Medication Education: Thinking Outside the Medicine Cabinet

By James Talley

Medications, whether prescribed by a doctor or purchased over the counter, should be safe and effective when used as directed. This ePublication was compiled to provide awareness of many of the aspects of personal medications problems that might be encountered. This is not a rigorous nor is it a complete discussion of the medication regimen, but rather a primer to alert the reader to be wise when dealing with medications, and to better understand that any medication may have significant risks in addition to significant benefits. The targeted reader is the average adult U.S. citizen.

• Language: English
• Publisher: BookBaby
• Release date: Jul 1, 2013
• ISBN: 9781483501758

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COMMENTS

WHAT ARE MEDICATIONS?

Medications are chemicals or compounds that are used to help in the diagnosis of illnesses, prevent, reduce or cure disease or ease symptoms.

They come from a variety of sources, including substances found in nature, byproducts of organisms such as fungus, some are biologically engineered and some are formulated from a mixture of chemicals. Medicines act in a variety of different ways, including fighting infections, relieving pain, killing harmful cells and controlling certain health conditions, such as heart disease or blood pressure.

Usually, when we think of medications, we think of pills, tablets or capsules, but medications may be delivered to a patient in a wide variety of means, including, but not limited to:

<> Pills, capsules, tablets; taken orally

<> Creams, ointments or gels; rubbed into the skin

<> Drops; placed in the nose, mouth, eyes, ears, etc.

<> Inhalants; sprayed into the nose or mouth

<> Injections or infusions; delivered by hypodermic needle

<> Liquids or syrups; taken orally

<> Patches that adhere to the skin

<> Sub-linguals; placed under the tongue to dissolve

<> Suppositories; inserted in the rectum

<> Vapors or gases; as used by anesthesiologists and dentists

IS IT A MEDICATION, A MEDICINE OR A DRUG?

The following definitions related to the discussion of ‘medication’ are found in the online reference dictionary at dictionary.com.

<> Drug: A substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans and other animals.

<> Medicament: (an archaic medical term): A healing substance, medicine or remedy

<> Medicine: Any substance or substances used in treating disease or illness; medicament

<> Medication: The use or application of medicines; a medicinal substance; medicament; treatment with drugs or remedies; a drug or remedy

Synonyms: medication, drug, pharmaceutical

Conclusion: The terms drug (or drugs), medication (or medications) and medicine (or medicines) are synonyms. It was agreed by all doctors and pharmacists who were interviewed; it is common to use the terms interchangeably in publications, and although there are subtle differences in the three names, for all practical purposes, they are synonyms. In this ePublication, the name used in a particular topic is generally the name used in references used for that topic.

In the United States, medications are ‘controlled substances’.

WHAT IS A ‘CONTROLLED SUBSTANCE’?

The legal definition of a ‘controlled substance’ is, according to the American Heritage Medical Dictionary: A drug or chemical substance whose possession and use are regulated under the Controlled Substance Act.

WHO HAS LEGAL JURISDICTION OVER CONTROLLED SUBSTANCES?

The Drug Enforcement Administration (DEA), a division of the U.S. Department of Justice (DOJ), is charged with the authority to control all substances defined as ‘controlled substances’. These substances are specified by the Controlled Substances Act (CSA) to fall into one of several ‘schedules’. These ‘schedules’ are specified in the DEA publication, the Pharmacist’s Manual, in Section II, titled Schedules of Controlled Substances, as follows:

Schedule I Controlled Substances – have a high potential for abuse, have no currently accepted use in treatment in the United States, and there is a lack of accepted safety for use under medical supervision. Items in this schedule may not be prescribed, administered or dispensed for medical use.

Items in Schedules II through V do have accepted medical use and may be prescribed, administered, or dispensed for medical use.

Schedule II Controlled Substances – have a high potential for abuse which may lead to severe psychological or physical dependence.

Schedule III Controlled Substances – have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV Controlled Substances – have a low potential for abuse relative to substances in schedule III.

Schedule V Controlled Substances – have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

Scheduled Listed Chemical Product (SLCP) – is defined as a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be marketed or distributed lawfully in the United States under the Federal Food, Drug and Cosmetic Act as a nonprescription drug.

The DEA has the authority over the classification of substances and the registration and regulation of manufacturers, distributors and dispensers of controlled substances. This includes labeling, packaging, production quotas, records and reports, order forms, prescriptions, certain machines, requirements relating to online pharmacies and telemedicines, etc. And the DEA has authority over offenses and penalties, enforcement, import and export of controlled substances.

THE PHARMACIST’S MANUAL

The complete copy of the DEA’s Pharmacist’s Manual, subtitled ‘An Informational Outline of the Controlled Substances Act", Revised 2010, can be viewed online by accessing the DEA website at http://www.deadiversion.usdoj.gov/ and doing a search of ‘Pharmacist’s Manual’

While on the DEA website, explore the myriad of information about prescriptions and prescription medicines not included in this ePublication.

THE FOOD AND DRUG ADMINISTRATION

The Food and Drug Administration (FDA) exists to guarantee that all medications are made available only after they are proven to be safe, and work as claimed. No medicine, either prescription or over-the-counter (non-prescription), can be sold unless it has been approved by the FDA. This includes brand name and generic versions.

Producers of new or modified medications must perform tests on all new or modified medications and submit the results to the FDA for approval before they are made available to the public. Producers of generic medications are held to the same strict requirements.

The FDA is an agency or operation in the Department of Health and Human Resources. The FDA maintains a website with a plethora of information on drugs. The following is an excerpt from the FDA website at: "http://fda.org/index.php?article=about-fda-product-approval ".

"The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers.

Some products, such as new drugs and complex medical devices, must be proven safe and effective before companies can put them on the market. The agency also must approve new food additives before they can be used in foods. Other products, such as x-ray machines and microwave ovens, must measure up to performance standards. And some products, such as cosmetics and dietary supplements, can generally be marketed with no prior approval.

At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great, especially for products used to treat serious, life-threatening conditions.

FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs.

FDA has streamlined its review process for medical products in recent years to help speed important new treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster."

THE U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

The United States government is highly involved with all areas of health and other human services. This ePublication will refer to a number of the organizations included in the U.S. Department of Health & Human Services (HHS), including the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and others. The following organization chart of the HHS should give an idea of how it is set up.

Office of the Secretary and the offices, agencies, administration, centers and operations reporting to it:

<> Office for Governmental and External Affairs (IEA)

<> Office of the Assistant Secretary for Health (ASH)

<> Office of the Assistant Secretary for Administration (ASA)

<> Office of the Assistant Secretary for Financial Resources (ASFR)

<> Office of the Assistant Secretary for Planning and Evaluation (ASPE)

<> Office of the Assistant Secretary Preparedness and Response (ASPR)

<> Office of the Assistant Secretary for Legislation (ASL)

<> Office of the Assistant Secretary for Public Affairs (APA)

<> Office of the General Counsel (OGC)

<> Office of Medicare Hearings and Appeals (OMHA)

<> Office for Civil Rights (OCR)

<> Office of Inspector General (OIG)

<> Office of Global Affairs (OGA)

<> Departmental Appeals Board (DAB)

<> Office of the National Coordinator for Health Information Technology (ONC)

<> Center for Faith Based and Neighborhood Partnerships (CFBNP)

<> Administration for Children