Adverse_Event_Action_Guide_FINAL.pdf

Adverse Event Action Guide For Voluntary Medical Male Circumcision (VMMC) by Surgery or Device

2nd Edition, Updated November 2018 ii

ACKNOWLEDGMENTS

This guide is the result of collaborative work between Population Services International (PSI) and the College of Surgeons of East, Central and Southern Africa (COSECSA) together with contributions from numerous clinical and public health experts. The U.S. Centers for Disease Control and Prevention (CDC) provided technical input throughout the development of this document. The following people contributed to the writing and production of the guide:

• Dr. Renee Ridzon (consultant to CDC)

• Dr. Stephanie Davis (Medical Epidemiologist, CDC)

• Dr. Dino Rech (Co-CEO, Centre for HIV and AIDS Prevention Studies [CHAPS])

• Mr. Christopher Samkange (Director, Continuing Health Education, University of Zimbabwe, COSECSA-ASEA)

• Dr. Karin Hatzold (Global Deputy Director HIV Clinical and Biomedical Interventions, PSI)

• Dr. Jonas Hines (Medical Epidemiologist, CDC)

The authors would like to acknowledge the contribution of:

Professor Milliard Derbew, President, College of Surgeons of East, Central and Southern Africa (COSECSA) and Chair of Paediatric Surgery Addis Ababa University; Professor Mohammed Labib, COSECSA and Professor of Urology, Namibia Medical School; Petra Stankard, Senior Technical Advisor HIV/TB, PSI; Jonathan Grund, Health Scientist, CDC; for their invaluable feedback and timely reviews; the clinical staff from Society for Family Health (SFH), CHAPS South Africa, PSI/Swaziland, PSI/Zimbabwe, and SFH/Zambia for their willingness to field test this guide and provide feedback.

Special thanks go to the participants at the World Health Organization (WHO) Expert Consultation on the Male Circumcision Adverse Event Action Guide for their contributions to this document:

Julia Samuelson, WHO; Timothy Farley, WHO/ Sigma3 Services; Elijah Odoyo-June, CDC; Timothy Hargreave, Consultant; Naomi Bock, CDC

ONLINE ACCESS

An electronic version of this guide is available on the Clearinghouse on Male Circumcision for HIV Prevention: http://www.malecircumcision.org http://www.malecircumcision.org/ iii

TABLE OF CONTENTS

ACKNOWLEDGMENTS .......................................................................................................................................................................................................... ii

SECTION 1. INTRODUCTION TO THE ADVERSE EVENT ACTION GUIDE

Organization of this Guide

SECTION 2. ADVERSE EVENT DEFINITION, CLASSIFICATION AND REPORTING

Adverse Event Definitions

Overview of Adverse Event Identification, Management and Reporting

SECTION 3. TREATMENT GUIDELINES FOR ADVERSE EVENTS IN MALE CIRCUMCISION

Excessive Bleeding

Infection

Tetanus

Wound Disruption

Pain

Scarring/Disfigurement, Torsion of Penis, Insufficient Skin Removal, Excessive Skin Removal

Injury to Penis (including glans injury and fistula)

Other Adverse Events: Excess Swelling of Penis/Scrotum Including Haematoma, Problem with Voiding (Urinating), Other

Sexual Difficulties or Effects/Undesirable Sensory Changes

Device Displacement

Anaesthesia-Related Events

Emergency Management

Occupational Exposure

Safe Injection Technique iv

SECTION 4. APPENDICES

Appendix 1: Adverse Event Recording and Reporting

Appendix 2: Adverse Event Timing

Appendix 3: Adverse Event Classifications and Definitions: During Surgery or Prior to Discharge from VMMC Clinic, or During Device Placement or Wearing

Appendix 4: Adverse Event Classifications and Definitions: Post-Operative Period After Discharge from VMMC Clinic or During or After Device Removal

Appendix 5: Anaesthetic Dosing

Appendix 6: Algorithm for Prevention and Management of Acute Bleeding During and Immediately After MC, by MC Providers

Appendix 7: Algorithm for Management of Bleeding After MC, by Non-MC Providers

Appendix 8: Job Aid for Management of Glans Amputations

Appendix 9: Algorithm for Management of Penile Haematoma

Appendix 10: VMMC Emergency Medical Supplies, Equipment and Medicines

SECTION 1. INTRODUCTION TO THE ADVERSE EVENT ACTION GUIDE

Purpose The purpose of this Adverse Event (AE) Action Guide is to:

• Reduce the incidence of AEs in medical male circumcision (MC) by providing guidance on how to avoid them

• Improve the outcomes of AEs associated with both surgical and device-related MC, by providing guidance on safe and appropriate management

• Facilitate standardized reporting of AEs

• Support monitoring of the quality of programmes and safety of voluntary medical male circumcision (VMMC) programme services

Audience This guide is appropriate for any programme implementing MC under local anaesthesia in adolescent and adult males as part of a comprehensive HIV prevention strategy. Although this guide has been prepared for programmes supported by the US President’s Emergency Plan for AIDS Relief (PEPFAR), it is hoped that it will be useful to providers in all VMMC programmes, as well as those who conduct post-operative reviews of clients but may not be trained to provide the MC procedures themselves.

