Formularies first surfaced in inpatient settings in the 1960s, primarily to control inventory, but evolved to ensure medication safety and efficacy, minimize therapeutic duplication, and reduce cost.1 Formularies remained hospital-based until managed care proliferated in the 1980s. Escalating drug costs prompted managed care companies and other programs to adopt formularies as cost-saving initiatives.
Formularies have changed significantly in the past 40 years. Early formularies frequently resembled inventory catalogs. Today's formularies often incorporate disease management protocols and treatment guidelines. Formularies should be dynamic, constantly changing content and function and, as such, will continue to evolve.
Formularies have also changed health care. What has not changed is staff resistance, even though current objections differ considerably from those of the 1980s. Understanding the fundamental dynamics of resistance helps shape solutions.
A Case Study
In the early 1990s, the government of the District of Columbia (DC) operated multiple pharmacies under the authority of 2 separate agenciespublic health and mental health. Drug costs were skyrocketing. They decided to consolidate all pharmacies under mental health, the agency that already had a formulary.
Pharmacists began to develop a single formulary that would meet the needs of both patient populations. The Pharmacy and Therapeutics (P&T) Committee approved a formulary common to the 1990s: limited options for each drug class, automatic generic substitution, and guidelines for requesting nonformulary items.
Fierce and unrelenting resistance surfaced, some from unlikely sources. The physicians' union objected to generic substitution, stating that pharmacists were practicing medicine without a license. Their strongly-worded letters argued that the requirement to justify nonformulary items encroached on clinical autonomy and caused negative patient outcomes. They vilified managers as cold-hearted, penny-pinching, and insensitive. Senior public health managers objected to transferring budgets and staff in the consolidation; they insisted pharmacy's centralization and formulary would destroy their specialized clinics that needed flexible prescribing authority, something their pharmacy staff respected.
In the first year, the consolidated system saved $2 million. Concurrent with formulary implementation, the P&T Committee conducted drug utilization reviews assertively and issued new PRN ("as needed") guidelines. Both actions decreased adverse events. Within 2 years, staff resistance faded to the background, as tailored interventions addressed the motivation and concerns underlying each type of resistance.
Resistance to change, including formulary expansion, emanates from different organizational dynamics, including:
Summarily dismissing resistance as a normal reaction is a grave mistake, and frequently becomes the Achilles' heel to genuine change. The objections of staff may be valid and should be addressed. Proposed changes may be poorly designed or incompatible with clinical standards, or involve unnecessary activities.5
Invalid objections also must be addressed. Perception is reality. In the DC experience, for example, generic substitution was not practicing medicine without a license, as physicians could always request exceptions. Attorneys clarified licensing laws. Upon closer examination, however, generic substitution was not the real issue. This is often the case. Physicians actually were more concerned about additional paperwork, which was modified with their input.
Resistance resulting from status quo satisfaction is low-grade.4 Generally, aggressive education by well-respected colleagues is successful. Externally driven resistance to change directed from the top, such as a distant central headquarters, tends to be magnified. The challenge is that those internal to the affected agency feel disrespected and slighted. This is what occurred in DC; direct patient care clinicians viewed policymakers as disconnected from front-line clinical care. Several medical directors and medical staff thought leaders were recruited for input and mediation.
The best offense prevails over defense. Responsibility for managing change must be clearly designated. The P&T Committee, for example, assumed direct responsibility for formulary management.
Analyzing potential objections and misperceptions is critical. Providing accurate and detailed information is only the first step, and rarely effective alone. Unless timing dictates otherwise, the pharmacist should seek participation and involvement from those affected, or obtain it after implementation, explaining why timing prevented earlier outreach.
Also, the pharmacist should acknowledge and openly address resistance and feelings. He or she should address known stumbling blocks up front, but balance them with their positive sides. Staff often has excellent suggestions for minimizing disruption. Using incentives or cost-shifting measures, like multitiered copayment systems, also allows patients to help implement the formulary.
Incentives need not be financial. Prior to the DC formulary, frequent stock outages frustrated clinicians and patients at public health clinics. The formulary effectively tracked inventory, and within months, out-of-stock items were rare. Previously, tuberculosis or STD clinic staff counted from open stock; they appreciated prepackaged doses provided after the switch. Also, with a single information system tracking prescriptions, patients filling duplicate prescriptions from multiple clinics were identified, eliminating waste. These improvements were well publicized in the pharmacy newsletter. Celebrating success is fundamental in implementation strategy.
Finally, the pharmacist should actively monitor and resolve conflict and resistance using negotiation.5 In this experience, several compromises were reached for staff reassignments, and while not ideal for either side, it facilitated implementation.
Today, formularies are common, but their function continues to be debated, and changes are still resisted. The best formularies result from examining clinical ramifications, including their impact on physician workload and patient outcome.6 As formularies continue to change, so will our experience for managing change.
Dr. Zanni is a psychologist and health-systems consultant based in Alexandria, Va.
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