The Pharmacist's Duty to Warn

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Notes

Prempro® is a registered trademark of Wyeth Pharmaceuticals, Inc. that contains a combination of estrogens and a synthetic progestin. Product information is available at http://www.prempro.com/prescribing.aspx (last visited Mar. 21, 2010).

Thrombotic events, or blood clots in the large veins within the body, may result in pulmonary emboli which can be life threatening. Acetylsalicylic acid, such as Bayer® aspirin, acts as an inhibitor of clotting, and may be indicated to prevent clotting in patients with a history of a thrombotic disorder to prevent pulmonary emboli. Product information is available at http://www.aspirin.com/scripts/pages/en/home.php (last visited Mar. 21, 2010).

Prozac® is a registered trademark of Eli Lilly and Company. It is generically known as fluoxetine hydrochloride, and is a selective serotonin reuptake inhibitor. It is used to treat depression as well as several other psychiatric diagnoses. Product information is available at http://www.prozac.com/index.jsp (last visited Mar. 21, 2010).

Coumadin® is a registered trademark of Bristol-Meyer Squibb Company, and is known generically as warfarin. Product information is available at http://www.coumadin.com/ (last visited Mar. 21, 2010).

Nardil® is a registered trademark of Pfizer, Inc., generically known as phenelzine sulfate. The drug is a monoamine oxidase inhibitor, and is contraindicated for use with patients taking a selective serotonin reuptake inhibitor—especially fluoxetine (Prozac®). Concomitant use of this combination may cause hyperthermia, rigidity, myoclonic movements, and death. See Nardil Product Information, http://media.pfizer.com/files/products/uspi_nardil.pdf (last visited Mar. 21, 2010).

Brian L. Porto, Civil Liability of Pharmacists or Druggists for Failure to Warn of Potential Drug Interactions in Use of Prescription Drug, 79 A.L.R.5th 409 (2000).

McKee v. American Home Prods., Corp., 782 P.2d 1045, 1050-51 (Wash. 1989) (citing William Prosser & W. Page Keeton, Prosser and Keeton on Torts 688 (5th ed. 1984)).

Id. at 1051.

Id. (citing Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 88 (E.D. Pa. 1986)).

Porto, supra note 6, § 3.

Inst. of Med., Health Literacy: A Prescription to End Confusion (2004).

McKee, 782 P.2d at 1049.

Id.

Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 395 (Ill. 1987).

McKee, 782 P.2d at 1053.

Id.

Id. at 1054.

Bobay v. Walgreen Co., No. 1:07-CV-119RM, 2009 WL 1940727, at *9 (N.D. Ind. 2009).

Id.

Amy L. Friedman et al., Medication Errors in the Outpatient Setting, 142 Arch. Surg. 278, 282 (2007).

McKee, 782 P.2d at 1054.

Audrey J. Lee et al., Clinical and Economic Outcomes of Pharmacist Recommendations in a Veterans Affairs Medical Center, 59 Am. J. Health-Sys. Pharmacists 2070, 2075 (2002).

Baker v. Arbor Drugs, Inc., 544 N.W.2d 727, 737 (Mich. Ct. App. 1996).

Kimberly Burns & Alan Spies, A Pharmacist's Duty to Warn: Promoting the Acceptance of a Consistent Legal and Professional Standard, 47 Duq. L. Rev. 1, 22 (2009).

Id.

Dooley v. Everett, 805 S.W.2d 380, 384 (Tenn. Ct. App. 1990) (citing Batiste v. American Home Prods. Corp., 231 S.E.2d 269, 273-74 (N.C. Ct. App. 1977)).

Id.

Hooks SuperX, Inc. v. McLaughlin, 642 N.E.2d 514, 519 (Ind. 1994).

Dooley, 805 S.W.2d at 380.

Theophylline is a generic drug that is used to treat asthma symptoms. For product information regarding Uniphyl®, a brand manufactured by Purdue Pharmaceutical Products, see Uniphyl Tablets, http://www.purduepharma.com/PI/Prescription/Uniphyl.pdf (last visited Mar. 21, 2010).

Erythromycin is a generic drug that is primarily used to treat upper and lower respiratory infections. One brand of erythromycin is ERY-TAB®, which is manufactured by Abbott Laboratories; product information is available at http://www.rxlist.com/ery-tab-drug.htm (last visited Mar. 21, 2010).

Dooley, 805 S.W.2d at 382.

Id.

Id.

Id. at 382-83.

Id. at 383.

Alison G. Myhra, The Pharmacist's Duty to Warn in Texas Reconsidered Within a National Framework, 27 Rev. Litig. 607, 642 (2008).

See, e.g. Podgurski v. United States, No. Civ.CCB-03-3180, 2005 WL 2338851 (D. Md. Sept. 21, 2005).

Id. at *3; Moore v. Wyeth-Ayerst Labs, 236 F. Supp. 2d 509, 512-13 (D. Md. 2002) (citing People's Service Drug Stores v. Sommerville, 158 A. 12, 13 (Md. 1932)).

Baker v. Arbor Drugs, Inc., 544 N.W.2d 727, 737 (Mich. Ct. App. 1996).

Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1129 (Ill. 2002).

