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Case Of The Month - Past Issues

The CAP Claims Review Committee regularly reviews cases where patients allege injury caused by medication errors and adverse drug interactions. One example is alleged mismanagement of Warfarin (Coumadin), a type of claim seen regularly by the Claims Review Committee that illustrates the risk.

LACK OF PHYSICIAN KNOWLEDGE

(When You’re Playing with Fire…)

Several months after starting Coumadin, Mr. Jones called his physician, complaining of muscle pain.  A non-steroidal anti-inflammatory was prescribed for Mr. Jones’ myalgia (NSAIDs may be contraindicated in certain situations). A week later, Mr. Jones was admitted for treatment of severe gastrointestinal bleeding.

From a risk perspective, the above scenario raises questions about the physician’s knowledge at the time of prescribing (e.g. Did the physician know the contraindication for Coumadin? Did the physician review the patient’s recent bloodwork?).

“Doctors need to be clear about Coumadin’s drug interactions, absolute and relative contraindication, recommended therapeutic ranges for the treatment of different conditions frequency of monitoring and recommended dosing for both initiating therapy and providing maintenance therapy. Managing a patient on Coumadin should not involve guesswork; the stakes are too high,” says Barbara Ailor, Clinical Coordinator for the Department of Pharmacy at Los Alamitos Hospital and former Pharmacy Coordinator of a local L.A. Coumadin clinic.

“Further, since patients’ responses to Coumadin are highly variable, it is important for the physician to know the patient,” she continues. “This means regularly updating medication lists, and inquiring specifically about the patient’s use of supplements and over-the-counter drugs. It’s also important to know your patients dietary and drinking habits.”

LACK OF INFORMED CONSENT (What Patients Don’t Know Can Hurt Them)

Mrs. Smith had chronic atrial fibrillation and was prescribed Coumadin. She had many questions about her new medication. Although she left several messages for her physician, her calls went unanswered. Mrs. Smith conducted her own drug research, online, and became extremely concerned after reading testimonials from patients injured while taking Coumadin. Without her physician’s knowledge, Mrs. Smith just stopped taking her medication. Shortly thereafter, she suffered a massive, fatal stroke.

“The ultimate safeguard is an educated patient. When patients understand their medication regimen – both the why and the how— they then can play an active role in monitoring their response, they can be your greatest risk asset,” says Pharmacist-Ailor. “Patients need to know that compliance is two-fold: not only must they take their medication as prescribed, but also they must comply with the monitoring aspect of therapy. Although educating a layperson is challenging at first, the key to success is reinforcement, reinforcement, REINFORCEMENT! Once the patient gets it, they become their own best advocate,” she concludes.

In addition to an informed consent discussion, the “Coumadin Curriculum” presented to the patient might include the following:

• The rationale for prescribing Coumadin and the basic action of the drug
• The absolute need for monitoring blood levels (INR, PT) and a drug schedule
• A list of contraindicated drugs
• Signs of bleeding and precautions (including what to do in the event of a fall)
• Herbs and supplements to avoid
• The need for consistency in diet and drinking
• Caution regarding invasive procedures while on Coumadin (e.g., dental work)
• The need to observe and report changes in pill color and shape

Physicians need to meticulously document informed consent discussions in the medical record. MPTmember, Shahram Parsa, M.D., Family Practice (Torrance) understands the importance of clear documentation: “This information is too crucial to be buried or marginalized in my chart,” he says.  “When it’s Coumadin, I underline it in red . . . my chart practically bleeds! ”

LACK OF WELL-COORDINATED CARE
(Crossing your T’s; Dotting your I’s)

Mr. Smith was a 75-year old, on Coumadin for his TIAs.  His physician changed his dose to 4mg (two, 2mg pills, daily). Two weeks after the dosage change, a friend requested a refill and revealed that the patient was taking 4 mg, twice a day. The physician OK’d the refill “as directed.” Soon after, the patient was hospitalized with severe internal bleeding.

Alison Atkinson, N.P., at the office-based Anticoagulation Clinic in Redondo Beach, shares her ideas about the essential components of Coumadin management. “To ensure successful therapy, we devote a separate, highly specialized aspect of our cardiology practice to the management of this drug alone.” Mrs. Atkinson identified the following for any office/clinic managing Coumadin:

• Monitor INRs regularly and stay within recommended therapeutic ranges.
• Maintain an INR flow record documenting lab values and dosing adjustments
• Document communication to the patient regarding lab results and dosage adjustment.
• Schedule patients for their blood draws and contact them if they do not comply
• Investigate the cause of changes in the INR for established patients
• Inquire about changes in the patient’s lifestyle, diet or medications regimen
• Explain the risks to non-compliant patients and document this discussion
• Reinforce strict refill guidelines for staff

LACK OF COMMUNICATION (Assumptions Can Lead to Increased Risks)

During Mrs. Jones’s hospitalization, a consulting neurologist recommended Coumadin. The patient’s dangerously elevated, post-discharge INR was faxed to both the neurologist and the patient’s attending physician. Each physician wrongly assumed the other would provide follow-up. Two weeks later, the patient suffered a stroke.

Health care providers need to ensure a smooth transition between inpatient and outpatient care.  Often, when patients are prescribed Coumadin, there is no explicit communication between health care providers regarding who will undertake responsibility for monitoring the medication. It appears that disruptions in routine care create an increased potential for injury. The patient is particularly vulnerable during transitions (such as hospital discharges, facility transfers, initiation of therapy or discontinuance of a drug before an invasive procedure). One physician should be specially appointed to monitor a patient’s Coumadin.

Although much of the information in this article is specific to the safe management of Coumadin, many of these suggestions constitute prudent riskreduction strategies for medications with serious side effects, as well as those that require special monitoring.