April Prepared by: Jeffery

Transcription

1 Impact of State Laws Regulatingg Pseudoephedrine on Methamphetaminee Trafficking and Abuse A White Paper of the National Association off State Controlled Substance Authorities April 2012 Prepared by: Patricia R. Freeman, PhD, RPh Jeffery Talbert, PhD Institute for Pharmaceutical Outcomes and Policy Department of Pharmacy Practice and Science College of Pharmacy University of Kentucky Lexington, Kentucky National Association of State Controlledd Substances Authorities 72 Brook Street Quincy, MA

2 CONTENTS I. Introduction.3 II. III. IV. Scope of Work.5 Review of Federal and State Laws Review of the Literature A. Impact of Federal Laws...14 B. Impact of State Laws V. Summary and Suggestions for Further Study VI. Appendix

3 I. Introduction Methamphetamine, a highly addictive drug with potent central nervous system stimulant properties, has a long history of use in the United States. Methamphetamine was first marketed by Burroughs Wellcome and Co. under the trade name Methedrine beginning in 1940 and by Abbott Laboratories under the trade name Desoxyn in By the 1950s, methamphetamine was readily available legally and widely used for a variety of conditions, including narcolepsy, attention deficit disorder, obesity, and fatigue. 1 Methamphetamine became extensively abused and diverted during the 1960s following its use as a treatment for heroin and cocaine addiction and, in response, the US Drug Enforcement Administration (DEA) classified methamphetamine as a Schedule II controlled substance in The scheduling of methamphetamine products had an immediate impact on reducing methamphetamine abuse in the US; however, a resurgence of abuse was noted in the 1980s following the FDA approval of ephedrine and pseudoephedrine (PSE), two common precursors used in the illicit production of methamphetamine, for use as non-prescription, or over-the counter (OTC) decongestants. Today, methamphetamine is recognized as a major drug of abuse. According to the United Nations Office of Drug Control (UNODC), methamphetamine abuse affects between 14 and 53 million people ( %) worldwide. 2 Data from the Substance Abuse and Mental Health Services Administration s (SAMSHA) National Survey on Drug Use and Health (NSDUH) indicate that 13 million people age 12 or older in the US have used methamphetamine at some point in their lives. 3 Use of methamphetamine produces an initial period of euphoria, which may cause the user to continue using to obtain/maintain the euphoric rush. Continued use/abuse of methamphetamine is associated with anorexia, weight loss, insomnia, aggression, hallucinations, paranoia, convulsions, stroke, cardiac arrhythmia, and hyperthermia. 4 Chronic abuse can lead to irreversible brain and heart damage, memory loss, psychotic behavior, rages, violence and ultimately the inability to care for oneself and one s children. 4 1 Congressional Report Services, Methamphetamine: Background, Prevalence, and Federal Drug Control Policies Report No: RL33857 available at Background,%20Prevalence,%20and%20Federal%20Drug%20Control%20Policies.pdf accessed November 20, United Nations Office on Drugs and Crime. World Drug Report United Nations; Substance Abuse and Mental Health Services Administration (SAMSHA). Results from the 2010 National Survey on Drug Use and Health: Detailed Tables. Available at accessed December 30, U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Methamphetamine Abuse and Addiction, Research Report Series, NIH Publication No , Revised September 2006, available at accessed November 18,

4 Global production of illicit methamphetamine is estimated at 290 tons per year with a retail value of $28 billion 5 with widespread availability in the U.S. largely fueled by illegal production and importation from Mexico, and by illicit production in large and small clandestine domestic laboratories. 6 In addition to the known harms associated with methamphetamine abuse described above, the production of methamphetamine by small labs poses significant environmental hazards such as toxic dumpsites, explosions and exposure to chemicals that can result in serious harm. 7 In 2005, an estimated 35 percent of the methamphetamine used in the United States was produced in small-scale laboratories. 8 The most recent estimates of the societal costs of methamphetamine abuse are detailed in a study conducted by the RAND Drug Policy Research Center. 9 This first national estimate suggests that the economic cost of methamphetamine use in the US reached $23.4 billion ($16.2 billion - $48.3 billion) in The authors analysis considers a wide range of consequences due to methamphetamine use, including the burden of addiction, premature death, drug treatment, and aspects of lost productivity, crime and criminal justice, health care, production and environmental hazards, and child endangerment. To address the problems of methamphetamine abuse, multiple approaches have been taken by federal and state agencies. Initial approaches focused on controlling wholesale distribution of bulk precursor chemicals, including ephedrine and PSE. Subsequent efforts have largely focused on controlling access to methamphetamine precursors purchased at retail outlets such as grocery and convenience stores and pharmacies, including the reclassification of PSE as a controlled prescription drug in some states. The illicit domestic production of methamphetamine should be sensitive to regulatory efforts that limit access to chemical precursors (ephedrine and PSE) because without them, methamphetamine cannot be readily synthesized. 5 United Nations Office on Drugs and Crime. World Drug Report United Nations; National Drug Threat Assessment, US Department of Justice, National Drug Intelligence Center; Available at accessed October 17, Dan Hannan, Occupational Hazards: Meth Labs Understanding Exposure Hazards and Associated Problems, June 2005, p Testimony of Gary W. Oetje to Subcommittee on Criminal Justice, Drug Policy, and Human Resources Committee on Government Reform, U.S. House of Representatives. Law Enforcement and the Fight Against Methamphetamine: Improving Federal, State and Local Efforts, August 23, 2005 available at accessed December 22, Nicosa et al. The Economic Cost of Methamphetamine Use in the United States, RAND Drug Policy Research Center; 2009; available at accessed on October 13,

