 degrees Fahrenheit C Controlled substance prescription: valid prescription (purpose) *for legit medical purpose by practitioner acting in usual course of practice *Not for practitioner to obtain supply for purpose of dispensing to patients Pharmacist's responsibility in controlled substance prescriptions Ensure that it is a valid prescription issued in the usual course of treatment Knowingly filling questionable prescription is a felony Define practitioner certified registered nurse anesthetist, a certified nurse midwife, a dentist, an optometrist, a nurse practitioner, a physician assistant, a physician, a podiatrist, or a veterinarian. Can physicians prescribe, dispense, or administer a controlled substance in excess of the recommended dosage for the treatment of pain? so long as such dosage is not administered for the purpose of causing, or the purpose of assisting in causing, death for any reason and so long as it conforms to policies and guidelines for the treatment of pain adopted by the Board of Medicine and Surgery Regulations regarding administration of narcotics to a narcotic dependent person *May be administered.dispensed for detox or maintenance treatment by practicioner who is registered to do so *Also when necessary to relieve acute w/drawal symptoms pending referral for detox/maintenance treatment -Only 1 day at a time for max of 3 successive calendar days 5 | P a g e -CII-CV -antianxiety -CS to spouse/child/parent/sibling/household (NOT self) only in emergency APRN-CNM prescribing authority Must specify in practice agreement which conditions require referral to the licensed practitioner Can only prescribe when delgated to do so by physician whose practice includes obstetrics CII for 72h only for pain CIII-V legend contraception nicotine cessation anti-anxiety weight loss (not CII) CS to spouse/child/parent/sibling/household (NOT self) for ob-gyn emergency only APRN-CNM scope of practice Based on educational prep/continued experience. May include: a. Attending cases of normal childbirth; b. Providing prenatal, intrapartum, and postpartum care; c. Providing normal obstetrical and gynecological services for women; d. Providing care for the newborn immediately following birth; and e. Prescribing legend drugs, Schedule II controlled substances for up to 72 hours and for pain control, and Schedule III, IV and V controlled substances. PA prescribing authority Only when delegated to do so by physician (MD or DO) -legend -CII-V -contraception -smoking cessation -anti-anxiety -wt loss -CS to spouse/child/parent/sibling/other household in emergency only (NOT self) Any restrictions placed by the supervising physician must be recorded on the PA's scope of practice agreement PA prescriptions: whose name goes on it? Name of the PA Name of supervising physician only required if needed for reimbursement purposes 6 | P a g e Dentist (DDS, DMD) prescribing authority • CII-CV for human teeth or jaws, or adjacent structures only • Legend drugs for human teeth or jaws, or adjacent structures only • Anti-anxiety for dental visit only • Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for human teeth or jaws, or adjacent structures for an emergency only NOT: contraception, wt loss, CS to self Veterinarian (DVM) prescribing authority ONLY to treat animals • CII-CV • Legend drugs • Contraception • Anti-anxiety • Weight loss Podiatrist (DPM) prescribing authority Only for human foot, ankle, and related governing structures • CII-CV • Legend drugs • Anti-anxiety for office visit only • Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for the human foot, ankle, and related governing structures for an emergency only NOT: contraception, nicotine cessation, wt loss, CS to self MD and DO prescribing authority • CII-CV • Legend drugs • Contraception • Anti-anxiety • Nicotine cessation • Weight loss • Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for emergency only • Cannot prescribe controlled substances to self Q1: How can a pharmacist verify that a prescriber is allowed to prescribe buprenorphine for treatment of opioid addiction? (Select ALL that apply.) 7 | P a g e A) Confirm that the prescriber has been granted a waiver via SAMHSA B) Check the prescriber's regular DEA registration number: It ends with "X" C) The pharmacist must contact the prescriber to verify prescriber eligibility D) Check the prescriber's special Drug Enforcement Administration (DEA) number; physicians granted a waiver under DATA 2000 are issued a special DEA number that always begins with "X" E) The pharmacist must contact the State medical board to verify prescriber eligibility A D Q2: According to Nebraska Pharmacy Law, which of the following practitioners may prescribe a narcotic Schedule II controlled substance in the course of their professional practices? (Select ALL that apply.) A) Physician assistant B) Nurse Practitioner (APRN-NP) C) Veterinarian D) Optometrist E) Physical therapist A B C D Q3: According to Nebraska Pharmacy Law, if a prescription is issued by a physician assistant, both the name of the physician assistant and the name of the supervising physician must appear on prescription when: A) Each prescription is issued B) The prescription is for a controlled substance C) The physician assistant has less than 2 years of practice experience D) It is issued for greater than a 30 day supply E) It is needed for billing purposes only E Q4: A licensed veterinarian, in the course of his professional practice, may prescribe a drug for: (Select ALL that apply.) A) Lucy the dog 10 | P a g e *directions for use *date *Refills (different from CII) *prescriber name *prescriber address *DEA # *signature (manual or digital) pretty much the same as CII except refills! CIII-V refills? Yes, 5 refills w/in 6 months -Can be PRN CIII-V faxed scripts? Yes, serves as the original CIII-V partial fills? Yes -each partial fill recorded in same manner as refilling -quantity dispensed does not exceed total quantity prescribed -each partial fill dispensed w/in 6 months What changes can pharmacist make on CII prescription? After discussing with prescriber, pharmacist can add or change: -dosage form -strength -quantity -directions -issue date NO -pt name -CS prescribed (except generic substitution) -prescriber's signature Procedures for CII oral prescription order *Emergency only (see card) *Practitioner phones pharmacist *Prescriber provides written/signed script w/in 7 days ("Authorization for Emergency Dispensing" and date of oral order) (deliverd in person or by mail-postmarked w/in 7-day period) *Limited to amount needed to treat pt during emergency period *Immediately reduced to writing by pharmacist *Pharmacist makes reasonable effort to ensure oral authorization came from registered individual 11 | P a g e practitioner *Once receive written, attach to the oral prescription (if electronic, make annotation of original authorization and date of oral order) Emergency CII oral prescription order: what if practitioner fails to deliver written prescription? Notify the nearest office of the Administration ID required for receipt of opiates? Unless individual receiving opiates (II-IV, not V) is personally/positively known, he/she must display driver's/operator's license/state ID card/military ID/alien registration card/passport *Does not apply to resident of health care facility Define drug paraphernalia equipment, products, and materials of any kind which are used, intended for use, or designed for use, in manufacturing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance in violation of sections 28-101, 28-431, and 28-439 to 28-444 or the Uniform Controlled Substances Act Regulations on drug paraphernalia (1) It shall be unlawful for any person to deliver, possess with intent to deliver, or manufacture with intent to deliver, drug paraphernalia, knowing, or under circumstances in which one reasonably should know, that it will be used to manufacture, inject, ingest, or inhale or otherwise be used to introduce into the human body a controlled substance in violation of sections 28-101, 28-431, and 28-439 to 28-444. (2) This section shall not apply to pharmacists, pharmacist interns, pharmacy technicians, and pharmacy clerks who sell hypodermic syringes or needles for the prevention of the spread of infectious diseases Q1: Faxing a written, signed paper prescription for Schedule II controlled drugs may serve as the original prescription in which of the following situations: A) For a patient undergoing home infusion of a narcotic that has been compounded for direct parenteral administration B) For administration to a patient living in a LTCF C) For a patient in hospice care receiving a narcotic, bearing the words "hospice patient" D) For a patient picking up medication at a community pharmacy E) None of the above A B C 12 | P a g e Q2: After verbally consulting with a practitioner, according to the Nebraska Board of Pharmacy, what changes may a pharmacist make to a prescription written for a Schedule II drug? (Select all that apply.) A) The patient's address B) Directions for use C) The quantity prescribed D) The name of the controlled substance E) The issue date A B C E Q3: A pharmacist receives a fax for a compounded narcotic CII prescription for direct parenteral administration to a patient for the purpose of home infusion therapy. The pharmacist should: A) Compound the prescription as ordered B) Not compound the prescription C) Ask for the original prescription prior to compounding D) Hold the prescription for a physician's authorization E) Call and verbally verify the prescription A Q4: Which of the following copies of a DEA 222 order from must the purchaser keep for his own record? I. Copy 3 II. Copy 2 III. Copy 1 A) I only B) III only C) I and III D) II and III E) I, II and III A Q5: In Nebraska, a prescription for morphine sulfate shall NOT be filled after how many months after issuance? A) 1 month B) 2 months 15 | P a g e Can CV be dispensed without a prescription? No-no controlled substances can be dispensed without a prescription in Nebraska Q1: Schedule I controlled drugs are classified as: (Select ALL that apply.) A) Having a high potential for abuse B) Having a low potential for abuse C) Having no accepted medical use in the US D) Having an accepted medical use in the US E) Having a lack of accepted safety for use even under medical supervision A C E Q2: Which of the following is/are classified as Schedule I controlled substance(s)? (Select ALL that apply.) A) Peyote B) Morphine C) Marijuana D) Codeine E) Amphetamine A C Q3: Which of the following is/are classified as Schedule II controlled drug(s)? (Select ALL that apply.) A) Heroin B) Morphine C) Methylphenidate D) Cocaine E) Modafinil B C D Q4: A DEA 222 form is required to purchase which of the following? A) MS Contin (morphine) B) Fiorinal (butalbital, aspirin and caffeine) C) Provigil (modafinil) 16 | P a g e D) Klonopin (clonazepam) E) Phenobarbital A Q5: A pharmacist is adding 1000 mg of codeine phosphate powder to 100 cc of Tylenol with codeine elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as: A) Schedule V B) Schedule IV C) Schedule III D) Schedule II E) Schedule I C Q6: According to Nebraska Pharmacy Law, which of the following shall be classified as Schedule IV controlled substances: (Select ALL that apply.) A) Ephedrine B) Bronkaid C) Primatene D) Soma E) Lyrica A D Q7: In Nebraska, Phenergan with Codeine (promethazine with codeine) syrup is classified as: A) Schedule II B) Schedule III C) Schedule IV D) Schedule V E) Schedule VI D Q8: Which of the following oral liquids is/are usually classified as a Schedule V controlled drug? I. Guaifenesin with codeine II. Hydrocodone with acetaminophen III. Acetaminophen with codeine A) I only B) I and II C) I and III 17 | P a g e D) II and III E) I, II and III C Can someone other than the prescriber communicate a prescription/order/refill authorization? Yes, an employee or agent of the prescriber may communicate it (except emergency oral authorizations for CII) Define prescription order for a drug or device issued by a practitioner for a specific patient, for emergency use, or for use in immunizations. Prescription does not include a chart order. Define chart order order for a drug or device issued by a practitioner for a patient who is in the hospital where the chart is stored or for a patient receiving detoxification treatment or maintenance treatment pursuant to section 28-412. Chart order does not include a prescription Components of a chart order 1. Patient's name, 2. Date of the order, 3. Name of the drug, device, or biological, 4. Strength of the drug or biological, if applicable, 5. Directions for administration to the patient, including the dose to be given, and 6. Prescriber's name. Expiration date for non controlled substances? 