Countering the Problem of Falsified and Substandard Drugs (2013) / Chapter Skim
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5 Weaknesses in the Drug Distribution Chain
5 Weaknesses in the Drug Distribution Chain
Pages 197-254
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From page 197... ...
Better controls on the wholesale market could improve the security of the distribution chain. Drug tracking systems could also improve security by preventing products that leave the legitimate supply chain from returning to it.
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• Drug distribution chains in developing countries are often fragmented and complicated. • The final leg of the drug distribution chain is exceptionally expensive and inefficient in developing countries.
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Supplier(s) Manufacturer Wholesaler distributor Pharmacy Patient (primary)
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PRIVATE SECTOR PUBLIC SECTOR NGO SECTOR 200 NGO international International Manufacturers Procurement agents warehouse Manufacturer's NGO national Central medical stores national subsidiary warehouse National Importers and wholesalers Regional Regional NGO regional Distributors medical stores warehouse Sub- Private District medical stores District wholesalers subscribers and district hospitals City or large town Pharmacies Health center Small town or rural community Second-tier pharmacies Community NGO clinics and chemical sellers health worker PATIENTS FIGURE 5–2 The private, public, and NGO drug distribution systems for essential medicines in developing countries. NOTE: NGO = nongovernmental organization.
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. Inefficient supply chain management directly drives up costs and causes drug stock-outs in
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. Such problems are not uncommon during emergencies, when quality control throughout long supply chains becomes difficult.
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. Supply chain managers are always concerned with the last-mile problem: the disproportionately expensive and inefficient final leg on the distribution chain.
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pharmaceuti cal distribution chain. • Wholesalers buy and sell drugs in response to market demand, re peatedly repackaging products.
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These companies exploit problems in the regulated drug market, such as drug shortages. Hospital pharmacists are under pressure to fill prescriptions even during drug shortages, forcing them to buy from gray market vendors at up to 10 times the standard prices for some drugs, including anesthetics and cancer drugs (Aleccia, 2011; ISMP, 2011)
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More rigorous licensing and regulation of the wholesale market, especially the secondary wholesalers, is another solution. The committee believes the secondary wholesale market is the weakest link in the U.S.
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Barbados 5–10 10–25 76 reduce the number of transactions in the drug distribution chain, thereby improving security. Recommendation 5-1: State licensing boards should only license whole salers and distributors that meet the National Association of Boards of Pharmacy accreditation standards.
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The U.S. Wholesale Market In the United States, state governments control professional practice, including the practice of pharmacy, which includes medicine distribution and wholesale.
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A reduction in the number of licensed wholesalers and use of more efficient distribution chains can help the wholesale market around the world.
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Criminals take advantage of places where the distribution chain breaks down and medicines depart from documented chain of custody. Drugs that leave the proper distribution system are called diverted drugs; the markets that trade diverted drugs, or more generally, markets that trade with little authorized oversight, are called gray markets.
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Figure 5-3 shows common diversion points in the distribution chain. In the United States, for example, the resale of prescription drugs is a common problem, but illicit vendors also circumvent the regulated distribution chain at other points.
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212 Legitimate National Retail VVVVVVVVVVV manufacturers wholesalers pharmacy Prescription Hospitals VVVVVVVVVVV resellers Secondary Patients wholesalers DispensingVVVVVVVVVVV VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV clinics Illegitimate manufacturers V VV VVVVVVVVVVVVVV Internet VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV pharmacies FIGURE 5–3 Risks in the medicine distribution system.
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Drug Resale and Late Diversion Drugs can also be diverted late in the distribution chain, after the drug has reached the patient. This is a far less common point of diversion than diversion at the vendor level and earlier.
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Small thefts and large diversions compromise the integrity of the drug distribution chain and confidence in the quality of medicines. In rich and poor countries alike, drugs often circulate outside of the main distribution channels without a drug pedigree, a record of "each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them" (FDA, 2011a)
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Two-dimensional barcodes can encode more information in a small space and are therefore gaining popularity for supply chain management (McCathie and Michael, 2005)
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The systems in Brazil and Turkey give vendors and motivated consumers a way to verify the safety of their products, and they allow regulators to better understand where and how frequently products leave the distribution chain. A data matrix or two-dimensional barcode on a medicine package.
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. The technology clearly has innovative potential, but a critical mass of intermediaries on the drug distribution chain need to upgrade their systems for it to be useful (Lefebvre et al., 2011)
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An immediate text message response confirms if the secret code number is registered with the manufacturer, or if it is from a shipment reported to have left the legitimate supply chain. Mobile verification of pharmaceuticals is gaining users in 17 sub-Saharan African countries and India (Mukherjee, 2012; Sproxil, 2012; Versel, 2012)
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A reliable system for tracking and tracing drugs through the distribution chain would greatly reduce the likelihood of falsified and substandard medicines reaching patients. Recent technological advances, such as the use of radio frequency identification and the expansion of mobile phones in developing countries, hold promise for supply chain security.
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220 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS A child uses a cell phone at a market in Ghana. SOURCE: © 2006 Joitske Hulsebosch, courtesy of Photoshare.
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This can help control the burden an inevitable shift to drug tracking will put on these businesses. Tracking primary packages through the drug distribution chain with unique serial numbers is a good defense against criminal infiltration (Ludwig, 2012; Pellek, 2009; Power, 2008)
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• Internet pharmacies are often the disorganized drug markets of de veloped countries. Only 7 percent of countries have a system for verifying legitimate online drug stores.
