Letters to the Editor - July 15, 2000 - American Family Physician

Letters to the Editor

Revealing a Medication Error

TO THE EDITOR: The "Curbside Consultation" piece¹about revealing a medication error was good, but I disagree with the author's opinion that the discussion with a patient should simply end with the query, "Do you have any questions for me?"

In 1971, Dr. Fred Rehfeldt, a senior neurosurgeon who taught in our family practice program, gave me some good advice. He told me that if I ever made a significant mistake and as soon as I realized it, I should go straight to the patient (or family), say I had made a mistake and what it had caused, that I would set it right or, if preferred, summon a doctor I trusted to do so, and that I would pay the second doctor's fee and any hospital expenses related to the mistake.

The neurosurgeon said, "Don't go on about how sorry you are; just let them know you made an honest mistake and you'll do whatever you can to make it right. I've done this several times--and I've made some big mistakes--and I've never once had it backfire on me."

About 10 years later I did that very thing--the only time in my career. I don't remember now what happened clinically. The part I remember was the strongly positive reaction by the patient's family. They not only kept me on the case, but the word went all around the little farm town about what a fine fellow I was. I learned many lessons from that, but the strongest one was the clear and strong feeling of rightness in dealing honestly with the patient's family.

Dr. Rehfeldt, may he rest in peace, was absolutely right.

C.G. DAUGHERTY, M.D.
8807 Wildridge Drive
Austin, TX 78759

REFERENCE

Brazeau, C. Disclosing the truth about a medical error [Curbside Consultation]. Am Fam Physician 1999;60:1013-14.

IN REPLY: I thank Dr. Daugherty for his reply. His comment about doing all he can "to make it right" brings up the issue of compensation. It is unfortunate that malpractice litigation is often viewed as the only way to compensate a patient for medical mistakes. In a poignant article,¹ Dr. David Hilfiker recounts some of his own mistakes and states, "Rather than establish a 'patient compensation fund' (similar to worker's compensation), we insist that the doctor be sued . . . judged guilty."

Another article² points out that our health care system has unrealistically relied on "individual error-free performance enforced by punishment" and that error prevention can best occur in a culture of "error recognition, accountability, honesty and rapid and fair settlement for injuries."

Need litigation be the main option? Could recognition of errors and fair compensation for injuries both be accepted as an inherent part of our medical system?

CHANTAL BRAZEAU, M.D.
New Jersey Medical School
Department of Family Medicine
Newark, NJ 07103-2714

REFERENCES

Hilfiker D. Facing our mistakes. N Engl J Med 1984; 310:118-22.

Leape LL, Woods DD, Hatlie MJ, Kizer KW, Schroeder SA, Lundberg GD. Promoting patient safety by preventing medical error. JAMA 1998; 280:1444-7.

Miglitol and Hepatotoxicity in Type 2 Diabetes Mellitus

TO THE EDITOR: Drs. Florence and Yeager¹ provided a current and comprehensive summary of the screening, diagnosis and treatment of patients with type 2 diabetes (formerly noninsulin-dependent diabetes). However, I want to point out that their discussion about the alpha-glucosidase inhibitors, miglitol (Glyset) and acarbose (Precose) tablets, is inaccurate with respect to hepatotoxicity.

The authors make the following statements: "Dose-dependent hepatotoxicity is associated with this drug class, so liver function tests should be carefully monitored in patients receiving higher dosages of these medications (i.e., more than 50 mg three times daily). Transaminase elevations are reversible with discontinuation of the drug and are often asymptomatic. Serum transaminase levels should be checked every three months for the first year patients take the medication and periodically thereafter."¹ These statements are misleading with respect to miglitol because one of the pivotal U.S. clinical trials revealed a similar and very low incidence of elevated liver enzymes when the drug was compared with placebo.²

As a result of these and other clinical trial safety data on miglitol, the U.S. package insert for miglitol does not contain a precaution statement about hepatotoxicity; monitoring of transaminase levels is unnecessary, and the drug is not contraindicated in patients with cirrhosis.³