5 As states grapple with the methamphetamine abuse problem, information relative to the impact of the varying approaches states have taken to control access to methamphetamine precursors is needed. Such information will assist policy makers in crafting future precursor control regulations with the greatest impact. II. Scope of Work The National Association of State Controlled Substance Authorities (NASCSA) engaged researchers at the University of Kentucky Institute for Pharmaceutical Outcomes and Policy to prepare a white paper summarizing the impact of state and federal PSE laws on methamphetamine abuse. The white paper will inform public officials and legislators relative to which laws may have the greatest impact on methamphetamine abuse and guide future policy decisions relative to PSE regulation. To complete the white paper, the following components were outlined in the scope of work to be conducted: 1) Conduct a review of current state and federal laws regulating PSE 2) Conduct a review of current findings from the literature relative to PSE laws 3) Prepare a summary of successes and failures relative to state PSE laws 4) Identify suggestions of areas for further study/research III. Review of Federal and State Laws Regulating Pseudoephedrine Federal Laws The first major attempt at controlling methamphetamine precursor chemicals occurred in 1988 with the passage of the Chemical Diversion and Trafficking Act (CDTA), which regulated bulk ephedrine and PSE. The CDTA required record keeping, reporting requirements, and import/export notification requirements for bulk, pure (single entity) ephedrine and PSE products only and did not apply to OTC tablets or capsules containing ephedrine and PSE. In 1993, Congress passed the Domestic Chemical Diversion Control Act (DCDCA) which removed the record-keeping and reporting exemption for pure (single entity) ephedrine products. It also required distributors, importers, and exporters to register with DEA and gave DEA the power to revoke a company s registration without proof of criminal intent. The Comprehensive Methamphetamine Control Act of 1996 (MCA) broadened federal regulation of listed chemicals to include those found in OTC cold and sinus medicines. Under the MCA, methamphetamine precursor chemicals containing ephedrine, PSE or phenylpropanolamine (PPA) were added to Schedule II of the controlled substance act. 5

6 Other provisions of the MCA also increased penalties for the trafficking and manufacturing of methamphetamine and methamphetamine-related listed chemicals. The Methamphetamine Anti-Proliferation Act of 2000 (MAPA) included provisions to address the problem of diversion of OTC drug products containing methamphetamine precursor chemicals from retail and mail order sources. MAPA established thresholds for single purchases of OTC medicines containing ephedrine, PSE and PPA at 9 grams per transaction and added the requirement that the products be packaged in containers of not more than 3 grams of precursor base chemical. Products packaged in blister packaging were provided a safe harbor exemption from the threshold limits set by MAPA. In 2005, Congress passed the USA PATRIOT Improvement and Reauthorization Act which contained the Combat Methamphetamine Epidemic Act (CMEA). The provisions of the CMEA further regulated the domestic and international commerce of methamphetamine precursor chemicals. Specifically, the CMEA established a new set of controls for methamphetamine precursor chemicals (ephedrine, PSE and PPA) designed to control illicit diversion including the following limits on the retail sales of OTC products containing methamphetamine precursor chemicals: limits sales of OTC products to 3.6 grams of the precursor base per customer per day (previously limited to 9 grams per transaction) and 9 grams per customer per month in drugstores, convenience stores and grocery stores limits mobile retail and mail-order sales to 7.5 grams of precursor base per customer per month requires that products containing methamphetamine precursor chemicals be kept behind the counter and, for mobile retailers, that the products be secured under lock and key requires retailers to maintain a logbook that must be kept for at least two years, recording the time and date of sale, the name and quantity of the product sold, and the name and address of each purchaser requires purchasers to present a government-issued photo identification, sign the logbook for the sale providing their name, address, and the date and time of the sale requires retailer s logbooks include a warning that false statements will be punishable with a term of imprisonment of up to five years and/or a fine of not more than $250,000 for an individual offender, or $500,000 in cases involving an organization requires retailers to train employees on the methamphetamine precursor products statutory and regulatory provisions of the law requires retailers to take measures against possible employee theft or diversion of OTC products containing methamphetamine precursor chemicals 6

7 Most recently, the Combat Methamphetamine Enhancement Act of was enacted. This law places restrictions on both distributors andd retailers who sell products used in the illegal manufacture of methamphetamine. Under the new law, retailers must self- that can be sold to an individual. Additionally, distributors are required to limit the sale certify that they are in compliance with regulations that limitt the amount of products of their products to only those retailers who have registered with the DEA. Figure 1 below summarizes the history of federal attempts to regulate methamphetamine precursors. For a full review of the federal legislative history of methamphetamine precursor controls, ncluding legal citations, the reader is referred to the Congressional Research Service s 2007 Reportt for Congress. 10 Figure 1: History of Federal Precursor Regulation Chemica al Diversion and Trafficking Act (CDTA) 1993 Domesti c Chemical Diversion Control Act (DCDCA) 1996 Compreh hensive Methamphetamine Control Act (MCA) Methamp phetamine Anti Prolifer ration Act (MAPA) 2005 Combat Methamphet tamine Epidemic Act (CMEA) Combat Methamphet tamine Enhancement Act Source: Congressional Report Services, Methamphetamin e: Background, Prevalence, and Federal Drug Control Policies Congressional Report Services, Methamphetamine: Background, Prevalence, and Federal Drug Control Policies Report No: RL33857 available at Background,%20Prevalence,%20and% 20Federal%20Drug%20Control%20Policies.pdf accessed November 20,

