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INTRODUCTIONMethamphetamine production and abuse has become a

worsening public health problem over the past five years in Alabama. Readily available precursors, new production techniques, and high market price have increased demand for the drug over the past few years. Alabama, in cooperation with federal agencies, has taken action to try and curb the production of methamphetamine. This paper is designed to discuss the severity of the problem currently in Alabama, the new methods of hindering methamphetamine addicts and producers from obtaining precursors, and to inform pharmacists of their role in halting illegal methamphetamine production.

METHAMPHETAMINE HISTORY AND ABUSE RATESMethamphetamine HCl, also known as desoxyephedrine, was

approved by the FDA on December 31,1943 and is still available under the brand name Desoxyn® and is indicated to treat ADHD in children and refractory obesity.1,2 Over the years it has been used to keep fighter pilots awake in World War II, as a nasal decongestant in the 1930s, and also as a drug to treat depression.3 In the United States it has been associated with outlaw motorcycle gangs, which is where the street name “crank” originated. The motorcycle gangs would keep the methamphetamine in the crank cases of their motorcycles to hide it from law enforcement. Although methamphetamine has legitimate uses in the medical world, it is one of the most abused controlled substances in the United States.4 Methamphetamine causes an intense short rush after smoking or injection similar to cocaine, however when taken orally it can produce a long-lasting high for up to 12 hours.5 Methamphetamine produces this high by releasing large amounts of dopamine into areas of the brain that regulate

pleasure. Long term use can lead to hallucinations, delusions, paranoia, and aggression.

According to the 2008 National Survey on Drug Use and Health five percent (12.6 million people) of the U.S. population 12 years and older reported using methamphetamine at least once. The methamphetamine abuse problem in Alabama has steadily been getting worse.4 The National Meth Center reports that nationally, around 6.1% of drug treatment admissions list methamphetamine as their primary drug of choice.5 Alabama averaged above this number in 2009 and 2010, with rates being 7.7% and 8.9%, respectively.5 The DEA has provided the approximate number of methamphetamine producing laboratories busted, and the numbers indicate that the amount of methamphetamine being produced has been on the rise over the past five years. There has been a dramatic increase in the number of labs discovered, which can be seen in Table 1.

PRODUCTION OF METHAMPHETAMINEPseudoephedrine can be used to make the powder, crystalline,

or liquid forms of methamphetamine. Pseudoephedrine from common cold products is the primary source used to produce methamphetamine domestically. The single ingredient tablets are the preferred dosage form to make methamphetamine, but

Pseudoephedrine Abuse in AlabamaGregory Guin, Pharm.D., Sean Heironimus, Pharm.D., and Allen Long, Pharm.D.

Harrison School of Pharmacy, Auburn University

corresponding author:Wesley T. Lindsey, Pharm.D., Assistant Professor of Pharmacy Practice

Drug Information and Learning Resource Center, Harrison School of Pharmacy, Auburn UniversityUniversal Activity #: 0178-0000-12-103-H04-P | 1.0 credit hours (0.1 CEUs) | Expires June 18, 2015

PROGRAM OBJECTIVESAfter completing this program, the participant will be able to:

• Discuss the abuse rate of methamphetamine in Alabama.• Discuss the different production methods of methamphetamine.• Review the current pseudoephedrine laws that are in place in Alabama.

Year 2006 2007 2008 2009 2010

# of labs discovered in AL 205 216 605 614 666

Table 1: Pharmacotherapy of Gout

Acute Gout TherapyDrug Dose Regimen(s)

[PO unless noted]Adverse Drug Reactions Comments

NONSTEROIDAL ANTIINFLAMMATORY DRUGS (NSAIDs)Ibuprofen (eg, Advil, Motrin)

800 mg QID GI bleeding/irritation, renal dysfunction

Cautions for GI bleeding/gastritis, other bleeding, renal dysfunction, fluid retention, hypertension, CHF, asthma, elderly.These are the most common NSAIDs, any in the class can be effective.

Prophylactic Dosing:Lowest effective dose 1-2 times daily, 2-6 for weeks to months.

Indomethacin* (eg, Indocin)

25-50 mg QID for 3 days; then BID for 4-7days.

Naproxen* (eg, Naprosyn)

500 mg BID for 3 days; then 250-500 mg QD for 4-7 days.

Sulindac* (eg, Clinoril) 200 mg BID for 7-10 days.

COLCHICINESColchicine (Colcrys)

[only approved product on the market]

1.2 mg (2 tablets) at the first sign of a goutflare followed by 0.6 mg (1 tablet) one hour later.