12 months (including devices) Can you back or forward date a controlled substance prescription? No, must be dated and signed on the day it was issued Regulations for prescriptions for gamma-hydroxybutyric acid Note on the face of the script the medical need of the patient for the script Requirements for non-controlled substance prescriptions *Pt name *Name of drug *strength 20 | P a g e Record keeping requirements for LTC automated pharmacy Monitor automated system electronically and keep records of compliance with such requirement for 5 years Labeling requirements for drugs dispensed from LTC automated pharmacy *Name/address of LTC automated pharmacy *Script# *Name/strength/dosage form *Name of resident *Name of prescriber *Date of fill *Directions Does the inventory transferred to an LTC automated pharmacy get included in the percent of total prescription drug sales revenue? No Current REMS programs Buprenorphine transmucosal products for opioid dependence ER/LA opioids Isotretinoin Mycophenolate Rosiglitazone Transmucosal IR fentanyl Can a pharmacy be open for the practice of pharmacy without the pharmacist there? No What must the board be notified of in regards to practice agreements? Initiation Changes (provided to BOP and board of the other HCP) Requirements for practice agreement signing All parties must sign at initiation and review/sign/date q2y thereafter When does a practice agreement end? *death of pharmacist or practitioner *loss of license to practice by either *disciplinary action limiting either party to enter into practice agreement *individual/mutual decision by either to terminate 21 | P a g e Can interns participate in agreements? Yes They do not have to be mentioned in the agreement if they are supervised by a pharmacist in the agreement Can pharmacists/interns administer drugs/devices? Yes, pursuant to a prescription, chart order, or practice agreement Q1: A chart order in a hospital must contain all of the following: (Select ALL that apply.) A) Patient's name B) Date of the order C) Prescriber's signature D) Directions for administration E) Prescriber's name A B D E Q2: In Nebraska, a pharmacist should not dispense any noncontrolled drug or device if the prescription is presented: A) More than 180 days after the date of issuance B) More than 90 days after the date of issuance C) More than 365 days after the date of issuance D) More than 30 days after the date of issuance E) More than 60 days after the date of issuance C Q3: According to Nebraska Pharmacy Law, a pharmacist may enter into a practice agreement with a licensed medical practitioner to provide pharmaceutical care according to written protocols. These practice agreements and written protocols must be signed and reviewed by the pharmacist and the medical practitioner every: A) 30 days B) 6 months C) 12 months D) 2 years E) 3 years D Requirements for labeling of poisons 22 | P a g e MUST have label on it -name -"poison" -name/place of seller -manufacturer/packager/distributor -date of sale What is the Poison Register? Before delivery, must document -date of sale -name/address of purchaser -name/quantity of poison -purpose for purchasing -name of dispenser -signed by person to whom it was delivered Requirements for selling poison Keep Poison Register (see card) for at least 2 years after the last entry Which drugs have restricted distribution programs? thalidomide (STEPS) iPLEDGE Lotronex (PPL) Tracleer (TAP) Clozaril Tikosyn (TIPS) Exjade IRESSA REACH Does a pharmacist/intern have the right to refuse to dispense? Yes Forms that practitioners/agents can transmit medical orders to pharmacists/interns (Techs can take any form for refill authorizations but not new orders) *Writing *Oral *Fax of written order or electronic transmission of order signed by practitioner *Fax of written order or electronic transmission of order NOT signed by practitioner-would need to be verified with the practitioner Requirements for fax or electronic transmission *Be transmitted by practitioner/agent directly to pharmacist/intern in a licensed pharmacy (if refill, can be transmitted to tech) 25 | P a g e *Cautionary statements *Side effects statement (see card) Can more than one drug/device/biological be dispensed in same container? Yes, if: *Prepackaged by manufacturer/packager/distributor and shipped directly to pharmacy this way, OR *No more than 31 days supply of compatible dosage units, labeled to identify each drug in container (and other info required by law) Can a pharmacy fill a CS prescription for another pharmacy? yes, if under contractual agreement or common ownership -label must contain DEA# of pharmacy at which scripts are filled Label requirements for pt name if no-human Name of owner and species must be on label Label requirements for prescription container of CS Same as before + -"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." **Not required for blinded trials **Not required for CV Label requirements: side effects statement *Sticker attached to container *Preprinted vial cap *Separate sheet of paper *Part of other consumer medication info *FDA-approved Med Guide Requirements for prescription record keeping Paper scripts for CII: separate file, at least 5 years, readily available CIII-V: separately from others or in form where info is ready retrievable from ordinary business records, 5 years Availability of prescription records to department/law enforcmenet Should be readily available to department and law enforcement for inspection without a search warrant Nebraska Drug Product Selection Act provide for the drug product selection of equivalent drug products or interchangeable biological products and to promote the greatest possible use of such products. When can a pharmacist drug product select? 26 | P a g e -if solid dosage form, must have ID code -must have expiration date -manufacturer/distributor/packager of drug product provides reasonable services to accept return of drugs that reached exp date -Man/distr/packager maintains procedures for recall of unsafe/defective drugs NO -Practitioner designates on script -Pt/representative refuses Requirements for selecting biological products Within 3 business days of dispensing, pharmacist or designee must document name/manufacturer of product dispensed Must be electronically accessible to prescriber (or fax, phone, other) NOT required if no interchangeable product approved by FDA or a refill is not changed from previous fill Requirements for patient communication when generic sub (etc.) occurs Must advise the pt/caregiver of the generic substitution Can prescriptions be transferred among pharmacies? Yes, CIII-V and non-CS -only once -may transfer up to available refills for pharmacies electronically accessing a real-time, on-line database -communicated btwn 2 pharmacists/interns (except when using database) Requirements for pharmacy transferring the prescription -indicate void on record of script -indicate that it was txfrd -name/address of receiving pharmacy (and DEA# if CS) -name of receiving/transferring pharmacist/intern -date of transfer -maintained by both pharmacies for at least 5y from date of txfr Requirements for pharmacy receiving the transferred prescription -date of issue -original refills -date of first fill -# refills left -date/location of last fill -name/address of txfring pharmacy (and DEA if CS) -name of txfr pharm/intern -original script# 27 | P a g e -date of txfr -indicate that it's transferred -any info normally required on new script Q1: When a pharmacist transfers any remaining authorized refills of a controlled substance prescription to another pharmacy, what things must the "transferor pharmacist" do to the original prescription? I. Write "void" on the prescription II. Write name, address, DEA number of receiving pharmacy III. Record name of transferring and receiving pharmacists A) I only B) II only C) I and II D) II and III E) I, II and III E Q2: Which of the following is not required when a prescription refill is transferred? A) Date of issuance of the original prescription B) Pharmacy license number of the transferring pharmacy C) Number of valid refills remaining D) Date of last refill B Q3: Which of the following shall be required on the prescription if the prescription is written for an animal? I. Name of an animal II. The species of animal III. The name of the owner of the animal A) I only B) I and II C) I and III D) II and III E) I, II and III D Q4: The labeling requirements do not apply when a Schedule II, III, IV, or V drug is prescribed for administration to an institutionalized patient provided that: (Select ALL that apply.) 30 | P a g e Can an LTC send prescibed medications with resident upon discharge? Only with order of the practitioner Containers must be properly labeled by dispensing pharmacy Options for LTC discontinued medications Return to dispensing pharmacy for credit Properly dispose of in facility and record medication name/strength/# disposed in reisdent's medical record Define unit-dose 1. That contains individual sealed doses of a drug; 2. That may or may not attach the sealed doses to each other by placement in a card or other container; 3. Where the container may not contain doses for a period of greater than 14 days; and 4. That is non-reusable. Can drugs/devices delivered to a community health center for dispensing be returned? May be delivered to pharmacist/pharmacy under contract for relabeling and redispensing to another patient o the health center -decision rests with pharmacist -drug/device in control of health center at all times -in original, unopened, labeled container w/ tamper-evident seal intact -must contain exp date and lot Can drugs/devices delivered to a correctional facility for dispensing be returned? May be returned to pharmacist/pharmacy under contract for credit or relabeling and redispensing to another patient of the facility -decision rests with pharmacist -drug/device in control of facility at all times -in original, unopened, labeled container w/ tamper-evident seal intact -must contain exp date and lot NO -CS -restricted distribution Define cancer drug Prescription drug used to treat: -cancer or its side effects -side effects of drug used to treat cancer or its side effects What is the cancer drug repository program? 