The Drug Quality and Security Act Essay

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

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

Drug Policy in the United States began under the Presidency of Richard M. Nixon, who launched the “War on Drugs” and oversaw the creation of the Drug Enforcement Agency (DEA). The sole purpose of both initiatives was to combat the copious amounts of drugs flowing out of our borders. Then First Lady Nancy Reagan, who will go down in history as the greatest First Lady of All Time, launched “Just Say No”. A campaign aimed towards the youth to refuse the vices of drug and alcohol abuse. These policies were perpetuated in the 1990s under the Clinton Administration who passed their own tough on crime initiatives as well. The upside, the implementation of these policies has caused the drug use rates to equal where they were 25 years ago. On the downside, the United States imprisons more people than any other industrialized nation in the world because of the drug offenses.

Pharmacy compounding is a practice that blends both science and art. It involves personalizing medications for patients. A Compounding pharmacist will put several ingredients in the medication. The patient will have a customized medication that meets his or her needs.

Over the last one hundred and eighty years, The United States has had numerous kinds of, chemist, doctors, politicians and concerns citizens that came together to form different types of groups and agencies to oversee consumer products and meet minimal guidelines. Over the decades the guidelines have become stricter with emphasis on intense processing and regulations on consumer products. During these early years, there were no federal agencies to protect the citizens from bad consumer products. Safety issues became such a major concerns for the American people that, the federal government proposed a bill to congress to make an office to oversees these consumer products. This bill came into

prevalent of national drug control regimes, and means a set of policies which establish criminal

Drugs have been around for a while now and till this day the exposure to drugs have become worse. Selling and buying drugs has become a well-known, large business around the United States. People from all ages, young children to seniors are in this business. But due to the prohibition and the harsher drug laws implemented during the war on drugs this business has become more risk taking. Yes, drug laws have become harsher but these laws vary from state to state. In this case, we will see comparisons and contracts between Massachusetts, located in the Northeast and California, located in the West.

Traditional compounding pharmacies are not registered with the FDA as drug manufacturers, adverse side-effects don’t need to be reported, nor does the agency approve their prescriptions before marketing. These practices stem from the origin of compounding and how policy was constructed under that notion: 1) Compounding was allowed in limited quantities before the receipt of a valid prescription order based on a history of receiving valid prescription orders. 2) Compounding is not needed if a drug is commercially available from a FDA-regulated facility. 3) States had authority to regulate traditional compounding pharmacies but national-scale businesses required federal coordination, distinguished by limiting interstate shipments to no more than 5% of the compounder’s business (Outterson, 2012). NECC violated all of these policies because it was operating more as a drug manufacturer than a compounding pharmacy, which made it difficult to delineate jurisdiction and allowed NECC to continue to operate even after reports of contamination had be made in previous years leading up to the

For example, the drug Thalidomide, which has been used to treat pregnant women in Europe resulted in newborns with missing limbs. But, if the drug would have been clinically tested, approved, and then used, these consequences might have not occurred. So, the idea of the FDA to regulate the new drugs is a good thing as they undergo a series of testing phases prior to full approval (Steiner, 2014). On the other hand, slow implementation of new drugs took the life of a nine year old in the last decade due to shortage in supply of the drug Methotrexate (Roman,

WHO defines fixed dose combination (FDC) as ‘a combination of two or more actives in a fixed ratio of doses’. In other words, FDC includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses. WHO has made it clear that, fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance. Accordingly, 19th WHO Model List of Essential Medicines, contains only 27 FDCs out of 414 total medicines. On the contrary, Indian pharmaceutical market is flooded with unnecessary, expensive, hazardous, irrational FDCs. Recent ban by MoHFW on 344 FDCs has again brought attention to these irrational formulations in market. The need of a drug policy guiding the rational use of FDC drugs is stressed more than ever. The following policy brief will address the possible actionable policy options for rational use of FDC drugs. These will include legal, regulatory and promotional measures, which will reinforce and expand the efforts of the Government to ensure that, the irrational FDCs are not manufactured, prescribed, sold or used.

Post-approval adverse drug effects (ADEs) are a major global health concern. An estimated cost of $ 75 billion per year [1] has been attributed to these ADEs alongwith more than 2 million injuries, hospitalizations and deaths in each year in the US alone [2]. It has become an important area of research to study the effect of drug-drug interactions. For example, in treatment of cancer sometimes cytotoxic drugs are used. It becomes very important to study the effects of DDI among these drugs at all levels. Failure to recognize these effects may lead to a lot of undesired complications ranging from overdosing to undertreatment. Drug interactions can be pharmaceutical, pharmacokinetic (PK), or pharmacodynamic (PD). PK interaction occurs when a drug influences the ADME (absorption, distribution, metabolism and excretion) process of another drug. For example,

Pharmaceutical formulations as prescription or over-the-counter medications are used to treat human and animal disease conditions (Thiele-Bruhn and Beck, 2005). Generally, drugs and other related compounds are biologically active and their molecular weights may range from 200 to 500 / 1000 Dalton. Currently, there is paucity of information on the total global administration of drugs to humans and animals. Despite the unavailability of data, sales in 2004 alone totaled $518 billion (Kümmerer, 2009). An increase to about $1.2 trillion by 2016 is expected due to the influence of merging markets, biologics and generics (IMS Health, 2012). Consequently, increased production, sales and ingestion of pharmaceutical chemicals (PHCs) may translate to higher residues in the environment. Typically, an ingested drug becomes metabolized and a part is excreted through urine and / or feces possibly in different forms. However, their removal during conventional wastewater treatments is inefficient because of their nature (Zuehlke et al., 2004; Daughton, 2007). Prescription (branded and non-branded) and over-the-counter medication are the major classifications of pharmaceutical products available to the United States (U.S.) population.

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

Pharmaceutical chemicals (PHCs) are important in the treatment of human and animal disease conditions (Thiele-Bruhn and Beck, 2005). They are recognized as biologically active compounds and their molecular weights may range from 200 to 500 / 1000 Dalton. Currently, there is little information on the total global administration of pharmaceuticals to humans and animals. Despite the unavailability of data on drug administrations across countries, the total global sales were $518 billion in 2004 (Kümmerer, 2009). This figure is even projected to increase to nearly $1.2 trillion by 2016 with the influence of merging markets, biologics and generics (IMS Health, 2012). Pharmaceuticals available to the United States (U.S.) population are categorized under prescription (branded and non-branded) and over-the-counter medications.

The Drugs Technical Advisory Body (DTAB) is a technical body with the Director General of Health Services as the chairman and Drugs Controller of India as the member-secretary. It has to be consulted before any rule is amended or introduced.