As medication safety experts, pharmacy is uniquely qualified to develop and institute effective, safe medication practices. The frequency at which medication security recommendations occur during accreditation surveys clearly necessitates the development and close monitoring of safe distribution practices. The possible repercussions of insufficient oversight—inconsistent staff adherence to policies and procedures (P&Ps), noncompliant medication storage and security practices, and the incremental development of a less-than-robust safety climate—may not only result in being cited in a survey, but may ultimately harm patients. Therefore, appropriate pharmacy management of medication storage and distribution must be a daily objective.
Developing P&Ps for Medication Management
From a medication safety perspective, establishing thorough P&Ps to ensure compliant practices is central to pharmacy’s purview. The director of pharmacy must take the lead in efforts designed to ensure medications are stored and used safely. However, policies that involve a higher authority—such as CMS’s conditions of participation (CoPs) or state board regulations—should be interdepartmental, hospital-wide policies that are developed in concert with all affected stakeholders. The director of pharmacy must still lead the effort to develop, implement, and ensure compliance to institutional-specific P&Ps, but pharmacy cannot be the sole proprietor. Pharmacy should be the author and owner of these policies, but a higher authority—such as the P&T committee, other medical staff committee, or risk management committee—must approve them as well.
Occasionally, other departments will attempt to write their own medication storage policies for their respective areas, but this practice is unwise; a hospital-wide definition should apply. Nonetheless, policies should be discussed and developed in combination with the department heads in the affected areas. When developing P&Ps for other departments, it is helpful to research and utilize literature and references specific to that department. A number of nursing and anesthesiology organizations have published safe and secure medication storage guidelines, including the Association of periOperative Registered Nurses (AORN) and the Anesthesia Patient Safety Foundation (APSF). Employees in other departments will be more likely to accept the reasoning behind P&Ps and adhere to these requirements when they are based on their own literature.
Once the director of pharmacy and the other department head concur, the P&P should be adopted and medications should only be stored according to the policy specifications. Performing monthly medication area inspections will ensure consistent adherence.
Medication Transportation Policies
Some states have adopted laws that specify who may enter medication rooms and transport drugs. The first step in creating a comprehensive P&P for medication transport is to identify your state’s requirements and refine your hospital’s current policy to reflect compliance. In addition, review any medical staff bylaws that may exist at your facility. A helpful method is to enlist a new staff member—who is more likely to observe practices objectively—and perform a walk-around of the hospital to view how medications are being transported and by whom. Requesting assistance from the pharmacy-nursing committee, which is involved in day-to-day, shift-to-shift operations, may help provide an accurate account of who, besides pharmacy, is currently transporting medications.
After the current policy is clear, review procedures critically to evaluate if any changes are required. Ideally, all transport should be performed by pharmacy personnel; however, this may not be practical in some institutions. If non-pharmacy employees must transport medications, determine who will be permitted and under what circumstances. Will non-licensed employees be allowed to transport medications? An issue of particular concern is the enlistment of volunteers to perform this task. When making such a decision, consider the maturity of the volunteer and what their other duties are. In most organizations, this is not an acceptable function for volunteers. If it is permitted, it might be more acceptable to allow long-term, adult volunteers to transport medications rather than teenaged volunteers who have less wisdom and experience. A general rule is that every volunteer transporting medications should have the same documented competency that would be required of an employee. Be especially wary of permitting volunteers to transport hazardous substances or controlled medications.
After these decisions have been finalized, update the P&P to accurately reflect the changes that have been made.
Drugs Requiring Secure, Locked Storage
All controlled substances (including Schedule V drugs) must be locked, including medications that are located in physicians’ clinics, offices, and procedural areas. Particular attention should be paid to items that have not always been classified as controlled, such as testosterone injections, which must be stored in locked locations. To further ensure security, many facilities have made the decision to lock noncontrolled medications as well. If a facility wishes to store some medications in an unlocked location, a risk assessment must be undertaken to evaluate possible safety hazards and compliance issues.
A frequent concern is the use of patient medications at bedside. The CMS CoPs and accrediting organizations delineate slight variances in whether, and how, to manage medications at the patient’s bedside; therefore, the director of pharmacy must carefully evaluate the applicable regulations before determining and instituting a hospital policy. Most facilities do not permit patients to keep medication at the bedside, and those that do typically limit such medications to certain classes, such as oral contraceptives or inhalers. Moreover, who administers these medications is equally important and is a separate regulatory concern. If a patient self-administers the medication, it still must be controlled by the hospital and stored in a secure location.
