Pharmacy Law Chapter 3

Codes

FDA uses a two-letter coding system for the therapeutic equivalence evaluations of multisource drugs. The first letter of the code is either an A or B.

AN

Therapeutically equivalent Solutions and powders for aerosolization

AT

Therapeutically equivalent Topical Products

Expiration date example

06/19, expires last day of the month

The FDA favors the OTC drug review process because

100,000 to 500,000 OTC drug products on the market, many have not been approved via New Drug Application process.--> Financial drain Litigation to remove unsafe or ineffective products would be time consuming and expensive. Nearly all the OTC drugs were prepared from only 200 active ingredients. FDA utilizes advisory review panels of experts to consider the drugs by class and to to make recommendations.

Switch of Prescription Drugs to OTC

A switch may occur in three ways: The manufacturer may request the switch by submitting a supplemental application to its approved NDA Manufacturer may petition the FDA The Drug may be switched through the OTC drug review process.

PPPA effect on Pharmacy

Act requires the use of child resistant containers for packaging of most OTC drugs and nearly all prescription drugs. Containers must be manufactured such that 80 percent of the children less than 5 years of age cannot open them, whereas 90% of adults can. A drug may only be dispensed one time in a child resistant container or vial because continued use has an impact on the effectiveness of the container.

BD

Active ingredients and dosage forms with documented bioequivalence problems

BP

Active ingredients and dosage forms with potential bioequivalence problems

Off-label use

Any time a drug is prescribed for a condition not listed in its official labeling, that use is considered off-label, unlabeled or unapproved. FDA position is a drug may be legally prescribed and dispensed for an unlabeled indication or dosage. Pharmacists must use professional judgment

Beyond Use Dating

Beyond use label--> one year after the date of dispensing, OTC products can be exempt from expiration dates because they are good for more than 3 years

NTI examples

Carbamazepine Clonidine Levothyroxine Lithium Phenytoin Warfarin Theophylline

Pharmaceutical Equivalents

Defined by the FDA as products that contain the same active ingredients and are identical in strength and are in the same dosage form.

BE

Delayed-release oral dosage forms with no therapeutic equivalence

Pharmacy compounding

Different from manufacturing, if pharmacy is manufacturing they need a license from the FDA

BX

Drug products for which the data are insufficient to determine therapeutic equivalence

Drug exemptions to PPPA

Drugs dispensed to institutionalized patients Certain prescription drugs (page 150 textbook) SL nitroglycerin SL and chewable forms of isosorbide dinitrate in strengths of 10mg or less Sodium fluoride products containing not more than 264 mg of sodium fluoride per package Anhydrous cholestyramine in powder form Methylprednisolone tablets containing not more than 84mg of the drug per package. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8g of the equivalent of erythromycin Mebendazole tablets Betamethasone tablets Potassium supplements in unit dose form Colestipol in powder Aerosol containers Pancrelipase preparations Prednison tablets not more than 105 mg per package cyclically administered oral contraceptives medroxyprogesterone acetate tablets sucrase preparations effervescent tablets with aspirin or acetominophen

FDA 1992 Compliance Guide

Emphasized that DFA had no intention of regulating pharmacy's historic exemption to compound drugs extemporaneously in reasonable quantities pursuant to prescriptions. Pharmacists may prepare very limited quantities of drugs before receiving valid prescriptions

OTC Drug Review

Evaluates OTC products on the basis of therapeutic category, rather than individually, and classifies products through rule making rather than on a case-by-case basis.

BC

Extended-release dosage forms (capsules, injectables and tablets)

FDA 2002 Compliance Guide

FDA believed an increasing number of pharmacies were engaging in manufacturing and distributing unapproved new drugs clearly outside of traditional pharmacy compounds. Certain pharmacies were compounding hormonal replacement products and the safety and efficacy of these drugs was not supported by the FDA and was considered misleading

FDAMA Compounding Provisions

Helped clarify for pharmacists those activities that would be considered compounding and those that would be considered manufacturing. Prescription could not be solicited. Pharmacies and physicians could promote and advertise that they compound, but they could not advertise or promote the compounding of any particular drug, class of drug, or type of drug

Product Advertising: Strict Liability

It shall be unlawful for any person, partnership, or corporation to disseminate, or cause to be disseminated, any false advertisement

The Orange Book

Lists thousands of currently marketed multi-source drug products that the FDA has approved as safe and effective. Drugs marketed before 1938 might not be in here

Bioequivalence

Means that the products display comparable bioavailability (rate and extent of absorption) under similar conditions.

Patent Issues

Minoxidil made in tablet form used as an antihypertensive. (Upjohn company ) side effect was hair growth, pharmacies were compounding it in topical form and Upjohn Company warned them they would bring legal action unless they stopped

Pharmacist duty to patient on off-label use

Off label and no unreasonable risk to patient, RPH may dispense the drug. If the risk is unreasonable, RPh has a duty to take additional action. Contact prescriber Significant risk or harm to patient, prescriber may have to justify the position to the RPh. Protect patient and protect RPh from liability. Third party insurance may not pay for off label uses Pharmacists who provide drug information to other health care providers regarding off label indication generally need not fear violating the FDCA as long as the intent of the information is advisory or educational, and NOT promotional.

