National Consumers League


NCL Health Issues

Behind-the-counter drug class good for consumer

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Consumers today are taking a more active role in their health care and self-diagnosing and self-medicating with over the counter medications, as well as dietary supplements and herbals. Historically NCL has been in favor of a "behind-the-counter" drug class to increase patient access to those medications they can safely use, after consultation with a pharmacist, to self-treat conditions they can self-diagnose. A BTC class would expand the range of conditions that patients can self-treat without spending time or money on a doctor’s visit. NCL's Rebecca Burkholder recently testified before the Food and Drug Administration about why and how NCL would support a new BTC class of drugs.


Testimony of the National Consumers League to the Food and Drug Administration Public Hearing on Behind the Counter Drugs

DOCKET NO. 2007N – 0356
Rebecca Burkholder

November 14, 2007

The National Consumers League (NCL) is a private, nonprofit advocacy group representing consumers on marketplace and workplace issues. We are pleased to be able to comment today on the concept of behind the counter (or BTC) availability of drugs. For years NCL has been in favor of a third class of drugs, where certain drugs would be placed behind the pharmacy counter and only available with the intervention of a pharmacist. NCL believes that this class of drugs could improve access for patients, but we have numerous concerns about how such a system will work safely and effectively. We will be including those concerns, as well as how BTC could benefit consumers, in our comments today. Our comments are focused around several of the questions posed in the Federal Register.

Question 1 – Should there be BTC availability of certain drugs products and why?

Historically NCL has been in favor of a BTC drug class to increase patient access to those medications they can safely use, after consultation with a pharmacist, to self-treat conditions they can self-diagnose. Consumers today are taking a more active role in their health care and self-diagnosing and self-medicating with over the counter medications, as well as dietary supplements and herbals. A BTC class would expand the range of conditions that patients can self-treat without spending time or money on a doctor’s visit. Quality pharmacy consultation would be critical to ensuring that the appropriate medication is selected and taken safely and effectively. While a BTC class would appear to benefit consumers by giving them greater access, questions remain – such as, which drugs should be in this class? How will pharmacists counsel patients? Because of the many questions regarding how a BTC class system would work, we support the suggestion put forth by Consumers Union that FDA should first test the BTC concept in a couple of states.

Questions 2, 9 and 11 on the impact of BTC on patient access and cost

A BTC class would likely increase access to medications for consumers since they would not have to obtain a doctor’s prescription for the medication. For the 47 million consumers without health insurance, a BTC class would increase their options for self treatment without the added expense of a doctor’s visit. We also need to remember that underserved and rural communities do not always have access to a pharmacy, and thus less access to BTC drugs.

Regarding the cost of BTC drugs, for consumers with insurance, a drug switched from prescription to BTC could mean the loss of insurance coverage for that drug. Thus, there may be additional costs for these consumers, if they now must pay the entire cost of the drug. But the consumer would also save the cost of a doctor’s visit, the co-pay for the medication, and the time spent in the waiting room. To ensure that costs are not shifted to the consumer, we suggest that when a drug moves from prescription to BTC, the insurance coverage stays the same.

Concerns about privacy regarding medications may also impact access because most pharmacies do not have private places to talk to the pharmacist. Some patients may not feel comfortable receiving counseling from a pharmacist for a BTC medication, such as oral contraception. If counseling is required, some patients may forgo the treatment due to embarrassment or feeling uncomfortable receiving counseling in a non-private area from a pharmacist they do not know For other consumers access would increase since it will be easier for them to purchase oral contraception at a local drug store, without the expense and hassle of a doctor’s visit. Establishment of a truly private pharmacy counseling area should be required for a BTC class to ensure that access would increase, and not decrease.

Question 5 – on the role of the pharmacist, including counseling and monitoring.

Clearly, the role of the pharmacist is critical to ensuring the safe and effective use of BTC drugs. We know that consumers do NOT always read the labels of OTC products they purchase, and over a quarter have trouble reading and understanding the label. Thus, the pharmacist should be available to provide one-on-one private counseling, to ensure consumers understand the appropriate use of BTC medications.

