Workers In Pharmaceutical Industry Research Articles

Selection of Containment System for Handling Cytotoxic Drugs in Pharmaceutical Industry

This article covers the topic of choosing the right containment system based on the occupational Exposure Limit (OEL) value to handle the cytotoxic drugs or waste generated in the pharmaceutical industry based on manufacturing steps/stages/activities associated with the pharma Industry. A safe and dedicated means of containment is essential for protecting both the person and their environment. The hazards in pharmaceutical industry workers or operators who handle, manufacture or dispose of cytotoxic drugs or waste are mainly caused by its toxicity and the extent and duration of exposure. Exposure to cytotoxic substances in pharma industry occurs during the production, testing & cleaning activity. It is occurring through inhalation of dust or aerosols, absorption through the skin, ingestion owing to unsafe practices, or from waste items.

Ensuring Access to Justice for Victims of Iatrogenic Crimes

The need to ensure access to justice for victims of intentional or negligent crimes causing harm or the death of the patient (iatrogenic crimes) committed by medical and (or) pharmaceutical industry workers is conditioned by the following. Crime report check and preliminary investigation take excessively long time and then result in orders to dismiss a criminal complaint, prosecution and a criminal case due to statutes of limitations on the prosecution of an offense. The authors substantiate a number of proposals aimed at improving legislation and law enforcement practice in iatrogenic crimes cases: amendments to the Criminal Code of the Russian Federation in order to proportionally increase the statute of limitations in these cases; supplement into clause 5, part 1, art. 198 of the Code of Criminal Procedure of the Russian Federation provides for the right of the suspect, accused, his defense attorney, victim, representative to be present with the permission of the investigator at the forensic examination, to give explanations to the expert via video conferencing systems if technically possible. The proposal expressed in the procedural literature on the production of forensic examinations in cases of iatrogenic crimes not in the expert institutions of those departments that conduct a preliminary investigation, but in «independent» expert institutions, is subjected to critical analysis. It is shown that the absence of expert methods in itself does not entail the inadmissibility of the expert’s conclusion.

Work ability psychological variables in workers of the pharmaceutical industry.

Internal Marketing is also positively related to job satisfaction. However, there is a gap in the literature on the influence of Internal Marketing (IM) on Work Ability (WA) in the workers of the Pharmaceutical Industry. The aim of our study is to assess this interaction, demonstrating evidence that the Internal Marketing's five dimensions affect, positively or negatively the WA in workers of the Pharmaceutical Industry. We collected data (N = 150) from workers of Pharmaceutical Industry mean age of 37.86 years (SD=10.788), through internal advertisements at the university posted on information dissemination panels, e-mail databases and through the social LinkedIn network. The Statistical Package R-Studio program was used for statistical analysis. We verified that the group with Poor WA had a lower average value of Perceived IM than the group with Good WA. This study seems to indicate that promoting IM protocols helps increase WA among pharmaceutical industry workers.

Actual issues of hygienic regulation and creation of safe working conditions at pharmaceutical manufacturing enterprises

Introduction. The working conditions of pharmaceutical industry workers are characterized by the combined effect of unfavorable factors of the production environment, among which the leading one is chemical. The aim of study is to substantiate the basic principles and criteria for hygienic regulation of pharmaceutical products in their production to ensure safe working conditions for employees based on the results of their own research and existing requirements of technical regulations. Materials and methods. Analysis of working conditions and the prevalence of health disorders in pharmaceutical workers (according to literature data), toxicological studies of pharmaceutical substances on laboratory animals, scientific justification of hygiene standards in the air of the working area. Results. Among employees of the pharmaceutical industry, the predominant forms of production-related health disorders are diseases of the respiratory system, as well as skin dermatitis of allergic origin, liver and biliary tract diseases. Based on the results of experimental studies of domestic pharmaceutical products for the treatment of cardiovascular, oncological and mental diseases that have priority socio-economic significance, the basic principles and features of the practice of justifying the hygienic standards of medicines in the air of the working area are developed and systematized. Conclusions. During hygienic rationing of medicines, it is necessary to use a differentiated approach that allows, based on the analysis of information about the chemical structure, physical and chemical characteristics, production conditions, pharmacotherapeutic activity, and the results of studying the toxic effect in an experiment on laboratory animals, to determine the maximum permissible content in the air of the working area of medicines or to justify the prohibition of isolation with reasoned recommendations for their safe production.

