How to use an adrenaline autoinjector
An epinephrine autoinjector (or adrenaline autoinjector) is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of odishahaalchaal.com first epinephrine autoinjector was brought to market in The EpiPen Auto-Injector and EpiPen Jr Auto-Injector (henceforth referred to as EpiPen and EpiPen Jr Auto-Injector) each contain 2 mL epinephrine solution. Approximately mL remains in the auto-injector after activation and cannot be used. Each mL in the EpiPen Auto-Injector contains mg epinephrine, mg sodium.
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Sep 14, · Mylan misclassified EpiPen as a generic drug, in order to avoid the higher rebates drug companies must pay. Patented drugs such as EpiPen are typically considered to be brand-name drugs, but Mylan classified the EpiPen as a generic on the basis that the active substance (epinephrine) used in EpiPens is common and widely used. EpiPen is a brand of adrenaline pen, used to administer life-saving medicine to someone suffering a severe allergic reaction (anaphylaxis). It is therefore essential if you have been prescribed an EpiPen that you carry two of them with you at all times. A. EpiPen ® is an adrenaline auto-injector (also known as an AAI), and is only available on prescription from the doctor. People who are at risk of anaphylaxis will be prescribed auto-injectors to use in an emergency. EpiPen ® delivers an appropriate and immediate dose of adrenaline to treat an anaphylactic reaction, while waiting for the ambulance to arrive.
Each year about 3. The EpiPen is a life-saving treatment for anaphylactic reactions, which are caused by allergens such as nuts, seafood, and insect bites. V, the owner of EpiPen, acted unethically. In , Mylan N. In , Mylan began to steadily increase the price of EpiPen. In tandem with these price increases, Mylan embarked on a strategy to cement the market dominance of EpiPen, while expanding the market for epinephrine as a whole. The first element of this strategy consisted of extensive marketing campaigns designed to raise awareness about the dangers of anaphylactic reactions.
In , for example, Mylan struck a deal with Walt Disney Parks and Resorts which produced a website and several storybooks designed for families living with severe allergies distributed in In addition, Mylan embarked on an extensive lobbying campaign. The company also added lobbyists in 36 states between and , in order to pressure lawmakers to require epinephrine be made available in public schools. The rate at which Mylan hired new lobbyists during this period was faster than any other US company, according to the Center for Public Integrity.
Increasingly, states have passed laws designed to encourage epinephrine injections to be made available in schools. In , Nebraska became the first state to introduce a requirement that public schools must be able to provide epinephrine injections. A further nine states have introduced similar requirements since , some prompted by much publicised deaths as a result of anaphylaxis. A further 38 states passed laws permitting epinephrine in schools during the same period.
In , President Obama signed off on a federal law, which provides financial incentives for states to require epinephrine treatments in schools. Schools that sign up to the program receive four free EpiPens. The scheme not only helps to increase the visibility of the EpiPen brand, but also has the potential to be lucrative for the company in the short term.
Donations of EpiPens are tax deductible. An individual who holds a right is thereby entitled to whatever that right guarantees.
Annual prescriptions for EpiPen products more than doubled to 3. In , and , Mylan alone exceeded a billion dollars in EpiPen sales. Multiple congressional committees requested Mylan explain the rapid price increases, resulting in a hearing by the House Committee on Oversight and Government Reform in September of In addition, she claimed that half of the wholesale price of EpiPens are received by middlemen such as insurance companies and pharmacy benefit managers, and that the US healthcare system was partially to blame for rising costs.
Though the amount the patients pay in co-pay for EpiPen is significantly reduced in using the savings card, insurance companies continue to pay for the high remaining cost of the drug. This results in higher healthcare premiums. For this very reason, such savings cards cannot be used by patients covered by Medicaid. Mylan misclassified EpiPen as a generic drug, in order to avoid the higher rebates drug companies must pay when they sell their brand-name products to state Medicaid programs.
Mylan misclassified EpiPen as a generic drug, in order to avoid the higher rebates drug companies must pay. Patented drugs such as EpiPen are typically considered to be brand-name drugs, but Mylan classified the EpiPen as a generic on the basis that the active substance epinephrine used in EpiPens is common and widely used. This clearly was a misclassification, considering the extremely high market share which EpiPen enjoys, and the fact that Mylan owns a patent for EpiPen which will expire in The Department of Justice pursued legal action against Mylan in September of As part of the settlement, Mylan agreed to reclassify EpiPen as a branded drug.
Schneiderman launched an antitrust investigation into Mylan, on the basis that the sales contracts with schools as part of the EpiPen4Schools program violated antitrust laws. In April of , Mylan faced two new lawsuits related to their business practices in selling EpiPen. The first, filed April 3rd, was a class-action lawsuit filed by three EpiPen purchasers who claim that Mylan engaged in illegal schemes to dominate the market with Pharmacy Benefit Managers PBMs.
PBMs serve as intermediaries between insurance companies, pharmaceutical companies, and pharmacies. The second lawsuit, filed April 24th by pharmaceutical company Sanofi SA, also accused Mylan of illegally attempting to prevent competition for the EpiPen.
Sanofi seeks damages against Mylan for the hundreds of millions of dollars they may have lost in sales due to these illegal agreements. Any damages which Mylan pays to Sanofi will be tripled under US antitrust law. A number of different factors interact in determining the price for a specific drug in a particular country. These include the market for the drug in question, the judgment and business practices of the manufacturer, and the conditions of the wider pharmaceutical market and healthcare system in the country of interest.
Examining these factors in relation to the EpiPen can explain the dramatic increase in its price between and Epinephrine is a hormone used to treat anaphylaxis severe allergic reactions since Anaphylactic reactions can be deadly due to swelling and closing of the airways.
