This document discusses employee safety when handling cytotoxic drugs. It notes that cytotoxic drugs can damage both cancer cells and normal cells, posing risks to employees. Anyone working with patients receiving these drugs is at risk of exposure. The risks include reported toxic effects on health workers like dermatitis, nausea, and increased risk of spontaneous abortion. The document outlines several factors that influence safety risks, including drug-related factors like carcinogenic potential and physicochemical properties, worker-related factors like seniority, stress, and duration of exposure, and equipment-related safeguards. It emphasizes the importance of protective measures and quality management in minimizing risks to employees from cytotoxic drugs.
Chemotherapy safety and handling-Thao's presentationHA VO THI
This document discusses chemotherapy safety and handling guidelines. It outlines the risks of hazardous drug exposure, engineering controls like ventilation requirements, personal protective equipment, safe storage, compounding and administration practices, decontamination procedures, medical surveillance, and future steps for improving safety in Vietnam. The key points are that chemotherapy drugs pose risks and strict protocols are needed to minimize exposure for healthcare workers handling these agents.
Cytotoxic agents used in chemotherapy have anti-cancer effects but can also damage normal tissues. Proper handling and protective measures are needed due to their hazardous nature. The document outlines guidelines for safely receiving, compounding, and administering cytotoxic drugs, even in resource-limited settings. Key recommendations include restricting access to drug storage areas, adhering to work practices to minimize exposure, using proper personal protective equipment, and following aseptic technique during compounding. The overall goal is to minimize risks to healthcare workers through application of hazard control measures.
TREATMENT OPTIONS FOR TNBC ESMO 2022.pptxSeraj Aldeen
Triple negative breast cancer (TNBC) is an aggressive form of breast cancer defined by a lack of estrogen, progesterone, and HER2 receptors. It accounts for 15-20% of breast cancers and is associated with poorer prognosis and shorter survival. Current treatment options for TNBC include chemotherapy. Immunotherapy with PD-1 inhibitors such as pembrolizumab shows promise based on results from the KEYNOTE-355 trial showing improved progression-free survival compared to chemotherapy alone in patients with TNBC. PARP inhibitors in combination with platinum-based chemotherapy may provide a preferred treatment option for patients with BRCA1/2 mutated TNBC based on clinical trial results and NCCN guidelines.
It is a PPT presentation talks about the magnitude of benefit from Adding Trastuzumab to Adjuvant Chemotherapy in Breast Cancer. It will discuss briefly the most important clinical evidence in this setting. The aim of such work is to know how worthy is to give your patient Trastuzumab with her adjuvant chemotherapy in your clinical practice as a medical oncologist.
Clinical pharmacist Managed Oncology Clinic In University Hospitalfathy alazhary
The document discusses the role and history of clinical pharmacists in managing oncology clinics. It describes how clinical pharmacists began in the 1960s and their role has expanded over the years. The main goals of clinical pharmacists are to assist physicians in prescribing and monitoring drug therapy, assist medical staff, and maximize patient compliance. Oncology pharmacists play a vital role on the healthcare team by ensuring optimal medication regimens for cancer patients, educating patients, and monitoring patients for side effects during chemotherapy treatment.
40 bmt nurse interview questions and answers pdfmillerwilliam635
This document provides information and interview questions for a bone marrow transplant (BMT) nurse interview. It includes 20 sample interview questions with detailed answers and tips for BMT nurses to prepare for interviews. Additional resources are provided, including ebooks on becoming a nurse, making extra money as a nurse, and avoiding mistakes in one's nursing career. Links are also included to materials on job interview skills like answering common questions, preparing for an interview, and negotiating salary. The document aims to equip BMT nurse candidates with guidance on successfully interviewing for nursing roles.
Medication Safety- Administration and monitoring.pptxLatha Venkatesan
The document discusses medication safety and reducing medication errors. It covers several key points:
1) Medication errors are common, especially during transitions of care between settings. The WHO aims to reduce medication-related harm by 50% through their "Medication Without Harm" challenge.
2) Medication errors can occur at various stages like prescribing, transcribing, dispensing, and administering. High-risk medications and situations like polypharmacy also increase error risk.
3) Strategies to improve safety include training, protocols, technology like CPOE, reconciliation, and empowering patients. A multidisciplinary team approach is important to strengthen systems and practices.
adverse events
their first 4 years of
practice or who have
completed Modules
1 and 2
Fundamental
For all participants Drug administration
regardless of
experience level
Module 1: National
Inpatient Medication
Chart
Module 2: Therapy
delivery pumps
Modules 3–5 build on the skills and knowledge from previous modules.
Module 1 focuses on the medication chart. Module 2 covers therapy pumps.
Module 3 addresses drug administration. Module 4 examines drug reactions
and adverse events. Module 5 considers error awareness.
Chemotherapy safety and handling-Thao's presentationHA VO THI
This document discusses chemotherapy safety and handling guidelines. It outlines the risks of hazardous drug exposure, engineering controls like ventilation requirements, personal protective equipment, safe storage, compounding and administration practices, decontamination procedures, medical surveillance, and future steps for improving safety in Vietnam. The key points are that chemotherapy drugs pose risks and strict protocols are needed to minimize exposure for healthcare workers handling these agents.
Cytotoxic agents used in chemotherapy have anti-cancer effects but can also damage normal tissues. Proper handling and protective measures are needed due to their hazardous nature. The document outlines guidelines for safely receiving, compounding, and administering cytotoxic drugs, even in resource-limited settings. Key recommendations include restricting access to drug storage areas, adhering to work practices to minimize exposure, using proper personal protective equipment, and following aseptic technique during compounding. The overall goal is to minimize risks to healthcare workers through application of hazard control measures.
TREATMENT OPTIONS FOR TNBC ESMO 2022.pptxSeraj Aldeen
Triple negative breast cancer (TNBC) is an aggressive form of breast cancer defined by a lack of estrogen, progesterone, and HER2 receptors. It accounts for 15-20% of breast cancers and is associated with poorer prognosis and shorter survival. Current treatment options for TNBC include chemotherapy. Immunotherapy with PD-1 inhibitors such as pembrolizumab shows promise based on results from the KEYNOTE-355 trial showing improved progression-free survival compared to chemotherapy alone in patients with TNBC. PARP inhibitors in combination with platinum-based chemotherapy may provide a preferred treatment option for patients with BRCA1/2 mutated TNBC based on clinical trial results and NCCN guidelines.
It is a PPT presentation talks about the magnitude of benefit from Adding Trastuzumab to Adjuvant Chemotherapy in Breast Cancer. It will discuss briefly the most important clinical evidence in this setting. The aim of such work is to know how worthy is to give your patient Trastuzumab with her adjuvant chemotherapy in your clinical practice as a medical oncologist.
