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Behind-the-Counter Products: A Third Class of Drugs

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

Gabriel E. Pray, PharmD Candidate
College of Pharmacy
Southwestern Oklahoma State University

Weatherford, Oklahoma
 



9/20/2011

US Pharm
. 2011;36(9):11-15. 

The issue of a third class of drugs has been controversial since the 1980s. The inciting event for the debate was the proposed switch of ibuprofen to OTC status in 1984.1 Opponents derided the switch as being liable to cause patient harm. Many of those commenting on the 1984 situation offered an alternative to full OTC status, suggesting the drug be placed in a third class of medications to be sold only in pharmacies, often referred to as behind-the-counter (BTC) products. At the time, the concept of a third class of drugs was widely hailed as a novel idea. 

Proponents of the BTC class offered the explanation that pharmacist counseling would add another layer of safety to the transaction. Opponents (e.g., the pharmaceutical industry) were quick to assert that pharmacist counseling would not benefit the consumer in any way if a third class was adopted.1 Physicians also voiced opposition to a third class. An editorial in a dermatology journal stated: “If pharmacists wish to practice clinical medicine, they should be required to go to medical school.”2 

The issue of a third class of medications has always had its supporters and detractors. During the 1980s, both sides overlooked the fact that pharmacists had clearly demonstrated their value in controlling a third class of drugs for over half a century. The classic illustration that proved this case was that of nonprescription insulin products, and Schedule V products add credence to this point as well. 

Insulin

A U.S. government report discussing insulin’s status stated that it is a prescription product in Australia, Italy, the Netherlands, and the United Kingdom.3 Why is it available on a nonprescription basis in the United States? When the prescription legend was codified by the 1951 Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act, medications that required administration by injection, or were of such toxicity that a patient could not self-treat, were made prescription only.4 Inexplicably, insulin was exempted from these laws in the U.S. despite its clearly meeting both of those criteria.4 Perhaps the legislators wished to ensure that patients requiring insulin on an emergency basis would not be denied this life-saving medication. However, this thinking is fundamentally flawed, as public health advocates could make an argument to add medications such as epinephrine pens, asthma rescue inhalers, and a host of others to the ranks of nonprescription products. One writer suggested that insulin was continued on as a nonprescription product because patients with diabetes “generally carry the diagnosis for life.”5 For obvious reasons, this explanation is equally unsatisfactory and could apply to such diagnoses as hypertension and terminal cancer. 

Nevertheless, the fact remains that nonprescription insulins have been available only from pharmacies since their introduction in the 1920s. Wholesalers and other suppliers will not sell them to nonpharmacy outlets. Thus, they have been a valid third class of medications within the U.S. for decades. 

Insulin sales should be undertaken only by the pharmacist to ensure that the correct insulin is chosen. In one case, a pharmacy clerk served as the intermediary when a patient requested SemiLente insulin (a nonprescription insulin that was discontinued several years ago).6 The clerk told the patient there was no prescription for a “Mr. SemiLente.” The patient informed the clerk that SemiLente was not his name, but the product he wanted to purchase. At this point, the confused clerk finally turned to the pharmacist, who said, “Give him some Lente.” The patient purchased the incorrect insulin and was hospitalized, leading to a successful lawsuit against the pharmacy. Had the pharmacist been involved from the outset, it is probable that the patient would not have suffered harm. 

Schedule V Cough Syrups

Some states have created a third class of medications by allowing nonprescription sales of certain codeine-containing (C-V) products. These Schedule V products included now-discontinued anti-diarrheals such as Donnagel-PG and Infantol Pink. C-V cough preparations are sold as a third class of medications by such states as Oklahoma.7 In that state, prospective purchasers must sign a bound record book providing their name, address, and date, and a pharmacist must initial each purchase. The number of C-V cough syrups has slowly dwindled. Naldecon-CX, Robitussin AC, Novahistine-DH, and Cheracol have all apparently been discontinued, but a product known as Cheratussin AC is still available without a prescription. 

Syringes

Some jurisdictions have passed laws placing syringes in BTC status to control sales. For instance, San Francisco undertook syringe control in the 1990s to minimize the spread of HIV in the heterosexual community.8 Pharmacies registered under the program can sell or  
provide up to 10 syringes to individuals aged 18 years and above without a prescription. Syringes must be stored behind the counter, and the pharmacy must provide verbal counseling or written information regarding how to access drug treatment, how to access HIV and hepatitis screening and treatment, and how to safely dispose of used syringes. 

Pseudoephedrine

The concept of a third class of drugs had languished for years chiefly due to opposition from the FDA and those who did not want the pharmacist to be granted additional medical responsibilities. However, the rise of methamphetamine (meth) labs created an environment favorable to the third class. Pseudoephedrine (PSE) was the most widespread starter chemical for meth production. Individual states (e.g., Oklahoma) passed laws to control PSE, making it a Schedule V medication only available in pharmacies.9,10 Despite criticism from the Consumer Healthcare Products Association, such state laws quickly reduced meth availability. Congress and federal authorities saw the wisdom of the state laws and realized that a national law would also be extremely beneficial. Eventually, President George W. Bush signed the Patriot Act, which contained within it the Combat Methamphetamine Epidemic Act of 2005.9 When the Act became effective in 2006, ephedrine and PSE became a third class of drugs across the U.S. With passage of this law, pharmacists became the gatekeepers for PSE sales. While nonpharmacy personnel can handle some aspects of the transaction, the law requires hands-on approval and completion of the sale by a pharmacist. The legal limit for purchase is 3.6 g daily.9 

In the ideal situation, pharmacists would ask the same types of questions of PSE patients that should be asked of patients requesting any other group of nonprescription products prior to sale.1 For example, PSE is only appropriate for self-care of nasal congestion when it is associated with the common cold or allergic rhinitis. It would be prudent to first ask patients whether they are experiencing additional symptoms. They should mention additional symptoms that help confirm presence of the common cold (e.g., cough or sore throat) or allergic rhinitis (e.g., nasal/ophthalmic pruritus, clear rhinorrhea, tearing, or sneezing).1 Patients should not be prompted by mentioning the symptoms to them, but should be made to list symptoms on their own. If a patient cannot do so, it is best to refer him or her to a physician for diagnosis of the problem causing the nasal congestion. Patients should be asked if they have such medical conditions as fever, heart disease, thyroid disease, hypertension, diabetes, or prostate insufficiency, or whether they are pregnant or breastfeeding. If so, they should be informed that these are labeled medical contraindications for self-use of PSE, and that they should seek a physician’s advice before using the products.1 

PSE products carry a warning against self-use if the symptoms do not improve in 7 days.10 If the patient indicates that usage to this point is beyond 7 days, the pharmacist is justified in refusing the sale and referring the patient to a physician. Overuse can be uncovered by asking such questions as, “Do you find this works for you? Have you been using it recently?” If pharmacists are to be active participants in reducing the number of meth labs, asking such fundamental questions to ensure proper use of PSE becomes part of our legal responsibility. Thus, legitimizing PSE sales goes far beyond the relatively simple step of detecting overuse via electronic logbooks. Of course, those seeking PSE for illegal purposes will eventually learn the questions and formulate acceptable responses in advance, but the questions should be asked nonetheless. 

State legal authorities have acted against pharmacists and pharmacies that refuse to obey the law. Chains have been disciplined, and in at least one case, an individual pharmacist was the target of an undercover “sting” operation that seemed to confirm that PSE sales were inappropriate.11 It is telling that the first widespread acceptance of a third class was not driven by acceptance of our knowledge and advanced training, but by the need to find a way to control the increase of meth labs.

Emergency Contraceptives

Another instance in which pharmacists were granted a BTC class was with Plan B (now discontinued) and Plan B One-Step. This agent was originally approved by the FDA in 2006 as a nonprescription product for women aged 18 years and above, but is now nonprescription for those aged 17 years and above.12,13 The tablet is taken to prevent pregnancy within 72 hours of a sexual assault or rape, when a condom breaks or slips out of place, or when the woman has forgotten to take an oral contraceptive or has not used any form of birth control.14 Consumers may confuse it with the “abortion pill” (RU-486), which may be taken 4 to 7 weeks after becoming pregnant. Emergency contraceptives most often function by preventing or delaying release of the ovum from the ovaries, but may also hamper implantation of a fertilized egg. The latter point is the focus of controversy, and has caused pharmacists to refuse to stock or sell it because of their personal beliefs. 

For pharmacists who do stock the product, there are many questions. Discovering the patient’s age is critical. Should pharmacists demand a driver’s license or other proof of age? Should sales be documented in a logbook? If a young man claims that his girlfriend is 17 years old, should the pharmacist demand that the woman come in herself to present her ID? Is any government agency responsible for monitoring these sales? Should the FDA or state authorities plan sting operations in the same manner as they control underage sales of tobacco or alcohol? What are the penalties for selling the product to a 16-year-old? FDA and state Web sites are generally silent on these issues, although educational materials and guidelines can be obtained from the manufacturer.15 

Conclusion

While a third class of drugs is no longer a novel concept, it is apparent that pharmacists are in a unique position to counsel patients and improve or restrict accessibility to nonprescription drugs with BTC status. 

