Application and review process

Application and Review Process

Applications for Mectizan for onchocerciasis are reviewed in detail by the Mectizan Expert Committee and Mectizan Donation Program staff. Applications for Mectizan and albendazole for LF elimination are reviewed by the Mectizan Expert Committee and the World Health Organization.

Community-Based Mectizan Mass Treatment Program: Onchocerciasis

Institutions requesting Mectizan for community-based mass treatment programmes must consider a number of technical and administrative matters including:

1. The prevalence and geographic distribution of onchocerciasis based on existing information, recent surveys including Rapid Epidemiological Assessment (REA) and Rapid Epidemiological Mapping of Onchocerciasis (REMO). See Appendix B for further details.

2. An appropriate treatment strategy for the designated population group based on the prevalence of onchocerciasis. The strategy for mass treatment is to administer Mectizan to all eligible people residing in high-risk areas (normally prevalence > 40% measured by skin snip).

3. The geographic distribution and intensity of the infection with Loa loa in areas where both loiasis and onchocerciasis occur.

4. The availability of sufficient programme resources to continue the treatment programme for a minimum of 5 years such as:

· Competent and well-trained staff;
· Transportation;
· Appropriate Mectizan storage facilities;
· Medical supplies to manage post-treatment effects.

5. The selection of Mectizan treatment program staff:

· The Programme Director is responsible for coordinating and overseeing the program and making decisions that assure its success. He or she need not be a physician but should have experience in managing health activities.
· The Medical Supervisor is responsible for assuring that sound medical practices are observed and treatment requirements are followed. He or she need not be physically present at all times but must be readily available for consultation. The Medical Supervisor must be a licensed physician, ideally with experience both in public health and onchocerciasis control. The Medical Supervisor and Programme Director may be the same person.
· The Mectizan Inventory Controller is responsible for managing the storage, security, accountability and distribution of the programme's Mectizan tablets. The Mectizan Inventory Controller need not be a physician.

6. Making plans to inform and gain the support of the community to be treated through appropriate health education and social mobilization activities.

7. Assuring that health workers and community-based drug distributors are trained and competent in such procedures as:

· Registering patients for treatment;
· Identifying patients to be excluded from treatment;
· Determining the correct Mectizan dose based on weight or height;
· Assuring that patients swallow the proper dose of the drug;
· Providing adequate standby medical care for adverse drug experiences after treatment;
· Monitoring for and reporting serious adverse experiences (SAEs).

8. Sustainability and the possible integration of Mectizan treatment programmes with existing primary health care systems or other established health care activities.

Organizing a National Programme to Eliminate Lymphatic Filariasis in an Onchocerciasis Endemic Country

Please refer to the following WHO technical, overview publications for more detailed information on essential programme elements required of a National Programme to Eliminate Lymphatic Filariasis (NPELF):

· “Programme background and overview towards initiating a national programme to eliminate lymphatic filariasis” (WHO/CDS/FIL/99.2);
· “Building partnerships for lymphatic filariasis – Strategic Plan (September 1999)” (WHO/FIL/99.198);
· “Preparing and implementing a national plan to eliminate lymphatic filariasis (in countries where onchocerciasis is co-endemic): A guideline for Programme Managers” (WHO/CDS/CPE/CEE/2000.16).