Cdcr Oig Report on Prison Pharmacy Operations 2010
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Special Report LOST OPPO RTU N ITIES F OR S AVI NGS W IT HIN CALI F O R N IA P R I S O N PHARM ACIES Office of the Inspector General Dav i d R . S h aw Inspector General S tat e o f C a l i f o r n i a April 2010 David R. Shaw, Inspector General Office of the Inspector General April 15,2010 J. Clark Kelso, Receiver California Prison Health Care Receivership Corporation 501 J Street, Suite 100 Sacramento, California 95814 Dear Mr. Kelso: Enclosed is the Office of the Inspector General's special report on California Prison Phannacies.· We conducted this review under the authority of California Penal Code section 6126, which assigns the Office of the Inspector General responsibility for oversight of the California Department of Corrections and Rehabilitation This special report found missed opportunities for significant savings due to the failure to restock unused medications, lack of adherence to approved formulary medications, an unreliable pharmacy inventory system, and inconsistent practices among prisons when transferring inmates with medications. This report contains the results of our review of California Prison Phannacies and presents four findings and twelve recommendations. Thank you for the courtesy and cooperation extended to my staff during the·special review. Please call Samuel Dudkiewicz, Chief Assistant Inspector General, at (916) 830-3600 if you have any questions. Sincerely, jJ,JJ/~ David R. Shaw Inspector General Enclosure: Special Report: Lost Opportunities for Savings within California Prison Phannacies P.O. Box 348780, Arnold Schwarzenegger, Governor 95834-8780 PHONE (9 16) 830-3600 FAX (916) 928-4684 SACRAMENTO, CALIFORNIA Contents Executive Summary..............................................................................................1 Introduction...........................................................................................................4 Background...........................................................................................................5 Parameters of Review...........................................................................................10 Finding 1...............................................................................................................12 Usable medications not being restocked in prison pharmacies cost California taxpayers at least $7.7 million annually. Finding 2...............................................................................................................17 Not ensuring the use of approved medications costs California taxpayers an additional $5.5 million annually. Finding 3...............................................................................................................20 Unreliable computer inventories in prison pharmacies result in additional staff labor and increased costs. Finding 4...............................................................................................................25 Inconsistent practices in handling medications for inmates who transfer between prisons result in waste and increased costs. Recommendations.................................................................................................28 California Prison Health Care Receiver’s Response............................................29 Office of the Inspector General’s Response..........................................................37 Executive Summary In 2001, the Prison Law Office filed a class action lawsuit on behalf of California inmates alleging that the state provided inadequate medical care at its prisons, in violation of inmates’ constitutional rights. As a result of this lawsuit, in October 2005, the U.S. Northern District Court of California imposed a Receivership on the California Department of Corrections and Rehabilitation (CDCR) to raise the delivery of medical care to constitutional standards. The Findings in Brief court suspended CDCR’s jurisdiction The Office of the Inspector General finds that: over prison medical health care, giving • Usable medications not being restocked in jurisdiction to the Receiver. The court prison pharmacies cost California taxpayers found CDCR prison pharmacy operations, at least $7.7 million annually. in particular, to be “unbelievably poor.” • Not ensuring the use of approved medications costs California taxpayers an additional $5.5 In January 2007, the Receiver entered million annually. into an agreement with Maxor National Pharmacy Services (Maxor) to assist in • Unreliable computer inventories in prison implementing an action plan it had created pharmacies result in additional staff labor and to improve CDCR’s pharmacy operations. increased costs. The Receiver retains overall responsibility • Inconsistent practices in handling medications for pharmacy operations and Maxor is for inmates who transfer between prisons responsible for providing guidance to result in waste and increased costs. facility level pharmacy staff in order to implement the objectives contained in the agreement. However, a vacuum in leadership was created when prison pharmacy managers started reporting to Maxor rather than through the Receiver’s management team who were more familiar with the challenges and complexities of state government. In the summer of 2009, during our regular, semi-annual inspections of CDCR facilities, inspectors for the Office of the Inspector General (OIG) were approached by pharmacy staff concerned