Clinical pharmacist Managed Oncology Clinic In University Hospitalfathy alazhary
The document discusses the role and history of clinical pharmacists in managing oncology clinics. It describes how clinical pharmacists began in the 1960s and their role has expanded over the years. The main goals of clinical pharmacists are to assist physicians in prescribing and monitoring drug therapy, assist medical staff, and maximize patient compliance. Oncology pharmacists play a vital role on the healthcare team by ensuring optimal medication regimens for cancer patients, educating patients, and monitoring patients for side effects during chemotherapy treatment.
40 bmt nurse interview questions and answers pdfmillerwilliam635
This document provides information and interview questions for a bone marrow transplant (BMT) nurse interview. It includes 20 sample interview questions with detailed answers and tips for BMT nurses to prepare for interviews. Additional resources are provided, including ebooks on becoming a nurse, making extra money as a nurse, and avoiding mistakes in one's nursing career. Links are also included to materials on job interview skills like answering common questions, preparing for an interview, and negotiating salary. The document aims to equip BMT nurse candidates with guidance on successfully interviewing for nursing roles.
Medication Safety- Administration and monitoring.pptxLatha Venkatesan
The document discusses medication safety and reducing medication errors. It covers several key points:
1) Medication errors are common, especially during transitions of care between settings. The WHO aims to reduce medication-related harm by 50% through their "Medication Without Harm" challenge.
2) Medication errors can occur at various stages like prescribing, transcribing, dispensing, and administering. High-risk medications and situations like polypharmacy also increase error risk.
3) Strategies to improve safety include training, protocols, technology like CPOE, reconciliation, and empowering patients. A multidisciplinary team approach is important to strengthen systems and practices.
adverse events
their first 4 years of
practice or who have
completed Modules
1 and 2
Fundamental
For all participants Drug administration
regardless of
experience level
Module 1: National
Inpatient Medication
Chart
Module 2: Therapy
delivery pumps
Modules 3–5 build on the skills and knowledge from previous modules.
Module 1 focuses on the medication chart. Module 2 covers therapy pumps.
Module 3 addresses drug administration. Module 4 examines drug reactions
and adverse events. Module 5 considers error awareness.
High alert medications are those that carry an increased risk of harming patients if used in error. They require an independent double check by two individuals and strict controls over prescribing, storage, and administration. High alert and concentrated electrolyte medications must be stored in a locked cabinet with the key held by the head nurse. They are to be prescribed only by physicians with complete order details and cannot contain prohibited abbreviations.
This document summarizes information about small cell lung cancer (SCLC), including its incidence, risk factors, staging, prognosis, diagnostic workup, and treatment approaches. Some key points:
- SCLC accounts for 15-20% of lung cancer cases and has a median age of diagnosis of 64. Most patients are smokers.
- Limited stage SCLC is confined to one lung and nearby lymph nodes, while extensive stage has spread further. Median survival is 25 months for limited vs 9 months for extensive disease.
- Workup includes imaging, biopsy, and brain MRI due to the risk of brain metastases. PET-CT helps determine extent of disease.
- Historically, surgery and chemotherapy alone did
Capecitabine is an oral chemotherapeutic agent used to treat metastatic breast and colorectal cancers. It is enzymatically converted in tumors to 5-fluorouracil to inhibit DNA synthesis and slow tumor growth. Clinical trials showed capecitabine monotherapy provided clinical benefit for 60% of metastatic breast cancer patients. When combined with docetaxel, capecitabine reduced the risk of progression and death compared to docetaxel alone. Common side effects included diarrhea, hand-foot syndrome, and fatigue, which were managed through supportive care measures.
Medication errors are preventable events that can harm patients. This presentation discussed medication errors, including classifications, types, causes, and strategies to prevent them. It summarized key points about prescribing errors, dispensing errors, administration errors, and monitoring errors. The presentation emphasized the importance of following proper procedures, such as double checking orders and medications, reconciling medications, and educating staff on policies to minimize errors. Overall, the presentation aimed to increase awareness of medication errors and promote safe practices to protect patients.
Everyday healthcare workers are exposed to hazardous drugs used in oncology and other chemotherapeutic patient treatments. The nurses, doctors, pharmacists, veterinarians, animal handlers, environmental services, and other workers are exposed to airborne dust and aerosols as well as surface contamination from contaminated gloves and gowns. The surface contamination spreads and unsuspecting workers are exposed inadvertently. NOSH has recognized at least 36 drugs of concern which may lead to cancer or reproductive issues. Learn more about this occupational health hazards and what can be done to protect workers from harm.
This document is the disclaimer for the 8th edition of the Philippine National Formulary. It states that the medicines and prescribing information listed were compiled through collaboration of various experts applying current clinical practice standards. However, there is no guarantee that new medicines or information made available after compilation are included. It also notes that the information provided is a synopsis and not a complete representation of official product labeling. Readers are advised to confirm the information with other sources, especially for new updates.
M. Shareef, a 65-year-old male with diabetes and coronary artery disease, presented with chest pain, breathlessness, fever and vomiting for 6 hours. He was admitted to the ICU where an ECG showed signs of a myocardial infarction. His treatment included aspirin, clopidogrel, streptokinase, morphine and metoclopramide. As a known diabetic and heart disease patient, he requires lifestyle modifications and optimized medical management to control his risk factors and prevent further cardiac complications.
Safe administration & preparation of cancer chemotherapy by irene weruKesho Conference
This document provides information on safe administration and preparation of cancer chemotherapy. It discusses the hazards of anticancer medicines and outlines various safety considerations for personnel, patients, and the environment. Specific guidelines are presented for reconstitution, administration, storage, spill management, oral drug handling, and waste disposal. The importance of patient safety is emphasized, and factors to consider for individual patients are described. Medication errors can occur at various stages, so communication and information sharing need to be standardized. Overall, strict protocols and protective measures are necessary when working with hazardous chemotherapy drugs.
Treatment of her2 positive breast cancerManar Malik
This document discusses treatment of HER2 positive breast cancer. It describes HER2 as a tyrosine kinase receptor that is overexpressed in 15-30% of breast cancers and promotes cell proliferation. Testing methods like IHC and FISH are used to detect HER2 status. Targeted therapies have been developed that block HER2 signaling including Trastuzumab, Pertuzumab, Lapatinib, and T-DM1. Several neoadjuvant and adjuvant clinical trials are summarized that demonstrate improved outcomes when these anti-HER2 therapies are added to chemotherapy regimens for both early-stage and metastatic HER2 positive breast cancer.
The document discusses oral mucositis, a common side effect of cancer treatment. It provides an overview of the pathobiology, risk factors, impact, and economic costs of mucositis. While research has improved understanding of the mechanisms involved, current guidelines still show few effective prevention and treatment options. Further research is needed to better understand mucositis at the molecular level and develop novel prevention and management strategies.
