Shared Flashcard Set

Details

General Review Questions for State Pharmacy Law exams
Washington
55
Law
Professional
04/21/2016

Additional Law Flashcards

 


 

Cards

Term
Number of Members on the Board of Pharmacy
Definition
15
Term
How are the members on the Board of Pharmacy divided?
Definition
10 Pharmacists
4 Lay persons
1 Pharmacy technician
Term
Which Medical providers have legend drug prescribing powers?
Definition
Advanced Registered NP, Doctor of Nursing Practice, nurse midwife - Within Scope
Certified RN Anesthetist - for anesthesia
MD, DO, PoD.D - All drugs for their patients
DPM - for podiatry
DVM - Animals only
ND - all except botulinum toxin
OD - Narrow scope opthalamic and oral
PA - all


PT and DPT has narrow scope to own and use, cannot prescribe
Term
Which Medical providers have CSA drug prescribing powers?
Definition
Advanced Registered NP, Doctor of Nursing Practice, nurse midwife - Within Scope
Certified RN Anesthetist - for anesthesia
MD, DO, PoD.D - All drugs for their patients
DPM - for podiatry
DVM - Animals only
ND - only codeine and testosterone, no C2s
OD - Not more then 7 days or 30 doses/rx
PA - all
Term
How long are Legend drugs valid from the date issued? How many refills may they have?
Definition
In washington: 1 year from the date issued, and they have no limit on number of refills except where the pharmacist sees it inappropriate to refill, or Insurance refuses to cover.
Term
How long are prescriptions for CII - CV good for? What are the maximum refills for C-3 and C-4, does it differ from federal?
Definition
CSAs are good for 6 months in washington.

No more than 5 refills, Unlimited refills for CV
Term
What must be on a prescription for it to be valid?
Definition
Patient Name, DoB and Phone number (if phoned in)

Drug Name, Str, Dosage, Sig, Route, Quantity, Refills if any, Notation of purpose if needed, whether a Generic is OK

Prescriber Name, Practice location, DEA (esp for CSA), (Name of agent calling in, and Phone number)
Term
Can the generic drug have the brand name on the label and if so what do we need to make it legitimate.
Definition
Yes, Must have the wording be "Generic for:_____"
Term
How to determine if a generic drug is suitable as a substitute for a brand drug
Definition
The Orange Book
Term
How much generic savings must be passed on to patients?
Definition
In Washington 60% or more of savings must be passed on to patients
Term
How does a prescriber indicate that substitution is not permitted?
Definition
They may use "Do Not Substitute", "Brand name only" "DAW 1" or sign on the valid signature area (The left side)
Term
Can Patients demand a brand name when the generic is prescribed? What if their prescriptions are paid for by public funds?
Definition
They may request the brand name if they are willing to pay for it and if they get their prescriptions through public funds they cannot get funding if they want brand name when the generic is available.
Term
Product interchange is permitted in washington. what must the pharmacist do when they do this?
Definition
Notify Practitioner under a therapeutic interchange agreement (see other card for the conditions)
Term
Under what conditions may Therapeutic interchange be done?
Definition
Prior authorization by the prescriber

Specific authorization for an individual rx

Via Collaborative Practice Agreement

in accordance with Therapeutic Interchange Program and preferred Drug list.
Term
What minimum sets of references are required in community pharmacies?
Definition
Up To date Copies of Washington Statutes (Available Online)
Term
What minimum sets of equipment are required in community pharmacies?
Definition
18" X 36 " work space, Sink, Fridge for chilled drugs
Term
What minimum sets of products are required in community pharmacies?
Definition
Adequate stock of product for a given day and ipecac syrup (Which is not being produced at this time)
Term
WHere must Hours be posted? What about in a department store, how must the pharmacy be secure.
Definition
Hours must be posted on the outside of the Pharmacy building and if in a dept store, Needs to be outside the pharmacy area in a clear location.
Term
Licenses on display? is a Copy OK? Must all personal info be displayed?
Definition
Licenses must be view-able in the pharmacy.
Only The original license or an official copy may be used. All pharmacists have the right to keep their personal information secure.
Term
What notices are required to be displayed to the public?
Definition
:...an equivalent but less expensive drug may in some cases be substituted for the drug prescribed by your doctor. Such substitution, however, may only be made with the consent of your doctor. Please consult your pharmacist or physician for more information."

And any restrictions to a RPh's license
Term
OBRA DUR rules
Definition
Must identify:
- THerapeutic duplication
- Drug-disease contraindications
- Drug-drug interactions
- incorrect dose or duration of treatment
Drug allergies
Clinical abuse or misuse
Term
Is OBRA counseling required for Medicaid only or all patients
Definition
all patients
Term
When to examine the medication record?
Definition
Any time the order for the prescription is processed.
Term
How to document the offer for counseling? Does refusal for counseling need to be documented? How?
Definition
Not required in Washington.
Term
is counseling required on new prescriptions, refills or both?
Definition
Offer to counsel required on all prescriptions, but must be counciled on new rx's. all others can be at the discression of the pharmacist.
Term
Time limit for pharmacists to give patients their records when requested under washington
Definition
15 days, max 21 with extension (of 6 days)
Term
How do you counsel for prescriptions that are delivered or mailed to the patient?
Definition
Offer in writing to provide direct counseling and info about the drug incl info on how to contact the pharmacist.
Term
Can legend drug prescriptions be faxed and transfered? What requirements and circumstances?
Definition
Yep and Yep.

