As health systems transition into integrated delivery networks with an array of outpatient locations, pharmacy leaders are tasked with responding to new challenges in the pharmacy supply chain created by these expanded footprints. Physician offices typically do not have the same infrastructure (eg, software, hardware), security, and oversight, and may not even adhere to the same regulatory standards as hospitals. Thus, it is crucial to review some important principles related to medication management in the physician clinic setting.

Regulatory Compliance for Physician Clinics

A number of key considerations supporting the safe stocking and use of medications in physician offices and clinics must be evaluated. For example, it is important to recognize that hospital-owned or affiliated clinics may have different, and in many cases fewer, regulations to abide by compared with hospitals.

Provider-based clinics are considered outpatient departments of the hospital and thus are usually held to the same regulatory requirements as the hospital, including Centers for Medicare and Medicaid Services (CMS) and accreditation bodies, such as The Joint Commission. Conversely, stand-alone or non-provider-based clinics are usually not considered part of the hospital, and consequently may not fall under the same rigorous CMS and Joint Commission regulations.

Nevertheless, regulatory bodies such as the Drug Enforcement Agency (DEA), board of pharmacy, FDA, Environmental Protection Agency (EPA), and other government organizations, may hold all sites under the health-system umbrella to the same expectations. As a result, the critical questions to answer when considering support of physician offices and clinics are:

• Which regulations are enforceable in this setting?
• Does the health system have different compliance expectations for different sites?

At Novant Health, pharmacy works in close partnership with medical group administration to ensure regulatory compliance of all clinics under the health system. Given the complexities of regulatory requirements and our commitment to providing a high standard of care in all facilities, a decision was made to hold all of our clinics, whether provider-based or non-provider-based, to the same regulatory standards with regard to pharmaceutical management. There are both risks and benefits to this decision; while holding all physician offices and clinics to the same regulatory standards simplifies the development of policies and training procedures, it also may increase costs due to an added regulatory burden at sites that otherwise may not require it.

To ensure that all health-system clinics are compliant with regulatory requirements, staff training, education, and formulary considerations must be addressed. Medication management strategies relevant to specific medical group needs (ie, refrigeration, multi-dose vials, controlled substances, etc) must be developed. Clinic-specific policies must also be established to address vendor access to clinics, recall and distribution processes, compliance with the Drug Supply Chain Security Act (DSCSA), as well as matters of auditing and disaster response.

Staff Training and Education

Regardless of the regulatory approach taken with a given clinic, training and education must be developed to support staff in maintaining compliance with relevant laws, regulations, and policies. When developing and implementing a training program, consider the various staff members and structures that may exist in a clinic versus those within the hospital. For example, depending on the clinic’s workflow, the procurement and storage of pharmaceuticals may be managed by nurse assistants, registered nurses, clinic managers, or providers. Specific responsibilities, as well as any limitations, for certain staff members must be delineated, and appropriate training and resources should be readily available. Pharmacy should play an instrumental role in developing the education and training program for the clinic group(s).

To increase standardization and improve formulary management across all clinics, our health system recently overhauled its medication procurement policy. At the outset, we engaged with medical group compliance to gain input on staff member expectations, competencies, and proposed workflows. Medical group compliance recommended the development of a streamlined policy and procedure (P&P) to aid with training, as well as a detailed standard operating procedure that would be kept within pharmacy for staff use and as a resource for the clinics. This P&P describes different procurement methods, clinic and pharmacy staff expectations, anticipated delivery times, purchase order requirements, and includes our standardized medication order forms.

Medical Group Formulary

Historically, many pharmacy and therapeutics (P&T) committees have not included physician clinics within their purview. As a result, well-established processes, such as considerations for high-alert medications, look-alike/sound-alike (LA/SA) drug review, and place in therapy may be new concepts for clinic staff.

The first step in establishing the medical group formulary is to determine the P&T committee’s role in managing the medical group formulary. Consider whether P&T membership will need to change to support this expanded effort, and examine existing processes or committees within the physician group in order to avoid duplicative or conflicting oversight.

The following formulary questions must be addressed:

• What are the requirements for adding or stocking a medication in the clinic setting?
• Does the hospital high-alert medication list and LA/SA medication list/policy apply?
• Is it necessary to add medications to these lists that are used only in the clinics?

The Novant Health system has adopted a standard P&T process of reviewing medications for clinical gap analysis, safety, efficacy, and affordability for use in every health-system setting. Note that payer formularies and reimbursement should be assessed with regard to medication use in the clinic setting. Because the comprehensive, consistent approach to all high-alert and LA/SA medications makes training, education, and enforcement easier, we apply these standard alerts to medications in all clinics.

Several types of medications may require specific scrutiny given the unique challenges they pose in the physician clinic setting. These medications are discussed in the SIDEBAR.

Process Considerations

Vendor Access

Pharmaceutical vendors’ access to hospital staff is typically strictly controlled and relatively easy to enforce within the walls of the hospital. However, outside of that environment, pharmaceutical vendor management can be significantly more challenging. Pharmacy leaders must establish their position on pharmaceutical vendor access in the clinic setting.

