Introduction

There has been an influx of healthcare providers who want to get into the prescription writing business: nurse practitioners, physicians’ assistants, medical doctors and DOs are now looking into how they can go about it. There have also been rumors of pharmacists (who are considered to be the protectors of the medications or the ones with the most knowledge about the medications) who want to get into the prescribing business.

I have never been a big fan of that because I believe that pharmacists would not be able to add value beyond what other prescribers are already doing. I hence wondered what the future of pharmacy is and if pharmacy as a profession is facing its end. However, the recent advent of patient communities and a recent FDA discussion of new opportunities for pharmacies and pharmacists may have breathed new life into the pharmacy profession.

Pharmacist Intervention Drugs

The FDA recently looked into creating a new category of pharmacist intervention drugs. They put out a federal register notice to discuss how hyperlipidemia (high cholesterol), hypertension (high blood pressure), migraine headaches and asthma drugs could be pharmacist-dispensed as opposed to prescribed or available over the counter.

Advantages

This would provide a new avenue for pharmacists to directly connect with patients. It eliminates phone calls for routine medications to prescribers and allows the prescribers to concentrate on urgent calls. It both allows pharmacists to be more hands-on and develop the necessary relationship with their patients and enhances clinical partnerships.

Disadvantages

However, it must be understood that such interactions would likely take more time from the pharmacist and would require the pharmacist to make clinical judgments beyond what he or she currently makes, thereby resulting in a dramatic increase in insurance costs for pharmacists.

Method of Operation

The FDA believes that some patient visits could be eliminated by making certain prescription medications available without prescriptions, but with other conditions of safe use that would ensure that these products are being used safely and effectively without the initial involvement of a healthcare practitioner. In some cases, a visit to a practitioner would be required for the initial prescription, but a certain number of refills could be authorized without a return visit under the conditions of safe use. This might be useful for certain rescue medications like inhalers for asthma or epinephrine for allergic reactions, which patients need to keep on hand for use in emergencies.

The conditions of safe use could include requiring pharmacist intervention to ensure appropriate non-prescription use. Additionally, the conditions could involve the use of innovative technologies, such as diagnostics approved or cleared by the FDA for use in the pharmacy or other setting.

New products that fall within these categories that are appropriately reviewed may result in pharmaceutical companies and life sciences companies targeting pharmacists as the primary mode of affecting patient care. Such targeting would also result in additional attention for pharmacists.

Part 15 Hearing

In light of the challenges that pharmacists would face in order to discover the appropriate way of executing a third class of pharmaceuticals, the FDA held a Part 15 hearing on March 27, 2012, where they discussed a variety of issues, including:

  • The types of technology and conditions of safe use
  • What other types of conditions of safe use (e.g., pharmacy monitoring or counseling) could be used to help ensure the safe and effective use of certain drug products as non-prescription products?
  • Are there types of diagnostic aids that could be used in the non-prescription setting after appropriate FDA review, either with or without the aid of a pharmacist to diagnose or monitor a disease or condition?
  • What data exists on the conditions of safe use, including novel technologies; on their effects on healthcare, access to medication; and/or disease and treatment education or awareness?
  • Is there data on how expanded access to medication or increased consumer education could affect patient or consumer behavior?
  • What types of studies must be conducted to evaluate the effects of conditions of safe use on the safety and efficacy of particular drugs and on behavior and health outcomes?
  • What types of studies could be conducted to evaluate the safety and efficacy of any technologies that might be relied upon as conditions of safe use?

Conclusion

Other countries, such as the UK, have products that are dispensed from behind the counter. I expect the FDA will look at data from these other countries to evaluate their experiences.

I’m glad to hear that there may be hope to go beyond the traditional role of pharmacists, where they have the opportunity to react and talk to patients and expand upon their professional role.

For more information on this issue, contact the Kulkarni Law Firm.