Epipen Case Summary

There are many checkpoints to reduce the risk of these medications reaching patients Boards of Pharmacy need to continue to filter out the bad actors (distributers, pharmacists, and non-pharmacist purchasing agents). But the pharmacist is the final gatekeeper. Pharmacists need the tools, financial resources, and time to protect our

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

That the modification involved a subsequent remedial measure. involving the issue of whether the federal law requirement that generic drugs must bear the same FDAapproved labels as their brand-name counterparts preempts state law claims for failure to warn? Answer Selected Answer: That federal law preempted state law claims for failure to warn based on strict liability but that failure to warn claims based on negligence could proceed. That federal law preempted state law claims for failure to warn. Correct Answer:

The current debate over the Mylan Company’s near monopoly of the epinephrine market through its EpiPen shows what can happen without monopoly regulation. While the cost to produce an Epipen is around $30, the price to the consumer is around $300 each. The economic implications for a family that needs to keep the device on hand to save a life can be excessively high, the emotional results of not having one when you need one are debilitating. This monopoly is further enhanced by state-enforced regulations requiring that schools keep EpiPens in stock and the, so-called, EpiPen law enacted in 2013, which leave little incentive for other pharmaceutical companies to develop their own technology for fast-acting emergency devices. (Bartolone, 2016) Breaking Mylan’s monopoly will not only lead to new product development but lower prices for consumers for a life-saving delivery

However, changing perceptions of prescribers and consumers will be necessary to launch the initiative. The education of providers regarding the therapeutic equivalent and efficacy of generic medications are therapeutic substitutes is very important—prescribers will be the driving force behind adoption of generics over brand-name drugs. The use of e-prescribing provides information regarding cost, formularies and available generics at the fingertips of providers (United States Department of Health and Human Services, 2010).

On January 1, 1991, The Medicaid Drug Rebate Program was set into place. The purpose of the Medicaid Drug Program was to help manage the cost of prescription drugs. The program allows each state to control a specific list of drugs covered, their generic counterparts, and alternative treatment options (Medicaid History).

The EpiPen device automatically injects a drug called epinephrine, which reverses potentially deadly allergic reactions. It is the only device of its kind available in the United States. Millions depend on carrying the device at all times. For decades the EpiPen was available at a low cost until the Mylan Company purchased it in 2007. Since then, the price has risen over 400% creating a public backlash of media reports, social media petitions, and politician’s calling out Mylan executives to explain the reason for the price raise. Lack of compassion and appearance of greed has tarnished the public image of the company. Mylan has begun looking for ways of rebuilding their image by releasing compensation to the public in the form of generic cheaper EpiPens and payment assistance to eligible patients, but it might be too little too late in this current ongoing communication crisis event.

Recently, there had been a controversy over the rise in pharmaceutical costs involving the EpiPen in the United States. The EpiPen, also known as adrenaline/epinephrine, is a widely used injection that is used to treat allergic reactions. This generic drug has been available for many years. The EpiPen controversy is a prime example of how monopoly

Note: If patient is allergic to epinephrine, the care provider must reassess the treatment plan. EMS personnel can consider the administration of 25-50g of oral diphenhydramine.

F. Scenario – You have a really intense blood pressure issue, and only one medication on the market works for you; however, it is only brand name, and you are allergic to the inactive ingredients in it. Now that generics are released and have different inactive ingredients, you can safely take the drug that works for you.

In the U.S., the Patient Protection and Affordable Care Act, authorized the FDA to approve generic versions of biologic drugs and grant drug manufacturers 12 years of exclusive use before generics can be developed. The FDA law offers PharmaCARE a 180 day exclusivity period to generic drug manufacturers in specific cases. Only one generic manufacturer can produce the generic version of a drug during the exclusivity period. This exclusivity period is only used when a generic manufacturer argues that a patent is invalid or is not violated in the generic production of a drug, and the period acts as a reward for the generic manufacturer who is willing to risk liability in court and the cost of patent court litigation. There is often contention around

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

Not only does the electronic method of prescribing save time, it has also cut down on the number of accidents caused by the misinterpretation of handwriting. Although now almost obsolete, hand-written prescriptions have been the cause of many medical errors because certain sound-alike or look-alike drugs have, in the past, been incorrectly substituted for one another. A report given by the insurance company, Excellus BlueCross BlueShield disclosed that if all physicians were to begin using electronic-prescription systems, “more than two million adverse reactions or events – ranging from inconsequential to severe – could be avoided each year” (wgrz.com). According to pharmacist and associate director for the Food and Drug Administration’s Office of Drug Safety, Jerry Phillips, “Six-hundred sound-alike or look-alike drug pairs have been identified as possible sources of error since 1992” (nytimes.com). For example, Lamictal, a mood-stabilizing anticonvulsant, is quite similar in spelling to Lamisil, an antifungal drug. Because of these strong similarities, it is not difficult to understand how easy it could be for medical personnel to mistake certain medications. But with e-prescribing, because the prescription is sent directly from the prescriber to the pharmacy, the number of accidents caused by misinterpretation of handwriting has already been

Parents and families around the world simply did not have enough money to take care of their health. Medications can be costly for families to purchase. Recently, the skyrocketing cost of EpiPens was in the news. EpiPens are life saving drugs that can open airways, slow heart rates down, and even reverse drops in blood pressure during severe allergic reactions. EpiPens are used so people do not go into anaphylactic shock during an allergic reaction. In 2007 the cost of EpiPens was

The EpiPen Auto-Injector’s contribution to our company’s financial performance currently represents about 10 %. Additionally, Mylan’s sales revenue from two pack EpiPen is approximately 45%, which covers manufacturing, distributing, enhancing, and investing in future development of high-quality products.