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Pseudoephedrine: Stricter Controls in the Future?

W. Steven Pray, PhD, DPh
Bernhardt Professor, Nonprescription Products and Devices
College of Pharmacy
Southwestern Oklahoma State University

Weatherford, Oklahoma



1/20/2010

US Pharm
. 2010;35(1):17-19. 

The Combat Methamphetamine Epidemic Act of 2005 (enacted in 2006) restricted pseudoephedrine (PSE) sales to pharmacies. Covered in this column in October 2006, the law was widely perceived to be a major step forward in the war on methamphetamine (meth).1 However, there are troubling new developments that will have profound impact upon pharmacies and pharmacists. 

Mexican Imports Decline

One result of the 2006 law was an increase in smuggling from Mexico. However, according to the Department of Justice (DOJ), Mexico announced in 2007 that it would prohibit importation of PSE and ephedrine in 2008 and ban their use by 2009.2 Thus, there was a predictable decrease in Mexican meth production in 2007 and 2008, and a corresponding shortage in many U.S. markets.2 In 2007, the price for an allegedly “pure” gram of meth increased from $150 to $284, while the purity actually decreased by 28%.2 

Domestic Meth Supplies Increase

Authorities expected that meth availability would continue to nosedive in 2008, but this was not the case. Law enforcement officials noted that the amount of meth stabilized and actually rose during mid 2008.2 According to the DOJ, the price per gram decreased from $284 to $238, and purity increased by 12% (from the fourth quarter of 2007 to the second quarter of 2008).2 There were 1,605 laboratory seizures in the first half of 2008, as compared to 1,475 during the first half of 2007. States observing this increase included Alabama, Arizona, Kansas, Michigan, Missouri, North Carolina, North Dakota, Oklahoma, South Carolina, and Wisconsin.2 While most seizures were of small-scale labs (e.g., <1 lb of meth per production cycle), large-scale labs were also proliferating in central California. 

The Rise of Smurfing

The reason for the unanticipated availability of meth was that the national law proved to be insufficient to predict and halt the ingenuity of those who wished to circumvent its provisions. Smurfing, a term widely known in the banking industry, refers to engaging in numerous small monetary transactions to avoid triggering specific record-keeping or reporting requirements legally mandated if the transaction is above a specific dollar amount. In pharmacy, smurfing PSE is the practice of visiting numerous pharmacies to purchase the legal limit of PSE (3.6 g daily), allowing the meth lab to obtain sufficient PSE for a production run.1,3 The labs often send many individuals in the same van or car, so they can maximize their cache of starter chemical. The DOJ discussed an operation in Fresno County, California, in which criminals solicited homeless individuals to get into their car, driving them from pharmacy to pharmacy to purchase PSE in exchange for alcohol or $30.3 The criminals’ car was found and contained several cell phones, pharmacy addresses torn from a phone book, and many PSE packages. Smurfing has become organized and widespread, leading directly to the rise of large-scale labs such as those discovered in California.3 

Meth Production Changes

Criminals also responded to the 2006 law by changing their method of meth production. The previous methods were relatively cumbersome, forcing lab operators to heat the mixture on a stove and yielding toxic ammonia fumes that sometimes led authorities to the illicit operation. The new “one-pot” or “shake-and-bake” method uses commonly available chemicals and recipes that can be found on irresponsible Web sites.4 Using this method, criminals can make meth in containers such as 2-liter soda bottles in as little as 30 minutes, even while driving the bottles around in the back of a pickup or a motorcycle. Waste products are simply tossed out on the roadside, endangering those who clean up litter, as the bottles may be toxic, explosive, and flammable.4 

Meth Lab Fires

An example of the consequences of the shake-and-bake method of meth production arose from an incident that occurred in Florida on October 31, 2009.5 A fire was reported in a motel room, and responding firefighters noticed suspicious materials in the room. Two suspects fled the scene but were eventually identified. The materials that provoked the report included digital scales, coffee filters with crushed PSE pills, lithium metal, sulfuric acid, fertilizer, lye, camp fuel, and the drain cleaner Liquid Fire. Apparently, the criminals allowed lithium battery strips to contact water, an event that results in fire. One suspect suffered second-degree burns on his hands, arms, and neck, and the motel was forced to relocate guests and hire a clean-up company that specializes in decontaminating meth labs. 

