Pharmacy Law: Filling and Dispensing Prescriptions (Lect. 6)

Less prominent place (bottom of label)

- information considered less critical such as expiration date, quantity

Prescription record storage: Most states require Rx records to be kept for __ GA REQUIRES Rx records be kept for ____

-2-5 years. -2 years

Child-Resistant Closure Waiver

-All new and refilled prescriptions must be dispensed in a child-resistant closure unless: =Prescriber requests one not be used +Must be specified for each individual prescription +Prescribers cannot request a "blanket waiver" applying all prescriptions =Patient requests one not be used +May request single Rx or "blanket waiver" +Advisable to have patient-signed waiver on file =Container is used in an institution in which drugs are maintained and administered by healthcare professionals

Bioequivalence Ratings: "B" rated products

-Are NOT bio-equivalent to pharmaceutical equivalents -NOT therapeutically equivalent -Products CANNOT be substituted for one another

Bioequivalence Ratings: "A" rated products

-Are bio-equivalent to pharmaceutical equivalents -Therapeutically equivalent -Products CAN be substituted for one another

A Few Drugs that were "GrandFathered" in from before 1938 (AKA not required to be listed in Orange Book)

-Aspirin with codeine -Codeine -Digoxin -Ephedrine -Epinephrine -Levothyroxine -Morphine -Nitroglycerin -Phenobarbital -Quinine

Biosimilar Medications

-Biologics Price Competition and Innovation Act of 2009 -Provided an abbreviated pathway for the approval of biologic products classified as "biosimilar" to an FDA licensed biological product -Because of their complexity, biologic drugs are much more difficult to replicate than chemically produced generics true "identical" generics are virtually impossible to produce -Zarxio was the first biosimilar drug approved by the FDA

There are two "brand" drug products of nifedipine products on the market

-Brand "1" is designated as AB1 and brand "2" as AB2 -Products designated as AB1 may NOT be substituted for AB2 products -Nifedipine 60mg by Watson MAY be substituted for Adalat CC 60mg -Nifedipine 60mg by Watson MAY NOT be substituted for Procardia XL

OBRA '90: Retrospective Review

-Conducted by a DUR board =Board is composed of MD's and RPh's -Reviews data concerning medication use =Looks at "ideal" therapy and determines if actual med use conforms to ideal

TALL Man Lettering System

-Designed to reduce medication errors by making a drug name more easily distinguishable from drugs with similar spelling -FDA and ISMP publish a list of recommended Tall Man letters for look-alike drugs

Pharmaceutical Alternatives: (Erythromycin ethylsuccinate vs. Erythromycin estolate)

-Drug product that contains the same therapeutic moiety but may consist of different: =Salts =Ester or complexes =Dosage forms =Strengths -Most states do not allow substitution among pharmaceutical alternatives

Narrow Therapeutic Index (NTI) Drugs

-Drugs with a relatively low difference between the minimum toxic concentration and the minimum effective concentration -Safe and effective use of NTI drugs requires careful titration and patient monitoring -Some states have established tighter regulations to limit substitution of NTI drugs

Poison Prevention Packaging Act (PPPA)

-Enacted in 1970 to protect children <5 years old from accidental poisoning -Enforced by the Consumer Product Safety Commission (CPSC) -Requires child-resistant closures that prevent access to prescription and non-prescription drugs, and hazardous household products -Pursuant to the PPPA, when refilling a Rx all parts of a plastic prescription container must bust be replaced =If Rx container body is glass, it may be reused but the plastic closure must be replaced -Some drug products are exempt from child-resistant packaging requirements =SL NTG, oral contraceptives, pancrelipase

Federal Anti-Tampering Act

-Enacted in 1982 following several incidents of deliberate contamination of OTC products with poisons -Required tamper-evident packaging be used for OTC products =Indicator or barrier present to limit access +Plastic film seal or tab around the container closure =Visible evidence of entry is evident if disturbed +Plastic film seal or tab around the container closure is "broken" -Product label indicates package is tamper-evident and how a consumer can determine if package has been tampered with

Bioequivalence References

-FDA provides bio-equivalence information for multi-source drug products -Innovator drug product ("brand") is the reference standard to which the bioequivalence of others ("generics") is compared -Resources include: =Approved Drug Products with Therapeutic Evaluations (AKA "The Orange Book") =United States Pharmacopoeia Dispensing Information (USP/DI) =Facts and Comparison, Inc. Approved Bioequivalence Codes =FDA website

