Clinical Practice Guideline

1 of 10 1.0 Purpose 1.1 To improve and focus efforts to respond to clusters and outbreaks of infectious syphilis and reduce transmission in the Winnipeg Health Region by enhancing treatment options for those who do not have access to appropriate health services and are at risk for undiagnosed and/or untreated infectious syphilis (incubating, primary, secondary, or early latent). 2.0 Scope and Goal 2.1 This clinical practice guideline applies to public health nurses (PHNs) working on the Healthy Sexuality and Harm Reduction team, Population and Public Health Program, Winnipeg Regional Health Authority, who have the competencies to perform these practices. 3.0 Definitions 3.1 Incubating Syphilis: An asymptomatic person with a history of sexual exposure within the past 10-90 days to a partner with a confirmed diagnosis of infectious syphilis; PLUS either a reactive serology (nontreponemal and treponemal); OR at least a four-fold (e.g. 1:8 to 1:32) increase in titre over the last known nontreponemal test. Incubating syphilis is a subset of Early Latent Syphilis (Manitoba Health and Healthy Living, 2007). 3.2 Primary Syphilis: Identification of T. pallidum by PCR or other available laboratory examination of material from a chancre or regional lymph node; OR presence of one or more typical lesions (chancres), and reactive treponemal serology, regardless of nontreponemal test reactivity, in individuals with no previous history of syphilis; OR presence of one or more typical lesions (chancres) and at least a four-fold (e.g. 1:8 to 1:32) increase in titre over the last known nontreponemal test in individuals with a past history of syphilis treatment (Manitoba Health and Healthy Living, 2007). 3.3 Secondary Syphilis: Identification of T. pallidum by PCR or other available laboratory examination of mucocutaneous lesions and condyloma lata OR presence of one or more typical mucocutaneous lesions, alopecia, loss of eyelashes and lateral third of eyebrows, iritis, generalized lymphadenopathy, fever, malaise, or splenomegaly; PLUS either a reactive serology (nontreponemal and treponemal); OR at least a four-fold (e.g.1:8 to 1:32) increase in titre over last known nontreponemal test (Manitoba Health and Healthy Living, 2007). Page 1 of 10

2 of 10 3.4 Early Latent Syphilis: An asymptomatic person with reactive serology (nontreponemal and treponemal) who within the past one year had ONE of the following: 1) non-reactive serology; 2) symptoms suggestive of primary or secondary syphilis; or 3) exposure to a sexual partner with primary, secondary or early latent syphilis (Manitoba Health and Healthy Living, 2007). 3.5 Bicillin is the trade name for long acting penicillin G benzathine injectable suspension. 4.0 Background 4.1 The prevention and control of sexually transmitted infections (STIs) are important components of a comprehensive communicable disease control strategy. While it is beneficial for all citizens of the Winnipeg Health Region to have a regular primary care provider, many people do not access care due to health, social and/or economic inequities or mainstream stigmatization. Not accessing care poses a potential health risk to the individuals themselves and to the community. To improve and focus efforts to test and treat mobile, socially marginalized and underserved populations for syphilis infections and respond to infectious syphilis clusters and outbreaks, designated Public Health Nurses (PHNs) may offer Bicillin treatment to eligible clients with infectious syphilis (incubating, primary, secondary, or early latent) and/or to contacts of confirmed infectious syphilis cases, while awaiting contact with primary care for a focused clinical examination. 4.2 These guidelines are developed using the principles recommended in the Guideline for Shared Competencies and Delegated Physician Services (College of Physicians and Surgeons of Manitoba and College of Registered Nurses of Manitoba, 2002) as indicated in the following 6 sections. 4.2.1 These guidelines and standard operating procedures are based on shared competencies and collaboration between the Medical Officer of Health (MOH) and PHNs with the knowledge and skill to perform these practices. 4.2.2 Staff competency for these practices includes access to all current sexually transmitted and bloodborne infection (STBBI) guidelines and resources (Healthy Sexuality and Harm Reduction team s clinical practice guidelines, Manitoba Health s Communicable Diseases Management Protocols, Public Health Agency of Canada s Canadian Guidelines on Sexually Transmitted Infections). Where there are differences between provincial and national Page 2 of 10