Novant Health has experienced issues with vendors providing education that conflicted with both our formulary and our internal staff education. Such discrepancies can increase the risk of medication safety events. However, we also recognize that vendors can be a source of important training and education, particularly for products such as vaccines. As a result, in partnership with other stakeholders across the health system, we have updated our policy to require prior approval for vendors to access clinics, in order to maximize their role as helpful resources.

Recalls

As pharmacy leaders expand their oversight to physician clinics, the recall response plan must be reviewed. Consider how communication of recalls will occur, and what processes will need to be in place to segregate and return recalled medications. Software solutions that support recall management in the clinic setting should be investigated. In addition, pharmacy must develop a strong partnership with risk management to respond to recalls that reach clinic patients. Collaboration is key to managing the response and notification at the patient level.

Distribution Methods

Because many physician clinics operate across a large geographic area with varied medication use, distribution of pharmaceuticals can be a challenge for pharmacy leaders. Large distributors may not be familiar with serving clinics. Conversely, some distributors have a separate division dedicated to serving physician clinics; however, this division may have more limited access to medications than a typical wholesaler. As a result, pharmacy leaders must determine the optimal distribution methods for physician clinic medications (see TABLE 1 for the pros and cons of the various distribution methods).

DSCSA Compliance

Passed in 2013 as part of the Drug Quality and Safety Act, the Drug Supply Chain Security Act (DSCSA) has been actively rolling out a system to ensure the integrity of the pharmaceutical supply chain.1 The primary feature of this system to date is the requirement of 3T information (transaction information, transaction history, and transaction statement), along with the purchase information for medications; this data must be stored in a readily retrievable format for a set period of time.2 These requirements hold true across all settings of care, so pharmacy leaders will need to consider how their DSCSA compliance program will be managed in the clinic setting.

Our health system has partnered with a third-party vendor to support all DSCSA compliance. While Novant Health purchases most medications through our distributor, a significant amount is acquired through other means. As a result, our third-party vendor maintains records for all purchases, including those in the clinic setting, either via electronic delivery or through a scan and log system, for a nominal fee per site per year, which is paid by the clinic. The corporate pharmacy team supports compliance with this program.

Auditing

Auditing is essential to provide support and oversight of medication management in the physician clinic setting. Pharmacy leaders should work with appropriate stakeholders in compliance, internal audit, risk management, and physician clinic administration to identify appropriate resources and establish audit schedules (see TABLE 2). Key areas to consider auditing include:

• Controlled substances
• Single-dose vials (SDVs)/multi-dose vials (MDVs)
• Sample medications
• Vaccine storage and handling
• Temperature logs
• Training/education of new employees

Click here to view a larger version of this Table

Disaster Response

Reinforced by The Joint Commission requirements, hospitals have a long tradition of establishing and practicing responses to a variety of disaster scenarios. As hospitals extend their networks to new sites, the complexity of these disaster responses and exercises increases and may require new plans for managing medications.

Unlike hospitals, clinics do not typically have access to generator power, so backup plans must address transport and/or storage of medications in the event of a power failure. For example, leaders may consider proactively relocating pharmaceutical inventories if flooding or strong storms are predicted, as roads may become impassable. Depending on the inventory volume, backup storage sites may be required, and processes will need to account for and eventually return medications and vaccines to their original locations.

In response to Hurricane Florence, Novant Health centralized high dollar medications to the regional hospital, Brunswick Medical Center, for the duration of the storm. This centralization required limited courier resources and organization. Given the costs and risks associated with the storm, our proactive efforts paid off, as many clinics were without power and inaccessible for an extended period of time during and after the hurricane.

Future Goals and Challenges

As the Novant Health System expands, the pharmacy team maintains its focus on providing safe, effective, and affordable medications. This goal requires continual strengthening of pharmacy’s partnerships with key stakeholders across the health system to increase standardization, implement or update processes, improve training and education, and provide an appropriate audit structure to ensure the effectiveness of our medication management system.

Looking to the future, key challenges will include optimizing pharmaceutical inventories in physician clinics, improving recall and DSCSA processes, expanding the diversion management program to support practice at all sites within the health system footprint, increasing our data and analytics capabilities to identify new opportunities in the supply chain, and ensuring all staff and systems are prepared to properly handle the next disaster—because there always is a next one.

References

1. US Food and Drug Administration. Drug Supply Chain Security Act. www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa. Accessed July 10, 2019.
2. US Food and Drug Administration. Drug Supply Chain Security Act Product Tracing Requirement Frequently Asked Questions. www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-product-tracing-requirements-frequently-asked-questions. Accessed July 10, 2019.

W. Joseph Maki, PharmD, MS, is senior director of pharmacy business operations at Novant Health in Winston-Salem, North Carolina. He received his PharmD from the University of Wisconsin-Madison and completed a 2-year health system pharmacy administration residency/MS at Wake Forest Baptist Medical Center and the University of North Carolina—Chapel Hill. Joe’s professional interests comprise the business of pharmacy, including procurement, contracting, revenue cycle, and the 340B program.

