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Mectizan Program Notes No. 21 text only
100-millionth Mectizan™ treatment given in Uganda
On July 23, 1998, a symbolic 100-millionth Mectizan treatment was administered by Dr. Stefanie Meredith, Director of the Mectizan Donation Program, in the community of Bushika, Uganda. Bushika is approximately 200 kilometers east of Uganda’s capital of Kampala and is located in the district of Mbale.
Accompanying Dr. Meredith for the 100-millionth treatment were representatives of the Uganda Ministry of Health, the Global 2000 River Blindness Program, and Sight Savers International; members of Bushika’s Local Council; and community members.
The visitors to Bushika for the event were greeted by singing school children and colorfully clad women as they hiked up the hill leading to the community’s schoolhouse. The leader of the Local Council welcomed the visitors in an address in which he stated, “The residents of this sub-county are indeed happy and pleased to receive and have you here today. This occasion to us as Bushika is a milestone to the history of our sub-county.” He went on to describe the onchocerciasis control program in Bushika that began in 1994, after a prevalence assessment and community sensitization to Mectizan were completed. As part of the celebration, 85-year old Bushika resident, Mr. Gizewa Batulumayo, received the symbolic 100-millionth treatment and was given a Mectizan T-shirt to commemorate the event.
Uganda’s Mectizan treatment programs, which began in 1990-91, are currently coordinated by the Uganda Ministry of Health in partnership with Christofel-BlindenMission (CBM), Global 2000 River Blindness Program (GRBP), Sight Savers International (SSI), the German Technical Cooperation (GTZ) and APOC. In the first half of 1998, over 500,000 people were treated through the Ugandan programs. The program plans to treat an additional one million persons before the end of 1998. In recent years, the program has treated over 70% of persons at risk, reaching nearly 90% in some communities.
Revisions Completed on the Mectizan Donation Program Information Booklet
The Mectizan Donation Program (MDP) has completed its revision of the Program Information Booklet which contains:
· General Information about Mectizan and the donation program
· Instructions for organizing a community-based mass distribution program
· A list of requirements for all community-based mass treatment programs
· Applications for Mectizan for programs initiating or continuing treatments
· A treatment program report form
· Serious adverse experience report forms
Changes have been made in the application and program report forms that:
· Reflect the transition to the new 3mg tablet formulation
· Simplify the calculations used to determine the number of tablets needed
· Will give Merck information regarding the optimal timing of Mectizan production and shipping
· Will allow programs to describe certain aspects of their transition to CDTI
· Will provide the MDP with more detailed information regarding treatments and tablet inventory
The final version of the booklet is dated June 1998 and has an orange cover. The MDP will send copies of the booklet to all current program directors. Please contact the MDP if you would prefer to receive your copy on diskette or via e-mail.
Donation Program Status Report
In the first seven months of 1998, 16 applications for Mectizan™ were approved. The majority of approved applications (13) requested tablets for the continuation of treatment programs in Cameroon, Yemen, Ecuador, Sudan, Southern Sudan, Democratic Republic of Congo, Brazil, Tanzania, Mexico, and Central African Republic. The remainder of approvals (3) were for amendment applications requesting supplemental tablets with which to complete ongoing treatment cycles. Amendments were approved for Chad, Central African Republic, and Nigeria. Altogether, these applications proposed giving over three million treatments.
The graph* represents the number of Mectizan treatments approved for community-based treatment programs since 1988. Tablets approved for initial programs and continuing programs are indicated separately. It is estimated that approximately 34 million treatments will be approved in 1998. The 3.3 million treatments approved thus far in 1998 seem inconsequential compared to the projection of 34 million; due to the seasonality of application submission, most applications for community-based programs are approved by the Mectizan™ Expert Committee between August and December of each year.
