After Hour Access to the Pharmacy
on 4/18/2017 10:00:00 AM
If your hospital is like many, you don’t have a 24/7 on-site pharmacy presence. So what is the expectation by CMS when it comes to after hour access to the pharmacy? The interpretive guidelines under Appendix A of the State Operations Manual for §482.25 forms the basis for this discussion.
The first thing that may surprise you is that CMS does not blankly prohibit after-hour access to the pharmacy by non-pharmacy personnel. It’s a common misconception. Part of the confusion stems from stricter regulations promulgated by accrediting organizations or State law.
CMS basically states that routine after-hours access to the pharmacy by non-pharmacists should be minimized and eliminated as much as possible. If access is necessary, then it should only be by personnel designated in hospital policy (approved by pharmacy and the medical staff), and in accordance with Federal and State law.
If after hour access is granted, then CMS will look to see that the following safeguards have been implemented:
- Access is limited to a set of medications that has been approved by the hospital. These medications can be stored in a night cabinet, automated storage and distribution device, or a limited section of the pharmacy. Medications chosen to be available for retrieval after hours should be intended to treat urgent or emergent conditions - not routine care needs. Basically, if it can wait until morning then it probably doesn’t need to be on the list
- Only trained, designated prescribers and nurses are permitted access to medications. Your hospital should define - by policy - who is permitted to have after-hour access and the minimum qualifications that these individuals must meet. Most hospitals limit individuals who perform after-hour access to just a few individuals such as a house supervisor or charge nurse. There should be documentation of formal training on the do's and don'ts of after-hour access for these individuals.
- Quality control procedures (such as an independent second check by another individual or a secondary verification built into the system, such as bar coding) are in place to prevent medication retrieval errors. For many hospitals, this is accomplished by having pharmacy review what was removed from the after-hour inventory against what was ordered when pharmacy next opens for service. This is fine but it doesn’t prevent retrieval errors. The double-check needs to be built in at the time the medications are retrieved.
- The hospital arranges for a qualified pharmacist to be available either on-call or at another location (for example, at another organization that has 24-hour pharmacy service) to answer questions or provide medications beyond those accessible to non-pharmacy staff. This means that your hospital has to assure that pharmacy personnel are available to come on-site, open the pharmacy, and prepare/dispense medications if needed.
- The process is evaluated on an on-going basis to determine the medications accessed routinely and the causes of accessing the pharmacy after hours. Surveyors will look to see that your hospital closely monitors after-hour access, the medications accessed, and the reason why access is occurring. Data should be collected, aggregated, and analyzed on a regular basis. Most hospitals do so quarterly.
- Changes are implemented as appropriate to reduce the amount of times non-pharmacist health care professionals are obtaining medications after the pharmacy is closed. The obvious focus would be to eliminate after-hour access that does not address an urgent or emergent care need.
Following these steps will go a long way in assuring that your hospital has both a compliant and safe process for after-hour access to the pharmacy and to medications.
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About the Author
Richard Curtis RN, MS, HACP
RN, MS, HACP
Richard (Rick) Curtis is the Chief Executive Officer for CIHQ. Rick is nationally recognized as an expert on the Medicare Conditions of Participation and the CMS Certification & Survey Process. As CEO, he successfully guided CIHQ in becoming the nation's 4th CMS approved deeming authority for acute care hospitals.
Rick's clinical background is in critical care nursing with a focus in cardiovascular and trauma service lines. He has held both clinical and executive management level positions in Quality, Risk, Education, Infection Control, and Regulatory Compliance.
Rick is a regular speaker at numerous state and national conferences on the federal regulations and accreditation standards, and is host of CIHQ's popular monthly webinars addressing key compliance challenges in today's environment.
Rick is nationally certified in healthcare accreditation, and serves as Chair of the Board of Examiners for the Healthcare Accreditation Certification Program (HACP). Rick has a degree in Nursing with a Master's Degree in Health Services Administration.