Filling and Dispensing Prescriptions Flashcards
Control Substances or Non-controlled Substances?
Regulations are typically stricter because of addiction and abuse possibilities.
controlled substance
T/F? Prescriptions written for controlled substances must meet non-controlled AND controlled substance requirements?
true
If there is a discrepancy between federal and state law, which law prevails?
the stricter regulation will prevail
Which physicians are granted BROAD treatment and prescriptive authority? (2)
MD, DO
Which healthcare providers have NARROW treatment and prescriptive authority? (3)
Dentists, veterinarians, podiatrists
What type of practitioners CANNOT treat outside of their scope?
(Mid-level) PA, NP and OD
T/F? Authority to prescribe for self or family members, is state dependent.
true
T/F? In the state of GA, physicians HAVE the authority to prescribe for self or family members?
False
RPh/Pharmacist may refuse to fill a prescription for a few “good” reasons. (5)
- Forged or fictitious RX
- to avoid violating the law
- out of stock RX
- harmful to the patient
- moral or religious opposition
Conscientious objection (2)
- a pharmacist can refuse to fill RX due to moral/religious belief
- pharmacist can’t obstruct a patient’s legal right to receive a lawful RX, therefore “other” arrangements should be made
T/F? Prescription refills must be indicated by the Pharmacist?
- False
- indicated by prescriber/physician
T/F? If no refills are indicated on the prescription then it assumed zero?
True
T/F? If Rx is for a non-prescription product, RPh is NOT bound to the refill instructions indicated on the Rx?
False
-RPh IS bound
Who legally owns a prescription once filled and dispensed by a pharmacy?
the pharmacy
T/F? A copy of an Rx CAN NOT be provided to prescriber / patient if requested?
False
- RX CAN be provided
The FDA requires drug distribution records including drug order invoices to be kept for how many years?
5 years
MOST states require Rx records to be kept for how many years?
2 to 5 years
GA requires Rx records be kept for how many years?
2
MMA requires RX records to be kept for how many years?
10
According to the 2013, USP adopted official standards for prescription container labeling, the TOP OF THE LABEL must contain what? (5)
- patient name
- Rx serial number
- drug name (full generic and trade name)
- strength
- clear directions for use
According to the 2013, USP adopted official standards for prescription container labeling, the less prominent place (bottom of label) should contain? (3)
- information considered less critical such as
- expiration date
- quantity
T/F? FONT on the RX label should be 14 or 15 point?
False
- 12 point Times Roman
- 10 point Arial
T/F? Drug names should be spelled out on the label using NO abbreviations?
true
What type of directions are recommended for a RX label?
implicit directions
i.e. “Take 2 tablets twice daily” versus “Take 2 tablets in the morning and 2 tablets in the evening”
T/F? Alphabetic characters should be used instead of numbers?
False
-numbers should be used
Based on patient preference, _________ purpose for use should be included if included on the prescription?
“layman’s terms”
Can directions be in patient’s preferred language?
yes
T/F? Drug name must be in ENGLISH on an RX label
true
T/F? Inclusion of expiration date, lot number, manufacturer is mandatory for all states?
false
- it is left to the DISCRETION of individual states
T/F? GA requires the date the RX was dispensed to be on the RX label.
true
Additional information besides the “top label” and “bottom label” requirements are? (3)
- Pharmacy name, address, telephone number
- Prescriber’s name
- Date prescription was written and/or dispensed
Pharmacy name, address, telephone number should be placed NEAR or AWAY from dosing instructions?
AWAY
TALL man lettering (2)
-Designed to reduce medication errors
- Made a drug name more easily distinguishable from
drugs with similar spelling
Who published a list of recommended Tall Man letters for look-alike drugs? (2)
FDA and ISMP
Poison Prevention Packaging Act (PPPA) 1970
-Enacted in 1970 to protect children
CPSC
Consumer Product Safety Commission ; enforced the Poison Prevention Packaging Act
Which drug products are exempt from child-resistant packaging? (3)
- SL NTG (sublinguial nitroglycerin: heart attack prone)
- oral contraceptives
- pancrelipase
All new and refilled prescriptions must be dispensed in a child-resistant closure unless: (2)
- Prescriber requests one not be used
- Patient requests one not be used
T/F? Prescribers cannot request a “blanket waiver” applying all prescriptions?
true
What must be specified by the doctor for EACH individual prescription?
child-resistant packaging for an RX
Prescriber or Patient?
May request single Rx or “blanket waiver”?