Monitoring Serious Adverse Experiences After Treatment With Mectizan
With Mectizan, as with all drugs, detecting previously unrecognized or unexpectedly serious adverse events or experiences (SAEs) possibly related to treatment is an important commitment in using the drug. Clinical field trials carried out before a drug is registered define more common post-treatment effects, but it is only when a drug is in regular use and being given to millions of people that rare events may be seen.
In sharing with Merck the responsibility for this "post-marketing surveillance," the Mectizan Donation Program requires applications for Mectizan to include an agreement from their Program Directors stating that patients with SAEs will be identified promptly, evaluated carefully, given proper medical care, and reported to Merck and the Mectizan Donation Program. Forms specifically for reporting SAEs are among official program documents.
Since some 100 million treatments have now been approved, most of what might be considered Mectizan?related SAEs have probably been described. Nonetheless, it is important to summarize what has been learned about SAEs during the ten years the Donation Program has been in existence and to urge that vigilance in their surveillance and monitoring continues.
Common Post Treatment Events
In general, following the first dose of Mectizan, about 25-30 percent of people infected with onchocerciasis report some symptoms and signs. These symptoms and signs generally result from the effect the drug has on the microfilariae of Onchocerca volvulus and are not an effect of the drug itself. Due to the reduction in skin microfilariae, second and subsequent treatments usually produce few or no post?treatment effects at all.
Among the commonly reported post?treatment symptoms and signs are fever, headache, itching or swollen skin and eyes, rash, enlarged lymph nodes, dizziness, vomiting, diarrhea, and, rarely, difficulty in breathing, or asthma. These effects generally appear within a day of treatment, last a day or two longer, and need no specific treatment. For effects that are more severe or last longer, a health worker, nurse, or doctor may prescribe drugs like antihistamines, antipyretics, and anti?inflammatories and recommend rehydration fluids.
If symptoms or signs persist and/or are getting worse, patients should be seen by a nurse or medical officer or taken to a hospital or clinic. Whether or not the medical problem is, in fact, associated with Mectizan treatment, all seriously?ill patients need prompt medical care. It is among these patients that thorough evaluation is particularly important in supporting or rejecting an association of an SAE to Mectizan treatment.
The Question of Reporting
The question of which SAEs need to be evaluated fully and reported is sometimes difficult to answer. A general guide for Program Directors and Medical Supervisors is to evaluate all cases that may be life?threatening, require lengthy hospitalization, have a long period of recovery, involve the central nervous system, are complicated by additional infections or other medical problems, result in residual clinical effects, or are fatal. SAE reports should be submitted on all severe cases thought to be Mectizan?related, especially if the SAE is one not previously described.
Special problems of causation and drug association occur in areas where onchocerciasis and other parasitic diseases co?exist. Treatment of one parasite might then result in a serious post?treatment adverse event related, in fact, to treating the other disease. This is the case in areas in which both onchocerciasis and loiasis are endemic. It is well known that treatment of loiasis with potent microfilaricides like DEC can result in serious or fatal post?treatment central nervous system effects. Although much rarer, similar but milder CNS effects have been associated with Mectizan treatment of patients with loaisis as well as onchocerciasis, prompting special recommendations for managing the treatment program and providing more intense post?treatment follow?up.
Ten Years of Surveillance of Post-Treatment SAEs
Since 1988, when the Mectizan Donation Program began, a total of only 49 SAE reports or other reasonably well?documented serious post?treatment adverse events have been notified to Merck & Co., Inc. and the Mectizan Donation Program. This obviously represents gross underreporting, since many times that number of purely coincidental serious medical events, including fatalities, would be expected to occur among the many millions of people receiving Mectizan. It is important to note, however, that despite the small number of reports, only already?recognized types of SAEs have been described. It is additionally important to note that the more serious and fatal cases were attributable to the lack of prompt or adequate medical and nursing care.