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Even when packaged medicines happen into these markets, their customers are not often sophisticated enough to analyze packages for irregularities. Illiteracy is a known predictor of buying falsified and substandard drugs (Erhun et al., 2001)
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They watch for suspicious products in the licit supply chain, educate patients on warning signs of problem drugs, and are
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. A critic of the Indian pharmacy education system observed, "Community pharmacy practice does not exist in its true sense, only drug selling" (Mohanta et al., 2001, p.
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226 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Density per 10,000 population 0 5 10 15 20 Malta Japan Jordan Spain Kuwait Iceland Republic of Korea Germany Belgium France Italy Portugal Canada United States Australia Switzerland Great Britain Syria Macedonia Czech Republic Denmark Israel Hungary Brazil Austria Costa Rica India Finland Mexico Argentina Paraguay Colombia Turkey Uruguay Singapore Albania Sudan Vietnam Zimbabwe Ghana Density of pharmacists per 10,000 Indonesia Density of pharmacies per 10,000 Kenya Pakistan Mali Nigeria Nepal Tanzania Rwanda Ethiopia Uganda FIGURE 5–4 Number of pharmacists per 10,000 people and number of pharmacies per 10,000 people in 50 countries. SOURCE: FIP, 2009 (http://www.fip.org/pharmacy_education)
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The committee recognizes two main problems with medicines retail in low- and middle-income countries. First, there are not enough high-quality vendors, driving customers to street markets and unlicensed shops.
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. The Tanzanian regulatory authority was eager to discourage illegal stocking and improve dispensing practices at unregistered drug stores through an accreditation program (MSH, 2012; Rutta et al., 2011)
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The drug sellers had been spending an average of 30 percent of their time purchasing from an unreliable wholesale market (Segrè and Tran, 2008)
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Ms. Apreku explained that the CareShop franchise drastically improved her business in several ways.
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Asiam has four competing LCS [licensed chemical sellers] within a kilometer of his own shop" (Segrè and Tran, 2008, p.
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. Because of task shifting, pharmacy technicians monitor adherence to antiretroviral treatment in Zambia and tuberculosis treatment in urban Uganda (Bolton-Moore et al., 2007; Mafigiri et al., 2011; Stringer et al., 2006)
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. And, because the internet facilitates easy international sales, online drug stores have spread the problem of falsified and substandard drugs "from small, unprofitable, markets in developing nations to the [drug]
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. The Rural Pharmacy Scholarship Scheme awards rural students $10,000 per year of study and pairs them with a mentor who also works in rural pharmacy (PGA, 2012a)
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One of the most common tools for governing internet pharmacy is accreditation and certification, though only 7 percent of responding countries have a national process for certifying, accrediting, or regulating internet pharmacies (WHO, 2011)
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. The Attraction of Internet Pharmacies Some of the more reputable-looking internet drug sellers keep up the pretense of having patients complete a health questionnaire before buying drugs, but many do not (Ivanitskaya et al., 2010; Orizio et al., 2011)
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. A study of American shoppers at internet pharmacies found that 37.6 percent perceive the costs as one of the main advantages of internet drug sellers (Crawford, 2003)
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. Distinguishing Rogue Pharmacies from Legitimate Ones In late September 2012, Interpol, an intergovernmental organization for police cooperation, organized an international raid of online pharmacies A GlaxoSmithKline ad campaign about the dangers of online pharmacies purporting to sell Canadian medicines.
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. Although there is value to shutting down criminal online drug stores, in the longer term, it may be more helpful to recognize the e-commerce division of legitimate pharmacies.
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A 2008 study found that about 20 percent of online drug stores displayed an approval of a regulatory or accrediting agency, but about 80 percent of these approvals were phony (Mayor, 2008)
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There is no pharmacist to counsel patients on online pharmacy, and a website claiming affiliation with a respected local chain might be lying. A 2005 study found that of the more than 11,000 online drug stores claiming to be Canadian, only 214 were registered with the Canadian authorities (Clabaugh, 2005)
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Training and task shifting could also improve the quality of patient counseling and drug dispensing in low- and middle-income countries. Consumer confidence in drug safety could be improved by strengthening the ability of every intermediary on the supply chain to track drugs' movement from the manufacturer to the patient.
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https:// www.health.gov.au/internet/main/publishing.nsf/Content/health-mediarel-yr1999-mw mw99010.htm (accessed October 5, 2012)
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http:// www.bluespherehealth.com/wordpress/? p=236 (accessed October 4, 2012)
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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm322492. htm#.UG2Q840J6nY.email (accessed October 22, 2012)
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http://www.theglobalfund.org/en/ amfm (accessed October 24, 2012)
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2011. The pharmaceutical distribution chain in the European Union and impact on pharmaceutical prices.
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2009. Private sector pharmaceutical supply and distribution chains: Ghana, Mali and Malawi.
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2011. Quality of online pharmacies and web sites selling prescription drugs: A systematic review.
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London: The Stockholm Network. SCMS (Supply Chain Management Society)
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http://www. securingindustry.com/pharmaceuticals/safety-in-numbers-brazil-s-medicine-serialisation initiative-/s40/a440 (accessed October 4, 2012)
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2005. HNP brief #2: Pharmaceuticals: Counterfeits, substandard drugs, and drug diversion.
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2011. The world's medicines situation 2011: Storage and supply chain management.
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