0.5-0.6 mg Q hour until ADRs (usually N/V, diarrhea) or 6-8mg. [ADRs 50-80%; rarely recommended]

Primary ADRs are GI (nausea/vomiting/ diarrhea).

Myopathy, neuropathy, dermatitis, alopecia.

Severe overdose can result in myelosuppression, kidney and liver damage and CNS effects.

Drug Interactions:CYP3A4 inhibitors (eg, macrolides, cyclosporine) ↑colchichine.

The “low dose” approach is currently favored.

Reduce dose in liver and renal dysfunction.

Most effective within 24 hours of attack; ineffective >48 hr.

IV form not available but rarely used due to toxicity and deaths.

Prophylactic Dosing:0.6 mg 1-2 times daily in adults >16 years of age. Max. dose 1.2 mg/day. Generally for 6 months.

CORTICOSTEROIDSPrednisone (or equivalent)

40-60 mg QD for 3 days; decrease by 10-15 mg /day Q 3 days to discontinuation.

Avoid long term use.Hyperglycemia.Hypertension.Infections.GI bleeding.CNS disturbances.

Useful when NSAIDs are inappropriate.Preferred for polyarticular gout.Avoid long-term use.Caution in diabetes,

Methylprednisolone 100-150 mg QD for 1-2 days.

TABLE 1

NUMBER OF LABS BETWEEN 2006-2007

quiz on page 60-61

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TABLE 3

RESISTANCE TESTING

it can also be made from combination products, liquids, or gel caps. Liquids and gel caps are typically not used due to requiring a more difficult process and a low yield with low purity.7 The crystalline form, also known as “ice” or “crystal meth”, is a more potent smokable form of methamphetamine, and can be produced in the same way as the powder with an added step. Liquid methamphetamine is the newest form of methamphetamine and has been discovered in tequila bottles and windshield washer reservoirs being brought across the border with Mexico.8 It is a clear yellowish liquid, which can be boiled down to the powder or crystalline form, once it is smuggled into the U.S.

According to the U.S. Department of Justice, methamphetamine availability in the U.S. increased from 2008-2009, while cost decreased and purity increased.9 Production by drug cartels in Mexican super labs which can produce at least 10 pounds of methamphetamine per cook, currently dominates the market and continues to grow due to restrictions on the sale of pseudoephedrine in the United States.9 According to the Drug Enforcement Administration, most of the methamphetamine produced in Mexico is performed using the phenyl-2-propanone (P2P) method, which uses P2P as the precursor, due to restrictions on pseudoephedrine in Mexico.9 Clandestine labs have traditionally been the main way that methamphetamine is produced in the Southeast and poses a great threat due to the hazardous chemicals used in production. Small labs use pseudoephedrine as the precursor to make methamphetamine using one of three methods: the red, white, and blue method; the Nazi method or Birch reduction; or the “shake and bake” or one pot method. All of these recipes are widely available on the internet and can be performed with minimal knowledge of chemistry. The red, white, and blue method gets its name from the red phosphorus, white pseudoephedrine, and blue iodine used in the reaction. The Nazi method requires sodium or lithium and anhydrous ammonia which react violently with each other and produce an extreme amount of heat. Each method requires different chemicals to complete the reaction of pseudoephedrine to methamphetamine with the “shake and bake” method being the most simple and popular due to the ability to conceal the lab. This method can be easily performed in a small soda bottle while driving down the road or out in the woods. A small soda bottle is much easier to conceal than a small laboratory and if the person is discovered by law enforcement, it does not give away the entire lab.

The reaction to convert pseudoephedrine to methamphetamine is relatively simple due to the similar structure of the two compounds.

Common chemicals required in the conversion process are

methanol, acetone, ether, hydriodic acid, lithium, muriatic acid, red phosphorus, sodium hydroxide, sulfuric acid, and toluene.10 Watching for individuals who purchase common chemicals used in the manufacturing process along with pseudoephedrine may be a way to detect illegitimate purchasers of pseudoephedrine. Everyday products containing these chemicals can be seen in Table 2 and can be purchased at most variety stores. The potential hazard of clandestine labs is that the waste from the labs is very toxic to humans and the environment and the gases produced are highly flammable and explosive. Some signs that a methamphetamine lab may be present in a residence are unusual odors, lots of trash (chemical containers, coffee filters, match boxes), windows covered with aluminum foil or black cloth, frequent visitors, and excessive security.12 Toxic waste is a large part of the manufacturing process: with each pound of methamphetamine made using pseudoephedrine, six pounds of waste are generated.10 For an updated list on property where clandestine labs have been found by state and county authorities go to www.dea.gov and search for National Clandestine Laboratory Register.

