Pharmaceutical Regulations Key Terms

Know the jargon of pharmaceutical regulations

The heavily regulated pharmaceutical industry is that way because of the nature and wide spectrum of drugs available. Regulations cover things such as whether or not the medication is safe for human consumption, the consistency of formulas and the brand name drugs vs. generic drugs scenario. There are also many regulations regarding the use of clinical trials to test the drugs before they hit the market to guarantee their safety and effectiveness. Understanding some of the key terms related to pharmaceutical regulations will give consumers the peace of mind that the medications they take are safe.

 

Pharmaceutical regulations

Pharmaceutical regulations, or rules and laws, not only ensure the safety of the medications or drugs that are being given to people, but also cover the ethics involved in marketing and selling the drugs to the public. Pharmaceutical companies have to abide by licensing regulations as well as sanitary and labeling regulations.
Try: The Food and Drug Administration (FDA) is the regulatory body when it comes to pharmaceutical regulations.

Pharmaceutical ethics

Pharmaceutical ethics is the same as any other kind of ethics: the right way of doing things, vs. the wrong way. When drug companies don't list all of a drug's side effects, for example, not only are they going against regulations, but they are being unethical since they are essentially lying by omission.
Try: PharmacoEthics.com has articles and discussions that deal with all areas of pharmaceutical ethics such as development, sales and use of drugs.

Compliance

When a drug company or medical professional complies with pharmaceutical regulations, it means that all of the rules laid out by regulation bodies such as the FDA are being followed. Some regulations-such as reporting requirements-may be inconvenient, but complying with that requirement means the company or medical facility won't be fined or lose its license to continue business.
Try: Pharmaceutical Compliance Forum has many valuable pieces of information to illustrate what compliance is and how pharmaceutical companies work to stay on top of it.

Clinical trials

Clinical trials are tests conducted in a laboratory setting to learn how drugs act when given to a living subject. This allows the companies to learn the side effects as well as the drug's effectiveness, which then assists them in complying with the regulations to be truthful on the drugs packaging.
Try: ClinicalTrials.gov is a comprehensive resource to learn what clinical trials are, what to expect if you are participating in one and how the government regulates them.

Dispensing guidelines

In order to know how much of a medication to give a patient, the doctor must have access to dispensing guidelines for the drug. These are regulations that both the FDA and the drug company provide to ensure that patients receive safe amounts of the drug based on their symptoms and overall health.
Try: Rx for Safety has helpful guidelines for medical professionals to follow to be sure that their patients remain safe and healthy if they are being prescribed medications.

Patient privacy

Protecting the information and privacy of patients is a hot topic now. This electronic age means that most medical and drug facilities have patient records in an electronic format. It is important that these companies spare no expense in ensuring that information remains safe. There are many pharmaceutical regulations to follow to make sure that the prescription and other health information of patients doesn't get into the wrong hands.
Try: This article on Wisconsin Technology Network delves into the important of compliance with regulations to protect patient privacy.

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