Health care workers (HCWs) involved with hazardous drugs (HDs) may be exposed to them in the air, on work surfaces, clothing, patient excreta, etc. At-risk workers include pharmacists, pharmacy technicians, nurses, physicians, operating room staff, environmental services workers, research laboratory workers, home HCWs, and others. Studies have linked workplace HD exposures with health effects such as skin rashes, adverse reproductive outcomes, leukemia, and other cancers. Because risk is influenced by the extent of HD exposure as well as the potency and toxicity of HDs, USP standards have been developed to minimize exposure and promote HCW safety. Although there is an increased awareness of the risks of HD exposure, these safety standards are not universally implemented and compliance is often inadequate. Occupational health/safety professionals are responsible for executing a comprehensive HD program that includes hazard communication, administrative, and engineering controls.
This document discusses fixed dose drug combinations (FDDCs), including their definitions, types, rationality, advantages, and disadvantages. It defines FDDCs as combinations of two or more active pharmaceutical ingredients formulated as a single medicine. FDDCs can be rational if they have complementary mechanisms of action, decrease resistance, and increase efficacy and compliance while decreasing adverse effects. However, irrational FDDCs lack pharmacological justification and may increase side effects and costs without additional benefit. The document also notes issues with overpromotion of irrational FDDCs in India and efforts to better regulate these combinations.
- Oral mucositis is a common side effect of cancer therapy like chemotherapy and radiation therapy. It involves inflammation and ulceration of the mucous membranes in the mouth.
- Chemotherapy-induced mucositis is caused by drugs damaging the basal epithelial cells. This triggers an inflammatory response and ulceration. Risk is higher with certain chemo agents and combinations with radiation.
- Radiation-induced mucositis occurs as radiation damages the mucosal stem cells, inhibiting cell regeneration and causing the epithelium to break down over the treatment period. The severity depends on factors like daily dose and total cumulative dose.
The document discusses four major clinical trials investigating the use of Herceptin (trastuzumab) in the adjuvant setting for HER2-positive breast cancer: HERA, NSABP B-31, Intergroup N9831, and BCIRG 006. The HERA trial is randomly assigning over 3,000 patients to 1 or 2 years of Herceptin or observation after standard adjuvant therapy. The other trials are comparing Herceptin-containing regimens to standard chemotherapy alone. The goals are to establish Herceptin's efficacy, safety, and optimal duration in early-stage disease.
This document outlines a strategic plan to minimize medication errors in healthcare. It begins by defining medication errors and classifying their significance. It then discusses the extent of medication errors, finding they occur in 1 in every 19 hospital admissions. The document examines the many factors that contribute to errors, including poor communication, look-alike drug names, and busy work environments. It also presents approaches to reduce errors such as electronic medical records, barcoding medications, and computerized physician order entry, which can reduce serious medication errors by up to 81%. The goal of the plan is to understand, prevent, and minimize medication errors to improve patient safety.
Dr. Jannatul Ferdoush discusses the importance of pharmacovigilance in her presentation. Pharmacovigilance is the detection, assessment, understanding and prevention of adverse drug reactions. It is needed because clinical trials provide insufficient safety evidence, medicines can have unexpected harmful effects like thalidomide in the 1960s, and adverse drug reactions can be life-threatening and expensive. Healthcare professionals should monitor and report any suspected adverse drug reactions to help improve patient safety, public health, and the assessment of drug benefits, harms, and risks.
Pharmacovigilance is the science of monitoring the safety of medicines. It plays a key role in identifying adverse drug reactions and preventing harm to patients. The goal of pharmacovigilance is to monitor drug safety, identify health risks, and prevent harm through careful tracking of side effects from clinical trials through a drug's entire lifecycle on the market. Major organizations like the FDA, EMEA, and WHO work to coordinate pharmacovigilance efforts internationally and protect public health.
The document discusses counterfeit medicine, including its definition, prevalence, consequences, evaluation, and methods to prevent it. It states that counterfeit medicine ranges from having no active ingredients to incorrect ingredients, and affects both developing and developed countries. Evaluation methods include using RFID, barcodes, Raman spectroscopy, and forensic analysis to identify counterfeits. Legislative authorities and improved regulation aim to curb the estimated $90 billion global counterfeit drug industry that causes over 1 million deaths annually.
Analytical method development of anticancer drugs by UV visible spectroscopySudip Khan
This document provides an overview of analytical method development for anticancer drugs using UV visible spectroscopy. It discusses cancer and its causes, definition and types of anticancer drugs. It describes the principle, instrumentation and applications of UV visible spectroscopy. The key techniques discussed are single beam and double beam systems. It also covers validation process for analytical methods and documentation requirements. UV visible spectroscopy is a commonly used technique for pharmaceutical analysis due to its simplicity, cost effectiveness and ability to provide accurate results.
Sustained and targeted drug delivery for breast cancer therapy using biodegradable polymeric nanoparticles can:
1) Deliver anti-cancer drugs directly to the tumor site, achieving higher drug concentrations in tumors compared to free drug administration.
2) Provide lowered toxic side effects by reducing the necessary systemic drug dose.
3) Potentially deliver multiple anti-cancer drugs simultaneously or sequentially for improved therapeutic efficacy.
High alert medications are those that carry an increased risk of harming patients if used in error. They require an independent double check by two individuals and strict controls over prescribing, storage, and administration. High alert and concentrated electrolyte medications must be stored in a locked cabinet with the key held by the head nurse. They are to be prescribed only by physicians with complete order details and cannot contain prohibited abbreviations.
This document summarizes information about small cell lung cancer (SCLC), including its incidence, risk factors, staging, prognosis, diagnostic workup, and treatment approaches. Some key points:
- SCLC accounts for 15-20% of lung cancer cases and has a median age of diagnosis of 64. Most patients are smokers.
- Limited stage SCLC is confined to one lung and nearby lymph nodes, while extensive stage has spread further. Median survival is 25 months for limited vs 9 months for extensive disease.
- Workup includes imaging, biopsy, and brain MRI due to the risk of brain metastases. PET-CT helps determine extent of disease.
- Historically, surgery and chemotherapy alone did
Capecitabine is an oral chemotherapeutic agent used to treat metastatic breast and colorectal cancers. It is enzymatically converted in tumors to 5-fluorouracil to inhibit DNA synthesis and slow tumor growth. Clinical trials showed capecitabine monotherapy provided clinical benefit for 60% of metastatic breast cancer patients. When combined with docetaxel, capecitabine reduced the risk of progression and death compared to docetaxel alone. Common side effects included diarrhea, hand-foot syndrome, and fatigue, which were managed through supportive care measures.
Medication errors are preventable events that can harm patients. This presentation discussed medication errors, including classifications, types, causes, and strategies to prevent them. It summarized key points about prescribing errors, dispensing errors, administration errors, and monitoring errors. The presentation emphasized the importance of following proper procedures, such as double checking orders and medications, reconciling medications, and educating staff on policies to minimize errors. Overall, the presentation aimed to increase awareness of medication errors and promote safe practices to protect patients.
