CONSUMER PACKAGE INSERTS NEEDED IN RX-TO-OTC PRODUCTS SAYS PATIENT INFORMATION EXPERT


Taking pills

Toronto, Canada–Consumers have more responsibility when self-medicating than when prescribed drugs and need product specific information, according to Dr. Dorothy Smith, Pharm.D., pharmacist and renowned author. At a recent presentation to the Nonprescription Drug Manufacturers Association in Toronto, Smith called for the implementation of consumer package inserts for over-the-counter (OTC) medications to help improve compliance and safety for millions of consumers taking OTC drugs every day.

“Patients are weighing the risks against the benefits” of OTC products and “making important decisions about their drug therapies that are affecting outcomes,” Smith said.

Noncompliance with medications increases health care costs in the U.S. approximately $100 billion annually. This includes the cost of treating adverse effects of drugs and complications of noncompliance. Up to 10% of all hospital admissions are linked to noncompliance, and over 20% of nursing home admissions are due to noncompliance with medications.

The main reason for noncompliance, Smith observed, is that “many patients are not given enough information and counseling in order for them to manage the medication at home and incorporate it into their daily lifestyles.” This is true of both prescription and OTC medications.

In the case of OTC medications, many studies show that consumers find terminology used in packaging and advertising to be confusing. For instance, Smith cited a study that found cold and allergy remedies to one of the most confusing product areas to consumers. She also noted a study which found that 80% of 414 patients with hypertension “were not aware that some products they took during a two-week period should not have been used.”

Smith warned that consumers often make erroneous and potentially dangerous decisions concerning OTC medications. She cited statistics showing that of 3,900 OTC decisions made by consumers over a nine-month period, only 500 parents treated their children with OTC products correctly. The statistics suggested that mothers did “slightly more harm then good for their children” and selected the wrong medications for a child’s condition, gave the wrong dose, and/or gave the medication for the wrong amount of time.

In discussing the idea for consumer package inserts, Smith suggested that these materials contain information about:

  • The purpose of the product and the symptoms it can be used to relieve.
  • When to seek professional advice from a pharmacist or physician with respect to contradictions, potential drug interactions with prescription drugs and allergies.
  • How long it will take to notice a benefit from the product.
  • How to administer the medication correctly.
  • Dosage and number of doses that can be taken per day.
  • Times of administration.
  • Length of treatment.
  • How to manage commonly occurring side effects.
  • How to avoid potential drug interactions.
  • When to call the physician.

“It is certainly possible for the drug manufacturer to provide the consumer with information on `how to use’ the specific product,” Smith told her audience. “It becomes extremely difficult to include this information about contraindications and drug interactions. This is where the pharmacist can assist you,” she added.