Acts Online
GT Shield

Mine Health and Safety Act, 1996 (Act No. 29 of 1996)

Notices, Guidance Notes, Compilation Guidelines

Guidance Note for the Management of Latent Tuberculosis Infection in the South African Mining Industry

Part A: The Guidance Note

8. Aspects to be addressed in the mandatory COP

 

8.1. Target population

 

8.1.1. The main target population for this guidance note is the employees in the South African mining industry, mining communities and peri-mining communities who are exposed to TB and may require TPT once the disease has been excluded through testing and the exclusion criteria has been considered.

 

8.1.2. Eligibility for TPT should be guided by the risk assessment of the mine, considering the risk populations.

 

See Annexure B: Algorithm for managing the population at risk of developing LTBIs in the South African mining industry.

 

8.1.3. The following are identified as risk populations for developing LTBIs:
8.1.3.1. Mine employees exposed to silica dust and those with silicosis.
8.1.3.2. Mine employees with compromised immune systems e.g. HIV disease, cancer, diabetes, etc.
8.1.3.3. Pregnant women with significant TB exposure irrespective of age, HIV status or TB exposure.
8.1.3.4. Healthcare workers exposed to employees with TB disease and those at the highest risk with compromised immune systems e.g. HIV disease, on cancer therapy, diabetes, etc.
8.1.3.5. Families of mine employees, mining communities and peri-mining communities where the contacts of mine employees with TB disease should be assessed for eligibility for LTB treatment. The high-risk groups include children under the age of five years, those living with HIV and the elderly.

 

8.2. Identifying LTB cases (case finding)

 

8.2.1. Screening for active TB should be done on all high-risk populations before LTB testing and assessing for TPT eligibility.
8.2.1.1. TB screening

 

See Annexure C: TB symptom screening tool for adults and children (adopted from the NDOH TB screening and testing standard operating procedure 2022)

 

8.2.1.1.1. All mine employees should be screened for TB symptoms at each clinic visit and all the points of care, and those that are symptomatic, should be tested and treated for active TB.
8.2.1.1.2. Employees who have been previously treated for TB should be screened and tested after each exposure to a person with TB.
8.2.1.1.3. Employees newly diagnosed with HIV should be screened and tested for TB at the HIV diagnosis.
8.2.1.1.4. PLHIV in care should be tested annually for TB and this should be linked to the viral load follow up visit. In between the testing, PLHIV should be screened, tested and offered TPT where TB disease has been ruled out.

 

See Annexure C: TB symptom screening tool for adults and children (adopted from the NDOH TB screening and testing standard operating procedure 2022)

 

8.2.1.1.5. All contacts of people with TB disease should be screened, tested - irrespective of symptoms - and treated for TB.
8.2.1.1.6. The identified risk populations for LTB should be screened for TB symptoms, TB radiological changes (chest X-ray) and TB sputum to exclude active TB disease.

 

See Annexure C: TB symptom screening tool for adults and children (adopted from the NDOH TB screening and testing standard operating procedure 2022)

 

8.2.1.1.7. Risk populations who have completed TB treatment and have bacteriological proof of cure should be screened for TB symptoms and assessed for TPT eligibility. If a bacteriological cure is not demonstrated after the completion of treatment, reassess the patient for TPT eligibility three months after completion of the TB treatment.
8.2.1.1.8. People with a history of silica dust exposure and those living with silicosis, may present with similar symptoms and signs of TB. Therefore, it is imperative to exclude active TB disease and offer TPT.

 

8.2.1.2. Diagnosis and confirmation of LTBI
8.2.1.2.1. TST may be used to identify those infected with LTB.

 

See Annexure D: Tuberculin Skin Test

 

8.2.1.2.2. The unavailability of TST should not be a barrier to the provision of TPT (once active TB disease has been adequately excluded)

 

See Annexure B: Algorithm for managing the population at risk of developing LTBIs in the South African mining industry.

 

8.3. Management

 

8.3.1. It is essential that TPT is scaled up to reduce the burden of TB in South Africa. Previously, TPT was offered only to people who were at the highest risk of progressing to TB disease after exposure (i.e. children younger than five years of age and all PLHIV, regardless of age). However, to achieve TB elimination, it is crucial to implement TPT more comprehensively for everyone with significant TB exposure and all other individuals at high risk of TB disease.
8.3.1.1. Those that are eligible for TPT:

 

See Annexure B: Algorithm for managing the population at risk of developing LTBIs in the South African mining industry.