OTC packaging and PPPA

PPPA allows manufactured to market one size of an OTC product for the elderly in noncompliant packaging. Must contain statement "This package for households without young children" or if the label is too small "Package not child resistant"

BR

Suppositories or enemas that deliver drugs for systemic absorption that are not therapeutically equivalent

Therapeutic Equivalence

Pharmaceutical equivalents that are bioequivalent are presumed to be therapeutically equivalent.

Retail pharmacy use of alcohol

Pharmacies that use alcohol to compound prescriptions commonly use tax paid ethyl alcohol, usually 190 proof grain alcohol, purchased from an authorized retail or wholesale outlet

Exemptions of PPPA

Physician or patient receiving the drug can request a non-compliant container. Result could be oral, however, pharmacist should document request. Best practice is to have the patient sign a statement that patient requests the non-complying container . Patient can make a blanket request for all medications to be dispensed in a non-complying container. However, physicians, may not request a blanket waiver, allowed for new prescription and its refills.

Patient Package Inserts

Prescription drug labeling by manufacturers is directed at the health care professional, not the patient. Exceptions to the rule are oral contraceptive drugs (Leaflets are provided to patients from manufacturer) Estrogen containing drugs Diethylstilbestrol (DES) IUD contraceptive device

Dispensing written, oral, or electronic prescriptions

Prescriptions may be dispensed pursuant to a written or oral prescription. Refills are allowed, as long as they are authorized in the original prescription. Does not specifically authorize electronic transmission of prescriptions.

Issues with DHA

Prescriptive refill authorization Third class of Drugs Could only be sold by a pharmacist. Prescriptive Authority "licensed by law to administer such drug" State not federal law Collaborative Practice Agreements Authority to Dispense Prescription Drugs Pharmacists v. Physician Dispensing

BS

Products having drug standard deficiencies

AA

Products in conventional dosage forms not presenting bioequivalence problems

Ab, AB1, AB2, AB3

Products meeting necessary bioequivalence requirements

Medication Guides

Program for drugs posing a serious and significant concern. Nontechnical language, uniform format, approved uses of product, proper use, serious adverse reactions, cautions, and other general information. FDA approval before distributed.

Poison Prevention Packaging Act

Protect children from accidental poisonings with "household substances". Consumer Product Safety Commission, has reported that there have been remarkable declines in the reported deaths of children as the result of accidental ingestion of household substances.

Durham-Humphrey Amendment

Section 502 of FDCA establishes different labeling requirements for drugs, depending if they are prescription or nonprescription (OTC).

How to store tax free alcohol

Tax free alcohol must be stored in a securely locked storeroom with the labels and markings on the container intact. After the containers are empty, the labels and markings must be obliterated before discarding

Drug needs medication guide if....

That patient labeling could help prevent serious adverse effects The product has serious risks relative to its benefits of which a patient should be aware to decide whether to use or continue to use the product. Patient adherence to directions is crucial to drug's effectiveness.

FDA Bioequivalence Standard

The FDA"s bioequivalence standards allows for a range between 80- to 125 percent. Some drug manufacturers and health care providers have stated that this is not precise enough for NTI drugs.

BT

Topical products with bioequivalence issues

FDA must prove two issues to change the status of a drug from OTC to prescription:

Toxicity and method of use require practitioner supervision, and collateral measures necessary to use the drug require supervision.

Narrow Therapeutic Index (NTI)

Where there is less than a 2-fold difference in the median lethal dose and median effective dose; or Where there is less than a 2-fold difference in the minimum toxic concentrations and minimum effective concentration in the blood. Patients' blood drug levels have to be continuously monitored

B (therapeutic code)

are not considered to be therapeutically equivalent to a reference drug product. Reasons Documented bioequivalence problems No adequate studies demonstrating bioequivalence.

Labeled as a prescription drug..

because of toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or is limited by an approved application under the new drug application approval process to use under the professional supervision of a practitioner licensed by law to administer such drug;

A (therapeutic code)

considered therapeutically equivalent to a reference drug product.

The Virginia Decision

established that the First Amendment applies to commercial speech, as well as to the listeners or recipients of the speech. The well-intended, paternalistic laws whose result is depriving consumers of information will be ruled unconstitutional

OTC Ingredient Category 3

includes ingredients for which data available are insufficient to permit classification.

OTC Ingredient Category 1

includes ingredients generally recognized as safe and effective and not misbranding.

OTC Ingredient Category 2

includes those ingredients that are not generally recognized as safe and effective or that are misbranded.

Tax paid alcohol

most of the time in pharmacy is tax paid. Ethyl-alcohol, sold in retail outlets

BN

not therapeutically equivalent: Products in aerosol-nebulizer drug delivery systems

Price Advertising

only purpose of advertising is to provide info on price, not info on drugs safety, efficacy or indications for use. contains proprietary name of the drug, generic name, strength, dosage form, and price charged for specific quantity of drug. price shall include all charges to the consumer

Tax free alcohol may be used for the following reasons

state or political subdivisions for scientific or mechanical purposes, educational institutions for scientific or mechanical purposes, laboratories for scientific research, hospitals, blood banks, sanitariums, pathology labs, and non profit clinics for scientific, mechanical and medicinal purposes or treatment of patients

Prescription labeling requirements

the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription.

AO

therapeutically equivalent Injectable oil solutions

AP

therapeutically equivalent: Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions