Drug Shortage In The United States: A Case Study

As a critical care nurse the concern with medication shortages really hits home. In my current practice I have been asked by our hospital pharmacy to decrease the amount of Ativan given to a patient because the supply was low and they did not have any more to restock our omnicell. I am unsure the reason behind this particular shortage, but several other drugs we currently use are in low supply, most importantly epinephrine. Epinephrine is a life-saving medication, not only for supply on our code carts for cardiac arrest, but available in injection form for people with severe allergies. The shortage affects everyone, from oncology patients to cardiac patients. Recent policy changes have been made in order to correct the major shortages to help keep these life-saving drugs on the market and available to the people that need them.

Consult www.phrma.org, The Pharmaceutical Research and Manufacturers of America. What steps is the branded industry taking to address the

In this essay, federal drug policy, and its correlation with the shortage of drugs in Canada, will be considered. In particular, the disruption of drug supply will be discussed, with a specific focus on drug supply within the province of Ontario. A discussion will ensue surrounding drug pricing and policy, and the ways in which these frameworks can ultimately serve to affect the efficacy of medical treatment and the safety of patients. In addition, the paper will focus on the accountability of multiple stakeholders, at both the federal and provincial levels, in terms of supplying medically necessary drugs to Canadians. This analysis will encompass the dominant role played by pharmaceutical actors in Canada. Finally, conclusion will be drawn which take account of existing federal and provincial programs that aim to address drug shortages and the recommendations on comprehensive and appropriate drug funding.

Market failure appears when there is a failure in allocation of goods and services. When the market is unsuccessful, the government is called to intervene and correct the failure. Over the years, government participation in the pharmaceutical market has been more wide-ranging than any other good or service. With the government’s ability to regulate, mandate, inform, finance and provide, their intervention to overcome market failure can be beneficial for the economy. Market failure plays a significant role in today’s economy.

During the 1970s, a drug U-47700 was created by researchers as an anesthetic, less addictive than a morphine substitute. U-47700 was eventually tossed out and discontinued. The Food and Drug Administration did not approve it for human use. Unfortunately, the patent, which included instructions on how to produce the drug, became public information (Mato, 2016). This resulted in foreign drug manufactures gaining access to the formula through academic journals and patent filings (Blau, 2016). Currently, dealers from out of the country are using the chemical recipe and selling the drug in the United States, (Mato, 2016).

In the business of drug production over the years, there have been astronomical gains in the technology of pharmaceutical drugs. More and more drugs are being made for diseases and viruses each day, and there are many more drugs still undergoing research and testing. These "miracle" drugs are expensive, however, and many Americans cannot afford these prices.

There is a major problem in this country that is not publicized by any major media outlet. In fact, it is almost as if the problem is actively ignored and swept under the rug. We are at war with drugs not the illegal drugs that are actively policed every day, but drugs prescribed by trusted medical doctors. The United States population consumes more prescription drugs than any other country in the world. In 2010 America alone accounted for over eighty percent of the global intake of prescription drugs (Zennie). That’s more than 110 tons of drugs being prescribed every year, which would be enough to give every single person in this country 64 pills. How can America need so much more drugs than everyone else in the world? The answer is simple we do not, but these drugs are continuously promoted and prescribed to the American public. This problem continues to increase exponentially, in the last ten years the consumption of these drugs have grown over 600% (Zennie). It is the governments job to raise awareness on this major problem effecting the American public. There are three ways the government can start to solve this problem: Starting a national campaign to raise awareness of the dangers of drugs, increasing scrutiny of doctors when it comes to prescribing drugs, and the discontinuation of advertising prescription drugs.

Specific struggles can occur as possible interventions to mitigate drug shortages are attempted. As discussed above, pharmaceutical manufacturers are private enterprises that are not obligated to manufacture any specific medication even if such medications are in short supply. Purchasing from foreign suppliers is a strategy distributors sometimes use to cope with drug shortages. Authors Dill and Ahn (2014) point out monitoring compliance of foreign suupliers is more challenging than monitoring and regulating facilities in one’s own country (2014). Another approach, used by some distributors, when medications are scare, is to turn to compounding facilities. According to Caulder, Mehta, Bookstaver, Sims, and Stevenson (2015) depending on compounding is a high risk practice. These authors explain that in some cases compounding practitioners do not have sufficient experience and contamination can occur (p. 180). Undoubtedly the most important goal is to avoid distribution of drugs that are contaminated. Using contaminated drug; and a subsequent recall, is the worst possible scenario for all

The four criteria that must be met for an prescription to be classified as over the counter is that the indication for the drugs over the counter use is similar to its use a prescription drug. It also must be easy enough for the patient to diagnose and monitor his or her own condition when using the drug from over the counter. The OTC drug must have a low toxicity/side effect rate and a small potential for abuse. Lastly the OTC drug must not require ongoing test or monitoring while taking this medication.

One of the biggest problems in the United States today is the widespread use of narcotics. Currently, the United States has a very stern policy regarding the use, distribution, and trafficking of drugs. However, it is clear that the current U.S. policy is failing, and the supply of illegal drugs as well as the demand is increasing. The U.S. government has focused for years on dealing with the demand aspect of this issue. Through government programs directed towards education and national awareness of the harm that drugs cause, the government has been attempting to severely reduce the demand for narcotics. In all actuality, the demand may be higher now than ever before. To prevent the supply of illegal drugs from

Optel Vision, a division of the Optel Group, is an organization that helps global pharmaceutical companies to comply with legal and regulatory requirements in the area of product serialization and traceability. The organization has regional offices in Canada, Brazil, India and Ireland with a workforce approximated to consist of 500 professionals. OptelMedevon division under Optel Vision focuses on the traceability project. Optel Vision’s mission is to integrate technologies to assure product safety and client business sustainability by putting in place or improving procedures based on ISO and GAMP standards.

There are many solutions that can be implanted in order to solve this inexcusable and exclusively American problem of drug sampling. The first implementing a European model of health coverage. Although rather extensive, it would involve negotiating with pharmaceutical companies on prices, benefits/risks, and ultimately deciding on the drugs that would be covered by the state. As a result, marketing drugs would have very little potential in market and every citizen would be covered on verified drugs. Moreover, the physician could refer the patient to over the counter drugs, which are proven to be effective and safe through all the years of use. More specifically, over the counter drugs are much cheaper than brand name drugs and can be found at a fraction of the price at RxOutreach.com, which provides patients at or below 250% of the Federal poverty level 20 to 30 dollars for a 90 day supply of drugs (Chimonas 2009). Along the same lines physicians could also refer patients to Walmart’s 4 dollar generic prescriptions for a 30-day supply and 10 dollars for a 90-dollar supply ("$4 Prescriptions"). Additionally, pharmaceutical companies offer patient assistance programs like NeedyMeds.com or RxAsist.org. Even, University hospitals like Michigan and Wisconsin are offering drug vouchers for use at hospital pharmacies (Chimonas 2009). Alternatively, a patient would want to avoid these programs since more work has to be done on the physician’s side to ensure the safety of the patient

Drug shortages have also been a key issues, particularly over the last decade (Quadri et al., 2015). Antibiotic shortages have occurred fairly regularly over the years which is of obvious concern with the recent emergence of increasing amounts of drug resistant organisms. The length of time that shortages exist before corrections is also of interest as the average time of a shortage is 9 months. Another critical issue is in the pharmaceutical industry is the uncertainty

Pharmaceutical quality affects every human being. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be helpful in understanding how CGMPs establish the foundation for drug product quality.

with this problem and searching for cost-effective solutions. It is therefore vital that supply chain