The Purpose of Risk and Quality Management: The Case of Janssen Pharmaceuticals

2104 Words5 Pages
bulb-icon

Recommended: Identify legislation relating to health and safety in care setting

Purpose of risk and quality management It is no secret that risk is prevalent in the healthcare industry. Healthcare organizations carry a large amount of risk just in their daily operations. Healthcare organizations not only have to worry about risks to their patients, but their staff, financial stability, or even a natural disaster. A healthc organization must have a risk management department with trained and qualified individuals that know how to handle various issues within the organization. At Janssen, they have a lot of risk when it comes to their product. They have compliance laws that must be meticulously followed to prevent severe punishments such as multi-million dollar lawsuits or imprisonment from criminal convictions. They must promote their products lawfully and keep them regulated by the FDA and keep medical decision making free from improper industry influence. To go along side with risk management, quality management also plays a vital role within a healthcare organization. Quality management oversees the quality of the services the organization provides as well as the products it may sell. With pharmaceuticals, the quality must be consistent and how Janssen maintains this quality must be overseen. Quality control is an important factor for them. Controlling all of the various elements within their production and also the satisfaction of their consumers plays a vital role for continual success. Key Concepts At Janssen Pharmaceuticals, managing the bountiful risks is mandatory because producing and developing medicine has the potential risk of adverse reactions along with many others risks, and even the possibility of a fatality. Understanding that medical science is rapidly evolving and they want to k... ... middle of paper ... ...ing development and manufacturing (Quality Risk Management, 2006). The population is every bit of reliant on medication to manage several life threatening conditions, and risk comes along with the medication and should not be overlooked. There are several laws and regulations that are set into place for specific reasons such as FDA Amendments Act, which sets forth risk identification, evaluation and mitigation objectives regarding post market drugs. This helps the overall population by making pharmaceutical companies more adherent to drug safety and incorporating safety into their pre-market processes and also once the drug has been released to the public. Janssen Pharmaceuticals have had a great run with their company with only a few hiccups along the way. They have learned through experience that putting profit before people can and does have consequences.

Show More
Related

  • The Great Gatsby American Dream Failure

    810 Words  | 2 Pages

    Many businesses that achieve great success become greedy and want more. Pharmaceutical companies, such as Turing, have been overpricing life-saving

    Read More

  • Nucleon Inc. Case Study

    1161 Words  | 3 Pages

    Nucleon is a small biotechnology start-up with a very promising potential product (CRP-1), which is also the first product that Nucleon is planning to go into the clinic market. Nucleon has reached to human clinical trials phase with its product and it has no manufacturing facilities that satisfy the guidelines for these clinical trials and testing. Nucleon is on the verge of making a critical choice of manufacturing strategy, which will affect Nucleon’s survival in the intense competition in the long haul. Nucleon management is aware of the facts that they have a limited budget to start with, the financial environment in biotechnology is rapidly changing and establishing the safety and efficacy of products like CRP-1 is complex, time-consuming and expensive; that’s why they want to evaluate risks and rewards of each manufacturing strategy before making their final decision.

    Read More

  • Pros And Cons Of Fda

    892 Words  | 2 Pages

    The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.

    Read More

  • Baccalaureate Nursing Essay

    1394 Words  | 3 Pages

    Baccalaureate nurses are responsible for providing and ensure our patients safety. The knowledge from others mistakes can help informs nurses of extra precautions that we can take to ensure our patient’s safety. Risk Analysis and Implication for practice course helped me understand the steps I as a nurse can take as well as the facilities I work for to help reduce the number of medication errors that occur. Interviewing the pharmacist help me get a better insight to what facilities already have in place to help prevent medication errors. However like most things you have to have educated and compassionate caring staff to enforce and follow the guidelines set in place.

    Read More

  • Wrong Site, Wrong Procedure, and Wrong Patient Errors

    1585 Words  | 4 Pages

    The purpose of this paper is to identify a quality safety issue. I will summarize the impact that this issue has on health care delivery. In addition, I will identify quality improvement strategies. Finally, I will share a plan to effectively implement this quality improvement strategy.

    Read More

  • Off-Label Use of Prescription Drugs

    2017 Words  | 5 Pages

    Although the pharmaceutical industry says that prescription medicines are as safe as they can possibly be, prescribed drugs have a high increase of risking a patient’s health. According to the law, drug makers seek Food and Drug Administration (FDA) approval for specific uses of their products and conduct trials to test their drugs safety and effectiveness in patients with specific conditions. The FDA demands that drug companies conduct rigorous clinical trials to prove a drugs safety and effectiveness in treating a particular disease. However, once the FDA approves a drug for one use, doctors can prescribe it for whatever they want. The FDA is considering loosening the monitoring of off-label prescriptions, but if anything, regulations should be tightened. Despite the practices of some medical personnel, the risk of serious medical complications demands that the FDA regulate and restrict off-label use of prescription drugs.