Id. at 1124.

Inst. of Med., supra note 11.

Riff v. Morgan Pharmacy, 508 A.2d 1247, 1253-54 (Pa. 1986).

Id.

Id. at 1247.

Cafergot is a combination of caffeine with ergotamine tartrate used to treat migraine headaches, and is dispensed in the form of suppositories. Product information is available at http://www.pharma.us.novartis.com/product/pi/pdf/cafergot_sup.pdf (last visited Mar. 21, 2010).

Riff, 508 A.2d at 1249.

Id. at 1253.

Jeffrey Woldt, Community Pharmacy Reaches a Turning Point, Chain Drug Rev., Aug. 28, 2000, at 8.

Ka Wae, et al., Detection and Prevention of Medication Misadventures in General Practice, 20 Int'l J. for Quality Health Care 192, 195-97 (2008).

Id. at 196.

42 U.S.C. § 1396r-8(g)(2)(A)(i) (2006) (emphasis added).

Jennifer L. Smith, Between a Rock and a Hard Place: The Propriety and Consequence of Pharmacists’ Expanding Liability and Duty to Warn, 2 Hous. J. Health L. & Pol'y 187, 210 (2002).

Id. § 1396r-8(g)(2)(A)(ii)(I) (emphasis added).

Burns, supra note 24 (citing Jesse C. Vivian & Joseph L. Fink III, OMBRA ‘90 at Sweet Sixteen: A Retrospective Review, 33 U.S. Pharm. 59, 65 (2008) (revealing that there are only six published opinions addressing the pharmacist's standard of care under OMBRA 90)).

Id. (citing Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (2003)).

Lee, supra note 22.

Friedman, supra note 20, at 280.

Id. at 282.

42 U.S.C. § 1396r-8(g)(2)(A)(i) (2006) (emphasis added); 42 U.S.C. § 1396r-8(g)(2)(A)(ii)(I) (2006) (emphasis added).

Daniel S. Budnitz et al., National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events, 296 J.A.M.A. 1858, 1863 (2006).

Id.

Id. at 1860.

H.R. Jennings et al., Reducing Anticoagulant Medication Adverse Events and Avoidable Patient Harm, 34 Joint Comm'n J. Quality & Patient Safety 196 (2008).

Id.

Edward Casmere, RX for Liability: Advocating the Elimination of the Pharmacist's No Duty to Warn Rule, 33 J. Marshall L. Rev. 425, 461-63 (2000).

John C. Smith & David E. West, A Prescription for Liability: The Pharmacy Mandate of the Omnibus Budget Reconciliation Act of 1990 and Its Impact on Pharmacists’ Common Law Duties, 2 J. Pharmacy & L. 127, 141 (1993).

Harris Flemming, Jr., No Rest for the Weary, Drug Topics, June 21, 1999, at 50.

Bobay v. Walgreen Co., No. 1:07-CV-119 RM, 2009 WL 1940727, at *7 (N.D. Ind. June 30, 2009).

V.H. Poole et al., Estimating the Cost of the Medicare Pharmacist Services Coverage Act of 2001, 23 Pharmacotherapy 955, 955-65 (2003).

Id.

Jeffrey A. Johnson & Lyle Bootman, Drug-Related Morbidity and Mortality: A Cost-of-Illness Model, 2 J. Managed Care Pharm. 39, 41 (1996).

Id.

T.L. Humphries et al., Evaluation of an Electronic Critical Drug Interaction Program Coupled with Active Pharmacist Intervention, 41 Annals Pharmacotherapy 1979, 1979-85 (2007).

Id.

Harit U. Trivedi, A Pharmacist's Duty to Warn: Sound Economics, Effective Medicine, and Consistent with Drug Regulation Theory, LEDA at Harvard Law School, available at http://leda.law.harvard.edu/leda/data/100/htrivedi.html (last visited Mar. 21, 2010) (citing Smith & West, supra note 68, at 140).

B. DeName et al., Identification of Medication-Related Problems and Health Care Provider Acceptance of Pharmacist Recommendations in the DiabetesCARE Program, 48(6) J. Am. Pharm. Ass'n 731, 731-36 (2008).

Lee, supra note 22, at 2073.

Id.

R.J. Zunker & D.L. Carlson, Economics of Using Pharmacists as Advisers to Physicians in Risk-Sharing Contracts, 57 Am. J. Health-Sys. Pharmacists 753, 753-55 (2000).

Tejal K. Gandhi et al., Patient Safety: Adverse Drug Events in Ambulatory Care, 348 N. Eng. J. Med. 1556, 1560 (2003).

Friedman, supra note 20, at 280.

Id. at 282.

Id.

W.N. Kelly, Potential Risks and Prevention, Part 4: Reports of Significant Adverse Drug Events, 58 Am. J. Health-Sys. Pharmacists 1407 (2001).

Lee, supra note 22, at 2074.

Id. at 2076.

Id.

42 U.S.C. § 1396r-8(g)(2)(A)(i) (2006); id. § 1396r-8(g)(2)(A)(ii)(I).

See the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (2010), available at http://democrats.senate.gov/reform/patient-protection-affordable-care-act-as-passed.pdf (last checked May 25, 2010).