Countering the Problem of Falsified and Substandard Drugs (2013) / Chapter Skim
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4 Causes of Falsified and Substandard Drugs
4 Causes of Falsified and Substandard Drugs
Pages 137-196
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REASONS FOR SUBSTANDARD DRUGS As Chapter 1 explains, substandard drugs are those products that fail to meet the specifications set by the regulatory authority and delineated in a pharmacopeia or the manufacturer's dossier. Substandard medicines may, for example, be made in such a way that they do not dissolve properly; they may be of incorrect hardness or osmolarity; they may contain improper doses of the active ingredients; or be made from impure or unstable ingredients.
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Model Quality Assurance The System for procurement is a useful independent standard for procure ment agencies. • ational and international procurement agencies should follow the N WHO's guidelines for procurement.
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. The market for active ingredients has been especially volatile in recent years because of increasing costs of raw materials and growing environmental regulation in India and China (Bumpas and Betsch, 2009)
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. There is significant expense necessary for pharmaceutical companies to follow good manufacturing practices.
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Recommendation 4-1: The International Finance Corporation and the Overseas Private Investment Corporation should create separate invest ment vehicles for pharmaceutical manufacturers who want to upgrade to international standards. Governments can complement this effort by encouraging partnerships between local and foreign manufacturers.
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. The equipment and supplies needed to observe good manufacturing practices must be bought on foreign markets with hard currency, which banks in poor countries may only have at certain times of year (McCabe, 2009)
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. Alongside investment in upgrading pharmaceutical standards, its membership structure could be used to set up partnerships between pharmaceutical companies in developing countries and those in countries with strict regulatory authorities.
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agencies and the larger international aid organizations will also refuse to do business with companies that cannot meet stringent regulatory authority quality standards. Manufacturers are aware, however, that low- and middle-income countries are less likely to enforce these standards.
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. Jiben Roy reported on a similar case: A Bangladeshi company deliberately kept the active ingredients in paracetemol, ampicillin, and cotrimoxazole below the labeled concentrations after repeated warnings from the regulatory authority (Roy, 1994)
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Procurement and Substandard Medicines When regulatory checks on production are inconsistent, procurement practices can help ensure that quality medicines get the largest market share. The Global Fund explains the goal of good procurement as supplying medicine "meeting agreed quality standards at the lowest possible price and in accordance with national and international laws" (Global Fund, 2009, p.
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. The Global Fund will accept WHO prequalification, the approval of stringent regulatory authorities, or the review of an expert panel, especially for finished pharmaceuticals that are not prequalified by the WHO (GAO, 2012)
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. The committee sees the model quality assurance system as a useful independent standard to assess procurement agencies.
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for procurement etc.) agencies Global Fund WHO prequalification; stringent WHO GMP and WHO MQAS Expert review panel dossier reviews regulatory authority approval; or (Global Fund, 2012)
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done through third parties such national drug regulatory authority through normal channels of as multilateral organizations, approval; WHO prequalification; oversight such as boards, steering partnerships, or procurement and expert review panel approval committees and program reviews agencies. DFID relies on the quality- (DFID, 2012)
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Food and Drug Administration; GMP = Good Manufacturing Practice; MQAS = Model Quality Assurance System for procurement agencies; PAHO = Pan American Health Organization; UNAIDS = Joint United Nations Programme on HIV/AIDS; Unicef = United Nations Children's Fund; USAID = United States Agency for International Development; WHO = World Health Organization. SOURCE: Adapted from Moore et al., 2012.
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The regulatory authority can then license national procurement agencies to buy medicines directly from manufacturers. Agencies that are not able to comply with the WHO's minimum standards will not be licensed for procurement.
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Use written quality manual and written standard operating procedures. Use of prescreening and prequalification is recommended for procurement agencies with limited capabilities.
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• ajor pharmaceutical companies have security departments that M work with regulators and law enforcement agencies. These depart ments gather 80 percent of the evidence for criminal prosecution.