Patient
Federal Anti-Tampering Act (2)
- Required tamper-evident packaging be used for OTC products
- Product label indicates package is tamper-evident and how a consumer can determine if package has been tampered with
What was enacted in 1982 following several incidents of deliberate contamination of OTC products with poisons? (Tylenol)
Federal Anti-Tampering Act
T/F? Products that are pharmaceutically equivalent are ALWAYS therapeutically equivalent?
false
NOT necessarily
T/F? Regulations of product substitution lies with individual states.
true
What is the intent of product substitution?
to provide a lower cost drug product in place of the drug product prescribed
Pharmaceutically or Therapeutically equivalent?
same active ingredient, dosage form, strength, route of administration?
Pharmaceutically equivalent
Therapeutically equivalent?
pharmaceutically + bioequivalence
PHARMACEUTICAL EQUIVALENT (4)
Same ACTIVE ingredient
Same dosage form
Same route of administration
Identical strength or concentration
THERAPEUTIC EQUIVALENT (2)
Pharmaceutically equivalent
BIOEQUIVALENT
Pharmaceutically or Therapeutically equivalent or both?
Products have to be __________ in order to be substituted in Georgia?
both
Bioequivalence References (4)
- Approved Drug Products with Therapeutic Evaluations (AKA “The Orange Book”)
- United States Pharmacopeia Dispensing Information (USP/DI)
- Facts and Comparison, Inc. Approved Bioequivalence Codes
- FDA website
Innovator drug product (“brand”) is the ___________to which the bioequivalence of others (“generics”) is compared
reference standard
“A” rated products (3)
- Are bioequivalent to pharmaceutical equivalents
- Therapeutically equivalent
- Products CAN be substituted for one another
“B” rated products (3)
- Are NOT bioequivalent to pharmaceutical equivalents
- NOT therapeutically equivalent
- Products CANNOT be substituted for one another
What type of products have actual or potential bioequivalence problems but studies have shown them to be ACCEPTABLE SUBSTITUTES?
“AB” rated products
The Orange Book does not contain drugs and related drug products marketed before 1938 that were “grandfathered” in. What are they (10)
Aspirin w/ codeine Codeine Digoxin Ephedrine Epinephrine Levothyroxine Morphine NTG Phenobarbital Quinine
Narrow Therapeutic Index (NTI) Drugs (2)
- Drugs with a relatively low difference between the min. toxic conc. and the min. effective conc.
- Safe and effective use requires careful titration and patient monitoring
NTI examples
Carbamazepine, Cyclosporin, Digoxin, Levothyroxine, Lithium, Phenytoin, Tacrolimus, Theophylline, Warfarin
Pharmaceutical Alternatives
Drug product that contains the same therapeutic moiety but may consist of different: (SAME CLASS)
- Salts
- Ester or complexes
- Dosage forms
- Strengths
T/F? Most states ALLOW substitution among pharmaceutical alternatives
false
-DO NOT ALLOW
Erythromycin ethylsuccinate and Erythromycin estolate are examples of what?
pharmaceutical alternatives
What type of drug products contain the SAME THERAPEUTIC MOIETY?
Pharmaceutical Alternatives
Which type of formulary allows only the drugs listed to be used? Open or closed formulary?
closed
Which type of formulary permits unlisted drugs to be used? Open or Closed formulary?
open
Therapeutic Substitution (5)
- Pharmacy has the “right” to substitute a different drug for the one that was prescribed without contacting the prescriber
- Generally limited to institutions that use a drug formulary
- Committee determines which drugs
- Prescribers agree to abide by the substitution policies
- Intent is to save money and reduce the need for a large inventory
Biologics Price Competition and innovation Act of 2009 (3)
- Provided an abbreviated pathway for the approval of biologic products classified as “biosimilar” to an FDA licensed biological product
- biologic drugs are much more difficult to replicate than chemically produced generics
- Zarxio was the first biosimilar drug approved by the FDA
Who prohibits mailing poisons and alcohol-containing products that could be considered beverages?
United States Postal Service (USPS)
Who establishes their own rules for mailing drug products?
UPS and FedEx
T/F?
Packages with non-alcohol containing medications CAN be mailed to a patient/consumer using the USPS.
true
What substances may be shipped using the USPS as long as they do not contain alcohol or are considered a poison? (2)
controlled and non-controlled
Requirements for mailing Controlled and Non-controlled substances via USPS (3)
- the inner package (e.g. the prescription vials) must be labeled so as to meet the legal labeling requirements for medications.
- the outer mailing container must be a “plain” container (e.g. a brown mailing envelope or mailing box).
- the outer mailing container cannot contain any markings or writing that would indicate the contents of the package contains prescription medications.
What mandated changes in pharmacy practice with uniform application?
Omnibus Budget Reconciliation Act of 1990- OBRA 90’
T/F?