about the sheer amount of wasted medication in prison pharmacies. This prompted us to look into policies and operational controls for pharmacy management; we discovered that controls were weak. Concerned about potential drug diversion and waste, we surveyed additional prisons, where we found such serious operational inconsistencies that we launched an in-depth review, selecting nine prison pharmacies as the sites of our close review. This report highlights the results of our review and focuses on waste in prison pharmacy operations in four areas: the failure to restock millions of dollars in unused medications each year; the lack of adherence to the formulary, which is an approved list of medications, resulting in millions of dollars overspent on medications each year; the functionally unreliable computerized pharmacy inventory system that bears no relation to the actual stock of medications at any prison pharmacy; and the inconsistent practices among prisons when transferring inmates with medications, resulting in excess medications that are most often destroyed. State of California • April 2010 Page 1 Contrary to expectation, there are almost no procedures for identifying and restocking medications. This managerial void costs taxpayers at least $7.7 million, and very likely close to $20 million, every year. In addition, due to the absence of oversight, CDCR clinicians routinely prescribe non-formulary medications, costing taxpayers at least another $5.5 million in 2009 alone. Additional costs are incurred for staff time as pharmacists find ways around the state-wide computerized inventory system, a system so unreliable that pharmacists prefer to rely on handwritten tallies. And in the absence of consistent medication transfer procedures when inmates are transferred among prisons, prison pharmacies routinely generate unnecessary prescription refills, which are often destroyed. Since over 100,000 inmates on medications are transferred among CDCR prisons each year, with each of those inmates receiving an average of 5.5 prescription medications, the costs of filling and destroying unnecessary and unused prescriptions are tremendous. Recommendations In this special report, the Office of the Inspector General shines a public light on specific areas lacking oversight and accountability in CDCR’s pharmacy operations resulting in millions of dollars in unnecessary costs to the taxpayers. To address the deficiencies identified in this report, the California Prison Health Care Receivership Corporation should take the following actions: Medication Restocking • Establish and enforce procedures to maximize the restocking of usable drugs. • Develop guidelines to determine when to purchase unit dose versus loose tab medications to maximize the return of drugs to pharmacy inventory, and monitor purchases to ensure compliance. • Review existing staffing levels within pharmacies to ensure that adequate resources are available to restock drugs to inventory. Formulary Adherence • Monitor the prescribing of over-the-counter items that have a limited medical necessity and develop processes to limit prescribers’ ability to provide such items. • Identify institutions and individual prescribers that consistently do not adhere to the formulary and provide instructions to rectify the prescribing behavior. • Ensure that there is a strong clinical pharmacy presence at prisons to provide training and direction to reduce the use of non-formulary prescriptions, maintain accurate inventories, and promote efficiencies. Bureau of Criminal Investigations, Office of the Inspector General Page 2 Inventory control • Develop and implement procedures to ensure an accurate computer inventory system in order to monitor inventory shrinkage, reduce staff labor, provide accurate management reports, and provide accountability. • Provide guidance to pharmacy staff on how to use the computer inventory system to account for medications dispensed to prison hospitals. • Ensure that the auto-refill and auto-reorder systems work effectively without manipulating the electronic inventory. Inmate transfers • Monitor transferring inmates and identify any prisons that are not forwarding medications to the receiving prison; identify the cause of the failure to follow procedure and take appropriate action. • Ensure that prisons transferring inmates to other institutions take into account the quantity of previously dispensed medications before requesting a three-day supply from the pharmacy, and monitor for compliance. • Develop a procedure to ensure that the receiving institution’s pharmacy does not refill medication before it is necessary, and monitor for compliance. State of California • April 2010 Page 3 Introduction This report presents the results of a review of pharmacy operations in California Department of Corrections and Rehabilitation (CDCR) prisons. The Office of the Inspector General (OIG) originally became aware of concerns regarding pharmacy operations during our regular, semiannual inspections of CDCR facilities. During the summer 2009 institutional inspections, pharmacy staff showed OIG inspectors substantial quantities of returned medications awaiting disposal which pharmacy staff believed could be reused. This prompted OIG inspectors to inquire about operational controls along with policies and procedures for handling medications returned to the pharmacy. The lack of controls raised concerns about potential drug diversion and waste. Consequently, we surveyed additional prison facilities and found