8 State Law The majority of states have enacted laws controlling the sale of PSE- and ephedrinecontaining products that are more stringent than the current federal laws. Electronic tracking and block of sales to those exceeding quantity limits is the most common approach states have taken. Additionally, some states have chosen to restrict purchase quantities to amounts that are less than currently allowed by federal regulations (CMEA restricts retail purchases to <9 grams per 30 days). Other states have chosen to reclassify PSE as a Schedule III controlled substance. More recently, some states have passed mandates to establish a registry of individuals with methamphetamine-related convictions and block the sale of PSE to these individuals. In the following section, a review of state approaches to PSE regulation will be presented. Table 1 provides a summary of state approaches. For a full accounting of state laws regulating PSE please see Appendix A. Table 1: State Approaches to Pseudoephedrine Regulation Regulatory Approach Electronic Tracking and Block of Sales States with Mandates AL, AR, FL, IL, IN, IA, KS, KY, LA, MI, MO NC, NE, ND, OK, SC, TX, TN, WA, WV Prescription-only Status Schedule V Controlled Substance AR a, MS, OR AR, IA, IL, KS, LA, MN, MO, NM, OK WI, WV Schedule III Controlled Substance Greater Restrictions on Purchase Quantities Block of Sales to Those with Previous Methamphetamine- related Convictions MS, OR AK, IA, IN, MN, WI OK a Prescription required for out of state residents only; Information current as of 12/31/11 8

9 Electronic Tracking and Block of Sales Since 2006, pharmacies and retail outlets have been required to keep a log book documenting the sale of PSE to meet the provisions of the CMEA. While logging PSE sales at individual pharmacies and other retail outlets can be used to track and compare purchases within an individual outlet, this approach has been less than effective at controlling PSE purchases for illicit uses, as persons with the intent of purchasing PSE for methamphetamine production can travel from pharmacy to pharmacy making multiple PSE purchases. With electronic tracking, the purchaser s driver s license or other allowed identification is scanned at the point of sale of PSE-containing products. The sale is then logged by the electronic tracking system documenting the date and amount of the PSE purchased. Future attempts to purchase PSE will be scanned and logged in the same manner at any retail purchase outlet. Sales data is stored centrally and can be shared among pharmacies and retail outlets in a state, and, in some cases depending on the tracking system used, across state lines. Once purchase thresholds have been reached, the individual completing the sale is alerted and the sale can be blocked. Thus, the major advantage of electronic tracking over paper log books is the sharing of aggregate data in real time that allows those selling PSE to more accurately determine if a PSE purchase would exceed an individual s legal limit. Additionally, electronic tracking systems can be used to alert law enforcement when individuals attempt to purchase more than the legal limit of a methamphetamine precursor in a more efficient and expedient manner than reviewing multiple paper logs. Oklahoma became the first state to require electronic tracking in 2004 using an internally developed system maintained by the Oklahoma Bureau of Narcotics. Arkansas and Kentucky soon followed suit; Arkansas has been using MethMonitor 11 to track methamphetamine precursor sales since 2006, and in 2008, Kentucky became the first state to pilot a new electronic system, MethCheck, for the tracking of PSE sales. Since 2008, the use of electronic tracking has increased substantially with twenty states having passed laws as of July 2011 requiring the electronic tracking of PSE sales (Table 1). Although states have implemented electronic tracking laws in a variety of ways, the most common approach taken by states has been to use the National Precursor Log Exchange (NPLEx) described in further detail below. National Precursor Log Exchange The National Precursor Log Exchange (NPLEx) is a real-time electronic logging system used by pharmacies, retail outlets and law enforcement to track sales of OTC cold and allergy medications containing methamphetamine precursors. To date, laws authorizing the use of NPLEx have been implemented in 17 states (Figure 2). 11 Leadsonlabs available at accessed December 18,

10 Figure 2: States Tracking Pseudoephedrine Sales using National Precursor Log Exchange Used with permission from NPLEx 11 The National Association of Drug Diversion Investigators (NADDI) is the provider of the service and Appriss, Inc., is the technology vendor whose product, MethCheck, won the competitive bid to provide the service. NPLEx is provided free of charge (sponsored by the manufacturers of PSE-containing OTC products) on a permanent basis to state governments that pass appropriate legislation and regulations. Services provided include implementation to all retailers, access to law enforcement, technical support, training for retailers and law enforcement, and maintenance and upgrades. 11 Retailers using the system voluntarily block the sale of precursors that would exceed the legal quantity limits (3.6 grams per day and 9 grams in 30 days per CMEA or more stringent requirements per relevant state laws). When a transaction is submitted by a retailer that would exceed the limits, a message is instantly transmitted recommending denial of the sale. A manual override can be used if the clerk feels in danger, and law enforcement is notified that the sale may have exceeded the limits. 11 According to NPLEx, currently 27,584 retailers and 6,591 law enforcement agents use the electronic system to log and track sales National Precursor Log Exchange, available at accessed January 5,

