Definition: Defining the Meaning of Pharmaceutical Drug
A pharmaceutical drug (medicine or medication and officially medicinal product) is defined as a drug used in health care. Such drugs aid the diagnosis, cure, treatment, or prevention of disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. Governments generally regulate what drugs can be marketed, how drugs are marketed, and in some jurisdictions, drug pricing. Controversies have arisen over drug pricing and disposal of used drugs.
In the United States a Drug is Defined as:
- A substance recognized by an official pharmacopoeia or formulary.
- A substance (other than food) intended to affect the structure or any function of the body.
- A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
- A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
- Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
Effective drug regulation on the part of nations both promotes and protects the health of the public through ensuring several things. Medicines that are of adequate quality, are safe and efficient are required. Health care professionals and patients must have the needed information to enable them to use the medications rationally. Medicines must be manufactured, stored, distributed and dispensed in appropriate manners. Any illegal manufacture and trade of drugs must be both detected and adequately sanctioned. Promotion and advertising of drugs must be balanced, fair and aimed at the rational use of drugs. Access to medications must not be hindered by unjustified regulatory work.
National governments are held responsible for the establishment for strong national drug regulation authorities (DRA's) that have a clear mission, realistic objectives, a solid legal basis, an appropriate organizational structure, suitable financing, an appropriate level of qualified staff, equipment and information, access to technical literature, and the capacity to exert effective market control. DRA's are accountable to both the government and the public at large for their decisions and should be transparent. The DRA's evaluation and monitoring mechanisms need to be built into its regulatory system to assess attainment of its established objectives.
The Food and Drug Administration's (FDA) Mission Statement
"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."
Health Canada's Mission Statement
"Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety. Working together with other levels of government, health care professionals, patient and consumer interest groups, research communities and manufacturers, our department endeavors to minimize the health risk factors to you and maximize the safety provided by the regulatory system for these products. We also strive to provide you with the information you need to make healthy choices and informed decisions about your health.
Health Canada is not a manufacturer or distributor of drugs and health products. We are the federal regulator. For additional drug information related to treatment options or where drugs or health products are sold, please contact your health professional or the individual company directly. Health Canada is committed to providing timely access to sound, evidence-based information. We want to ensure that Canadians remain up-to-date on current developments and issues pertaining to drugs and health products in Canada."
Medicines and Healthcare products Regulatory Agency - United Kingdom
"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks.
We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. We aim to make as much information as possible publicly available. We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public. We encourage everyone - the public and healthcare professionals as well as industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action."
Quick Facts: Interesting Pharmaceutical
- Antibiotics first arrived on the medical scene in 1932 Penicillin, introduced a few years later, provided a broader spectrum of activity compared to sulfa drugs and reduced side effects.
- Streptomycin, found in 1942, proved to be the first drug effective against the cause of tuberculosis and also came to be the best known of a long series of important antibiotics.
- A second generation of antibiotics was introduced in the 1940s: aureomycin and chloramphenicol. Aureomycin was the best known of the second generation.
- Americans pay more for prescription meds than anyone else in the world: $200 billion in 2002 alone.
- It takes an average of between 11 and 14 years to go from a laboratory setting to getting a drug approved by the Food and Drug Administration, according to The Independent Institute.
- According to the U.S. National Institutes of Health's ClinicalTrials.gov website, there are currently 139,372 clinical studies being conducted throughout 182 countries as of Jan. 28, 2013.
- According to PhRMA, $49 billion was spent last year on researching more than 2,900 compounds.
- The FDA approved 39 new drugs in 2012, a dramatic rise from the 23 per year it's averaged in the previous 15-year period, according to Bloomberg.
- Generic drug shortages have risen by greater than 330% since 2004, to more than 250 in 2011, based on figures from the Wall Street Journal.
- According to one estimate, the top 20 drug-makers in India spend about $600 million a year on only freebies for doctors. It is still a paltry sum compared to the US, where drug-makers spend $58 billion or more annually on marketing drugs, including freebies for doctors.
- The price of drugs is increasing faster than anything else a patient pays for, with some medications having a mark-up of 1,000 percent over the cost of their ingredients.
- The combined wealth of the top 5 pharmaceutical companies outweigh GNP of sub-Saharan Africa: In fact, the combined worth of the world's top five drug companies is twice the combined GNP of that entire region.