Adverse outcomes from prescribed medications are often more complex than the result of prescribing the wrong drug for the diagnosis. Adverse effects, toxicities and contraindications can commonly be predicted by and are related to the pharmacology of the drug. Drug interactions causing treatment failures or undesired adverse outcomes are increasingly the result of complicated drug metabolizing enzyme or transporter processes, some of which have a genetic variant component. A pharmacology expert will be a resource to make factual statements identifying association or causation in a medication litigation case. More importantly, the right expert in a medication related case will thoroughly evaluate and convey the pharmacologic basis for the clinical outcome. Importantly, the same expert may also determine that an adverse medication event was idiosyncratic or otherwise unrelated to the prescribing, dispensing or administration of a drug.
Community Pharmacy Expert
In the 21st Century, the professional training to become a pharmacist requires the successful completion of a doctorate level degree (Doctor of Pharmacy, or PharmD). This training reflects the ever increasing number and complexity of medications approved by the US Food and Drug Administration. Some pharmacists also pursue post-graduate residency training in focused areas of practice. These factors have resulted in the ability for pharmacists in the community setting to provide a more comprehensive role in patient care, including what is known as collaborative drug therapy management or medication management. Regardless of the state of advanced practice that a community pharmacist maintains, a community pharmacist has a duty to evaluate each prescription for appropriateness in the context of known drug and patient specific variables, and the accuracy of dispensing the prescribed medication remains critical. Unfortunately, errors may still occur in the dispensing process and in the accurate processing of prescriptions associated with drug interactions, duplications, dosage errors, warnings and contraindications. A pharmacy expert with an academic background and a personal understanding of the nature of pharmacy practice in the community setting can be an important resource in a medication litigation case, addressing standards of care and evaluating the pharmacologic and therapeutic basis of a medication related case.
Hospital Pharmacy Expert
In hospitals, the role of the pharmacist has evolved over many decades to include far more than the oversight of dispensing medications to acutely ill patients. There has been a clear shift toward higher patient acuity among hospitalized patients and an increasing complexity of medications used in the acute care setting (including but not limited to chemotherapy, biologics and antibiotics). These factors warrant the oversight of medication use by pharmacists with post-graduate residency training or extensive experience. The hospital pharmacist’s practice may involve autonomous or collaborative management of medication therapies such as: pharmacokinetic dosing of aminoglycosides or vancomycin; adjustment of drug doses based on kidney or liver function; alteration of antibiotic selection or route of administration based on clinical data; and discontinuation of overlapping or unsupported therapies. Additionally, the task of medication reconciliation at transitions of care is well suited for involvement or management by a pharmacist in collaboration with a prescriber, and many health systems now place a pharmacist in the admission, discharge and transfer process to facilitate optimal continuity of a patient’s medication list. Coincident with ever-increasing regulatory standards applied to sterile and hazardous drug handling, a hospital pharmacist also has the burden of assuring not only the accuracy but the sterility of compounded sterile (injectable) medications while minimizing unintended exposure of potentially hazardous drugs to patients and healthcare workers alike. A hospital pharmacy expert can be an important resource in a medication litigation case, evaluating apparent dispensing errors, addressing standards of care related to medication use in the hospital or health-system setting, and evaluating the pharmacologic and therapeutic basis of a medication related case attributed to one or more points along the medication management continuum.
Clinical Pharmacy Expert
In some hospitals or health system associated outpatient clinics, clinical pharmacy specialists with advanced training in targeted areas of healthcare engage in collaborative or autonomous activities to manage medication treatment plans. In the hospital, these activities may encompass therapeutic drug monitoring, renal dosing of medication and antimicrobial stewardship. In the clinic setting, a pharmacist’s patient focused services may include medication management of anticoagulation, diabetes, hyperlipidemia, hypertension, asthma, cancer, HIV, and hepatitis, among others. Advanced practice in these areas is associated with increased accountability for outcomes, including potential misadventures. In a medication related litigation, an expert with direct or management experience in areas of clinical pharmacy or ambulatory care pharmacy practice can provide valuable perspective. The expert can address standards related to a prescriber’s or pharmacist’s management of a patient’s medication regimen, including but not limited to the context of current guidelines, and the underlying pharmacologic basis of therapeutics.