Pharma fraud
Pharma fraud is a term to describe several illegal activities involving the manufacturing, marketing, and distribution of pharmaceuticals.[1]
For example, Pharma Fraud refers to:
- Trade involving counterfeit drugs: the practice of falsely claiming to be an authorized product of another firm, including but not limited to the use of another firm's mark to deceive the public.[2]
- Deliberately manufacturing and marketing products that do not contain the required active ingredients or not contain the right amount of active ingredient.[3]
- Packaging and labeling of drugs that make false claims regarding medical properties, including but not limited to the active medical ingredients, the date of expiration of products, or the methods of storage.[4]
- Marketing of products using false claims regarding the efficacy of the product which will lead to the irrational use[5] of medicines or deliberately failing to provide information about safety concerns of the product.
- Deliberate suppression of data, including evidence from clinical trials,[6] that reveal adverse effects of the medicine.
The situation today
Today, the quality of drug products and therefore also their effectiveness and safety is less and less certain, especially for the poorest populations who are attracted by lower priced drugs sold outside pharmacies.
Recent years have seen an increase in the circulation of counterfeit and substandard drugs on the market. Counterfeit drugs are those that mimic authentic drugs; substandard drugs are those produced with little or no attention to good manufacturing practices. [7] Because of a lack of regulation and enforcement, the quality, safety and efficacy of both imported and locally manufactured medicines in many developing countries cannot be guaranteed. Subsequently, smuggling and illegal importation of drugs are common. Substandard and counterfeit drugs are then not only sold in these countries but also exported or re-exported. [8]
Consequences
One example of the consequences pharma fraud, and the loss of ethics in pharmaceutical sales, could have happened during the meningitis epidemic in Niger from February to May 1995 (41, 000 cases reported), the Niger authorities organized an extensive vaccination campaign. In March 1995, Niger received a donation of 88,000 Pasteur Mérieux and SmithKline Beecham vaccines from neighboring Nigeria. A Médecins Sans Frontières (MSF) team working with local health authorities noticed that the vaccines from Nigeria had an unusual appearance and inquiries were made. Pasteur Mérieux laboratories confirmed that the batch numbers and the expiration dates did not correspond to their manufacturer records. The drugs supplied by these companies had been substituted with counterfeit drugs. Tests carried out found no traces of active product, which confirmed that they were false. Bottles and labels were, however, copied to perfection. According to estimates, around 60,000 persons were inoculated with false vaccines out of a total 5 million vaccinated during the campaign.[9]
Examples
Medicaid Price Reporting
A Medicaid beneficiary obtains a prescription drug from a participating pharmacy, which has purchased the drug in the marketplace from a manufacturer or wholesaler. The pharmacist submits a claim and then receives payment from the state Medicaid agency based on the state’s formula for typically AWP less a percentage. The seller then pays a rebate, months later, for all of its drugs reimbursed by Medicaid each quarter.
The rebate for drugs are based in part on two prices submitted by the manufacturer to CMS each calendar quarter. The first is the AMP (Average Manufacturer Price), which is the average price that a drugmaker receives in a given quarter for sales to wholesalers of a drug distributed in the retail class of trade. The second, is the lowest transaction price, or “Best Price,” charged to any buyer in the private market (and reflecting all rebates or discounts) during that quarter.
The AMP and the Best Price must be reported for each respective dosage form and strength of all prescription drugs purchased on behalf of Medicaid beneficiaries. Those prices, which remain confidential, serve as reference points in determining drugmakers’ rebate obligations.
CMS calculates the unit rebate amount (URA) for each covered drug using price data submitted by the drug manufacturers. Each quarter, each State Agency sends an invoice to each drug manufacturer/labeler, using the URA from CMS and the units dispensed for each drugs (from its own records), to determine the actual rebate amounts due from the manufacturer. The manufacturer has 38 days from the day a State Agency sends an invoice to pay the rebate and avoid interest charges.
See also
References
- ↑ The phrase was proposed by Ellen 't Hoen of MSF, during the 61st World Health Assembly meeting in Geneva, in response to controversies over the use of the term "counterfeiting" in draft WHA resolutions, to describe activities that often involved health risks from unsafe, substandard or fake medicines. The use of the term counterfeit was problematic and inaccurate to describe all of these activities, and health experts were seeking a new term to collectively describe these harmful activities.
- ↑ See, for example, Counterfeit medical products, Report by the Secretariat, A61/16, 7 April 2008.
- ↑ "Fake Malaria Drugs Made In China: Tracking Down The Threat To Global Health," ScienceDaily, Feb. 13, 2008. Newton PN, Fernandez FM, Plancon A, Mildenhall DC, Green MD,et al. (2008) A collaborative epidemiologica investigation into the criminal fake artesunate trade in South East Asia. PLoS Med 5(2): e32.
- ↑ Claire Panosian Dunavan, "Drug safety crisis hits home", Baltimore Sun, May 9, 2008.
- ↑ Laing, R.O., "Rational Drug Use: An Unsolved Problem," Tropical Doctor 1990, 20, 101-103. Rational use of medicines: progress in implementing the WHO medicines strategy, Report by the Secretariat, EB118/6, May 2006. A group that monitors this issue in developing countries is the International Network for the Rational Use of Medicines.
- ↑ Ed Silverman, "2000 study by Merck showed Vioxx risk Results not given to FDA," Star-Ledger, July 03, 2005. Morse Mehrbanm, "Failure to disclose adverse health consequences of a product constitutes health fraud,"NCRHI Newsletter, Jul/Aug 1998.
- ↑ “Access to essential drugs in poor countries: a lost battle?” [1]
- ↑ "Substandard and counterfeit medicines"[2]
- ↑ “Access to essential drugs in poor countries: a lost battle?”[3]
