India: Central Tuberculosis (TB) Division Releases FAQs On Mandatory TB Notification For Chemists/Pharmacies

The Ministry of Health and Family Welfare (MoH&FW), on March 16, 2018, has notified that tuberculosis is a dangerous epidemic disease, a threat to life and is a major public health problem accounting for substantial morbidity and mortality in the country. Early diagnosis and complete treatment of tuberculosis is the cornerstone of tuberculosis prevention and control strategy. Further, inappropriate diagnosis and irregular or incomplete treatment with anti-tubercular drugs may contribute to complications, spread of disease and emergence of drug-resistant tuberculosis.

However, the said notice also announced mandatory TB reporting measures, where all health care providers treating TB patients, and all pharmacies/chemists/druggists dispensing anti-tubercular medicines, shall notify every TB case they find and treat, to the public health departments. The notification further suggested patients to self-notify themselves with their own details and that of treating medical practitioners6.

On June 13, 2018, the Central Tuberculosis (TB) division has released Frequently Asked Questions (FAQs) on mandatory TB notification for easy reporting practice for Chemists/ Pharmacies7:

Is online submission of information mandatory for pharmacies/chemists & druggists?

Submission of information is mandatory; either electronically (online) or in hard copy (paper based). Modalities of reporting of information can be any of the following:

  • Hard copy by post, courier or by hand to the nodal officer
  • Electronic copy by email from persons / institutes authorized for this purpose to the nodal officer
  • Uploading of information directly on to the Nikshay portal - http://nikshay.gov.in
  • Using authorized mobile numbers by phone call on 1800 11 6666
  • Direct online information transmission from laboratory or hospital MIS to NIKSHAY

The patient or his relative does not want to disclose their name & identity. How to notify such TB patients?

It is estimated that a TB patient, if left untreated, can spread the infection to at least 10-15 persons in a year. Hence, in case of TB, the concerned public health authorities should be informed immediately. Moreover, the information remains secured within the TB Notification system – NIKSHAY of the Government of India. Only authorized users of Nikshay, on behalf of 'Revised National TB Control Program (RNTCP), will have access to the information on patient for ensuring public health measures (to support TB patients in ensuring cure from the disease and prevent spread of the disease) as mentioned in section 5 of the Gazette. The information will not be shared outside the RNTCP and health officials. Confidentiality of the data gathered will be ensured as per EHR/ EMR standards and IT Act 2000 of Government of India & its amendment 2008.

Patient and their relatives are not ready to provide detailed residential address, their ID & Mobile or Telephone Number. How to provide this information in such instances?

TB is a communicable disease and it is estimated that, if left untreated, a TB patient can spread the infection to at least 10-15 persons in a year. Hence, TB patients should be treated at the earliest and certain public health measures like contact investigation, chemoprophylaxis for the households, treatment support (if required), nutrition support, comorbidity testing and drug susceptibility testing need to be undertaken in order to ensure complete cure. To deliver this, the public health system needs at least the mobile number and residential address of the patient. Moreover, Government of India has recently initiated a scheme which provides the TB patients Rs. 500/- per month for nutrition support through Direct Benefit Transfer (DBT) for the duration of treatment. To provide this support, contact details of TB patients are essential. Mobile number is particularly useful in contacting the patient and informing him before reaching-out to him.

It is difficult to do photocopy of every anti-TB prescription, when electricity is not regular in villages. How to get records of such patients who even bring prescription?

As per the Drug and Cosmetic Rule, 1945, the supply of a drug specified in Schedule H1 shall be recorded in a separate register. Anti-TB drugs have been specified under the Schedule H1. Photograph of prescription can also be taken which later on can be printed or preserved as electronic copy.

How to report on monthly basis from remote villages where there are issues related to internet availability, courier or post services?

Reporting of anti-TB drug sale is desirable to be sent from pharmacies on monthly basis to DTO and Drug Inspector. In case of unavailability of communication measures, public health staff can support collection of such reports in consultation with DTO / Drug inspector.

If Doctor notifies TB patient at the time of prescribing medicine, why are pharmacies asked to provide information?

The Gazette mandates health facility, pharmacy and laboratories to notify each TB patient at the earliest. Accordingly, the health facility/doctor will notify TB patients. But, in case it does not happen, the Government cannot afford to lose any TB patients from being notified, as it is a public health responsibility to prevent the spread of disease in the community. Those health facilities/ doctors who are not notifying TB patients will attract the Gazette provisions and it will be ensured that health facility notifies at diagnosis. Moreover, there are now incentives for notification of TB patient, which will be provided to the provider (doctor / chemist / laboratory) whoever notifies the TB patient.

Do pharmacies have to or don't have to retain the original, or a photocopy of the prescription of the doctor?

As per the Drugs and Cosmetic Act, 1940, it is mandatory for pharmacies to keep a copy of prescription of drugs covered under Schedule H1 in a separate record and such record should be maintained for three years and be available for inspection. As per Drugs and Cosmetic Rules, 1945, the supply of a drug specified under schedule H1 shall be recorded in a separate register at the time of supply, giving name and address of prescriber, the name of patient, the name of drug and the quantity supplied and such record shall be maintained for three years and be open for inspection.

What all information need to be furnished or to be maintained with regards to TB, by the pharmacies?

Annexure III is the TB notification format for pharmacies. It includes information of medical practitioner who prescribed the anti-TB drugs in addition to TB patient's information, diagnosis and drug dispensing information. Details of the drugs prescribed are to be furnished or maintained as per annexure IV in line with Schedule H1 of Drugs and Cosmetic Rules, 1945. This includes dosages, formations (to be read as formulation) and duration of anti-TB drug dispensed for.

Note - As per the Gazette on mandatory notification of Tuberculosis (TB), it is the duty of the registered pharmacies to divulge the information to the authorized notification official as regards TB which is a notifiable disease in the country. It is estimated that a TB patient, if left untreated, can spread the infection to at least 10-15 persons in a year. Hence, in case of TB, the concerned public health authorities should be informed immediately.

Footnotes

6. http://www.egazette.nic.in/WriteReadData/2018/183924.pdf

7. https://tbcindia.gov.in/showfile.php?lid=3328

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