In contrast, the U.S. package insert for acarbose includes the following statement in the precautions section: "In long-term studies (up to 12 months, and including Precose doses up to 300 mg t.i.d.) conducted in the United States, treatment-emergent elevations of serum transaminases (AST and/or ALT) above the upper limit of normal (ULN), greater than 1.8 times the ULN and greater than 3 times the ULN occurred in 14 percent, 6 percent and 3 percent, respectively, of Precose-treated patients as compared to 7 percent, 2 percent, and 1 percent of placebo-treated patients."⁴ According to the product label, acarbose is contraindicated in patients with cirrhosis.

A synopsis of clinical trial safety data for acarbose concluded that sustained treatment-emergent increases in serum transaminase levels of at least 1.8 times the ULN were evident in 3.8 percent of patients receiving acarbose versus 0.9 percent on placebo in U.S. clinical trials.⁵ A recent, thorough review of clinical trial safety data for miglitol confirmed that "Unlike acarbose, treatment with miglitol was not associated with elevated serum transaminase (alanine or aspartate transferase) levels."⁶ In conclusion, I want to emphasize that physicians should be aware that the alpha-glucosidase inhibitor, miglitol, has not been linked to hepatotoxicity.

RODNEY F. CARLSON, M.D.
Pharmacia & Upjohn
7000 Portage Road
Kalamazoo, MI 49001

REFERENCES

Florence JA, Yeager BF. Treatment of type 2 diabetes mellitus. Am Fam Physician 1999;59:2835-44.

Johnston PS, Coniff RF, Hoogwerf BJ, Santiago JV, Pi-Sunyer FX, Krol A. Effects of the carbohydrase inhibitor miglitol in sulfonylurea-treated NIDDM patients. Diabetes Care 1994;17:20-9.

Glyset [Package insert]. West Haven, Conn.: Bayer, 1999.

Physicians' desk reference. 53rd ed. Montvale, N.J.: Medical Economics 1999:667-9.

Balfour JA, McTavish D. Acarbose. An update of its pharmacology and therapeutic use in diabetes mellitus. Drugs 1993;46:1025-54.

Scott LJ, Spencer CM. Miglitol: a review of its therapeutic potential in type 2 diabetes mellitus. Drugs 2000;59:512-49.

IN REPLY: This letter was sent to the authors of "Treatment of Type 2 Diabetes Mellitus," who declined to reply.

Dr. Carlson is an employee of Pharmacia & Upjohn.

Corrections*

Question 26 of the March 15, 2000, "Clinical Quiz" (page 1616), pertaining to the article "Update on Colorectal Cancer," contained an unclear answer choice. Answer D should have been stated as follows: Digital rectal examination and colonoscopy every 10 years.

The article "Thyroiditis: Differential Diagnosis and Management" (February 15, 2000, page 1047) contained four incorrect dosages on page 1048 in the last complete paragraph of the right-hand column. The dosages for levothyroxine should have been expressed in micrograms, not in milligrams; the correct starting dosage for levothyroxine is 25 to 50 µg per day.

The editors of AFP welcome input concerning topics of current medical interest and feedback in response to articles and other material published in AFP. Send letters to Jay Siwek, M.D., Editor, American Family Physician, 11400 Tomahawk Creek Parkway, Leawood, KS 66211-2672; fax: 913-906-6080; e-mail: afplet@aafp.org. Please include your complete address, telephone number and fax number. Letters should be double-spaced, fewer than 500 words and limited to one table or figure and six references. Letters submitted for publication in AFP must not be submitted to any other publication. Letters pertaining to AFP subject matter must be received within two months of publication. Any financial associations or other possible conflicts of interest must be disclosed at time of submission. Submission of a letter constitutes transfer of copyright to the American Academy of Family Physicians. The editors reserve the right to edit correspondence to meet style and space requirements.

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