operational inconsistencies among the various prison pharmacies in the packaging and restocking of medications, in inventory control, in the medication transfer process, and in maximizing the use of the CDCR formulary. The OIG conducted this review under the authority of California Penal Code section 6126, which assigns the OIG responsibility for oversight of the CDCR. Photo 1: Unused medication returned to a pharmacy from facility clinics. Source: Office of the Inspector General. Bureau of Criminal Investigations, Office of the Inspector General Page 4 Background History of CDCR’s Pharmaceutical Program CDCR provides for the custody and care of approximately 167,000 inmates, which includes pharmacy services at each of the 33 adult prisons. Between 2000 and 2005, CDCR’s management of its pharmacies has been the focus of several audits and reviews, all of which have identified major issues that impede pharmacy operations. Even though the auditing agencies made recommendations for improvement, CDCR routinely failed to implement meaningful changes. This failure contributed to a class action lawsuit filed in 2001 by the Prison Law Office on behalf of California inmates alleging that the state provided inadequate medical care at its prisons, in violation of inmates’ constitutional rights. In October 2005, the U.S. Northern District Court of California imposed a Receivership on CDCR to raise the delivery of medical care to constitutional standards. The court determined that the management of prison pharmacy operations was “unbelievably poor.” The court found that there was no statewide coordination among pharmacies and no statewide pharmacist to provide centralized oversight, control, and monitoring of the pharmacy program. The court also found that the failure to transfer medications among prisons or to accept prescriptions from other institutions disrupts the continuity of medical care and results in waste. The court order appointing the Receiver outlined the Receiver’s duties in restructuring CDCR’s medical delivery system. The Receiver was required to develop a plan of action that included goals, tasks, and metrics, and was required to make progress reports to the court. The court gave the Receiver the powers necessary to fulfill those duties. At the same time, and for the duration of the Receivership, the court suspended the Secretary of the CDCR’s jurisdiction over prison medical health care. The Secretary, however, was ordered to assist with the accomplishment of the Receiver’s duties. The Receiver’s action plan includes the objective to “establish a comprehensive, safe and efficient pharmacy program.” In March of 2006, then-Receiver Robert Sillen requested that Maxor National Pharmacy Services (Maxor) conduct a review to identify the actions necessary to improve the California prison pharmacy operation. In June 2006, Maxor concluded its review and issued a report titled, “An Analysis of the Crisis in the California Prison Pharmacy System Including a Road Map from Despair to Excellence.” In this report, Maxor asserted that the “CDCR pharmacy program does not meet minimal standards of patient care, provide inventory controls or ensure standardization.” Maxor found: • Lack of centralized oversight and coordination among pharmacies, resulting in poor management controls. • Lack of an effective clinical management process to ensure medically-appropriate and costeffective treatment through use of the drug formulary. State of California • April 2010 Page 5 • Lack of consistency in ordering and managing inventory. • Lack of an electronic information system capable of medication monitoring and cost containment. In addition to outlining numerous deficiencies in the program, the Maxor report included a plan for improving the CDCR pharmacy operation. The plan, which incorporated many of the recommendations from previous audits, consists of seven goals along with measurable objectives to achieve those goals. An abbreviated description of the goals follows: • Develop meaningful, effective centralized oversight, control and monitoring of the pharmacy program. • Implement and enforce effective clinical management processes (including formulary controls, a pharmacy and therapeutics committee, disease management guidelines and regular audits). • Review, audit, and monitor pharmacy contracting and procurement for cost efficiency. • Develop a pharmacy human resource program. • Redesign and standardize institution pharmacy drug distribution, including development of a centralized pharmacy. • Design and implement a uniform pharmacy information management system. • Develop processes to ensure that pharmacy accreditation standards are met. In January 2007, the Receiver entered into a contractual agreement with Maxor to provide management consulting services to the prisons’ pharmacies. This agreement included an operating budget for Maxor of just over $15,000,000 for the three-year period of the contract from January 1, 2007 to December 31, 2009. Two subsequent revisions to the original agreement resulted in changes to the scope, a one-year extension, and a total revised budget of almost $40,000,000. Although Maxor is responsible for providing guidance to facility level pharmacy staff in order to implement the objectives contained in the agreement, Maxor is under the direction of the Receiver, who maintains overall responsibility for the delivery of medical services, including pharmacy operations. However, when prison pharmacy staff contacted the Receiver’s office to resolve issues, they