Everyday healthcare workers are exposed to hazardous drugs used in oncology and other chemotherapeutic patient treatments. The nurses, doctors, pharmacists, veterinarians, animal handlers, environmental services, and other workers are exposed to airborne dust and aerosols as well as surface contamination from contaminated gloves and gowns. The surface contamination spreads and unsuspecting workers are exposed inadvertently. NOSH has recognized at least 36 drugs of concern which may lead to cancer or reproductive issues. Learn more about this occupational health hazards and what can be done to protect workers from harm.
This document is the disclaimer for the 8th edition of the Philippine National Formulary. It states that the medicines and prescribing information listed were compiled through collaboration of various experts applying current clinical practice standards. However, there is no guarantee that new medicines or information made available after compilation are included. It also notes that the information provided is a synopsis and not a complete representation of official product labeling. Readers are advised to confirm the information with other sources, especially for new updates.
M. Shareef, a 65-year-old male with diabetes and coronary artery disease, presented with chest pain, breathlessness, fever and vomiting for 6 hours. He was admitted to the ICU where an ECG showed signs of a myocardial infarction. His treatment included aspirin, clopidogrel, streptokinase, morphine and metoclopramide. As a known diabetic and heart disease patient, he requires lifestyle modifications and optimized medical management to control his risk factors and prevent further cardiac complications.
Safe administration & preparation of cancer chemotherapy by irene weruKesho Conference
This document provides information on safe administration and preparation of cancer chemotherapy. It discusses the hazards of anticancer medicines and outlines various safety considerations for personnel, patients, and the environment. Specific guidelines are presented for reconstitution, administration, storage, spill management, oral drug handling, and waste disposal. The importance of patient safety is emphasized, and factors to consider for individual patients are described. Medication errors can occur at various stages, so communication and information sharing need to be standardized. Overall, strict protocols and protective measures are necessary when working with hazardous chemotherapy drugs.
Treatment of her2 positive breast cancerManar Malik
This document discusses treatment of HER2 positive breast cancer. It describes HER2 as a tyrosine kinase receptor that is overexpressed in 15-30% of breast cancers and promotes cell proliferation. Testing methods like IHC and FISH are used to detect HER2 status. Targeted therapies have been developed that block HER2 signaling including Trastuzumab, Pertuzumab, Lapatinib, and T-DM1. Several neoadjuvant and adjuvant clinical trials are summarized that demonstrate improved outcomes when these anti-HER2 therapies are added to chemotherapy regimens for both early-stage and metastatic HER2 positive breast cancer.
The document discusses oral mucositis, a common side effect of cancer treatment. It provides an overview of the pathobiology, risk factors, impact, and economic costs of mucositis. While research has improved understanding of the mechanisms involved, current guidelines still show few effective prevention and treatment options. Further research is needed to better understand mucositis at the molecular level and develop novel prevention and management strategies.
Health care workers (HCWs) involved with hazardous drugs (HDs) may be exposed to them in the air, on work surfaces, clothing, patient excreta, etc. At-risk workers include pharmacists, pharmacy technicians, nurses, physicians, operating room staff, environmental services workers, research laboratory workers, home HCWs, and others. Studies have linked workplace HD exposures with health effects such as skin rashes, adverse reproductive outcomes, leukemia, and other cancers. Because risk is influenced by the extent of HD exposure as well as the potency and toxicity of HDs, USP standards have been developed to minimize exposure and promote HCW safety. Although there is an increased awareness of the risks of HD exposure, these safety standards are not universally implemented and compliance is often inadequate. Occupational health/safety professionals are responsible for executing a comprehensive HD program that includes hazard communication, administrative, and engineering controls.
This document discusses fixed dose drug combinations (FDDCs), including their definitions, types, rationality, advantages, and disadvantages. It defines FDDCs as combinations of two or more active pharmaceutical ingredients formulated as a single medicine. FDDCs can be rational if they have complementary mechanisms of action, decrease resistance, and increase efficacy and compliance while decreasing adverse effects. However, irrational FDDCs lack pharmacological justification and may increase side effects and costs without additional benefit. The document also notes issues with overpromotion of irrational FDDCs in India and efforts to better regulate these combinations.
- Oral mucositis is a common side effect of cancer therapy like chemotherapy and radiation therapy. It involves inflammation and ulceration of the mucous membranes in the mouth.
- Chemotherapy-induced mucositis is caused by drugs damaging the basal epithelial cells. This triggers an inflammatory response and ulceration. Risk is higher with certain chemo agents and combinations with radiation.
- Radiation-induced mucositis occurs as radiation damages the mucosal stem cells, inhibiting cell regeneration and causing the epithelium to break down over the treatment period. The severity depends on factors like daily dose and total cumulative dose.
The document discusses four major clinical trials investigating the use of Herceptin (trastuzumab) in the adjuvant setting for HER2-positive breast cancer: HERA, NSABP B-31, Intergroup N9831, and BCIRG 006. The HERA trial is randomly assigning over 3,000 patients to 1 or 2 years of Herceptin or observation after standard adjuvant therapy. The other trials are comparing Herceptin-containing regimens to standard chemotherapy alone. The goals are to establish Herceptin's efficacy, safety, and optimal duration in early-stage disease.
This document outlines a strategic plan to minimize medication errors in healthcare. It begins by defining medication errors and classifying their significance. It then discusses the extent of medication errors, finding they occur in 1 in every 19 hospital admissions. The document examines the many factors that contribute to errors, including poor communication, look-alike drug names, and busy work environments. It also presents approaches to reduce errors such as electronic medical records, barcoding medications, and computerized physician order entry, which can reduce serious medication errors by up to 81%. The goal of the plan is to understand, prevent, and minimize medication errors to improve patient safety.
Dr. Jannatul Ferdoush discusses the importance of pharmacovigilance in her presentation. Pharmacovigilance is the detection, assessment, understanding and prevention of adverse drug reactions. It is needed because clinical trials provide insufficient safety evidence, medicines can have unexpected harmful effects like thalidomide in the 1960s, and adverse drug reactions can be life-threatening and expensive. Healthcare professionals should monitor and report any suspected adverse drug reactions to help improve patient safety, public health, and the assessment of drug benefits, harms, and risks.
Pharmacovigilance is the science of monitoring the safety of medicines. It plays a key role in identifying adverse drug reactions and preventing harm to patients. The goal of pharmacovigilance is to monitor drug safety, identify health risks, and prevent harm through careful tracking of side effects from clinical trials through a drug's entire lifecycle on the market. Major organizations like the FDA, EMEA, and WHO work to coordinate pharmacovigilance efforts internationally and protect public health.
The document discusses counterfeit medicine, including its definition, prevalence, consequences, evaluation, and methods to prevent it. It states that counterfeit medicine ranges from having no active ingredients to incorrect ingredients, and affects both developing and developed countries. Evaluation methods include using RFID, barcodes, Raman spectroscopy, and forensic analysis to identify counterfeits. Legislative authorities and improved regulation aim to curb the estimated $90 billion global counterfeit drug industry that causes over 1 million deaths annually.