PATIENT INFORMATION

This third group is known as behind-the-counter or BTC medications. BTC drugs do not require a prescription, but they are not available in just any location either. Instead, you can only buy them in locations where a pharmacist is present. The pharmacist is a highly educated professional whose college years were spent learning about the body’s functions, how to recognize minor medical conditions, when to refer you to a physician, and the uses of medications. 

Why Do These Medications Require a Pharmacist?

The reason you must visit a pharmacist before purchasing these BTC products varies with the specific item. For example, insulin is too dangerous to allow its sale by those without a pharmacy degree, as even a small overdose can lead to deadly insulin shock. In some states, codeine-containing cough syrups are available in the BTC category. 

Pseudoephedrine

You may be aware that certain cold products are not available except from a pharmacy. These BTC products all contain pseudo-ephedrine (PSE), a safe and effective nasal decongestant found in such products as Sudafed and in combinations like Allegra-D and Claritin-D. However, illegal drug lab operators found that PSE could be used as a starting element to make methamphetamine (meth). They began to buy PSE in large quantities, many times from nonpharmacy outlets such as convenience stores. 

To help control the growing problem of meth, state and federal authorities decided to pass laws that would restrict sales to pharmacies. Purchasers must show photo identification, have their transaction logged, and are subject to daily and monthly limits. 

Pharmacists were chosen as the critical gatekeepers for PSE sales because they have the knowledge to determine whether sales are legitimate. They may ask you about such issues as other symptoms of a common cold to ensure that you have a medical need for a proposed purchase of PSE. If the pharmacist is not convinced that you have a legitimate need for PSE, he or she may ask you to visit a physician to determine whether a prescription product is more appropriate. 

Emergency Contraceptives

You may also have heard about Plan B One-Step, a “morning after” hormone tablet that can be taken after unprotected sex to help prevent an unwanted pregnancy. It is available on a BTC basis for those aged 17 years and above. For younger patients, a prescription is required. In this case, pharmacists were again chosen to be the point of control to make sure that those too young to obtain an emergency contraceptive would see a physician instead of using it on their own. 

Pharmacy Request Cards

If you have any questions regarding nonprescription drugs or products that are only available BTC, your pharmacist will be there to address any concerns. Some pharmacies even provide pharmacy request cards in the aisle that you can bring up to the counter to help facilitate the sale. 

REFERENCES

1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
2. Lober CW. The pharmacist physician. J Am Acad Dermatol. 1985;13:817-8178.
3. Nonprescription drugs: considerations regarding a behind-the-counter drug class. U.S. Government Accountability Office. February 2009. www.gao.gov/htext/d09245.html. Accessed July 28, 2011.
4. Pray WS. A History of Nonprescription Product Regulation. New York, NY: Haworth Press, Inc; 2003.
5. Fenichel RR. Which drugs should be available over the counter? BMJ. 2004;329:182-183.
6. Simonsmeier LM. Insulin sales result in injuries. Legal Aspects Pharm Pract. 1987;19:10-12.
7. 2010 Oklahoma Pharmacy Law Book. Oklahoma State Board of Pharmacy. December 2010. www.ok.gov/OSBP/documents/
law10.pdf. Accessed July 28, 2011.
8. Syringe access and disposal programs. San Francisco Department of Public Health, HIV Prevention Section. http://sfhiv.org/syringe.php. Accessed July 28, 2011.
9. Pray WS. The meth crisis: new federal law should help. US Pharm. 2006;21(10):16-23.
10. Pseudoephedrine. www.drugs.com/pseudoephedrine.
html. Accessed August 22, 2011.
11. Pray WS. Pseudoephedrine: stricter controls in the future? US Pharm. 2010;35(1):17-20.
12. FDA approves over-the-counter access for Plan B for women 18 and older. FDA News Release. August 24, 2006. www.fda.gov/NewsEvents/
Newsroom/PressAnnouncements/ 2006/ucm108717.htm. Accessed July 28, 2011.
13. Plan B (0.75 mg levonorgestrel) and Plan B One-Step (1.5 mg levonorgestrel) tablets information. FDA approves Plan B One-Step emergency contraceptive. August 26, 2010. www.fda.gov/drugs/drugsafety/
postmarketdrugsafetyinformatio nforpatientsandproviders/ ucm109775.htm. Accessed July 28, 2011.
14. Emergency contraception. MedlinePlus. www.nlm.nih.gov/medlineplus/
ency/article/007014.htm. Accessed July 28, 2011.
15. Plan B One-Step. www.planbonestep.com. Accessed August 22, 2011.
16. Plan B One-Step. www.drugstore.com. Accessed July 28, 2011. 

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

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