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Chapter 7: Managing, Monitoring, and Reporting VMMC Adverse Events

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Chapter Goals

Ensuring that staff providing voluntary medical male circumcision (VMMC) in sites supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) can:

  • Screen for, diagnose, and document adverse events (AEs) during and after VMMC surgery
  • Manage clinical AEs
  • Provide appropriate referrals when AEs occur.

What Users Need to Know

To ensure the safety and quality of VMMC service provision, sites or implementing partners must:

  • Have all essential commodities for managing AEs and (if needed) referring clients for management of the most severe AEs.
  • Have sufficient staff trained to provide VMMC services and use VMMC commodities, including equipment for managing AEs. U.S. Government agencies or implementing partners should provide annual assessment of VMMC site readiness.

To ensure the safety and quality of VMMC services, clinical providers must:

  • Screen all VMMC clients for complications during surgery, before discharge, or at follow-up. [See WHO Manual for Male Circumcision Under Local Anaesthesia, 1st edition].
  • Communicate in language appropriate for a layperson to be sure that each client understands the VMMC procedure, post-surgical care, and possible post-surgical problems that may need treatment, and how to obtain treatment. [See VMMC In-Service Communication: Best Practices Guide].
  • Know how to diagnose and manage for AEs. [See Adverse Event Action Guide for Voluntary Medical Male Circumcision by Surgery or Device, 1st Edition, 2016].
  • Document AEs according to type and severity (Table 7.1), and report them to the Ministry of Health and funding agency field office.
  • Immediately report the most severe AEs to the Ministry of Health and the Office of the Global AIDS Coordinator (OGAC). [See PEPFAR Reporting Protocol for VMMC Client Death and Notifiable Adverse Events, Form 1]. Implementing partners should check with their funding agency to ensure they have the current version of the protocol, since it is subject to updates. These six events are rare, but require immediate notification if they occur within 30 days of circumcision: 1) death; 2) partial or complete amputation of the glans or shaft; 3) tetanus (nonfatal); 4) any AE resulting in permanent disability (probable or definite); 5) any AE resulting in permanent anatomic deformity (probable or definite); and 6) any AE resulting in hospitalization > 3 days. Staff should begin the reporting process for any of these events the same day they learn of them.

Six Adverse Events Subject to Immediate Notification Requirements (If Any Occurs During or Within 30 Days of Circumcision)

  1. Death
  2. Partial or complete amputation of the glans or shaft
  3. Tetanus
  4. Any adverse event resulting in permanent disability (definite or probable)
  5. Any adverse events resulting in permanent anatomic deformity (definite or probable)
  6. Any adverse event resulting in hospitalization > 3 days.
  • Site staff should use this form [see PEPFAR Reporting Protocol for VMMC Client Death and Notifiable Adverse Events, Form 1] to initiate the reporting process on the same day that they become aware of any of the six events listed above. Implementing partners should check with their funding agency to ensure they have the current version of the protocol, since it is subject to updates.

Note: Tetanus cases have been identified following VMMC. The World Health Organization (WHO) issued updated information to national VMMC programs to help mitigate tetanus risk. [See Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation, Report of the WHO Technical Advisory Group, 12 August 2016]. Additionally, PEPFAR provided a resource to enable site-level staff to translate national policies on tetanus vaccination and risk mitigation into practice. [See Considerations for PEPFAR-Supported VMMC Programs Incorporating Tetanus Vaccination and Other Risk Mitigation Activities].

Tools, Instruments, and Guidance Documents

  1. Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation, Report of the WHO Technical Advisory Group, 12 August 2016
  2. WHO Manual for Male Circumcision Under Local Anaesthesia, 1st edition
  3. Adverse Event Action Guide for Voluntary Medical Male Circumcision by Surgery or Device, 1st Edition, 2016
  4. PEPFAR Monitoring, Evaluation, and Reporting Indicator Reference Guide
  5. PEPFAR Reporting Protocol for VMMC Client Death and Notifiable Adverse Events, Form 1: Can be obtained by contacting in-country USAID Mission staff.
  6. Considerations for PEPFAR-Supported VMMC Programs Incorporating Tetanus Vaccination and Other Risk Mitigation Activities: To be updated to reflect new WHO tetanus guidance.

To read more about the frequently referenced information, additional information, and to read related case studies download the chapter PDF.

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