were re-directed to Maxor; this created confusion regarding the management structure of pharmacy operations. In its original agreement, Maxor developed seven goals and numerous objectives for improving pharmacy operations. The majority of the objectives related to our findings were scheduled for completion during the first 12-24 months, or by December 31, 2008. Pharmacy Costs In the past decade, the amount of money spent annually on medications for California’s inmates between 2000 and 2008 (the latest year for which we had complete data) has more than doubled. Bureau of Criminal Investigations, Office of the Inspector General Page 6 Figure 1: Cost for pharmaceuticals per inmate per day. Compared with two other large correctional operations and adjusting CDCR for pricing differentials, CDCR spends two and three times as much per inmate per day on medications. $2 $1 $1.91 $0.59 $0.83 $2.04 $0.67 $0.83 CDCR 2006/2007 Texas Dept. of Corrections 2006/2007 Federal Bureau of Prisons 2006/2007 CDCR 2007/2008 Texas Dept. of Corrections 2007/2008 Federal Bureau of Prisons 2007/2008 This is far greater than the seven percent increase in the inmate population at its peak and the 33 percent increase in the cost of prescription drugs over the same time period (See Figure 2 on page 8). However, during the last two years (2007-2008), the rate of increase is significantly less than the previous three years. Facility pharmacy staff attributed this improvement to better drug purchasing contracts negotiated by Maxor and the Receiver. For the fiscal year 2009-2010 Governor’s budget, CDCR proposed to spend close to $2 billion to provide medical, dental and mental health care services to California’s inmates. Almost 10 percent of that amount, $190 million, is allocated for pharmaceuticals. In comparing California with other large correctional operations for fiscal years 2006/2007 and 2007/2008, we find that the daily pharmaceutical cost per inmate is significantly higher at CDCR (see Figure 1). Even after adjusting CDCR’s cost per inmate downward to account for preferential pricing advantages that Texas and the Federal Bureau receive, CDCR spends more than two times the amount that the Federal Bureau of Prisons spends per inmate per day on medications, and more than three times the amount spent by the Texas Department of Corrections. In reviewing data for approximately 111,000 inmates in July, August and September of 2009, we found that 65 percent or 73,000 inmates received 403,000 prescribed medications. These 73,000 inmates averaged 5.5 prescriptions per inmate. Given the amount of money and the number of prescriptions involved, the potential for waste is significant. Pharmacy Operations and Medication Delivery Each prison pharmacy is under the direction of a Pharmacist-In-Charge, employed by CDCR, who is referred to as a lead pharmacist for the purposes of this report. The lead pharmacist has State of California • April 2010 Page 7 oversight and supervision of the storage, distribution and control of all prescription medications. Each pharmacy uses an electronic database to assist in tracking orders placed, medications received, medications dispensed, and medications returned. In addition to electronically recording medications purchased and drugs dispensed, physical inventories are conducted. The lead pharmacist purchases medications to stock the prison pharmacy and fill prescriptions. Depending on the type of medication, the lead pharmacist facilitates the purchase of the medication in either prepackaged unit doses or in loose tablets. Policy requires that pharmacists substitute generic medication—drugs no longer protected by a patent—for patented name-brand medication, unless otherwise specified. However, it is health care providers that determine which medication is prescribed to the patient. They can specify any medication in their prescriptions, including name-brand medication, by submitting a nonformulary drug request to prescribe a drug not listed on the CDCR drug formulary. The drug formulary is a list of approved medications, many of which are the generic versions of name-brand medications. Provided to all CDCR licensed medical professionals, the drug formulary is developed by CDCR’s Pharmacy and Therapeutics Committee to help clinicians provide medically appropriate and cost effective treatment. The Pharmacy and Therapeutics Committee consists of medical, dental, nursing, psychiatry and pharmacy staff as well as court-appointed experts from the Coleman (mental health) and Perez (dental) lawsuits. Only this committee can add or delete items from the formulary. Since formulary medications cost, on average, 65 percent less than non-formulary medications, adherence to the formulary to the extent possible can result in considerable cost-savings to CDCR. The lead pharmacist supervises the pharmacists and pharmacy technicians who prepare and dispense medications upon orders from appropriately licensed medical professionals. After Figure 2: Comparing rates of change, 2000 - 2008. From 2000 to 2008, CDCR more than doubled its spending on inmates’ medications, yet the total inmate population increased only seven percent at its peak. During that same period, the cost of prescription drugs rose only by a third. 