Overview of Drug Development Process: From the Idea to the Finished Product

Drug development is an extensive process that takes time to be completed. Depending on which therapeutic area the drug is being developed for, more specifically, which disease it is targeting, the process might be slightly faster or slightly slower. To give you an idea, on average, it can take over 10 to 15 years for a drug to be developed. Especially now, with new technology and innovative thinking, many of us don’t understand why it takes so long for a drug to be developed. To better understand this process, let’s take a look at some of these steps. There are 5 core stages of drug development: discovery and development, preclinical research, clinical research, Food and Drug Administration (FDA) drug review, and FDA post-market drug safety monitoring.

Discovery and Development

Preclinical Research

Clinical Research

FDA Drug Review

FDA Post-Market Drug Safety Monitoring

These stages show just how long the process and steps are for drug development. If you want to learn more in detail about each process, the FDA has a great section on the drug development process. Also, the FDA has a section on novel drug approvals. In that section, it includes the FDA’s Center for Drug Evaluation and Research (CDER) approval of many new drugs and biological products. That list doesn’t include approvals of all products, but it does include new molecular entities and new therapeutic biological products. It is an incredible list to see exactly how many drugs get approved yearly.

It is fascinating to witness how many drugs undergo development, especially in recent times. Hopefully, in the future, we will continue to see innovative processes that move medicine forward. Overall, drug development is an extensive process that includes many stages and phases which shows just how much time it takes for everything to be completed to have an end product that is safe and effective.

Dagmara Zajac

RxPharmacist Team

References:

How to handle the transition from being a student to being a full-time employee

When you start school, most of us only think about how far the end is to attain that degree, but as cliche as this might sound, the future is closer than we feel it is. For some of us, we might know what we want to do with the degree that we are trying to achieve. Then there are others who hope that education will steer them toward a career path during school. Either way, it is good to start thinking about how to make the transition from school to a full-time job. At the end of the day, even though some of us might be ahead of others by knowing what our end goal is, we are all going to heavily rely on our transferable skills to make that transition smoother.

What are transferable skills?

Transferable skills help you adjust to a new position or setting in your career. These are the general core skills that you have gained throughout all of your life experiences that you can apply to that new step in your life.

These are some examples of transferable skills, but depending on the environment of your previous experiences, jobs, education, etc., you’ll attain different transferable skills.

One of the first questions that might come up when thinking about transitions in life is, “How do I know what skills I will need so I can prepare myself to be successful,” or “How do I know what I want to do with my degree?”

Prepare yourself ahead of time. Extracurriculars are one way that can help you attain skills while doing things outside of your coursework that exposes you to possible job prospects. It is important to take advantage of all the opportunities you can because once you graduate, it is not the same as when you are a student. Being a student, you have a special advantage that some forget to utilize to learn things from others. Remember that everything you did when you were a student has shaped you become a full-time employee. Make sure to strategically approach those years, so you can get the most out of them.

Often, we hear that connections are very important. Well, this is one example where your connections might help you. If you’re going into an entry-level job, residency, or fellowship, people before you had to go through the change from being a student to a full-time employee. Don’t forget to reach out to your connections to hear how they handled their transitions. Even though your post-graduate plans may be unique or your road in life is different from others, don’t disregard others’ experiences and opinions. Connecting with others makes you more educated about life. At the end of the day, what you do will be what’s best for you.  

Overall, transferable skills and preparing yourself ahead of time for that transition will help you in the long run. In the future, others may reach out to you to understand how you handled your career transition. You will be able to share your story at that time, and in sharing those experiences, you will be able to set the stage for other people’s success in their journey of finding their ideal career.

Dagmara Zajac

RxPharmacist Team

References:

The Importance of Medication Use Evaluation

The continued drug development expands the drugs available on the market for patients. How do we determine if patients are on the best drugs available? How do we determine if the drugs on the formulary for a given healthcare system are appropriate based on the market or trends seen within a healthcare system? The answer to these questions is in the importance of medication use evaluation (MUE). This type of evaluation does not provide answers to all the questions surrounding medication use but helps us get to a place of understanding, which can facilitate changes that are beneficial for patients in the long-term sense.

When discussing MUE, there are other processes needed to be addressed. Those processes are the drug utilization review (DUR) and the drug use evaluation (DUE). DUE and DUR are regarded as being synonymous with each other as these are ongoing drug therapy reviews. DUR is a quality assurance measure. For example, DUR encompasses three categories: prospective, concurrent, and retrospective. There are different categories for these drug therapy reviews depending on if we are addressing the drug review before dispensing, evaluating medication use during ongoing treatment, or reviewing therapy after treatment completion. Overall, DURs are put in place to ensure safety and efficacy of medication use.

DURs and DUEs are precursors to the MUE, which provides a more detailed performance tool for healthcare professionals. The difference that stands out about MUE from other processes is that it focuses on outcomes and quality of life. Well, the next question someone may ask is, “how do you know if an MUE needs to be initiated?” From the various MUE objectives, one can realize that the MUE process can begin for a variety of reasons. For example, it can be because of increased medication errors seen within a healthcare system, or the withdrawal of approved products. Depending on the objective to start an MUE, a therapeutic or process outcome is usually determined at the end. There are different types of MUE objectives, such as:

• Patient safety improvement
• Drug therapy optimization
• Cost minimization
• Innovative practices assessment

According to the American Society of Health System Pharmacists (ASHP), the framework one can utilize to begin the MUE process is FOCUS-PDCA:

• Find
• Organize
• Clarify
• Understand
• Select
• Plan
• Do
• Check
• Act

Depending on the site utilizing this framework, the approach will differ. On the other hand, MUEs can have its limitations due to the lack of scope, poor documentation, or poor communication. Pharmacists are a very important component of these evaluations because of their expertise. Medication therapy management (MTM) is a big part of many pharmacists’ everyday jobs, and in the long run, MTM results in better patient outcomes. ASHP has a great guidelines documents for those interested in MUE and learning about its in-depth practices.

It is important to be aware of the various processes within systems that determine how patients are treated so they can ultimately receive the best outcomes. The MUE is a long process, but the findings from an MUE can help healthcare systems in various areas. As with any process, there are limitations, and for this reason it is important to have the right healthcare professionals assess these medication evaluations. 

Dagmara Zajac

RxPharmacist Team

References:

1. ASHP guidelines on medication-use evaluation. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/medication-use-evaluation-current.ashx?la=en&hash=4927E9E8F085C17B19CA40AC0BAACBA229F47B07. Accessed December 23, 2022.
2. Faley B, Fanikos J. Best Practices for Medication Utilization Evaluations in Postsurgical Pain Management. Curr Emerg Hosp Med Rep. 2017;5(1):33-40. doi:10.1007/s40138-016-0121-2
3. Fanikos J, Jenkins KL, Piazza G, Connors J, Goldhaber SZ. Medication use evaluation: pharmacist rubric for performance improvement. Pharmacotherapy. 2014;34 Suppl 1:5S-13S. doi:10.1002/phar.1506
4. Drug utilization review. AMCP.org. https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/drug-utilization-review. Accessed December 23, 2022.