Health system pharmacists ready for BTC medications

The American Society of Health-System Pharmacists (ASHP) says pharmacists in hospitals and health systems are ready to play an expanded role in patient care and medication therapy if FDA decides to designate certain prescription-only drugs as behind-the-counter (BTC) drugs.

Testifying at an FDA hearing on the proposal, ASHP deputy executive vice president William Zellmer, MPH, said that much of what hospitals do today occurs in the outpatient setting, treating hundreds of thousands of patients each year. Some 28% of general and children's medical-surgical hospitals have an outpatient pharmacy, he said.

According to Zellmer, ASHP has had official policy supporting establishment of a BTC class of drugs that would not require a prescription but would be available only from a pharmacist or other licensed health care professional authorized to prescribe medications since 1985.

"ASHP believes that behind-the-counter availability of certain medications that are currently prescription-only and that have unmet potential for improving health status would be in the public interest," he testified. "It has been shown that reclassification of some prescription medications to nonprescription products resulted in increased patient autonomy and healthcare knowledge, as well as improvements in self-care behavior.

"However, from a safety perspective, some medications that may be potential candidates for nonprescription status may not be ready for widespread sale in any retail outlet. For such medications, consumers should be able to draw on the education, training, and experience of pharmacists to help them assess their need for the medication, and, if use of the medication is appropriate, to learn how to take it and monitor its effects."

Based on best practices in hospitals and health systems, Zellmer said, ASHP believes that a pharmacist's practice when providing these therapies should optimally include these features:

  • an initial assessment of a patient, using a standardized protocol such as might be developed by professional pharmacy associations, to determine appropriateness of the medication;
  • obtaining required patient health information, such as laboratory data, to aid in the assessment;
  • counseling the patient about proper medication use, at the patient's literacy and comprehension level;
  • maintaining a standardized record of behind-the-counter medications provided and the accompanying professional services;
  • with patient consent, informing the patient's primary care provider of any BTC medication provided; and
  • ongoing monitoring for effectiveness and safety.

Zellmer told FDA that ASHP is developing a policy statement on criteria for determining if a medication is appropriate for BTC availability. He said a draft of that statement said medications for BTC status should:

  • have a well-established benefit-to-risk ratio and high safety margin;
  • have been marketed as a prescription product for a sufficient length of time and been used in sufficient numbers of patients;
  • have evidence of effectiveness and safety at the dose and regimen recommended for BTC formulation;
  • be used to treat a disease, symptom, or condition that can be readily detected or diagnosed by a patient or pharmacist;
  • be associated with measures that can be used to assess the medication's effectiveness as well as signs and symptoms of potential toxicity that can be reliably detected and interpreted by the pharmacist or patient; and
  • not be an anti-infective agent to which emergence of resistance is a concern.

Zellmer's testimony suggested that as FDA further examines potential for a BTC category, there may be merit in having some BTC demonstration projects for one or more medications in selected markets, with FDA oversight and systematic data collection. "The experiences documented in such projects would help answer the public policy questions in the context of conditions here in the United States," he said.

He said any such demonstration projects should include some hospital and health system outpatient pharmacies as demonstration venues and offered ASHP to help design such a study.

[Editor's note: Download Zellmer's testimony at:]