31 | P a g e Program for accepting donated cancer drugs and dispensing to NE residents. Participation in cancer drug repository program mandatory? No Participation in immunosuppressant drug repository program mandatory? no Cancer drug repository: drugs that can be accepted -original, unopened, sealed, tamper-evident packaging (single unit dose ok even if outside package open) -no limit on # of doses -includes injectables -can't have temp requirements other than controlled room temp -within date -not adulterated or misbranded -no restricted distribution meds -dispensed under the medical assistance program -not a CS Cancer drug repository: define participant physician's office, pharmacy, hospital, or health clinic that has elected to voluntarily participate in the program and that accepts donated cancer drugs under the rules and regulations adopted and promulgated by the department for the program Cancer drug repository: requirements for participants -comply with laws regarding storage/distribution/dispensing -inspect drugs prior to dispensing -only dispense pursuant to script or distribute to another participant for dispensing Cancer drug repository: can participants distribute drugs to other participants for dispensing? yes Cancer drug repository: can participants charge anything? May charge handling fee for distributing or dispensing (must be in rules/regs) -can't exceed Medicaid provider dispensing fee the drugs CAN'T be resold Cancer drug repository: how can someone donate a drug? 32 | P a g e Contact a participant to obtain a form -name of drug -quantity -name to whom it was originally prescribed -relationship btwn person donating and person it was prescribed to -signature of donator -date signed Immunosuppressant drug repository: how to donate a drug Contact a participant to obtain a form -name of drug -quantity -name to whom it was originally prescribed -relationship btwn person donating and person it was prescribed to -signature of donor -date signed Cancer drug repository: who is authorized to dispense the drugs? -licensed physicians who do not charge handling fee -licensed physicians who charge handling fee and hold valid dispensing practitioner pharmacy license -licensed pharmacists Immunosuppessant drug repository: who is authorized to dispense 1. Licensed physicians; 2. Licensed physician assistants; 3. Licensed pharmacists. Cancer drug repository: requirements for communication to patient prior to dispensing Must be notified by prescriber that drugs receiving were originally dispensed to another patient and were returned for redispensing through the program. Immunosuppressant drug repository: requirements for communication to patient prior to dispensing Must be notified by prescriber that drugs receiving were originally dispensed to another patient and were returned for redispensing through the program. Cancer drug repository: storage requirements for participant Proper temperature Maintain inventory separate from other inventory Establish secure storage location Immunosuppressant drug repository: storage requirements for participant Proper temperature Maintain inventory separate from other inventory Establish secure storage location 35 | P a g e Immunosuppressant drug repository: when can the department inspect for cause? -accident/natural disaster damaging the location -interruption of utility services -compliant alleging violation of the regulations -complaint that raises concern about maintenance/operation/mgmt of the participant -any other event that raises concern Immunosuppressant drug repository: what is done with results of insepctions -participant not compliant and would cause imminent danger of death/serious harm or immediate AE: cease participation immediately -participant not compliant but no immediate danger: correct deficiencies w/in 30d of receiving results -if not after 30d: no longer allowed to participate Q1: In accordance with Nebraska Pharmacy Law a pharmacist may accept return of the dispensed drug or device when: I. A device is defective or malfunctioning II. The patient changes their mind and wants a refund III. It is collected for the purpose of disposal by the pharmacy IV. In response to a recall by the manufacturer, packager, or distributor A) I only B) I and II C) I, II, and III D) I, III, and IV E) I, II, III and IV D Q2: Which of the following defines a Unit Dose Packaging System? (Select ALL that apply.) A) It is a packaging system that contains individual sealed doses of a drug. B) It is a packaging system that is non-reusable. C) It is a packaging system where the container may not contain doses for a period greater than 3 days. D) It is a packaging system where the container may not contain doses for a period greater than 14 days. E) It is a packaging system designed to help patients remember when to take their medications A B D 36 | P a g e Q3: Under the Cancer Drug Repository Program a cancer drug can be accepted if: (Select ALL that apply.) A) It is an injectable drug that does not have temperature requirements other than controlled room temperature B) The drug bears an expiration date prior to the date of donation C) The drug is adulterated or misbranded D) The drug is not in tamper-evident packaging E) The drug is in unopened single-unit-dose packaging A E CS disposal: record keeping requirements Complete record of destruction maintained for 5 years CS disposal: who can destroy them if the owner is a registrant? -pharmacy inspector -reverse distributor -the administration -liquid in opened container which originally contained 50 mL or less or compounded w/in facility: witnessed by 2 individuals credentialed under Uniform Credentialing Act -Solid CS in opened unit-dose containers or which have been adulterated within a hospital where they were to be administered: witnessed by 2 individuals credentialed under the Uniform Credentialing Act CS disposal: who can destroy them if the owner is a resident of an LTC of hospital? by two individuals credentialed under the Uniform Credentialing Act and designated by the facility or hospital Theft/loss of CS: what to do with DEA Form 106 Send to local DEA Diversion Field Office and Neb Dept of HHS LTC emergency boxes: types of drugs included -Drugs required to meet immediate therapeutic needs of patients -Not available from other sources in sufficient time -tamper-evident seal -provided/sealed by supplying pharmacy LTC emergency boxes: storage requirements Medication room or other secured area -prevent unauthorized access -ensure proper environment LTC emergency boxes: labeling of exterior 37 | P a g e -indicate use in emergencies only -list of drugs (name, strength, #, route, exp) -name/address/phone of supplying pharmacy LTC emergency boxes: labeling of medications Must be in original container or repackaged by supplying pharmacy -manufacturer/distributor name -lot -drug name -strength -dosage form -NDC -route -exp LTC emergency boxes: inspection By pharmacist designated by supply pharmacy: -q30d -after reported use -record and retain by LTC for 5y LTC emergency boxes: documentation required by supplying pharmacy -keep list identical to the one on exterior of box -obtain receipt signed by director of nursing of facility or designee and keep for 5y -prescription and documentation of use provided to pharmacy LTC emergency boxes: what happens when opened -notify pharmacy w/in 24h -pharmacist restocks/reseals box and updates list on exterior Requirements for pharmacist in LTC? -facility must employ/obtain services of Neb-licensed pharmacist LTC pharmacist responsibilities 1. Consultation on all aspects of the provision of pharmacotherapy services in the facility; 2. Ensuring that the pharmacotherapy service has procedures for control and accountability of all medications throughout the facility; 3. Ensuring that medication records are in order and that an account of all Schedule II and III controlled substances is maintained and reconciled; 4. Maintaining records of receipt and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation; and 5. Reviewing the drug regimen of each resident at least monthly and reporting any irregularities to the primary medical practitioner and Director 40 | P a g e Q1: Which DEA form is used when CIIs are lost or stolen? A) Form 41 B) Form 106 C) Form 222 D) Form 222a E) Form 222d B Q2: According to Nebraska Pharmacy Law, all emergency boxes shall be inspected: (Select ALL that apply.) A) By a pharmacist designated by the supplying pharmacy B) Within 48 hours after opening C) At least once every 30 days D) At least once every 90 days E) Can be inspected by a pharmacy technician A C Q3: Who can be a witness for destruction of controlled substances in a long-term care facility? (Select ALL that apply.) A) A licensed physician B) A licensed pharmacist C) A licensed nurse practitioner D) A licensed massage therapist E) Any two people credentialed under the UCA and designated by the facility A B C D E Q4. The responsibilities of a long-term care pharmacist engaged in pharmacotherapy services supervision include: A) Consultation on all aspects of pharmacotherapy services in the facility B) Ensuring that medication records are in order C) Ensuring that the pharmacotherapy service has procedures for control and accountability of all medications throughout the facility D) Reviewing the drug regimen of each resident of the facility at least monthly and reporting irregularities to the primary medical practitioner and Director of Nursing Services 41 | P a g e E) B and D only F) All of the above F Q5. Disaster Preparedness and Management plans and procedures must include how the pharmacy will: (Select ALL that apply.) A) Secure the drugs, devices, and biologicals from the public B) The pharmacy has no role in securing the drugs, devices, and biologicals from the public C) Maintain patient records and inventory records D) Obtain drugs, devices, and biologicals in the event of a natural disaster E) Provide for the disposal of drugs, devices, and biologicals that have been adversely affected A C E Q6. Which of the following may be considered by the FDA, a violation of its compounding requirements? I. Compounding of drugs in anticipation of receiving prescriptions II. Compounding a product pursuant to an order III. Compounding drug products that are commercially available in the marketplace IV. Compounding in a hospital for in hospital use A) I and III B) I and IV C) II and IV D) III E) III and IV D Prospective DUR requirements • Therapeutic duplication • Incorrect drug dosage or duration of therapy • Drug-disease contraindications • Drug-drug interactions • Drug-allergy interactions • Clinical abuse/misuse Also make sure that patient record is complete (see card) Components of patient record 42 | P a g e • (i) The name, address, telephone number, date of birth, and gender of the patient; • (ii) The patient's history of significant disease, known allergies, and drug reactions and a comprehensive list of relevant drugs and devices used by the patient; and • (iii) Any comments of the pharmacist relevant to the patient's drug therapy. Patient counseling requirements Pharmacist shall ensure that a verbal offer to counsel the pt or caregiver is made -refusal of offer must be documented In person or via telepharmacy at no cost -written info as supplement, not substitute When is verbal offer to counsel pt not required? -pharmacist judges that it may be detrimental to the pt care or relationship btwn pt and prescriber -pt is resident of health care facility or service to whom drugs/devices are administered -medical gas or device from certain person -device from certain person Q1: Under which of the following sections of the law is it the pharmacist's duty to offer to counsel Medicaid patients? A) Kefauver-Harris B) Durham-Humphrey C) OBRA-90 D) Prescription Marketing Act E) Food, Drug, and Cosmetic Act C Q2: Checking for therapeutic duplication by pharmacists before dispensing is generally classified as: A) Introspective DUR B) Retrospective DUR C) Triospective DUR D) Prospective DUR E) Concurrent DUR D Q3: A pharmacist conducting a prospective drug utilization review shall ensure that a reasonable effort is made to record and maintain which of the following information about a patient: (Select ALL that apply.) 45 | P a g e showing of good cause by the seller that he or she is otherwise unable to submit log information by electronic means, including, but not limited to, any financial, technological, or other reason which would place an undue burden on the seller, as established by the Attorney General. Methamphetamine precursor sales: what if exchange generates a stop-sale alert? Do not complete sale unless seller has reasonable fear of bodily harm if not completed (override fx available for this) Methamphetamine precursor sales: what if it's a prescription order? Requirements do not apply. Dispense as prescription Q1: Tamper-resistant packaging provides protection against: A) Accidental poisoning B) Intentional contamination of OTC drugs C) Damage to the reputation of the brand name product D) Accidental breakage of containers B Q2: Which of the following is required on an OTC medication label: (Select ALL that apply,) A) Inactive ingredients B) Directions C) Expiration date D) NDC number E) Purpose of the medication A B C D E Q3: The label on the container of an OTC drug intended for sale directly to a patient must include: A) Adequate directions for safe and effective use B) Cautions and warnings needed for the protection of the user C) Name and address of the manufacturer, packager, or distributor D) A and B E) All of the above 46 | P a g e E Q4: A 30 year old customer wishes to know how many 30 mg Sudafed tablets he can purchase at one time. Which of the following is the correct answer? A) 12 B) 60 C) 120 D) 240 E) 360 C Q5: According to Nebraska Pharmacy Law, no customer shall be allowed to purchase, receive, or otherwise acquire more than: A) 3.6 grams of pseudoephedrine base during a 24-hour period and a total of 9 grams in 30 days B) 3.6 grams of pseudoephedrine base during a 48-hour period and a total of 9 grams in 7 days C) 5.2 grams of pseudoephedrine base during a 24-hour period and a total of 30 grams in 30 days D) 5.2 grams of pseudoephedrine base during a 24-hour period and a total of 30 grams in 7 days A Q6: According to the Combat Methamphetamine Epidemic Act of 2005, a customer does not have to sign the logbook or show identification if they buy a single package containing not more than: A) 30 milligrams of pseudoephedrine B) 60 milligrams of pseudoephedrine C) 90 milligrams of pseudoephedrine D) 120 milligrams of pseudoephedrine B PDMP in Nebraska? Yes, ALL dispensed prescriptions must be reported daily by the dispenser or designee What info needs to be reported to the PDMP? (a) The patient's name, address, and date of birth; (b) The name and address of the pharmacy dispensing the prescription; 47 | P a g e (c) The date the prescription is issue; (d) The date the prescription is filled; (e) The name of the drug dispensed or the National Drug Code number as published by the federal Food and Drug Administration of the drug dispensed; (f) The strength of the drug prescribed; (g) The quantity of the drug prescribed and the number of days' supply; and (h) The prescriber's name and National Provider Identifier number or Drug Enforcement Administration number when reporting a controlled substance. Who can information (with regard to a patient maintained by a pharmacist) be released to? -pt, caregiver, or others authorized by patient -pt legal representative -physician treating the pt -other physicians/pharmacists when release of info is necessary to protect pt -other persons/gov't agencies authorized by law How long do HIPAA privacy notices need to be kept? 6 years from date of signature or last date of rx dispensed Original hard copies of all dispensed prescriptions must contain the following information a. All information required for prescriptions as set forth in 175 NAC 8-006.04B; b. Prescription serial number; c. Date of initial filling; d. Quantity dispensed; e. If an emergency verbal Schedule II controlled substance prescription, "authorization for emergency dispensing" must appear on the face of the prescription; How long to original hard copies of prescriptions dispensed need to be maintained? 5 years from date of dispensing Q1: Which of the following are the intentions of HIPAA? (Select ALL that apply.) A) To assure health insurance coverage B) To prevent or reduce healthcare related fraud and abuse C) To ensure the safety and security of each patient's health related information D) To enforce the standard for health insurance E) To allow individuals to purchase insurance on a government exchange C 50 | P a g e Q3: A prescriber can write multiple prescriptions for the same CII on the same day to be filled on different dates, as long the total quantity does not exceed a ___ day supply. A) 15 B) 30 C) 60 D) 90 E) 120 D Q4: In Nebraska, the inventory of controlled substances must be done every: A) Six months B) Year C) Two years D) Three years E) Five years B Q5: When taking an inventory of controlled substances: (Select ALL that apply.) A) Controlled substances awaiting return or destruction must be included in the inventory B) An exact count of all controlled substances listed in Schedules III, IV, or V must be made if the container holds greater than 1,000 tablets or capsules C) An estimated count of all controlled substances listed in Schedules III, IV, or V may be made if the container holds fewer than 1,000 tablets or capsules D) An exact count or measurement of all controlled substances listed in Schedule I or II must be made E) An exact count of all controlled substances listed in Schedules I, II, III, IV, or V must be made A B D E Q6: According to Nebraska Pharmacy Law, a Schedule II controlled substance can be: (Select ALL that apply.) 51 | P a g e A) Unlocked in a movable cabinet B) Distributed throughout the inventory of non-controlled substances C) Stored on a separate shelf within the inventory of non-controlled substances D) Stored in a cabinet that is locked when the pharmacy is closed E) Stored in a locked cabinet B E Q7: The computerized application shall have the capacity to retrieve records of all controlled substance prescriptions refilled. Which of the following information must be retrievable by prescription number for refills? (Select ALL that apply): A) Quantity dispensed B) Patient's address C) Date of refill D) Prescriber's name E) The identification code or dispensing pharmacist's initials A B C D E Pharmacist license expiration? January 1 of even-numbered years (notice sent out by dpet at least 30 days before) Minimum age to be credentialed under the Uniform Credentialing Act 19 (unless otherwise specified) When is re-credentialing needed? Credential previously: 1. Placed on lapsed status; 2. Placed on inactive status; 3. Revoked for failure to meet the renewal requirements; 4. Suspended or limited for disciplinary reasons; or 5. Voluntarily surrendered or voluntarily limited for an indefinite period of time; Can you re-credneital if your credential was revoked for disciplinary reasons? May apply for reinstatement after at least 2 years from date of revocation Purpose of the licensee assistance program 52 | P a g e -provide education -referral assistance -monitoring compliance with tx for abuse/dependence/addiction to alcohol/CS/mind-altering substances Voluntary participation only Licensee assistance program: confidential? Yes, unless program determines that the abuse/dependence/addiction may constitute danger to public health and the person Nebraska BOP: composition 5 members -4 actively practicing pharmacists (at least one that practices in hospital) -1 public member interested in health of Nebraska people Nebraska BOP: terms 5 years No more than 2 consecutive terms unless otherwise specified Starts on Dec 1 following expiration of term of preceding member Qualifications for pharmacy inspector Only a licensed pharmacist who is or who has been engaged in the active practice of pharmacy shall be appointed by the department to serve as a pharmacy inspector with the consent and approval of the board Eligibility for taking pharmacist licensure exam -proof of graduation from accredited program -non-accredited program located outside US: provide satisfactory evidence to the department of graduation and passing equivalency exam Requirements for licensure as pharmacist -pass licensure exam -have graduated from pharmacy program -present proof of competency (see card) How to present proof of competency to license as a pharamcist One of the following: -w/in 3y, has passed licensure exam approved by board -active practice in another state for at least 1y within previous 3y -board certified in specialty w/in 7y -licensed in another state (with similar conditions for granting license as NE) -completed continuing competency in pharmacy that is approved by the board 55 | P a g e -valid for 1y -not renewable -may be converted to pharmacy license once compliance demonstrated How to get from provisional license to pharmacy license Department conducts initial on-site inspection w/in 60d of issuing provisional license notified of results w/in 10d Q1: What are the requirements of a pharmacist if he or she wishes to reciprocate or transfer a pharmacist license to Nebraska? A) A pharmacist had his or her first professional degree outside of the United States B) Have a pharmacy degree from a school or college approved by the Board and pass the MPJE with a score of 75 or greater C) Have an active license in good standing D) A and B E) B and C E Q2: In Nebraska, revocation