Other incidents have been far more serious. This country is awash in an epidemic of meth lab fire-related deaths and many cases of serious, life-threatening injury. In August 2009, authorities suspected that a meth lab close to a baby’s playpen in a mobile home exploded.6 The 1-year-old girl suffered second- and third-degree burns on 40% of her body, a situation in which her physicians predicted that her risk of death from infection was fairly high.

States Look at Meth Control

In 2005, Oregon passed a law that made PSE a Schedule III controlled substance.7-9 The law forced the State Board of Pharmacy to make the classification change by July 1, 2006. A similar law in California failed in July 2009.10 

Oklahoma was widely lauded as the first state to limit PSE sales to pharmacies, prior to the national Combat Methamphetamine Act. An extension of the state law took effect November 1, 2009, requiring PSE purchasers to provide their birthdates, a stricter provision not found in the national law (states are allowed to create laws that are stricter than federal laws).11 This provision was enacted to stop the widespread practice of using multiple identification cards. The law also bans out-of-state driver’s licenses or identification cards, a move intended to decrease use of bogus or altered ID cards. Oklahoma is also considering a state law to make PSE prescription-only, a move opposed by the Consumer Healthcare Products Association (CHPA) and the state pharmacy association.12 Both groups assert that present laws are sufficient, but that they are not being enforced properly. 

Cities Attempt to Control Meth

The city council of Washington, Missouri, voted to help stem the tide of meth by making PSE prescription-only on July 6, 2009, the first city in the country to do so.13,14 On July 9, the American Civil Liberties Union (ACLU) requested that the ordinance be repealed, a move that was criticized by one council member.15-17 Nevertheless, the council voted to table the ordinance on July 20 to avoid a lawsuit from the ACLU.18,19 On August 3, the council voted to keep the new law and risk the lawsuit.20 The city of Union, Missouri, voted on a similar ordinance on October 12, 2009.21 The law was criticized by the Missouri Medical Association, the Missouri Retailers Association, and the Missouri Pharmacy Association.22 On October 26, Washington, Missouri, police reported that sales of PSE had been charted at 4,346 boxes in the 3 months before the law, but at only 310 boxes for the 3 months after its passage (a 93% decline), and that sales in surrounding communities had also dropped.23 Pharmacies reported that the decreasing PSE sales were not accompanied by an increase in sales of alternative products (e.g., phenylephrine or nasal strips), a sign that the sales were not for legitimate reasons.24 

The Manufacturers’ Stance on PSE Control

The CHPA is the newer name for the Proprietary Association, the group that defended patent medicines as far back as the 1800s.25 It now bills itself as a nonprofit trade association that represents the makers of nonprescription products, dietary supplements, and homeopathic remedies (e.g., Hyland’s).26 The group stated that its mission is to “protect access to nonprescription medicines with as few barriers for consumers as reasonable.”27 It is worth observing that laws to restrict access to PSE would impact the profits of those manufacturers who produce the meth precursor. The CHPA estimated that PSE generates $500 million in sales each year in the U.S. alone, excluding sales at all Wal-Mart outlets.28 If Wal-Mart data were available to be added to the total, it would be far larger and give a more realistic indication of the massive profits made from sales of the meth precursor, and of the corresponding loss of income to the OTC manufacturers if PSE were moved to prescription status. 

The CHPA inserted itself into the Missouri PSE debate, sending a letter to the Jefferson County (Missouri) council on July 13, 2009.27 (The council had been considering a proposal to make PSE prescription only.29,30) In an attempt to determine the veracity of the manufacturers’ claims, the letter was examined closely by Rob Bovett, district attorney of Lincoln County, Oregon (also the chair of the Oregon Meth Task Force).31 In the letter, the CHPA stated that it opposed prescription PSE, but offered the alternative of funding a statewide electronic tracking system. Mr. Bovett explained that the CHPA’s solution is vulnerable to smurfing, both by criminals using multiple false IDs and also by labs that use massive numbers of smurfers, each of whom purchases lawful amounts of PSE. He referred to the CHPA’s tracking system solution as “very unfortunate for public safety, the environment, and drug endangered children” and as “a distraction from proven solutions to end smurfing.” The CHPA also complained that “the millions of people who still go through all the inconvenience of waiting in line at the pharmacy to buy PSE demonstrate that for them, PSE is their medicine of choice.” Mr. Bovett pointed out that many of those purchasers are smurfers. He also explained that Oregon’s prescription-only PSE law eliminated smurfing and drastically reduced the number of meth labs. However, states with the CHPA’s electronic monitoring system experienced a resurgence of both smurfing and meth labs. He backed up his assertions by comparing Oklahoma to Oregon. Oklahoma’s electronic monitoring system was so vulnerable to smurfing that the state suffered more meth lab incidents in May 2009 (64 incidents) than Oregon had in the last 3 years combined (61 incidents). With data such as this in hand, Mr. Bovett felt justified in concluding that the CHPA’s solution was inherently flawed and that moving PSE to prescription-only status would be the only way to control meth. 