 

8.3.1.1.1. All people, regardless of age and HIV-status, after significant TB exposure.

 

See Annexure B: Algorithm for managing the population at risk of developing LTBIs in the South African mining industry.

 

8.3.1.1.2. Those who are immune-compromised, regardless of known exposure, after TB disease has been ruled out.
8.3.1.1.3. People living with silicosis regardless of whether they have a known significant exposure, regardless of prior TB treatment or TPT unrelated to silicosis.
8.3.1.1.4. Pregnant women living with HIV should be provided with TPT irrespective of the clusters of differentiation (CD4) cell count.

 

8.3.1.2. Other risk groups that may be considered for TPT based on risk assessment and selection criteria:

 

See Annexure B: Algorithm for managing the population at risk of developing LTBIs in the South African mining industry.

 

8.3.1.2.1. Healthcare workers to be considered during a routine occupational TB screening programme.
8.3.1.2.2. People who have previously had TB and those who previously completed TB treatment since they are at higher risk of getting TB again. Some may experience multiple significant exposures or, acquire or develop immune-compromising conditions over the course of their lives. TPT is indicated at each new TB exposure to a TB contact or each period of immuno-compromise.

 

8.3.1.3. Those that are not eligible for TPT:
8.3.1.3.1. Individuals diagnosed with TB disease.
8.3.1.3.2. Individuals that have active liver disease (acute or chronic).
8.3.1.3.3. Individuals that have signs or symptoms of severe peripheral neuropathy (could consider 4R).
8.3.1.3.4. Individuals that have a history of adverse reactions to any of the medication used for TPT.
8.3.1.3.5. Individuals that drink alcohol excessively and are unwilling, or unable, to scale down. Use the following measures:
(a) For men: more than five standard drinks on any day or 15 drinks per week.
(b) For women: more than four standard drinks on any day or eight drinks per week.

 

8.3.1.4. For individuals with abnormal baseline liver function test results, sound clinical judgement is required to ensure that the benefit of TPT outweighs the risks, and these individuals should be tested routinely at subsequent visits.

 

8.3.1.5. Treatment
8.3.1.5.1. Initiation
(a) If TB symptoms appear, the employee needs to be tested for TB to exclude TB disease.
(b) People offered TPT should be offered appropriate education (including information on adverse events), counselling prior to TPT initiation and support throughout the TPT journey. This is also for adherence purposes.
(c) Education on TPT should consider the following:
(i) Adverse drug reactions.
(ii) Duration of the treatment.
(iii) Distance from a health facility.
(iv) Absence of the perception of the risk.
(v) Presence of stigma.
(vi) Alcohol and drug use.
(vii) Socio-economic factors.
(viii) Time lag between diagnosis and treatment.

 

NOTE:

All healthcare providers need to be trained and updated on TPT guidelines.

Education should address that subsequent TPT will be required following completion of the treatment.

If another significant TB exposure occurs, they should access care for TB evaluation.

 

 

8.3.1.5.2. Treatment options
(a) As per the guideline for TPT of the NDOH, the treatment regimen chosen will depend on:
(i) The weight (for children)
(ii) The HIV-status.
(iii) The type of patient.
(iv) The circumstances.
(v) Household or family considerations.
(vi) Other medications including anti-retroviral therapy (ART).
(vii) The availability of formulations.
(viii) Current evidence.

 

NOTE:

Refer to the prevailing National Guidelines on the Treatment of LTBIs of the NDOH.

 

