Leg 500 Assignment 4 Week 10

This week assignment was very interesting and fascinating. We are all born with gifts and talents. Having God-given gifts inside us that has the power to give life, direction, and purpose. First Peter 4:10 says” As each has received a gift, use it to serve one another, as good stewards of Gods varied grace”. God works in different ways in each of us.

Pharmaceutical companies also defend the costs because of the patent laws. When a patent expires, a generic drug can be made and sold for lower cost. "Although

09-2 Pharmagen . Answer the questions that are given below, not as given in the case text.

* Slows down medical results. If a company holds a gene patent, they own sole rights to research and testing on that gene. So if a patient has a test done on that gene, the samples must be sent to the company owning the gene patent in order to be tested. This could cause delays in getting test

There are many factors that a pharmacy and pharmacist must consider when deciding whether to offer compounding services. Some factors to consider are following the laws and guidelines that regulate a compounding service, if there is a need for a compounding service in the area, and additional training/knowledge for pharmacy technicians to know. There are many regulations that oversee a compounding service such as the FDA (Food and Drug Administration), DEA (Drug Enforcement Act), USP (United States Pharmacopeial), and PCAB (Pharmacy Compounding Accreditation Board). Regulations and oversight is an important factor to consider, as the pharmacy must follow the laws and guidelines of a compounding service such as the recording of formulations

These themes will be useful for understanding the past and potential errors in the processes to improve the medication and patient safety through recommended set of preventive actions to advancing the safety in the pharmacy compounding sciences. The study will benefit the organization to maintain the high quality standard of compounding medication and the potential risks to patients will be minimized.

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.

Pharmaceutical compounding is the creation of a particular pharmacological product to fit the unique needs of a patient, using various tools. Compounding medications allows for patient-specific dosing of the medication and therefore less risk of side effects. It is great for children and infants since they might need a much lower dose of a medication for a different or easier to take dosage form, or a better-tasting one. It’s great for patients with unique or unusual medication needs, it is necessary when a certain medication is discontinued or back-ordered by the manufacturer. Compounding pharmacies also include Bio-identical hormone replacement therapy which has been shown to have better effects

While this case is literally full of negative aspects, we will only focus on the main points for both arguments. Pharmaceutical companies want to be sure that the products they spend years and millions of dollars to create are not easily reproduced and sold at discount prices. The profits pharmaceuticals make of their patented products are supposed to refinance new research. So taking away their exclusive distribution rights and allowing other manufacturers to just copy the product and sell it at

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

Drug compounding is a big business around the world—and in fact in Brazil where Fagron has a significant amount of sales, a large percentage of all drugs are actually compounded by a pharmacist rather than being made in pill form. Part of the reason for that is that these are generic drugs whose ingredients are cheap and pharmacists don’t charge a lot to make the drug. In Brazil a prescription would cost $15-20 whether it was compounded or not. In addition a lot of the compounded drugs taken in Brazil are OTC type items like vitamins or diet supplements.

Pharmacy compounding is the practice of manufacturing personalized drugs for patients when they may not be capable of using a commercially available medicine, or they may require a medicine, which is currently not available or discontinued.

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

Inhibit biomedical analysis by limiting access to materials and strategies that are key to developing new treatments. Patents may also impede analysis if they produce a cumbersome or costly “tollbooth” through that researchers should pass.

The concept of product patent for pharmaceutical products is likely to make life saving medicine beyond the reach of the poor and deprived section of the society around the world.