Q & A with Darryl S. Rich, PharmD, MBA, FASHP
Surveyor, Division of Accreditation
and Certification Operations
The Joint Commission (TJC)

Pharmacy Purchasing & Products: Which medication management (MM) standard posed the greatest challenge to hospitals in 2009?
Darryl Rich: About one-third of organizations struggled with MM.03.01.01, the medication storage standard. The biggest challenge with compliance to this was ensuring medication security. We require organizations to keep medications stored according to the Centers for Medicare and Medicaid Services (CMS) interpretive guidelines for medication security, which are more stringent generally than state laws, and many hospitals are not familiar with these guidelines. For example, some organizations assume that a locked cart is fine, which is not the case. CMS is clear that locking a mobile cart by itself is not sufficient. It needs to be under constant surveillance, in a locked room, or tethered so it is not mobile. Therefore it is important for every pharmacy director to review the CMS interpretive guidelines.

Insufficient storage space is a common hindrance for many hospitals. A facility without a designated storage area may store carts in the hallway for convenience. In addition to possibly violating CMS regulations, we find hallway clutter to be a red flag for life safety code violations. I suggest this be evaluated as part of a hospital’s monthly safety inspection rounds. Pharmacy should participate in those inspections to make sure all medications are secure and appropriately stored.

Other challenges we have seen with the medication storage standard relate to managing inventory when a refrigerator goes out of range and understanding expiration dating on multi-dose vials.

PP&P: In regard to refrigerator temperature going out of range, are organizations with automated temperature monitoring having more success?
DR: Yes, hospitals with automatic temperature monitoring systems do score better. However, simply having the system does not guarantee compliance. The key with this issue is having a distinct action plan in place in the event of an out-of-range temperature alert. We expect organizations to determine whether those drugs are still good. That means reviewing the package insert, calling the manufacturer, and ensuring the product remains stable for the length of time the temperature was out of range. With an automated system, prompt alerting allows staff to address the problem quickly. In many cases, the product will remain stable because the temperature in the refrigerator does not drop significantly in an hour. But if the refrigerator goes out of range over a weekend and is only checked periodically, the likelihood of product loss is much greater.

PP&P: Do you request documentation on how hospitals are resolving alerts?
DR: No, but we do want to know what happens when a temperature goes out of range. If a nurse tells us that they contact the pharmacy and the pharmacist tells us that under those circumstances they normally check with the manufacturer to see if any products need to be pulled, that is acceptable to us. On the other hand, if the nurse tells us that they contact maintenance to get the refrigerator checked but do not notify the pharmacy, then there is a problem.

PP&P: Why is expiration dating on multi-dose vials such an issue for pharmacies?
DR: USP and APIC clearly indicate that multi-dose sterile vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise. Yet we continue to see facilities taking different approaches; I was in a hospital that used 60 days as their expiration time and we find many facilities using 30 days. We often see noncompliance in the ambulatory environment, where they may only use one dose in a month and are concerned that they have to throw 98% of the multi-dose vial out. Another important point is that the vials must be relabeled with the new beyond-use date or expiration date, not the date opened. This summer we posted five new FAQs on our Web site to clarify these requirements further (www.jointcommission.org/AccreditationPrograms/Hospitals/Standards/09_FAQs/MM/Multi-dose_Vials.htm).

PP&P: What was another problematic MM standard?
DR: Compliance with MM.04.01.01, which deals with medication ordering, presented problems for many organizations, specifically element of performance (EP) 13, which relates to implementation of policy. The particular problem was failure to clarify unclear, illegible, or incomplete orders. We commonly find this with titration drips. An order might state, “titrate propofol,” but provide no guidelines as to initial rate or the parameters to titrate. Organizations need to have a protocol for this, but too often pharmacists fail to clarify this when they receive a titration order lacking protocol or titration parameters.

We also found some problems with consistent interpretation of range orders, though most organizations are starting to address this. We expect to see a consistent interpretation of range orders by all nurses (eg, under what conditions nurses would use the high versus the low dose in the range). Creating a policy or a protocol guideline for interpreting range orders, and then educating the nurses has helped organizations improve compliance with this. As far as unclear, incomplete, or illegible orders, this also is a matter of training and education.
 
PP&P: What issues are organizations having with MM.05.01.01?
DR: There have been two common challenges with compliance to this standard. One, which has been around for a while, has to do with pharmacists not reviewing orders, and the most common areas for noncompliance are often in radiology and nuclear medicine involving non-contrast medications. While we allow a protocol-based approach for contrast medications, non-contrast medications have to be reviewed by a pharmacist unless they are administered during an interventional radiology procedure or an emergency situation. Pharmacies need a system in place for reviewing orders from radiology or nuclear medicine for non-contrast medications. This is particularly imperative for organizations without order management technology or other mechanisms for getting orders to the pharmacy for review. Noncompliance to the requirement for pharmacist review also is common in stress labs, where non-contrast medications (eg, adenosine) are often used.