SIDEBAR

Clinic-Specific Medication Management Strategies

Refrigerated/Frozen Products
Physician clinics often do not have the same medical-grade refrigerator and freezer infrastructure that is found in hospital pharmacies and nursing units. It is not uncommon for clinics to utilize dorm-style refrigerators or household combination refrigerator/freezer units, despite the fact that they are not designed to maintain temperatures to the same standard as medical-grade refrigerators. While the temperature may appear consistent, units designed for home use go through highly variable thaw cycles that could potentially compromise refrigerated or frozen products even without a specific incident, such as a power outage. Note that some medications, such as vaccines, may require medical-grade units.

Our health system has adopted the exclusive use of medical-grade refrigerators across all clinics to ensure medications are stored in the safest manner. Nonetheless, excursions can and do happen, so pharmacy partners with medical group risk and compliance staff to investigate and mitigate excursions, including collecting incident data, segregating stock, and facilitating returns.

Single-Dose vs Multi-Dose Vials
MDVs are popular for obvious reasons: decreased waste, longer dating, and improved ease of use. However, they are particularly challenging to manage, as labeling, dating, and disposal can be inconsistent.

If MDVs will be utilized in clinics, determine how appropriate labeling and expiration dating requirements will be ensured. To avoid potential patient harm from inappropriate MDV use, we treat all medications as SDVs (with a few exceptions, such as vaccines). With clear expectations communicated to all staff, this strategy has simplified management of these medications and is easily enforced system-wide.

Rescue Medications
When responding to emergencies, physician clinics operate either as Advanced Cardiac Life Support (ACLS) clinics or 911 clinics. As the name implies, ACLS clinics have the appropriate supplies, equipment, and trained staff to administer ACLS to stabilize patients while arranging transport to a higher level of care. These clinics typically utilize a crash cart, sometimes supplied by the associated hospital. When supplying a crash cart tray for a physician clinic, pharmacy should ensure clinic staff are trained and competent to perform ACLS.

Clinics without ACLS capabilities simply call 911 in response to a patient emergency, as staff at these sites may be trained only in basic life support. These clinics will not typically order or store drugs that would only be used in ACLS situations. However, commonly used drugs to treat allergic reactions to medications, such as diphenhydramine, dexamethasone, and EpiPens, may be stored and administered, and as such warrant careful scrutiny from pharmacy leadership.

Controlled Substances
With the impact of the opioid epidemic apparent nationwide, there has been increased scrutiny of the use of controlled substances in all health-system settings; clinics are no exception. Pharmacy leadership will be expected to provide oversight for and ownership of controlled substances in the physician clinic setting. Audits must be performed by designated parties (such as pharmacy or non-pharmacy audit and regulatory staff) to ensure adherence to P&Ps. In addition, monitor non-opiates with a high risk of diversion, such as testosterone products.

For any clinics that maintain their own DEA license, the parties responsible for registration must be established; similarly, determine how Form 222 (and any other forms) will be stored and maintained.

At Novant Health, a pharmacy technician operates as our DEA specialist and performs regular audits with the internal audit group to monitor compliance with laws, regulations, and policies at all sites, including physician clinics. A standard process is in place for ordering, transporting, receiving, and documenting controlled substances.

Medication Samples
As pharmacy leaders are well aware, the issue of whether to allow sample medications has been controversial for many years. In defense of samples, they can be useful as a short course of therapy to determine effectiveness and patient tolerance, and they often serve as a safety net for patients who otherwise could not afford certain therapies. Conversely, the potential for misuse increases the risk of patient harm.

Because The Joint Commission expects samples to be handled similarly to other medications,1 including following all relevant labeling, dispensing, and counseling requirements, the clinic must establish clear processes for dispensing samples. Our health system has standardized sample management, ensuring that all clinics uphold The Joint Commission requirements for storage, handling, and dispensing.

Vaccines
Vaccines often require refrigerated or frozen storage, in addition to other special handling considerations. First, pharmacy leaders should work with the P&T committee and/or physician clinic stakeholders to determine whether a vaccine formulary is appropriate for the health system, and whether one consistent formulary is appropriate for all settings. Having a single formulary provides a number of advantages, including contracting opportunities, streamlined education, and, most importantly, reduced risk of errors resulting from different vaccine schedules. To support vaccine use across physician clinics, a thoughtful cold chain transport P&P is necessary, along with appropriate refrigerator/freezer units and a temperature excursion response process.

For clinics that participate in the Vaccines for Children program,2 a host of requirements for ordering, storage, and documentation must be followed. This extraordinarily beneficial program requires specific training that pharmacy is in a position to support.

Sidebar References

1. Joint Commission Requirement. Applicability of MM Standards to Sample Medications. www.jointcommission.org/assets/1/18/JCP0114_MM_Stds.pdf. Accessed July 19, 2019.
2. Centers for Disease Control and Prevention. Vaccines for Children Program. www.cdc.gov/vaccines/programs/vfc/index.html. Accessed July 10, 2019.