Updates in the Second Edition This document has been updated from the initial version, primarily to include definitions and management of AEs associated with WHO-prequalified MC devices, as well as to provide other updates based on additional VMMC implementation experience, including AE reporting to WHO and to PEPFAR through the Notifiable Adverse Event reporting system. These updates include:

• Definitions for PrePex and ShangRing device-related AEs, the only two WHO-prequalified devices at the time of writing, including an additional device-specific AE: Device Displacement

• Timing scheme for device-related AEs

• Infection chapter expanded to include tetanus and serious necrotising infection

• Reference to WHO recommendations regarding the risk of tetanus with use of the PrePex device

• Additional guidance on the prevention and management of bleeding and additional discussion on bleeding disorders

• Additional guidance on infection control through safe injection techniques and avoidance of contamination through use of multi-dose vials

• Renaming of AE “Sexual difficulties or complications/undesirable sensory changes” to “Sexual difficulties or effects/undesirable sensory changes”

• Local anaesthetic dosing charts simplified and modified to include suggested starting doses; volumes of both starting and maximum doses are limited based on syringe size

• Bupivacaine can be used with lidocaine in VMMC clients of all ages

• Additional detail on policies and responsibilities for reporting AEs

• Inclusion of references to pertinent updated guidelines (such as for postexposure prophylaxis) and other documents

• Additional material added including an AE definition chart, algorithms for management of bleeding and haematomas, AE timing chart, anaesthetic dosing charts, and recommended emergency management supplies

• Charts within the text of the guide and as appendices that can be used to produce full colour job aids

• Addition of colour-coding to the AE charts, with yellow, pink, and orange denoting surgery, devices, and surgery and devices, respectively

Organization of this Guide

Reading the entire guide will result in the best understanding of classification, management and reporting of AEs. Throughout this guide, the phrase ‘male circumcision’ or ‘MC’ is used to denote the procedure of removal of the foreskin, and the phrase ‘voluntary medical male circumcision’ or ‘VMMC’ refers to the programme providing circumcision services for HIV prevention.

Section 1 is this introduction.

Section 2 gives key background information about AEs, including criteria for classifying severity (mild, moderate or severe) and timing of AEs for both surgery and device circumcisions; an overview of the process of AE identification, management and reporting; and PEPFAR-specific reporting requirements.

Section 3 gives detailed diagnosis and management information for each specific AE type. It will likely be of most interest to providers who manage AEs, and they should familiarize themselves with these definitions and management principles prior to providing care to VMMC clients.

Each AE type has a separate chapter, which begins with general information and considerations for that AE type, including a section on “additional and special considerations for devices”. This is followed by charts providing definitions and specific management for first surgical and then device methods. In some cases, these are identical, and in others they differ.

Section 4 consists of appendices that can be used as job aids, including a guide to abbreviated AE coding, condensed charts listing diagnostic criteria for all AE types, a list of recommended emergency supplies for sites performing MC, flow charts for management of bleeding or haematomas, and anaesthetic dosing charts.

SECTION 2. ADVERSE EVENT DEFINITION, CLASSIFICATION AND REPORTING

General definition for AEs related to MC: Any injury, harm or undesired outcome that occurred during or following the male circumcision procedure that would not have occurred if the client had not undergone the procedure. This includes not only events related to any error in screening, performance, or follow-up of the procedure, but those in which no error occurred.

AEs are inevitable with an intervention such as MC, and occurrence of an AE does not automatically imply provider error or fault. Nonetheless, much can be done to reduce the risk and severity of AEs, including:

• Use of proper supplies

• Use of instruments that are in good working order

• Correct cleaning and sterilization of instruments

• Proper training of providers and retraining as needed

• Emergency supplies on site with periodic emergency training

• Early recognition of and follow-up of clients with AEs

• Correct management of AEs

• Documentation of AEs

• Evaluation of ae data and institution of changes and corrections to programmes and policies as indicated

• Policies empowering all staff to alert an appropriate above-site party of practices that could lead to AEs (such as use of the forceps-guided circumcision technique in adolescents under 15 years), without fear of untoward ramifications

Adverse Event Definitions AE definitions used in this guide are based on those in the PEPFAR Monitoring, Evaluation and Reporting (MER) Indicator Guidance. Because the majority of VMMC programmes are PEPFAR-funded, discussions of reporting in this guide also include PEPFAR reporting requirements.

Other definitions have been in used in some settings, and some ministries of health may require providers to use different definitions in reporting.

AE classification has three common components: type, severity and timing. Severity and timing are defined here, and types are explained in detail in the management section. AE relatedness to MC is a fourth component that is primarily important in AE investigation and monitoring, and discussed on p.11.

In most cases, classification and definitions for surgical and device-related AEs are the same or quite similar. However, in some cases there are differences due to technique and mechanisms of action.

Adverse Event Severity AEs have been classified into three categories of severity: mild, moderate, and severe.