CURRENT PSEUDOEPHEDRINE LAWSPseudoephedrine is currently a listed precursor chemical

per section 20-2-181 of the Code of Alabama.13 The Code of Alabama defines a listed precursor chemical as “any chemical substance that in addition to legitimate uses is used in the unlawful manufacture of a controlled substance”. Examples of other listed precursor chemicals are ephedrine, ergotamine, hydriodic acid, methylamine, phenylpropanolamine, and piperidine. This designation requires special monitoring and sales procedures for pseudoephedrine. Current laws apply to any product that contains 30 mg or more of pseudoephedrine and is not being sold due to a legitimate prescription. Any product that contain 30 mg or more of pseudoephedrine must be sold in blister packages and must be stored behind the counter where the public is not permitted, or in a locked display case where a customer must ask for employee assistance. No more than 3.6 grams of pseudoephedrine can be sold to a single customer per calendar day or more than 9 grams per 30 days. Any person buying pseudoephedrine must be at least 18 years of age, provide a government issued photographic identification, and sign a record of the transaction.

According to Act 2010-215 amending section 20-2-190 of the Code of Alabama, as of January 1, 2011 any retailer wishing to sell pseudoephedrine, whether a pharmacy or a non-pharmacy business registered with the Alabama Alcoholic Beverage Control Board, must use the National Precursor Log Exchange (NPLEx) system. The NPLEx is provided to retailers and law enforcement agencies for free through the National Association of Drug Diversion Investigators (NADDI). The system creates an electronic record for each attempted purchase of OTC cold and allergy medications containing pseudoephedrine in Alabama through the National Precursor Log Exchange system. This information then

*taken from http://www.pharmgkb.org/index.jsp

Methamphetamine Pseudoephedrine

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TABLE 3

RESISTANCE TESTING

is transferred to the NPLEx database, where it can then only be reviewed by law enforcement agencies. Pharmacies may only access the information that their specific store has entered, so they do not have access to the entire database.

This new system still requires the purchaser to be at least 18 years of age, present a government issued photographic identification, and sign a record of the transaction; however, it logs sales throughout Alabama in real time.14 The NPLEx hopes to cut down on “smurfing”, which is when a group of people go from one store to another buying the maximum legal amount of pseudoephedrine at each store in order to obtain enough to cook methamphetamine. The NPLEx logs the name and address of the patient, the time and date of the sale, the name of the product, the total quantity (in grams) of pseudoephedrine contained in the transaction, and the total amount purchased by the individual in 30 days. If the patient exceeds the limit of 3.6 grams/day, or 9 grams/30 days, the system will issue a “stop-sale” alert. If a “stop-sale” alert is generated, the seller should not complete the sale unless they fear of bodily harm if they do not complete the sale. Any person who overrides the “stop-sale” alert without fear of bodily harm is guilty of a Class C misdemeanor for the first offense, which can include up to three months in jail and up to a $500 fine, a Class A misdemeanor for the second offense, which can include up to one year in jail and up to a $6,000 fine, and a Class C felony for each subsequent offense, which includes up to 10 years in prison and a maximum of a $15,000 fine.15 The owner or operator of a store cannot be penalized for conduct of an employee as long as he or she documents employee training either conducted or approved by the Alabama Drug Abuse Task Force. If a store selling pseudoephedrine in compliance with the previous laws experiences a mechanical or electronic malfunction, the store can continue to sell pseudoephedrine by maintaining a written log or an electronic record until they are able to comply with the previous laws. Any store in compliance with the previous laws may submit an exemption from submitting to the NPLEx to the Alabama Alcoholic Beverage Control Board stating the reason why they are seeking exemption. The Board may grant an exemption for a maximum of 180 days. The retailer must still maintain a log of transactions and each purchaser must meet the sales requirements as mandated by law.

Currently 1,042 pharmacies in Alabama (approximately 97%) have registered with the NPLEx. As of March 31, 2011, only 41 of the 4,351 non-pharmacy businesses that sell products with pseudoephedrine were registered with the NPLEx system.14 Many of these that have not registered with the new system have notified the task force that they no longer intend to sell OTC medications containing pseudoephedrine.

