FDA Takes on Unsafe Pill Splitting

Concerns about the common but risky practice of splitting tablets led the FDA to issue clearer guidelines for drug makers.

When a survey of pharmacists reported that more patients were splitting tablets to save money during the economic recession, federal regulators took notice. Although approved for certain drugs, the FDA generally discourages the practice, which is made riskier by differences in the way tablets are scored.

The agency took the first step in resolving those manufacturing inconsistencies with its recent draft guidance for industry on tablet scoring, issued September 8, 2011. In the document, the FDA wrote that although no current regulations address the issue, consistent scoring is needed to “ensure that the patient is able to adjust the dose by splitting the tablet.”

The increasing prevalence of pill splitting was the subject of 2 meetings conducted by the FDA’s Drug Safety Oversight Board over the past 2 years. During those meetings, officials discussed “how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ dose or as a cost saving measure.”

This presents safety issues, especially when tablets have not been evaluated for splitting. After conducting internal research on the practice, the FDA expressed concerns over variations in tablet content, weight, disintegration or dissolution, and stability when split. All could easily impact whether or not patients receive the intended dose when dividing a single tablet.

According to the new recommendations, tablets that are split should still adhere to the drug’s approved minimum therapeutic dose and meet stability requirements for 90 days when stored in standard pharmacy vials. Tablet scoring is not appropriate for modified-release drugs, and scoring of generic products should be identical to branded counterparts.

Splitting dos and don'ts

The FDA is accepting public comments and suggestions on the draft guidance until November 28, 2011. In the meantime, pharmacists should educate patients about the following risks to consider when deciding whether or not to split pills:

Forgetting to split. Patients who buy a higher dose with the intention to split may forget to do so, resulting in a double dose of medication.

Unequal halves. Even scored tablets can be difficult to split into 2 perfect halves, and medicine is sometimes distributed unevenly within a single tablet. The parts could look the same, but contain different amounts of active ingredient.

Crumbling and breakage. Tablets that are round or too small may crumble easily or unevenly when split, compromising dose accuracy.

Coatings and capsules. Certain medications, such as those in capsule or controlled-release form, are not safe to split and should always be taken whole.

When in doubt about a pill's suitability for splitting, patients should defer to the drug’s prescribing information, available in the patient package insert or on consumer health sites like the National Library of Medicine's DailyMed or Drugs.com. “FDA does not encourage the practice of tablet splitting unless it’s specified in the drug’s professional prescribing information,” explained Mansoor Khan, PhD, of the FDA’s Office of Pharmaceutical Science.

For approved drugs, the FDA outlines these best practices to follow when splitting tablets. Patients should also speak with a health care professional, who can supply an approved tablet splitter and demonstrate proper technique, where appropriate. “If a patient is considering splitting a tablet, the FDA recommends that the patient get advice directly from his or her doctor or pharmacist,” said Dr. Khan.

For other articles in this issue, see:

• NSAID Use Tied to Miscarriage Risk
• Petition Calls for Boxed Warning on PPIs