A customized 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.
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 understand what this really means.
Pharmacy technician dilutes cancer patient’s morphine IV’s
Three weeks ago (as reported by the Associated Press and several other sources), the lead pharmacy technician at a Birmingham, Alabama pharmacy (ContinuumRx of Central Alabama) was indicted for diluting patients’ IV’s that contained pain medications such as hydromorphone and morphine. The tech admitted to diluting the infusions that were compounded for cancer patients and then shipping off the diluted IV bags that were ineffective in alleviating the cancer patient’s pain. After several calls from Hospice nurses inquiring why the medications were not effectively treating their patient’s pain, the tampering was revealed when the technician came forward and confessed what he had been doing.
Why this particular case is a great example of a pharmacy’s need for a written (and up to date) P & P manual is that now many are asking how this could have happened and why it was allowed to go on for so long. The pharmacy tech admitted that he had been doing this for well over a year and that because of a lack of supervision it was “actually pretty easy”! He also stated that in September of 2016 one of the pharmacists on duty and supervising him actually saw him take a vial of morphine and place it in his pocket. The pharmacy is now being scrutinized for a failure to notify the State Board and certainly their policies and procedures for compounding IV infusions and controlled substance security will be reviewed quite closely. It must be noted that the pharmacy did terminate the technician after the incident, but have refused so far to comment to inquiries from the press and online media news sites.
Philadelphia pharmacists accused in $4.7 million pain cream lawsuit
The Liberty Mutual Insurance Company filed a $4.7 million dollar lawsuit last month accusing eighteen Philadelphia doctors and several local pharmacists for their roles in dispensing an allegedly “ineffective and fraudulent” pain cream to workers comp patients and then billing the insurance company “tremendously inflated” prices for claim reimbursements. Although the suit is actually centered on the doctors and pharmacists defrauding the Pennsylvania workers’ compensation system and insurance fraud, two interesting allegations by Liberty Mutual in the lawsuit are pertinent to our discussion of a pharmacy having a customized policy and procedures manual.
The first additional allegation in the law suite that was directed at the pharmacies that were designated as defendants (Omni Pharmacy, 700 Pharmacy, Empire Pharmacy and Armour Pharmacy), was that they were in violation of non-sterile compounding laws and regulations required by the State of Pennsylvania and the FDA. Liberty Mutual alleges that the pharmacies compounded the creams in mass batches and not individually “tailored” to the individual patient as is required. Manufacturing the creams in mass production or in large batches is in direct violation of FDA (the U. S. Food and Drug Administration) regulations. Secondly, the suite alleges that the pharmacies again violated the FDA standards that cover the non-sterile compounding of medications by dispensing pain creams that were not listed as safe and effective.
What makes this case so relevant is that the pharmacies named in the lawsuit had no policies and procedures regarding the procedures involved in both the compounding of the medications and their distribution.
Who Can Create a Customized P & P Manual for You?
Healthcare Consultants Pharmacy Staffing can help you. 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 28 years of experience in Policy and Procedure development 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.