Packaging / Drug Delivery / Aseptic Processing / QRM Process

Minimize Bisect Risk (Part 1)

As “pill-cutting” becomes the dispensing norm, improperly designed or nonfunctional tablet bisects could pose liability issues

By Fred A. Rowley, Solid Dosage Training, Inc.

The “bisect” or “score,” that groove or debossed line that is formed on some drug tablet surfaces, has been taken for granted for decades [1]. These days, though, it’s creating quite a stir, one that ripples from the board rooms of the nation’s largest HMOs right down to the individual consumer’s medicine chest.

Bisects were originally designed to prevent tablet stress fractures. Over the years, though, their function has become more “cosmetic” than functional.

Many patients view them as “guides,” designed to allow them to cut a more concentrated pill, neatly and evenly, into two or more dosages of lower concentration [3]. However, cutting along nonfunctional tablet scores will yield uneven pieces, compromising dosage and potentially posing manufacturer and pharmacist liability issues [4-6].

Guidelines exist for adding a score to any tablet, but these deal with the subject from a purely technical viewpoint. There are no guidelines for when to use a bisect, and approaches vary from company to company, and even country to country.

Some companies put a bisect on their tablets, but don’t mention what it is used for. Others include a bisect, but state that the tablet “may be divided for the convenience of administration” in their inserts and PDR. Still others direct patients to their pharmacist or doctor for instructions.

Generics Mandate

Further complicating the picture is the fact that generic drug manufacturers are required to place a bisect on their tablets “whenever the innovator did so.” Confused? This article will offer some suggestions for ensuring minimal risk from improperly designed or nonfunctional tablet bisects.

Enter Cost Control

The prime reason why tablet bisects have become so important today is the fact that HMOs and pharmacies are controlling costs by stocking fewer shelf keeping units (SKUs), dispensing a single stronger dose and asking their patients to use pill cutters to adjust the dose [7].

For example, if a pharmacist is out of stock of 5 mg. lisinopril, he or she might split 10 mg. tablets and dispense them that way (sometimes for additional cost), or supply a free pill cutter with the prescription [8].

Because companies sometimes charge different prices for different strengths, pill cutting can save pharmacists, and patients, hundreds of dollars a year [9].

Tablet manufacturers, drug distributors and pharmacists must now ask the following questions:

    • How effective is the bisect in facilitating a sharp break of the tablet?


  • What is the potential liability if the break is less than perfect and the resulting dosage is less than what was prescribed [10]?

The onus is now on the manufacturer to ensure that bisects will allow safe “pill cutting,” and to engineer them for success (Part Two of this article, to be published in our November/December edition, will deal with the technical issues involved).

If pill cutting becomes the norm, the requirements for a functional bisect may change, generating multiple layers of legal and procedural revisions. Right now, there are several unanswered questions. For example:

    • Will a fully functional bisect become part of the overall product qualification?


    • Will standards for successful cutting of the tablet become an additional product specification?


    • Will both halves of the tablet, with a small variation, need to contain the same quantity of active ingredient(s)?


  • What is the impact on tablets with multiple active ingredients?

Immediate answers will likely be needed [12]. But, clearly, tablet bisects must be engineered for success, particularly if they’re on a product that was introduced more than 10 years ago.

When reviewing a product, if the tablet features a bisect, verify that the bisect is fully functional. Distinguish a shallow bisect from a deep, wide bisect. Define the fully functional bisect as delivering a drug content equivalent to the full tablet with a small additional variation for small particles lost. Understand that some shallow bisects may perform very well due to the nature of the active ingredient.

For generics, don’t assume that the currently marketed tablet has a bisect that is fully functional. The drug going off-patent today may have a cosmetic bisect that was never intended to meet tomorrow’s standard.

Study the innovator’s bisect and be prepared to engineer a change. Some products need only a slight but effective bisect change. And note that this class of product change is usually considered by the FDA as reportable on an annual basis.

Part Two of this article will discuss pre-emptive thinking and provide a technical guide to analyzing tablet bisects.



References

    1. Boyles, S: “Cutting Pills in Half Could Pose Problems”, WebMD, May 19, 2004, posted Sept. 26, 2006; webMD.com


    1. Tableting Specifications Manual, 7th edition, APhA Tableting Specification Steering Committee, AphA Publishing, 2005.


    1. Dieleman, L: “Is Cutting Your Pills a Safe Way To Save Money?” Consumer Health Information Corporation Bulletin, consumer-health.com


    1. Baker, K: “Pill Splitting–Is it Legal? Is It Covered By Malpractice Insurance?”, Epothecary, Pharmacy Marketing Group Bulletin, pmgrx.com


    1. Parker-Pope, T: “Health Journal: Health Insurers Push Pill Splitting”, Pittsburgh Post Gazette, Nov. 22, 2005; post-gazette.com


    1. Merx, K., “Cost Cutting Pill-Splitting Plan Could Be Big Money Saver”, Detroit Free Press, January 26, 2006; redorbit.com


    1. Article: “Freehand Pill Cutting Can Lead to Improper Dosing of Misoprostol. (Brittle Pills A Problem)”. OB GYN News, Published Oct 15, 2001; Accessmylibrary.com


    1. Riklin, S: Letter to the Editor: East Bay Newspapers, on-line edition, Nov. 18, 2004; eastbayri.com


    1. Health Issues: “Pill Splitting Can Save Money On Prescription Drugs”, National Center for Policy Analysis, Aug. 1, 2001; NCPA.org.


    1. Editorial, Wall Street Journal: “An easy remedy: Cut your drug bills in half by cutting pills in half,” July 28, 2001; destinationrx.com


    1. Carson, B: “Health industry Divided on Splitting Pills”. July 9, 2005, Herald-Review.com


  1. Brody, H: “Split Your Pills and Save Money? In Some Cases, Yes”, Feb 19, 2003, Lansing City Pulse; lansingcitypulse.com

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