Pill splitting

Pill-splitting refers to the practice of modifying a tablet, capsule or pill to obtain a lower dose of the active ingredient, or to obtain multiple smaller doses, either to reduce cost or because the drug is not available in the dose desired.

There are a number of situations where it is unsafe to split a prescription medication.

Any modification of a prescription medication should be undertaken only at the direction of a doctor or under the supervision of a medical specialist. Do not split any medication or supplement unless you know it is safe to do so.

 

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Pill splitters

A pill-splitter is a simple and inexpensive device to split medicinal pills or tablets, comprising some means of holding the tablet in place, a blade, and usually a compartment in which to store the unused part. The tablet is positioned, and the blade pressed down to split it. With care it is often possible to cut a tablet into quarters.

Dosage uniformity

In the U.S.—and for more than 130 countries which use or recognize American pharmaceutical standards—"uniformity of dosage units" is defined by the United States Pharmacopeia (USP), which describes itself as "the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States."^[2]

The USP standard for dosage uniformity expresses statistical criteria in the language of sampling protocols which defies simple explanation. The pharmaceutical dosage literature sometimes boils this down as requiring a standard deviation in dosage weight of less than 6%, which roughly corresponds to the weaker rule-of-thumb offered for public consumption that the vast majority of dosage units should be within 15% of the dosage target. "Dosage unit" is a technical term which covers oral medications (tablets, pills, capsules), as well as non-oral delivery methods.^[3]

A 2002 study of pill-splitting as conducted in four American long-term care facilities determined that 15 of the 22 dispensed prescriptions evaluated (68%) had fragment weight variance in excess of USP standards.^[4]

Cost savings

Pill-splitting can be an effective way to save money on pharmaceutical costs. Many prescription pharmaceuticals are sold on a per dose or tablet basis. For example a 10 mg tablet of a given drug might be sold for the same or nearly the same price as a 5 mg tablet. Splitting a 10 mg tablet allows the patient to purchase half the number of tablets while still receiving the same amount of the active drug.

Potentially suitable medications

Dr Randall Stafford from the Stanford School of Medicine published a study in 2002 of common prescription medications in the United States in which he evaluates pill splitting for "potential cost savings and clinical appropriateness". The study identifies eleven prescription medications that satisfied the study criteria, based on American pharmaceutical cost structure, pill formulation, and dosages available at that time.^[5] Most of the medications listed in the table from the psychiatric drug class are antidepressants.

Uniformity of split

Not all tablets split equally well. In a 2002 study, Paxil, Zestril and Zoloft split cleanly with 0% rejects. Glucophage was described as a hard tablet, requiring significant force, causing tablet halves to fly. Glyburide exhibited very poor splitting with many splitting into multiple pieces. Hydrodiuril and Oretic crumbled. Lipitor did not split cleanly, and the coating peeled. The diamond shaped Viagra tablets made location of the midline difficult. The worst result reported was Oretic 25mg in which 60% of tablets failed to split to within 15% of target weight.^[6][7]

Risks

Care must be taken in identifying drugs that may be safely split while still delivering half the dose with the same or similar efficacy. Generally scored pills may be safely split however time release and capsule supplied drugs should not be split. Split pills may be uneven and thus the amount per dose may vary. In practice these variations are often minor enough as not to cause major dosing issues and are in fact within generic drug active ingredient guidelines. Patients wishing to split their pills should request their physician to write their prescriptions as such to help avoid incorrect dosing.

Lawsuits

Timmis v. Kaiser Permanente

In a California court filing dated April 2001 Trial Lawyers for Public Justice (TLPJ) brought a class-action lawsuit against Kaiser Permanente on the grounds that "Kaiser's mandatory pill-splitting policy endangers patients' health solely to enhance the HMO's profits" in violation of the California Unfair Competition Law (UCL) and the California Consumer Legal Remedies Act (CLRA). ^{[8] [9]} In December 2004, the California Court of Appeal affirmed the trial court ruling that Kaiser's policy did not violate UCL or CLRA, noting the suit had failed to present evidence that the policy was unsafe. ^[10]

References

1. ^ Pill Splitting: Know When To Avoid Splitting The Difference
2. ^ About USP, USP web site, undated, accessed 25 Nov 2007
3. ^ Explanatory Note: USP–NF General Chapter <905> Uniformity of Dosage Units, United States Pharmacopeial Convention, 20 April 2007
4. ^ Weight Variability of Pharmacist-Dispensed Split Tablets, Jack M. Rosenberg, Journal of the American Pharmaceutical Association, Volume 42 Number 2 March-April 2002, pp. 200-205
5. ^ http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12212758&dopt=AbstractPlus
6. ^ Two For The Price Of One: Beauty of Pill-Splitting Catches On, MargaretAnn Cross, Managed Care Magazine, undated
7. ^ Tablet Splitting: Imperfect Perhaps, but Better Than Excessive Dosing, J.S. Cohen, Journal of the American Pharmaceutical Association, Volume 42, Number 2, 1 March 2002, pp. 160-162(3)
8. ^ http://www.tlpj.org/pr/kaiser_split.htm
9. ^ http://www.tlpj.org/briefs/timmis_kaiser.htm
10. ^ http://www.aishealth.com/ManagedCare/HMOLawsuitWatch/TimmisvKaiser.html

• http://www.split12.com/en/faq.html
• The Potential of Pill Splitting to Achieve Cost Savings
• http://www.ncpa.org/pub/st/st262/st262d.html
• Pill Splitting Can Save Money, but Talk to Your Doctor First
• Pill Splitting Can Save Money On Prescription Drugs
• Pill Splitting: Know When To Avoid Splitting The Difference
• Pill-splitting can yield cost savings on common prescription drugs, Stanford researchers find
• A Look at Pill Splitting - Should you cut your antidepressant in half to save money?
• Health Care Hot Topic: Tablet Splitting, 25 July 2007, adapted from Journal of Clinical Psychology 62:10