• Mild classification indicates minimal or no intervention is required beyond reassurance and observation

• Moderate classification relates to those AEs that are neither mild nor severe, require intervention, and are usually managed on site

• Severe classification requires extensive intervention with referral or specialist input

Moderate and severe AEs are those that in the past PEPFAR has required be reported and monitored. AEs are no longer a required reporting indicator for PEPFAR MER, but moderate and severe AEs should still be the AEs of greatest interest to national reporting systems.

As VMMC programs expand into more remote areas where health care facilities have limited capacity, increasing numbers of males are presenting with AEs to facilities that are unable to provide care for mild and moderate AEs. Transfers necessitated by this situation should not automatically result in a "severe" classification: severity should instead be determined based on clinical characteristics of the AE and level of intervention required as recommended in this guide. Similarly, hospital admissions necessitated only by distance or social considerations rather than the level of care needed should not result in an automatic 'severe' classification.

This recommendation applies to device-based MCs as well: if a client presenting with an otherwise moderate AE is transferred because the site to which he presented cannot provide appropriate care (e.g. suture materials are not stocked or staff are not trained in suturing), the transfer itself does not constitute a severe AE criterion. Surgical intervention for device AEs, including circumcision, remains a criterion for severe AE.

Adverse Event Timing For MCs performed surgically, AEs are classified by their timing in relation to surgery as follows:

• A = intra-operative (AE occurs during surgery or prior to discharge from clinic)

• B = post-operative (AE occurs 1–6 days after surgery and discharge from clinic)

• C = post-operative (AE occurs ≥7 days after surgery and discharge from clinic)

For MCs performed using devices that remain in situ, AEs are classified as follows:

• A1 = during placement of PrePex or ShangRing device

• A2 = after device placement and before removal (these AEs typically occur 1–6 days post-placement)

• B = during device removal

• C = after device removal (typically after day 7)

• If a device is displaced or removed early:

o This should be classified as Device Displacement in the A2 period o However, complications or AEs after removal of the device should be classified as C, even though the device was removed early.

This chart and a list of AE definitions are included as Appendices 2, 3 and 4.

In the diagnosis and management charts in this guide, device AEs occurring in time period A1 are addressed in the intra-operative charts, and those occurring in periods A2, B, and C are addressed in the post-operative charts. For example, pain that occurs during device removal (B) is found in the post-operative, not intra-operative, chart.

AE timing is classified by when the first AE occurs. For example, if a client presents 8 days after surgery with an AE but gives a history of onset at day 6, timing would be classified as B, not C. The exception is injury to the penis, where the AE should be classified by when it was noted, since management can depend on how much time has passed since circumcision.

By the nature of their natural history, not all AEs can occur at all time points. For example, scarring can only be classified as C since it cannot occur at the time of the procedure and cannot be identified in the first week after surgery, since seven days is insufficient time for scar formation.

AEs sometimes occur together and can be related (for example, wound disruption may result from wound infection). Each AE noted should be recorded as a separate diagnosis (wound infection with disruption would be recorded as 2 AEs), and the presence of one AE may affect treatment for another (e.g., wound disruption should not be closed while untreated infection is present).

With many AEs, documentation by photographs is very helpful in classification and monitoring progress and treatment. When photographs are obtained, client/guardian permission should or must be obtained, depending on the policy or preferences of national programmes. Permission may be written or verbal, also depending on policy or preferences of national programmes. In this guide, chapters on specific AEs indicate where repeated photographs may be particularly helpful.

Adverse event relatedness AEs can also be categorized with regard to relatedness to the procedure. This is most often done during an investigation process for a serious AE, rather than in routine diagnosis of common AEs. During this process, the assessed degree of relatedness to the procedure may change as new information is obtained. Relatedness does not impact management of an AE.

An AE is considered related to the procedure if it would not have happened had the procedure not been performed. This does not necessarily imply any error or wrongdoing on the part of the provider. For example, infection of the circumcision wound as a result of applying a traditional remedy, or displacement of a device due to sexual activity, are considered definitely related to the procedure, even though the clients did not follow instructions, as neither would have occurred had there not been MC. Neither, however, occurred because of provider error.

Regardless of being determined to be related to MC or not, all AEs should be recorded and reported, even when the AE seems to be completely unrelated (e.g., client involved in a road traffic accident 3 days after operation).

Relatedness can be classified as:

• Definitely related: Direct association with the procedure, i.e., follows a reasonable temporal sequence from the procedure and is a recognized AE of the procedure.

• Likely/Possibly related: More likely explained by the procedure, i.e., follows a reasonable temporal sequence from the procedure and is a plausible AE of the procedure, but could have another cause.

• Likely unrelated: More likely explained by other cause.

• Definitely unrelated: Clearly explained by other cause.

Overview of Adverse Event Identification, Management and Reporting In general, identification and management of an AE follows the time course depicted below.

1. Identification: The AE may be revealed by the client or discovered by the provider during surgery, during the post-operative observation period, or at a subsequent visit. The health care worker providing care should first identify and classify the AE. As many people own cell phones with the capability of taking and sending photographs, providers may find it helpful to have clients send photos when they call with complaints or with reports of progress. While cell phone communication and photos about healing during the post-operative period are acceptable and can be used for monitoring, all initial AE identification and treatment must be conducted through direct observation by a clinician. A list of the various types of MC-related AEs, as well as definitions of the respective severity levels, can be found in Section 2.