3 of 10 guidelines, provincial guidelines apply. The MOH or designated back-up MOH is available for immediate consultation as required. 4.2.3 Mechanisms to maintain quality and safety will include regular peer review at team meetings, regular consultation with the MOH through the CD Coordinator, and an annual random chart audit by the CD Coordinator (at least 5 charts per nurse). Every month, the PHN will send to the Administrative Secretary2 (AY2) a list of clients who received a shared competency function from the PHN. When guidelines and shared competencies are not followed, this will be documented, investigated and evaluated with the PHN by the MOH in collaboration (as appropriate) with a designated individual (Team Manager, Clinical Nurse Specialist, CD Coordinator). Bi-annual performance reviews with the team manager are required. 4.2.4 All WRHA guidelines for documentation and storage of records will be followed according to existing WRHA standards and protocols. 4.2.5 Continued and ongoing competence will be maintained through ongoing education and review of practice. Reliable provincial and national guidelines are available and updated regularly, and are used by PHNs for each shared competency. PHNs are competent healthcare professionals with skills in teaching about risks, benefits, side effects and reporting of adverse events. 4.2.6 Collaboration between MOH and Registered Nurse This document, when signed by the MOH and PHN, is a clear agreement regarding shared competency. Competence Physician: The MOH s (Dr. Pierre Plourde) professional qualifications include a Certificate of Special Competence, Infectious Diseases, Royal College of Physicians of Canada (FRCPC) In the absence of the above-named MOH, consultation is available through Dr Joss Reimer or Dr Bunmi Fatoye at the WRHA. Drs Reimer and Fatoye have advanced professional qualifications including Certification with the Royal College of Physicians of Canada (FRCPC). Public Health Nurse: Page 3 of 10

4 of 10 PHN competence will include a Baccalaureate Degree in Nursing with recent PHN experience, in addition to an orientation to specialized healthy sexuality and harm reduction services. Competency will normally be achieved over a 6 month full-time period. The PHN must be oriented and competent in infectious syphilis case and contact management in order to be eligible to perform this shared competency. As determined in concert with the PHN and staff advisor, this apprenticeship will begin when the PHN has shown competency in management of sexually transmitted infections with the Healthy Sexuality and Harm Reduction team. Maintenance of competency will be achieved through ongoing review of practice in team meetings with the Manager, MOH, Clinical Nurse Specialist and CD Coordinator and annual chart audits. 5.0 Procedure 5.1 Determine eligibility according to criteria below. It is important that all eligibility criteria are reviewed to the degree possible with the client prior to booking an appointment with a PHN, including review of medication allergy history. This can help avoid time wasted, client frustration, and facilitate timely appropriate referral. 5.2 Obtain a focused sexual health history including last serologic syphilis results and other STBBI testing. If appropriate, collect a sexual contact and social network information. 5.3 Obtain informed consent ensuring client has appropriate information and capacity to give such consent. 5.4 to infectious syphilis and cases that have not been physically assessed require referral for a focused clinical assessment for symptoms of primary, secondary, and neurological syphilis, however this assessment may follow Bicillin treatment by the PHN. 5.5 In the event of unusual neurological symptoms or readily apparent signs of neurological disease, a referral to Infectious Diseases is necessary (see Appendix A). The PHN is responsible for drafting a summary of the client s sexual health history (relevant to the referral), serological history, and a summary of the findings from the assessment. This will be forwarded to the CD Coordinator, who will review and forward to the appropriate MOH for review and assistance with referral to Infectious Diseases as indicated. Page 4 of 10

5 of 10 5.6 Draw serology for syphilis screen. This includes follow up serology for untreated clients with evidence of new syphilis infection, or initial serology for contacts to infectious syphilis. Assess for eligibility within the following Practice Guidelines and Shared Competencies: 5.6.1 Blood Testing for HIV, Hepatitis C virus, Hepatitis B virus, Hepatitis A virus, syphilis and Communicating Test Results, AND Urine Testing for Chlamydia & Gonorrhea Genital Infections, Pharyngeal and Rectal swabs for Gonorrhea and Chlamydia, Urethral Swab for Gonorrhea. 5.7 Infectious syphilis contacts or cases who meet the eligibility criteria should receive 2.4 million units of Bicillin divided in 2 doses (1.2 million units each syringe), administered by deep intramuscular (IM) injection to each ventrogluteal or dorsogluteal site. Do not inject into or near an artery or nerve. Bicillin comes in pre-loaded disposable syringes. See Appendix B for IM land marking. 5.8 Administering Bicillin in the absence of a proven or strongly suspected bacterial infection or clear prophylactic indication is unlikely to provide benefit to the patient and increases the risk of a development of drug-resistant bacteria. 5.9 Staging is determined by a combination of sexual history, serologic results and history, and symptoms, and should be determined by the practitioner who performs the clinical examination. If PHNs are requested by the practitioner to stage clients with syphilis, the staging should be confirmed with the appropriate Medical Officer of Health, via the Communicable Disease Coordinator. 5.10 Make arrangements for clients to receive a clinical examination specific to syphilis if required. Follow up with the client to share results and/or follow up to monitor response to treatment in 10 working days. Clients requiring ongoing serologic response monitoring (infectious syphilis cases) should be assisted to attain appropriate care for this follow up. Public health nurses are not to assume ongoing care of clients as this is the role of primary care or infectious disease specialists. Bicillin Treatment Eligibility Criteria This shared competency does not apply in the following situations. Referral to appropriate medical practitioner/rn(ep) is needed: Page 5 of 10