Low-risk Medication Storage
Performing a risk analysis is necessary to implement a P&P for the storage of low-risk items. While some institutions have specific guidelines for conducting a risk analysis, a straightforward, pragmatic approach also can be effective. Simply walk through each department to uncover areas and medications of concern. For example, walk through each specific area and treatment room in the emergency department (ED), pretending to be a child, an adult, and a drug-seeking patient. If any items, such as povidone-iodine solution or topical anesthesia, can be identified and diverted without being noticed by a staff member, those items would likely not be considered secure by a surveyor and should be stored in a more secure location.
Because state laws vary—some specify that low-risk medications be kept in locked storage, while others are less stringent—research local regulations to identify what is required in your state. Pharmacy may choose to collaborate with the hospital’s risk manager to perform this assessment, as he or she is familiar with the day-to-day workflow of each department. The risk manager also has a slightly different purview than pharmacy, which will help ensure all angles are considered during the evaluation.
Medication Security in the ED and OR
As drug distribution in the ED has become increasingly automated, many of the medication storage issues of the past have been eliminated. EDs commonly use ADCs—sometimes supplemented by ED tackle boxes—to house the majority of medications. If your facility uses automated cabinets in the ED, ensure that there is a sufficient number of units to adequately support your volume. If P&Ps are in place but medication rounds uncover improperly stored medications, it may be indicative of an insufficient number or improper placement of cabinets.
While ADC technology has been effective in improving ED medication security, developing and instituting ED medication management P&Ps is still necessary. The P&P should specify the medication storage plan for the ED, and pharmacy must verify that this P&P is consistently followed.
In ORs, properly housing and managing anesthesia medications is the most significant concern. While anesthesia cabinets are an effective means to this end, utilizing anesthesia drug kits or tray exchanges also can be an effective solution. Adopting ready-to-use IV products for the majority of IV medications eliminates many of the safety risks of compounded IV drugs. Full compliance in the OR requires that all medications are controlled and managed; lack of a compliant medication storage plan in the OR not only exposes the hospital to regulatory and accreditation risk, but can potentially harm patients. Pharmacy directors must work together with anesthesiologists to develop a compliant plan and verify adherence.
Survey citations have demonstrated that medication security practices are insufficient at many facilities, and hence should be reviewed carefully. For example, it is not uncommon for a technician to enter a medication room to fill an ADC and leave the medication cart in the hallway. This is a potentially dangerous practice that will undoubtedly be cited by surveyors during an audit; from a risk assessment standpoint, the possibility exists that medication could be removed from the cart while the technician is in the medication room.
Another common concern is ensuring the security of medications that are transported via the pneumatic tube system. Because this technology was typically implemented years ago when heightened security requirements were not in place, pneumatic tubes often open into public areas, where drugs could potentially be accessed by other staff members, hospital visitors, and patients. Systems that were installed more recently may include a locking mechanism to circumvent this problem. Pneumatic tube systems should either include such locking technology or they must open into a staffed nursing station or locked medication room. When evaluating the security of the pneumatic tube system, be sure to review laboratory areas, as well as pharmacy.
Ensure Safe Medication Distribution Hospital-wide
In order to ensure safe medication distribution, all departments must agree on and work toward the common goal of improving patient safety. Pharmacy should be instrumental in this pursuit by interfacing with nursing, respiratory therapy, anesthesiology, and other departments to understand each area’s medication needs; these requirements should be met while simultaneously ensuring compliance. Areas that require special scrutiny include clinics, procedural areas, the interventional radiology department, employee health, and locations in the hospital that house vaccines, as these areas are most often overlooked.
The effort to develop a safe medication distribution system facility-wide must not be pharmacy-centric; rather, the process should consider the needs of the entire hospital. Listening to and communicating regularly with each department to determine how their medication needs can be safely met will improve medication management throughout the facility.
Patricia C. Kienle, RPh, MPA, FASHP, an employee of Cardinal Health since 1999, currently serves as the director of accreditation and medication safety. She is the recipient of an MPA in health service administration from Marywood College in Scranton, Pennsylvania, a BSc in pharmacy from Philadelphia College of Pharmacy and Science, and has completed an executive fellowship in patient safety from Virginia Commonwealth University. Patti is also an adjunct associate professor at Wilkes University in Wilkes-Barre, Pennsylvania.