11 Purchase Quantity Restrictions Since the passage of the CMEA in 2005, retail purchases of PSE have been limited to 9 grams per 30 days. Several states, including Arkansas, Iowa, Indiana, Minnesota and Wisconsin, have implemented more stringent laws restricting the retail purchase of PSE to 7.5 grams, or as in the case of Indiana, 7.2 grams per 30 days and Minnesota, 6 grams per 30 days. The maximum daily dose of PSE is 240 mg, thus if a person requiring PSE takes the maximum dose every day for 30 days, a quantity of 7.2 grams would be needed for the 30 day supply. Restricting quantities to a maximum of 7.2 grams per day should have no impact on persons purchasing PSE for legitimate selfcare uses. Additional states are considering legislation to restrict purchase quantities to this limit. Schedule V Controlled Substance Eleven states have reclassified PSE as a Schedule V controlled substance - Arkansas, Illinois, Iowa, Kansas, Louisiana, Minnesota, Missouri, New Mexico, Oklahoma, West Virginia and Wisconsin. As Schedule V, products are available OTC with specific requirements for purchasing, including maintaining a log of all transactions and presentation of identification showing proof of age (18 years or older). Additionally, the classification of PSE and other precursors as Schedule V substances restricts their purchases to pharmacies. States with prescription monitoring programs (PMPs) that monitor Schedule V substances may require data on Schedule V PSE sales to be transmitted to the PMP. Such is the case with Oklahoma, which has classified all PSEcontaining medications as Schedule V prescriptions and requires that they be submitted to the Oklahoma PMP database. Prescription-only Status/ Schedule III Controlled Substance Two states Oregon and Mississippi have adopted the strictest PSE laws to date, making PSE a Schedule III controlled substance available by prescription only and subject to the states PMP. In 2011, legislation was passed in Arkansas limiting the OTC sales of PSE to Arkansas residents and imposing new duties on pharmacists. Specifically, the new law makes it illegal to dispense any product containing PSE (or ephedrine or PPA) without a prescription, unless the purchaser can provide an Arkansas-issued Driver s License or ID card, or an identity card issued by the U.S. Department of Defense for active-duty military personnel. Additionally, the law requires pharmacists to verify the legitimate medical need of individuals purchasing products containing PSE, based on a pharmacist-patient relationship, before allowing the purchase of a PSE (or ephedrine or PPA) containing product. Prior prescription history and/or information obtained during patient screening can be used to provide professional reassurance to the pharmacist that a legitimate medical need exists. 11

12 Methamphetamine Registry/Block of Sales to those with Previous Methamphetamine-Related Convictions Oklahoma passed legislation, effective November 2010, requiring all individuals convicted of possession, manufacture, distribution or trafficking of methamphetamine to register with the state. Pharmacies and other retail outlets who register with the state to sell or dispense PSE-related products and law enforcement agencies can access the registry through a central repository and the state s PMP. Customers listed in the registry due to a previous methamphetamine-related conviction will be blocked at the point of sale from buying PSE and are prohibited from possessing any detectable quantity of the drug. When a pharmacy sells PSE OTC, the purchaser s name is checked against the Meth Registry and the sale will be blocked if the individual has a prior methamphetamine-related conviction, without regards to quantity limits. IV. Review of the Literature Relative to Pseudoephedrine Laws A review of the literature was conducted to identify published studies evaluating the impact of federal and state laws regulating methamphetamine precursors on methamphetamine abuse. Published reports utilize a variety of data sources to assess impact including healthcare-related data and data collected and aggregated from lawenforcement agencies. In addition to the published literature, information from governmental agency reports, news reports, legislative policy reports and personal interviews were used as mechanisms for gathering data evaluating the impact of state and federal precursor control laws and are referenced throughout the report as appropriate. Impact can be assessed in two main ways the use of law enforcement data (to assess changes in the manufacture of methamphetamine in domestic clandestine labs, amount of methamphetamine seized during lab raids and other law enforcement activities and methamphetamine-related crimes) and the use of healthcare data (to assess changes in the actual abuse of methamphetamine such as surveys, admissions to treatment facilities for methamphetamine abuse and emergency department (ED) visits related to methamphetamine.) The most common datasets used for assessing impact are summarized below. For the purposes of the report, the impact of federal and state laws are discussed separately. Law Enforcement Datasets Data from law enforcement agencies commonly utilized for assessing impact of precursor control regulations include the National Clandestine Laboratory Surveillance System (NCLSS), the System to Retrieve Information from Drug Evidence (STRIDE) and Uniform Crime Reports (UCR). 12