Epinephrine is widely used and very cheap to produce. It takes less than one US dollar to manufacture one millilitre of epinephrine. A single EpiPen dispenses less than a third of that amount. What makes the EpiPen valuable is it quickly administers the correct dose of epinephrine, and is simple enough to operate that a person suffering from anaphylaxis can self-administer the treatment if necessary.
The marginal costs of most drugs to manufacturers are typically low. More influential supply-side factors in determining drug pricing are research and development costs and marketing costs. Heather Bresch, in her September congressional hearing, testified that the price increases for Epipen were in part due to research and development costs involved in improving the drug. Since purchasing EpiPen in , Mylan has made incremental upgrades to the EpiPen, designed to make the drug easier to administer and clarify instructions about how to use the product.
This cannot be said for the subsequent price increases between and Usually, such heavy marketing costs are reserved for new products, which are often advertised widely in order to introduce to the drugs to the medical community. For the most part, drug prices in the US predominantly rest on demand-side considerations.
New drugs with a significant therapeutic advantage over old ones are the subject of large amounts of demand, which warrant high prices. The EpiPen, however, has been on the market since Typically, innovative products such as the EpiPen offering a large therapeutic advance are introduced with high prices that decrease over time.
The high price of EpiPen can better be explained by the lack of competition the product faces. The amount of competition a particular drug faces in its specific category has a significant effect on price, as prescribing physicians must select between rival drugs. A study by Lu and Comanor finds that launch prices of pharmaceutical products are significantly lower when there are more branded rivals in direct competition with them.
In contrast, prior to June of , when the Adrenaclick autoinjector was reintroduced by Amedra, few direct competitors to the EpiPen existed in the US.
Since its relaunch, the Adrenaclick has faced manufacturing constraints, which prevented it from gaining significant market share until recently. Auvi-Q, manufactured by French pharmaceutical Sanofi S.
Fiona Scott Morton and Lysle T. Generic applicants hoping to create a new version of a patented product face navigating through unclear FDA guidelines concerning how to avoid infringing on the existing patent.
In the case of EpiPen, developing competitor drugs may have been particularly difficult due to the fact the patented element being the injector rather than epinephrine, which is an old generic.
A similar patent issued helped to facilitate the recent dramatic price increases of Evzio, an autoinjector for naloxone, used to treat opioid overdose. As was mentioned previously, EpiPen prices in Europe are lower in part due to a larger number of direct competitors to the EpiPen there. But the most significant factor causing this price differentiation is the healthcare system in the US. The UK, France, and Germany all have different forms of universal health care systems, which severely restrict the price of pharmaceutical drugs.
In the UK, there exists a long-held consensus among lawmakers that there is a need for price regulation of pharmaceuticals, as the supply of pharmaceuticals is viewed as non-competitive due to the patent system.
Pharmaceutical companies are required to repay any amount that exceeds this fixed cap. This agreement is renegotiated every time the existing PPRS agreement expires, which typically occurs years after they come into effect. The UK is a hub of research and development in the pharmaceutical sector, and has continued to attract investment, despite the decline in pharmaceutical research and development in Europe as a whole.
A system such as the one the PPRS sets out is not be feasible in the US, where no universal public healthcare option exists. In the US, in contrast, a lack of price controls set by the government allows drugs to be sold at whatever prices pharmaceutical companies see fit. State Medicaid programs mandate that pharmaceutical companies sell these drugs at a rebate, which is higher or lower depending on whether the drugs in question are classed as innovators brand-name drugs or generics. However, even taking into account rebates, certain drugs such as EpiPen are sold to state Medicaid programs at far higher prices than they are sold to the NHS in the UK.
This does not necessarily mean all drug prices are much higher in the US than they are in other countries. Reports by the US Government Accountability Office GAO in and show that the cash prices for the same branded products are generally higher in the United States than elsewhere.
However, the GAO reports, and other studies of a similar nature fail to account for a number of factors which obfuscate price comparisons. One issue is the GAO report relies on established nominal prices of drugs.
These prices do not take into account the rebates and discounts granted to large-scale buyers of pharmaceutical products. This is a huge oversight, considering these bulk buyers comprise the largest segment of demand for pharmaceutical products in the US.
Given the prices at which large-scale buyers buy drugs are not disclosed, it is difficult to estimate the magnitude of how this skews the GAO results. Even more significantly, the GAO report fails to account for the influence of generic drugs in the US pharmaceutical market. Generic drugs are more widely used in the US than in most other countries, accounting for about half of the total sales in pharmaceutical products, and are also generally much cheaper than their branded counterparts.
The generic version of the EpiPen introduced by Mylan costs about half the price of the branded version, for example. As such, it is insufficient to simply compare US prices of popular branded drugs to those in other countries. The market share of generic drugs, and their prices should also be compared. It should be noted this argument is predicated on the idea that generic drugs are identically effective to branded drugs, which is not necessarily the case. However, the inactive ingredients in branded drugs may result in slightly different outcomes for patients than generic drugs in some cases.
Furthermore, as was the case with the EpiPen until Mylan introduced its own generic version of the product, some pharmaceutical products do not have generic counterparts. In sum, the problem of inflated pharmaceutical prices does not apply to all drugs in the US. Many drug prices are well regulated in the US by market forces. The main conclusion from empirical studies comparing US drug prices to drug prices in other countries is the US system gives pharmaceutical companies license to sell certain drugs, most often brand-name drugs, at extremely inflated prices.
Rather than a lack of regulation in the US giving license to companies to increase prices, the healthcare system actually forces companies such as Mylan to raise prices, according to Bresch.