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Balancing Access with the Need to Prevent Abuse
The nasal decongestant pseudoephedrine (PSE) has a long history of use as an effective OTC treatment for the relief of nasal congestion due to the common cold, hay fever, or other respiratory allergies. However, because traditional PSE formulations may be easily converted to methamphetamine (meth), PSE has also been diverted for abuse. In an effort to prevent illegal meth synthesis, in 2005, the US government passed the Combat Methamphetamine Epidemic Act (CMEA) to restrict the quantity of PSE sold at retail. The CMEA requires pharmacies to store PSE behind the counter, check photo ID for all purchasers, and record the names and addresses of all purchasers.1,2 To help pharmacists and law enforcement track nationwide PSE sales and to prevent criminals from obtaining large quantities of PSE, the National Precursor Log Exchange (NPLEx; a multistate, real-time electronic tool) was developed.3
Despite these efforts, the illegal manufacture and use of meth continues.1,4 As of July 2014, law enforcement agencies have identified and seized the contents of almost 6000 illegal meth laboratories.5 According to data from the Substance Abuse and Mental Health Services Adminstration’s National Survey on Drug Use and Health, meth use is on the rise, with over 100,000 more people using meth in 2013 than in 2012.4 Although the sale of PSE is currently restricted to small amounts, meth makers may simply enlist a greater number of people to purchase PSE to amass adequate quantities. Many operations have adopted a practice known as “smurfing,” which involves the use of multiple purchasers with multiple identities to circumvent purchasing restrictions and obtain large quantities of PSE. Furthermore, anti-meth legislation may have had unintended consequences. As large-scale labs were shut down due to PSE sale restrictions, smaller-scale clandestine labs proliferated. The smaller labs may be more dangerous than their larger counterparts, as they may be more difficult to locate and can be associated with even greater potential for collateral damage caused by fires and toxic waste in highly populated local communities.1 Meth abuse is also associated with social costs, including health care, drug treatment, and child endangerment.6
Restricted access to PSE is an inconvenience for legitimate customers, and product formulations that have substituted other decongestants, such as phenylephrine (PE), in place of PSE have not been well accepted. Many patients prefer PSE, as suggested by reports of dissatisfied patients who returned PE products to the pharmacy.7 Pharmacists also overwhelmingly prefer PSE to PE, and perceive PSE as more effective than PE.8
Tamper-Resistant Technology to Combat Illegal Manufacture of Methamphetamine
Recent efforts to restrain the illegal use of PSE include the development of tamper-resistant formulations of PSE by pharmaceutical companies. Such formulations have been developed using technology that helps deter the use of PSE in manufacturing meth by limiting the extraction of PSE. Formulations of PSE that incorporate tamper-resistant technology can substantially limit the supply of a key ingredient used in the manufacture of illicit meth, while ensuring that patients who need PSE to control nasal congestion symptoms continue to have access to PSE.1
Some pharmacies have voluntarily begun to stock solely tamper-resistant PSE products, such as NEXAFED Nasal Decongestant tablets, resulting in substantially reduced meth manufacturing in their communities. More recently, to deter illegal use of PSE, major retailers such as Rite Aid, CVS Health, and Walgreens have discontinued stocking conventional single-ingredient PSE formulations altogether in West Virginia and bordering communities, replacing them with meth-resistant formulations like NEXAFED.9 This practice is an innovative way to help deter the production of meth while continuing to provide access to PSE for use as a decongestant by patients in need.
Community Experience with NEXAFED
According to reports from various communities in the United States, offering tamper-resistant forms of PSE as the sole option for purchasing PSE in local pharmacies has resulted in impressive decreases in meth production. For example, after NEXAFED became the only form of PSE available in the local pharmacies of 2 counties in Tennessee, law enforcement officials reported an 88% reduction in meth production labs in Campbell county and 90% fewer labs in Scott County.10 Similar findings were reported in West Virginia, where a 40% reduction in meth lab seizures was reported after a substantial number of retailers replaced conventional PSE product formulations with tamper-resistant products such as NEXAFED.11 In West Virginia, the Kanawha County Commission Substance Abuse Task Force advocates restricting the sale of OTC PSE to tamper-resistant PSE products only.12
NEXAFED incorporates IMPEDE technology (an advanced polymer matrix) to help prevent the illicit manufacture of meth by preventing or disrupting the extraction of PSE. During laboratory tests, attempts to extract pure, crystalline PSE hydrochloride from NEXAFED tablets led to the formation of a thick gel, effectively disabling several methods of extraction. In a series of 1-pot synthesis attempts using PSE obtained from NEXAFED tablets formulated with the IMPEDE technology, recovery was significantly reduced versus conventional PSE tablets.1
NEXAFED is the only meth-resistant PSE product that both meets the USP standard for dissolution and has demonstrated bioequivalence to Sudafed 30-mg tablets using FDA bioequivalence standards.1,13 In a pharmacokinetic analysis, 30 healthy adults received 2 separate single 60-mg doses of PSE in the form of conventional immediate-release PSE or an equivalent dose of NEXAFED. Analysis of pharmacokinetic parameters (ie, maximum concentration [Cmax] and area under the concentration-time curve [AUC]) demonstrated bioequivalence between conventional immediate-release PSE and NEXAFED, as shown by the ratio of test to reference substance for the AUC (~96%) and Cmax (~92%), which were well within the accepted limits to establish bioequivalence of 80% to 125% (Figure).1
Role of the Pharmacist
Because NEXAFED tablets are tamper-resistant and abuse-resistant, they offer an option for pharmacists to help balance the need for patient access to PSE products while reducing the risk of illicit meth synthesis.1 Pharmacists can encourage the adoption of tamper-resistant formulations of PSE, such as NEXAFED, which result in documented reductions in local meth production and lessen the pressure to enact further prescription-only legislation that would create additional barriers to access of PSE by patients who need it.
At the time of this publication, NEXAFED was subject to the same regulations as non—tamper-resistant PSE. Therefore, NEXAFED must be stored behind the counter, and customers may not purchase more than 3.6 grams per day or 9 grams in 30 days, according to federal law.2 However, it is important that pharmacists be aware of regulations in place at their pharmacy and also of state laws that may be more restrictive.
NEXAFED, like other IR PSE tablets, are taken 1-2 tablets 3-4 times daily. Each package of NEXAFED contains 24 tablets, and the labeling for NEXAFED is consistent with labeling for existing single-ingredient immediate-release PSE products. Advise patients with heart disease, hypertension, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland to consult a physician prior to using NEXAFED. Adverse events associated with the use of PSE include nervousness, dizziness, or sleeplessness. Patients using monoamine oxidase inhibitors should not take PSE.14