Pill splitting

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A pill-splitter holding a tablet of Seroquel.

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. Often, pills that are meant to be split (Aspirin for instance) come pre-scored so that one may easily divide the pill into halves or quarters.

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

Close-up of the blade and place holder.

Contents

[edit] 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.

[edit] 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."[1]

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.[2]

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.[3]

[edit] 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.

U.S. medications suitable for pill splitting
As listed in 2002 Stanford study
Medication Drug class
clonazepam psychiatric
doxazosin blood pressure
atorvastatin cholesterol
pravastatin cholesterol
citalopram psychiatric
sertraline psychiatric
paroxetine psychiatric
lisinopril blood pressure
nefazodone * psychiatric
olanzapine psychiatric
sildenafil erectile dysfunction
* Serzone brand discontinued 2004 in U.S.

[edit] 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.[4] Most of the medications listed in the table from the psychiatric drug class are antidepressants.

[edit] 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 25 mg in which 60% of tablets failed to split to within 15% of target weight.[5][6]

[edit] Alternative purpose

Some drugs have few different uses and usually sold in different packages and different doses. For marketing purposes it is common to cheat and inflate prices for some drug types[citation needed]. One example is Minoxidil which is well known as expensive hair growth stimulant, but same drug under different name Loniten is used for blood pressure control in much larger doses and for much lower price.[citation needed]

[edit] Research on cost effectiveness

The same medication with a double dose of the original medication do not cost that much more than the lower dose of the medication, and often do not change the copayment for the prescription. For these reasons, pill splitting is an effective way to cut out-of-pocket prescription costs, yet there are many risks to pill splitting so it is suggested to consult a physician first. Physicians should not only know the different strategies to reducing out-of-pocket costs but should realize that prescribing goes beyond the prescription pad and communicate with their patients by asking them if they have a financial burden when it comes to their prescriptions.[7]

Along with other cost-reducing strategies such as switching to generic medicines, selective medication discontinuation, and referrals to assistance programs, pill or tablet splitting provides an effective way of reducing costs. The real problem, however, is a lack of physician communication about out-of-pocket costs, which affects both specialists and generalists alike.[8]

Look here for more ways to reduce costs:Talk to Your Doctor to Reduce Prescription Costs

[edit] 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.

[edit] Lawsuits

[edit] 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). [9] [10] 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.[11]

The emergency physician – Charles Phillips, MD - who originally spotted the massive pill splitting within Kaiser Fresno in 1998 has tried ever since – including early 2011 - to get the regulatory agencies or safety organizations to either stop pill splitting due to greatly uneven weights or force proper informed consent for patients. Dr. Phillips believes that pill splitting is unsafe in all diseases, as the fragments are very uneven and almost medications work by precise interactions with precise receptors sites - molecule to molecule. And he also believes no one really follows the requirement that the two split fragments be taken following each other from day one to day two. In fact, many patients[who?] get tired of splitting and take the double dose every other day - which is very dangerous; that has been reported by the NASA group watching over the VA safety issues. Audrey Timmis was his patient, and Dr. Phillips joined her and other patients on the lawsuit mentioned above. He was not to be paid even if the suit succeeded. But patients swallow the evidence, so the judges thought regulatory agencies should make the decision.[citation needed]

[edit] See also

[edit] References

  1. ^ About USP, USP web site, undated, accessed 25 Nov 2007
  2. ^ Explanatory Note: USP–NF General Chapter <905> Uniformity of Dosage Units, United States Pharmacopeial Convention, 20 April 2007
  3. ^ Rosenberg JM, Nathan JP, Plakogiannis F (2002). "Weight variability of pharmacist-dispensed split tablets". J Am Pharm Assoc (Wash) 42 (2): 200–5. doi:10.1331/108658002763508498. PMID 11926663. http://japha.metapress.com/app/home/contribution.asp?referrer=parent&backto=issue,10,24;journal,7,9;linkingpublicationresults,1:120081,1. 
  4. ^ Stafford RS, Radley DC (August 2002). "The potential of pill splitting to achieve cost savings". Am J Manag Care 8 (8): 706–12. PMID 12212758. http://www.ajmc.com/pubMed.php?pii=228. 
  5. ^ Cross M (February 2003). "Two for the price of one beauty of pill-splitting catches on". Manag Care 12 (2): 36–8. PMID 12658856. http://www.managedcaremag.com/archives/0302/0302.pillsplitting.html. 
  6. ^ Cohen JS (2002). "Tablet splitting: imperfect perhaps, but better than excessive dosing". J Am Pharm Assoc (Wash) 42 (2): 160–2. doi:10.1331/108658002763508443. PMID 11926659. http://www.medicationsense.com/about_cohen.html. 
  7. ^ Alexander GC, Tseng CW. Strategies to identify and assist patients burdened by out-of-pocket prescription costs. Cleveland Clinic Journal of Medicine. 2004;71:433-437 [alexander.uchicago.edu/img/pdf/Alexander504.pdf]
  8. ^ Alexander GC, Casalino LP, Metlzer DO. Physician strategies to reduce patients’ out-of-pocket prescription costs. Archives of Internal Medicine. 2005;165:633-636 [alexander.uchicago.edu/publications/image/.../OOPC%20mail%20survey.pdf]
  9. ^ TLPJ — Press — Timmis v. Kaiser Permanente (pill splitting) - Dec. 6, 2000
  10. ^ TLPJ — Briefs — Timmis v. Kaiser Permanente (pill splitting) - April 22, 2001
  11. ^ http://www.aishealth.com/ManagedCare/HMOLawsuitWatch/TimmisvKaiser.html
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