The second issue, and one of the fastest growing concerns, is that pharmacists are not reviewing orders for therapeutic duplication, particularly for pain medications. If a patient is prescribed multiple pain medications but no protocol or clear distinction exists as to when one is given over another, pharmacists should be clarifying that. In many cases, pharmacy is not doing so, and they are being cited for this. Guidelines always should be established for when and how each drug is used. Some hospitals have a policy that allows the pharmacists to make these determinations and incorporate notations on the medication administration record for the nurses to use. The pharmacists can note in the record that one drug is to be used for mild pain, another for moderate, and still another for severe. In the absence of such a policy, pharmacists have to clarify those individual orders and too often they are not doing so.

PP&P: Why are some pharmacies so far removed from medication management in nuclear medicine and radiology?
DR: Oftentimes, these are areas pharmacy has never addressed before. In some hospitals, the nuclear medications are obtained from an outside radiology pharmacy and the other medications are floor stocked, meaning pharmacists just send them by requisition to the departments. While pharmacy is becoming more involved with the radiology department, rarely is pharmacy involved with nuclear medicine, so we are finding more issues there. Pharmacy needs to look at how these departments handle medications and work with them to ensure compliance. This does not entail pharmacy simply reviewing non-contrast medications; rather pharmacy must assess the department’s practices for drug storage, labeling, and all the other medication-related issues. These other departments may not be familiar with the medication management standards, and pharmacy can provide that expertise. The goal is not for pharmacy to provide day-to-day oversight, but to help the departments establish compliant processes they can manage themselves.

PP&P: What other MM standards are causing compliance difficulties?
DR: In the procedural areas, we are seeing some issues with medication labeling (MM.05.01.09), where the drugs are not being labeled properly. TJC requires that IV admixture labels not only include an expiration date, but also the date they were prepared. TJC also requires pharmacy to be responsible for all drug preparation in every area of the hospital, including remote outpatient clinics (MM.05.01.07), and compliance with this has been troublesome as well. Of particular concern is oxytocin preparation in labor and delivery and elastomeric infusion pumps (pain balls) in the OR. The elastomeric infusion pumps, for example, are commonly delivered directly to the OR, completely bypassing the pharmacy. Because of the name, OR staff often consider this a pump and do not realize it is an IV bag and needs to be treated as any other IV admixture in the hospital. Pharmacy needs to visit the OR to determine if these pumps are made in-house and then establish the proper procedures for preparation, as this is solely a pharmacy function—OR staff cannot prepare them. However, for urgent situations, there needs to be a functionally separate, clean, uncluttered area or counter space set up for preparation, and we find this is not always the case, particularly in the emergency department, procedural areas, and intensive-care units.

In addition, 7% of hospitals scored noncompliant with MM.01.01.03, which requires pharmacies to identify their high-alert medications and to set policies and procedures for managing them. While many pharmacies have policies and procedures in place, too often staff is not following them. This is an awareness issue that can be addressed via training. Finally, 4% of organizations had issues complying with the system evaluation standard, MM.08.01.01. This standard addresses risks in the medication management system. Hospitals have to look at new technology and the literature and take action to minimize these risks. They also have to review their procedures against USP Chapter <797> to see if any changes need to be made to meet the standard. Surveyors will determine if you have done a gap analysis and developed an action plan for compliance with those problematic areas of USP <797>. However, compliance with each component of <797> is only required if mandated by state law.

PP&P: How are MM standard changes impacting hospitals?
DR: We made 12 changes in the wording of our standards for 2010, but only two have caused any concern. The first is that we expect organizations to define a timeframe for dispensing medications to patients, both under normal and urgent or STAT conditions. In surveys, we find most places do not have a clearly defined timeframe for dispensing.

The requirement that pharmacists review variations in drug use from hospital-approved indications is another change. There has been a lot of concern expressed over this requirement, although I have not seen any compliance issues with it on survey. Basically, when drugs are approved for the formulary, they are approved for specific indications. These are hospital-approved indications, regardless of whether they are FDA-approved indications or not. The hospital has to review these indications annually, and pharmacists need to review orders to make sure they follow hospital-approved indications. If a drug is prescribed for a non-hospital-approved use, we expect a process to be followed. Pharmacists can start by clarifying the order with the doctor. If the use is not in fact hospital-approved, then the issue should be reported to the pharmacy and therapeutics (P&T) committee. The P&T committee is then responsible for determining whether off-label uses for drugs are safe.

Other MM standard changes from 2009 are related to CMS. Most are pretty basic, like having a prescription or order before preparing and administering a medication, reporting narcotic losses to the CEO, supervision of in-house preparation of radiopharmaceuticals, medication error reporting, and notifying the attending physicians immediately if a medication administration problem, adverse drug reaction, or incompatibility occurs. Most hospitals are not having problems with these changes. They may have had problems understanding them or establishing processes, but most are easy fixes and hospitals have dealt with them.