2. Treatment: Once the AE is identified and classified, the provider is encouraged to follow the treatment guidelines in this document. The management of AEs described in this guide constitutes the basic standard of care. Where there are national protocols with enhanced standards of care, these should be used.

a. Please note that the medications mentioned in this guide, specifically antibiotics, are given as examples. Local availability, drug resistance patterns, and national treatment protocols may vary. Thus, national programmes should adapt this guidance accordingly.

b. In most cases, management of surgical and device-related AEs is the same or similar. However, with device-related AEs, management may also include early removal of the device and/or performance of a surgical circumcision, based on clinical judgement.

3. Referral, if necessary: Referral to another health facility or provider (e.g., specialist doctor) may be necessary. Providers are advised to refer clients or request help with every AE that they do not feel comfortable with or capable of managing according to the treatment guidelines provided, even if the site of care is in theory equipped to handle the AE. Even when admission to a higher level of care is not called for in the management of the AE per se, consideration should be given to the travel conditions and distance required for return visits to the local site;

sometimes transfer and admission may be needed to assure client safety and follow-up, even if not strictly medically required. Ensuring successful referrals depends on adequate planning beforehand. VMMC service delivery points should have a readily-available, up-to-date contact list of sites and appropriate specialists to which referrals can be made at any time the need arises. This list should be checked every six months to make sure that it is up to date. These providers and sites should be aware of the possibility of MC clients being referred for assistance.

Identification Treatment Referral, if necessary Reporting Follow-Up

4. Reporting: Proper reporting is important so that providers can follow-up with the client as necessary, and managers and providers can monitor the quality and safety of a programme and take actions to improve client care. Reporting should follow nationally prescribed reporting pathways and protocols. Providers and other clinic staff need to understand and follow these protocols. Site and programme managers must understand how and when to report AEs and when to inform external stakeholders. PEPFAR-funded programmes are no longer required to report all moderate and severe AEs to PEPFAR, but are still required to follow the PEPFAR Reporting Protocol for MC Client Death and Notifiable Events (see next section), and should follow any additional reporting guidance provided by national programmes and by their funding agency’s in-country VMMC staff.

5. Follow-up: Routine follow-up ensures that clients receive sufficient care after circumcision. Providers and site managers should ensure that clients are well-informed about the importance of routine follow-up visits and when they are expected, as well as the importance of specific and additional follow-up visits when an AE has occurred. Clients with a documented AE who default on follow-up appointments should be contacted by telephone or any other appropriate means. An enquiry should be made as to their current status as well as actively encouraging them to present for follow-up review.

Reporting and Monitoring Adverse Events Reporting AEs involves passing summary information about AE rates and/or notifiable individual AEs up through designated channels to programme and/or ministry of health leadership. Monitoring can be done at any level and involves reviewing and analysing these data for trends and concerning findings.

Adverse event reporting Reports of AEs provide data necessary to conduct monitoring of service delivery, safety, programme progress and patient outcomes. AEs should be reported according to national ministry of health guidelines if present, and regardless, programmes should continue internal AE reporting for quality control. Reporting systems should include clear guidance on:

• The severity threshold for AE reporting. Historically, PEPFAR programmes have been required to report all moderate and severe AEs. This routine reporting is no longer required. However, “moderate and severe” can still be a useful threshold for reporting.

• Standard AE definitions to be used, such as the standard definitions provided in this guide. This document recommends the use of AE definitions originally provided by PEPFAR for AE reporting, but some ministries of health may require programmes to report using different AE definitions.

• Reporting methods and timing.

• The expectation that AE’s should be reported regardless of the appearance of relatedness; follow-up investigations as needed will make the final determination of relatedness.

There is a subset of severe AEs for which reporting is also expected to external stakeholders such as donors, WHO, or technical advisory groups.

WHO requests reporting on serious AEs, including deaths; hospital admissions to intensive care within 30 days of an MC; tetanus cases within 30 days of an MC; and serious glans, penile or urethral injuries. National ministry of health reporting structures should include this step at some level.

Similarly, programmes for which PEPFAR provides direct service delivery support are still required to rapidly report specific notifiable AEs through a separate PEPFAR process, under the PEPFAR Protocol for VMMC Client Death and Notifiable Adverse Events. The most recent version of this protocol should be followed, under the direction of the in-country VMMC staff of the funding agency. The protocol includes information on processes to ensure that appropriate parties at the country and headquarters levels are rapidly notified of any client deaths or notifiable AE, including:

• Complete or partial amputation of the glans or shaft of the penis

• Tetanus, including non-fatal cases

• Any AE that results in disability that is likely permanent

• Any AE that results in anatomic deformity that is likely permanent

• Any AE that results in hospital admission for ≥3 days

This protocol applies to any death or notifiable AE(s) that occurs during the MC procedure or within 30 days following surgical circumcision or device removal, for any male, regardless of age, who was circumcised through services or research directly funded by PEPFAR. If there is any evidence that a death or notifiable AE occurring after the 30-day post-MC mandatory reporting period is related to the MC, this should also be reported. The list of reportable AE types may change in the future, and providers at PEPFAR-supported sites should be aware of the up-to-date requirement for AEs that need to be rapidly reported.

