Pharmacy Law – Flashcards
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How many members serve on the Board of Pharmacy? How many are public members?
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7 (5 RPh, 2 public)
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Which of the following can prescribe legend drugs: O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician's Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Clinical Psychologist, Physical Therapist, Respiratory Therapist, Pharmacist? May any of them purchase legend drugs for use in their practice?
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O.D., ARNP, PA, nurse midwife (=ARNP), naturopath, PharmD.* OT, PT, naturopath
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Which of the following can prescribe CSA drugs (and which classes): O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician's Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Clinical Psychologist, Physical Therapist, Pharmacist?
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All: ARNP*, allopathic PA, PharmD* C3-C5: O.D., osteopathic PA, ND
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How long are prescriptions for legend drugs valid from the date issued?
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1 year
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Is there a maximum number of refills allowed for legend drugs? What is it?
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No
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How long are prescriptions for each of the following valid: C-2s, C-3s, C-4s, C-5s?
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C2: 1yr (WA), never (federal) C3: 6mo (WA + federal) C4: 6mo (WA + federal) C5: 1yr (WA), never (federal)
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Is there a maximum number of refills allowed for C-5s? What is it? Are the number of refills for C-3s and C-4s the same as federal or less?
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C5 refill max: none C3 + C4 refill max same for WA and federal
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Which of the following must be on the label of an outpt Rx: pt address, quantity, Expiration Date, Lot#, drug name, RPh initials, technician initials, pharmacy telephone number? Other items?
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quantity, name of drug, RPh initials patient name, prescriber, dose, directions, expiration date
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Can the prescribed brand name be placed on the label when a generic is dispensed? If so, what wording is required?
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Yes, "generic for ..."
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How does a pharmacist determine whether a particular generic drug is suitable as a substitute for a brand name drug?
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Orange book
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Must generic savings be passed on to patients? If so, what proportion, and how determined?
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Yes; 60% of savings to the patient Brand Acquisition Cost - Generic Acquisition Cost = SAVINGS
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How can a prescriber indicate that substitution is or is not permitted?
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DAW 1
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Do patients have the option of demanding the brand name when substitution is permitted? How about patients whose prescriptions are paid for by public funds?
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Yes, No
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What documentation is required of the pharmacist when product interchange is performed?
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prior authorization
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Under what conditions, if any, is therapeutic substitution allowed?
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prior auth, CPA, or therapeutic interchange program
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What minimum sets of references, products, or equipment are required in all community pharmacies?
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up-to-date copy of WA statutes (now online), 2 bottles of ipecac
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Do pharmacy hours have to be posted? Where?
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Yes, adjacent to the entrance of the pharmacy (+ entrance of larger establishment if applicable)
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Can the store be open but the pharmacy department closed? Under what requirements?
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Yes; all products sold by RPh must be secured, no Rx's dispensed without RPh present
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Do pharmacist licenses have to be on display? The original or official copy? Is a photocopy ok? Can you obscure your address on the copy displayed to the public?
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Yes, copies acceptable; no rule against obscuring address
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Are there any required notices that must be displayed to the public?
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restrictions to a RPh's license
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Is a separate patient counseling area required?
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Yes
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Is OBRA counseling required for Medicaid only or all patients?
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all patients
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How must the offer to counsel be made?
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offer needed only if drug is delivered outside of the pharmacy
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Does the offer to counsel need to be documented? Does the refusal of the offer need to be documented? How?
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no, no, N/A
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Is counseling required on new prescriptions, refills, or both?
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Both
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Can printed materials satisfy the counseling requirement? Under what circumstances?
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Yes, Rx's delivered out of the confines of the pharmacy
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What about prescriptions that are delivered or mailed to the patient?
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Yes, Rx's delivered out of the confines of the pharmacy
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Under what circumstances may a pharmacist fill prescriptions written in another state?
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if authorized prescriber (MD; osteopathic physician, DO; dentists, DMD, DDS; podiatrists, PodD, DPM; vets, DVM)
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Is there any provision for dispensing an emergency refill supply of legend drugs when there are no refills left and the prescriber cannot be contacted? What is allowed/required?
