Orphan Drug Report

Day 2 (OB) – Vaginal Birth and preparation for birth. Hanging Pitocin, and Lactated Ringers, and being able to watch an epidural insertion.

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.

Another issue involving the Orphan Drug Act that has caused great conflict and controversy is the market exclusivity it provides as an incentive. In 1989 Amgen’s drug erythropoietin was approved by the FDA to treat anemia. Amgen was given exclusive marketing rights for seven years and erythropoietin became one of the most successful drugs in history. In these types of instances, the issue is that these companies have essentially created a monopoly where they have complete control. [6][7] Since there is no competition, companies have the opportunity to drive up the prices forcing people to be left with the ultimatum of either paying high out of pocket prices or leaving their condition untreated. The reduction in competition also severely limits the access to treatments for patients with rare diseases. [6]

Possible side effects: “dry mouth, sedation, blurred vision (disturbance of accommodation, increased intra-ocular pressure), constipation, nausea, difficulty with micturition; cardiovascular side-effects (such as ECG changes, arrhythmias, postural hypotension, tachycardia, syncope, particularly with high doses); sweating, tremor, rashes and hypersensitivity reactions (including urticaria, photosensitivity), behavioural disturbances (particularly children), hypomania or mania, confusion or delirium (particularly elderly), headache, interference with sexual function, blood sugar changes; increased appetite and weight gain (occasionally weight loss); endocrine side-effects such as testicular enlargement, gynaecomastia, galactorrhoea; also convulsions (see also Cautions), movement disorders and dyskinesias, dysarthria, paraesthesia, taste disturbances, tinnitus, fever, agranulocytosis, leucopenia, eosinophilia, purpura, thrombocytopenia, hyponatraemia

Some of the immediate physical complaints include constantly feeling cold, bloodshot eyes with dark circles, finger calluses, dizziness, weakness, lackluster hair, moodiness, insomnia, no menstruation, swollen glands, weight loss, sore throat, or dry skin. Some of the long-term effects include extreme weight loss, gastrointestinal pain, diarrhea and/or constipation, malnutrition, loss of tooth enamel,

Some of the side effects are: Loss of appetite, Nausea and vomiting, weakness and fatigue, weight gain, premature menopause and hair loss.

Short-term effects are increased respiration, rapid heart rate, decreased appetite, increased physical activity, irregular heartbeat, increased body temperature, and increased blood pressure (www.drugabuse.gov). The long-term effects include: skin sores, extreme weight loss, and severe dental problems, as well as higher risk of contracting infectious diseases (www.drugabuse.gov).

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

Some people do not fully understand what orphan drugs are. Orphan drugs are defined as drugs that have not been developed yet because the need for that drug to be made is not in that of high demand from the general public. Also,

Methaqualone, is also referred to as Disco Biscuits, Down And Dirties, Jekyll-and-Hyde, Joe Fridays, Lemmon 714, Lemons, Lennon's, Lovers, Ludes, Mandies, Mandrake, Q, Qua, Quack, Quad, Quaaludes, Soaper, Supper, Vitamin Q, The Love Drug, Wallbangers, Whore Pills, and Sopor. This list of street names for the drug goes on and on.

Belladonna alkaloids is used to treat irritable bowel syndrome (IBS) and intestinal inflammation in combination with other medications. IBS is an invasive gastrointestinal functional bowel disorder, characterized by a recurrent crampy diarrhea and abdominal pain. Belladonna works by decreasing motion of muscles in the intestine and stomach providing them with a mild sedation

Adverse reactions to this medication are migraine, speech disorders, rhinitis, sinusitis, hyperglycemia, elevated liver function, elevated serum creatinine level, pancytopenia, bronchitis, dyspnea, toxic epidermal necrolysis, anaphylaxis, elevated creatine kinase, generalized pain, and infection. Nursing considerations with this medication is to have the patient swallow the whole tablet and not to chew. Watch for aspiration while watching the patient take the medication. Educate the patient about the medication and inform them to notify a physician if bleeding

-Ledipasvir has various side effects which include chest pain, unusual tiredness, and shortness of breath , the occurrence of fainting , cough, diarrhea, headache, irritability muscle pain, nausea, trouble sleeping, lack of appetite, loss of interest, trouble concentrating.

There are many different methods of dispersing and accumulating data from subject self-reports, but for the purpose of this research proposal we have elected to adopt a method used in relatively recent study published by the Journal of Drug Issues entitled: “Substance Use, Drug Treatment, and Crime: An Examination of Intra-Individual Variation in a Drug Court Population”.

Other side effects include cloudy urine, proteinuria, irregular heartbeats, and chest pain. Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril (Capoten, 2014). If these effects happen nurses should be ready to administer epinephrine to reduce swelling. Other adverse effect according to Karch (2014) include, “CV: Tachycardia, angina pectoris, heart failure, MI, Raynouds syndrome, hypotension in salt-or volume depleted patients.”