13 The NCLSS is a national database which became operational in January 1999 and serves as a clearinghouse for all federal, state, and local clandestine laboratory seizures. 12 The El Paso Intelligence Center (EPIC) is the central repository for these data. Although commonly used, the data do have limitations, including incomplete reporting of data by states. STRIDE is the DEA s administrative data system for collecting data on drug evidence purchased, seized or collected during investigations by the DEA, the Federal Bureau of Investigation, other federal organizations and some state and local law enforcement. Data collected includes information on type, amount, form and purity of the drug. 13 The UCR database is maintained by the Federal Bureau of Investigation (FBI). The FBI s primary objective in maintaining the UCR is to generate a reliable set of crime statistics for use in law enforcement administration, operation, and management. 14 Healthcare-Related Datasets Healthcare-related datasets that provide information relative to methamphetamine use and are commonly utilized for assessing impact of precursor control regulations include the Treatment Episode Data Set (TEDS), the Drug Abuse Warning Network (DAWN) and the National Survey on Drug Use and Health (NSDUH). TEDS is maintained by the Office of Applied Studies, Substance Abuse and Mental Health Services Administration (SAMHSA), an agency of the U.S. Public Health Service in the U.S. Department of Health and Human Services and includes records for some 1.5 million substance abuse treatment admissions annually. 15 DAWN is a public health surveillance system that monitors drug-related visits to a sample of hospital emergency departments and drug-related deaths investigated by medical examiners and coroners. 16 The NSDUH provides national and state-level data on the use of tobacco, alcohol, illicit drugs (including non-medical use of prescription drugs) and mental health in the United States. NSDUH is sponsored by SAMHSA DEA, El Paso Intelligence Center, Clandestine laboratory Seizure System. Available at accessed November 16, US Drug Enforcement Agency, System to Retrieve Information from Drug Evidence, available at accessed December 18, Federal Bureau of Investigation, Uniform Crime Reports, available at accessed December 18, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set, available at accessed December 18, Substance Abuse and Mental Health Services Administration, Drug Abuse Warning Network, available at accessed December 18, Substance Abuse and Mental Health Services Administration, National Survey on Drug Use and Health, available at accessed December 18,

14 A. Impact of Federal PSE Laws A review of the literature relative to the impact of Federal PSE regulations found several relevant articles. First, Nonnemaker et al. in Are Methamphetamine Precursor Control Laws Effective Tools to Fight the Methamphetamine Epidemic estimated the impact of federal MAPA legislation (2000) that restricted PSE purchases to 9 grams per transaction. 18 The author used a conceptual model based on economic theory that precursor control is a supply side measure that should reduce supply and drive up prices of methamphetamine; because methamphetamine is price elastic (i.e., a small change in price is accompanied by a large change in the quantity demanded), increases in price will lead to fewer users and decreased consumption. Data sources used included NCLSS to measure domestic production and availability of methamphetamine from lab seizure data, STRIDE to measure drug prices and purity, and TEDS to identify methamphetamine related admissions to drug abuse treatment facilities as a proxy for methamphetamine use. Results from the evaluation suggest that MAPA had no impact on per capita methamphetamine lab seizures but a small yet significant decline in amount of methamphetamine seized by law enforcement agencies occurred following MAPA. Additionally, results indicate that methamphetamine prices fell and average purity rose post MAPA (pre-post 2000) which was opposite of what was expected. Finally, results indicate that methamphetamine-related treatment episodes were not significantly different pre-post MAPA implementation. From these results, the authors conclude that the net benefit of MAPA is unclear. The counterintuitive rise in methamphetamine purities and lower prices may suggest flow of finished methamphetamine from international sources and increased domestic use. Cunningham and Liu evaluated the impact of federal precursor chemical regulations on methamphetamine-related hospital admissions 19 and arrests 20 in California. The authors found in both studies that federal regulations targeting regulation of precursor chemicals was associated with immediate declines in both methamphetamine-related hospital admissions and arrests lasting between 2 4 years. Ultimately, both admissions and arrests rebounded to levels greater than that observed pre-regulation. 18 Nonnemaker, J., Engelen, M. and Shive, D, Are methamphetamine precursor control laws effective tools to fight the methamphetamine epidemic? Health Economics, 2011, 20: Cunningham and Liu, Impact of methamphetamine precursor chemical legislation, a suppression policy, on the demand for drug treatment. Soc Sci Med Apr;66(7): Cunningham and Liu, Impacts of federal precursor chemical regulations on methamphetamine arrests. Addiction, 2005, 100:

15 McKetin et al. conducted a systematic review of methamphetamine precursor regulations published in The authors used 12 databases to identify studies that had evaluated the impact of methamphetamine precursor regulations on methamphetamine supply and/or use. Ten studies met the inclusion criteria with all interventions occurring between 1989 and 2008 in North America. The outcome measures included both indicators of methamphetamine use (e.g. treatment admissions, hospital admissions, arrests, toxicology) and indictors of methamphetamine supply (e.g., price, purity, seizures and detections of clandestine labs). The results are summarized in Table 2 below. From this systematic review of the literature, McKetin and colleagues conclude that the effectiveness of legislative efforts to control methamphetamine precursors varies significantly with some effective and others not effective. Additionally, they conclude that regulations coupled with enforcement activities can have the greatest impact but warn that the importation of methamphetamine and its precursors from neighboring countries limits effectiveness of precursor regulations. Further research is needed to determine which precursor regulations work best and in what context. Table 2: Impact of Methamphetamine Precursor Laws Intervention (Implementation Date) Type Impact Chemical Diversion and Trafficking Act (1989) Domestic Chemical Diversion Control Act (1995) Action Against Rogue Pharmaceutical Company And Large Scale Seizure (1995) Comprehensive Methamphetamine Control Act: Ephedrine Regulation (1996) Comprehensive Methamphetamine Control Act: Pseudoephedrine Regulation (1997) Import/export, wholesale Import/export, wholesale, retail Enforcement Retail Retail Moderate Large Large Weak Large Methamphetamine Anti-Proliferation Act (2001) Retail Weak Oklahoma House Bill (2004) Retail Weak Texas House Bill (2005) Retail Weak Source: McKetin, R., Sutherland, R., Bright, D. A. and Norberg, M. M. A systematic review of methamphetamine precursor regulations. Addiction, 2011, 106: McKetin, R., Sutherland, R., Bright, D. A. and Norberg, M. M. A systematic review of methamphetamine precursor regulations. Addiction, 2011, 106:

