News Archive
3/27/2012 - P & T Update
By Kim Richards, Pharm. D., RPh.
FORMULARY UPDATE
· PAC will be changing to Lovenox® (enoxaparin) as the formulary low molecular weight heparin (LMWH). The class was reviewed at physicians request since a generic version of Lovenox® was approved at the end of 2010. Enoxaparin is the first “bioequivalent” generic to hit the market. It is technically not a biologic drug - a complex medicine made inside special, live cells rather than by combining chemicals. However, functionally and effectively it is because it’s derived from animal materials and is heavily processed and purified.
The FDA's decision could have much broader implications for the biotechnology and generic industries. Generic companies for years have wanted to expand from making copycat versions of pills to making complex drugs equivalent to biologic drugs, which command high prices. The healthcare overhaul gave the FDA the authority and a process to approve such so-called bioequivalent drugs. FDA scientists established a scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of enoxaparin. This scientific approach is reflected in five criteria, which involve (1) the physical and chemical characteristics of enoxaparin, (2) the nature of the heparin material and the chemical process used to break up heparin chains into smaller pieces, (3) the nature and arrangement of components that constitute enoxaparin, (4) certain laboratory measurements of the product’s anticoagulant activity, and (5) certain aspects of the drug’s effect in humans. These five criteria ensure that a generic enoxaparin drug product will have the same effects as the brand-name drug product when injected into a patient.
When PAC P&T committee reviewed the class, the prices for branded LMWH had significantly decreased and with our GPO contract pricing we actually get branded Lovenox® cheaper than the generic. When the time comes that generic is the more cost advantageous product we will switch. Lovenox® was chosen over Fragmin® (which we’ve used since March 2009) because of transfer issues to other facilities that are not familiar with Fragmin® dosing. Our anticoagulant dosing card will be updated and current inventory depleted before the switch. Pre-printed order sets will also be updated with enoxaparin so when the generic product is utilized we don’t have to update the forms again.
· PAC will also be switching the formulary echinocandin to Mycamine® (micafungin). It is the preferred product on our GPO contract and the class (including Cancidas® and Eraxis®) has similar safety and efficacy. Micafungin is dosed 100-150mg/day depending on indication and of the 3 products available does not require a bolus for any indication.
· Teflaro® (ceftaroline) is a new “5th generation” active against Gram-positive and Gram-negative bacteria. It is indicated for community acquired pneumonia (Staphylococcus aureus and Streptococcus pneumonia) and skin/soft tissue infections. It does have MRSA coverage but ONLY in skin/soft tissue. It does not cover MRSA in the lungs and is not indicated in Hospital or Healthcare Associated Pneumonia. It is currently not on our Adult Pneumonia order set and should be reserved for those patients who are not responding to traditional therapy or who may have already been on those types of antibiotics in the outpatient setting. It is available only as IV and is dosed 600mg q12h.
OTHER NEWS
During the past few years, the number of drug shortages has continued to increase. As a result of these shortages, health care professionals sometimes face situations where they need to identify suitable alternative medications to treat their patients. In 2010, there were 178 drug shortages reported to FDA, a record high. In 2011, FDA has continued to see an increasing number of shortages, especially those involving older, sterile injectable drugs
The major reason for recent drug shortages has been unanticipated manufacturing problems. These problems have affected product quality and sometimes caused firms to voluntarily halt production. Some problems may involve lower risks, such as the wrong expiration date on the package, or significant issues such as particulates in the product or sterility problems.
FDA works with companies to evaluate the risks of the quality problems against the benefits of getting medically necessary drugs to patients. In some cases, the company can continue to market the product by notifying health care professionals about the problem and what they should be aware of when using the product.
A firm’s decision to stop marketing a product is another factor that contributes to shortages. Usually, older drugs are discontinued by companies in favor of newer, more profitable drugs. FDA cannot force companies to manufacture a drug that is in short supply, and cannot require a firm to keep producing a drug it chooses to discontinue manufacturing. Other reasons for drug shortages include supply shortages, reformulations, unanticipated demand, new therapeutic guidelines or disease outbreaks.
The drug shortage problem has had a profound effect at PAC. We currently have issues with ondansetron inj, metoclopraminde inj., midazolam inj., fentanyl inj., morphine inj., lorazepam inj, and diazepam inj. In some cases we are using a compounding pharmacy to make the product for us which, of course, is more expensive and takes longer to acquire. Please consider using orally available products where possible.
This is not unique to PAC and every healthcare setting has been affected. The American Society of Health System Pharmacists lists drug shortages, resolved shortages, drugs no longer available and has advice to pharmacists who have to look outside normal supply chains for drugs: http://www.ashp.org/shortages
5/20/2011 - KENTUCKY HOSPITAL ASSOCIATION PRESENTS AWARDS AT ANNUAL CONVENTION The Second Annual Pattie Cake Bellies to Babies Celebration showcased dozens of local vendors, as well as, the physicians of Gordon & Salter, Richmond Women's Healthcare and Madison Pediatrics.
However, the hit of the fair was the amazing prize giveaways. Below is a list of the prize winners from the Saturday, May 14 event. If you did not pick up your prize on Saturday, you can do so by contacting Jill Williams, Director of Marketing at 859-625-3675 or
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