Transfer: Sending pharmacist must make record of transfer, where it was transfered and the NAME fo the pharmacist who recieved it. For CSA They must be VOIDed, record location, Full Name, DEA nuumber of receiving pharmacist/cy

Receiving pharmacist must: Indicate that rx is a TRANSFER, Give Original Writ date, # remaining refills, Dte of last refill, Name of transfering pharmacy and adfddress, and Name of pharmacist. CSAs: # original refiills, dates of every refill, Number of valid remaining refills, and name/location DEA of Source pharmacy.
Term
Are patient profiles required?
Definition
Yep, for all prescriptions, and they must be maintained.
Term
Can a patient refuse to give certain information for the profile? If so, must the refusal be documented, and how?
Definition
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
Term
OBRA requirements
Definition
Mandatory rebates from mfxrs of Rx drugs for medicaid pts
fund demonstration projects allowing Online Prospective DUR, and Payment to pharmacists for cognitive services
mandates Retrospective DUR
Requires PDUR for medicaid
Requires counseling offers for Medicaid recipients
And Patient records - Name, Phone#, DOB, Sex, Disease states, allergies, All drug.
Term
Time needed to correct patient records in Washington?
Definition
10 days min, 21 days after 11 day extension
Term
Drugs which are not subject to substitution upon refills
Definition
Antipsychotics
Antidepressants
Antiepileptics
chemotherapy
antiretroviral
Immunosuppressives
Immunomoodulator/antiviral for hep C.
Term
What about returns?
Definition
No drugs may be returned to the pharmacy for resale except in the case of Unit dose packaging from hospitals or LTCF.

Must meet USP and Labeling must be intact
Term
Levels of Recalls
Definition
Wholesaler Level - Only inventory on wholeslaers are affected

Retail Level - only products in a pharmacy inventory or wholsaler

Consumer level - All levels of people who have the affected medication
Term
Classes of recall
Definition
Class 1 - Likelihood of injury or death from the use of the product may include a public warning.

Class 2 - Health problems if any, are expected to be reversible.

Class 3 - use of the product is Not likely to cause health problems

Market withdrawal - minor risk or minor FDA violation
Term
Compounded Label Requirements
Definition
Patient's name (species if applicable)
Prescrivber name
Contact info of the pharmacy
Rx #
Medication's established name
Str
Quantity
Sig
Date filled
Exp date
Storage instructions
Compounding statement
All other state labeling rewuirements.
Term
Definition of not-legitimate medical purpose for controlled substances.
Definition
- Prescriptions issued for "Office Use"
- Fraudlent or Forged prescription
- Rx to maintain an addiction (narcotic maintenance OK)
- Self prescribing or Self dispensing
Term
Can the store be open but the pharmacy department closed? Under what requirements?
Definition
Yes; all products sold by RPh must be secured, no Rx's dispensed without RPh present
Term
Is a separate patient counseling area required?
Definition
yes
Term
Under what circumstances may a pharmacist fill prescriptions written in another state?
Definition
if authorized prescriber (MD; osteopathic physician, DO; dentists, DMD, DDS; podiatrists, PodD, DPM; vets, DVM)
Term
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?
Definition
72hr supply if RPh deems necessary, prescriber must be notified promptly of the emergency refill
Term
What information is required on the patient profile?
Definition
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
Term
What are the requirements for use of computers to process prescriptions?
Definition
system must be approved by the Board
Term
What must be done if the computer system goes down?
Definition
pharmacy must have an auxiliary record system for use (with provisions for prompt entry of info into the system, within 2 working days)
Term
Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout?
Definition
RPhs must sign a daily log sheet/book indicating the correctness of the computer records
Term
Can a pharmacist legally repackage another pharmacy's prescription? Under what circumstances?
Definition
No; unless the product has all of the required labeling (otherwise, misbranded)
Term
Can legend drug prescriptions be transferred electronically (ie, by computer)? Under what circumstances and requirements?
Definition
Yes; pharmacies with a common electronic database track refills for legend drugs at any outlet in this common database
Term
Under what circumstances are FAXed CSA prescriptions allowed?
Definition
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
Term
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?
Definition
Recorded in the computer (legend drugs only, CSA drugs must have original copy with "VOID" written)
Term
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?"
Definition
original Rx (2yrs), drug samples (3yrs), CSAs (2yrs), computer-CSAs (2yrs after last possible refill = 2½yrs), Medicaid (6yrs)
Term
What is the maximum amount of pseudoephedrine that can be sold OTC to an individual in a given day?
Definition
2 packages in 24hr (each containing ≤ 3 gm)
Term
What is the status of carisoprodol? Tramadol?
Definition
Carisoprodol CIV
Tramadol CIV
Term
What are the requirements for storage and accountability for controlled substances in a long-term care facility?
Definition
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)
Term
What are the requirements for storage and accountability for controlled substances in a hospital?
Definition
perpetual inventory of C-II drugs, physical counts at each shift change, CSA records kept for 2yrs, significant losses reported to DEA
Supporting users have an ad free experience!