of one's pharmacist license is for all time, except that any time after ___ years the licensee may reapply to the Board of Pharmacy for reinstatement. A) One B) Two C) Three D) Four E) Five B Q3: Mrs. Tudor owns three pharmacies in Nebraska. How many pharmacy licenses does she require? A) One B) Two C) Three D) Four E) Five C Q4: Which of the following is/are TRUE about a pharmacy license? I. A license is issued only for the premises and persons named in the application, and is not transferable or assignable 56 | P a g e II. Change of ownership terminates the license III. If there is a change of ownership and the pharmacy remains on the same premises, the inspection is not required IV. If the location of the pharmacy changes, a new license is required as well as an inspection A) I only B) I and II C) II and III D) I, II and III E) I, II, III, and IV E Q5: In Nebraska, pharmacy permits expire on which of the following dates each year? A) November 30 B) January 31 C) July 1 D) December 31 E) January 1 C When is the pharmacy quality assurance report (PQAR) due? within 30 days of due date due date is 1 year from date of initial on-site inspection and annually thereafter Components of pharmacy quality assurance report 1. Adequate security; 2. Proper environmental controls; 3. Appropriate cleanliness and sanitation; 4. Reference requirements are met; 5. Poison control phone number is posted; 6. Required equipment is available; 7. A verbal offer to counsel the patient or the patient's caregiver is being made; 8. Documentation of refusal of patient counseling exists; 9. Only pharmacists or pharmacist interns are providing patient counseling; 10. Prospective drug utilization review is being conducted; 11. Record keeping requirements have been met; 12. Computer back up, if applicable, has been completed; 13. Outdated inventory is segregated from stock that is intended to be sold or dispensed 14. Misbranded or adulterated inventory is segregated from stock that is intended to be sold or 57 | P a g e dispensed 15. Unit-dose labels meet requirements, if applicable; 16. Controlled substances inventory records are complete and accurate; 17. A copy of the biennial inventory and other required inventories was sent to the Department, when applicable; (annual inventory for CS) 18. All D.E.A. Forms 222 are properly completed; 19. All controlled substance Schedule II invoices are properly maintained; 20. All controlled substance Schedule III-V invoices are properly maintained; 21. All controlled substances are properly stored; 22. All controlled substance transfers between registrants have been properly recorded; 23. Date of issuance is recorded on all prescriptions; 24. Date of initial filling on all prescriptions; 25. All prescriptions bear the name of the patient; 26. All controlled substance prescriptions contain the patient's address; 27. All prescriptions contain the name of the prescriber and if written, the prescriber's signature in indelible ink or indelible pencil and contain the name of the prescriber either stamped, typed or clearly handwritten; ** Mandatory reporting for incompetent, gross negligent, or unprofessional conduct or impaired/disabled person? yes, must be reported to the department w/in 30d of occurrence Mandatory reporting requirements for the same profession Report first-hand knowledge of facts giving you reason to believe that any person in profession: • Has acted with gross incompetence or gross negligence; • Has engaged in a pattern of incompetent or negligent conduct • Has engaged in unprofessional conduct • Has been practicing while his or her ability to practice is impaired by alcohol, controlled substances, mind-altering substances, or physical, mental, or emotional disability; or • Has otherwise violated the regulatory provisions governing the practice of the profession Mandatory reporting for different professions Must report first-hand knowledge of facts giving you reason to believe -acted with gross incompetence or negligence -practicing impaired Mandatory reporting requirements for yourself • Lost privileges/employment or been disciplined for a reportable behavior • Had an adverse judgment, settlement, or award arising out of a 60 | P a g e initial triennial inspection for cause Wholesale drug distributor: license requirements -must have license from dept for each facility -must designate representative Prescription drugs: tracking? Yes, need paper or electronic pedigree (information concerning each sale or other transfer in the chain of distribution of the prescription drug from the manufacturer, through acquisition and sale by any wholesale drug distributor, until final sale to a pharmacy or other person dispensing or administering such drug) Pedigree information requirements 1. Name of the prescription drug; 2. Dosage form and strength of the prescription drug; 3. Size of the container; 4. Number of containers; 5. Lot number of the prescription drug; 6. Name of the original manufacturer of the finished dosage form of the prescription drug; 7. Name, address, telephone number, and if available, the e-mail address of each owner of the prescription drug and each wholesale drug distributor who does not take title to the prescription drug; 8. Name and address of each location from which the prescription drug was shipped if different from the owner's; 9. Transaction dates; 10. Certification that each recipient has authenticated the pedigree; 11. Name of any repackager, if applicable; and a. Name and address of person certifying the delivery. b. Each paper or electronic pedigree must be maintained by the purchaser and the wholesale drug distributor for three years from the date of sale or transfer and available for inspection or use upon request of law enforcement or an authorized agent of the Department. How long must the pedigree information be maintained? 3y from date of sale/transfer 61 | P a g e Q1: Who has the authority to perform and submit annually the Pharmacy Quality Assurance Report (PQAR) within 30 days of the due date of the report? A) Any pharmacist B) The Attorney General C) The Pharmacy Manager D) The Pharmacist-in-charge E) Anyone granted Power of Attorney under the pharmacy's license D Q2: Which of the following is (are) true about the mandatory reporting of the unprofessional conduct of a licensee? I. All pharmacists, pharmacist interns, and pharmacy technicians are required to report II. Must report in writing within 30 days of occurrence III. Spouses of the credential holders are exempted from reporting A) I only B) III only C) I and II D) II and III E) I, II and III D Q3: How often does the department require mail-order ophthalmic providers located outside of this state to provide the registration to dispense contact lenses to Nebraska residents? A) Every 6 months B) Every year C) Every 2 years D) Every 3 years E) There is no registration requirement B Q4: According to Nebraska Pharmacy Law, the Pharmacy Quality Assurance Report is due: A) One year from the date of the initial on-site inspection, and annually thereafter B) Six months from the date of the initial on-site inspection, and annually thereafter C) Thirty days from the date of the initial on-site inspection, and annually thereafter D) One year from the date of the initial on-site inspection, and biennially thereafter E) Six months from the date of the initial on-site inspection, and biennially thereafter A 62 | P a g e Q1: What federal law was created after the thalidomide incident that required manufacturers to show effectiveness and safety of a drug before marketing? A) Food Drug & Cosmetic Act (FDCA) 1938 B) Kefauver-Harris Amendment 1962 C) Orphan Drug Act 1983 D) FDA Modernization Act 1997 E) Durham Humphrey Amendment 1951 B Q2: If Ciprofloxacin pills accidentally fall on the pharmacy floor, and are unknowingly dispensed by the pharmacist to the patient, the dispensed drug is: A) Adulterated B) Misbranded C) Deteriorated D) Mislabeled E) Adulterated and misbranded A Q3: If a bottle of 250 mg of Cephalexin contains 500 mg of Cephalexin, the product is: A) Adulterated B) Misbranded C) Deteriorated D) Adulterated and misbranded B Q4: If a pharmacy technician accidentally mixes two bottles of Tylenol syrup with the same strength but different lot numbers and expiration dates, the resultant mixture in the pharmacy's inventory is: A) Adulterated B) Misbranded C) Deteriorated D) Contaminated E) Adulterated and misbranded B Q5: The FDA has notified a pharmaceutical manufacturer that several lots of their OTC analgesics have been found to be contaminated with digoxin and present serious threat to patients' safety. The FDA is likely to request that they announce which class 65 | P a g e -Location of all patient records Return pharmacy license, DEA registration, and unused DEA 222 forms (including a and d) What to do if pharmacy has change of ownership Notify the Department within 15 days A pharmacy may hire an outside firm to inventory, package, and arrange for the transfer of its controlled substances to another pharmacy, the original supplier, or the original manufacturer. The pharmacy is responsible for the actual transfer of the controlled substances and for the accuracy of the inventory and records. The records involving the transfer of controlled substances must be kept readily available by the pharmacy for two years for inspection by the DEA. How to transfer schedule III-V medications (to a pharmacy, wholesaler, etc.) Must be documented in writing -Drug name -Dosage form -Strength -quantity -date transferred -name/address/DEA# of parties involved How do reverse distributors for controlled substances work? Submit DEA 222 form to the pharmacy to "order" drugs (or just record for CIII-V) When destroying, must submit DEA Form 41 Practice of Pharmacy definition *Interpret/evaluate/implement medical order *dispense drugs/devices *drug product selection *administration of drugs/devices *drug utilization review *counseling *provide pharmaceutical care *MTM *compound/label dispensed/repackaged drugs/devices, proper storage, maintain proper records Can orders from presciber's from outside state be filled? Yes, if that prescriber could be authorized to prescribe in this state Is it illegal for unauthorized people to provide pharmaceutical care and compound/dispense drug/devices? 