Counseling Patients on Quality Expectations, Regulations in the Pharmacy Both Behind, in Front of the Counter

Pharmacy Times interviewed Jeanne Sun, PharmD, JD, counsel, legal at US Pharmacopeia (USP) to discuss counseling patients on quality expectations in the pharmacy.

This discussion is the third video in a series between Pharmacy Times and USP. In this video, Sun discusses her work at USP in the legal space around quality expectations of products sold in the pharmacy both in front of and behind the counter.

One of Jeanne’s Sun’s first jobs as a teen was working in the pharmacy at her local community pharmacy. She then went to pharmacy school, became a pharmacist, and eventually got a job at USP working in the Healthcare Quality Standards department. More recently, she got a law degree and now works in the legal department.

Sun explained that in front of the pharmacy counter, there's a wide range of products that are available to consumers from over-the-counter (OTC) non-prescription drugs to dietary supplements and so-called health foods that are often located near the counter.

Specifically, OTC drugs are an important aspect of the pharmacy’s offerings for many customers.

“OTC drugs play a vital role in the health care system. There actually was a recent survey done by [American Pharmacists Association] APhA that found that, on average, pharmacists, on average, make 29 OTC recommendations in a week, and approximately 81% of consumers actually purchase what the pharmacist recommends,.” Sun said.

Additionally, the regulatory framework of OTC drugs, whether in front of the counter or behind it, are very different from the regulatory process for prescriptions drugs. However, there are still strong quality expectations for OTC products.

“OTC drugs are typically defined as drugs that are generally safe for use by the public. There are over 300,000 marketed OTC products on the market, and FDA reviews the active ingredients and labeling for over 80 therapeutic drug classes,” Sun said. “FDA has OTC monographs that talk about the active ingredients, formulation, doses, and labeling requirements for these OTC products.”

On the other hand, USP also has OTC monographs that have a different purpose. USP’s OTC monographs discuss quality expectations for these products and their standards for identity, strength, quality, and purity.

“OTC products that conform to an FDA monograph really don't require any further FDA review, and if a product doesn't meet the monograph, the manufacturer can either submit an OTC monograph order request to ask the FDA to update the monograph, or the manufacturer can submit an application or a new drug application for the FDA to review the ingredients, the formulation, and the label,” Sun said. “But regardless of how this OTC product becomes marketed, USP has monographs that have standards to help assess the quality, strength, identity, and purity of it.”

Additionally, Sun noted that dietary supplements are also regulated very differently from drugs in the pharmacy.

“First and foremost, they're actually regulated as a category of food. Dietary supplements actually, for the most part, do not require FDA approval. The modern regulation of dietary supplements begins with the Dietary Supplements Health and Education Act of 1994, most often known as DSHEA,” Sun said. “DSHEA defines the dietary supplement as a product that's intended to supplement the diet and contains one or more of the following: a vitamin, a mineral, an herb, a botanical, an amino acid, a dietary supplement intended to increase the total dietary intake, or a concentrate, metabolite, or an extract of one of the above.”

For this reason, a dietary supplement is specifically classified as a food that is ingested as a tablet, capsule, or liquid and thus doesn't require any pre-market approval by FDA, unless it contains a new dietary ingredient.

“A new dietary ingredient is an ingredient that is not on the market prior to October 15, 1994, which was when DSHEA was enacted,” Sun said. “Any of those products that were on the market prior to DSHEA were grandfathered in. But new dietary ingredients can still come onto the market.”

Due to the introduction of new dietary ingredients on the market, DSHEA named USP as the official compendium for dietary supplements. This means that a dietary supplement can be deemed misbranded if it is covered by a monograph in the USP National Formulary, and it is represented as conforming to the monograph, but it fails to conform.

“This actually creates an unintended consequence where a dietary supplement, even though USP has a monograph, they might not follow the USP monograph, and they could still do so as long as they don't label themselves to be conforming to USP,” Sun said. “Dietary supplement manufacturers many years ago approached USP to develop some kind of program for them to help show the quality of their products.”

Following this request, USP developed and launched the USP Dietary Supplements Verification Program, which is a voluntary program that provides independent testing and auditing of dietary supplements to assess quality.

“These manufacturers can submit the products for testing by USP, and USP would test these products against quality standards, including those in the USP monograph, and it would audit the facility for compliance with current good manufacturing practices.” Sun said. “Only if the product meets all the testing criteria and evaluation criteria of USP does USP award the distinctive USP verified mark, which many of us might be familiar with as it’s on a lot of those dietary supplement bottles that are out there.”