CURRENT STATE OF PSEUDOEPHEDRINE SALESIn a statement released by the Alabama Drug Abuse Task

Force, as of April 12, 2011, the new electronic system used to track OTC sale of products containing pseudoephedrine, issued a “stop-sale” alert and blocked a total of 26,354 purchases.14 This

represents a total of over 64,000 grams of pseudoephedrine. The task force also released that 399,345 sales, with approximately 829,875 grams of pseudoephedrine, were purchased legally during the same time frame. The Drug Abuse Task force estimates that using the current methods of manufacturing methamphetamine, 1 gram of ephedrine or pseudoephedrine can manufacture 1 gram of methamphetamine. This means that approximately 64,000 grams of methamphetamine were kept off of the streets in the first three months of 2011, thanks to the implementation of this new electronic system. The current street value of methamphetamine is approximately $150/gram, meaning that $9.6 million of methamphetamine was prevented from entering our society.14

CURRENT STATE OF PSEUDOEPHEDRINE SALESIn a statement released by the Alabama Drug Abuse Task

Force, as of April 12, 2011, the new electronic system used to track OTC sale of products containing pseudoephedrine, issued a “stop-sale” alert and blocked a total of 26,354 purchases.14 This represents a total of over 64,000 grams of pseudoephedrine. The task force also released that 399,345 sales, with approximately 829,875 grams of pseudoephedrine, were purchased legally during the same time frame. The Drug Abuse Task force estimates that using the current methods of manufacturing methamphetamine, 1 gram of ephedrine or pseudoephedrine can manufacture 1 gram of methamphetamine. This means that approximately 64,000 grams of methamphetamine were kept off of the streets in the first three months of 2011, thanks to the implementation of this new electronic system. The current street value of methamphetamine is approximately $150/gram, meaning that $9.6 million of methamphetamine was prevented from entering our society.14

WHAT CAN BE DONEPharmacists can play a unique role in limiting the

amount of pseudoephedrine that is sold to questionable buyers. Pharmacists and pharmacy technicians are the main gateway which illegitimate purchasers must go through in order to acquire pseudoephedrine. Pharmacists can get involved in the process by not letting technicians handle all of the pseudoephedrine sales. If the pharmacist recognizes that the person comes in every month to buy the legal limit and does not exhibit signs of a cold or allergies, then they can refuse to sell the pseudoephedrine to the person. Other states have recognized that even increased monitoring systems will not prevent pseudoephedrine abuse and have created laws requiring a prescription from a doctor to buy pseudoephedrine. Mississippi and Oregon are the only states in the United States that have prescription pseudoephedrine laws. The Oregon Board of Pharmacy adopted a rule requiring a prescription for all pseudoephedrine products on July 1, 2006.16 There were 473 meth labs discovered in 2003, 448 in 2004, 192 in 2005, and 48 in the first 6 months of 2006. Since the law went into effect there were only 15 labs shut down from July-December

AL ABAMA PHARMACY ASSOCIATION SUMMER 201256

of 2006, 20 in 2007, 21 in 2008, and 26 in 2009-2010 combined. The initial drop in busts between 2005-2006 was due to requiring pseudoephedrine products to be kept behind the counter and logging each sale. Since the state required a prescription for pseudoephedrine the meth lab busts have drastically dropped compared to when the state required products to be kept behind the counter and logging each sale. Mississippi’s law requiring a prescription for all pseudoephedrine products went into effect on July 1, 2010. Two hundred and three meth labs were found from July 2010 to February 2011 which was a decrease of about 70% from the 607 busted in July 2009 to February 2010.17 Ninety-eight percent of the meth labs found since July 2010 were operating with pseudoephedrine purchased from other states. Legislators from other states such as Missouri, West Virginia, and Oklahoma have initiated bills to require a prescription for all

pseudoephedrine products.18,19,20 Requiring a prescription for all pseudoephedrine products can increase the price of care for patients who rely on pseudoephedrine to treat their allergies.

CONCLUSIONMethamphetamine has been, and continues to be, a problem

in Alabama. With the new NPLEx system now in place, precursor acquisition has been reduced, as evidenced by the number of patients denied access to pseudoephedrine products in the first three months of 2011. But the NPLEx system is only part of the solution; the pharmacists of Alabama must also be able to recognize and report problems as well. Without proactive pharmacists, methamphetamine use in Alabama could continue to rise or the Alabama legislature could follow the examples of Oregon and Mississippi to further restrict patient access to pseudoephedrine.

