Question

Consider the following scenario: You are working as a health care provider, and have started prescribing a new medication for difficult to manage seizures as part of the treatment of epilepsy. Several of your patients start to develop unusual previously not reported side effects in the clinical trials for that drug. The side effects include peripheral vision blindness and skin turning blue. In addition to alerting the FDA, you want to publish your patient observations so that other doctors are made aware. In your paper, using this scenario, describe the process you would take to write these cases into a paper and describe the peer review process of medical journals from start to finish. Demonstrate your knowledge of the assigned readings and lecture.   Describe any obstacles or challenges in getting your observations published.

At least 500 words

Answer 1

Answer :

SUBJECT OF THE PAPER :

The subject of the paper is about developing unusual previously not reported side effects in the clinical trials of medication to manage seizures as part of the treatment of epilepsy.

ACTIVITY :

Introducing new medication in treatment of epilepsy

CLINICAL OBSERVATIONS :

• Peripheral vision blindness
• Skin colour turning blue

COMMON SIDE EFFECTS OF EPILEPTIC DRUG TREATMENT :

• Common side effects that may occur in the first few weeks of taking seizure medicines include feeling tired, stomach upset or discomfort, dizziness, or blurred vision. Some of these may not occur or are tolerated okay if the medication is started at a low dose and increased slowly.

Drug Development and observation of side effects Challenges :

• · Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed.
• · The unknown pathophysiology for many nervous system disorders makes target identification challenging.
• · Animal models often cannot recapitulate an entire disorder or disease.
• · Challenges related to heterogeneity of the patient population might be alleviated with increased clinical phenotyping
• · Greater emphasis on human data might lead to improved target identification and validation.
• · There is a lack of validated diagnostic and therapeutic biomarkers to objectively detect and measure biological states.
• · Unfamiliarity with current regulatory processes for investigational new drug (IND) applications can be resolved through pre-IND meetings.
• · The majority of older home care patients were taking more than five prescription drugs. Many patients were taking medications in ways that deviated from the prescribed medication regimen. The results also suggest that patients are experiencing many adverse effects from medication errors. The reasons for these errors were reported to be a result of individual patient characteristics and, most frequently, communication problems in the system.

Personal Observation on Epilepsy Drug:

We are sending this notification from XXX Name of Medical Center, Address, City USA, between Oct 01, 2020 and till DATE.

We have started prescribing a new medication for difficult to manage seizures as part of the treatment of epilepsy.

During this procedure, we were administered a drug produced was started side effects. Also, this is informing the FDA and my peers that Several of the patients start to develop unusual previously not reported side effects in the clinical trials for that drug.

But after in take the drug for the above-mentioned date several patients started to have peripheral vision blindness and skin turning blue as side effects. So, this journal will help to have the alert to FDA and my peers.Also we want FDA and CDC department to have this drug for more research and clinical trials before prescribing to patient.