Moving Toward a Federal Law

Given the controversial nature of the issue, some believe the answer may be a federal law that makes PSE prescription-only. Sen. Ron Wyden (D-Oregon) is reportedly planning to introduce such a law, tentatively titled the Meth Lab Elimination Act.28,32 Pharmacists who have opinions about the issue should not hesitate to contact their congressional representatives to share their views. 

PATIENT INFORMATION

What Can You Do About Nasal Congestion?

Nasal congestion is one of the most troubling symptoms of the common cold, as it affects the ability to breathe freely. In that sense, it is somewhat worse than sore throat, cough, or fever. 

Which Nasal Decongestant?

You have a choice of nasal decongestants. The one that is most readily available is known as phenylephrine, found in such products as Sinutab Sinus, Sudafed PE, and SymptomPak. Other patients may prefer pseudoephedrine, but the drug has some issues and problems associated with its use. While it is effective at decongesting the nasal passages, it is also the preferred starter chemical for making methamphetamine (meth). For this reason, pseudoephedrine has been available only behind the pharmacy counter since a national law was enacted in 2006. Even with that law, meth lab operators have found creative ways to obtain enough pseudoephedrine in order to make the addictive and destructive drug. Thus, some states and towns have enacted state or local laws that make pseudoephedrine available only by prescription. One U.S. senator has stated that he will pursue a national law. Pseudoephedrine is found in such products as Sudafed, Claritin-D, and Zyrtec-D. 

Are Combination Products Best?

Some manufacturers combine several ingredients in the same product, such as Tylenol Sinus Severe Congestion. It contains pseudoephedrine, but if you use it, you also get guaifenesin for cough and acetaminophen for pain in the same caplet. This product assumes that you always have cough and pain when you have nasal congestion, which might not be true. You should only use it when you have all three symptoms. Thus, it is not suitable for the patient who only has nasal congestion. 

Are Single-Ingredient Products Best?

Many patients are turning away from fixed-combination products to single-ingredient products, as these allow you to be more selective in treating only the symptoms that you have at that time. Thus, to get the best treatment of cold or flu, you might have one bottle each of pseudoephedrine or phenylephrine to treat the nasal congestion; acetaminophen (e.g., Tylenol) to treat the aches and fever; guaifenesin (e.g., Robitussin Chest Congestion) to treat a productive cough; dextromethorphan (e.g., Delsym) to treat a nonproductive cough; and chlorpheniramine (e.g., Chlor-Trimeton) or loratadine (e.g., Claritin) to treat runny nose and sneezing. If you prefer, you may purchase five of these ingredients in a new product known as SymptomPak, with individual containers of phenylephrine, acetaminophen, guaifenesin, dextromethorphan, and chlorpheniramine. Refills can be obtained when one bottle is depleted. 

What About Nasal Strips?

Some people find that nasal strips (e.g., Breathe Right Nasal Strips) allow them to breathe more easily when they are congested. Patients are instructed to clean and dry the bridge of the nose, remove the adhesive backing from the strip, apply it to the bridge of the nose, and use a few seconds of firm pressure to make a more secure bond before releasing it. The strips act to gently pull the nostrils open, making breathing easier. A newly introduced product (Breathe Right Extra) claims to be even more effective. 

Remember, if you have questions, Consult Your Pharmacist. 

REFERENCES

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To comment on this article, contact rdavidson@uspharmacist.com.

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