(b) It is recommended that where possible, individuals in one household or a group receive the same treatment regimen to lessen the burden and complexity of TPT on the individuals.
(c) Treatment options in South Africa as recommended by the NDOH include:
(i) Six months INH.
(ii) Twelve months INH.
(iii) 3HP; or
(iv) 4R; or
(v) 3 -  4 months of daily INH plus Rifampicin (3HR).
(d) A short course treatment regimen such as 3HP and 4R are considered safer and effective since it has higher completion rates and lower risks of adverse effects than the longer regimens. Therefore, where feasible, shorter treatment options should be offered.
(e) Options for TPT regimens may be revised as new evidence regarding safety, efficacy, appropriate dosing and the required patient friendly formulations become available.
(f) Prevailing approved regimens may be undertaken by mines as per the prevailing NDOH recommendations.
(g) The employer is to familiarise themselves with the health benefits and possible adverse health effects of each regimen.
8.3.1.5.3. Treatment under special conditions
(a) Pregnant and breastfeeding women should be treated as per the national guidelines on the treatment of LTBIs of the NDOH.
(b) Contacts of people with DR-TB to be treated as per the national DR-TB guidelines.
8.3.1.5.4. Clinical monitoring and outcomes
(a) For the duration of the treatment, employees must be monitored for the emergence of TB symptoms and any adverse health effects for safety, support and adjusting the dose as needed.
(b) In the event that the employee who is on treatment for LTBI, is diagnosed with active TB, they must be treated for TB as per existing South African mining industry TB management guidelines and prevailing NDOH guidelines.
8.3.1.5.5. Management of individuals who decline treatment
(a) Contacts who are eligible for TPT but decline treatment despite counselling, should be counselled further regarding TB symptoms and should be offered TPT again at the next opportunity.
(b) If individuals develop symptoms suggestive of TB, they should be evaluated for TB disease again and be offered TB treatment if they test positive for TB. Alternatively they should be offered TPT once more if TB disease has been excluded.
8.3.1.5.6. Management of individuals who miss doses of TPT
(a) Adherence and completion of TPT treatment are important for ensuring the successful prevention of TB. It is important to be incorporated into the education and counselling provided to employees. Table 1 below provides guidance on how to manage individuals who interrupt TPT.

 

Table 1: Management of individuals who miss doses of treatment, NDOH guidelines TB Preventive Therapy-2021

DURATION OF INTERRUPTION

MANAGEMENT

If an individual misses one dose

• The individual should take the missed dose(s) as soon as they remember within the same day. If the day's dose is missed, take the next scheduled dose and continue with the regular schedule. Do not take two doses on the same day.
• For the weekly doses, take the missed dose as soon as they remember. If this is on the following day, continue with the next dose on the new day.

If an individual interrupts treatment for:

 

Less than one month for a short regimen
• Enquire about the reasons for the treatment interruption.
• Address the concerns of the individual.
• Counsel the individual on the importance of adherence.
• Screen clinically for TB symptoms.

or

Three consecutive months for a longer TPT regimen

 

• Conduct investigations to exclude TB, if signs and symptoms of TB are present.
• If asymptomatic and there are no signs of TB disease, continue TPT to complete the remaining treatment.

If an individual interrupts treatment for more than one month for a short regimen or Three consecutive months for a longer TPT regimen.

• If this is the first interruption, the individual returns at any point and commits to taking treatment.
• The individual may be reassessed for eligibility, counselled and restarted on treatment and referred to relevant health workers (psychologist, dietitian, social worker, pharmacist, etc.).

If an individual interrupts treatment for a second time regardless of the duration of interruption, despite adherence counselling.

• Do not consider for treatment

 

(b) Should there be situations where treatment is not adhered to, the prevailing NDOH adherence guidelines for TB should be followed.
8.3.1.5.7. Completion of treatment
(a) It is important to ensure that individuals who start TPT, complete it. Monitoring and support are important throughout the course of the treatment. The clinician is to determine the outcomes at the completion.

 

8.3.1.6. Management of adverse health effects
8.3.1.6.1. Completion of treatment
(a) It is important to ensure that individuals who start TPT, complete it. Monitoring and support are important throughout the course of the treatment. The clinician is to determine the outcomes at the completion.
8.3.1.6.2. Drug-specific adverse reactions can occur with:|
(a) Isoniazid (asymptomatic elevation of serum liver enzyme concentrations, peripheral neuropathy and hepatotoxicity).
(b) Rifampicin and Rifapentine (cutaneous reactions, hypersensitivity reactions, gastrointestinal intolerance and hepatotoxicity).
8.3.1.6.3. Early identification and management of an adverse reaction is critical to ensure retention on treatment.
8.3.1.6.4. It is crucial that employees are furnished with information to identify and report signs and symptoms of adverse health effects to the clinician.
8.3.1.6.5. The clinician must carefully assess the employee and report all the adverse health effects using the standard reporting form as per the National Pharmacovigilance Centre guidelines.