SENATE BILL REPORT

ESHB 931

BYHouse Committee on Health Care (originally sponsored by Representatives Leonard, Padden, Braddock, Day, Hine, Lewis, Appelwick and Sprenkle)

Regulating the possession and distribution of legend drug samples.

House Committe on Health Care

Senate Committee on Human Services & Corrections

Senate Hearing Date(s):March 26, 1987; March 31, 1987

Majority Report:     Do pass as amended.

     Signed by Senators Wojahn, Chairman; Stratton, Vice Chairman; Anderson, Deccio, Johnson, Kiskaddon, Kreidler, Tanner.

Senate Staff:Carol Pedigo (786-7417)

                April 13, 1987

AS REPORTED BY COMMITTEE ON HUMAN SERVICES & CORRECTIONS, MARCH 31, 1987

BACKGROUND:

For marketing purposes, pharmaceutical manufacturers give sample complimentary prescription drugs to physicians and other prescribers.  There is currently no regulation or control over the distribution of these samples and there have been occasions when these drugs have been diverted for other purposes or disposed of in a dangerous manner.  Manufacturers' representatives who distribute sample controlled substances are exempt by law from registration with the Board of Pharmacy.

SUMMARY:

Pharmaceutical manufacturers who intend to distribute complimentary drug samples in Washington must register with the Board of Pharmacy annually.  They must also provide the Board with a 24 hour-a-day telephone number and the name of an individual responsible to respond to the Board's inquiries should reasonable cause arise for the Board to believe that a possible law violation had occurred.  Should a violation incident indicate the need, the Board may request the addresses of storage sites and the name and phone number of the individual responsible for each site.

If a 24 hour number is not available the manufacturer must provide the Board with the address of each storage site and the name and address of the person or persons responsible for the samples stored there.

The manufacturers must account for all samples distributed by them and, upon reasonable cause, must make this information available to the Board.  Upon discovery of any loss or theft of samples, the manufacturer must report to the Board within one business day.

In the case of controlled substance sample distribution, the manufacturer must report to the Board the name and address of the medical practitioner who received the samples, as well as the strength and quantity of the samples received.

Requirements for storage, transportation and disposal of samples are specified.

Medical practitioners are required to make written request for samples and may only request drugs they are legally authorized to prescribe.

Manufacturers are liable for the acts of their representatives.  The Board may impose upon manufacturers a civil fine up to $5,000 for noncompliance.

All records, reports and information obtained by the Board under this chapter are exempt from public disclosure, except the identity of persons found by the Board to have violated the restrictions of this act.

SUMMARY OF PROPOSED SENATE AMENDMENT:

The Joint Select Committee on Pharmacy Issues is established.  The Committee will be composed of two members of each caucus in the House and Senate.  They are to study legend drug sample distribution, therapeutic substitution and neuroleptic drug usage.  The Committee is to report to the Legislature by January 1, 1988.

The Board is restricted from taking any civil action under this act until a hearing is held following the Administrative Procedure Act.

Fiscal Note:    available

Senate Committee - Testified:   Representative June Leonard, Prime Sponsor; Lars Hennum, Pharmacists Association; Jerry Farley, Pfizer Pharmaceuticals; Doug Beeman and Don Williams, Board of Pharmacy; Cliff Webster, Pharmaceutical Manufacturer's Association; Dr. Art Zolath, Virginia Mason Hospital; Larry Pelham, Hospital Pharmacy Manager; Bill Baluch, Eastside Hospital