This reporting requirement does not apply for programmes receiving only technical assistance from PEPFAR. However, programmes and ministries of health are encouraged to require that all deaths and notifiable AEs be reported to them regardless of funding source, to enable more complete reporting from all service delivery points.

Admissions to a hospital for ≥3 days to provide care for mild and moderate AEs that are necessitated by the non-medical circumstances of the client, such as limited capacity at health care facilities near clients’ home and far distances between clients’ homes and health care facilities, should not be reported as a notifiable AE.

Implementing organizations and ministries of health should have processes in place by which providers and other staff can alert the organization (at above-site level), the funding agency, and/or the ministry of health to improper conduct that has led or could lead to AEs, such as use of forceps-guided technique in those under 15 years of age. These processes and accompanying policies should ensure there are no untoward ramifications for submitting such alerts. Field staff should be urged to use these processes whenever unsafe practices are observed.

Adverse event monitoring and investigation Regular monitoring of reported AE data provides the necessary insight for quality assurance and improvement. All programmes should monitor the number of VMMC clients experiencing AEs as a way of measuring safety and the quality of service provision. Reports are used to calculate AE rates and, as with definitions and reporting methods, calculations of AE rates should be done using defined formulae. One such formula is:

Number of clients with at least one AE in a given time period / Number of clients with at least one post-MC follow-up visit in the same period

An AE rate above ‘an acceptable level’ (often considered 2% for moderate and severe AEs combined) is an indication of the need for investigation into causes of AEs and possible corrective interventions. Conversely, extremely low AE rates (near 0%) may suggest problems in the monitoring and reporting systems, such as poor follow-up rates, failure to recognize AEs, or incorrect classification of AEs. Monitoring should be conducted at multiple levels (e.g., site, region, implementing partner), so that comparisons can be made. Such comparisons allow recognition of possible problems with specific sites, regions, implementing partners, or an entire national programme, so that any needed improvements can be made at the appropriate level.

For PEPFAR-supported programmes, PEPFAR participates in investigation of reported notifiable AEs. For all programmes, it is recommended that ministries of health and/or programmes direct such investigations for all instances of severe AEs, AE clusters or high AE rates. These should include classifying AEs by relatedness to MC.

Determining reporting responsibilities In cases where multiple providers or sites are involved in a client’s care, confusion can arise over who is responsible for reporting AEs. Examples would be: a client with an AE presents to the site where the procedure was performed, but requires referral to another site for management of the AE, and because of concerns about duplicate reporting, neither site reports the AE; or, a client with an AE presents to a different site from where the MC was performed, and this site is concerned about inflating its own AE rate by reporting the AE. It is important to have a single, clear policy that governs reporting responsibility. Below is an example of a possible policy. Programmes may choose to adopt some or all of the elements of the example in their policies. Regardless of the details of the policy, national programmes and implementing partners need to collaborate to develop policies for reporting of AEs that:

• ensure that all reportable AEs are reported to the national programme

• define proper reporting channels and responsibilities for reporting

• avoid duplicate reporting

• provide education on proper management, referral and reporting of AEs to all sites where men with MC-related AEs may present

Example of a policy for reporting MC-related AEs:

• When one provider performs a MC and another provider at the same site diagnoses an AE, the provider diagnosing the AE should document it and ensure it will be reported.

• When an AE is diagnosed at the site where the MC was performed, that site should report the AE, regardless of whether the client is then transferred elsewhere for care.

• When an AE is diagnosed at a site that did not perform the MC (and possibly does not perform MCs at all), as may be common in the case of campaigns or mobile services, the site that performed the MC should be notified, and it should document and report the AE. To ensure this is implemented correctly, VMMC sites should educate health posts and clinics in their catchment areas about the need to contact the MC provider in the event that a recently circumcised client presents with an AE.

• This policy requires that sites performing MCs have a standard procedure for ensuring that when one of their MC clients is diagnosed with an AE at another site and they are notified, the MC site staff reliably document the AE in the client’s MC chart and report it.

• Providers at all VMMC sites sharing a catchment area (and ideally, nationally) should have a common understanding of where reporting responsibility lies, to avoid duplicate- and non-reporting.