66 | P a g e Yes, and it is illegal to permit or direct a person to do so Is it illegal to (attempt to) coerce a pharmacist to enter into a delegated dispensing agreement? Yes Can you split fees with a person for bringing/referring a consumer? No, except: (a) with a partner or employee of the applicant or credential holder or his or her office or clinic, (b) with a landlord of the applicant or credential holder pursuant to a written agreement that provides for payment of rent based on gross receipts, (c) with a former partner or employee of the applicant or credential holder based on a retirement plan or separation agreement, or (d) by a person credentialed pursuant to the Water Well Standards and Contractors' Practice Act Define unprofessional conduct any departure from or failure to conform to the standards of acceptable and prevailing practice of a profession or the ethics of the profession, regardless of whether a person, consumer, or entity is injured, or conduct that is likely to deceive or defraud the public or is detrimental to the public interest Can you prescribe a controlled substance to yourself? No Can you prescribe a controlled substance to family members, etc.? Only in case of medical emergency -spouse -child -parent -sibling -living in household Can an employer or employer's agent coerce a pharmacist to dispense a drug product against the professional judgment of the pharmacist or as ordered by prescriber? No Define delegated dispensing practice of pharmacy by which one or more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or more persons pursuant to sections §38-2872 to §38-2889 under a protocol which provides that such person may perform certain dispensing functions 67 | P a g e authorized by the pharmacist or pharmacists under certain specified conditions and limitations Components of a delegated dispensing agreement Address of dispensing site Name/license # of each pharmacist Name/signature of individuals who will be dispensing pursuant to the agreement Manner in which inspections will be conducted by delegated pharmacist Any other info required by the board Not effective until permit issued by department with recommendation of the board Define consultant pharmacist actively practicing Nebraska pharmacist who holds an unrestricted license designated on the drug dispensing permit as the pharmacist who is responsible for all duties set forth in Part 009.01A of these regulations in Nebraska statutes, the term "consultant pharmacist" refers specifically to those working with a public health clinic How can public health clinics dispense legend drugs/devices? shall have an actively practicing pharmacist with an unrestricted Nebraska license listed as the consultant pharmacist on the drug dispensing permit Duties of a consultant pharmacist *Be in the clinical at least once q30d *Monthly inspections *Approve and maintains policies/procedures for storage/control/distribution/dispensing of the drugs/devices *Approve info/instructions dispensed to patients *Approve proficiency of the clinical workers dispensing refills of contraceptives at least annually (maintain in personnel file and policy/procedure manual) *Approve training of the clinic workers *Report inventory discrepancies to the Board and the clinic administrator *Periodically review fridge storage conditions Define availability of a constultant pharmacist At any time that dispensing is occurring in the public health clinic, the consultant pharmacist (or other pharmacist) must be available in person or by phone -notify clinic if won't be available during the required time-must be documented Can dispensing occur in a public health clinic if there is no consultant pharmacist or on-call pharmacist? 70 | P a g e *High school graduate or equivalent *Never convicted of nonalcohol, drug-related misdemeanor/felony *File application with Division of Public Health of the Dept of HHS *Pay fee Tech identification requirements Must be identified as a pharmacy tech while performing tech duties Define pharmacist intern • A student currently enrolled in an accredited pharmacy program, or • A graduate of an accredited pharmacy program serving his or her internship, or • A graduate of a pharmacy program located outside the United States which is not accredited and who has successfully passed equivalency examinations approved by the board How long is an intern license valid for? 15 months after graduation or at time of professional licensure If based on graduation from non-accredited program, expires 15 months from date of issuance or at time of professional licensure Components of intern application Legal name Place/DOB SSN Mailing address Phone/email/fax optional Permanent address Name/location of accredited pharmacy program, official documentation of month/year of enrollment, and expected month/year of graduation Statement that must not practice w/o immediate supervision of licensed pharmacist Statement that all info is correct Fee Birth cirtificate/marriage license/driver's license/other age verification Intern identification requirements Must have registration card available while functioning as intern and be identified as an intern Intern supervision requirements At all times by Nebraska pharmacist w/o disciplinary measures -Does not apply to those receiving experiential training from accredited pharmacy program in which intern is enrolled Interns can't supervise other interns/techs 71 | P a g e Supervision ratio Up to 3 techs/interns (in combination) Q1: Who may counsel a patient, according to Nebraska Pharmacy Law? (Select ALL that apply.) A) Pharmacists B) Certified pharmacy technicians C) Pharmacist interns D) Registered pharmacy technicians E) Cashiers employed by a pharmacy A C Q2: A pharmacy technician may perform all of the following duties EXCEPT: A) Entering prescription data into a data processing system B) Taking a new oral medical order from a prescriber C) Receiving refill authorization requests D) Reconstituting medications E) Compounding sterile preparations of medications B Q3: A registered pharmacy technician shall: (Select ALL that apply.) A) Be a high school graduate or be officially recognized by the State Department of Education as possessing the equivalent degree of education B) Have never been convicted of any nonalcohol, drug-related misdemeanor or felony C) Become certified within a period of six months D) Submit to a mandatory preliminary urine drug screen A B Q4: Which of the following statements are TRUE according to Nebraska Pharmacy Law? (Select ALL that apply.) A) A pharmacist may supervise up to three pharmacy technicians at any time B) A pharmacist may supervise up to three pharmacist interns at any time C) A pharmacist may supervise any combination of pharmacy technicians and pharmacist interns at any time up to a total of three people D) Supervision ratios do not apply to pharmacist interns receiving experiential training E) Ratios for pharmacist supervision of technicians and pharmacist interns are not explicitly defined 72 | P a g e A B C D Q5: What combination of pharmacy employees is allowed by law? A) One pharmacist, two technicians, and one student who is receiving experiential training, directed by their accredited school B) One pharmacist, one intern, and three technicians C) One pharmacist, one intern, two technicians, and one APPE student D) A and C only E) All of the above D Food and Drug Act 1906 Prohibited interstate commerce of adulterated food/drinks/drugs (not cosmetic products or medical devices) Fair Packaging and Labeling Act of 1967 Requires consumer products in interstate commerce to be properly labeled (including OTC) Prescription Drug Marketing Act of 1987 *Products manufactured domestically and exported can only be re-imported by original manufacturer *States required to establish controls on wholesale distribution of legend drugs *Sale/purchase/trade of drug purchased by public/private hospital/other health care entity is prohibited *Sale/purchase/trade of drug sample/coupon is prohibited Drug Supply Chain Security Act (DSCSA) *Provide product tracing information (lot-level) *Handle suspect/illegitimate product: quarantine and investigate suspect product and notify FDA/immediate trading partners if illegitimate *Confirm authorized trading partners Can retail pharmacist receive or dispense prescription samples? No, only starter packs -Not considered samples, intended for initiation of therapy Possession of prescription drug samples by retail pharmacies would be considered ___ by the FDA Drug diversion Can institutional pharmacies receive samples? 75 | P a g e continued admin or dispensing of opiates for a period in excess of 21 days at stable doses Record keeping requirements for opioid treatment program 1) name and strength of drug 2) dosage form 3) date dispensed/administered 4) adequate identification of the patient 5) amount of drug consumed 6) amount and dosage form taken home by patient 7) dispensers initials 3-day-rule a narcotic may be administered or dispensed to a narcotic-dependent person when necessary to relieve acute withdrawal symptoms pending the referral of such person for detoxification treatment or maintenance treatment by a physician who is not registered to provide detox treatment. A max of one day's supply at a time for a max of three successive calendar days may be administered or dispensed what prescriptive authority do APRNs have (NP, CRNA, CNM)? can dispense sample medications (incident to practice only) can prescribe anything relevant to their scope of practice What prescribing authority do APRN-CNS have? None (no samples either) CRNA prescriptive authority includes Legend drugs, CII-CV, anti-anxiety, controlled substance to spouse, child, parent, sibling, or any other person living in the same household as a prescriber in an emergency only, Cannot prescribe controlled substance to self, limited to scope of practice CNM prescriptive authority Only prescribe when delegated to do so by a physician whose practice includes obstetrics CII x72 hours only, CIII-CV, legend drugs, contraception, nicotine cessation, anti-anxiety, weight loss (not a CII), controlled substance to spouse, child, parent, sibling, or any other person living in the same household as prescriber for obstetric/gynecologic emergencies only, cannot prescribe controlled substances to self, limited to scope of practice Nurse practitioner prescriptive authrority legend drugs, CII-CV, contraception, smoking cessation, anti-anxiety, weight loss, Controlled substance to spouse, child, parent, sibling, or any other person living in the same household as prescriber cannot prescribe controlled substances to self, limited to scope of practice Dentist prescriptive authority 76 | P a g e CII-CV for human teeth, jaws, or adjacent structures only, legend drugs for human teeth, jaws, or adjacent structures only, anti-anxiety for dental visit only, controlled subtance to spouse, child, parent, sibling, or any other person living in the same house as prescriber for human teeth, jaws or adjacent structures for an emergency only. CANNOT prescribe contraception, weight loss, controlled substance to self Dental hygienist prescriptive authority mouth rinses and fluoride products Optometrist (OD) prescribing authority Can prescribe and apply: Lenses, devices with lenses, prisms, contact lenses, ophthalmic devices, orthoptics, vision training, pharmaceuticals, prosthetics Can dispense: Contact lenses Limited to prescribing for the eyes: legend drugs for eyes only, CII but only topical ophthalmics, CIII-CV only for eye pain Can prescribe: epinephrine for ttx of anaphylaxis, an oral steroid, oral glaucoma agent, oral immunosuppressive agent Podiatrist (DPM) prescribing authority CII-CV, legend drugs, anti-anxiety for office visit only CANNOT prescribe contraception, nicotine cessation, weight loss, controlled substances to self When did Nebraska start requiring prescriptions for controlled substances to be issued using electronic prescription technology? Jan 1 2022 When did Nebraska start requiring prescriptions for controlled substances from dentists to be issued using electronic prescribing technology? Jan 1 2024 Who is exempt from using CPOE to prescribe Controlled substances in nebraska Veterinarians, circumstances where E prescribing is not available due to technological or electrical failure, prescribers who issue fewer than 50 prescriptions in one calendar year that are otherwise subject to electronic ordering How long is a CII prescription valid for? 6 months from the date of issuance What are the requirements for a CII prescription to be valid? (what must be included on the script) 77 | P a g e patient name and address, name of drug/device/biologic, strength of drug or biologic, dosage form, quantity prescribed, directions for use, date of issuance, prescribers name and address, Prescribers DEA number IF WRITTEN ON PAPER must include the manual signature of the prescribers What is required for an emergency CII prescription if ordered orally? 