Heparin Case Study

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

The history, briefly, this is a 66-year-old gentleman who presented to the hospital for an elective admission because he was failing outpatient diuresis. The patient complained of increased shortness of breath, weight gain and lower extremity edema for 3 weeks. He had no (UI) symptoms, no chest pain. He did have (dyspnea exertion) at 8 blocks, now worse, and had recently gone from 2 pillow orthopnea to (three) pillow orthopnea. He denies post-op PND. He also complained of skin lesions over his chest, back, arms and upper thighs, which were new onset and pruritic.

Angiomax is considered as a potential substitute for heparin. It has 3 major advantages when compared with Heparin. First, the effects of Angiomax are more accurate and more predictable. Second, it works better among patients at risk for bleeding, where heparin often proves problematic. Third, the product works faster than heparin and patients do not need to wait for 2 – 3 hours to identify the results. The major disadvantage of Angiomax is its high production cost against Heparin. As Heparin has a very long history dated back in 1916, the price is only $2 per unit while the production cost of Angiomax takes nearly $40 per unit.

Dr. David Graham is the senior scientist within the FDA’s Office of Drug Safety. Graham became concerned when he started to see an increased number of patients having heart attacks and strokes after taking a large does of the drug Vioxx, back in 2002. He raised his concern to the FDA saying that the warning label needs to be changed due to his new findings. He had trouble getting this any attention from the FDA’s administration and decided it was time to ‘blow the whistle’ and go to the media.

I was well versed with the patient’s medical history and current treatment, as I was the Long Call IM PGY – II Resident who supervised the medical intern when this patient was being downgraded from the ICU to the medical floor on 5/20/17 (and even suggested to the medical intern to add in her notes that the patient would benefit from statins, ACE inhibition and Spironolactone given CAD, CVA and HFrEF (LVEF < 35%.) The medical team subsequently started the patient on Atorvastatin 40 MG PO QHS, Lisinopril 10 MG PO QD and Spironolactone 12.5 MG PO QD.

Issues have recently started developing around the drug since just a few years after it was put onto the market. Hundreds of people have died from taking the drug for the

With the growing reliance on medication therapy as the primary intervention for most illnesses, patients receiving medication interventions are exposed to potential harm as well as benefits. Medicines have proven to be very beneficial for treating illness and preventing disease. This success has resulted in a dramatic increase in medication use in recent times. Unfortunately, this increase in use and expansion of the pharmaceutical industry has also brought with it an increase in hazards, error and adverse events associated with medication use.

Literature searches were performed utilizing online databases which included Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, and PUBMED. The key search terms included heparin, unfractionated heparin, and safety of heparin use, heparin safety, medication errors, intravenous heparin

Aspartame has now been on the market for many years and most people seemingly haven’t had adverse reactions. Or have they? Russell L. Blaylock, M.D. warns that many people don’t notice of the serious symptoms because “they’re more resistant to the obvious toxic effects, but they’re still getting very subtle toxic effects that over many years is going to produce obvious disease in those persons.” However, some people have had more direct, severe reactions. For example, FDA officials have estimated that only 1% of toxic reactions are likely to get reported and the agency received reports of 7,000 toxic reactions with aspartame from 1982 until 1995. In fact, there were likely more official reports of toxicity, but we can’t be sure to the extent. After all, Congress found out in 1987 that the FDA had been transferring aspartame toxicity calls to the AIDS Hotline.

clotting in vessels. This makes the person more vulnerable if when cut for the blood flow to cease in

Preventing errors relating to commonly used anticoagulants. (2008). Joint Commission perspectives. Joint Commission on Accreditation of Healthcare Organizations, 28(11), 13-15.

In reviewing Heparin flushes in Central Venous Catheters (CVCs); one must first understand the importance of their placement. To properly investigate central venous catheter (CVC) care; documentation will focus on Heparin flushes as it relates to renal care. The renal dialysis patient undergoes CVC placement as a basis of receiving hemodialysis treatments. It is essentially the first access point placed in preparation of a more permanent access point. Central venous catheters, fistulas, and grafts are considered the lifeline of a dialysis patient. Their function and patency is of the utmost importance to the morbidity and mortality rate of a renal patient. “Venous catheters generally develop a fibrin sheath at the tip, which evolve into a clot due to body’s physiological response to the vein injury and the foreign catheter 1 and subsequent catheter obstruction.” (Journal of Evolution of Medical and Dental Sciences, 2014, pg. 46).

Due to these findings patient was directly admitted to the hospital and placed on a heparin drip. On physical exam patient had absent pulses below the right femoral artery. However, there was no discoloration, change of temperature, or sensory as well as motor deficits of the right lower extremity. Patient was taking a low-dose aspirin and red yeast rice for cholesterol management at that time.

After reading this scenario about this patient, there are a few things that I wonder about and things that could have potentially contributed to this patient’s death. First, I do not understand why they did not place an Ewald tube down this patient and perform some sort of gastric lavage with activated charcoal (Gastric, 2017). They did all the work to stabilize the patient, but did not remove the remainder of the product, causing the acidosis. Basically, I feel that the patient came in with metabolic acidosis because of the aspirin, was stabilized, but then developed metabolic acidosis again. Which could have lead to a whole new list of complications to develop.

As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).