POTENTIAL RISKS The pharmaceutical industry faces a variety of risks when releasing a new product into the market for consumers. The largest risk with releasing a new product to the consumer market is the potential for new discoveries on side effects with taking a medication. Even though years of research, development, and experimentation have occurred there is always a risk of finding new side effects that could make the product harmful for consumer consumption. Pfizer, like many other pharmaceutical companies start to market and promote a new medication once it receives the approvals from the Federal Food and Drug Administration (FDA). Millions of dollars are spent marketing a new medication from the point of FDA approval. It is important
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Discovery of a new side effect is the largest reason products are removed from the market. Many times, this can happen shortly after a new product release or years later a new discovery can be found regarding a product. Pfizer must keep newly discovered information up to date and this could potentially cause lawsuit cases for them. Society today is always looking for reasons why something happened to them whether it is intentional or not. With new medications being released into the market Pfizer must be prepared for anything that can arise or occur within the lifespan of the product.
RISK MITIGATION PLAN In recent years, the FDA released a series of concept paper that summarized the agency’s plans for risk management. One of them included the new mandate for pharmaceutical companies to develop a plan for each new medication and it must be submitted to the FDA at the time of the new drug application. Risk management is the continuing process of minimizing risks throughout a product’s lifecycle to optimize its benefit/risk balance. A risk management program is a strategic safety plan designed to decrease product risk by using on or more interventions or tools (Morris, …show more content…
The RMP should start with a goal which specifies the overall goal of the risk management program. In many cases with Pfizer and new medication being released, this could be the desired endpoints for using the medication safely. If the largest risk with taking a new medication for diabetes is decreased blood sugar. A person should monitor their blood sugar more closely while on this medication until you know how it affects you. Goals may not be fully met however, making process improvements towards meeting the goal can be an acceptable outcome. The next step is developing objectives for the goals. The objectives must be specific and measurable. They must outline the behaviors and processes necessary for the stated goals to be achieved. Objectives often identify the individual patient, pharmacist, physician, or allied health professional responsible for the desired behavior. This aids in developing a communications plan directed at that individual, which will likely be a core element of the RMP (Morris,
Discovery of a new side effect is the largest reason products are removed from the market. Many times, this can happen shortly after a new product release or years later a new discovery can be found regarding a product. Pfizer must keep newly discovered information up to date and this could potentially cause lawsuit cases for them. Society today is always looking for reasons why something happened to them whether it is intentional or not. With new medications being released into the market Pfizer must be prepared for anything that can arise or occur within the lifespan of the product.
RISK MITIGATION PLAN In recent years, the FDA released a series of concept paper that summarized the agency’s plans for risk management. One of them included the new mandate for pharmaceutical companies to develop a plan for each new medication and it must be submitted to the FDA at the time of the new drug application. Risk management is the continuing process of minimizing risks throughout a product’s lifecycle to optimize its benefit/risk balance. A risk management program is a strategic safety plan designed to decrease product risk by using on or more interventions or tools (Morris, …show more content…
The RMP should start with a goal which specifies the overall goal of the risk management program. In many cases with Pfizer and new medication being released, this could be the desired endpoints for using the medication safely. If the largest risk with taking a new medication for diabetes is decreased blood sugar. A person should monitor their blood sugar more closely while on this medication until you know how it affects you. Goals may not be fully met however, making process improvements towards meeting the goal can be an acceptable outcome. The next step is developing objectives for the goals. The objectives must be specific and measurable. They must outline the behaviors and processes necessary for the stated goals to be achieved. Objectives often identify the individual patient, pharmacist, physician, or allied health professional responsible for the desired behavior. This aids in developing a communications plan directed at that individual, which will likely be a core element of the RMP (Morris,