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72hr supply if RPh deems necessary, prescriber must be notified promptly of the emergency refill
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Are patient profiles required for all patients?
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Yes
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What information is required on the profile?
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via WA: name, address, phone#, Rx number, date of disp., dispenser, drug, refills, prescriber, complete directions, allergies, auth. for non-CRC use via OBRA: DOB, gender, phone #, other drugs/devices used, RPh comments regarding therapy
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What use of the profile is required? Review prior to dispensing new Rx's? Review prior to refills?
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PDUR, review each Rx and refill
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What is expected to be looked for during profile review?
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TD, DDI, dosing, allergies, CI's, etc.
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Can a patient refuse to give certain information for the profile? If so, must the refusal be documented, and how?
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elements under required by OBRA-90 may be withheld (age/DOB, gender, phone); no documentation needed, though RPh cannot be held responsible for errors d/t the withheld patient info
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What are the requirements for use of computers to process prescriptions?
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system must be approved by the Board
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What must be done if the computer system goes down?
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pharmacy must have an auxiliary record system for use (with provisions for prompt entry of info into the system, within 2 working days)
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Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout?
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RPhs must sign a daily log sheet/book indicating the correctness of the computer records
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Can a pharmacist legally repackage another pharmacy's prescription? Under what circumstances?
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No; unless the product has all of the required labeling (otherwise, misbranded)
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Can legend drug prescriptions be FAXed? Under what circumstances and requirements?
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Yes; faxes treated as telephoned orders; directly from prescriber to pharmacy, date, time, telephone # of fax machine, fax will be legible for 2 years (not printed on thermal paper), RPh responsible for verification of validity of each faxed prescription
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Can legend drug prescriptions be transferred electronically (ie, by computer)? Under what circumstances and requirements?
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Yes; pharmacies with a common electronic database track refills for legend drugs at any outlet in this common database
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Under what circumstances are FAXed CSA prescriptions allowed?
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CII: injectable to be compounded by RPh for patient use, Rx for LTC or hospice patient, Rx signed by the prescriber, non-emergent situation (RPh may rely on the fax to prepare the order for delivery to the patient until hard copy is presented), emergent situation (Auth for Emergency Supply), order is faxed to a hospital for a patient being admitted or discharged from the hospital
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Can refills of legend drugs be transferred from one pharmacy to another? Can they be transferred back?
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Yes
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Can an intern transfer refills?
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Yes
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Must information regarding the transfer of legend drugs be recorded on the hard copy of the original prescription, or can it merely be recorded in the computer?
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Recorded in the computer (legend drugs only, CSA drugs must have original copy with "VOID" written)
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What information must be recorded by the transferring pharmacy?
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name and address of receiving pharmacy, name of RPh
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What information must be placed on the original copy of the transferred prescription by the receiving pharmacy?
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date written, # refills, date of last refill, name/address of transferring pharmacy, name of transferring RPh
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Is it possible for pharmacies under a common ownership to share a single patient/prescription database? If so, what are the rules for prescription transfers?
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Yes, do not have to follow typical transfer rules if share a common database
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How long must the pharmacy maintain the following records: original prescriptions, refill records, drug purchase records, patient profiles? Are any of these different for CSAs? If any of these can be maintained on computer, how long do they need to be maintained "on-line?"
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original Rx (2yrs), drug samples (3yrs), CSAs (2yrs), computer-CSAs (2yrs after last possible refill = 2½yrs), Medicaid (6yrs)
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Must every pharmacy have a pharmacist-in-charge?
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Yes
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Are there any special requirements to be pharmacist-in-charge?
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an active license in the state, must be specially trained (aseptic technique, quality assurance)
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May a person be pharmacist-in-charge for more than one pharmacy?
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Yes
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When must the Board of Pharmacy be notified of any of the following: Change of pharmacist-in-charge, change of pharmacy address, closing or sale of a pharmacy, change of pharmacy telephone number, change of an individual pharmacist's address, change of an intern's address, change of a technician's address, change of a person's name?
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RPh/Intern's name/address ("promptly"), closing a pharmacy (15d prior)
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What must be on the label of a unit-dose or single-dose package of a legend drug dispensed for a patient in a hospital or nursing home?