16 In 2008, Maxwell and Rutkowski conducted a review of available epidemiological information about methamphetamine production and use in North America using a range of sources including historical accounts, peer-reviewed papers, population surveys and large national databases. 22 Of particular interest is the authors review of clandestine lab data incidents and the percentage of all substances identified by forensic laboratories that were methamphetamine in the years The results show a marked decrease in lab incidents and in the percentage of all substances identified as methamphetamine in 2006 (following passage of the CMEA). From their review, the authors conclude that the indicators show the problem is greatest in the western parts of the North American countries and is moving eastward, but that decreased availability of PSE may have a significant impact on the nature of the epidemic in the future, as evidenced by the sharp decline in lab incidents and the percentage of all identified substances that were methamphetamine in Most recently, Maxwell and Brecht compiled historical and recent data from supply and demand indicators to provide a broad context within which to consider the changes in trends in the use of methamphetamine over the past five years. 23 To assess trends in indicators of methamphetamine supply, the authors reviewed information from CLSS and STRIDE relative to the number of lab incidents reported, the percentage of all substances identified as methamphetamine, and methamphetamine price and purity over a number of years, respectively. The authors found that lab incidents in the U.S. decreased through 2007 as an initial response to the CMEA but have steadily increased as methamphetamine cooks found ways to circumvent the legislation and obtain PSE and other ingredients used to produce the drug. 23 Figure 3 below, adapted from Maxwell and Brecht, depicts lab incidents and percent of all substances identified as methamphetamine by the National Forensic Laboratory Information System (NFLIS). 23 Close review of Figure 3 shows a clear relationship between methamphetamine use as evidenced by the percent of all substances identified as methamphetamine (by the NFLIS) and the number of clandestine labs, with this indicator of methamphetamine use declining in concert with the number of clandestine lab incidents reported. This tracking relationship provides strong evidence that methamphetamine production in domestic clandestine labs fuels methamphetamine use. To assess trends in indicators of methamphetamine demand, the authors reviewed information from surveys, including the NSDUH, and on healthcare utilization related to methamphetamine, including data from DAWN and TEDS. 22 Maxwell and Rutkowski. The prevalence of methamphetamine and amphetamine abuse in North America: a review of the indicators, Drug and Alcohol Review, 2008, 27: Maxwell and Brecht. Methamphetamine: Here we go again? Addictive Behaviors 36, 2011,

17 From their review of the trends in indicators of methamphetamine demand, the authors conclude that demand for methamphetamine decreased following precursor chemical bans. However, since 2008, trends in indicators of methamphetamine demand are increasing. Figure 3: Methamphetamine Clandestine Laboratory Incidents and Percent Methamphetamine Related Tests from the NFLIS, Lab Incidents % of NFLIS with Methamphetamine Lab Incidents % of NFLIS tests with Methamphetamine Ultimately, the authors conclude that the supply and demand data show that methamphetamine indicators are again increasing following a few years of decline in the mid-2000s and suggest that supply-side accommodations occur in response to changes in precursor chemical restriction. The authors conclude that the results support the need for continuing attention to control and interdiction efforts appropriate to the changing supply context and to continuing prevention efforts and increased number of treatment programs. 23 B. Impact of State PSE Laws Since Oklahoma in 2004, states have implemented various precursor control laws in hopes of addressing the methamphetamine abuse problem. Specifically, these regulations target the domestic production of methamphetamine in small clandestine laboratories. Little is known, however, relative to the impact of state PSE regulations. Two early studies conducted and reviewed by McKetin et al. assessed the impact of the Oklahoma and Texas House bills passed in 2004 and 2005 respectively. Both laws, which exerted retail controls on PSE, were deemed rather ineffective in controlling 17

18 methamphetamine abuse. 21 In the following section, available data relative to the impact of varying approaches taken by states to control methamphetamine precursors is summarized. When available, reports from the published literature were reviewed. Data from other sources, including government reports, reports to state legislators, news reports and personal interviews are included. Impact of Reclassifying PSE as a Schedule V Controlled Substance As discussed previously, eleven states including Arkansas, Illinois, Iowa, Kansas, Louisiana, Minnesota, Missouri, New Mexico, Oklahoma, West Virginia and Wisconsin have reclassified PSE as a Schedule V controlled substance, placing further restrictions on the retail sale of PSE over that imposed by the CMEA. A review of the published literature identified two articles that assessed the impact of making PSE a Schedule V controlled substance. Oklahoma In 2004, Oklahoma was the first state to reclassify PSE as a Schedule V controlled substance and impose retail sales restrictions. Brandenburg and colleagues evaluated the association of PSE sales restrictions in Oklahoma on emergency department urine drug screen results using all urine drug screen results in the Saint Francis Hospital Trauma Emergency Center, in Tulsa, Oklahoma from January 2003 through May The authors found a significant increase in the total tests performed and the percentage of positive test results for the amphetamine drug class over time. The authors conclude that while the manufacture of methamphetamine in clandestine laboratories declined following implementation of the law, methamphetamine use in the emergency department patient population did not decrease and that possibly, methamphetamine use in Oklahoma was not impacted by the passage of HB 2176 due to an increase in drug trafficking of methamphetamine into the state. 24 Iowa Senate File 169, which classified PSE as a Schedule V controlled substance, became effective law in Iowa in May, Burke et al. conducted a study on the impact of this legislation with the outcome of interest being the impact on methamphetamine laboratory-related burns using a retrospective analysis of patients admitted to University of Iowa Burn Treatment Center 2004 and 2005 (pre-post law) Brandenburg MA, Brown SJ, Arneson WL, Arneson DL. The association of pseudoephedrine sales restrictions on emergency department urine drug screen results in Oklahoma. J Okla State Med Assoc. 2007, 100(11): Burke BA, Lewis RW, Latenser BA, Chung JY, Willoughby C. Pseudoephedrine legislation decreases methamphetamine laboratory-related burns J Burn Care Res Jan-Feb;29(1):

