A Collaborative Initiative for Patients and Clinical Professionals

Reciprocal Dosing Agreement

Ruby Gordon, M.S.S.W., manager More Center in Louisville, KY and Carol McPherson, manager of the Southern Indiana Treatment Center

RECIPROCAL DOSING AGREEMENT

NEED
In 1990 and 1991, the Kentucky State Methadone Authority started a discussion with existing methadone programs in the State of Kentucky to address the need to develop emergency dosing plans. As other priorities took precedence, no definitive action was taken. Then in January, 1993, the Jefferson County area which includes the highly populated urban area of Louisville had a 15 inch snow storm which totally crippled the community for five days. The National Guard with four-wheel vehicles transported essential methadone staff (nurses, one social worker and a guard) daily to and from the clinic. The patients somehow made it to the clinic through their own ingenuity and need for the methadone. It was recognized at this time that additional emergency planning needed to occur for times when the clinic actually could not be opened due to major catastrophe.

PLANNING
In June of 1994, the Methadone/Opiate Rehabilitation & Education (MORE) Center formerly known as the Jefferson County Health Department Methadone Maintenance Program in Louisville, Kentucky and the Southern Indiana Treatment Center (SITC) in Jeffersonville, Indiana met to develop a Reciprocal Dosing Agreement to be used in the event of a major disaster such as a fire, tornado, flood, chemical leak, etc. The participants in this meeting were Carol McPherson, Manager of the SITC, Ruby Gordon, manager of the MORE Center, and Mark Jorrisch, M.D., Medical Director for both programs. It was understood by all present that any arrangement which was worked out would need approval by all regulatory agencies including the Food & Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the State Methadone Authorities in Indiana and Kentucky.

IMPLEMENTATION STEPS
1. June 14, 1994-Phone contact followed by formal request letters were made with all regulatory agencies requesting permission to develop a Reciprocal Agreement.
2. Replies were received from FDA, DEA and the State of Kentucky in July and August 1994 and from the State of Indiana in January, 1995 (although verbally given earlier) giving permission to develop a Reciprocal Agreement with final approval contingent upon receipt of the written agreement and concurrence by all other regulatory agencies.
3. Draft Reciprocal Agreement was developed in September, 1994 and presented for review to both programs and the legal staff of the Health Department. Modification was made from input from reviewers. Official agency signatures were not requested until after receipt of approval to develop a Reciprocal Agreement from the State of Indiana was received in January, 1995.
4. T.S. Wallace, Jr., M.D., M.P.H., Interim Health Director for the Jefferson County Health Department signed the Reciprocal Agreement on March 2, 1995 and Patricia Lewin, Owner, of the Southern Indiana Treatment Center signed the agreement on March 22, 1995.
5. Copies of the signed Reciprocal Agreement were sent to all regulatory agencies on March 31, 1995 seeking final approval for the implementation of the agreement.
6. In April and May, 1995, the agreement was approved by FDA and the State Authorities in Indiana and Kentucky, but DEA requested some revisions in the agreement prior to giving formal approval.
7. In June, 1995, Ruby Gordon, Matthew Glass (Supervisor at SITC, sitting in for Carol McPherson), and Dr. Jorrisch met to develop an Addendum for the Reciprocal Agreement to address the DEA concerns.
8. A draft copy of the Addendum was sent to DEA on June 5, 1995, and on August 3, 1995, DEA responded that the addendum satisfactorily resolved their concerns.
9. On August 10, 1995, Melinda Rowe, M.D. M.P.H., the new Health Director for Jefferson County Health Department signed the Addendum, and on August 28, 1995, Patricia Lewin signed the Addendum for SITC.
10. On September 11, 1995, all regulatory agencies were sent the Reciprocal Agreement and Addendum asking for final approval to implement the agreement.
11. Final approval was received from all regulatory agencies in September and October of 1995.
12. The first exchange of quarterly data between the programs occurred in October, 1995, a 17-month period from the initial discussion to initiation of exchange of information.

HIGHLIGHTS OF THE RECIPROCAL AGREEMENT
1. Each clinic agrees to dose the patients of the other clinic in the event of a major disaster which causes one of the clinics to close.
2. Identification of patients from the MORE Center will be by patient I.D. cards while SITC participants will show state I.D. and/or driver's licenses.
3. All available staff from the closed clinic will report to the open clinic to assist with correct dosing of patients and to maintain order. In the even that dosing staff from the closed clinic are unable to get to the open clinic, patients will be allowed to identify their dose. Patients misrepresenting their dose will receive appropriate consequences from their home clinic.
4. Patients 'guest' dosing will pay the guest dose daily fee but not the yearly intake fee for guest dosing privileges during the emergency.

CONCERNS OF DEA
1. Wanted better controls to insure that both clinics had accurate dosing and take-home information for each client.
2. Wanted sanctions for patients who attempted to misrepresent their dose or take-home privileges spelled out in detail.

HIGHLIGHTS OF THE ADDENDUM
1. Three Lines of Action were set to insure that correct patient identification and dose levels would be given:
A. 1st Line of Action-All available staff from closed clinic will report to open clinic (quarterly exchange of current staff names and positions will occur between clinics).
B. 2nd Line of Action-Telephone and fax communication will occur if these communication systems are operational and staff is unable to get to open clinic due to conditions.
C. 3rd Line of Action-There will be quarterly exchange of patient data including current dose levels which are number coded to coincide with Patient ID numbers. If the 3rd Line of Action is used, doses are given at the level of the last quarterly exchange of information unless the patient states that his/her dose is lower. In this situation, the lower dose will be given. New patients to either program since the last quarterly exchange of information will be dosed at a standard dose of 50 mgs. regardless of their current dose unless the patient states their dose is lower. The 3rd Line of Action will occur on subsequent days only until the 1st or 2nd Line of Action can be implemented or the emergency situation is over.
2. There will be no take homes given to patients guest dosing during the emergency unless the dosing clinic will be closed the following day. SITC is closed on Sundays and holidays, and the MORE Center is closed for holidays.

OTHER CONSIDERATIONS
Both clinics have a method of accessing additional methadone supplies should the need arise due to the large increase in number of people being dosed during the emergency. The MORE Center gets its methadone supplied from a local state operated hospital where additional supplies can be furnished upon request. SITC has other locations in Indianapolis & Evansville, Indiana where additional methadone can be obtained.
Although the two clinics are in two different states, they are only about ten miles apart. It is possible that a major catastrophe could close both clinics. In this event, patients of the MORE Center may be required to go to the Lexington, Kentucky methadone clinic which is another state operated facility or be dosed at the state operated hospital that has methadone supplies while the patients from SITC would probably attend sites in Indianapolis & Evansville, Indiana which are owned by the same private operator. Formal agreements for these alternatives have not yet been worked out, but could probably be implemented with less preparation as these sites are administratively related.

SUMMARY
The Reciprocal Dosing Agreement from initial discussion to initial exchange of information took 17 months. It required the interest and cooperation of a public funded methadone clinic (the MORE Center) and a private for profit operated methadone clinic (SITC). Four regulatory agencies were involved from the beginning for input, consultation, and approval. These agencies helped to better define the agreement and facilitated its implementation.
Copies of the Reciprocal Agreement and Addendum will be provided to interested parties who request it by writing or phoning Ruby Gordon, M.S.S.W., Manager of the MORE Center, 1448 South 15th Street, Louisville, Kentucky 40210, Phone: (502) 574-6414, Fax: (502) 574-6503.