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on cassette (pt name, location), drug name, strength/conc, dosage, lot no., CSA schedule
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What must be on the label of a multiple-dose container dispensed for a patient in a hospital? In a nursing home?
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hospital: drug name, conc., exp. date, storage, auxiliary labels LTC: pharmacy name/address, Rx#, pt name, drug name, conc., CSA schedule, quantity, date prepared/disp., RPh initials
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What is required on the label of a parenteral solution dispensed for a patient in a hospital?
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hospital: pt name, location, drug name, conc., exp. date, exp. time, RPh initials, preparer initials
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What is required on the label of a parenteral solution dispensed to a patient for home infusion therapy?
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pharmacy name/address/phone#, Rx#, 24-hr phone, pt name, prescriber, drug name, conc., directions, infusion rate, date prepared/disp., exp. date, exp. time, storage, RPh initials, auxiliary labels, transfer caution label
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What are special requirements, if any, to be a nuclear pharmacist?
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certification of ≥ 6 months on-the-job training, completed nuclear pharmacy training program in an accredited COP
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How rapidly must a pharmacy respond to a patient's request to amend the information in his or her medication record?
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[WA]: 15d (+ 6d extension) [HIPAA]: 30d (+ 60d extension)
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May a pharmacy transmit a patient's prescription claim information electronically to a third party payor without the patient having provided written consent to the payor or the pharmacy?
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Yes, as long as used for typical pharmacy health care operations (e.g., determining eligibility/coverage, preauth of Rx's, PDURs, billing 3rd party payers, refunding charges)
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When must a pharmacy provide a copy of its Notice of Privacy Practices to a patient or other person requesting one?
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at first point of contact
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How can changes in the NOPP be communicated to patients?
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changes posted within the pharmacy
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Can a non-custodial parent act on behalf of a minor to authorize disclosure of information in the patient medication record?
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"relatives" (incl. grandparents, aunts/uncles, siblings): may require a signed authorization from the child's parent, or declaration that the caregiver is responsible for the child
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What is the maximum amount of pseudoephedrine that can be sold OTC to an individual in a given day?
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2 packages in 24hr (each containing ≤ 3 gm)
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May pharmacists administer drugs? By which route(s)?
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Yes, by ANY routes (assuming RPh is trained appropriately)
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What are the requirements for immunizations administered by pharmacists?
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must be certified and adhere to the terms of a prescriptive authority protocol
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What is the status of carisoprodol? Tramadol?
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carisoprodol (C-IV), tramadol (non-CSA)
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Under what circumstances may a pharmacist refuse to fill a lawful prescription?
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exceptions to the "timely manner rule": Rx's with an obvious or known error, national or state emergencies or guidelines affecting availability of supplies, lack of specialized equipment/expertise, failure of patient to pay the pharmacy's usual and customary or contracted charge
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What is the maximum ratio of technicians to pharmacists? Of interns to pharmacists?
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retail: 1:1, *unless a specific RPh-to-technician utilization plan exists interns: 1:2, however, 2 interns may not disp. cc/ under the same preceptor
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What are the requirements for storage and accountability for controlled substances in a hospital?
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perpetual inventory of C-II drugs, physical counts at each shift change, CSA records kept for 2yrs, significant losses reported to DEA
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What are the requirements for storage and accountability for controlled substances in a long-term care facility?
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C-II's locked and stored separately, C-III's separate from legend but may be with C-II's, bound log book for C-II and C-III, physical counts by 2 individuals licensed to admin drugs q24h (C-II's) and qwk (C-III's)
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Are tech-check-tech programs allowed? Under what circumstances?
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Yes; no more than a 48hr supply may be filled in a cassette via tech-check-tech (interns CANNOT check tech's work)
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What is the ratio of pharmacists to technicians? Does it differ by setting?
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inst.: 1:3 inpt meds, 1:1 outpt meds *unless a specific RPh-to-technician utilization plan exists
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Can techs fill IVs? Can techs fill or check drug dispensing machines?
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Yes; techs can fill IVs (who have met specialized training), techs can fill/check drug dispensing machines