*taken from http://www.kci.org

Typical Chemicals Found

in Lab Sites

Common Legitimate Uses Poison Flammable Toxic Vapors Explosive Corrosive Common Health

Hazards

Acetone Fingernail polish remover, solvents X X X Reproductive disorders

Methanol Brake Cleaner fluid, fuel X X X Blindness, eye damage

Ammonia Disinfectants X X X Blistering, lung damage

Benzene Dye, varnishes, lacquers X X X X Carcinogen, Leukemia

Ether Starters fluid, anesthetic X X X Respiratory Failure

Freon Refrigerant, propellants X X X Frostbite, Lung damage

Hydriodic Acid Driveway cleaner X X X Burns, Thyroid Damage

Hydrochloric Acid(HCL Gas)

Iron ore processing, mining X X X Respiratory, Liver

Damage

Iodine Crystals Antiseptic, Catalyst X X X X Birth Defects, Kidney Failure

Lithium Metal Lithium batteries X X Burns, Pulmonary Edema

Muriatic Acid Swimming pool cleaners X X X Burns, Toxic Vapors

Phosphine Gas Pesticides X X Respiratory Failure

Pseudoephedrine Cold medicines X Abuse: Heart Damage

Red Phosphorus Matches, fireworks X X X X Unstable, Flammable

Sodium Hydroxide Drain cleaners, lye X X X Burns, Skin Ulcers

Sulfuric Acid Battery Acid X X X Burns, Thyroid Damage

Toluene Paint, thinners, solvents X X X X Fetal Damage, Pneumonia

TABLE 2

CHEMICALS FOUND IN LABS

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CE quizzes WILL NOT be accepted. Mail to: APA,1211 Carmichael Way, Montgomery, AL 361063. CE processing is free for APA members. Non-members must include a processing fee of $20 per quiz. 4. No more than 3 quizzes will be accepted per month per individual.5. Credit will be awarded for a passing grade of 80% or better. If you fail the exam, you may retake it once, and corrected

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CO NTI N U I N G ED U CATI O N

Continuing Education

quiz inform

ation

AL ABAMA PHARMACY ASSOCIATION SUMMER 201260

1. How much methamphetamine can be manufactured from 1 gram of pseudoephedrine?a. 0.5 gramsb. 0.75 gramsc. 1.0 gramsd. 0.25 grams

2. Of the following options, which is not included in the database once a person purchases a product containing ephedrine or pseudoephedrine?a. Patients addressb. Total quantity (in grams) purchasedc. Patients phone numberd. Time and date of purchase

3. Which of the following have access to the ENTIRE NPLEx system?a. Pharmacistsb. Patientsc.LawEnforcementd. A and C are correct

4. The manufacture of 1 pound of methamphetamine produces approximately how many pounds of waste?a. 1 poundb. 3 poundsc.6poundsd. 10 pounds

5. The NPLEx System for tracking the sale of pseudoephedrine is provided for:a. A yearly subscription feeb. Free to law enforcement agenciesc. Free to Retailersd. B and C are correct

6. What is the brand name of Methamphetamine HCl currently on the market?a. Dexedrine®b. Desoxyn®c. Adipex-P®d. Adderall®

7. What is the precursor mainly used to produce methamphetamine by drug cartels in Mexico?a. Pseudoephedrineb. Ephedrinec. Phenyl-2-propanoned. Coca

8. What is the maximum amount of pseudoephedrine that can be purchased in 1 calendar day?a. 3.3 gramsb.3.6gramsc. 4.0 gramsd. 2.8 grams

9. What is the maximum amount of pseudoephedrine that can be purchased in 30 days?a. 7 gramsb. 8 gramsc. 9 gramsd. 10 grams

10. Which of the following is not a common method of making methamphetamine?a. Nazi Methodb. Shake and Bake Methodc. Allied Methodd. Red, White, and Blue Method

11. Which of the following is the preferred pseudoephedrine product for making methamphetamine?a.Liquidproductsb. Multiple ingredient tabletsc. Gel capsulesd. Single ingredient tablets

12. True or False. The street value of 1 gram of methamphetamine is approximately $150.

13. True or False. The sale of pseudoephedrine after a “stop-sale” notice is received is considered a class A misdemeanor for the first offense.

14. True or False. If a patient picks up a prescription medication that has contained pseudoephedrine, you are still required to scan this into the NPLEx system.

15. True or False. According to recent data methamphetamine lab busts are on the rise.

16. True or False. Methamphetamine use in Alabama is lower than the national average.

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CONTINUING EDUCATION QUIZ - PSEUDOEPHEDRINE | ACPE#: 0178-0000-12-103-H04-P

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2. A B C D

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