Resources

• Slide show: An overview of AE reporting, including purpose, rationale, characteristics of the PEPFAR notifiable AE reporting system, and introduction to the 2nd edition of the AE Guide: https://project-iq-resources.jhpiego.org/download/6865/

• Slide show: An example of an investigation of a cluster of infections following VMMC in Zimbabwe: https://project-iq-resources.jhpiego.org/download/6861/ https://project-iq-resources.jhpiego.org/download/6865/ https://project-iq-resources.jhpiego.org/download/6861/ https://project-iq-resources.jhpiego.org/download/6861/

SECTION 3. TREATMENT GUIDELINES FOR ADVERSE EVENTS IN MALE

CIRCUMCISION

General Information

• Depending on level of training, knowledge and experience, providers will differ in surgical and AE management skills. Management of some

AEs, especially those that are severe, requires an experienced provider. Depending on the AE and the management required, different provider skills may be needed. For example, severe injury to the penis may require management by a plastic surgeon, a complex fistula by a urologist, and tetanus by a physician skilled in intensive care. When it is recommended that an AE be managed by an experienced provider, the provider should be familiar and comfortable with the methods and skills required for managing the client’s AE(s). Depending on the type of facility and its staffing, there may or may not be providers with the requisite skills present. In stand-alone facilities and those associated with primary health care facilities, it is likely that providers will NOT have the skills to manage complex or serious AEs and in these instances, clients will require referral. Decisions on whether management should be on site or there should be client referral should be made by the provider in charge at the site, and should follow existing plans for transfer.

• Prior to discharge from the clinic after MC, all clients should be given a contact phone number to call in the event that they experience an AE or have questions.

• In instances of mobile, outreach or campaign services, trained MC providers may not always remain in the area, and clients with AEs may present to local health clinics staffed by providers not trained in MC or surgical techniques. In such situations, it is important that local providers are made aware that MC services have been provided in the community, are given contact information for the VMMC team, and are asked to call when any client recently circumcised presents with an AE.

• When AEs require surgical repair, this repair, like the circumcision procedure itself, should be done under local rather than general anaesthesia when at all possible. General anaesthesia may rarely be necessary, as in the case of prolonged surgery or extensive debridement, but should only be selected when the procedure cannot be safely performed under local anaesthesia.

Excessive Bleeding MC-related bleeding AEs typically occur in the first 72 hours after the procedure. Bleeding-related AEs occurring after 72 hours are often associated with new trauma to the genital area such as early commencement of masturbation or sexual intercourse, a previously unidentified bleeding vessel, or a bleeding disorder.

Bleeding related to MC is classified according to when the excessive bleeding occurs and by the extent and persistence of bleeding:

• Ongoing intra-operative or immediate post-operative bleeding (classified as A for surgery and A1 for devices)

• Post-operative bleeding (classified as B or C for surgery or A2, B or C for devices), though significant bleeding is unlikely after 72 hours

• Bleeding related to device circumcision for PrePex and ShangRing may occur at the time of removal of the device and would be classified accordingly (i.e., as category B)

In clients with bleeding disorders, bleeding during or immediately after surgery is difficult to control, and in the post-op period, it may be prolonged or recurrent. The most common bleeding disorders are von Willebrand disease and haemophilia. Severe forms of these and other bleeding disorders are usually identified during childhood. However, particularly with less severe cases, sometimes bleeding disorders are not identified and are unknown to clients. Because MC may be the first medical procedure that some clients undergo (especially younger clients), it may be the first instance where a previously undiagnosed bleeding disorder becomes apparent.

Before MC, it is important for providers to question each client or, in the case of a minor, their parent or guardian, about whether there is a history of bleeding problems in the client or the family. If there is such a history in the client or family, MC should not be performed under routine conditions. Instead, there should first be consultation with a specialist. Mild or moderate bleeding disorders in the client or family members are not an absolute contraindication to MC. However, the specialist may have specific recommendations, including administering medications before the procedure to reduce the risk of bleeding in these clients. Furthermore, if MC is performed, it should be under tightly controlled conditions with experienced providers in a setting where there is access to blood or clotting factor transfusions.

Similarly, as some bleeding disorders are hereditary, other family members of a client with a suspected or confirmed bleeding disorder could also be affected. Haemophilia is an inherited disorder that is passed from mothers to sons; in clients with suspected or confirmed haemophilia, brothers and cousins related through maternal aunts could also be affected and should not have MC performed until there is assurance that a bleeding disorder is not present. Other kinds of genetic bleeding disorders may have different inheritance patterns, so a thorough screen for any family members with easy bleeding or bruising is necessary, and all male relatives of clients found to have bleeding disorders should also see specialists before circumcision.

Particularly in instances of mobile or campaign services, trained MC providers may not always remain in the area for follow-up, and clients with AEs may present to local health clinics staffed by providers not trained in MC or surgical techniques. Clients with bleeding may be especially vulnerable in such situations. In addition to the general guidance above about ensuring local providers contact the MC team about AEs, local providers also need to be given specific guidance on how manage and refer clients who present with bleeding. Appendix 7 contains a flow chart for management of bleeding that can be distributed to local health care facilities and potentially displayed after VMMC campaigns or mobile services to aid local providers.

It is very important to consider a bleeding disorder in a client with excessive bleeding, even if there is no prior history of this. Even if pre-operative screening was unremarkable, these clients should be asked again about easy bleeding tendencies, as experience has shown that not all clients with known bleeding disorders have reliably reported this before circumcision. Clients with a suspected bleeding disorder should be referred for specialist medical and surgical care. In the global VMMC programme experience, clients who have had serious consequences from bleeding events have often been those with recurrent bleeding episodes and health care visits after MC who were not recognized as having a bleeding disorder. An algorithm for management of excessive bleeding during or immediately after surgery, device placement or removal is included as Appendix 6.