120% Percentage of change 90% 60% 30% 0 -10% CDCR pharmeceutical expenditures CDCR prison population changes Consumer price index of prescription drugs 2000 0 0 0 2001 19.56 -0.31 5.43 2002 36.45 -2.48 10.9 2003 39.75 -0.66 14.33 2004 39.07 0.93 18.11 Bureau of Criminal Investigations, Office of the Inspector General 2005 58.42 1.35 22.28 2006 2007 2008 88.71 100.34 106.40 6.52 6.98 5.54 27.51 29.35 32.55 Page 8 a medication is dispensed, it is then sent to the designated housing unit clinic for delivery to the inmate. For certain medications, the entire prescription is given to the inmate to take as directed. Other medications are kept in the facility medical clinic, where a nurse provides the medication to the inmate and observes the inmate take the medication. This medication delivery method is called Direct Observation Therapy (DOT). If, for some reason, medication is unused by an inmate, it is to be returned to the pharmacy for disposition. When medication is returned to the pharmacy, pharmacy staff determine whether it should be returned to inventory (restocked), returned to the manufacturer for partial credit, or incinerated. Restocking of medications involves consideration of: • Delivery method – only medication that remained in the control of health care staff can be considered for restocking. • Type of packaging and storage – whether the medication is in unit dose packaging or loose tablets and stored in a manner as to ensure it has not been adulterated or that the efficacy of the medication has not been compromised. • Expiration date. When inmates transfer in and out of an institution, a coordinated effort among custody staff, health care staff and pharmacy staff is required to ensure that required medication accompanies each transferring inmate. When inmates transfer between CDCR prisons, they are required to have at least a three-day supply of their prescribed medications. If there is less than a threeday supply of already dispensed medication available prior to transfer, the pharmacy is to be notified to provide a minimum of a three-day supply. Upon an inmate’s arrival at the receiving institution, health care staff verify the receipt of medication; the pharmacy receives the transferred prescriptions and makes medication available. State of California • April 2010 Page 9 Parameters of Review This review was conducted to determine whether California ’s state prison pharmacies effectively manage the expenditure of state funds for the distribution of medications to inmates. Although there are seven goals and numerous accompanying objectives contained in Maxor’s action plan and CDCR has reportedly met objectives in some areas, our review does not address all seven goals. Our report focuses specifically on the issue of waste, which has considerable cost implications for CDCR and, more importantly, California taxpayers. This report focuses on four areas: inventory control, inmate transfer medications, the return to stock of unused medications, and the practice of formulary adherence. These are the areas of primary concern brought to our attention by pharmacy staff during facility inspections. We surveyed 16 prison pharmacies, which included reviewing management reports and interviewing pharmacy, medical and custody staff to identify potential problems and their impact on pharmacy operations. As a result of our survey, we selected nine prisons to perform a more in-depth review of pharmacy operations. The nine prisons were: • California State Prison, Corcoran • California State Prison, Sacramento • California Substance Abuse Treatment Facility and State Prison, Corcoran • Central California Women’s Facility • Deuel Vocational Institution • Mule Creek State Prison • Pleasant Valley State Prison • Salinas Valley State Prison • Valley State Prison for Women In the process of performing this review during the second half of 2009, we: • Interviewed pharmacists, pharmacy staff, custody and other related medical staff. • Reviewed the medication restocking process in which prescribed medications not picked up by inmates can be placed back into inventory. • Reviewed inventory reports and manually counted selected pharmaceutical medications. • Reviewed the auto-reorder procedures where medications are automatically reordered when the inventory runs low. • Reviewed the auto refill procedures where an inmate’s prescription is automatically refilled. Bureau of Criminal Investigations, Office of the Inspector General Page 10 • Reviewed the non-formulary request process whereby prescribers order medications that are not on the formulary list. • Reviewed the transfer process where medications are sent with inmates when they are transferred from one prison to another. Based on our analysis of the data collected, we developed four findings and twelve recommendations regarding the management of pharmacy operations. State of California • April 2010 Page 11 Finding 1 Usable medications not being restocked cost California taxpayers at least $7.7 million annually. Due to lack of direction and oversight, CDCR pharmacies have lost taxpayer money by failing to restock returned medications. We estimate that not maximizing the restocking of medications costs taxpayers at least $7.7 million annually. Unused medications may be returned to the pharmacy for a number of reasons. For example, unused medications are returned when they are refused by the inmate, or when left behind after an inmate is paroled or transferred to another institution. Pharmacy staff evaluate the unused medication to determine whether it Photo 2: Returned unused medication waiting to be sorted. should be incinerated, returned to Because many pharmacies lack the staffing to sort inventory (restocked), or returned to the returned medication for possible restocking, returned