By Carol Murray, CPHRM, CPPS, Senior Patient Safety Risk Manager, The Doctors Company

Medication often plays a key role in psychiatric therapy. Medication regimens can, in many cases, be highly complex and involve a variety of drugs. They must meld with the other medications prescribed by both primary care physicians and specialists for acute or chronic conditions. Added to these complexities, the psychiatrist cares for patients who are sometimes resistant to therapy or profoundly limited in following complicated regimens. Psychiatric drugs may also cause adverse effects, some that can be managed or ameliorated with additional medications. Those additional medications contribute to the complexity of maintaining safe and effective patient care.

A review of The Doctors Company psychiatric closed claims from 2010 through 2022 showed that 22 percent of the cases included an allegation of improper management of the medication regimen. Contributing factors included problems with the selection and management of drugs, patient/family education about risks, medication monitoring involving ordering specific tests at predetermined times, nonadherence with the medication regimen, lack of adequate patient assessment, and weak or nonexistent informed consent related to side effects. The most frequent drug involved in these claims was lithium, at 19 percent.

The following case example illustrates the types of challenges practitioners experience with medication management.

Case Example

A teenaged patient was treated on an outpatient basis for feelings of hopelessness, depressed mood, acting out hallucinations, and poor socialization. The patient had a strong family history of depression, including suicide attempts. The patient did not report any attempts but had suicidal thoughts without a plan. The patient was diagnosed with major depression and oppositional defiant disorder. The psychiatrist saw the patient weekly for one month and prescribed the antidepressant Celexa (citalopram) 10 mg at bedtime. Celexa has a black box warning for patients under 24 years of age that they are more likely to become suicidal while taking the drug.

On the third visit, the dose was increased to 15 mg at bedtime. Two months later, the patient was reported as doing well, and Celexa was increased to 20 mg. The dosage change was documented in the medical record without a rationale for the increased dosage.

The patient was also under the care of a licensed clinical social worker for weekly visits. The social worker was responsible for assessing suicidal ideation. The patient continued to do well but had a problem at school and was suspended. The patient came home from school and committed suicide by overdose.

The medical record lacked documentation that the patient and family were advised of the risk of suicide when taking Celexa. The record stated that the social worker would work with the patient and the patient’s mother to assess for suicidal ideation, but it included no documentation of discussions between the psychiatrist and social worker about any observation of suicide concerns.

This case was difficult to defend because of documentation issues: (1) The patient record was missing documentation of medication informed consent with cautions about the medication’s risks, and (2) none of the interactions between the psychiatrist and licensed clinical social worker were recorded.

Medication Management Strategies

Consider the following strategies for effective medication management:

• Assess the patient’s medication history, including current medications and any medications prescribed in the past that caused side effects or were not well tolerated. It is vital that the medication history include prescription drugs, recreational drugs, over-the-counter drugs, supplements, and herbal medications. Patients may not always be forthcoming and may not be reliable historians. Obtain medical records from other providers, including hospitals, and ask the patient to bring in any medication bottles on hand to improve the completeness and accuracy of your records.
• Query state prescription drug monitoring programs to identify whether the patient is receiving prescriptions for the same or similar medications from other practitioners.
• Obtain informed consent for medications prescribed and document the patient’s understanding of the risks.
• Ask targeted questions to ascertain patient compliance with medications, including not taking, changing dosage, or not taking as prescribed. Enlist the help of a family member or friend (if permitted by the patient) to assist with medications and to alert you to nonadherent behaviors.
• Screen patients at each visit for vital signs, weight loss or gain, skin rashes, and other objective findings that may be due to the medication prescribed.
• Develop an office tracking process for patients who take drugs that require periodic monitoring with specific lab tests (e.g., lithium). Establishing an effective process can prevent omissions or timing errors in lab testing.
• Provide additional monitoring and oversight when using polypharmacy (combinations of medications to improve outcomes) as there may be a heightened likelihood of drug interactions and side effects from the combination. Ideally, controlled trials for polypharmacy would increase patient safety, but few studies exist. The paucity of research studies places a greater burden on the clinician.
• Share information with other concomitant caregivers and solicit information from them that is relevant to your current treatment. Regular contact with the patient’s primary care physician may be particularly valuable. Document these interactions in the medical record.
• Provide very detailed instructions and counseling to patients on how to take medication and what to watch for as possible side effects. Additional patient handouts may be available from the drug manufacturer. If any handouts are given to the patient, document the information in the medical record for future reference. Do not distribute handouts that you have not personally read and support.
• Address any healthcare literacy issues. One way to verify understanding is to ask patients to explain in their own words how they will take the medications. If you use this process, document the verification in your medical record. When patients return, have them repeat exactly how they are taking their medications.

Drug Safety

Information related to drug safety is not always clearly defined by the FDA. In an interview, Marc Stone, MD, deputy director for safety, FDA Office of Neuroscience, Division of Psychiatry, stated, “No regulations exist around the word ‘safe.’ Regulations do exist, though, around a drug company saying that their drug is ‘safer’ than another drug, or that their drug will not cause a specific type of harm.”¹ Therefore, FDA approval does not necessarily guarantee a medication’s safety.

The psychiatrist is responsible for selecting and managing the medications prescribed for a particular patient. Incorporating the medication management strategies outlined above and considering available drug safety information when selecting and managing medications can help psychiatrists keep patients safe.

For additional assistance, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.