Kathryn and Amanda Policy Paper

Colorful Reminders
Bacteria that are antibiotic resistant have become a major public health threat, causing a substantially high mortality rate.1 A major cause of antibiotic resistance is patient noncompliance with medication schedules. When outpatients are prescribed with an antibiotic many of them do not comply with prescription instructions or misuse the antibiotic given to them.
Noncompliance in taking antibiotic prescriptions is an ongoing dilemma for healthcare providers all over the world. There are many different forms of noncompliance. For example some patients are upset by the side effects of the prescription given, and become noncompliant towards taking their antibiotics.2 Adherence of the outpatient to dosing schedules is crucial to reduce antibiotic resistance. Without the adherence of outpatients, the rate of antibiotic resistant bacterial infections becomes increasingly higher.3
Another problem outpatients have been accused of is misuse of antibiotics. An example of misusing antibiotics is patients that have instability of symptoms or symptoms begin to abate while the patient is taking antibiotics. This leads the patient to believe that he or she is better and stop taking his or her medication.4 While there are many other forms of misuse of antibiotics, this problem of misusing antibiotics still remains. Noncompliance and misuse of antibiotics will lead to more bacteria that are antibiotic resistant.2 Patients who are given prescription antibiotics often do not understand the problems that they create when they either do not complete the full dosage or they do not take the antibiotics when they are supposed to. As a result of patients misunderstanding of antibiotic use, more bacteria will become antibiotic resistant leading to an increase in health problems. It is imperative that patients comply, and for this matter the Forgey Chemical Association Team (FCAT) has created a proposal.
The FCAT will collaborate with a pharmaceutical company to develop a dye that could be added to antibiotics that would change the patient’s urine a bright color, such as purple for the duration of their antibiotic treatment. By changing the color of patient’s urine, that patient can then be better informed if the antibiotic is working, as well as have a reminder to take his or her antibiotics. Once this dye is developed, doctors can tell their patients that they need to keep taking their antibiotics until the patient’s urine returns to its normal color. By doing this, patients will be more compliant to take the proper amount of their antibiotic. As a result, fewer bacteria will become antibiotic resistant. In order to implement this plan here are the steps we plan to follow:
1) Finding a pharmaceutical company (that our chemical company can collaborate with) that has a division which is focused on antibiotic studies to implement bacterial resistance. Examples of pharmaceutical companies we might choose from include: Abbot, Glaxo Smith Kline, Novartis, Eli Lilly, Genentch, Amgen, Johnson and Johnson, Sanofi Aventis. During this process we will interview specifically for pharmaceutical companies that meet our standards. Our standards will consist of:
a. Division must have prior experience with bacterial resistance to antibiotics
b. Proper work place for this program
c. Highly qualified staff (Doctoral people, PhD. researchers, and statisticians on staff)
d. Proper understanding of the program our chemical company wants to accomplish
2) In order to fund this research, our chemical company will be willing to fund $800 million dollars for this program. Our company decided on this amount because it will help cover the coast to bring the new product to market, as well as, covering funds for multiple trials of testing (to reach FDA requirements). Not only will the pharmaceutical company receive a substantial amount of funds from our company, but the pharmaceutical company is chosen will also have to pitch in with the clinical trials.
3) In order to have the most effective FDA approved product, our company will provide resources for the program such as: chemicals, tools, clinical trials and any other necessary resources for clinical trial testing. Clinical trials will consist of
a. Animal testing: This will provide information whether the drug is safe enough for human testing as well as providing information on the amount of dosing per prescription.5 All animal testing will then be reviewed by the FDA for further approval. Once approved by the FDA, human testing can then be initiated.
b. Clinical trials in humans (the FDA requires 3 levels of trials):
i. First level: is to determine the range of dosage for patients with the least amount of side effects. 5
ii. Involves more patients (hundreds) who are closely monitored. The dosage will also be more controlled by giving different groups of patients’ different doses of the test drug. There will also be a placebo group to act as the control. 5 (The patients will be devised into groups at random. This will also be a double blind test (where neither the patients nor the doctors giving the “drug” will know the dosage). Researchers will then compare results of these different groups. Once conclusions have been made from the tests, the FDA and our pharmaceutical company will then determine whether the drug is safe enough to move on to the third level of testing and how to design and conduct further test trials for the third level.5
iii. Third level: In these trials, approximately 300 to 600 patients will be involved in the trials, for more than six months. This level of testing is to determine what the long term usage of the drug does (for example: side effects of long term use). This level will also provide more information of the safety and effectiveness of the drug. In order to be approved by the FDA, the benefits have to outweigh the risks of the drug5.
Once these trials have been completed successfully and approved by the FDA, our company will then discuss and analyze all of the data with the pharmaceutical company. Once elaborated, our company will submit an application to the FDA for approval of placing the product on the market in treatments for patients. Once the FDA approves the application, our product is then monitored by the FDA, and any updates of our product must be submitted to the FDA. 5
By initiating this collaboration with a pharmaceutical company, it will prevent from having noncompliant patients and prevent patients from misusing medications. Some opponents of our product might try to counter our policy by saying that patients will continue to misuse or be noncompliant towards antibiotic prescriptions prescribed to them. The color change is not to stop the misuse or noncompliance, but to remind patients to take their antibiotics. This reminder will help reduce the overall reoccurrence of noncompliance and misuse of antibiotic prescriptions.
Others who oppose our product might also say that patients will still be noncompliant by not making it high priority to stay on top of taking their antibiotics. Our product will help show patients that taking the full dosage of a prescribed antibiotic is required, by not turning the patient’s urine back to a normal color until the full dose has been taken. Over all, funding a pharmaceutical company will help decrease bacterial resistance with outpatients. Not only will our company’s name be recognized by the community, but our company will revolutionize the way patients understand the importance of taking the whole prescription.
References
1) D'Agata EMC, Dupont-Rouzeyrol M, Magal P, Olivier D, Ruan S, 2008 “The Impact of Different Antibiotic Regimens on the Emergence of Antimicrobial-Resistant Bacteria.” PLoS ONE 3(12): e4036.

2) Jing J, Sklar G, Min Sen Oh V, and Chuen Li S, 2008 “Factors affecting therapeutic compliance: A review from the patient’s perspective.” Ther Clin Risk Manag 4(1): 269–286.

3) Konto-Ghiorghi Y, Mairey E, Mallet A, Duménil G, Caliot E, et al. 2009 “Dual Role for Pilus in Adherence to Epithelial Cells and Biofilm Formation in Streptococcus agalactiae.” PLoS Pathog 5(5): e1000422.
4) D’Ignazio J, Camere M, Lewis D, Jorgensen D, and Breen J, 2005 “Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults.” American Society for Microbiology 49(10): 4035–4041.

5) Galson S, 2005 “Drug Safety/Drug Approval Process.” www.fda.gov.

Are you saying in this paper…say i was taking a steroid and was slowly working my way off of it. I don't take the 1 pill I am suppose to on the last day, hypothetically speaking, my urine would be blue until i take that last pill? say i lose it…will i forever have blue urine?

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