Analytical method development of anticancer drugs by UV visible spectroscopySudip Khan
This document provides an overview of analytical method development for anticancer drugs using UV visible spectroscopy. It discusses cancer and its causes, definition and types of anticancer drugs. It describes the principle, instrumentation and applications of UV visible spectroscopy. The key techniques discussed are single beam and double beam systems. It also covers validation process for analytical methods and documentation requirements. UV visible spectroscopy is a commonly used technique for pharmaceutical analysis due to its simplicity, cost effectiveness and ability to provide accurate results.
Sustained and targeted drug delivery for breast cancer therapy using biodegradable polymeric nanoparticles can:
1) Deliver anti-cancer drugs directly to the tumor site, achieving higher drug concentrations in tumors compared to free drug administration.
2) Provide lowered toxic side effects by reducing the necessary systemic drug dose.
3) Potentially deliver multiple anti-cancer drugs simultaneously or sequentially for improved therapeutic efficacy.
DiaGenomi Ltd. is a genetic testing company that offers several tests through their MyRISQ platform, including CardioRISQ. CardioRISQ is a cardiac risk assessment test that combines genetic testing for mutations in several genes related to cardiovascular disease with a lifestyle questionnaire. It provides a personalized assessment of cardiovascular disease risk. The test involves collecting a saliva sample for genetic analysis, completing an online lifestyle questionnaire, and receiving a medical report integrating this genetic and lifestyle data to provide a risk assessment and treatment plan tailored to the individual. DiaGenomi aims to improve prevention and management of disease through this holistic, personalized approach to genetic testing.
Advanced study of natural sources of anti-cancerharmoini
This document discusses natural sources of anti-cancer agents. It notes that plant-based drug discovery has resulted in important anticancer agents derived from plants, marine organisms, and microorganisms. It also outlines numerous phytochemicals found in fruits and vegetables that can be used in anticancer therapy, including curcumin, resveratrol, genistein, and compounds from garlic, soybeans, tomatoes, and other foods. The review suggests that active principles from natural products represent an opportunity to discover novel anticancer agents and mechanisms of action.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
Guidance for Industry and Other StakeholdersToxicological Principles for the...Dmitri Popov
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
Oncology clinical pharmacy from practice to researchNoha El Baghdady
The document provides an overview of the history and current state of oncology clinical pharmacy from practice to research. It discusses how clinical pharmacists can play important roles in patient care by developing pharmaceutical care plans, managing side effects of cancer treatment, preventing and treating complications, and counseling patients. Clinical pharmacists are also involved in research by conducting clinical trials, publishing original research and reviews, and developing evidence-based guidelines. Overall, the involvement of clinical pharmacists in direct patient care and research has been shown to improve outcomes and reduce healthcare costs.
This study evaluated circulating mitochondrial DNA (mtDNA) as a potential biomarker for exposure to halo-alkane based pesticides. The study found elevated levels of cell-free mtDNA in the serum of 164 individuals with presumed intoxication from exposure to pesticides like methyl bromide and ethylene dichloride, compared to unexposed controls. Higher mtDNA levels were associated with more recent exposures. MtDNA levels decreased over time after exposure, but remained elevated for months, suggesting mtDNA could be a sensitive biomarker for detecting effects of toxic chemical exposure.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
A investigatory project on carcinogens.
A very fatal disease causing bacteria tht can develop cancer cells in body. So as to get rod of cancer cells bacteria there are many therapy that can actually a boon to the patient of the india..
This document outlines a study on the influence of pharmacogenomics on drug therapy and personalized medicine. The study focused on analyzing gene polymorphisms related to thyroid function in the Saudi population and their association with thyroid cancer risk and thyroxine drug dose requirements. The study found several novel and common single nucleotide polymorphisms in genes like DIO1, DIO3, PAX8, TSHB, and NIS. Some of these gene variants were associated with increased thyroid cancer risk. Additionally, polymorphisms in DIO1, PAX8 and TSHB were found to predict differences in required thyroxine drug doses for patients.
Detoxification of the major organ systems of the body is ever increasingly important. Environment, genetics, nutritional status and lifestyle all play interacting roles that can influence one's quality of life. Learn how to safely detoxify using real food and basic nutrients with the Detox 360 Program. This is an introduction for informational purposes only and is not intended to diagnose or replace medical care.
The document provides an overview of the drug development process from discovery of a lead compound through clinical trials and regulatory approval. Key steps include identifying a biological target, using high-throughput screening to discover lead compounds, conducting preclinical testing on lead compounds, and then Phase I-III clinical trials on humans to test safety and efficacy before regulatory approval and marketing. The process takes over a decade and costs billions due to extensive testing required to bring a new medicine to patients.
Lifestyle changes can prevent at least 60% of all Cancers - By Dr Sanjiv Hari...Sanjiv Haribhakti
5–10% of all cancer cases can be attributed to genetic defects, whereas the remaining 90–95% have their roots in the environment and lifestyle factors. Learn how can we prevent lifestyle related cancers. For more details visit at http://gisurgery.info
The International Conference on Harmonization (ICH) aims to harmonize technical requirements for pharmaceutical registration internationally. ICH involves regulators and industry from the EU, Japan, and US. Its objectives are to ensure safe, effective, and high-quality medicines are developed efficiently through international agreement on guidelines. ICH has produced guidelines addressing safety issues like carcinogenicity and QT prolongation. Proposed changes to rodent carcinogenicity testing aim to introduce a more comprehensive risk assessment approach.
The document discusses neurotoxicity and neurodegeneration in drug development. It notes that safety issues, especially related to the cardiovascular system and central nervous system, are among the most common reasons for drug development failure. Biomarkers for early detection of potential neurotoxicity could help improve success rates by facilitating safety screening earlier in the development process. The central nervous system is particularly vulnerable, as neurotoxicity is a frequent cause of failure in both pre-clinical and clinical phases of development.
Cytogenetic, Hematological and Enzymes Levels Parameters in the Biomonitoring...inventionjournals
Studies have demonstrated genotoxic effects by the presence of micronucleus in exfoliated cells from the buccal mucosa of agricultural workers exposed to pesticides. This study has assessed the genotoxic effects of pesticides on 61 agricultural workers from the state of Piauí, Brazil. 31 individuals were exposed to pesticides and 30 are from the same area, but were not involved in pesticides application. Cytogenetic damage were evaluated through micronucleus test in cells from the buccal mucosa and some parameters such as hematological and levels of enzymes. Exposed individuals exhibited cytogenetic damage with increased number of micronuclei in cells from the buccal mucosa in comparison with subjects from the control group with significant statistical difference (P < 0.01). We perceive that there is a statistically no significant (P > 0.05) increase in levels of plasmatic and eritrocytaireacetylcholinesterase and no statistically significant increase of phosphatase alkaline were detected in exposed workers in relation to the control group. No association was found in relation to smoking habits, alcohol consumption, protection utensils and the biomarkers analyzed or the biochemical analysis. Analysis of variance revealed a correlation between occupational exposure to pesticides of workers in Piauí and the presence of micronuclei (P < 0.05).
