Drug Recalls Assignment
For this Drug Recalls Assignment, follow the following instructions.
Prepare a 4-page paper including the following:
Identify a recent drug recall action.
Describe steps required by FDA for recalling a drug.
How you would lead recall preparations and communications in your company for this recall activity?
Present strategies, provides justification, solid reasons and data to support choice. Addresses the complexities and expectations of leading an organization in the development stages. Identifies and describes leadership qualities, organizational style and impact of culture.
5 references
Textbook: New Drug Development: A Regulatory Overview ( Mathieu) 8th Revised Edition
ANSWER
Drug Recalls
Drugs are tested rigorously for safety and effectiveness before they are made available to the consumer. In the United States, the FDA is responsible for the testing of drugs to ensure that they are safe for use. Drug recalls are announced once the over the counter medicine or prescription is removed from the market after it is examined and found to be potentially harmful or defective (Hall, Stewart, Chang and Freeman, 2016). A recall may be issued once FDA has detected that the medicine is a health hazard, packaged or mislabeled or packaged poorly, contaminated or manufactured poorly. This paper will focus on a recent drug recall that occurred due to reasons safety. Drug recalls are the most effective mechanisms of protecting the public from potentially harmful and defective drug products.
Recent Drug Recall
In recent years, there have been a number of high-profile drug recalls. These events often result in serious consequences for patients, and can cause widespread panic among the general public. The most recent notable drug recall was for Johnson & Johnson’s popular heartburn medication Zantac. The recall was announced in April 2020, after it was found that the drug contained a potentially cancer-causing ingredient. This is after the last step of investigation which found out that the drug was containing N-Nitrosodumethylamine. The FDA agency has indicated that the impurity in some ranitidine products which have increased overtime and when stored at a high temperature than the room temperature, it may lead to consumer being exposed to undesired levels of impurity (Mahase, 2019). Zantac was immediately pulled from store shelves, and patients were advised to stop taking the medication. This recall led to a widespread panic, as Zantac is one of the most commonly used medications in the United States. Patients who had been taking the medication for years were suddenly faced with the possibility of developing cancer. Fortunately, the recall was ultimately successful in removing the dangerous medication from shelves. However, it highlights the importance of always being aware of the potential risks associated with taking any medication, no matter how seemingly innocuous it may be.
Steps of Drug Recall
FDA drug recall requests are directed to the company that has the duty of producing or marketing the drug when the company fails to assume the product recall in their initiative. Before FDA considers the Drug recall, they have to examine the drug and ensure that there enough evidence that is capable for pursuing actions such as injunction, seizure and warning letter (Perisetti, Goyal and Tharian, 2021). The FDA requested recalls begin with different communications between the company and the headquarter units.
During the recall, the FDA conducts a health hazard examination, classifies the recall and advises the company in writing regarding the given recall arrangement. During a recall request by the FDA, a company will first have to submit a recall plan. This should include what the problem is, how they plan to fix it, and what steps are being put in place to prevent it from happening again in the future. If the FDA believes that the recall is warranted, they will issue a recall order. FDA notifies the company of the problem and works with the company to develop a recall plan. The company then has 15 days to notify distributors and customers of the recall, as well as provide a list of all affected products (Natof and Pellegrini, 2022). FDA announces the recall and provides instructions to consumers, healthcare providers, and others on what they should do. FDA monitors the progress of the recall to ensure that it is being carried out properly. Once the recall is underway, the FDA will monitor its progress and may take further action if necessary.
There are three classifications for drug recalls, depending on the level of health risk involved. Class I recalls are the most serious, and involve products that may lead to serious injury or death. Class II recalls includes products that may lead to minor injuries or limited ill effects, while Class III recalls are for drugs that are not likely to lead to any hostile health effects (Perisetti, Goyal and Tharian, 2021).
Products are typically recalled voluntarily by the manufacturer, but the FDA may also order a recall if it determines that a product poses a significant health risk. In either case, the FDA will work with the company to ensure that the recall is conducted in a safe and effective manner. FDA investigates the cause of the problem and takes action to prevent it from happening again in the future.