Intra-operative (or prior to discharge from clinic) bleeding or bleeding during device placement or wearing Defined as: Oozing/swelling/haematoma/obvious bleeding during or immediately after initial surgery or during device placement and wearing

Intra-operative bleeding that is difficult to control can be due to a number of reasons.

Look for:

• An unidentified bleeding vessel, commonly occurring in the region of the frenulum. This bleeding can be difficult to stop and is best controlled with ligatures and not diathermy cautery, since the area of the frenulum and the underlying urethra is vulnerable to cautery-related burns and subsequent fistula development.

• Caution: If the identified bleeding area is in the vicinity of the urethra/frenulum, take care not to place the haemostatic sutures too deep, since there is a risk of penetrating the underlying urethra with the sutures, possibly causing a future urethral stricture or fistula.

• If a haematoma has started to form or if there is extravasation of blood into the tissue, the source of bleeding can be difficult to identify. This situation is often associated with a cut blood vessel that has retracted from the plane of the incision, or overly deep dissection with the scalpel blade or dissecting scissors into the highly vascular corpus cavernosa or other deep vascular penile tissue.

• An expanding haematoma is a sign of ongoing bleeding and should be managed as with other acute bleeding.

Excessive bleeding during surgery or immediately thereafter may increase the risk for subsequent wound infection, as bacteria easily reproduce in a hematoma; close follow-up may be needed (e.g., visits at day 2 and day 4 or 5) to ensure that an infection does not develop.

Additional and special considerations for devices With devices, control of bleeding should be managed in the same manner as with surgery. If bleeding occurs when the device is in place and is not easily controlled, the device may need to be removed to identify the source of the bleeding with surgical intervention to complete the circumcision and achieve haemostasis.

PrePex

• Bleeding with placement should not occur as there is no cutting of live tissue

• Bleeding at the time of removal is usually minimal, but can require pressure or, on occasion, placement of sutures for haemostasis

ShangRing Because foreskin is removed at the time of placement, bleeding can occur with device placement if the ring is not placed properly to attain haemostasis, or if the device becomes displaced. In these instances, bleeding needs to be controlled and removal of the device, investigation for cause of bleeding, and placement of sutures will likely be needed.

The Algorithm for Management of Acute Bleeding after MC (below and Appendix 6) may be used for evaluation and management of bleeding during or immediately following MC. This algorithm can be adopted as needed by programmes and can be displayed in operating theatres.

In all cases:

• Stay calm and remember that it is almost always possible to control bleeding with manual pressure onto a gauze swab over the area of bleeding. In cases of severe bleeding it may be necessary to wrap gauze around the penis and to apply manual pressure to the whole circumference of the penis. This technique can be maintained for as long as necessary, for example, while thinking about next steps or calling for assistance, or even during transfer of the client.

• Reassure the client.

• Monitor the client’s blood pressure and heart rate for any signs of shock (heart rate more than 100 beats per minute, decrease in systolic blood pressure to less than 100 mm Hg).

o Note: Blood pressure may remain normal despite significant blood loss; a fall in blood pressure in a young person often occurs late and is an indication of massive blood loss.

Additional treatments to consider when a bleeding disorder is suspected:

Providers should be aware of several treatments that might be considered when a bleeding disorder is suspected in a VMMC client. Providers might have the opportunity to administer one of these medicines, or clients might receive these medicines when referred to a specialist.

• Antifibrinolytic medications such as tranexamic acid and aminocaproic acid, work by preventing blood clot breakdown at the site of bleeding.

These drugs are easy to use, safe, and work for most bleeding disorders. These medicines are often all that is needed to completely stop bleeding in a client with a bleeding disorder; if they are not, they can temporarily reduce the intensity of bleeding to enable to the provider to make unhurried decisions about the next steps for the client. The only time it is not safe to use these medicines is if a person has a pre-existing blood clot, a highly unlikely situation in a typically healthy man undergoing VMMC. Oral, intravenous, and topical formulations exist.

The oral formulation is very inexpensive. The IV formulation is on the WHO Essential Medicines List because it can be lifesaving in the event of massive bleeding. These medicines are safe to use in combination with the other medicines described below, with the exception of blood clotting factors.

• Desmopressin (aka DDAVP) works by stimulating platelets. It is easy to use, safe, and works for mild von Willebrand disease and Haemophilia A. It is given orally and is also on the WHO Essential Medicines List.

• Fibrin sealants (aka fibrin glue) work by stimulating the final stage of the clotting cascade at the site of bleeding. They are effective in all types of bleeding disorders. These medicines are applied like an epoxy glue, using a two-syringe system to administer the components to the site of bleeding. Once they are combined, the clot forms in seconds. These medicines should never be given intravenously. While the cost may be high, these medicines are relatively cheap compared to clotting factor replacements that may be needed to stop bleeding in someone with a severe bleeding disorder. Another drawback to these medicines is they are freeze chain-dependent for transportation and storage. A group of similar medicines are thrombin sealants, which also work by stimulating clot formation at the site of bleeding. Thrombin sealant derived from a bovine (cow) source can lead to development of a secondary bleeding disorder (called factor inhibitor) and are no longer recommended.