Cytogenetic, Hematological and Enzymes Levels Parameters in the Biomonitoring...inventionjournals
This study assessed the genotoxic effects of pesticide exposure on 61 agricultural workers in Piauí, Brazil. Workers exposed to pesticides had significantly higher numbers of micronuclei in buccal mucosa cells compared to unexposed controls, indicating cytogenetic damage. No significant increases were found for hematological or enzyme levels. Longer exposure time (10 years vs 1 year) correlated with higher micronuclei frequency, and smoking/alcohol consumption among long-term exposed workers was also associated with more micronuclei. The results suggest occupational pesticide exposure induces genetic damage detectable via the micronucleus test.
Cytogenetic, Hematological and Enzymes Levels Parameters in the Biomonitoring...inventionjournals
Studies have demonstrated genotoxic effects by the presence of micronucleus in exfoliated cells from the buccal mucosa of agricultural workers exposed to pesticides. This study has assessed the genotoxic effects of pesticides on 61 agricultural workers from the state of Piauí, Brazil. 31 individuals were exposed to pesticides and 30 are from the same area, but were not involved in pesticides application. Cytogenetic damage were evaluated through micronucleus test in cells from the buccal mucosa and some parameters such as hematological and levels of enzymes. Exposed individuals exhibited cytogenetic damage with increased number of micronuclei in cells from the buccal mucosa in comparison with subjects from the control group with significant statistical difference (P < 0.01). We perceive that there is a statistically no significant (P > 0.05) increase in levels of plasmatic and eritrocytaireacetylcholinesterase and no statistically significant increase of phosphatase alkaline were detected in exposed workers in relation to the control group. No association was found in relation to smoking habits, alcohol consumption, protection utensils and the biomarkers analyzed or the biochemical analysis. Analysis of variance revealed a correlation between occupational exposure to pesticides of workers in Piauí and the presence of micronuclei (P < 0.05).
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3) Body fluids from chemotherapy patients may contain drug residues for up to 7 days after treatment. Protective equipment should be worn when handling such fluids and contaminated materials to prevent exposure.
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
The Nervous and Chemical Regulation of Respiration
Employee Safety in Chemopreparation Unit
1. 1
الرحيم الرحمن ا بسم
Employee’s Safety with Cytotoxic
Drugs
Ph. Areeb Ahmed Abbasi
Pharmaceutical Care Department
King Abdullah Medical City
2. 2
What are Cytotoxic drugs?
•Drug that inhibits or prevents the function of cells.
•Used to treat cancer and other benign conditions as indicated.
•CD preparations are available in oral, IV, and other dosage forms.
•Also used to treat psoriasis, Rheumatoid Arthritis & Juvenile RA, Steroid
resistant muscle conditions.
•CD cannot distinguish between normal and malignant cells. As a result of the
treatment, many normal cells such as hair follicles and the lining of the digestive
system are damaged along with the cancer cells.
3. 3
The American Society of Hospital Pharmacists (ASHP) considers CDs to be:
•Genotoxic – a substance that damages DNA. Such damage can lead to the growth of
a malignant tumor.
•Carcinogenetic – a substance that may cause mutations leading to the development of
tumors in healthy cells.
•Mutagenic – a substance that alters the DNA of a living being, increasing the
likelihood of a mutation.
•Teratogenic – a substance that may cause malformations of an embryo or fetus
(birth defects).
•Contact with CD can cause immediate problems such as dermatitis, dizziness, nausea
and headache.
•(Mutation is a natural process that changes a DNA sequence.)
7. 7
When are we at risk???
Anyone who works with patients receiving
cytotoxic drugs are at risk of exposure, and
must be protected at all times while
working with cytotoxic drugs. Exposure
may occur when
•Preparing,
•Administering,
•Storage,
•Transporting drugs,
•Handling patient waste,
•Disposing of waste, and
•Cleaning spills.
8. Employee’s Safety with Cytotoxic Drugs
Factors:
-Reported toxic effects of CD on health workers.
-Drug related factors
-Worker related factors
-Equipment related factors
-Quality management role
8
9. Employee’s Safety with Cytotoxic Drugs
-Reported toxic effects of CD on health workers
-Drug related factors
-Worker related factors
-Equipment related factors
-Quality management role
9
10. Employee’s Safety with Cytotoxic Drugs
Reported Direct Toxic Effect of CD on Health
workers
In two studies there were association between self-
reported skin contact with CD and the occurrence of
acute symptoms. Questionnaire Data: Valanis B, et al,
Cancer Nurs 16(4): 288-295, 1993 ; Valanis B, et al, AJHP,
50: 455-62, 1993
10
11. Employee’s Safety with Cytotoxic Drugs
Toxic Effect of CD-(contin.)
-In two studies higher prevalence of menstrual
dysfunction noticed in nurses who handle CD. The
highest prevalence in nurses over 30 years of age.
Questionnaire Data: Shortridge, LA, et al, Cancer Nurs
18(6): 439-44, 1995 ; Shortridge, L, Dissertation, 1977.
11
12. Employee’s Safety with Cytotoxic Drugs
Toxic Effect of CD-(contin.)
Spontaneous Abortion: Three studies reported
increased rate of spontaneous abortion in female
health workers handling CD. The most recent one
was NCI-USA study involving 2976 pharmacy and
nursing personnel. Spouses of men handling CD had
the same risk. Questionnaire Data: Valanis, B, et al,
JOEM, 41(8): 632-638, 1999
12
13. Employee’s Safety with Cytotoxic Drugs
Toxic Effect of CD-(contin.)
Infertility: NCI-USA funded study on 4659 nursing and
pharmacy personnel which demonstrated lower
fertility in women handling CD. Questionnaire Data:
Valanis, et al, JOEM, 39(6): 574-580, 1997
13
14. Employee’s Safety with Cytotoxic Drugs
Toxic Effects of CD( Indirect)-contin.
17 out of 27 studies found cytogenetic
abnormalities in health workers
14 out of 30 studies were (+) for urine
mutagenicity test (Ames test) on health workers
handling CD
14
15. Employee’s Safety with Cytotoxic Drugs
Toxic Effects of CD-(contin.)
83 non-smoking nurses and pharmacists:
23 pharmacists preparing CD, 28 nurses preparing
and administering CD , 32 nurses only
administering CD.
5/32 of nurses reported skin contact in the group
administering CD.
11 of 83 (13%) of scans were (+) (8 nurses and 3
pharmacists).
15
16. Employee’s Safety with Cytotoxic Drugs
Toxic Effects of CD-(contin.)
