Medicaments By Prescription

At times of illness, the temptation to skip the visit to a doctor and recover with the help of medicines bought over the counter is great. Often, this works well enough - especially for common everyday ailments - but it is not safe to indulge in this habit for more serious cases.

The medicines a doctor gives you to manage pain, treat or cure a health condition such as diabetes, pain, cancer, mental disease or common infections, are licensed and have gone through a stringent testing process. They cannot be obtained from a chemist without producing a doctor's prescription.

The safety of prescription medicaments in the US is ensured and overseen by the federal Prescription Drug Marketing Act of 1987. The FDA (The Food and Drug Administration) is authorized to implement this law.

The FDA does not regulate herbal preparations, vitamins, minerals and food supplements - which fall under the category of over-the-counter drugs or OTC, and can be bought without a prescription.

Often, a much lower strength of a drug is sold as an OTC, while the higher strengths require a prescription to be obtained. People taking OTC drugs should be careful about the possible negative effects and also of the reactions these medicines have to the prescription drugs they may be taking.

For a Medical Practitioner to have the authority to write out a prescription, he or she must be an MD, DO, PA, OD, DPM,   DVM, DDS or DMD. Some Psychologists and Nurse Practitioners too can write prescriptions - but basic level registered nurses, medical assistants, clinical nurse specialists, nurse anaesthetists, nurse midwives, emergency medical technicians, psychologists and social workers are not authorized to do so.

Prescription medicaments are referred to as "Rx" in the US. It is the short form of the Latin "recipiere", meaning "take thus". Patients should strictly follow the dosage and method of taking prescription medicaments as directed by a doctor. Abusing these medicaments, meaning having too many of them at a time, or combining them with left over medicines from another time or another prescription can lead to serious detriment to health.

Prescription medicaments are also known as "legend drugs" in the US after the "legend" or literature inserted in the package. This legend is nothing but description of the drug's constituents, details of what the drug is intended for, how it works on the body, how it should be taken and in what dosage, what its side effects can be and what precautions should be taken for possible allergies to it, etc.

The FDA has made it mandatory that all prescription medicaments, to be allowed to be sold by chemists and pharmacies, must carry this legend.

In Europe, dispensation of prescription medicines include a PIL, or Patient Information Leaflet, which has a detailed description of the medicament.

OTC medicaments are considered safer for self medication because they are used to treat conditions not necessarily requiring the services of a health care professional. Prescription medicaments on the other hand, though they help sufferers to control their symptoms, treat and cure their diseases, control pain and fight infection - are habit forming - and unsafe for use except under a doctor's supervision.

Painkillers such as OxyContin and Vicodin for example are prescription medicaments which are habit-forming like heroin and impact the same areas of the brain. They must not be taken without a doctor's direction.

Between 1995 and 2005, treatment admission for dependence on prescription painkillers grew more than 300% in the US , proving the contention that abuse of prescription medicaments before the age of 16 leads to greater medicament dependence in later life.

The most frequently prescribed medicaments are:

Doctors can legally prescribe medicaments for uses other than those approved by the FDA. This is called 'off- label' use - but drug companies may not promote and market the drugs for these uses.

With the consciousness towards public health and safety, a keen awareness permeates the whole business of disease and medicaments in the present times. Patients now are in a better position than they were ever before of obtaining a cure or a palliation.

This process of acquiring safety of medicines began in 1938 when the Congress passed the Food, Medicament, and Cosmetic Act , which required manufacturers for the first time to document the safety of their products. The FDA had 60 days to object to a newly produced drug before it came to the market.

Then came the 'thalidomide' tragedy in Europe - when thousands of severely deformed babies were born to mothers who had taken that sedative during pregnancy. This shocking occurrence moved the Congress to serious thought - and the result was the Kefauver-Harris Amendment, passed in 1962.

This amendment revolutionalized the whole process of medicine manufacturing - and may be alluded to as the usherer of a new era in the history of the medicine industry.

Now the drug making companies would have to go through a detailed grilling process of roughly around 9 to 10 years, involving several stages of investigations and testing - both on animals and on humans - before a medicament would be given the green signal to be marketed as a safe medicine.

The testing process begins with the pre-clinical stage and goes on progressively through the Phases 1, 2 and 3 of clinical testing as follows:

Pre-clinical testing
Laboratory and animal studies are done to show biological action against a targeted disorder and the compounds are tested for safety. These tests take around 3.5 years. After this period, the company files an Investigational New Medicament Application (IND) with the FDA to begin to test the medicament's effect on humans.
It submits details of results of past experiments, whether any toxic effects were found in animal studies - how, when, where and by whom future studies will be conducted, the chemical structure of the compound, how it is manufactured and how it works in the human body.
Moreover, The Institutional Review Board has to review and approve the IND at the centre where the studies are conducted - and yearly progress reports of clinical trials must be submitted to the FDA.
Clinical trials - phase 1
This takes about a year to complete during which period a medicament's safety profile and safe dosage range is tested on around 20 to 80 normal, healthy volunteers.
The studies also bring out the facts of how a medicine is absorbed, distributed, metabolized, and excreted - and the duration of its action.
Clinical trials - phase 2
This is a period of about 2 years. Controlled studies are conducted about the effectiveness of the medicament created to treat a particular disease on approximately 100 to 300 volunteers suffering from that disease.
Clinical trials - phase 3
This lasts around 3 years, during which usually around 1000 to 3000 patients are closely monitored in clinics and hospitals by doctors to determine efficacy and identify adverse reactions.