manufacturer for partial credit. While medications are often incinerated. Source: Office of the many of the returned medications Inspector General. are routinely destroyed, they could be restocked and re-dispensed if they meet certain conditions involving their packaging and distribution thereby saving millions of dollars. Depending on the medication, the pharmacy normally dispenses medications in one of two delivery methods. Some medications are picked up by the inmate for use as prescribed. Other medications require direct observation therapy (DOT), in which nursing staff gives the medication to the inmate and observes the inmate take the medication. Prison pharmacies typically provide the DOT medications either in unit dose packaging (pills individually wrapped by the manufacturer) or in loose tablets placed in baggies by pharmacy staff. DOT medications that have been dispensed to nursing staff but are unused can possibly be restocked; however, medications picked up by inmates, irrespective of their packaging, cannot be restocked. Bureau of Criminal Investigations, Office of the Inspector General Page 12 Photo 3a, 3b: Unit dose medication and loose medication. Under certain circumstances, unused unit dose medication may be restocked for later use. Unused loose tablets of medication are usually not restocked. Source: Office of the Inspector General. Appropriate direction is not provided to prison pharmacies to minimize waste Although a computerized inventory system has been implemented by the Receiver to “track returned medications and re-circulate returns when possible to maximize inventory value,” the Receiver’s policy regarding the disposition of medications returned to the pharmacy did not describe when a medication could be restocked. Instead, it provided guidance on when a medication could not be restocked. According to the policy, a medication cannot be restocked if it is past the expiration date, contaminated, mislabeled, or recalled. As a result, there is no uniform protocol to channel returned medication back into prison pharmacy stock. However, some of the pharmacists we spoke to have developed criteria for identifying medications that can be restocked. The consensus among these pharmacists was that returned medications could be restocked if they: • had been continually maintained by a health care professional only and; • are packaged as unit dose, unadulterated and; • have not expired as indicated by the manufacturer’s expiration date. Although purchasing medications in unit dose packaging facilitates medication restocking and therefore facilitates savings, other variables in purchasing also affect savings. To determine the difference between the costs of purchasing in unit dose packaging versus loose tablet form, we selected eight medications that were commonly restocked; four were name brand and four were generic medications. We found that there is no difference in the cost of name brand medications when purchased in either unit dose packaging or in loose tablet form. Generic medications, however, on average doubled in cost when purchased in unit dose packaging. Therefore, when ordering medications, pharmacists must consider the availability and cost of unit dose packaging, compared with loose tablet form, in both name brand medications and generic medications. State of California • April 2010 Page 13 When a pharmacist was asked In discussing with pharmacists how they determine whether to why he only purchased loose purchase medications in unit doses or in loose tablet form, we tablet drugs, he responded: found significant inconsistencies among purchasing practices. “Because that is just the Pharmacists did not take into account both the medication’s way we have always initial cost and the ability to restock the medication. Although our sample indicates that name brand drug manufacturers charge purchased our drugs.” the same price for either unit dose packaging or loose tablets, — Lead Pharmacist several pharmacists preferred to buy loose tablets because they believed that they were choosing the less expensive option. They explained that loose tablets have historically been less expensive than unit dose packaging. Other pharmacists noted that they buy medications in loose tablets because loose tablets take up less space on their shelves, and that space is a critical factor in their particular pharmacies (photo 4). These pharmacists also told us that although they were encouraged to purchase drugs in unit dose packaging, they had not been given any verbal or written directives. Pharmacies do not evaluate returned medications in a timely manner Some pharmacies incinerate returned unit dose medications because the pharmacy staff does not evaluate the returned medications in a timely manner. The evaluation process includes sorting the returned medications according to whether they are to be destroyed, returned to the manufacturer for partial credit, or restocked. We observed large quantities of returned medications stored in tote bins and plastic bags, waiting to be sorted. Several of the pharmacists said they did not have adequate staffing to sort the returned medications. These pharmacists estimated that it would take 20 to 60 hours of staff labor per month to sort returned medications, but explained that they have no control over their staffing. The pharmacists claimed that the focus was primarily on filling and completing the inmate prescriptions, rather Photo 4: Loose tablet medications stored in bulk. than on sorting returned Adequate space to store