Flash Returns Newsletter May 2018

Compliance and Your SOPs


Lately, every industry stakeholder and even public media outlets have focused on opioids like a laser. Rightfully so, as this crisis has already cost more lives than the Vietnam War and shows few signs of being under control. Further, hazardous drug definitions and requirements continue to expand and change. As an independent pharmacy, risks associated with these areas are encountered hourly. Before an incident occurs, taking time to establish written standard operating procedures (SOPs) and doing regular training can pay off. Some processing software can go a long way towards proper documentation as well. Pharmacy staff doesn't always have time outside of work flow to build these processes and do the documentation. Let outside experts save you money and decrease risk of costly regulatory action.


Many GPOs, specialty specific industry groups (specialty pharmacy, hospital, compounding, etc), and state pharmacist associations are great resources to get a copy of some generalized SOPs. Often, someone knowledgeable about your company’s workflow can make the SOPs pharmacy specific easily. From there, updating software, and identifying choke points in workflow to catch mistakes and documenting staff training are all that is left. If an unexpected incident were to occur, showing there are proactive controls and a quality control program in place can go a long way in preventing civil or criminal issues. When unusable controlled substances are identified, a web of state and federal law governs what can be done. Do not attempt to destroy these onsite. A legitimate reverse distributor will help guide you to exact count and return the schedule 3-5 products and send you a 222 form for the schedule 2 items. Hazardous drugs that become unusable due to age or other factors can be quarantined and sent to a qualified reverse distributor who knows the requirements for destruction and reporting. Use one reverse distributor who can do all your controlled and hazardous, as well as standard returns. The pharmacy will have a receipt to prove compliance and won’t get bogged down with lists and routing the hazardous pharmaceuticals to different companies.


There are serious financial penalties for issues as simple as leaving a DEA number off a hard copy prescription. Taking the time to integrate such a change into common pharmacy software in the form of a prompt or alert can smooth out work flow gaps.