- At least 15 out of 18 studies detected CD in urine of
workers (pharmacists, pharmacy technicians, nurses,
health care workers) (1975-2000)
- 13 studies detected cyclophosphamide (CP) and one
study detected ifosfamide (IFS) and two studies
detected platinum derivatives. One study 5-FU
metabolite.
16
18. Employee’s Safety with Cytotoxic Drugs
Toxic Effects of CD-(contin.)
Cancer risk is difficult to assess. However, data
from patient studies were used.
Cancer risk is about 1.4-10 per million annually
after 10 years of work. This is additional risk due
to CP.
Senssink, PJM, et al, Rev Environ Health, 21(1): 43-58, 1997.
18
19. Employee’s Safety with Cytotoxic Drugs
-Reported toxic effects CD on health workers
-Drug related factors
-Worker related factors
-Equipment related factors
-Quality management role
19
20. Employee’s Safety with Cytotoxic Drugs
Drug Related Factors:
-Carcinogenic potential.
-Physicochemical characteristics.
-Pharmaceutical and manufacturing factors
-Quantity of drug handled.
20
21. Employee’s Safety with Cytotoxic Drugs
Drug Related Factors:
-Carcinogenic potential.
-Physicochemical characteristics.
-Pharmaceutical and manufacturing factors
-Quantity of drug handled.
21
22. Employee’s Safety with Cytotoxic Drugs
Carcinogenic Potential:
Eight antineoplastic agents are carcinogenic to humans:
Cyclophosphamide, melphalan, busulphan,
chlorambucil, treosulphan, chlornaphazine,
azathioprine, and 13909-09-6 (IARC).
22
23. Employee’s Safety with Cytotoxic Drugs
Probable carcinogenic agents: Carmustine lomustine,
cisplatin, nitrogen mustard, thiotepa, doxorubicin,
and procarbazine.
Possible carcinogenic agents: Dacarbazine,
bleomycin, daunorubicin, mitomycin C, streptozocin,
daunorubicin, and nitrogen mustard N-oxide.
Unclassiffied agents: Antimetabolites, antimitotic
inhibitors, and ifosfamide.
23
24. Employee’s Safety with Cytotoxic Drugs
Drug Related Factors:
-Carcinogenic potential.
-Physicochemical characteristics.
-Pharmaceutical and manufacturing factors
-Quantity of drug handled.
24
25. Employee’s Safety with Cytotoxic Drugs
Physicochemical Characteristics:
-Lipophilicity: cyclophosphamide, platinum
-Volatibility: cyclophosphamide (Sessink PJM et. al., Arch.
Environ. Health, 1997, Kiffmeyer T. et. al., Pharm. J., 2002;
Mason, H. J. et. al., Ann. Ocup Hyg, 2005)
-Aerosolization
Platinum
25
26. Employee’s Safety with Cytotoxic Drugs
Drug Related Factors:
-Carcinogenic potential.
-Physicochemical characteristics.
-Pharmaceutical and manufacturing factors
-Quantity of drug handled.
26
27. Employee’s Safety with Cytotoxic Drugs
Pharmaceutical and Manufacturing Factors
-Surface contamination of CP and IF packaging.
Hedmer, M., et al., Ann. Occup. Hyg., 2005).
-Cytotoxic contamination on the outside of vials
(platinum, CP, IF, MTX). Mason, H. J. et al., Ann.
Occup. Hyg., 2003).
27
28. Employee’s Safety with Cytotoxic Drugs
Drug Related Factors:
-Carcinogenic potential.
-Physicochemical characteristics.
-Pharmaceutical and manufacturing factors
-Quantity of drug handled.
28
29. Employee’s Safety with Cytotoxic Drugs
Quantity of Drug Handled
-The center with highest number of preparation had
more contamination with CP, IP, and 5-FU. Connor,
T.H., et. al., AJHP, 1999.
- Bulk manufacturing of Cytotoxic tablets: CP, MTX,
Hydroxyurea, 6-MP…
29
30. Employee’s Safety with Cytotoxic Drugs
-Reported toxic effects of CD agents on health workers
-Drug related factors
-Worker related factors
-Equipment related factors
-Quality management role
30
31. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
31
32. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
32
33. Employee’s Safety with Cytotoxic Drugs
Susceptibility
Staff with family history of cancer are probably at
higher risk.
33
34. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
34
35. Employee’s Safety with Cytotoxic Drugs
Seniority
Handling technique may be poorer when handled by
new employee .Labuhn, K. R. N. et. al., Cancer Nurs.,
1998.
35
36. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
36
37. Employee’s Safety with Cytotoxic Drugs
Smoking and Nutritional Habits
-Smoking is known to predispose to lung,
nasopharyngeal, bladder------> Cancers.
-Fried meat is known to increase likelihood of (+) urine
mutagenicity. Baker, R. et. al., Cancer Lett., 1982.
37
38. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
38
39. Employee’s Safety with Cytotoxic Drugs
Stress
Nurses with (+) scans for contamination handled
more doses than nurses with (-) scans who handled
less doses per week. This could reflect inattention to
technique because of stress.(Also applies to
pharmacists)
More acute symptoms reported were significantly
associated with the number of doses handled. Valanis B, et
al, AJHP, 50: 455-62, 1993
There should be uniformity.
Labuhn, K. R. N. et. al., Cancer Nurs., 1998.
39
40. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
40
41. Employee’s Safety with Cytotoxic Drugs
Gender and body mass
Significantly more acute symptoms in females handling
chemo with higher body mass. This was not
significant in males. Valanis B, et al, AJHP, 50: 455-62,
1993
41
42. Employee’s Safety with Cytotoxic Drugs
Worker Related Factors:
-Susceptibility
-Seniority
-Smoking and nutritional habits
-Stress
-Gender and body mass
-Duration of exposure
42
43. Employee’s Safety with Cytotoxic Drugs
Duration of Exposure
In one study nurses exposed for 20-31 years show
higher cytogenetic abnormalities than nurses
exposed for 1-19 years. There was no difference
between the control group and the group exposed
for 1-14 years. Kasuba , V, et al, J Appl Tox, 19(6): 401-4,
1999.
43
44. 44
Training and Management:
Who should be trained?
•Physicians
•Nurses,
•Pharmacists
•Assistants,
•Stores and receiving personnel,
•Housekeeping and maintenance
•Any person who interact with CDs…
•What training can be given to patients???
45. 45
These training procedures should:
•Be for the proper handling, mixing, and disposal of cytotoxic drugs
and waste by-products.
•Be written, posted, and available to all employees;
•Include how training will be developed, delivered, and evaluated;
•Include descriptions of the roles of supervisors to ensure that all
proper regulations are followed.
•Be informed about full hazards of cytotoxic drugs.
•Methods of preparation.
•Use and disposal procedures.
•Patient care.
•Protective equipment and how to use it properly.