19 The results demonstrated a decrease in burn admissions related to methamphetamine from 21% in 2004 to 4% in 2005 while no change in treatment admissions to substance abuse treatment centers during same time period were noted. Thus, it appears that Senate File 169 impacts the production of methamphetamine in clandestine laboratories as evidenced by a reduction in burns, but does not impact indicators of methamphetamine abuse. According to a report to the Iowa legislature from the Iowa Governor s Office of Drug Control Policy published in January, 2006, methamphetamine-related laboratory incidents in Iowa decreased nearly 80% following implementation of the law. 26 Data from the Iowa Division of Narcotics Enforcement showed an average of 125 methamphetamine lab incidents per month during 2004 and an average of 119 per month in the first 5 months of 2005 prior to implementation of the law. Following implementation of the law, an average of 20 methamphetamine lab incidents per month were reported for the remainder of Review of National Clandestine Laboratory Data Review of data on the number of methamphetamine clandestine laboratory incidents for the years for all states that currently have PSE classified as a Schedule V controlled substance are shown in Table 3 below. For comparison, the same data are shown for Oregon, which reclassified PSE as a Schedule III controlled substance available via prescription only in Table 3: Methamphetamine Clandestine Laboratory Incidents in States with Schedule V Mandates State Trend Arkansas Iowa Illinois Kansas Louisiana Minnesota Missouri New Mexico Oklahoma West Virginia Wisconsin Oregon (CIII) bold = year Schedule V mandated (Schedule III mandate in Oregan presented for comparison) Source: EPIC NSS 26 Marvin L.Van Haaften. The Impact of Senate File 169 on Meth Abuse in Iowa: A Report to the Legislature.January17, 2006 available at accessed December 19,

20 In a 2006 report to the legislature, officials from Iowa documented a significant decrease in the number of clandestine lab incidents following the reclassification of PSE as a Schedule V controlled substance. 26 Review of the data in Table 3 above for the years shows that while an initial decrease in lab incidents was observed (from a low of 182 incidents reported in 2007), the number of lab incidents in Iowa is increasing although it remains considerably lower than what was reported in 2004 and 2005 prior to implementation of the Schedule V PSE law. The passage of Oklahoma s 2004 law reclassifying PSE as a Schedule V controlled substance had a dramatic impact on methamphetamine clandestine laboratory incidents as shown in Table 3. Reported lab incidents dropped from a high of 679 in 2004 to a low of 93 in Since 2007, reported clandestine lab incidents have increased considerably, rebounding to levels almost equivalent to those observed prior to implementation of the Schedule V PSE law. Similar trends, suggesting an initial impact followed by some degree of rebound in reported methamphetamine lab incidents are observed in Table 3 for the majority of states that have reclassified PSE as a Schedule V controlled substance. For comparison, the number of reported lab incidents in Oregon, which classified PSE as Schedule III controlled substance in 2006, is reported. The number of reported clandestine methamphetamine lab incidents in Oregon has steadily declined since implementation of the law with no rebound observed to date. Review of Abuse Indicators Data from TEDS shows considerable variability in methamphetamine-related treatment admissions to substance abuse treatment facilities (Table 4). In some states, admissions with methamphetamine as the primary substance reported represents up to 20% of admissions in 2010 (Oklahoma) whereas in other states it represents only 1% of admissions (Wisconsin, Illinois). Data show that methamphetamine abuse continues to be a significant problem and is on the increase in some states after an initial period of decline. 20