    Read More

  • Food and Drug Administration (FDA)

    1205 Words  | 3 Pages

    both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling

    Read More

  • EMR Implementation Part III

    1839 Words  | 4 Pages

    This organization in Miami, Florida conducts research to the biotech industry. The upcoming clinical pharmacological testing in a patient with diseases accelerates the needed of the EMR system in this research facility. Some financial issues, inadequate technical support, and government requirements are organizational barriers, which affect the implementation of these changes. Individual’s barriers affect the implementation of the EMR system as well as the required training from staff, resistance to change, and loss of status quo from employees. The EMR implementation has to lead to improve patient safety, and reduction in medical errors. The competitive external environment demands in this organization the implementation of this system. For the readiness in this process, the organization could develop objectives, policies and conduct a several workshops to build consensus for the key deliverables. The Kurt Lewin’s theoretical models apply to implementation to these changes, external forces driven to executives and employees to identify the needed of changes, and the implementation of this system (Spector, 2010). Internal sources as well as human source, leadership, and the experience from employees guarantees the implementation of this system. External fa...

    Read More

  • Johnson & Johnson Company Analysis

    518 Words  | 2 Pages

    Johnson & Johnson is a successful company in the health industry : Johnson & Johnson a company that, through the years, has been diversifying and expanding worldwide as leader in the market for health products , consumer, professional , ethical pharmaceuticals and industrial . The vision is "To be the world's most successful company in the healthcare , prioritizing the needs of the people " their corporate philosophy is having Responsibility for internal, external customers and Justice for Suppliers and distributors, with a Commitment to the shareholders and Respect for environmental protection and natural resources

    Read More

  • Johnson And Johnson: The Competitive Environment Of Johnson & Johnson

    1604 Words  | 4 Pages

    Janssen is a division of Johnson and Johnsons that primarily focus on diseases that can help develop new strategies in improving prevention as well as developing vaccines and its accessibility to the world. The pharmaceutical company of J&J invests large amounts of money in research and development of its products. The competitive environment of Johnson and Johnson is very high for pharmaceutical companies due to which that many companies are releasing drug products and other devices. However, this company does not face any potential competitors due to which that it is a large company that provides a wide range of opportunities such as finances, and experiences. This leads to advantages compared to other competitors due to whom the pharmaceutical companies creates a barrier because of the high cost in research and development in medicine. In addition, Johnson and Johnson have to make sure that it has many suppliers for different categories for their products especially in medicine if one supplier causes shortages. Although suppliers do not bargain for the price values of its products, it still influences the price in the market in different countries. In addition, finding

    Read More

  • Technological Developments in Pharmaceutical Industry

    1751 Words  | 4 Pages

    The pharmaceutical industry is a highly regulated industry that is subject to continuous audits and monitoring form the government. The regulatory oversight to assure that the drug products meet the identity, strength, quality, and purity regulations begins with manufacturing of the investigational drug for its first use in human subjects and continues through the shelf life of the product (Velagaleti, Burns & Gill, 2003). Automation is one of the tools being used by the industry to minimize costs while complying with these regulations. In the beginning the Food and Drug Administration, FDA, government agency that regulates the industry, was very concerned on the effect that automation and cost reduction could have on the final product. This led to the review of the Code of Federal Regulations to regulate how to automate processes. The industry has invested a great deal of effort in demonstrating that automation, if handled correctly, does not jeopardize the final product or the consumers’ safety.

    Read More

  • Importance Of Quality Improvement In Healthcare

    1233 Words  | 3 Pages

    Good leadership, fostering a culture of change and safety, team work are essential in implementing quality improvement and risk management in the organization. Leaders and the governing body must demonstrate commitment to the processes and define their expectations for all stakeholders. Leadership team should make sure that the team’s attention is focused on the core business of the organization, which is to provide care and treat patients in a safe and high quality clinical environment. There are different tools that can be used for quality improvement that also applies to analyzing risk issues. These are measurement of quality, benchmarking, RCA, FMECA, and so

    Read More

  • The Importance Of Medical Safety

    1017 Words  | 3 Pages

    The risk management of a product does not end once a product is on the market -- in fact, it becomes more rigorous. The work that Medical Safety does in post market surveillance and vigilance are integral in ensuring marketed products perform as intended and do not harm patients. ISO 14971 provides guidance on what should be included in a post-market monitoring process:

    Read More

  • Medication Safety: An Essay On Medication Safety

    1050 Words  | 3 Pages

    I’ve read specifically about creating a “safety culture” in professional organizations and I think that’s a great way to look at it1. Every step of the process should have checks to eliminate as much error as possible, possibly even two checks if there is a big enough work force to accomplish that. Keeping up to date with all new drug information will be something I strive for. I want safety to always be my number one priority and I want to instill that attitude in those I work with. Safety is definitely a group effort, if any one link is weak it could cause a chain reaction leading to more errors. It is the expectation of the patient that when they go to the pharmacy that what they are given is one hundred percent correct and safe for them to take and they are right to think so. I plan on striving to ensure their trust in us is never

    Read More

  • The Importance Of Quality Management

    714 Words  | 2 Pages

    Design need to be detail. Maintain the layout with the full facilities, machineries to make product, design information system is very important to improve worker 's performance through monitor and controlling. Planning is system planning describe as how management available in various situation. Planning helps to cope with changing environment situation, Managing is also key driver for the operation management. Team work is very important of successful operations. Employee encouragement that is effective on improvement and better performance. It included training and leadership. Coordinating is a very important way of interrelating things by various part of the work. It is coordinating between various roles and responsibilities of the job

    Read More

More about The Purpose of Risk and Quality Management: The Case of Janssen Pharmaceuticals

Open Document