•Spill procedures.
•Maintenance of the facilities and equipment.
46. 46
Chemo dept should maintain a record of information on the
•Toxicity,
•Exposure treatment procedures,
•Solubility,
•Stability,
•General description of the appearance for all CDs that are used in the
facility.
•This record should be easily accessible at all times of day, and
available to all staff who interact with CDs.
47. 47
Drug preparation and reconstitution
•Trained personal.
•Centralized dedicated location. (Separate from normal medications)
1.Engineering controls
•Room specification (USP chapter 797)
•Pre room ( ISO class 8,9)
•Ante room (Buffer room) (ISO class 7)
•Vertical Hood (ISO class 5)
•Room pressure.
•A minimum of a Class II biological safety cabinet with HEPA filter exhaust
systems that does not allow air to be circulated back into the room.
•Medications should be isolated and locked.
•Puncture proof containers for the disposal of needles, syringes and vials must
be provided and available in the preparation area. Contaminated needles,
syringes, and vials should be disposed of intact.
48. 48
2. Personal Protective Equipment (PPE)
• Protective gloves made of vinyl or nitrile rubber. Gloves should be changed frequently,
or immediately if punctured, cut, or torn. (Some times 2 pairs)
• A moisture resistant, long sleeved gown with elastic cuffs.
• Chemical splash goggles, and if necessary, full-face protection.
• In cases where there is a possibility of the medication becoming airborne, a powered air
purifying respirator is recommended.
• Face mask (Sometimes n95)
• Head cover
• Shoe cover
50. 50
3. Additional controls
•Eating, drinking, smoking, or the storage of food should be
completely prohibited in the preparation area.
•Pregnant or breastfeeding women must be placed on
protective reassignment and given a position that does not
expose them to the cytotoxic drugs.
•To prevent the spread of hazard, protective clothing should
not be worn outside of the preparation area.
53. 53
4. Spill kit
A clearly labeled cytotoxic spill kit should be kept wherever cytotoxic
medications are being prepared, stored, administered or received (shipping).
The kit should contain:
•At least two sets of surgical gloves
•Disposable eye protection
•Shoe covers
•Scoop and scraper
•Sharps container
•Warning signs
•Two large plastic disposal bags (minimum of 4mm thick)
•Decontamination agent (i.e. a basic detergent of pH 8-9 and water)
•Puncture and leak resistant waste container
•Two sheets at least 30 cm square of absorbent material
54. 54
Material safety data sheets – MSDS
•Suppliers are required to provide safety data sheets for those
chemicals classified as hazardous substances if they supply to
workplaces.
•Employers must ensure that safety data sheets and other
sources of information are accessible to workers who may be
exposed to the substances.
55. Employee’s Safety with Cytotoxic drugs
-Reported toxic effects of CD on health workers.
-Drug related factors
-Worker related factors
-Equipment related factors
-Quality management role
55
56. Employee’s Safety with Cytotoxic drugs
Equipment Related Factors
-Personal Protective Devices (PPE)
-Safety Cabinets
-Isolators
-Closed System
56
57. Employee’s Safety with Cytotoxic drugs
Equipment Related Factors
-Personal Protective Devices (PPE)
-Safety Cabinets
-Isolators
-Closed System
57
58. Employee’s Safety with Cytotoxic drugs
Personal Protective Equipments (PPE)
No studies found, studying this factor alone but
usually with other factors.
However, they have a major role in protecting the
worker. Selection of the proper gown and glove is
important.
Also the duration of glove in contact with skin is a
major determinant of permeation in several studies.
58
59. Employee’s Safety with Cytotoxic drugs
Equipment Related Factors
-Personal Protective Devices (PPE)
-Safety Cabinets
-Isolators
-Closed System
59
60. Employee’s Safety with Cytotoxic drugs
Safety Cabinets
In three studies the use of biological safety
cabinet (BSC) reduce chance of getting (+) urine
mutagenicity test in pharmacy technicians
In one study less cytogenetic abnormalities with
use of BSC. Jakab, et al, JTEH, 62(2):307-18, 2001
(Maintenance of BSC by deep clean and microbial
contaminations)
60
62. Employee’s Safety with Cytotoxic drugs
Equipment Related Factors
-Personal Protective Devices (PPE)
-Safety Cabinets
-Isolators
-Closed System
62
63. Employee’s Safety with Cytotoxic drugs
Isolators (Glove boxes)
The major advantage is that isolators will effectively
protect handlers from contact with
contamination inside the isolator.
Crauste-Manciet et. al. Ann. Occup. Hyg., 2005.
Isolators can reduce the exposure .There is no major
difference between positive pressure or negative
pressure isolators as far as exposure. Mason. H. J.
et. al., Ann. Occup. Hyg., 2005.
63
65. Employee’s Safety with Cytotoxic drugs
Equipment Related Factors
-Personal Protective Devices (PPE)
-Safety Cabinets
-Isolators
-Closed System
65
66. Employee’s Safety with Cytotoxic drugs
Closed System
Several studies have shown that closed system
(Phaseal®) did reduce contamination.
Closed system should be combined with other safe
handling practices. Crauste-Manciet et. al. Ann. Occup.
Hyg., 2005.
66
67. Employee’s Safety with Cytotoxic drugs
Objectives:
-Introduction
-Reported toxic effects of CD on health workers
-Drug related factors
-Worker related factors
-Equipment related factors
-Quality management role
67
68. Employee’s Safety with Cytotoxic drugs
Quality Management Role
-Safe Handling Guidelines Implementation
ASHP, … (including CD store areas)
Selection of staff to handle CD is important
by interview: chronic problems, smoking,.. etc.
documentation is important for future use.
68
69. Employee’s Safety with Cytotoxic drugs
Technique
Best preparation, administration techniques
should be chosen.
Contamination of syringe plunger during
sampling of CP solution. Regular
replacement of syringes is enforced. Gilles,
F.B., et. al. J Onc. Pharm. Pract., 2005.
69
71. Employee’s Safety with Cytotoxic drugs
Conclusion
Occupation exposure to CD is still occurring.
Some sources of contamination are unknown
and/or difficult to control.
However, implementation of the latest
recommendation for protection is essential.
Awareness of the health worker is important in
order to keep alert.
Quality Management has a big role in employee
safety.
71
72. Immediate management:
If at any time there is skin contact with any cytotoxic drug, the
affected worker should
Wash the affected area by soap & water.
Should not scrape or abrade the skin (may increase the
exposure)
For eye contact, flush the eye with copious amount of water by
holding back the eye lids for atleast 15 mins
Seek medical evaluation by physician.
72
Diarrhea and throat irritation
Organ system : more GI and allergic in women and more cardiac and general systemic in men.
A remote possibility is that the the pregnant spouse had been exposed through contact with the perspiration of their partner. 22
Other possibility is that germ cell damage from such exposure could have affected pregnancy outcome.