Practice of Toxicovigilance, Hemovigilance and Diagnostic Vigilance

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1. What is Toxicovigilance? Elaborate with an example/case study.

Toxicovigilance is a program on lines with pharmacovigilance in which the effect of the drugs on long term exposure to the public is collected and evaluated for its impact on health. In toxicovigilance, the toxicity caused by insecticides and pesticides along with agrochemicals are documented, assessed for various signals of toxicity to the public and health consumer. The patient safety is a paramount issue and there are many toxic reactions manifestations which come to the knowledge of public. For example, use of DDT for control of mosquitoes in order to control vector-borne diseases like malaria, dengue, chickungunya is proved to be counter-productive. The DDT entered the food chain via rivers and fishes and is the cause for endocrine disruption leading to early onset of puberty in girls. The consequences of endocrine disruption on health is far-reaching and there is a need to be vigilant over the toxicity due to agro-chemicals and pesticides.

2. What is the scope for toxicovigilance practice?

The toxicovigilance comprises of identifying the toxicity due to environmental exposure of poisons used in agriculture and other industrial processes. It also involves the development of measures to control the further contamination along with minimizing the exposure of poisons to the public.

3. Give some examples of toxicovigilance activities

The toxicovigilance includes the system of alerting the consumers regarding hazards arising due to irresponsible (accidental or intentional) exposure of overdose of toxicants. One of the common problem is want of accurate information on prevention and handling of exposure to toxicants. The regulatory agencies insist on provision of necessary information regarding prevention of overdose and the symptoms of critical poisoning arising due to toxicants. The literature should be a part of product package containing classified information on first aid measures along with poison centers, contact numbers. The toxicovigilance program also takes into account, the toxicity events arising due to hazardous cosmetic products.

4. Give the process flow for toxicovigilance program.

Process of Toxicovigilance

5. Give the examples of toxicity caused by agricultural chemicals.

S. No.

Agricultural chemicals




Endocrine disruption & Hormonal imbalance



Endocrine disruption & Hormonal imbalance



Endocrine disruption & Hormonal imbalance


Carbamate compounds

Developmental neurotoxicity


Organophosphate compounds

Developmental neurotoxicity

6. Identify the important toxicants need to be checked for public health interest.

S. No.

Toxicants of serious public health concern

Toxicity caused



Air pollutants

Respiratory disorders

Polluted air



Cardiovascular diseases and Night blindness

Ground water



Mesothelioma & Asbestosis

Asbestos factory & mine



Leukemia & Multiple myeloma

Hydrocarbon products such as paints, varnishes, glues etc.



Metal fume fever, pneumonitis

Cadmiun containing fumes



Reproductive and developmental problems, carcinogen

Meat and dairy products



Hypocalcemia, nervous disorders

Fluoride salts



Nervous disorders, nephropathy

Inhalation or ingestion of lead compounds



Acrodynia, Hunter-rusell syndrome, Minamata Disease




Endocrine disruption, neurotoxicity

Accidental, Occupational, residential

7. Discuss the burden of environmental pollutants on human health.

The burden of environmental pollution is directly linked to unregulated industrial practice along with increased population. The pollution is posing a major threat all across the world in several forms e.g. climatic change, melting of glaciers on the poles, global warming and hole in the ozone layer. The world is moving towards brink of destruction due to several factors which have become difficult to control. For example, the energy consumption itself escalates the air pollution by using fossil fuel. Search for green energy options to resolve energy crisis seems to be a losing game.

8. Who are the stakeholders of toxicovigilance programs?

The toxicants ultimately affect the livestocks and destroy the biological chain which is essential for sustenance of global environment. The toxicants used for some purpose like improving productivity is likely to find its way in food and water chain and can easily enter the livestock. The government, the health ministry, the regulators and industry along with public are going to be affected directly by the toxicants are prima facie stakeholders.

9. What is the corporate ethics for control of toxicity induced by effluents and industrial wastes?

The corporate world was supported on agreement that their activity shall not affect the environment and cause pollution affecting the health of livestocks and humans. The corporate can be only allowed to function in case they follow strictly the agreement. Many a time the corporate are found to cause pollution because of lack of commitment and surveillance. However, the corporate should realize only those industries can sustain which are committed to ethical practices.

10. How to establish a link between toxicants and food cycle?

The establishment of therapeutic drugs to the adverse drug reactions is done on a program of continuous observations of episodes of ADR among the public. A system of collection, report and review are the fundamental activity for pharmacovigilance. Similarly, a toxicant influence on human health is based on observation, reporting and reviewing any untoward incidence happening among public. The establishment is also confirmed by number of episodes and a sound scientific evidence for being the cause of toxicity.

11. What is International program on chemical safety?

Under the leadership of WHO, the initiative to establish and monitor the impact of identifying toxicants on health was established in the year 1992 in the World health assembly resolution on International program on chemical safety. In further there were many resolutions highlighting the guidelines and possible hazards posed by public exposure of poisonous substances that were by indiscriminate handling of chemical substances in environment. It became mandatory for surveillance of chemicals in environment and also fixing the maximum tolerable limits for many of the toxicants observed in the environment.

12. What is Hemovigilance?

Haemovigilance is a program engaged in supervising and scrutinizing the issues and challenges arising in the area of blood donation and blood transfusion. The blood is increasingly used to save patients in many clinical conditions like accidents, heavy blood loss in the operations as a volume-replenisher and nutrient. There is no substitute for blood, hence one needs to take blood from donor. Blood donated is handled by blood banks which are special clinical facilities established in hospitals or as stand-alone facility. There are many issues and problems associated with blood bank which are usually preventable. There is a need for system to establish high quality protocol to prevent blood donation related casualties. The hemovigilance is the program on lines with pharmacovigilance which collects the episodes and incidents of untoward effects in blood donation in blood bank with an objective to achieve high quality output and assure the zero defect safety.

13. What are the quality systems needed for hemovigilance?

The quality systems of hemovigilance requires to establish Organizational management systems which ensures the maximum utilization of the blood collected for all the needy patients. The establishment of Standards of operation and protocols ensure smooth functioning of blood bank and blood donation. Documentation is a legal requirement which can be utilized for retrospective analysis of the data to optimize the safety and cost effectiveness. The training of human resource in the data management is an essential requirement to establish a functional hemovigilance centre. The overall outcome of the hemovigilance can assist the demand and supply planning, signals of adverse events and timely action taken to mitigate the accidents which can help in the overall assessment of the functions of hemovigilance.

About the Author

Anantha Naik Nagappa's picture

I am professor, intrested in developing the community pharmacy services in India, We have an association called ASSOCIATION OF COMMUNITY PHARMACISITS OF iNDIA. CHECK AT for further detials


Albert Ana-Maria's picture

What do you think about codein? Almost in cough?

Anantha Naik Nagappa's picture

Codein is a narcotic drug and regulated by Drugs and Cosmetics Act 1945 and NDPS Act 1985. The codein mixture is having a hydroalcoholic base which comes under regulation of M&TP Act 1955. It is also reported to be abused by the addicts who get into the trap of narcotic addiction due to euphoric effects of codein. The cough and cold is a common ailment which can be managed by several non-sedative anti-histaminics for example, Cetrizine which is an OTC medication. If the cough and cold is also accompanied by fever and malaise, lethargy, there can be an infection by bacteria or virus. It is also well-known like drinking extra water helps as a good expectorant by hydrating the lungs and turning the thick mucus watery which can clear the lungs from obstruction by mucus causing cough. In conditions described above the use of cough remedies based on codein needs to be taken with care.

Prof Anantha Naik Nagappa

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