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More Information on the Drug Approval Process

Testimony on Behind-the-Counter Availability of Certain Drugs

November 14, 2007

Sidney M. Wolfe, M.D.
Director, Health Research Group
FDA Hearing on Behind-the-Counter Availability of Certain Drugs

When the Food and Drug Administration (FDA) makes an important policy decision, the evidence for the benefits and risks of that decision needs to be weighed as carefully as the evidence concerning the benefit/risk balance of a drug. In the case of behind-the-counter availability of drugs, it is useful to hear the opinions of various parties, including those with obvious financial conflicts of interest whose opinions can be predicted. But before any decision is reached there needs to be evidence that benefits outweigh the risks of such a new system, particularly because new legislation would probably be needed if behind-the-counter availability of drugs is to be established as a general principle. The necessary evidence does not currently exist, as I will discuss later.

Thirty-three years ago, spurred in part by pharmacists’ desires to restrict certain over-the-counter (OTC) drugs to pharmacist-only or behind-the-counter availability, the FDA stated that “There is at this time no public health concern that would justify the creation of a third class of drugs to be dispensed only by a pharmacist or in a pharmacy. The ‘third class of drug’ issue is at this time solely an economic issue. The Commissioner therefore categorically rejects the establishment of a third class of drugs at this time” (39 Fed. Reg. 19881 [June 4, 1974]).

More recently, in 1994, Congressman John Dingell asked the Government Accountability Office (GAO) to do a comprehensive study to collect data on the experiences of other countries that had, by then, implemented such systems. Congressman Dingell's request was prompted in part by the wishes of some individuals in Congress to revive the idea of behind-the-counter availability for certain drugs. The study involved 10 countries: Canada, Australia and eight European countries. It was made public in August, 1995, and was entitled “NONPRESCRIPTION DRUGS — Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated.”

I will quote from the findings of this study, which is the last comprehensive review of this topic to be done.

The results in brief were:

Little evidence supports the establishment of a pharmacy or pharmacist class of drugs in the United States at this time, as either a fixed or a transition class. The evidence that is available tends to undermine the contention that major benefits are being obtained in the countries that have such a class. This conclusion is substantiated by six points. (1) Reliable and valid studies that examine the effect of different drug distribution systems on overall health and health care system costs do not exist. (2) While a pharmacy or pharmacist class exists in all 10 countries, it is not used with any frequency in any of them to facilitate the movement of drugs to sale outside specialized drug outlets. (3) The European Union has decided not to impose any particular drug distribution system on its member countries because it has found no evidence of the superiority of one system over another. (4) There is no clear pattern of increased or decreased access to drugs as nonprescription products where a pharmacist or pharmacy class exists. (5) While a pharmacy or pharmacist class is assumed by some to improve safeguards against drug misuse and abuse, in the 10 countries these safeguards are easily circumvented, and studies show that pharmacist counseling is infrequent and incomplete. (6) Experience in Florida with a class of drugs similar to a pharmacist class has not been successful; pharmacists have not regularly prescribed these drugs, and recordkeeping requirements have not been followed.

The body of the GAO report elaborated on some of these points:

COST

Our interviews with officials in the study countries indicated that the cost savings from fewer physicians’ visits may not be as great as expected. They said that many patients do not pay the full price for a prescribed drug. For instance, an insured patient might have only a $5.00 copayment for a prescription drug while having to pay the full price for a nonprescription product. Patients might thus have an incentive to go to doctors for a prescription.

PHARMACY COUNSELING

The results of the studies in the United States are rather similar to those in countries where the sale of at least some nonprescription drugs is restricted to pharmacies. In general, the theory of pharmacy practice diverges from the reality (emphasis added). The advice of pharmacists is often appropriate but not universally given. In addition, it is often incomplete, with little information being given to customers on such items as possible side effects. In other words, what information is given is accurate, but not enough was passed on to consumers. Researchers consistently found a lack of information-gathering on the part of pharmacists. For instance, information is often not gathered on symptoms and other medications.

The theory that pharmacists can counsel patients on OTC, prescription or behind-the-counter drugs diverges from the reality, as stated by the GAO. Evaluation of this includes the 1990 OBRA law requiring a system of pharmacist information for patients for prescription drugs that has not worked nearly as well as hoped and the above-mentioned pharmacist counseling for OTC and behind-the-counter drugs.

More recently, there are some evaluations—surveys of pharmacists—of the 2004 UK decision to make the statin drug, simvastatin, available in a pharmacist-only setting without requiring a doctor’s prescription. Some of the findings of two published studies[1],[2] on this topic are as follows:

Questionnaires were returned by 1,156 community pharmacists (57.8%). Nine hundred and fifty-six respondents (82.7%) reported no sales of simvastatin in the previous fourteen days. Eighty-two (7.1%) sold one pack, 40 (3.5%) sold two.

Health promotion material aimed at reducing cardiovascular risk was displayed to customers in just over half of the pharmacies (602, 52.1%).

This is the first relatively large-scale national study to report community pharmacists’ experiences of OTC simvastatin in Great Britain. The majority of respondents had undertaken an array of continuing education, had established sales protocols and expressed confidence in making an appropriate cardiovascular risk assessment in line with the OTC licence. Most considered this to be an area requiring personal input from the pharmacist rather than being delegated to other pharmacy staff. However, very few sales had actually taken place during the study period…. major concerns relating to the need for full cardiovascular risk assessment, access to full clinical information prior to simvastatin use and the lack of an evidence base for the licensed dose reflect reservations voiced by the medical profession.

This notion of a third class of drugs has been tried, and there is much evidence that it did not work. A doctor writes a prescription, a pharmacist fills it. If the doctor is removed from the equation, the public could be harmed, as evidenced by the concerns of UK pharmacists about simvastatin.

The positions taken by those involved are very predictable.  Pharmacists support it, but doctors oppose it because their roles are replaced. Some drug companies like it because they see it as a way to boost sales (as in the case of the third try to switch a statin to this category). Companies who sell to 7-11s and other markets, represented here today by CHPA, don’t like it because many of their outlets don't have a pharmacist so they can't sell third-class drugs.

Pharmacists are well-skilled and often know a lot about the drugs they dispense. But in practice, they often do not counsel when asked to because they do not have the time. There is no mechanism to reimburse them for their time. As a policy it wouldn't work. It would probably take a Congressional law to make it happen.

Twenty years ago, the painkillers ibuprofen and naproxen were only available by prescription. As we learned more about the drugs and their safety, those drugs became available over the counter. Pain is an easy self-diagnosis. Thus far, the prescription-to-OTC switch process has worked quite well.

The current push for a behind-the-counter class was precipitated by drug companies who make statins and want to switch them to OTC. I have testified twice already and I'm going to testify next month for a third time opposing statins becoming OTC. 

I am also concerned about the privacy issue. Even with prescription drugs, there have been pharmacists who have sold information regarding doctors' prescribing practices although there is, as of yet, no evidence that patient confidentiality has been compromised.  In order to protect patients, there would have to be some safeguards built in to extend to the patient-pharmacist relationship the confidentiality that people now have with their doctors.


[1] Pharm World Sci. 2007 Aug;29(4):380-5. Epub 2007 Mar 15. Community pharmacists' views, attitudes and early experiences of over-the-counter simvastatin.

[2] Pharmacoepidemiol Drug Saf. 2007 Oct 4; [Epub ahead of print] A comparison of community pharmacists' views of over-the-counter omeprazole and simvastatin.

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