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The victims' youth lent an emotional appeal to this incident, making it the public face of drug regulation agenda, but Argentina was no stranger to tragedy of this sort. Fake drugs for treating Parkinson's disease circu lated in 1997 and exacerbated the symptoms they were taken to prevent (Loewy, 2007)
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Interpol uses the term pharmaceutical crime to describe "the manufacture, trade and distribution of fake, stolen or illicit medicines and medical BOX 4-3 Adulterated Cancer Drugs Robert Courtney, a pharmacist in Kansas City, Missouri, made mil lions selling adulterated drugs to patients and physicians throughout the 1990s until 2001, when he was prosecuted for his crimes. Most famous for diluting chemotherapy drugs such as Taxol, Gemzar, Paraplatin, and Platinol, Courtney regularly sold tampered versions of 72 different pre scription drugs.
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. Enforcement and Punishment When falsified medicines are also counterfeits that infringe on the trademarks of multinational pharmaceutical companies, the company targeted tries to respond.
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. Law enforcement agencies, for their part, are cracking down more on pharmaceutical crime.
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These data indicate 1,311 arrests for pharmaceutical crime in 2011, a 14 percent increase from their 2010 records (PSI-Inc., 2012b)
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. Considering that the profit margin for falsified drugs runs in the billions, the risk-to-profit
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Tables 4-6 and 4-7 show penalties for patent and trademark infringement, which are dealt with more severely in some countries. Stricter and more consistent penalties could do much to fight the public health crime of producing and trading fake medicines.
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A more straightforward registration and application process would reduce burdens on industry and regulators. • alsified and substandard medicines circulate because of weaknesses F in the regulatory system.
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. Reducing the costs and increasing the availability of medicines would remove some of the financial incentive to produce and procure falsified and substandard medicines.
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(n=4) Public sector, generics Private sector, generics Private sector, originator brands World Bank income group FIGURE 4–3 Average of country-level mean percentage availability of medicines by World Bank income group.
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The Singaporean drugs regulatory authority has promoted the common format, citing its ease of use and the way it facilitates sharing information among other regulators in the region (Poh, 2011)
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When the overwhelmed regulatory authority will allow it, companies avoid the expense by submitting no proof of bioavailability; others falsify bioavailability data (Silverman, 2011)
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. The regulatory authority also provides health workers and the public with accurate information on the rational and safe use of medicines and punishes illegal trade in drugs (WHO, 2012b)
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Any viable solution will include strengthening the drug regulatory system, including building the inspectorate, enforcing quality standards, and licensing in accordance with international standards. Without a competent regulatory authority to inspect wholesalers, distributors, and manufacturers, opportunities to corrupt the drug supply abound.
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Though the government approved an independent drug regulatory authority in 2005, political tensions prevented action (Arie, 2012)
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In the least developed countries, international organizations should support their efforts. International quality standards for drug manufacture depend on the competence of the national regulatory authority.
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. The FDA's October 2012 inspection report indicated gross violations of good manufacturing practices, including visible contamination of equipment and drug ingredients at the New England Compounding Pharmacy (FDA, 2012b)
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, but the FDA's authority over these organizations is unclear and has been for some time. In 1996, David Kessler, then FDA commissioner, testified that compounding pharmacies threatened to create "a shadow industry" of unregulated drug manufacture (Kessler, 1996)
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Increasing public awareness will not in and of itself decrease falsified and substandard medicines, because consumers cannot distinguish safe and unsafe medicine in the marketplace. However, public awareness is a useful way to drive political will for correcting the problem and to educate people on warning signs of compromised medicines.
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Often, well-educated urban consumers understand the threat of fake drugs and take precautions to avoid them. The poorest patients, and those living in areas with few to no reliable pharmacies, are often the least aware.
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The agency broadcast short public service announcements on television and radio in English and local languages. "There is a development," a young businessman tells an obvious kingpin in one television piece; "you can no longer use my warehouse or any of my outlets for the distribution of your fake drugs!