RPh may refuse to fill a prescription for a few "good" reasons

-Forged or fictitious prescription -Filling would cause RPh to violate law -Drug is not in stock -RPh believes drug product may be harmful to the patient

Health Insurance Portability & Accountability Act (HIPAA)

-Intended to assure the security and privacy of patients' medical records while providing high quality health care -Intended to limit the use, requests for, or disclosure of protected health information (PHI) =Prescription records, patient records, and documented pharmacist comments relevant to patient therapy -PHI is used and disclosed for treatment, payment, and operations (TPO) -PHI MAY be disclosed to: =Healthcare providers involved in treating the patient =Law enforcement, legal agencies -PHI MAY NOT be disclosed to: =Family members or other unless patient gives permission

Out-of-state Rx's

-Legality of filling prescriptions written by prescribers from other states is unclear from a federal viewpoint -States regulations specify that only licensed practitioners may write prescriptions and may specify the practitioner must be licensed in THAT state -Pharmacist MUST use professional judgment to establish if the prescriber, patient and prescription are legitimate

Prescription refills

-Must be indicated by prescriber (# of refills or time-frame) -States may impose stricter limitations (may not be law) -If Rx is for a non-prescription product, RPh is bound to the refill instructions indicated on the Rx. -Rx or refills doesn't expire as long as the patient-provider relationship still exists. -Company says that rx expires in a year as a way to make sure the relationship exists.

OBRA '90: GA DUR Requirements

-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 information the RPh deems necessary

OBRA '90: Federal DUR Expectations

-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

OBRA '90

-Omnibus Budget Reconciliation Act of 1990 -Mandated changes in pharmacy practice with uniform application =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 +Remember...Medicaid is a federally funded program that is administered by States -In order for a state to receive federal funds for its Medicaid program, it must have a drug use/utilization review (DUR) program =Must include retrospective and prospective reviews

Prescription ownership

-Once filled AND dispensed, Rx is legally OWNED by pharmacy -COPY of Rx can be provided to prescriber / patient if REQUESTED

OBRA '90: Prospective Review

-Patient's medical record and/or medication profile before dispensing a medication to look for: =Over or under utilization of drugs =Therapeutic duplication =Incorrect doses or dosing regimens -RPh extends verbal offer to counsel

Product Substitution: THERAPEUTIC EQUIVALENT

-Pharmaceutically equivalent -BIOEQUIVALENT (Products have to be pharmaceutical AND therapeutic equivalents in order to be substituted in Georgia)

Therapeutic Substitution

-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 ="Closed" formulary - only the drugs listed may be used ="Open" formulary - permits unlisted drugs to be used -Institutional committee determines which drugs will be included in the formulary =Pharmacy and Therapeutics Committee; P&T Committee -Institutional prescribers agree to abide by the substitution policies of the committee -Intent of a drug formulary is to save money and reduce the need for a large inventory

RPh Considerations: Controlled or non-controlled substance

-Prescriptions written for controlled substances must meet non-controlled and controlled substance requirements -Regulations are typically stricter for controlled substances

Product Substitution

-Regulations of product substitution lies with individual states -Intended to provide a lower cost drug product in place of the drug product prescribed =Two products must be PHARMACEUTICALLY equivalent -Products that are pharmaceutically equivalent are NOT necessarily therapeutically equivalent

Conscientious objection

-Right to refuse to dispense prescription to which the RPh has moral or religious opposition -RPh should not obstruct a patient's legal right to receive a lawful medication "other" arrangements should be made -Make arrangements for patient to legally receive the medication (ex. Plan B pill) & they have the right to know why.