1) does not require a signature 2) the word EMERGENCY must be written on the Rx 3) A written and signed prescription must be sent to the pharmacy within 7 days 4) CAN ONLY BE CALLED IN BY PRESCRIBER, NOT AN AGENT ON THEIR BEHALF 5) Must be the minimum amount needed to treat the patient during the emergency period federal law requires a physical Rx be delivered to the dispensing pharmacist within how many days of authorizing an emergency oral prescription? 7 days (if mailing must be postmarked within 7 days) What must be written on the face of the written prescription sent to replace the emergency CII prescription? "Authorization for emergency dispensing" and the date of the oral order What is the process for the RPh if the prescriber fails to send the physcial copy for the emergency oral CII fill within the 7 days time frame? Contact the nearest DEA office administration right away What situations can a Rx for a CII be sent and dispensed via fax? compounds for the purpose of direct parenteral administration via home infusion therapy, administration to a patient enrolled in hospice (must include the words HOSPICE PATIENT on the rx), and for administration to a resident of a long-term care facility What is used as the hard copy for a faxed prescription the faxed prescription (maintain as a CII hard copy x5 years) How are CII prescription hard-copies stored? keep in a separate file and maintain for a minimum of 5 years readily available for inspection How are CIII-V prescription hard-copies stored? Separately from other prescriptions and maintained for a minimum of 5 years readily available for inspection What are the label requirements for CII-V? 80 | P a g e 8) original Rx number 9) date of transfer How long do the original and transferred prescriptions need to be maintained by the pharmacies from the date of transfer? 5 years from the date of transfer What does state statute recommend a max DS should be for opiate prescriptions for children? (<18 years) 7 days for most situations, but 2-3 days is often sufficient - recommend reevaluating the patient after 3 days before issuing an additional prescription If a prescriber determines a DS >7 is needed due to a chronic condition (cancer or palliative care) what is required by all practitioners? documentation of the medical condition in the patient record and indication that a non-opiate was not an appropriate option The practitioner shall note on the face of the prescription the medical need of the patient for which medication? Gamma-hydroxybutyric acid What types of things may be included in a collaborative practice protocol in Nebraska? State laws do not govern but includes things like administration of medications, management of a patient's drug therapy, dose adjustments, ordering of labs What must be reported/provided when entering into a practice agreement? notify both the board of pharmacy and the board which licensed the health care practitioner - include the name of each pharmacist participating and each licensed health care practitioner authorized to prescribe independently participating in the agreement - include a description of the therapy being monitored or initiated How should practice agreements be maintained? in writing and signed by the pharmacist and licensed healthcare providers participating - Sign at the start and review and sign every two years thereafter What is the definition of pharmaceutical care? the provision of drug therapy by a pharmacist with a goal of achieving therapeutic outcomes like 1) disease cure 2) elimination or reduction of a patient's symptoms 3) the arrest or slowing of the disease process 4) the prevention of a disease or symptomatology 81 | P a g e Design, implement, and monitor a therapeutic plan that will produce specific therapeutic outcomes for the patient What date did Nebraska allow insurers to contract with a licensed pharmacist for pharmacist professional services? Jan, 1 2016 Can written information substitute verbal counseling? NO When should a pharmacist offer patient counseling? Refills and new prescriptions what qualifies drugs from a long term care facility to be returned to the dispensing pharmacy? 1) not a controlled substance 2) no restricted distribution by the FDA 3) pharmacist discretion 4) must have been in the control of the long-term care facility at all times 5) must be in the original and unopened labeled container with a tamper-evident seal intact. Must also have an expiration date, and lot number 6) tablets or capsules must have been dispensed in a unit dose container that is impermeable to moisture and approved by the board Who contracts with the DEA to dispose of controlled subtances? A reverse distributor Who do you contact to determine options for Controlled substance disposal? The local DEA diversion field office In Nebraska who may destroy controlled substances? a pharmacy inspector, a reverse distributor, or by the administration What special circumstances exist for destroying liquid controlled substances? liquids in opened containers which originally contained 50mls or less or compounded liquids within the facility where they were compounded may be destroyed if witnessed by two individuals What special circumstances exist for destroying solid controlled substances? solids in opened unit dose containers or which have been adulterated within a hospital where they were to be administered to patients in such hospital may be destroyed if witnessed by two individuals What is an authorized collector? 82 | P a g e an authorized entity that can maintain take-back/collection receptacles for unused controlled substances to allow safe and effective disposal. manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals and clinics with an onsite pharmacy and retail pharmacies. How does one become an authorized collector? modify DEA registration to obtain authorization Who can maintain recepticals at long-term care facilities? Hospitals/clinics with a in-house pharmacy and retail pharmacies Where should collection receptacles be placed? in general, in the immediate proximity of a designated area where controlled substances are stored and an employee is present (can be seen from the pharmacy counter) Where should collection receptacles be placed in a hospital? an area regularly monitored by employees and not in the proximity of any areas where emergency or urgent care is provided Where should collection receptacles be placed at a narcotic treatment facility? in a room, that does not contain any other controlled substances and is securely locked with controlled access Where should collection receptacles be placed at a long term care facility? in a secured area monitored by employees What design specifications must a receptacle have? securely fastened to a permanent structure, be a securely locked with a permanent outer container and removable inner liner, Outer container shall include an opening that allows contents to be added in but does not allow removal, clearly labeled as to what is allowed (CII-V and/or non-controls) What are not allowed to be placed in the receptacles? CIs, anything not lawfully possessed, dangerous or illicit substances How should the receptacle liner be removed? by at least two employees What paperwork is required when disposing of CIIs via a reverse distributor? the reverse distributor must fill out a form 222 What paperwork is required when disposing of CIII-Vs via a reverse distributor? a record of distribution that includes: drug name, dosage form, strength, quantity and date transferred. What form does the DEA registered reverse distributor fill out when they destroy the controlled substances? 85 | P a g e for 6 years from date of signature or last date of Rx dispensed Refill reminders should not include what information? drug name/use What is the intent of HIPPA? 1) assure security and privacy of patients medical records 2) allow the flow of PHI to provide high-quality healthcare To adapt a prescription what must happen first? Patient consent What are the stipulations to be able to change the quantity of a drug prescribed? 1) The prescribed quantity or package size is not commercially available 2) The change in quantity is related to a change in dosage form What ways of prescription adaptation are allowed? 1) Change the quantity 2) Change the dosage form (must also change the directions for use to equate an equal amount of drug dispensed as prescribed) 3) Dispense multiple month's supply of a drug if it is written with sufficient refills 4) Sub any chemically equivalent drug product to comply with a drug formulary (unless rx is written as DAW) --> if subbing any equivalent product, must provide notice to the prescribing practitioner or their designee What requirements are there for error reporting in Nebraska? None What are some responsibilities set forth by the Food, Drug, and Cosmetic Act 1) Seize any adulterated or misbranded food, drug, or cosmetic with court approval 2) approves new drug entities 3) approves drug package insert labeling What is the application that must be submitted prior to starting phase 1, 2, and 3 trials? INDA (submitted before testing on humans) By filing and INDA the sponsor obtains an exemption of what federal law? INDA allows the sponsor to ship investigational drug to clinical investigators in many states which would otherwise be prohibited due to federal law without an approved marketing application How long does the FDA have to review the INDA? 30 days What application is submitted after phase 1, 2 and 3 trials? 