Medicaid is a federally funded program controlled by the states?
true
OBRA 90’ mandated (3)
- Required an indirect approach because
- States, not the federal government, regulate professional practice
- Federal government proclaimed states must expand pharmacists standards of practice as a condition of participation in Medicaid
What must a state have in order to receive federal funds for its Medicaid program? (2)
- must have a drug use/utilization review (DUR) program
- Must include retrospective and prospective reviews
T/F?
The FEDERAL GOVERNMENT regulate pharmacy practice?
false
-states regulate pharmacy practice
Failure to require pharmacists to perform drug use/utilization review would result in what?
a state NOT receiving their full Medicaid funding.
What type of review is conducted by a drug utilization review (or DUR) board?
A retrospective review
T/F?
The DUR board is composed of Physicians only?
-false
composed of both Physicians and Pharmacist
Retrospective Review: reviews data concerning what? (2)
- medication use
- Looks at “ideal” therapy and determines if “actual” med use conforms to ideal
What happens of the DUR board finds that “actual” medication use deviates too much from “ideal” medication use?
then the board will make procedural changes to encourage more ideal drug use (e.g. prior authorization requirements may be required).
What occurs when a pharmacist reviews a patient’s medical record and/or medication profile BEFORE dispensing a prescription?
A prospective review
In a prospective review the RPh is looking for what? (3)
- Over or under utilization of drugs
- Therapeutic duplication
- Incorrect doses or dosing regimens
T/F?
As a part of a RETROSPECTIVE review pharmacists must extend a verbal offer to counsel the patient or patient’s caregiver on their medications at the time of dispensing.
false
-PROSPECTIVE REVIEW
Who may not make the offer to counsel on behalf of the pharmacist? (2)
A pharmacy technician or a pharmacy clerk may
GA DUR Expectations (9)
- Name and DESCRIPTION of drug
- DOSAGE FORM, DOSE route of administration, and duration of therapy
- Use of drug and EXPECTED RESULTS
- Special directions for USE
- Techniques for self-monitoring
- STORAGE INFORMATION
- Refill information
- What to do if a dose is missed
- ANY OTHER INFO THE RPH DEEMS NECESSARY
Federal DUR Expectations (8)
- Name of drug
- Route of administration and duration of therapy
- Use of drug
- Special directions or cautions
- Common adverse effects
- How to evaluate effectiveness of therapy
- Refill information
- What to do if a dose is missed
Who requires a more comprehensive prospective DUR, GA or Federal?
GA
HIPAA abbreviation?
Health Insurance Portability and Accountability Act
What was the purpose of HIPAA?
designed and intended to assure the security and privacy of patients medical records while s providing high quality health care
What does HIPAA limit?
the use, requests for and or disclosure of protected health information (PHI)
Prescription records, patent records, and documented pharmacist comments relevant to pt therapy are considered ______
protected health information
PHI is used and disclosed for (3)
- treatment (T)
- payment (P)
- operations (O)
Who can PHI be disclosed to? (2)
- healthcare providers involved in treating the patient
- law enforcement, legal agencies
Who can PHI not be exposed to?
-family members or others unless patient gives permission to do so
_______ regulate which licensed practitioners are permitted to write prescriptions
individual states
T/F Legality of filling prescriptions written by prescribers from other states is unclear from a federal viewpoint
TRUE
What MUST a pharmacist use o establish if the prescriber, patient, and prescription are legitimate? Why?
professional judgement; because it may be difficult to ascertain if a valid patient-provider-pharmacist relationship exist
T/F States regulations specify that only licensed practitioners may write prescriptions and may specify the practitioner must be licensed in THAT state
TRUE
Foreign Prescriptions
can not be filled if not authorized by the state
When does it “appear” to be legal to fill a foreign rx and export directly to a foreign country?
if for a reasonable quantity
Why might it not be a good idea to fill a foreign prescription? (2)
- prescriptions must be used under the supervision of a prescriber
- difficult to determine whether or not a patient is being properly monitored in a foreign country
T/F When it comes to obtaining prescription drug products from foreign sources it is approved by the FDA.
False; FDA does not approved, but at the current time appears to be flexible
What does it mean by the FDA being “flexible” on the foreign product policy?
meaning they do not aggressively seek punitive actions against the patient
When are the FDA flexible in regards to foreign prescription products? (5)
- Intended use of the drug is unapproved AND is for a serious condition for which effective treatment is not available
- Drug product will not be distributed to others
- Drug product does not represent an unreasonable risk
- Patient affirm in writing that the drug product is for the patient’s own use, provides the name and address of the US licensed doctor responsible for treatment, or provides evidence the drug product is for the continuation of treatment begun in a foreign country
- Drug product may be shipped directly to the patient, or their physician or pharmacy
Internet Pharmacies
FDA states businesses operating as internet pharmacists MUST sell ONLY FDA-approved drug products
