US Pharm. 2006;5(Student suppl):6-7. 

Nonprescription, or over-the-counter (OTC), products are a group of pharmaceuticals considered by the FDA to be sufficiently safe for use without the intervention of a physician or other licensed professional. The vast majority may be purchased in virtually any location, including airport shops, gas stations, vending machines, hotel lobbies, and grocery stores.

Widespread availability of OTC products has fostered a false belief in the minds of many consumers. Many feel that the products are safe to use in any dose, at any time, by anyone. Surveys indicate that a substantial number of self-care patients fail to read OTC product labels to determine active ingredients, dosing information, adverse reactions, and usage directions. Many patients intentionally exceed the labeled dose. Thus, the misconception of safety leads to thousands of incidents each year in which patients incorrectly use OTC products, such as those containing acetamin­ ophen, that result in morbidity and death.

The yearly incidence of therapeutic misadventures with OTC products could be greatly reduced through the intervention of a professional who is specifically trained in the intricacies of self-care. The only professional with this unique background is the trained pharmacist, who serves as a learned intermediary between the patient and the product. Thus, the presence of a caring pharmacist is the most compelling justification for purchasing OTC products in a pharmacy.

The ability of the pharmacist to help patients in this manner is dictated in part by the practice venue. Pharmacies that force the pharmacist to fill large numbers of prescriptions with an inadequate support staff seldom allow the time necessary to facilitate pharmacist-assisted patient self-care. The newly licensed pharmacist who does not wish to engage in this type of practice might seek a venue that allows more time for one-on-one patient care. Pharmacies endeavoring to survive by entering a niche (e.g., compounding) would be well advised to consider embracing patient self-care, as it does not require expensive investments in training or equipment purchases.

Gathering information from the patient. In the pharmacist's role as a learned intermediary, it is critical to gather information from the patient. The pharmacist must keep in mind that the purchaser is not always the patient. Once the identity of the patient is determined, the pharmacist must also determine the age of the patient, the duration of the condition, any contraindications that would require professional intervention, manifestations of the condition, other medications being taken by the patient, and and other medical conditions present. Any of these factors can make self-care inappropriate. For instance, OTC products are not indicated for diarrhea in any patient younger than 6 years. Also, no patient should self-treat a cough that has lasted longer than seven days.

Choosing appropriate OTC products. Pharmacists must have a thorough understanding of the OTC product arena. The FDA is conducting a comprehensive review of OTC product ingredients that has clearly demonstrated those with proven safety and efficacy. The review justifies ages below which ingredients should not be used in self-care, durations of conditions beyond which referral is required, and contra­ indications that mandate referral. However, many ingredients lack evidence of safety and/or efficacy (e.g., herbals, homeopathics, dietary supplements). Pharmacists recommending unproven products must be aware that they may not provide any benefit to the patient and may expose them to unwarranted hazards.

Making a triage decision. As the pharmacist completes the self-care interview, a decision must be reached. There are three possibilities: (1) The patient does not need any product for the condition (e.g., sleeplessness that can benefit from sleep hygiene rather than an antihistamine). (2) The condition requires professional intervention, such as in cases of ear pain, vomiting not due to motion sickness, edema, bacterial skin infection, and diarrhea lasting beyond two days. The pharmacist must instruct these patients to seek professional care and may provide contact information for local physicians, emergency departments, dentists, etc. (3) The patient is a candidate for self-care. In this case, the pharmacist can choose a safe and effective product and point out and clarify dosage directions and usage information.

The pharmacist and pharmaceutical care. The community pharmacist's role with prescription products is mostly limited to filling prescriptions, adjudicating insurance sub­ missions, and counseling the patient on a prescription product that has been prescribed by another professional. However, through pharmacist-assisted patient self-care, the pharmacist is able to triage patients, perform minor assessment, choose therapy, and monitor the patient through a follow-up phone call. Thus, for the average community pharmacist, serving as a learned intermediary in pharmacist-assisted patient self-care is one of the most direct applications of pharmaceutical care.  

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