Medical Products &Samples

Thomas Hazlet, PhPH, PharmD

Agenda

• Review of the literature• History of federal / state control• What is “known” by the medical products

industry

Agenda

• Review of the literature• History of federal / state control• What is “known” by the medical products

industry

Medical Products Samples Literature

• Westfall et al. JAMA 1997;278(2):131– Personal use of drug samples by

physicians and office staff• Chew et al. J Gen Intern Med

2000;15:478– A physician survey of the effect of drug

sample availability on physician’s behavior

Literature

• Hall et al. Medical Care 2006;44(4):383– Perceptions of the

Influence of Prescription Medicine Samples on Prescribing by Family Physicians

• labeling• record keeping• diversion• wasted & expired• influence on prescribing

– after hours– indigent– trial before purchase

Literature

• Wolf et al. J Allergy Clin Immunol 2006;115(6):1320 [redux]– Largess, excess and tithing [retail value of samples; tithe Pharma

to support indigent]• Fuhlbarigge & Sullivan. J Allergy Clin Immunol

2006;116(1):230– Response to Wolfe [sic] [segue to value of samples]

• Scott et al. Journal of Managed Care Pharmacy 2007;13(5):412– Effects of a physician office generic drug sampling system on

generic dispensing ratios and drug costs in a large managed care organization

Agenda

• Review of the literature• History of federal / state control• What is “known” by the medical products

industry

Prescription Drug Marketing Act 1987 & 1992 State Mandates

• Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100-293) • Prescription Drug Amendments of 1992 (PDA) (Public Law 102-353)

– pedigree prior to (re)distribution

• WA RCW 69.45– Registration– Records by manufacturer (CS issues, storage, transportation, disposal)– Written request

• WAC 246-877-020 Drug sample prohibitions.– (1) The possession, distribution or dispensing of legend drug samples

by a pharmacy is hereby prohibited.

http://www.fda.gov/cder/regulatory/PDMA/default.htm

More state mandatesRCW 69.41.050Labeling requirements — Penalty.(1)To every box, bottle, jar, tube or other container of a legend drug, which is

dispensed by a practitioner authorized to prescribe legend drugs, there shall be affixed a label bearing the name of the prescriber, complete directions for use, the name of the drug either by the brand or generic name and strength per unit dose, name of patient and date: PROVIDED, That the practitioner may omit the name and dosage of the drug if he or she determines that his or her patient should not have this information and that, if the drug dispensed is a trial sample in its original package and which is labeled in accordance with federal law or regulation, there need be set forth additionally only the name of the issuing practitioner and the name of the patient.

(2) A violation of this section is a misdemeanor.

Agenda

• Review of the literature• History of federal / state control• What is “known” by the medical products

industry

Samples & Medical Products Industry

• Accounting – part of the advertising budget– costed at list