A customized Policy and Procedures (P & P) manual is no longer an option, it is truly a requirement. As we’ve previously discussed, every pharmacy is required to have and maintain a written Policy and Procedures manual on its premises. As noted by the NABP (the National Association of Boards of Pharmacy) each state has their own specified policy requirements, laws and regulations that every pharmacy is required to incorporate into their manuals and update as needed that operates in that particular state. Note that this is also true for the majority of third party PBMs. Perhaps even more importantly, the pharmacy is required to actually implement and follow their policies and procedures and must also be able to show proof through documentation that they are indeed doing this. Another relevant issue that also “comes into play” is the updating required to every P & P manual (whether custom written or not) that the inspectors want to see. Creating your P & P manual is not the end, but an ongoing and never-ending task that must be done in order to maintain your manual to be as up to date as is possible.
Recently while discussing State Board of Pharmacy inspections with a client, the discussion centered on how much the inspection process has changed over the past several decades. Instead of going directly to the pharmacy’s prescription records as was commonly seen in years past, the State Board of Pharmacy inspectors now immediately ask to see the pharmacy’s Policy and Procedure manual. Perhaps taking a good look at two recent events concerning pharmacies that are getting a lot of national media attention will help us all to better understand what this change really means.
Ohio Board of Pharmacy Pursuing Disciplinary Action Against 3 Pharmacists
Earlier last week (on October 17th) The Ohio Board of Pharmacy announced that it will be actively pursuing disciplinary actions against three pharmacists and the Mount Carmel Health System (The Mount Carmel West Hospital in Columbus, Ohio employed the three pharmacists) based on the dispensing of “excessive”amounts of painkillers. Dr. William Husel, the physician who ordered the painkillers for his patients, worked as an intensive care practitioner at The Mount Carmel West Hospital and is currently charged with twenty-five counts of murder.
Two of the pharmacists were cited for verifying unusually large doses of fentanyl, while the third R. Ph. was cited for his “supervisory failures in reference to 28 cases in which nurses overrode controls on automated dispensers in non-emergencies to access drugs ordered by Dr. William Husel for patients who then died”.
Mount Carmel has publicly apologized, terminated over twenty pharmacists, nurses and managers, plus stated that they have thoroughly reviewed and improved their Drug-safety Policies and Procedures. Mount Carmel has additionally agreed to pay over $13 million in settlements to patients’ families so far.
Why this particular case is a great example of a pharmacy’s need for a well written, customized, and up-to-date written P & P manual is the fact that the three pharmacists and Mount Carmel West were cited by the Ohio Board of Pharmacy for their “failure to create or enforce policies that provided for the safe and efficient distribution of drugs in all areas of the institution”. Both the hospital and pharmacists were additionally cited for their “failure to provide appropriate supervision and control of automated dispensing units (which allowed nurses to override controlled substances for non-emergency cases) due to the lack of the appropriate and adequate policies and procedures in place”.
Recent FDA Inspections – FDA 483 Forms and Warning Letters
A tremendous amount of national media attention regarding 503A compounding pharmacies and 503B outsourcing facilities has centered for the past year or more on The FDA (U.S. Food and Drug Administration) taking such unprecedented aggressive actions that were previously non-existent. These actions have included numerous on-site inspections, the issuing of observation based warning letters, instituting recalls, and other various actions such as the issuing of Compounding Risk alerts.
What makes this so relevant is that in our ongoing blog posts discussing all the recent FDA actions including new FDA 483 Forms and Warning Letters, there is always the same “common thread” seen in every one! The meticulously detailed observations documented by the FDA inspectors always centers around one of two issues:
1. The pharmacy or facility simply had no policies and procedures, or the ones that they did have were inadequate.
2. Even if adequate written policies and procedures were in place, there was neither compliance with those in place, and/or a lack of documented accountability that the policies & procedures were being followed or adhered to. This was pointed out over and over in the inspectors detailed observations that are included in each and every Warning Letter that we’ve reviewed so far.
Who Can Create a Customized P & P Manual for You?
Healthcare Consultants Pharmacy Staffing can! Our experienced consultants can help you and your staff develop a new P & P manual and/or customize your existing one. We will also define and document a process that will allow your pharmacy manager to update and modify the manual as required. HCC has over 30+ years of experience in both Policy and Procedure development, (including Custom 503A and 503B Policies & Procedure manuals) and operational evaluation and can provide your pharmacy team with valuable insights and recommendations.
Healthcare Consultants is a leading national Pharmacy Consulting company offering expertise in all areas of pharmacy consulting. Known nationally as one of the industry leaders in providing a full range of professional pharmacy consultation services to its vast array of clients, HCC is owned and operated by pharmacists. Healthcare Consultants can provide proven expertise and experience in all facets of pharmacy operations, including retail, hospital and all specialty pharmacy venues. Contact us online or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.