 "Mitigate workplace hazards with better risk assessment in pharma industry")
Pharmaceutical workforce faces a broad spectrum of workplace hazards such as chemical (in form of dust, gases, vapours, etc); physical (in form of temperatures, noise, humidity, etc); ergonomics (in form of awkward and static posture); mechanical safety (in form of moving parts on equipment etc); biological (in form of virus, bacteria, blood-borne pathogens etc) and work related stresses (poor levels of support and respect).
Unknown hazards
However, due to the lack of reporting systems (specifically the long terms effects) in new chemical entities (NCEs) and active pharmaceutical ingredients (APIs), little is known about the chronic effects of these hazards on humans. Reports do however suggest that the effects of ‘hormonal and cytotoxic drugs’ have more chronic effect on pharmaceutical workforce that any other chemical.
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Chemical hazards are also caused due to inhalation and skin absorption as these are the two major routes of entry of chemicals in the human body. Skin rashes, reproductive health illness, cancer and chronic respiratory diseases are some of the effects of chemicals exposure on humans. While working on ‘new’ chemicals for making effective drugs, very little is known at the outset about the effects and hazards of NCEs, APIs or intermediates that would be produced during the manufacturing process. Tests are conducted on biological media/animals using set regulatory protocols to understand the acute and chronic effects of these new chemicals on humans; however it is very difficult to conclude on the effects of these chemicals on humans when exposed to the actual manufacturing process. Recently, there has been more focus on endocrine disrupter chemicals (EDCs), which have been reported to have reproductive hazards on both male and female workforce.
Nanoparticles can pose a challenge
Exposure to microscopic particles or nanoparticles is a concern these days as these may have adverse effects on humans. These microscopic particles generally occur during the R&D/ primary production / early stages of secondary production. Whatever may be the stage, the chronic effects of these particles on pharmaceutical workforce is quite harmful and reports have suggested women workforce has been more affected than their male counterparts. Viruses, moulds, bacteria, and blood-borne pathogens generally present in R&D labs are some of the biological hazards that are difficult to be seen by naked eye but have long term effects on humans.
Ergonomics is all about fitting jobs to workers’ physical and psychological needs. Reports have suggested that ergonomic hazards contribute to the largest amount of claims and reported injuries in a pharmaceutical industry. Poor ergonomic designs like On/Off switches on machines; colours on computer monitors and other displays; awkward postures while working can lead to other hazards as well (like process safety).
Assess risk to take right action
ALSO READ: Reducing silica dust risk by adopting right workplace safety measures
Other hazards (eg, ergonomic design and stressors) are reported at higher rates in internal company systems, but are rarely discussed in the public literature. For female pharmaceutical workers, the lack of gender/sex analysis and information makes it unclear whether the latter category of hazards actually are more common in their work - as they are for women in other sectors - or whether chemical and biological hazards are more important factors for their health and safety.
In order to prevent and reduce the exposure to these hazards, ‘risk assessment’ is the most prevailing and acceptable approach in the pharma industry. This approach scientifically evaluates and determines the dangers that a particular chemical can cause on the human health and the ways in which the humans can be exposed to this chemical/ substance. Some of the other ways to reduce the exposure of humans to these hazards are elimination of hazardous chemical; substitution of less hazardous chemical in place of very hazardous chemical; and enclosures of machines/processes (so as to eliminate the effects of human knowledge/behaviour during manufacturing operations).
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The author is the Lab Head at 3M’s R&D Centre in Gurgaon
Unknown hazards
However, due to the lack of reporting systems (specifically the long terms effects) in new chemical entities (NCEs) and active pharmaceutical ingredients (APIs), little is known about the chronic effects of these hazards on humans. Reports do however suggest that the effects of ‘hormonal and cytotoxic drugs’ have more chronic effect on pharmaceutical workforce that any other chemical.
ALSO READ: Robust HSE strategy, the safety key to success
Chemical hazards are also caused due to inhalation and skin absorption as these are the two major routes of entry of chemicals in the human body. Skin rashes, reproductive health illness, cancer and chronic respiratory diseases are some of the effects of chemicals exposure on humans. While working on ‘new’ chemicals for making effective drugs, very little is known at the outset about the effects and hazards of NCEs, APIs or intermediates that would be produced during the manufacturing process. Tests are conducted on biological media/animals using set regulatory protocols to understand the acute and chronic effects of these new chemicals on humans; however it is very difficult to conclude on the effects of these chemicals on humans when exposed to the actual manufacturing process. Recently, there has been more focus on endocrine disrupter chemicals (EDCs), which have been reported to have reproductive hazards on both male and female workforce.
Nanoparticles can pose a challenge
Exposure to microscopic particles or nanoparticles is a concern these days as these may have adverse effects on humans. These microscopic particles generally occur during the R&D/ primary production / early stages of secondary production. Whatever may be the stage, the chronic effects of these particles on pharmaceutical workforce is quite harmful and reports have suggested women workforce has been more affected than their male counterparts. Viruses, moulds, bacteria, and blood-borne pathogens generally present in R&D labs are some of the biological hazards that are difficult to be seen by naked eye but have long term effects on humans.
Ergonomics is all about fitting jobs to workers’ physical and psychological needs. Reports have suggested that ergonomic hazards contribute to the largest amount of claims and reported injuries in a pharmaceutical industry. Poor ergonomic designs like On/Off switches on machines; colours on computer monitors and other displays; awkward postures while working can lead to other hazards as well (like process safety).
Assess risk to take right action
3M India's Vinay Pathak
The pharmaceutical industry is quite unique in the sense that its workers are exposed to a range of new chemicals and compounds whose effects at times are quite unknown. Moreover it seems reasonable to assume that chemical-related health effects of working in the pharmaceutical industry, particularly long-term effects, are likely under-reported and underestimated.ALSO READ: Reducing silica dust risk by adopting right workplace safety measures
Other hazards (eg, ergonomic design and stressors) are reported at higher rates in internal company systems, but are rarely discussed in the public literature. For female pharmaceutical workers, the lack of gender/sex analysis and information makes it unclear whether the latter category of hazards actually are more common in their work - as they are for women in other sectors - or whether chemical and biological hazards are more important factors for their health and safety.
In order to prevent and reduce the exposure to these hazards, ‘risk assessment’ is the most prevailing and acceptable approach in the pharma industry. This approach scientifically evaluates and determines the dangers that a particular chemical can cause on the human health and the ways in which the humans can be exposed to this chemical/ substance. Some of the other ways to reduce the exposure of humans to these hazards are elimination of hazardous chemical; substitution of less hazardous chemical in place of very hazardous chemical; and enclosures of machines/processes (so as to eliminate the effects of human knowledge/behaviour during manufacturing operations).
____________________________________________________________________________________________________
The author is the Lab Head at 3M’s R&D Centre in Gurgaon