Expanded Access-IND Definition

Thomas Jefferson University Hospitals (TJUH) has 951 inpatient beds, with a wide variety of clinical specialties. Jefferson University Hospitals provides more than 200 departments, centers, and services for the healthcare specialists to diagnose, treat, and satisfy the patient’s healthcare needs. Jefferson’s Department of Pharmacy provides a number of pharmaceutical services to support the provision of the best patient care and assist with the research and educational development in the Hospital. Investigational Drug Services (IDS) is the service within the TJUH pharmacy department that provides the procurement, storage, dispensing and maintenance of records for all inpatient and outpatient drug studies. The IDS pharmacy is also responsible for ensuring drug study medication safety, patient safety, and local, state, national, and federal regulatory compliance for all investigational drug research. Over the past 11 years, the IDS pharmacy at TJUH has seen a significant growth in the number of inpatient and outpatient drug studies. Currently, there are over 200 active drug studies managed by the IDS pharmacy with an average of X new studies initiated per month.

2. Review the drug profile to identify what medications are being used and for what purpose.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

The proposed Right-to-Try bill requires the federal government to allow for unrestricted access to investigational drugs, biological products, or devices to patients who are considered to have been diagnosed with a life-threatening illness when prescribed by a physician. The proposed law stipulates that the patient must have exhausted all other treatment options, and the investigational drug must have completed a

In my opinion, the medication side effects are the most important risk to be considered. The reason for my opinion, is the direct relation between the medication side effects and the patients’ safety.

announced its intention to submit an application to the U.S. Food and Drug Administration (FDA)

D- the patient arrived on time for his appointment. Reports stable on his dose. Deny the need for a dose increase when offered by the writer as he denies any sort cravings/withdrawals. The patient reported he hasn't used since his last UDS result and is confident that his UDS result for the month of June will be a negative. Furthermore, the patient is seeking assistance with ImmaCare, Inc. for supportive housing. The patient handed this writer a form that needs to be completed and signed by a qualified professional for disability verification, referring to the supportive housing.

Investigate and clarify how the patient meets criteria for the disorder(s) as per the patient 's side effects and the criteria sketched out in the symptomatic manual.

A conflict with any medication that the individual has or is previously taking. Ingredients that forms the medication are also examined vs. the ingredients of recent drugs to find out if they would clash with one another or if they would hamper the influence of the medication. Medications are also examined to see if there is duplicate therapy, which takes places when the individual is taking another medication in the same exact class and the medication could result in the individual having an overdose. Furthermore, allergy records are examined to see if the individual has food and drug allergies that could possibly be provoked by the new medication. The individual’s diagnosis is examined to make out if the individuals has a medical condition

When deciding on which area to focus on for this task it was important for me that medication administration is done with no room for error to occur. When administering any type of medication to a patient it must be clear as well as concise as to what you are doing. One thing that has to be correct at all times is the five rights’ to medication administration are followed and done correctly. The five rights’ are: Right patient, Right route, right time, right medication, Right dose. If you miss even one of these important rights you can cause severe harm to your patient.

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.

Considering that USA based ABC Company is planning to conduct clinical trials in ICH concern countries by following the ICH and USFDA guideline. The FDA encourages communicating with them before conducting clinical trial for the rare disease and follow ICH E5 guidance to provide references for regulatory and development strategies to authorize clinical data gathered in one region to be used for the evidence of product registrations in another region following the effect of ethnic factors (FDA, 1998).The regulatory attentions for planning a multinational pivotal phase III clinical trial for drug used for rare disease (Orphan drug by the FDA) which is touching less than 200,000 US population comprise the subjects enrolled in the clinical trials, clinical trial investigators, regulatory agencies, institutional review boards (IRB), and ethics committees, recommending physicians, formularies, and insurance companies. Phase III pivotal study should base on clinical trial designed and performed to acquire statistically important proof of efficacy and safety required by the USFDA for NDA approval. It should include examination with the goal to include statements into the label as well as postmarketing surveillance commitments. The Orphan Drug Act of 1983 gives intensive as well as flexibility of using a single study and subsidiary evidence, for example multiple event measures and extrapolation studies to the ABC Company (Praiser, 2014).

Medication management would reduce the incidence of adverse drug events, hence reducing harm and mortality of patients in hospitals and improved mortality and morbidity due to diseases which require precise use of medication. Some examples include asthma, peptic ulcer disease and schizophrenia.

It is now accepted worldwide, that before a drug is brought into routine use its efficacy, safety, and the balance between two (sometimes the “risk-to-benefit ratio’) need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.

The pharmaceutical industry is one of the most heavily regulated of all industries and Pfizer is a global US based pharmaceutical company and in the pharmaceutical industry companies are regulated by the Food and Drug Administration (FDA), World Health Organization (WHO), and Medicines and Healthcare Products Regulatory Agency (MHRA). Each of these regulatory bodies focus on the manufacturer, drug sellers, and prescribing to physicians process. (World Health Organization). In accordance to the Internal Revenue Service, the US firms must meet government regulatory requirements. The drug company must get market approval and show it safe for human consumption through animal and human testing and prove it is effective for the illness and its intentions to alleviate. The scientific community established a four-phase method to establish effectiveness. First phase is animal and toxicity studies, second phase is the investigational new drug application filed to test small numbers of human and allow transportation of unapproved drugs. Thirdly, a large scale trials conducted with thousands of patients proves the product is effective against a specific disease. Human trial subjects must provide consent for the experimental group. Lastly, a post approval marketing testing which are conducted to generate marketing data for the competitive market (involves competitor products) (Internal Revenue Service, 2015) These measures must be in compliance with the FDA in