Exposure assessment of pharmaceutical powders based on an environmental monitoring method: a pilot study.

About 8 million healthcare workers in the USA are potentially exposed to hazardous drugs or their toxic metabolites over a long period of time despite the fact that both the Occupational Safety and Health Administration and the European Parliament recommend the monitoring of exposure among workers dealing with substances which have carcinogenic, mutagenic or toxic effects on the reproductive system. The objective of this study is to determine exposure to active pharmaceutical ingredients (APIs) among pharmaceutical industry workers, and to develop a methodology which promotes the accurate monitoring, evaluation and control of exposure to active pharmaceutical ingredients, also in compliance with good manufacturing practice. The pilot study was designed in accordance with "Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice," issued by the U.S. Food and Drug Administration. The samples were collected with the swab technique which was recommended in the "Validation of Cleaning Processes (7/93)" guideline. The minimum numbers of locations (NL = 9) and sampling points (NL(T) = 63) were determined according to ISO 14644-1:2015 "Cleanrooms and Associated Controlled Environments" issued by the International Organization for Standardization. The samples were analyzed using an ultra performance liquid chromatography system, with an analytical method which was developed and validated according to "Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" issued by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The low limit of quantification of the employed method (17 ng/ml) enables the determination of exposure at low concentrations. While contamination was detected in 43 (68.3%) of the 63 samples collected, 20 (31.7%) could not be detected. The environmental monitoring results ranged 0-15 000 ng/cm2 and the potential risk of exposure to API was considered to be >2 g. The results clearly prove and reveal the magnitude of the hazard, both objectively and scientifically, when compared to the research which suggests that 10 ng/cm2 should be considered the prohibitory risk level in quantitative terms. Med Pr. 2020;71(6):649-63.

Occupational Health and Safety of Workers in Pharmaceutical Industries

Workers are the most significant resources for an association as they contribute the most towards the accomplishment of an association which relies upon the basic abilities of its human capital that pays to the occupational safety and health of employees in the work environment. The present study is led with the objective to highlight occupational safety and health actions for the employees and their satisfaction level accompanied occupational health and safety services provided by the chosen pharmaceutical organizations. It additionally highlighted the awareness and training program undertaken by the organizations. The analysis of the current study has been done by suitable mathematical and statistical tools consisting of percentage analysis, mean (average), standard deviation, and correlation and regression analysis depending upon the objectives of the study. The outcomes demonstrated that the representatives of both organizations are genuinely happy with the continuous training program on risk of health and safety of workers. With regard to health and safety at work, the chosen pharmaceutical companies offer their employees with numerous facilities. Likewise, the fulfillment level of the employees by means of these measures is high, which is a decent picture of a balanced relationship between the management and the employees.

Occupational Health and Safety of Workers in Pharmaceutical Industries, Himachal Pradesh, India

In this research paper a comparative study on occupational health and safety of workers has been done for two pharmaceutical companies in and around the city of Solan in Himachal Pradesh, India. The results show that more workers have accepted that workers have been provided with appropriate procedures and instructions before completing the task. Therefore, it can be concluded that management takes it seriously that workers understand the exact course of action before carrying out the task so that it is safer for workers to carry out the operations. At the same time, some employees denied that they had proper procedures and instructions. This may be due to a lack of employee awareness. The majority of employees agreed that companies regularly follow the procedures for documenting the investigation of incident, and employees appear to be contented with this provision. Thus, it can be concluded that administration appropriately reviews each incident that occurs during the execution of the task and follows the correct documentation system to determine the real cause for the incident. It is noted that most employees have accepted that companies have followed the proper procedures for inspecting and assessing equipment hazards and that workers are satisfied with them. It can therefore be concluded that the organization has recognized the need to review and investigate the risks to facilities that exist or may exist in the facilities in order to affect workers' health.

