Organizational Health and Safety New Chemical Entities

Question: Describe about the Organizational Health and Safety for New Chemical Entities. Answer: I have been hired in a pharmaceutical R D named X pharmaceuticals. X pharmaceuticals is mainly working on the new chemical entities (NCEs) and these NCEs were being evaluated in different animal models like rat and mice. After completion of evaluation of NCEs in animal models, these NCEs would be evaluated in clinical trial in respective disease areas. These NCEs were being evaluated on different therapeutic targets for respective disease area. Vision of this company is to provide cost effective medicine to the common people. Mission of this company is to provide safe and efficacious medicine to the people. X pharmaceuticals was established in 2002. X pharmaceutical was doing good business since 2008. Two molecules were successfully completed phase 3 clinical trials and these molecules were proved effective and safe in respective disease area. By virtue of licensing of these two compounds, X pharmaceuticals generated good amount of revenue and company is planning to invest further i nto the research on new medicine. X pharmaceuticals is taking care of both personnel and national culture. In case of personnel culture, company proposes to employees to adapt to the company culture. X pharmaceuticals is vey employee friendly company. In this company, safety of the patients is of prime importance. In case of national culture, company adopted all the rules and regulations of the national interest (Bamfield, 2006). I implemented training programme for occupational Health and Safety in the organization. For this purpose, I had analyzed safety standards in the organization. For this purpose, analysis of the safety standards were analyzed at the three levels like organization, task and person. At the organizational level, these standards were evaluated by understanding rules and regulations implemented by the organization, training provided for safety, knowing budget allocated for safety, understanding willingness of the management and knowing past activities of the organization for the implementation safety standards in the organization. In task based analysis, I focused on the activities related to the experimental animals like rat and mice. I considered mainly two safety issues in the handling of the animals. I considered, these two safety issues based on the frequent reporting of these two issues. First is safe handling of the animals. If person who was handling animals had not been trained pr operly, then there is possibility of bite off by the animals. Second safety concern was the proper disposal of needle used for the injection to the animals. If needle thrown in the dustbin after use without applying any closure, there would be possibility of hurting to the people who would clean dustbin. I analyzed persons based on the past history of unsafe handling of the animals and unsafe disposal of the needle. I selected those persons, who had experienced frequent rat and mice bite and persons who had frequently disposed off needles without taking any safety precautions (Clarke, 2016; Homer, 2013). Objective of the training programme was implementation of the safe animal handling procedures in the organization. This objective helped in improving the quality of work with all the safety precautions. This helped in the overall productivity of the organization. There would be interruption in the work due to injury caused by unhealthy or unsafe handling of the animals. I incorporated both practical and theoretical training to the person. Person who would handle animals should be experienced and properly trained for handling the animals. This training was provided by the well experienced trainer and continuous monitoring was done by expert in the field. Along with the experimental training, person was given theoretical or class room knowledge. This theoretical training incorporated video demonstration of handling of animals and route of administration of drugs to the animals. Also, it incorporated power point presentation based on the theoretical information of handling of animals. I incorporated standard operating procedure for the handling of animals and administration of drugs to the animals. This standard operating procedure comprised of step wise procedure, troubleshooting instructions and safety precautions. After the completion of the training, person was evaluated for all the practical aspects. Person was allowed to perform independent experiments, after the successful completion of the evaluation of handling of the animals. Learning principles involved in this training programme were behavior of the animals, disease of the animals and risk factors due to animals bite or due to the infection caused by the animals. I also gave knowledge about the use of personal protective equipment (PPE) for the experimenter. These PPEs included hand gloves, face mask, head cap and apron. These PPEs helped in the protection from the bite of animals and infection due to the animals. Experimental training was provided on-the-job training and theoretical training was provi ded off-the-job training. In both experimental and theoretical training, my experience was very encouraging. Trainee adopted all the experimental procedures and these trainees are now well skilled with the handling of the animals. In theoretical training also, trainees acquired all the knowledge and currently following all the instructions provided in the training session (Donovan Brown, 2013; Ducommun, 2008; Rose Cohrssen, 2011). This training provided all the required information and skills for the safe handling of the animals. These training contents were delivered to the trainees in a very efficient and sophisticated manner. Delivery of the contents of training programme was well accepted by all the trainees and they were happy with the overall training procedures. These trainees would be evaluated on the regular interval of one month both for experimental and theoretical aspects. I would like improve in the training procedure by incorporating recent advancements in the handling of the animals. Recently different catheters were developed to infuse continuous drug in the animals, so that there would be less handling of the animals and risk of bite and infection due to animals would be reduced. I would plan for unscheduled visit to the workplace to observe experimental procedure. This would help to implement accurate animal procedure on day to day basis. By implementing, both experimental and theoretical tra ining, I strongly believed in the requirement of the both types of knowledge in the effective implementation of safe procedures in the organization (McGreevya et al., 2014; Reese, 2015). References: Bamfield, P. (2006). Research and Development in the Chemical and Pharmaceutical Industry. John Wiley Sons. Clarke, S. (2016). Occupational Health and Safety. CRC Press. Donovan, J., Brown, P. (2013). Care and Handling of Laboratory Mice. Current Protocols in Microbiology. DOI: 10.1002/9780471729259.mca03ns31. Ducommun, D. (2008). The Complete Guide to Rat Training: Tricks and Games for Rat Fun and Fitness. T.F.H. Publications. Homer, L.C., Alderman, T.S., Blair, H.A., Brocard, A.S., et al., (2013). Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories. Biosecurity Bioterrorism, 11(1), 10-9. McGreevya, P. D., Henshalla, C., Starlinga, M., J., McLeanb, A. N., Boakesc, R. A. (2014). The importance of safety signals in animal handling and training. Journal of Veterinary Behavior: Clinical Applications and Research, 9(6), 382387. Reese, C.D. (2015). Occupational Health and Safety Management: A Practical Approach. CRC Press. Rose, V. E., Cohrssen, B. (2011). Patty's Industrial Hygiene. John Wiley Sons.