• Lastly, a host of blood products might be used for someone with excessive bleeding. Red blood cells (RBCs) are given if the person has lost a lot of blood and becomes anaemic, regardless of whether a bleeding disorder is suspected. Platelets are given if a lab test (i.e., blood count) shows that the concentration of these cells is low. Blood clotting proteins (called factors) can be provided using blood serum components like fresh frozen plasma or cryoprecipitate, if clients with excessive bleeding are suspected of having a bleeding disorders caused by lack of these factors. Concentrations of specific blood clotting factors (e.g. FEIBA, NovoSeven) are also sometimes used for this when a client has a known deficiency of a specific factor, but can be difficult to obtain, are very expensive, and should not be used in combination with antifibrinolytic medications (because of risk of causing a blood clot).

Resources

• Job Aid: VMMC pre-screening questions to ask to detect clients at risk of excessive bleeding: https://project-iq-resources.jhpiego.org/resource/provider-verbal-pre-screening-questions-for-voluntary-medical-male-circumcision/

• Slide show: Overview of detection and management of excessive bleeding: https://project-iq-resources.jhpiego.org/download/7315/

• Slide show: Presentation and management of an excessive bleeding case in Mozambique: https://project-iq-resources.jhpiego.org/download/7309/

• Slide show: presentation and management of an excessive bleeding case in South Africa, and an overview of excessive bleeding:

https://project-iq-resources.jhpiego.org/download/6863/ https://project-iq-resources.jhpiego.org/resource/provider-verbal-pre-screening-questions-for-voluntary-medical-male-circumcision/ https://project-iq-resources.jhpiego.org/resource/provider-verbal-pre-screening-questions-for-voluntary-medical-male-circumcision/ https://project-iq-resources.jhpiego.org/download/7315/ https://project-iq-resources.jhpiego.org/download/7309/ https://project-iq-resources.jhpiego.org/download/7309/ https://project-iq-resources.jhpiego.org/download/6863/

Algorithm for Prevention and Management of Acute Bleeding During and After MC

ADVERSE EVENT MILD MODERATE SEVERE

Excessive Bleeding Intra-operative or prior to discharge from clinic

Surgery

A-BL: Intra-operative bleeding that is more significant than usual or post-operative spotting of the bandage with blood; both easily controlled.

A-BL: Intra-operative bleeding or bleeding that occurs prior to discharge that requires a pressure dressing to control, or that requires additional skin sutures without surgical re-exploration of the wound.

A-BL: Intra-operative bleeding requiring blood transfusion, transfer to another facility, or hospitalization; or post-operative bleeding that requires surgical re-exploration, hospitalization, or transfer to another facility.

Excessive Bleeding During device placement or wearing

Device

A1/A2-BL: Bleeding during placement that is more significant than usual or spotting of the bandage or clothing with blood; both easily controlled.

A1/A2-BL: Bleeding during placement that requires a pressure dressing to control without surgical re-exploration of the wound or removal of the device.

A1/A2-BL: Bleeding during placement that requires blood transfusion, transfer to another facility, or hospitalization; or bleeding that requires surgical exploration, removal of device, placement of sutures, hospitalization, or transfer to another facility.

TREATMENT

FOR SURGERY

• Apply pressure manually with gauze swab and maintain for 5 minutes. Use a clock to measure the time and do not lift gauze to check until time is done.

• Gently remove swab. If bleeding has stopped, reapply the wound dressing.

• If bleeding continues, this is a moderate

AE.

FOR DEVICE

• Apply pressure manually while taking care not to move or displace device and maintain for 5 minutes.

• If bleeding continues, this is a moderate

AE.

FOR SURGERY

• Apply pressure manually with gauze swab and maintain for 5 minutes. Use a clock to measure the time and do not lift gauze to check until time is done.

• Gently remove swab and attempt to identify the origin of the bleeding vessel.

• If the wound is closed or partially closed, remove sutures since it is easy to miss a bleeding vessel under a fold of skin.

• Re-administer local anaesthesia if necessary.

• If the bleeding vessel is clearly identifiable, place a suture at that point and tie securely or use electrocautery for haemostasis if the bleeding area is not in the vicinity of the frenulum.

• If the bleeding vessel is not identifiable, under-run the bleeding area by starting at a dry point and insert continuous

FOR SURGERY

• Refer to the higher-level facility.

• Apply manual pressure to control bleeding during transfer of the client.

• Establish intravenous access and administer crystalloid replacement fluids (e.g., sodium chloride) of 1–2 litres.

• Re-exploration of the wound should be performed with good lighting and removal of all sutures so that there can be thorough inspection of the wound.

• If there is excessive bleeding from the frenular artery, an underrunning haemostatic stitch should be used to occlude the artery. Avoid biting too deeply, which can damage the urethra.

• If one or two re-explorations of the wound have failed to identify a…