86 | P a g e NDA What application is submitted to develop a generic version of a brand name drug? ANDA What makes and ANDA different from an INDA or NDA? does not require animal or human (preclinical or clinical) studies to establish safety and efficacy - must ONLY demonstrate bioequivalency to the innovator drug What is an SNDA? used to switch a drug product from legend to non-legend (Rx only to OTC) What is included in the package insert? description of drug, adverse reactions, clinical pharmacology, abuse/dependecy potential, indications/usage, symptoms/treatment, overdose, contraindications, dosage/admin, warnings/precautions, date of most recent revision What is FDA form 3500 medwatch - used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care or product quality issues Class 1 drug recall Drug products may cause serious adverse health consequences including death - recall pharmacy stock and notify patients who received or may have received the drug Class II drug recall temporary or reversible effects, remote probability of serious effects - recall pharmacy stock Class III drug recall drug product is not likely to cause adverse health consequences Safe Medical Device act of 1990 Designed so the FDA could quickly be informed of any medical product that has caused or is suspected to have caused a serious illness, injury or death. - Gives the FDA authority to recall devices - manufacturers required to conduct post-marketing surveillance on all permanently implanted devices whose failure may cause serious harm or death Americans with Disabilities Act of 1990 87 | P a g e A law that requires employers and public facilities to make "reasonable accommodations" for people with disabilities and prohibits discrimination against these individuals in employment. - all companies employing 15 or more people Omnibus Budget Reconciliation Act of 1990 (OBRA) Drug utilization review (prospectively done by pharmacist) and (retrospectively done for state medicaid) - Counseling requirements (offer to discuss medications with patient/caregiver) - Obtain patient specific info - Goal is to save government money (but elevated standard of care given to medicaid patients by pharmacists) Medical Device amendment of 1976 This calls for classification, safety and efficacy of medical devices. - establish good manufacturing practice standards conformance FDA Modernization Act of 1997 - provisions for the fast tract review of some NDA submissions to expedite approval of new drugs used to treat serious or life-threatening conditions - clarified conditions under which pharmacies can compound (state regulated, pharmacies exempt from GMP and NDA apps)) - Required legend drugs to say "Rx only" Orphan Drug Act of 1983 provided incentives (tax and licensing) to promote research, approval and marketing of drugs for rare diseases - rare = <200,000 persons in U.S Federal Anti-Drug act of 1988 worked to create a drug free america - prohibits employees from having unlawful possession of CS at work - employees must inform their employer w/in 5 days of conviction due criminal possession of drugs Pure Food and Drug Act of 1906 prohibits the adulteration or misbranding of food and drugs - required active ingredients to be placed on label - drugs must not fall below purity levels established by the USP or The National Formulary Kefauver-Harris Amendment of 1962 Drugs must be safe and effective (new and ones already on the market at the time of approval) - result of thalidomide birth defects - FDA authorized to regulate Rx drug ads - Informed consent in clinical investigations - Reporting of ADRs - Creation of GMPs 90 | P a g e initial fill and every refill - institutions: prior to first admin and every 30 days after What drugs/classes are generally targeted for package insert use? Estrogens, birth controls When are FDA med guides required? when patient labeling could prevent serious adverse effects, when product has serious risks relative to benefits, when patient adherence to directions is crucial - all new and refill prescriptions on certain medications What are some common classes of drugs that require med guides? antidepressants, ADHD, NSAIDs, Fluoroquinolones, Thiazolidinediones, opioids Most common exemptions from poison prevention packaging act nitroglycerin-SL, Isosorbide dinitrate SL/Chew <10mg, ASA or APAP effervescent or granules, Potassium supplements (unit dose packaging), anhydrous cholestyramine or colestipol packets, aerosol containers, oral contraceptives in reminder packs (mnemonic) How many noncompliant packages may a manufacturer market of an OTC product? 1 and it must be labeled with the statement "this package is for households without young children" or "package not child resistant" Who regulates the poison prevention packaging act? the Consumer Product Safety Commission What drugs are subject to the poison prevention packaging acts 'special packaging requirements? both Rx and certain non-rx drugs Containers must be manufactured so what percent of children under 5 cannot open them? 80% Containers must be manufactured so what percent of adults can open them? 90% What OTC drugs require a special child resistant package? ASA containing preparations, iron-containing drugs/supplements, APAP (if >1g in a package), Diphenhydramine (if >66mg of base in a single package), ibuprofen (>1g per package), anything regulated by the FDA What constitutes a drug as being adulterated? - Contains in whole/part any filthy, putrid, or decomposed substance - has been prepared, packaged, or held under insanitary conditions 91 | P a g e - has been manufactured under conditions that do not meet GMP standards - contains an unapproved color additive - Strength, quality, or purity differ from official compendium What makes a drug midbranded? - the labeling is false or misleading in any manner - Missing name/location of manufacturer, packer or distributor - quantity of container contents is not present - all required information is not prominent - missing adequate directions for use/warnings (OTC) - imitation of or offered for sale under the name of another article Examples of misbranded drugs mixing lot numbers, labeling Rx with trade name but dispensing generic, refilling Rx without authorization of prescriber, labeling Rx with one strength, but actually dispensing another, medication errors THC delta-9 tetrahydroconnabinol What is the percentage of dry weight of THC federally and at the state level that no longer is considered a controlled substance? 0.3% or less dry weight THC Federal antitampering act of 1982 tamper resistant or tamper evident packaging is required for foods, drugs, devices, cosmetics, and other housefold products that are consumed by individuals or used for personal care What did the Drug Facts Label (1999) require? a standard order of information - active ingredient - purpose - uses - warnings - directions for use (which a layperson could follow) - other information - inactive ingredients How long should a poison register be kept? at least two years after the last entry Can you dispense a controlled substance without a prescription in Nebraska? no 92 | P a g e STEPS program thalidomide restricted distribution program Combat methamphetamine act of 2005 all items containing ephedrine, pseudoephedrine, and phenylpropanolamine must be stored behind the counter or in locked cabinet and sales limited. daily limit of pseudophed 3.6g 30 day limit of pseudophed 9.0 gram max pseudophed sent through mail 7.5g Pseudophed logbook requirements does not apply to single sales <60mg, each entry maintained for 2 years, product and quantity purchased, purchaser name, address and signature, date and time of sale, must see photo ID How soon should written reporting of excessive or unusual purchases of meth precursors be given to the local DEA field office? w/in 15 days of the transaction Ephedrine schedule in Nebraska Schedule 4 (exception of Bronkaid dual action, and primatene tablets brand names only) Exclusions to CMEA of 2005 non-legend products filled and dispensed via Rx minimum age to buy pseudophed OTC 18 years (to buy and sell) When was the CMEA exchange required in Neb (if available) Jan 1 2012 Fair packaging and labeling act of 1967 Requires consumer products in interstate commerce to be properly labeled (including OTC) drug supply chain security act (DSCSA) requires - product tracing information to be provided (lot-level) 95 | P a g e Glutethimide CII What morphine products may be considered CIII combo products that contain no more than 50mg of morphine per 100ml or per 100g with one or more active non-narcotic ingredients What codeine products may be considered CIII products with no more than 90mg of codeine per dosage unit with an equal or greater quantity of isoquinolone alkaloid of opium (Tylenol with codeine) Buprenorphine CIII Benzphetamine (didrex) CIII phendimetrazine CIII ketamine CIII anabolic steroids oxandrolone CIII Tramadol C IV Benzodiazepines C IV Carisiprodol C IV CLorazepate C IV Ephedrine C IV What ephedrine products are NOT considered C IV? 96 | P a g e Brand name Bronkaid dual action and primatene tablets only Acetaminophen with codeine (<200mg of codeine per 100ml or 100g) CV Robitussin AC and Phenergen with codeine CV How many copies of DEA form 222 does a purchaser create (old method)? 3 - copy 1 and copy 2 d submit to supplier - Retain copy 3 in purchasers files What sections of the 222 form does the supplier fill out? the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser. How long after the date of DEA form 222 can a supplier ship additional shipments to the purchaser to fulfill a complete order? 60 days How long is a DEA form 222 valid for? 60 days When did the Form 222 triplicate system end? Oct. 30 2021 What is the current process to fill out a form 222? single sheet - purchaser makes a copy of the form 222 for its records and submits the original to the supplier - when the items are received the purchaser must document on their copy of form 222 the actual number of commercial or bulk containers received and the date received How long are DEA forms required to be kept available for inspection? 5 years in Nebraska (2 years federal) How can a reistrant order CIIs electronically? via CSOS How does a purchaser cancel an order for a CI or CII? notify the supplier in writing, the supplier then draws a line through the canceled items and prints canceled in the space provided for the number of items shipped. If using CSOS do you have to fill out a separate form 222? 97 | P a g e no how long should CSOS records be kept? 2 years Prior to Oct. 1, 1985 DEA registration number for physicians, dentists, and vets started with what letter? A What are the letters used after Oct 1, 1985 to begin practitioners DEA numbers? B, F, G, or X What letter do mid level practitioners DEA numbers begin with? M What is almost always the second letter in the DEA registrants number? the first letter of their last name How many numbers then follow the first two letters of a DEA number? 7 What can you do to confirm the numbers of the DEA number make sense and are legitamate? add the first, third, and fifth digits then add the second, fourth, and sixth digits and multiply that number by two Then add the result of both sets of numbers The last digit of this result must be the same as the last digit of the DEA number How long are controlled substance receipt and disposed of records to be maintained? 5 years Who obtains a CSOS certificate? every individual who wants to sign electronic orders for controlled substances must acquire his or her own personal CSOS certificate What temperature should drugs requiring refrigeration be stored at? between 36 and 46 degrees fahrenheit What temperature should drugs requiring a freezer be stored at? -13 and 14 degrees fahrenheit What temperature should drugs requiring storage at -4 degrees be stored at? must stored within plus or minus 10 degrees