Recommendations to Program Directors
The demonstrated safety of Mectizan in treating onchocerciasis is reassuring to all of us associated with its donation. There is no reason to alter existing recommendations for its field use or its monitoring. There is reason, however, to reinforce the importance of recommendations and requirements relating to SAEs, their identification, evaluation, management, and reporting. It is only by systematic education of health workers and communities that serious adverse post?treatment events can be identified early and brought to the attention of health personnel for evaluation and care, if needed. A clear lesson from ten years of experience with the reporting of SAEs is that early intervention is key to predicting outcome and expectation of full recovery.
An equally important lesson is that detection and reporting of SAEs need added encouragement to assure that the spectrum of serious post?treatment adverse experiences is recorded and that the safety profile of Mectizan is regularly documented and reinforced.
Etienne Barathon Takes Over Mectizan Shipping Responsibilities
Etienne Barathon is the new Mectizan Coordinator in the Merck Export Department, based in Riom, France. He processes orders, oversees transportation, and handles the customs operations involved in shipping Mectizan to endemic countries. Consignments of millions of tablets are exported each month from the Merck plant in Riom to countries in Africa, Latin America, and the Middle East.
An international trade graduate from Lille, France, Etienne had several years of experience in African and Latin American countries during his nine years as the Export Customer Service Supervisor for Merck. Prior to his employment at Merck, Etienne was with the Xerox Corporation in the north of France as the supervisor of international transit and customs.
Dr. Ken Brown Retires from Merck & Co., Inc.
Dr. Ken Brown retired from Merck & Co., Inc. on June 1, 1998. Dr. Brown, a physician who specializes in tropical medicine, was one of the three original liaison members on the Mectizan Expert Committee when it was organized in 1988. Dr. Bill Foege observes, “He was the expert on technical information, clinical use, safety, stability, disease manifestations and clinical protocols. But he was also familiar with field problems because of his past experience working in Africa. The committee will miss his openness, his integrity, his ability to see the big picture and his role as ‘conscience.’ He has set an impressive gold standard for global health workers.”
New Program Assistant Named
Joni Lawrence is the new Program Assistant for the Mectizan Donation Program. She began work in May 1998, having worked in a similar capacity for the Carter Center's Global 2000 River Blindness Program. Her everyday tasks vary and best fit her own description of "assisting the program however I can."
With an undergraduate degree in political science and ongoing work toward a Masters in Public Health at Emory University, Joni is pursuing her goal of a career in the field of international health. She is grateful for her experience in learning how a public/private partnership operates on a global scale. "Merck's generosity has resulted in improving the lives of millions of people, and I'm excited to be a part of it," Joni says, adding, "I think Merck has set a great example in corporate philanthropy. I'm glad to see that other pharmaceutical companies are beginning to follow it."
Three Members Named to the Mectizan Expert Committee
Three new members, serving overlapping terms of two and three years, have agreed to serve on the Mectizan Expert Committee. Their combined experience in the areas of administration, field direction, medicine and policy is impressive.
An original member of the Mectizan Expert Committee, on which he served an extended term, Dr. Adetokunbo Lucas returns ten years later to be a member of the committee. Dr. Lucas, a Nigerian, has a wealth of experience. He has worked with WHO as the Director of Tropical Disease Research and also has taught at the Harvard School of Public Health. He will be a solid advisor both in policy and science.
Ms. Catherine Cross, who is British, is the Director of the Overseas Programme Department of Sight Savers International, which has sponsored Mectizan programmes in Cameroon, Ghana, Guinea, Mali, Nigeria, Sierra Leone, Tanzania, and Uganda. Her broad experience as an administrator and manager will be invaluable to the committee.
Dr. Tony Ukety, an ophthalmic surgeon, is a citizen of the Democratic Republic of Congo, the former Zaire. Working with the Center of Medical Evangelism and under the support of the Christoffel-BlindenMission (CBM), he has been director of a Mectizan treatment programme since 1991. CBM supports treatment programs in Central African Republic, Democratic Republic of Congo, Nigeria, Tanzania, and Uganda. Dr. Ukety will provide the committee with a broad understanding of field program development and supervision.