When a drug recall is necessary, prompt and effective action is essential to mitigating the potential damage. By having a clear plan in place and ensuring effective communication, companies can minimize the impact of a recall and protect their reputation. There are a few key steps that should be taken in order to ensure an effective and efficient recall process. First, it is important to establish a clear and concise plan of action. This plan should be designed to address all aspects of the recall, from identifying the affected products to notifying consumers and retailers. Additionally, it is important to have a designated team in place to handle all aspects of the recall. This team should be responsible for conducting an investigation, issuing a press release, and coordinating with all relevant parties. Effective communication within the company and with external partners is also critical to ensuring a successful recall. For instance, all the employees should be aware of the recall and the procedures that need to be followed. Similarly, retailers should be contacted and made aware of the affected products so that they can take appropriate action.
Leading an organization in Drug Recall
Leading an organization during a drug recall is a difficult and demanding process. There are many complexities and expectations that come with this type of situation. First and foremost, it is important to ensure that the safety of the public is the top priority. This means conducting a thorough investigation to identify the cause of the problem and taking immediate steps to correct. When a drug is recalled, it can be a complex and difficult process for the organization involved. There are many different aspects that need to be considered and managed in order to ensure a successful recall. First and foremost, it is important to have a dedicated team in place to manage all aspects (Nagaich and Sadhna, 2015). The first step in managing a drug recall is to identify the root cause of the problem. Once the root cause is identified, steps can be taken to correct the issue and prevent it from happening again in the future.
In addition, it is important to develop a communication plan to notify all affected parties of the recall. This includes customers, distributors, retailers, and anyone else who may have come into contact with the affected product. Finally, it is important to have a plan in place to properly dispose of the recalled product. Drug recalls can be difficult to manage, but by following these steps, you can help ensure a successful recall.
Considerably, when it comes to drug development, leadership qualities, organizational style and company culture can have a significant impact. An effective leader will possess certain qualities that can help to guide and motivate their team towards success. They will also be able to adapt their leadership style to the specific needs of their team and the company culture.
An important aspect of leadership that affects drug development is the ability to create a shared vision and motivate employees to work towards it. Leaders need to be able to articulate the company’s goals and values in a way that inspires employees to buy into the vision and make it a reality. It’s also important for leaders to be able to build trust and credibility with their team. This can be done by demonstrating their own commitment to the company’s success and always behaving in an ethical and transparent manner.
The organizational style of a company can also have a significant impact on drug development. Companies that are more hierarchical in nature tend to be more risk-averse and may be less willing to take risks when it comes to developing new drugs. On the other hand, companies that are more flat and decentralized may be more willing to take risks, which can lead to faster development but also higher failure rates. Finally, the culture of a company can also have an impact on drug development. Companies that are more innovative and open to change may be more likely to succeed in developing new drugs compared to companies that are more traditional and resistant to change. Thus, it is clear that leadership qualities, organizational style and company culture can all have a significant impact on the success of a company’s drug development efforts.
Drug Recalls Assignment References: Contact us to get a customised paper
Hall, K., Stewart, T., Chang, J., & Freeman, M. K. (2016). Characteristics of FDA drug recalls: A 30-month analysis. American Journal of Health-System Pharmacy, 73(4), 235-240.
Mahase, E. (2019). FDA recalls ranitidine medicines over potential cancer causing impurity.
Nagaich, U., & Sadhna, D. (2015). Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history. International journal of pharmaceutical investigation, 5(1), 13.
Natof, T., & Pellegrini, M. V. (2022). Food And Drug Administration Recalls. In StatPearls [Internet]. StatPearls Publishing.
Perisetti, A., Goyal, H., & Tharian, B. (2021). The ‘burn’of ranitidine recall: current insights and mitigation strategies. European journal of gastroenterology & hepatology, 33(1S), e1013-e1016.
Need Help with this assignment?