PP&P: Why is the requirement for pharmacist review of variations from hospital-approved indications for use causing such anxiety?
DR: Even though most hospitals are meeting this requirement, the concern over compliance is driven by hospitals that are interpreting it on an order-by-order basis rather than as a long-range system issue. Some hospitals think we are saying they cannot use drugs for non-hospital-approved indications, when what we are saying is the P&T committee has to make this determination. The example I use on survey is a case where a physician ordered amphotericin B for hair loss. With a clinical intervention program in place for reporting non-hospital-approved uses of drugs, P&T would be able to make the assessment that amphotericin B is a high-risk drug and that there are better products for hair loss. Our goal is to prevent inappropriate use of non-hospital-approved drugs for reasons of safety, and the standard is for hospitals to have a mechanism to do that.

PP&P: Do you have any recommendations for how hospitals should prepare for these changes?
DR: The new changes are usually released in October, at which point hospitals should promptly review them and their impact on the organization. Next a self-assessment should be conducted to compare what the hospital is doing against what it needs to be doing. The hospital should then come up with a solution and implement it by January 1. What I find is that most organizations do the things the same way they did the year before until a surveyor comes in. Then they are shocked to learn the standard has changed.

I advise organizations to look at every area of the hospital where medications are and to make sure the staff in each area understands the standards. When we see an area that is not familiar with the standards, it is rarely just one issue that is noncompliant but rather multiple issues. I also advise pharmacists to spend time in the departments. Most hospital administrators look at medication management as a pharmacy responsibility, even though it is a hospital-wide concern.

PP&P: What do you suggest hospitals do overall to ensure greater compliance to TJC standards and NPSGs?
DR: The number-one root cause of noncompliance is an organization not following its own policies. A system monitoring policy is the only way to make sure policies are realistic and people are educated about them and are following them. Second, hospitals have to make sure that all departments that store and use drugs know the rules. Third, organizations must keep up with the latest issues in the literature and news; when a major medication error occurs at one hospital, all hospitals need to look at their systems. Finally, hospitals can always call TJC with questions at 630-792-5900.

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Top MM Standards Scored Noncompliant*

*Based on 1414 surveys, 2009

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Compliance Issues with National Patient Safety Goals

The medication-related National Patient Safety Goal (NPSG) that posed the greatest challenge to facilities in 2009 was NPSG.03.04.01, which deals with medication labeling in procedures. Many organizations are not labeling products immediately before or after the transfer of a drug in procedural areas. I see this frequently in interventional radiology and the cardiac catheterization lab, although I do occasionally see this happen in the OR as well. Often, staff members are either using empty containers pre-labeled by the manufacturer or they are labeling all the empty containers before the procedure, and then adding the drug when the procedure starts. Neither of these are acceptable practices; the medication container must always be labeled immediately before or immediately after the drug is transferred into it. Pharmacy can help by providing education on labeling practices in these settings. The other medication-related NPSG causing a significant amount of difficulty for hospitals is NPSG.02.02.01, which deals with unapproved abbreviations. Compliance with this is often a matter of changing prescribing practices, which can take time.

While most organizations did not have trouble complying with the anticoagulation management goal (NPSG.03.05.01) in 2009, there were a few common issues that cropped up during audits with those hospitals that were noncompliant. One such issue dealt with lack of an approved written protocol for the initiation of maintenance anticoagulation therapy. Many organizations have explicit protocols—even preprinted order sheets—for heparin therapy; however, this is not always the case for warfarin. We expect approved written protocols for both of these drugs, and these guidelines need to be created, distributed to physicians, and monitored and complied with over time. What we often find is pharmacists embark on this task, but do not involve other staff members. This is a hospital-wide issue that has to include prescribers and nurses; it is not simply an internal pharmacy policy. Another common challenge deals with lack of physician and patient education. Hospitals need to deliver education to patients when anticoagulation therapy is initiated; providing education only upon discharge is not an acceptable solution. The patient also needs to receive this education in a way that is understandable to them. Although not as prevalent as the first two, another compliance complication with anticoagulation management is lack of a periodic evaluation process. We require organizations to measure, assess, and improve their anticoagulation programs. Hospitals can do this monthly, quarterly, or annually, but it must be ongoing.

Of note, the medication reconciliation NPSG is on hold until July 1, 2011, as there are concerns that the goal is too prescriptive. Until then, organizations should just continue with their current processes for medication reconciliation.

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Top Medication-related NPSGs Scored Noncompliant*

*Based on 1414 surveys, 2009

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Darryl S. Rich, PharmD, MBA, FASHP, is a surveyor for TJC in the hospital, home care, and ambulatory accreditation programs. In addition, he works for the Standards Interpretation Group serving as an internal resource for TJC on issues related to pharmacy and medication management. He previously served as associate director for surveyor management and development at TJC for 11 years.