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Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by mouth or by injection into a vein. Onset is typically within twenty minutes and lasts for about two hours.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy.
Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its history.
Many countries have measures in place to limit advertising by pharmaceutical companies.
Ranitidine was once a common medication used to decrease stomach acid production and was sold under the brand name Zantac, among others. It was used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. It was given by mouth, injection into a muscle, or injection into a vein. In September 2019, the probable carcinogen N-nitrosodimethylamine (NDMA) was discovered in ranitidine products from a number of manufacturers, resulting in recalls. In April 2020, ranitidine was withdrawn from the United States market and suspended in the European Union and Australia due to these concerns. In 2022, these concerns were confirmed; in a nationwide population study "ranitidine increased the risk of liver", lung, gastric and pancreatic cancer by 22%,17%, 26% and 35%, respectively. It increased overall cancer risk 10%, p < 0.001. A 2023 Bloomberg Businessweek investigative report by Anna Edney, Susan Berfield and Jef Feeley reported and presented documentary evidence that back in a 1982 study, the manufacturer, Glaxo, had detected very high levels of the potent carcinogen NDMA developed from Zantac (ranitidine) in the presence of processed meat preservatives (nitrates). Court documents under seal show Glaxo kept the study secret, Bloomberg reported.
Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Andrew Strempler is former president and chief executive officer of Mediplan Health Consulting Inc., and RxNorth.com, which he founded in 1999. In June 2012, he was arrested in Florida on multiple charges relating to the sale of foreign and counterfeit pharmaceuticals. In October 2012, he pleaded guilty to conspiracy to commit mail fraud in connection with his role as owner and president of Mediplan Health Consulting Inc., a Canadian company, that also operated under the name RxNorth.com. He was sentenced to four years in a U.S. prison, ordered to pay a forfeiture of US$300,000 and a $25,000 fine.
Robert Ray Courtney is an American former pharmacist from Kansas City, Missouri. In 2002, after initially being caught diluting several doses of chemotherapy drugs, he pleaded guilty to intentionally diluting 98,000 prescriptions involving multiple types of drugs, which were given to 4,200 patients, and was sentenced to 30 years in federal prison.
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding CA$1 billion. By 2016, Apotex employed over 10,000 people as one of Canada's largest drug manufacturers, with over 300 products selling in over 115 countries. Revenues were about CA$1.19 billion annually. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.
The United States Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) provides the FDA with a specific office to conduct and coordinate its criminal investigations.
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.
The Prescription Drug Marketing Act (PDMA) of 1987 is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market for prescription drugs.
In the field of pharmacy, compounding is preparation of a custom formulation of a medication to fit a unique need of a patient that cannot be met with commercially available products. This may be done for medical reasons, such as administration in a different format, to avoid a non-active ingredient the patient is allergic to, or to provide an exact dose that isn't commercially available. Medically necessary compounding is referred to as "traditional" compounding. It may also be done for medically optional reasons, such as preference of flavor or texture, or dietary restrictions.
ApothéCure was a Dallas, Texas-based compounding pharmacy that specialized in custom compounded formulas and nutritional supplements for both patients and physicians. ApothéCure was a sister corporation of the Texas Institute of Functional Medicines. The company was the subject of multiple lawsuits starting in the mid-2000s.
A pharmacy is a retail shop which provides pharmaceutical drugs, among other products. At the pharmacy, a pharmacist oversees the fulfillment of medical prescriptions and is available to counsel patients about prescription and over-the-counter drugs or about health problems and wellness issues. A typical pharmacy would be in the commercial area of a community.
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.
Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, in the mid-1990s there were fewer than 30, by 2008 there were 200, and by 2015 there were 300. Drugs are often defined as specialty because their price is much higher than that of non-specialty drugs. Medicare defines any drug for which the negotiated price is $670 per month or more, as a specialty drug which is placed in a specialty tier that requires a higher patient cost sharing. Drugs are also identified as specialty when there is a special handling requirement or the drug is only available via a limited distributions network. By 2015 "specialty medications accounted for one-third of all spending on drugs in the United States, up from 19 percent in 2004 and heading toward 50 percent in the next 10 years", according to IMS Health, which tracks prescriptions. According to a 2010 article in Forbes, specialty drugs for rare diseases became more expensive "than anyone imagined" and their success came "at a time when the traditional drug business of selling medicines to the masses" was "in decline". In 2015 analysis by The Wall Street Journal suggested the large premium was due to the perceived value of rare disease treatments which usually are very expensive when compared to treatments for more common diseases.
References
- 1 2 3 Aidan Hollis, "How Cheap are Canada's Drugs Really?", Pharma Marketing News,Vol. 3, No. 8, VirSci Corp., Sept. 2004.
- 1 2 3 4 5 6 Palmer, Eric. 2015 August 11. "Feds indict Canada Drugs for sales of fake and foreign Avastin." FiercePharma.
- 1 2 3 4 5 6 Joseph Keenan, "Feds get guilty plea in Canadian counterfeit internet drug sales case", FiercePharma. Apr 25, 2018.
- 1 2 3 4 5 6 Eric Palmer, "Clients shrug as FDA slams Canadian firm shipping cheap drugs to U.S.", FiercePharma. Mar 7, 2019.
- 1 2 3 4 Pauls, Karen. 2012 June 20. "Kris Thorkelson, internet pharmacy pioneer." CBC News.
- 1 2 3 4 "The Case Against Canada Drugs – Partnership for Safe Medicines". www.safemedicines.org. Retrieved May 28, 2021.
- 1 2 3 4 "Canadian pharmacy to be fined millions for illegal imports in US | CBC News".
- ↑ "Counterfeits of cancer drug Avastin found in U.S". Reuters. February 15, 2012. Archived from the original on September 24, 2015.
- 1 2 3 4 5 6 Pauls, Karen. 2017 June 19. "6 Canadians arrested in U.S. extradition request for allegedly selling fake cancer drugs online." CBC News.
- 1 2 3 4 5 "CanadaDrugs.com still has Manitoba pharmacy licence | CBC News".
- ↑ "Canadian Drug Firm Admits Selling Counterfeit and Misbranded Prescription Drugs Throughout the United States". www.justice.gov. April 17, 2018. Retrieved May 28, 2021.