Engineering intervention to reduce API dust exposure during milling operation

The health of workers in pharmaceutical industry is at risk as a result of inhalation of Active Pharmaceutical Ingredient (API) dusts generated during powder processing. A good number of workers are employed in powder processing areas where they are exposed to high concentrations of API dust. The work presented in this paper focuses on the efficiency of dust collection system in reducing API dust exposure from the working atmosphere near a powder milling machine. The dust was captured by creating suitable air stream at milling station which was further collected in a dust collector with HEPA (High-efficiency particulate arrestance) filter. The air stream was created by a blower, which was selected on the basis to get minimum air speed of minimum 0.5 m/s in the working zones of workers. It was observed that the dust collection system successfully collects the significant amount of respirable API dust from the working atmosphere and able to reduce the dust concentration up to 80%. Further, the respirable dust concentration reduced below occupational exposure limit (OEL) of the API after the installation of engineering control.

Evaluation of genome damage in subjects occupationally exposed to possible carcinogens.

In occupational exposures, populations are simultaneously exposed to a mixture of chemicals. We aimed to evaluate DNA damage due to possible carcinogen exposure (phenylhydrazine, ethylene oxide, dichloromethane, and 1,2-dichloroethane) in lymphocytes of pharmaceutical industry workers from the same production line. Population comprised 16 subjects (9 females and 7 males) who were exposed to multiple chemicals for 8 months. Genome damage was assessed using alkaline comet assay, micronucleus assay, and comet assay coupled with fluorescent in situ hybridization (comet-FISH). After 8 months of exposure, the issue of irregular use of all available personal protective equipment (PPE) came into light. To decrease the risk of exposure, strict use of PPE was enforced. After 8 months of strict PPE use, micronuclei frequency and comet assay parameters in lymphocytes of pharmaceutical workers significantly decreased compared with prior period of irregular PPE use. Comet-FISH results indicated a significant shift in distribution of signals for the TP 53 gene toward a more frequent occurrence in the comet tail. Prolonged exposure to possible carcinogens may hinder DNA repair mechanisms and affect structural integrity of TP 53 Two indicators of loss of TP 53 gene integrity have risen, namely, TP 53 fragmentation rate in lymphocytes with persistently elevated primary damage and incidence of TP 53 deletions in undamaged lymphocytes.

Structural, Level and Typological Properties of the Psychological Aspect of Professional Responsibility of Pharmaceutical Industry Workers

The present article determines the timeliness of studying the psychological aspect of professional responsibility. It outlines its structural components: functional component including personal characteristics for actualization of the responsibility and reflective-axiological component, which stands for the understanding of responsibility and its subjective value basis by the person. It presents the results of the research, carried out on the basis of pharmaceutical industry. The research describes the following levels of professional responsibility development: operational, social and personal. It states that the formedness of the personal level of professional responsibility development decreases the manifestation of the features, distinctive on the operational and social levels. The present article outlines the typological groups of respondents, different from each other in the distinctive features of the psychological aspect of professional responsibility. It demonstrates that the highest functional indicators of professional responsibility are manifested by the group with the personal level of professional responsibility development, while the lowest belong to those with the operational level.

Systemic mistakes in hand hygiene practice in Ukraine: detection, consequences and ways of elimination.

