Authorization

The work of the Special Task Force Studying the Practice of Therapeutic Interchange was completed pursuant to House Joint Resolution 630 passed by the General Assembly of Virginia during its 1997 Session. The full text of HJR 630 can be found in Appendix A of this report. A summary of the provisions of HJR 630 is provided below.

Resolution Summary

HJR 630 established a special task force to study the practice of therapeutic interchange of chemically dissimilar drug products. The special task force was directed to:

1. State the practice of therapeutic interchange to reach consensus on its incidence and prevalence.

2. Determine the impact of the practice of therapeutic interchange on health care, the affected professions, the overall costs of health care products and services, and patients.

3. Identify the components of the cost of the practice.

The resolution defined the membership of the Task Force and directed that the Department of Medical Assistance Services provide staff support to the Task Force. The Department contracted with the Virginia Commonwealth University School of Pharmacy to facilitate the Task Force meetings and provide documentation.** This report was written by Dr. Michael A. Pyles of the Virginia Commonwealth University School of Pharmacy, in his role of facilitator for the Task Force under contractual arrangements with the Department, and does not contain the personal views, opinions, positions or perspectives of Dr. Pyles or the School of Pharmacy.

The first meeting of the Special Task Force was held on June 19, 1997, in Richmond. Subsequent meetings were held on July 16, 1997, August 20, 1997, and September 17, 1997. All meetings were held in House Room D of the Virginia General Assembly Building except the September 17 meeting, which was held in House Room C. Mr. Joseph M. Teefey, Director of the Department of Medical Assistance Services, and a member of the Task Force, served as chair of the Task Force and presided over all of its meetings.

Agendas and transcripts for each meeting can be found in Appendices B and C, respectively. Each meeting included a public comment period so that Task Force members could hear from interested parties concerning the practice of therapeutic interchange of chemically dissimilar drugs.

In an effort to ensure that Task Force members had access to as much pertinent information as possible, and to ensure that they would be able to make informed decisions concerning the practice of therapeutic interchange of chemically dissimilar drugs in the Commonwealth, several speakers were invited to make presentations and give comments on the topic.

The Task Force believed that it was very important to clearly define the term “therapeutic interchange of chemically dissimilar drugs." The following definition was unanimously adopted by the Task Force on August 20, 1997.

Therapeutic interchange is the dispensing of a drug, by any person authorized by law to dispense drugs, that is a chemically dissimilar alternative for the drug initially prescribed. The alternative drug is expected to have the same clinical results and similar safety profile, when administered to patients in therapeutically equivalent doses, as the drug initially prescribed, and is dispensed with the approval of the person who prescribed the initial drug, or their lawful designee.

The adoption of this definition was crucial to the work of the Task Force as it attempted to describe the practice of therapeutic interchange of chemically dissimilar drugs and identify the impact of the practice in the Commonwealth. Prior to the adoption of this definition, the Task Force had an in depth discussion centering around this issue.

Two important questions emerged from Task Force deliberations.

1) Is the practice of therapeutic interchange harmful to Virginia residents?

2) How many Virginians are affected by this practice?

Is therapeutic interchange harmful?

The first question was addressed by interested parties representing two points of view. Interested parties who expressed concern that the practice is harmful and dangerous articulated the first point of view. Many of the comments made by speakers holding this point of view called attention to a piece of legislation that failed during the 1997 session of the Virginia General Assembly (SB 1114, see Appendix A) which sought to outlaw the practice of Drug Switching in the Commonwealth. The consensus of those persons holding this point of view is that the practice of therapeutic interchange is indeed harmful and dangerous and that we do not have sufficient empirical data to suggest otherwise.

The other point of view contends that accounts of the harmful and dangerous nature of the practice are inaccurate and rely solely on anecdotal evidence. The consensus of persons holding this point of view is that the practice must be allowed to continue because it makes good economic sense and any attempt to make the practice unlawful in Virginia, or otherwise restrict it, would result in substantial increases in health care costs for the residents of the Commonwealth as well as employers whose health care benefits include prescription drug coverage.

How many Virginians are affected by therapeutic interchange?

In an attempt to understand the potential impact of this practice in the Commonwealth, a Task Force member raised the question on the number of Virginians affected by the practice. The Task Force staff concluded that there is no exact answer to this question. At best, the number of Virginians covered by prescription benefit programs could only be estimated, since such data are not routinely or uniformly collected and reported. The staff estimates that over 5,000,000 Virginians are covered by such plans. Current population data indicate that 87% of Virginia’s population is covered by health insurance. National health insurance data indicate that between 42% and 94% of persons who are covered by a health plan have coverage for their prescription drugs under those plans.

One issue that engendered a lengthy discussion by the Task Force was the statutory and regulatory authority of the Board of Pharmacy to oversee out-of-state pharmacies. Members of the Task Force raised questions about the dispensing of prescription drugs to Virginia residents by pharmacies operating in other states, especially by means of mail order. According to information that it received, the Task Force acknowledges that the Virginia Board of Pharmacy has limited regulatory authority over these out-of-state pharmacies and their dispensing operations.

Conclusions

The chair of the Task Force solicited policy options and recommendations from Task Force members and interested parties regarding the practice of therapeutic interchange of chemically dissimilar drugs in the Commonwealth. During the last meeting of the Task Force, members heard from the Executive Director of the Board of Pharmacy and considered policy options from a Task Force member and interested parties.

In the course of its deliberations, the Task Force came to the conclusion that additional information is needed before any specific recommendations regarding the practice of therapeutic interchange can be made. Although an abundance of information was disseminated to Task Force members, and despite the impassioned testimony of invited speakers and interested parties on both sides, it is the collective opinion of the Task Force that final recommendations about the practice of therapeutic interchange of chemically dissimilar drugs in the Commonwealth of Virginia be deferred.

Recommendations

After a lengthy discussion, and in light of its deliberations, the Special Task Force Studying the Practice of Therapeutic Interchange of Chemically Dissimilar Drugs made the following recommendations.

1. The addition of the following to the Code of Virginia, § 54.1-3434.4, as subsection B thereof.

It is unlawful for any nonresident pharmacy to dispense a drug that is chemically dissimilar from the drug initially prescribed without the approval of the prescriber or his lawful designee.

This is a part of a policy option submitted by Matthew Jenkins in a letter to Mr. Joseph M. Teefey dated September 12, 1997.

2. The introduction of a joint resolution during the 1998 session of the General Assembly to continue the Task Force for another year so that the Task Force will have the opportunity to consider the findings of a study to be performed by the Virginia Commonwealth University School of Pharmacy pursuant to House Joint Resolution 574 from the 1997 session of the General Assembly.

These recommendations were adopted by a unanimous vote of the Task Force.