Product Substitution: PHARMACEUTICAL EQUIVALENT

-Same ACTIVE ingredient -Same dosage form -Same route of administration -Identical strength or concentration (Products have to be pharmaceutical AND therapeutic equivalents in order to be substituted in Georgia)

Receipt of Foreign Products

-Some patients obtain prescription drugs from sources outside of the US by mail or visiting the country of origin -FDA does not approve but appears to be flexible provided: =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

Foreign Prescriptions

-States regulate who is authorized to prescribe...therefore, unless explicitly allowed in the state, foreign prescriptions should not be filled -"Appears" to be legal to fill a foreign prescription and export directly to a foreign country if for a reasonable quantity =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

Mailing Prescriptions

-United States Postal Service (USPS) prohibits mailing poisons and alcohol-containing products that could be considered beverages -USPS has no restrictions for mailing prescription products, including controlled substances =Inner container packaged and labels as required by law =Inner container placed in a plain outer container or securely wrapped in plain paper =Outside wrapper or container is free of markings that would indicate the nature of the contents -UPS and FedEx establish their own rules for mailing drug products

Explicit instructions must be clarified

-Use NUMBERS instead of alphabetic characters ="3" instead of "three" -IMPLICIT DIRECTIONS are recommended ="Take 2 tablets twice daily" versus "Take 2 tablets in the morning and 2 tablets in the evening"

Verapamil tablet, extended-release 180mg by Apotex:

-is substitutable for Calan SR 180mg -is NOT substitutable for Covera-HS 180mg

OBRA '90:

-legislation requires the dispensing pharmacists to offer patient counseling to Medicaid patients -Most states require dispensing pharmacists to offer patient counseling to ALL patients

Prescription record storage: Medicare Modernization Act of 2003

-requires Rx records be kept for 10 years (only for beneficiaries)

In ____, ___ adopted official standards for prescription container labeling

2013; USP

Prescription record storage: FDA required DRUG DISTRIBUTION RECORDS to be kept for _____ (ex. pharmacy sales bottle of drug to another rx company)

5 years

Drug names should be SPELLED OUT

Avoid using ACRONYMS or abbreviations (APAP = acetaminophen)

Prescription Container Labeling

Based on patient preference, "layman's terms" purpose for use should be included if included on the prescription "for high blood pressure" versus "for hypertension

CHART1

CHART2

NTI examples:

Carbamazepine Cyclosporin Digoxin Levothyroxine Lithium Phenytoin Tacrolimus Theophylline Warfarin

Authority to prescribe for self or family members, is state dependent

Dentist prescribing tetracycline for treatment of acne is outside scope of practice prescription is invalid. Pharmacist who knowingly dispenses is in violation of state pharmacy practice act

The Orange Book

Drugs and related drug products market before 1938 were "grandfathered" and are not required to be listed in the Orange Book

Internet Pharmacies

FDA states businesses operating as internet pharmacies must sell only FDA-approved drug products

-should be familiar (12-point Times Roman or 11-point Arial)

FONT for prescription container

Bioequivalence Ratings: "AB" rated products

Have actual or potential bioequivalence problems but studies have shown them to be ACCEPTABLE SUBSTITUTES

Out-of-state Rx's: (con't)

Ms. Jones is under the medical care of a the neurology department at an academic medical center in Texas. Ms. Jones is seen by her provider in Texas q6months. She presents to your pharmacy in GA today with a prescription for Keppra 500mg po BID #60 with 6 refills. What must you consider? Can you legally fill the prescription? Do you fill the prescription?

Verapamil ER 180mg by Apotex is NOT bioequivalent

NOT therapeutically equivalent and NOT substitutable for Covera-HS 180mg

Prescription Container Labeling

Pharmacy name, address, telephone number should be placed away from dosing instructions Prescriber's name Date prescription was written and/or dispensed States may require refill date Inclusion of expiration date, lot number, manufacturer is left to the discretion of individual states

Prescription Container Labeling

When possible, directions should be in patient's preferred language Drug name must be in English to aid emergency personnel

TALL Man Lettering (examples)

buPROPion vs. busPIRone chlorproMAZINE vs. chlorproPAMIDE cycloSERINE vs. cycloSPORINE DOBUTamine vs. DOPamine hydrALAZINE vs. hydrOXYzine

Prescriptive Authority: Physicians (MD, DO)

granted BROAD treatment and prescriptive authority

Prescriptive Authority: Dentists, veterinarians, podiatrists

have narrow treatment and prescriptive authority

Prescriptive Authority: Mid-level practitioners (PA, NP, OD)

have the most narrow treatment and prescriptive authority

Top of label

patient name, Rx serial number, drug name (full generic and trade name), strength, clear directions for use

Bioequivalent

products have similar "kinetic" properties (absorption, distribution, metabolism, and elimination)

Health care practitioners are licensed by

state law

Federal vs. State regulations: If there is a discrepancy between federal and state law

the stricter regulation will prevail