6 of 10 Client with known or suspect allergy to penicillin. History of a previous hypersensitivity reaction to any of the penicillins is a contraindication to Bicillin treatment. Client with signs, symptoms or other clinical findings that do not fit within definition of infectious syphilis (Manitoba Health and Health Living, 2007) including late latent, remote treponemal infection (possible yaws, pinta, or bejel), or tertiary syphilis. Client with symptoms suggestive of neurological syphilis (requires referral to infectious disease specialist) Pregnant clients (requires referral to infectious disease specialist and/or obstetrician) HIV positive clients (should be referred to HIV care provider) Client does not consent to antibiotic treatment. To be eligible for Bicillin treatment by a PHN under this shared competency guideline, the client must meet at least 1 of the following 3 criteria: o Named as a contact to a confirmed case of infectious syphilis. o Clinical symptoms of primary or secondary syphilis as per Communicable Disease Management Syphilis Protocol (Manitoba Health and Healthy Living, 2007). o Presents to PHN with syphilis serology suggestive of recent syphilis infection, regardless of symptoms or contact history, or a 4-fold increase in titre from last nontreponemal result. AND Client does not have timely access to a Primary Care Practitioner for assessment/treatment related to syphilis (e.g. greater than 1 week wait). AND Client is able to understand the information, benefits and risks that are relevant to making a decision to be treated. If there are any doubts about the individual s capacity to consent, the treatment should not be provided by the PHN, and the client should be referred to a physician/nurse practitioner for medical assessment. AND Client is at least 16 years of age. Note: For those clients between the ages of 13 and 15, a reasonable attempt must be made by the nurse to obtain parental/legal guardian consent prior to treatment. For street involved youth, the persistent refusal Page 6 of 10

7 of 10 to disclose guardianship will be considered a reasonable attempt to locate parents/guardians, and the mature minor provision will be followed. 6.0 Validation 6.1 College of Physicians and Surgeons of Manitoba and College of Registered Nurses of Manitoba (2002), (Guideline No. 132) Guidelines for Shared Competencies and Delegated Physician Services revised.http://www.cpsm.mb.ca/guidelines/132.php. 6.2 Manitoba Health and Healthy Living (2007, April) Communicable Disease Management Protocol Syphilis. http://www.gov.mb.ca/health/publichealth/cdc/protocol/syphilis.pdf. 6.3 Manitoba Health and Healthy Living (2008), Communicable Disease Management Protocols. http://www.gov.mb.ca/health/publichealth/cdc/protocol/index.html. 6.4 Public Health Agency of Canada (2006). Canadian Guidelines on Sexually Transmitted Infections. http://www.phac-aspc.gc.ca/stdmts/sti_2006/sti_intro2006-eng.php 6.5 Euerle, B. (2012) Syphilis. Medscape Reference. http://emedicine.medscape.com/article/229461-overview Page 7 of 10

8 of 10 Acknowledgement of Shared Competency between MOH and PHN The Medical Officer of Health (MOH), Winnipeg Regional Health Authority (WRHA), provides the authority for designated PHNs to administer Bicillin treatment and collection of swabs for T. pallidum PCR for infectious syphilis cases and contacts. Dr. Pierre Plourde PHN (sign and print name) Page 8 of 10

Appendix A - Common Findings with Neurosyphilis Hyporeflexia - 50% Sensory impairment (e.g., decreased proprioception, loss of vibratory sense, otosclerosis, vertigo, sensory ataxia, chorioretinitis) - 48% Pupillary changes (anisocoria, Argyll Robertson pupils, skew deviation) - 43% Cranial neuropathy - 36% Dementia, mania, or paranoia - 35% Romberg sign - 24% Charcot joint - 13% Hypotonia - 10% Optic atrophy 7% Euerle, B. (2012) Medscape Reference. http://emedicine.medscape.com/article/229461- overview Page 9 of 10

Appendix B Ventrogluteal Injection Wash your hands. Place the palm of your hand over the greater trochanter. For the right hip, you should landmark with your right hand and vice versa. Place your index finger on the anterior superior iliac spine (hip bone) Move your middle finger back along the iliac spine as far as possible to make a V with your index finger and middle finger. The centre of this V or triangle is the injection site. Prepare the site with alcohol and inject deep IM at a 90 degree angle to the skin. Dorsogluteal Injection Wash your hands. Visually divide each buttock into four quadrants Landmark the upper outer region of the upper outer quadrant of the buttocks. The inner lower region of the upper outer quadrant of the buttocks is proximal sciatic nerve and must be avoided. Prepare the site with alcohol and inject by deep IM at a 90 degree angle to the skin Page 10 of 10