21 Table 4: Number and (Percentage) of Methamphetamine/Amphetamine Treatment Admissions in States with Schedule V Mandates State Arkansas 3471 (25.2) 2943 (21.5) 2605 (17.3) 4340 (15.2) 4037 (16.4) 2544 (18) Iowa 5558 (19.7) 5779 (20.3) 4513 (15.8) 3436 (12.8) 2652 (10.1) 2945 (10.6) 4232 (12.8) Illinois 2608 (3.2) 2568 (3.3) 2395 (2.8) 1302 (1.8) 1001 (1.3) 892 ( 1.3) 948 (1.5) Kansas 1808 (11.7) 2190 (13.9) 1578 (12.1) 1961 (13.1) ) 2036 (10.8) 1912 (12.8) Louisiana 1055 (3.7) 1229 (4.9) 950 (4.2) 978 (4.0) 718 (2.8) 746 (2.6) 830 ( 3.2) Minnesota 5934 (12.9) 7159 (15.8) 5380 (11.2) 4903 (9.8) 6386 (7.4) 3600 (6.9) 4139 (8.1) Missouri 4914 (12.5) 6154 (14.1) 5295 (11.7) 4513 (9.5) 4544 (9.2) 5056 (9.6) 5088 (10.5) New Mexico 315 (5.7) 703 (7.7) 910 (7.3) 1018 (8.5) 846 (7.3) 698 (7.0) 668 (9.1) Oklahoma 4007 (23.5) 4194 (25.1) 3728 (23.8) 3365 (20.4) 2687 (15.8) 2965 (17.5) 2523 (20) W. Virginia 77 (1.7) 175 (2.6) 187 (2.4) 138 (1.8) 147 (1.5) 68 (1.1) 46 (2.1) Wisconsin 259 (1.1) 483 (1.9) 443 (1.4) 355 (1.2) 275 (0.9) 289 (1.0) 308 (1.0) Oregon 8561 (19) (21.1) 9226 (18.8) 8803 (16.8) 7354 (13.9) 6283 (12.9) 6650 (14.1) Bold = year Schedule V mandated (CIII mandate in Oregon presented for comparison) Source: Is Reclassifying Pseudoephedrine as a Schedule V Controlled Substance Effective? Taken together, the information suggests that implementation of state laws relative to reclassifying PSE as a Schedule V controlled substance has an initial impact on the number of clandestine lab incidents and associated hazards, but may not have an impact on indicators of abuse. A significant rebound effect in clandestine lab incidents is observed in most states that have implemented such laws, with the exception of Minnesota and West Virginia (Table 3). Impact of Electronic Tracking Published data demonstrating the impact of tracking programs is somewhat lacking as the approach is relatively new. Theoretically, electronic tracking can provide an advantage over paper logs as data are centralized and can be shared among retail sellers of PSE in a state, and, in many instances, across state lines. Proponents of a national electronic tracking system cite data from NPLEx relative to block of sales in states currently using the system as evidence that NPLEx works. According to the NPLEx website, during 2011 participating pharmacies sold 58,124,904 grams of PSE with the sale of 1,784,618 grams blocked by NPLEx National Precursor Log Exchange Stats, available at accessed December 29,

22 Block of sales data for 11 of the 17 states currently using NPLEx is presented in Table 5 below. Data for 6 states which recently enacted electronic tracking laws are excluded as no 2011 data is available. Table 5: Purchases and Block of Sales (Rate per 1,000 People) in States with Electronic Tracking, 2011 State Purchases Purchases Blocked Grams Sold Grams Blocked Alabama 1,529,300 88,141 3,234, ,608 (320) (18) (677) (46) Florida 3,950, ,093 7,845, ,499 (210) (6) (417) (15) Illinois 3,030,382 54,548 5,662, ,482 (236) (4) (441) (11) Iowa 896,292 23,262 1,820,827 61,555 (294) (8) (598) (20) Kansas 1 512,249 13,494 1,110,700 39,583 (180) (5) (389) (14) Kentucky 1,302,254 29,141 2,742,849 78,188 (300) (7) 632 (18) Louisiana 1,139,099 28,577 2,300,520 74,801 (251) (6) (507) (17) Missouri 1,665,681 45,581 3,518, ,174 (278) (8) (587) (20) North Dakota 3 19, ,503 1,437 (30) (1) (41) (2) South Carolina 1,191,258 41,211 2,379, ,281 (258) (9) (514) (23) Washington 2 292,333 4, ,143 11,068 (158) (2) (291) (6) partial year data from May Dec, 2011; partial year data from Oct Dec, 2011; partial year data from Nov Dec, 2011 Source: Aaron Davis, NPLEx, Manager, Creative Services via January 5, Review of National Clandestine Laboratory Data Review of data on the number of methamphetamine clandestine laboratory incidents for the years for all states that currently have enacted electronic tracking laws are shown in Table 6 below. For comparison, the same data are shown for Oregon and Mississippi which reclassified PSE as a Schedule III controlled substance available via prescription only in 2006 and 2010, respectively. 22

23 Table 6: Methamphetamine Clandestine Laboratory Incidents in States with Electronic Tracking, E Tracking States Trend *2011 Alabama Florida Illinois Indiana Iowa Kansas Kentucky Louisiana Michigan Missouri Nebraska North Carolina North Dakota Oklahoma South Carolina Tennessee Texas Washington Rx States Mississippi Oregon bold = year electronic tracking implemented (CIII mandate in Oregon and Mississippi presented for comparison) Source:EPIC NSS *2011 data is a partial year through October Oklahoma began electronically tracking PSE in The law was initially thought to be successful as lab incidents dropped from 679 in 2004 to 93 in 2007 (Table 6). However, this trend quickly reversed with lab incidents increasing to a high of 655 in Kentucky was the first state to fully implement electronic tracking with MethCheck, the system currently utilized in the NPLEx program, in As depicted in Table 6 above, the number of reported methamphetamine in clandestine laboratory incidents has climbed steadily since electronic tracking was implemented from a low of 297 in 2007 to a high of 1070 in Trend lines for most states show an initial decline around 2005 or 2006 following retail sales control measures implemented by states and the CMEA, with a rebound effect. Thus, electronic tracking laws do not appear to be having a sustainable impact on the domestic production of methamphetamine by clandestine labs as evidenced by the numbers of reported lab incidents. 23