When all three phases of clinical trials are completed and the data successfully shows efficacy and safety, the company files a New Medicament Application (NDA) with the FDA , including all the scientific information gathered. The FDA is allowed 6 months to give its approval, but it mostly always takes some more time to do so.

The development process may be cut down by 2 to 3 years by combining phases 2 and 3 for drugs that show sufficient promise in early testing and are targeted against serious and life-threatening diseases such as aids and cancer. Once the FDA gives the 'go ahead 'to the NDA, the medicament may be freely prescribed by physicians.

However, the company still has to submit periodic reports to the FDA including any cases of adverse reactions and appropriate quality control records. For some medicines, the FDA requires additional research to measure long term effects.

The common man can now be assured that his health interests is not a matter of his lone concern. He may reach without a qualm for that capsule, pill or mixture when he needs it under doctor's orders.

Prescription medicament safety

Of the more than two thousand prescription medicaments deemed safe and effective by the FDA virtually all carry some risks. This means that they may fail to work, or have harmful side effects under certain circumstances. Makers of prescription medicaments are required to list all potential adverse reactions. Manufacturers have options. Adverse reactions can be categorized by organ system (heart, lungs, liver, etc.), by severity or frequency, by toxicological mechanisms, or by a combination of these. However, listing adverse reactions does not necessarily mean that they occur frequently. Pharmaceutical manufacturers sometimes list a reaction if it happened in one or two persons out of tens of thousands taking the medicament worldwide. On the other hand, you may personally have a reaction that is not listed.

Before the FDA approves a new medicament for marketing, agency scientists and health professionals work with the product's manufacturer to develop its official labeling. The labeling summarizes the results of scientific research on the product, including studies in humans to assess safety and effectiveness. But these studies, which seldom involve more than a few thousand people, can't generate a perfect picture of how a medicament will behave when it's used by hundreds of thousands or millions of people. As a result, it's often hard to anticipate all adverse effects-those that may occur only once in 10,000 or more uses.

The FDA has in place systems to continue to monitor the safety of approved medicaments after they come into general use. As those systems disclose safety problems, the agency takes corrective action.

In one year, the agency receives some 52,000 medicament-adverse reaction reports, about 10 percent of which come directly from health professionals. Each of these reports is checked against the agency's computerized Adverse Reaction Reports Data Base.

The FDA determines if the problem is occurring frequently, and whether the adverse reaction is described in the product labeling but is being seen more often than expected, or is one that the labeling doesn't even mention.

If adverse reaction reports tied to a specific product accumulate, the FDA is faced with an important question: Is the problem so serious that the product has to come off the market, or can it be dealt with responsibly by adding a warning to the labeling or taking other steps to inform doctors and patients of the need to guard against the hazard?

When isotretinoin (Accutane) was approved in 1982 for treating severe cystic acne unresponsive to other therapy, the labeling warned against its use by pregnant women. Animal studies had shown that the medicament could cause birth defects. Soon after it came into general use, the FDA began to receive reports of human birth defects associated with the medicament. One of every four fetuses exposed to the medicament was injured by it. Clearly, the warning against use by pregnant women was not being well heeded.

The labeling for Accutane was changed several times to strengthen the warning against use in pregnancy. Manufacturers sent letters to physicians emphasizing the risk of fetal damage.

Adverse reaction monitoring and evaluation has identified problems with medicaments, required relabeling and that safety problems be publicized, and enabled valuable medicaments to stay on the market.

In addition to labeling, how else do physicians find out about a medicament? Much of it comes from pharmaceutical company sales personnel, medical journals, and direct mail advertisements.

In a federally funded study, prescription medicament advertisements targeted for physicians were found to be misleading in 66 of the 109 medicament advertisements reviewed. It was determined that medicament advertising for doctors sometimes has misleading headlines and insufficient information on side effects.

How can you obtain more information about a prescription medicament? For example, you can request a "package insert." The FDA tried to get a mandatory patient-package insert program in the early 1980s for ten classes of medicaments. But companies and pharmacists complained that the inserts would require considerable storage space, and constant reprinting due to changes in medical knowledge. These complaints are no longer valid, according to the FDA, because of the rapid expansion of computer technology. Easily updated software could allow pharmacists to print needed patient information while filling a prescription.


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