However, pharmacists are not always available for counseling, or the line at the pharmacy counter is too long, and time short. And many times consumers sign away their right to counseling, without even knowing what they are signing. We know from experiences in other countries with a BTC or pharmacy class of drugs that counseling is not always engaged in or complete. A 2004 study of Australian pharmacy counseling found that the majority of time the advice given was “poor” and questions were not asked to ensure that the medication discussed was appropriate. Also of note was that often the first contact for the consumer was the pharmacy assistant, not the actual pharmacist.[1] In a 2002 study of New Zealand pharmacies, consumers often found it difficult to distinguish between the pharmacist and other assistant staff. Consumers were able to confirm that a pharmacist was definitely involved in counseling in only 46% of visits. And no counseling was given at all for 10% of the consumers obtaining an anti-fungal medication (which required pharmacy intervention). [2]

In the United States, pharmacists continue to be a trusted source for consumers, and in some neighborhoods more accessible than a primary care physician, but they need to come out from behind the counter. A pharmacist’s role includes assisting consumers who have trouble reading English or need extra help to understand the drugs they are taking.

When self-medicating, consumers need assistance with diagnosing because they may not recognize the symptoms of a more serious condition and delay a necessary visit to the doctor. For example, stomach pain – gastrointestinal distress – can be a symptom of a number of medical problems. While consumers may use a proton pump inhibitor, such as Prilosec, for symptomatic relief, potentially serious GI problems may be missed because a doctor was not consulted. This underlines the need for appropriate pharmacy counseling about when consumers should consult a doctor.

For certain chronic conditions, such as high cholesterol and diabetes, pharmacists should encourage an initial physician evaluation and follow up to assess the progress of the disease. While it may be possible for pharmacists to conduct some follow up testing, (and the logistics of this would need to be worked out), there must be clear pharmacy counseling urging people to check with their physician before use and to continue to have regular visits while taking the medication. A few years ago, with the possible switch of a low-dose statin medication to OTC status, NCL was concerned that consumers would not consult their doctors before or during the use of an OTC statin. Based on a survey we commissioned, consumers overwhelmingly demonstrated their willingness to continue to consult with their doctors. If FDA determines low dose statins are appropriate for a BTC class, how would pharmacists be able to ensure that patients visited their physician? Would a consumer need to document that they saw a physician before a pharmacist dispensed a BTC drug?

A pharmacist’s role would also include providing continuing education on safe and effective use of BTC medications. Even though a drug may be in a BTC class for years and consumers who have been counseled may need less assistance, the consumer who just begins therapy will need active pharmacy counseling. Because consumers often mistakenly believe that more is better, particularly with medications that do not require a prescription, pharmacists will need to continue to check for appropriate dosage. And, pharmacists will also need to pay special attention to the risk of interactions between BTC drugs and other prescriptions, OTCs, and dietary supplements. A pharmacist should have access to the patient’s full medication list to avoid interactions and double dosing. Since many consumers receive their medications by mail or by Internet, it would be the responsibility of the consumer to maintain an up to date medication record to share with their pharmacist. Ideally, an integrated E-prescribing system is needed for a BTC class to be safe and not result in more confusion among multiple prescribers in multiple settings.

Question 6 – Should BTC availability be a temporary status as prescription drugs transition to OTC, or a permanent status?

While a transition class may be appropriate for some medications in order to determine if they can be used safely and effectively as OTCs, for other medications a permanent BTC class may be more appropriate. This would depend on the safety profile of the drug, including potential for side effects and harmful interactions.

Regarding how the FDA determines which drugs are moved into a BTC class, we suggest, as Consumers Union does, that rather than respond to random petitions to move a drug to a BTC status, that FDA convene an advisory committee once a year to consider several drugs the FDA staff believes are good candidates for BTC.

The issue of whether BTC is a permanent or temporary status raises the question of how the drug is regulated regarding advertising – can the drug be advertised to consumers as an OTC, or as a prescription drug (and therefore required to include a summary of risks and benefits.)? How a drug is advertised will impact consumer perception of its risks and benefits, and subsequent use of the medication.

Question 13 – What measures would be necessary to ensure patient safety?

1) Establishment of a system that ensures quality pharmacy counseling occurs, which would require more than just the consumer’s signature. The consumer could be asked to check off and certify that they received counseling in specific areas (such as interactions)

2) Certain information should be conveyed to consumers through counseling, labeling and any promotional materials. This includes:

- When a doctor should be consulted.
- Common interactions, AND  
- A 1-800 number and website for consumers to contact if they have any questions, along with MedWatch contact information to report adverse events.

Lastly, before a drug moves to BTC status, drug manufacturers should be required to conduct a public education campaign for consumers, as well as prescribers and pharmacists, to explain that the drug will be available BTC, that a pharmacist must be consulted to obtain the medication, and any potential risks.

Thank you for this opportunity to comment.


[1] CHOICE, Australian Consumer’s Association, 2002, see

[2]Pharm World Sci, 220 August:24 (4): 149-53. “Purchasing restricted medicines in New Zealand pharmacies: results from a “mystery shopper” study”