Drug Supply Chain Security Act Case Study

In recent years, it has become an increasingly popular practice for drug companies to perform their clinical testing of new drugs in foreign countries that might not have the consumer protections or product liability laws present in the United States. Please answer each of the following questions using a theory studied in Module 2 specifically and thoroughly and using examples and facts from the readings and resources.

For several industries in Asia, in particular pharmaceuticals, security issues include fake branded products and the substitution of goods with counterfeit or inferior quality replacements. Recent supply chain security initiatives are also designed to address security problems relating to the sale of counterfeit goods. In August of 2008, Hong Kong customs discovered 2.5m cigarettes in a container that was marked to contain other goods. If these items had not been identified as fake, they could have been sold as original brand goods, resulting in a substantial shortfall in excise income for the Hong Kong Government.

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.

The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there

The item is unlawful medications. The individuals who bargain these medications are Culprits. That is the thing that makes the medication business diverse then whatever other. Alcohol is a medication, yet grown-ups are permitted to utilize liquor items. Nicotine is a medication, yet grown-ups are permitted to utilize a wide range of structures of tobacco items, all which have tobacco in them. The drug Caffeine can be found in numerous ordinary things, similar to pop confection bars. Consider what number of cops we would require if caffeine items were illicit.

In this situation the drugs were originally manufactured in the United States or an FDA approved facility. The danger to the end user or patient is simply not knowing where the drugs came from to begin with. This is where the FDA feels the patient could ingest either weak, over potent or counterfeit drugs with potentially deadly side effects. Many on-line Canadian pharmacies have actual drugs imported from U.S. sources and some do not. As long as the consumer can find a reputable and licensed Canadian pharmacy that has a strong Internet presence there is no real danger of impure or counterfeit drugs(2). Several top FDA officials have testified to Congress regarding the importation of drugs from foreign sources. Their conclusion has been consistently, the burden this would place on the director of the FDA would be unfair(4). The Center for Drug Evaluation and Research (CIDER) has attempted to evaluate the potential for regulation of such drugs, with the conclusion that regulation would be extremely costly and nearly impossible. The main reason the task would be difficult would be the need to test every pill, vial, or suppository that entered the United States. Since the drug is generally destroyed in the process the consumer would never receive their prescription. The position of the FDA is, and should be to protect the American public. However during my

In looking into the opioid epidemic, Joe Rannazzisi, the head of the Office of Diversion Control in the DEA, started to notice a trend of distributors shipping large amounts of opioids to midsize to small pharmacies around the country. Based on the alarming consequences of pushing opioids in these communities, Rannazzisi decided to step in and freeze the distribution to these pharmacies. In addition, he decided to investigate them. The DEA has a broad authority to stop opioids being pumped into communities based on an imminent threat to the community. This all changed when lobbyists for the big pharmacies got legislation through Congress that essentially stopped the DEA from freezing the distribution of opioids to these communities. This legislation

Pharmacies in the U.S. rarely get visits from the U.S. Drug Enforcement Agency. It is normally the job of state authorities to handle inspections and enforcement of regulations surrounding pharmacies. However, in cases of drug diversion from pharmacies, and in certain cases of "doctor shoppers" and forged prescriptions, the DEA may become involved.

A terrible incident happened in Tennessee in 1937 when a drug called Elixir Sulfanilamide was mislabeled and contained toxic quantities of antifreeze that killed over 100 people (FDA's Origin & Functions - FDA History). Before this event, Congress debated substituting the 1906 Act and this instance in Tennessee drove Congress to approve the Food, Drug and Cosmetic Act of 1938 that provided an updated set of standards. Unlike before when the government had to disprove a drug was effective, the new act stated that drugs had to be proven effective before being sold. It not only replaced the Pure Food and Durg Act, but the Sherley Amendment as well (Centennial Edition of FDA Consumer).

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

In both developed and underdeveloped economies, there is a need to put regulations which ensure that profits are not abnormally earned at the expense of the innocent clients. It is therefore the mandate of the territorial authorities to put in place measures that introduce checks and balances in all trades. The respective companies or business must also follow the same suit lest they find themselves in the crossroads of law. However,

Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.

Project Technical Paper Reliable Pharmaceutical Supply Index Introduction 1. Entity-relationship diagram that shows the data strorage requirements for Relable Pharamceutical Supply -------------------3 2. Domain meta class for RPS. -------------------4 3. Activity diagram for each use case related to entering new orders -------------------5 4.

A standardized public health supply chain provides easy access to affordable, high-quality commodities. At State owned public health facilities, the average accessibility is of health care commodities is about 38 percent; and at private health facilities, where products are often high-priced to most of the population, accessibility is sometimes still under 60 percent (WHO/HAI 2008; Asante, Aikins.

There is also a slight issue between consumer and manufacturer as both are in dis-agreement of keeping up with cool chain requirements. This is an operational issue as from an employer and employee perspective their always needs to be a good relationship between manufacture and consumer as the pharmaceutical products needs to have high level in security measures and the manufacturer intrusts the consumer with his products. This is related to another issue found with theft in organisation MISHAIR.