Strengthening safety through surveillance: notifiable adverse events in the U.S. President's Emergency Plan for AIDS Relief's voluntary medical male circumcision program through 2020


BACKGROUND: Circumcision reduces males' risk of heterosexual HIV acquisition by ~60%. Since inception, the President's Emergency Plan for AIDS Relief (PEPFAR) has supported over 28 million voluntary medical male circumcisions (VMMCs) in 15 countries. PEPFAR monitors defined adverse events (AEs) occurring within 30 days of VMMC through its Notifiable Adverse Event Reporting System (NAERS). Systematic reporting of deaths started in 2014, expanding to other event types in 2015.
METHODS: Standardized forms are used to report notifiable adverse events (NAEs) which include: death, hospitalization '¥3 days, penile injury, permanent or probable deformity or disability, tetanus, and circumcision device displacement. Detailed case investigations by reviewing physicians further classify diagnoses and determine NAE relatedness to the VMMC procedure. We analyzed NAE reports submitted to PEPFAR since the first ad-hoc report in 2011 through December 2020.
RESULTS: Fourteen countries reported 446 clients with NAEs; 394/446 (88%) were determined VMMC-related, 37/446 (8%) were unrelated, and 15/446 (3%) were unknown. There were 56 deaths reported, 24/56 (43%) were determined VMMC-related with 13/24 (54%) of these from tetanus. The remaining 390 NAEs were non-fatal with 370/390 (95%) VMMC-related. Of clients with a reported NAE, 16/446 (4%) were among infants aged '¤2 months, 5/446 (1%) were among clients aged 2 months-9 years, 236/446 (53%) were among clients aged 10-14 years, 182/446 (41%) were among clients aged '¥15 years, and 7/446 (2%) were of unknown age.
Infection was the most common cause of hospitalization '¥3 days. There were 175 severe non-tetanus infections and 26 cases of tetanus reported. Disability or anatomic deformity was reported for 115 clients, including 40 glans injuries and 51 fistulas. Severe bleeding was reported in 70 clients, with 18 having a secondary infection. There were 4 circumcision device displacements.
CONCLUSIONS: Although it is not possible to completely eliminate all AEs from surgical interventions, surveillance of rare but serious AEs can identify pre-existing or new safety concerns and guide continuous programmatic improvement. Several policy changes including updated guidance on surgical technique, restricting VMMC eligibility to clients '¥15 years old, and improving tetanus prevention practices, were made following analyses of NAERS data to improve program safety.

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