Aim: Every year, millions of people around the world suffer from different infectious diseases, considerable part of which are hospital-acquired infections. WHO considers hand hygiene as a priority measure aimed to reduce the level of infection. We evaluated various aspects related to the situational behavior and prioritization regarding hand hygiene measures among the healthcare workers of Ukraine.Method: Identification of system mistakes in hand hygiene was carried out first of all by direct and indirect observation of the activities of medical and pharmaceutical personnel in their everyday practice as well as during their participation in trainings on routine hand hygiene. Questionnaires also were used to estimate the level of hand hygiene compliance of participants of the study. During this period 112 training courses, 315 master-classes and presentations on proper hand hygiene were realized. The target audience included health care workers of medical centers, clinics, maternity hospitals, health care organizations and staff of pharmacies and pharmaceutical manufacturing enterprises in all regions of Ukraine. 638 respondents took part in anonymous survey on hand hygiene practice. Results: The most common mistakes were to regard hand washing and hand disinfection equally, to wash hands before doing a hand disinfection, to neglect the five moments for hand hygiene and to ignore hand hygiene before and after wearing protective gloves. Practitioners, medical attendants, pharmacy and pharmaceutical industry workers highlighted the need for practical and understandable instructions of various hand hygiene procedures, including the clarification of the possible technical mistakes. This became a ground for us to create individual master classes on hand hygiene for each cluster of healthcare workers.Conclusions: Changing hand hygiene behavior and attitude is possible by beginning to observe clinical practice and by involving healthcare workers in teaching and training.

Investigation of occupational health status of female workers in pharmaceutical industry of Shandong and Gansu provinces

To investigate occupational health status of female workers in pharmaceutical industries and to propose the protective measures for the occupational health. A total of 2816 female workers from 19 pharmaceutical industries in Shandong and Gansu provinces were investigated by a questionnaire. 73.1% of female workers exposed to occupational hazards, mainly to toxic chemicals. 63.2% of them suffered from dysmenorrhea; 38.5% of them have reproductive system diseases, i.e. mammary gland hyperplasia (44.1%), cervical erosion (26.5%), uterine annex inflammation (24.2%); 17.1% of them suffered from accidental work injuries; 34.7% of them complained about low back pain, and 29.7% of them perceived hearing loss. 94.9% of female workers hoped to get the occupational health and labor protection knowledge and skills. Strengthening the supervision of labor protection for female workers, including technical measures occupational hazards control and health-related knowledge, and improving the occupational health status of female workers should be conducted.

Analysis on reproductive health status and influencing factors of female workers of pharmaceutical industry in Gansu province

To understand the reproductive health status of female workers in pharmaceutical industry of Gansu Province, to explore influencing factors, and to propose some reference basis of intervening measures. The cluster sampling method was used to study 1801 female workers from 16 pharmaceutical industries in 6 cities (Pingliang, Qingyang, Lanzhou, Dingxi, Zhangye and Jiuquan cities) of Gansu Province. The investigation was performed by interviewing and adopting questionnaires. There were the problems of labor and organization, which included the overtime work, continuous work, standing for long periods, rapid monotonous action assignments, the loading work and a variety of harmful factors in the working environment of the pharmaceutical industry in Gansu Province. There were many problems in the reproductive health status of female workers. The morbidities of abnormal menstruation and breast diseases in female workers were 43.25% and 20.43%. The order of high morbidities was hyperplasia of mammary glands (91.30%), breast adenofibroma (5.43%) and mastitis (2.99%). The order of morbidities for three reproductive system disease was adnexitis (21.57%), cervical erosion (20.06%) and vaginitis (11.09%). The rates of abnormal menstrual cycle, abnormal menstrual amount and cervical erosion increased with the length of service (P < 0.01). The taking breaks, long standing, loading work, exposure to harmful factors were related to abnormal menstruation (P < 0.05). The rapid repeat monotonous action was an important influencing factor for female reproductive system disease (OR = 1.255, 95%CI = 1.031 ∼ 1.528). There are relatively serious occupational hazards in the pharmaceutical industry of Gansu Province. The reproductive health status of female workers is not improved. Social public should pay attention to the protection for female workers.

Berufsbedingte Inhalationsallergie gegen die gemeine Hausfliege (Musca domestica)

Isolated allergy to the common housefly (Musca domestica) has only been described in four cases. Predisposing factors include high concentrations of allergens and prolonged exposure time. Two pharmaceutical industry workers, 59 and 34 years of age, both without atopy, presented with recent onset of allergic rhinitis. Their symptoms appeared about 30 minutes after exposure to Musca domestica in the closed breeding rooms. They were symptom-free with other insects, on weekends and on vacation. Skin prick tests with common inhalant allergens were negative. Prick testing with crushed Musca domestica adults, hatched eggs, contaminated nets and sand, as well as fly feces were all positive. One patient had specific IGE antibodies against Musca domestica. Both patients lacked specific IgE antibodies against other insect species and common aeroallergens. In these two patients there was a species-specific sensitization without relevant cross reactions to other arthropods. The patients were transferred to new work sites where they had no contact with Musca domestica and became symptom-free. Thus this common insect can be a relevant occupational aeroallergen.