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Awareness campaigns and investigative reporting reach health workers as well as they reach the rest of the public. There is also a need for targeted health worker education on falsified and substandard medicines, emphasizing the correct reporting channels health workers can use to confirm suspected cases of falsified and substandard drugs.
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. These concerns are well grounded, and an appropriate communication strategy will convey accurate information is a way that is sensitive to all stakeholders.
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Figure 4-6, for example, shows a Cambodian health education poster promoting licensed pharmacies. Similarly, as Box 4-7 explains, the Nigerian drugs regulatory authority improved public understanding of the problem with relatively simple steps: public service announcements, newspaper ads, and school essay contests.
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Buy medicines only from state-licensed pharmacies that are located in the United States. Find your state's contact information from the National Association of Boards of Pharmacy (NABP)
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Health workers are the first line of pharmacovigilance and will be point persons in any consumer education campaign. Their training should include information on falsified and substandard drugs.
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Programs for policy makers would include a broader summary of the conditions encouraging the trade in falsified and substandard medicines, as presented in this chapter. In summary, careless manufacturing, whether deliberate or accidental, causes substandard medicine.
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Presentation given at International Conference of Drug Regulatory Authorities, Singapore. l Therapeutic Medicines Act.
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2012. Phake: The deadly world of falsified and substandard medicines.
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Dollars) No imprisonment Grenada,a India,b Damages are recovered for infraction Malaysia,c Pakistan, d Philippines, e South Africa,f Uganda, g United States h Taiwan i Infringer must may patentee profits earned Jordan, j Nigeria k Patentee may file a civil or criminal lawsuit China,l Peru m $100,000 or more Mexico n $80,000 or more Up to 1 year Brazil o Monetary penalty not disclosed Canada p Up to $500 Singapore q Up to $10,000 Switzerland r $100,000 or more *
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Up to 2 years Thailand s Up to $13,150 Up to 3 years Germany t Monetary penalty not disclosed Lebanon u Up to $33,000 Up to 4 years Indonesia v Up to $50,000 Up to 5 years Cambodia w Up to $5,000 France x Up to $650,000 Japan y Up to $100,000 with labor Kenya z Up to $6,000 Tanzania aa Up to $300 5 or more years Argentina bb, cc Monetary penalty not disclosed South Korea dd Up to $100,000 with labor q Singapore Patents Act as amended by Act No.
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Sentences Country Dollars) No imprisonment Cambodia, a Germany,b Damages are recovered for infraction India,c Pakistan,d Philippines, e Singapore, f South Africa, g Uganda,h United States, i Korea j Up to $47,000 China, k Taiwan l Infringer must pay the trademark owner profits earned from the infringement or the amount of losses that the trademark owner has suffered Jordan m Up to $8,500 Up to 3 days Mexico n Up to $70,000 Up to 1 year Switzerland o Up to $110,000 Brazil p Monetary penalty not disclosed Up to 2 years Argentina q Up to $30,000,000 Up to 3 years Lebanon r Up to $0.40 Up to 5 years Japan s Up to $60,000 with labor Indonesia t Up to $105,000 *
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DOI: 10.1590/S0034-89102012005000005. AMRH (African Medicines Regulatory Harmonization)
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2012a. The problem of substandard medicines in developing countries.
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Joint WHO and UNAIDS consultation meeting with pharmaceutical companies, December 9-10, Geneva, Switzerland. DFID (Department for International Development)
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2003. Report of the Expert Committee on a Comprehensive Examina tion of Drug Regulatory Issues, Including the Problem of Spurious Drugs.
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2012b. Pharmaceutical crime.
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2011. African medicines regulatory harmonization strategic plan: 2011-2015.
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http://www.opic.gov/who-we-are/our investment-policies (accessed November 2, 2012)
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Procurement processes and the risk of substandard medicines. London: The Stockholm Network.
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2006a. Annex 6: A model quality assurance system for procurement agencies (rec ommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products)
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196 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Wilson, K
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Key Terms
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