Occupational Allergy Caused by Inhalation of Pancreatic Extracts in Medical Personnel and Identification of The Major Allergens

Background: Digestive drugs, including pancreatic extracts, have been widely prescribed in this country. There have been several reports of occupational asthma and rhinitis caused by digestive enzymes in workers in pharmaceutical industries; however, there has been no epidemiologic study among the medical personnel. Objective: We evaluated the prevalence of occupational allergy and sensitization rates to digestive drugs in medical personnel and its pathogenic mechanisms. Method: Eighteen pharmacists, 135 nurses and 123 non atopic normal controls were enrolled. Skin prick tests with 12 common aeroallergens and 5 commonly exposed drugs and its ingredients were performed. Serum specific IgE, IgG1 and IgG4 to α-amylase were measured by ELISA. SDS-PAGE followed by IgE and IgG4 immunoblot analysis was performed. Result: Work-related allergy symptoms were observed in 27.8% of pharmacists and 27.4% of nurses. IgE immunoblot analysis demonstrated 3 components which of 19 and 24 kDa were more frequently identified in sera from symptomatic subjects. IgG4 immunoblot analysis demonstrated 2 components of which 19 kDa was more frequently identified in sera from asymptomatic subjects. Conclusion: Digestive drug powders could induce IgEmediated respiratory allergy symptoms in the medical personnel. Two major allergenic components of α-amylase (19, 24 kDa) were identified. Specific IgG4 response to 19 kDa might have a role for preventing the development of workrelated allergy symptoms after exposure to α-amylase powder. (Korean J Asthma Allergy Clin Immunol 2007; 27:10-19)

Liver damage in pharmaceutical industry workers.

A group of workers who were employed at a pharmaceutical manufacturing company and who participated in the entire production cycle were studied. Numerous substances, including iodo-chloro-oxyquinoline, erythromycin, disinfectants, small amounts of cortisones, and preserving agents (prevan and parabenzoates), were used in the manufacturing processes. A control group comprised individuals who were not exposed to hepatotoxic substances. This investigation was designed to determine the risk of hepatotoxicity in the pharmaceutical industry, and a protocol was used that allowed for ease of screening. In the presence of a physician, all subjects completed a clinical history questionnaire. They all underwent a general clinical examination, and specific blood chemistry tests were performed. Certain liver indices that were correlated with cytotoxicity were significantly higher in the pharmaceutical workers than among the controls. The findings confirmed that there was a problem of hepatic involvement among workers in this sector, indicating that the clinical-biohumoral screening protocol used in this study was valid for identifying subjects at risk of hepatotoxicity.

Census based mortality study of pharmaceutical industry workers.

This study was designed to investigate whether the mortality of British pharmaceutical industry workers showed any evidence of occupationally related patterns associated with particular sections of the industry with special emphasis on cancers and respiratory diseases. The data were extracted from census schedules by the Office of Population Censuses and Surveys using occupational categories recorded by pharmaceutical workers at the 1961 and 1971 censuses of England and Wales. Subsequent mortality was ascertained through the National Health Service Central Registry. Both cohorts, followed up to the end of 1981, showed a "healthy worker effect," with overall SMRs ranging from 0.77 to 1.04, though comparison with the employed populations of the longitudinal study reduced this effect by 25%. Evidence of inconsistent excess mortality was noted in small numbers for suicide (SMR 0.91 to 2.79) and cancer of the large intestine (SMR 1.09 to 2.38). There was no clear association between the type of industry and the causes of death investigated. Although the census based study has several methodological shortcomings, there was no evidence, on the basis of this study, to suggest any excess mortality risk from employment in the pharmaceutical industry.