medications is a concern at many prison medications. We did not pharmacies. Source: Office of the Inspector General. verify these pharmacists’ assertions; however, the large quantities of unsorted returned medications indicate ineffective oversight of the pharmacies’ restocking processes. Even without additional resources or assistance though, some pharmacists changed their staff’s responsibilities and successfully demonstrated how medications could be restocked. Bureau of Criminal Investigations, Office of the Inspector General Page 14 One pharmacist told us that he addressed the staffing shortage in his pharmacy by authorizing overtime for pharmacy staff to sort returned medications. This pharmacist estimated that sorting returned medications at his pharmacy takes 20 hours and costs approximately $500 per month in overtime, but he believes that paying the overtime is justified by the savings derived from returning the drugs to stock. To illustrate his point, he noted that during a three-month period in 2009, his pharmacy reported $191,000 in drugs returned to stock at a cost of approximately $1,500 for overtime. Photo 5: Typical shelving of bulk and unit dose pharmaceutical stock. Bottles contain up to 1,000 pills while unit doses are typically ten to a card. Source: Office of the Inspector General. Another pharmacist made sorting returned medications part of the daily duties for his pharmacy staff. He reported $235,000 in medications returned to stock during the three month period from April through June 2009. In comparison, another pharmacy of comparable size in pharmaceutical purchases that didn’t make sorting a priority reported only $14,000 in medications returned to stock during the same period. Such differences in results suggest that the intended objective of ensuring that all pharmacies maximize their restocking of medications was not met. Certain pharmacies achieve higher restocking rates by purchasing in unit dose forms and focusing on restocking Based on our review of pharmacy reports, we noted that some pharmacies had higher rates of restocking medications than other pharmacies. We found that the pharmacists at the high-restocking rate pharmacies purchased medications in unit dose form, which facilitated the restocking of the drugs back into the pharmacy’s inventory, and that they incorporated restocking responsibilities as part of their staff’s duties. We reviewed the return-to-stock data for twenty prisons for the period of April through June 2009. For those twenty prisons, the average return-to-stock rate was 3.9 percent of the pharmaceutical expenditures for that three-month period. The range of the return-to-stock percentage varied greatly from a low of .05 percent to a high of 14.87 percent. If we project the 3.9 percent to the total pharmaceutical expenditures of $188 million for 2008-2009, the amount of the return to stock would be $7.3 million. On September 2 and 3, 2009, we visited three prisons and had in-depth discussions with State of California • April 2010 Page 15 pharmacy staff regarding their restocking procedures. Following our visits, these three prisons immediately increased their return-to-stock percentage. The data from return-to-stock reports included in Figure 3 below show return-to-stock rates for these institutions before and after our visits. The return-to-stock rate for August at these institutions was less than ½ of one percent; however, after our visit, the return-to-stock rate increased to more than 8 percent for the month of September. Given that the restocking applied to medications purchased before our visits, it is unlikely that there were any significant changes in the packaging of the medications. These increases resulted directly from our review. The financial implications are significant. If the average return-to-stock percentage at all CDCR prison pharmacies statewide were to increase from 3.9 percent to 8 percent, which we believe is a conservative number, the increased restocking would generate an additional savings of $7.7 million. Moreover, additional data we gathered indicate that the savings from restocking could be even higher. We evaluated three other prisons specifically because their pharmacists had already made restocking a priority. We analyzed their return-to-stock data for different periods in 2009 and found that those pharmacies had an even higher average returnto-stock rate of 14.3 percent. If the statewide return-to-stock rate were to increase from 3.9 percent to 14.3 percent, the increased restocking would generate a savings of $19.6 million. In addition to seeing an increase in restocking values after our site visits, we learned that the policy on returned medications was clarified during an October, 2009 meeting with the lead pharmacists. However, there was no reference to the need for uniform purchasing practices that take into account initial costs and the ability to restock medications, or to the need for the timely processing of returns. Figure 3: Savings from procedural changes in restocking Central California Women’s Facility California State Prison Los Angeles Valley State Prison for Women $64,223 $60,000 $47,016 $34,960 $30,000 $11,104 $10,000 0 $616 $810 Monthly Totals June 09 $1,878 $451 $1,016 $1,731 July 09 $13,850 $5,034 $207 $1,751 August 09 $6,992 Bureau of Criminal Investigations, Office of the Inspector General September 09 $146,199 Page 16 Finding 2 Not ensuring the use of approved medications costs California taxpayers an additional $5.5 million annually. CDCR spent $5.5 million more than necessary as a result of health care providers prescribing non-approved medications. The expenditures for non-approved medications have increased significantly because medical staff ignore approved medical alternatives or prescribe items that have a questionable medical necessity. In addition, there is inconsistent oversight of nonapproved medication expenditures. The list of approved medications is referred to as a formulary. This list represents the collective clinical judgment of CDCR’s Pharmacy and Therapeutics Committee for the treatment of disease and the prevention of illness. It is a tool to “There is a lot of waste in assist health care providers to prescribe treatment that is both non-formulary items.” medically appropriate and cost effective. Because the Food and Drug Administration authorizes a number of new medications, — Lead Pharmacist alternative preparations for existing medications, and over-thecounter combinations of medications each year, medical and mental health professionals can use a formulary to ensure they are providing cost-effective medications that are therapeutically appropriate. There are occasions when physicians need to prescribe medications that are not on the formulary. In some cases, formulary agents are ineffective or not tolerated by the patient. In addition, the only available drug to treat a specific condition may be a non-formulary selection. In these cases, the medical or mental health care professional is expected to make a written request to their supervisor justifying the non-formulary medication as a clinically prudent choice. The medical or mental health supervisor then either approves the request or suggests an alternative. Photo 6: An example of a prescription item. Items available over the counter outside of prisons are prescribed to inmates. Some of these items are not on the formulary because they may not be considered medically necessary. Source: Office of the Inspector General. State of California • April 2010 Page 17 During the course of our review, the OIG analyzed prescription information for 24 prisons for the months of July, August and September, 2009. Our analysis revealed that the average amount spent on non-formulary prescriptions was approximately $2,200,000 per month for the 111,000 inmates in our sample, or $19.85 per inmate per month (PIPM). In 2007, the amount spent on non-formulary prescriptions was $19.76 PIPM and CDCR successfully reduced that rate to $14.98 PIPM in 2008. However, in 2009, the rate increased by almost a third over the previous year to $19.85 PIPM. The need to minimize the amount of non-formulary use is because non-formulary prescriptions are typically significantly more expensive than formulary prescriptions. During the months of July, August and September, 2009, the average cost of a formulary prescription for the 24 prisons was 35% of a non-formulary prescription ($30.54 compared to $86.74). As a result, if the average PIPM rate for non-formulary prescriptions for 2009 stayed at the same rate as 2008, adjusted for inflation, and the medications were prescribed off the formulary, we estimate CDCR would have saved in excess of $5.5 million. In addition, health care providers write prescriptions for many items that are not included on the formulary because they have limited medical necessity. Items such as sunscreen, fish oil, vitamin E, and cough drops, which are sold over-the-counter outside of the prison environment, are often prescribed for inmates who would have difficulty accessing these items in prison. However, some of the items we found, such as the sunscreen (photo 6), could be available in the canteen. In its 2006 analysis of CDCR’s pharmacy system, Maxor found that there was a lack of adherence to the existing formulary, observing that Photo 7: This binder shows 760 non-formulary requests at one prison over a two month period. Source: Office of the Inspector General. (s)ystem-wide policies and procedures for a formulary are established, but left open to institution level interpretations and compliance … . In short, while the CDCR health services central office states that updated policies and procedures and formulary have been implemented, institution level observations revealed that in many cases, guidelines are not followed and prescribing practices follow individual institution developed formularies and treatment approaches. With the absence of central office oversight, compliance and monitoring are difficult at best. In an effort to correct this issue, Maxor included two goals in its action plan: A) to Bureau of Criminal Investigations, Office of the Inspector General Page 18 develop meaningful and effective centralized oversight, control and monitoring over the pharmacy services program, and B) to implement and enforce clinical pharmacy processes including formulary controls. “Over here we do a lot of non-formulary, and it seems like every request for non-formulary gets approved. We very rarely see one denied, so I The plan for ensuring formulary compliance included 1) think the process needs reconstituting the Pharmacy and Therapeutics Committee, 2) to be looked at. 99.9% issuing an up-to-date formulary along with the related policies and procedures, 3) developing a monitoring tool, and 4) creating are approved, only three denials in two years.” a group of clinical pharmacy specialists who would conduct reviews of formulary adherence at each institution and provide — Lead Pharmacist feedback at both the regional and institutional level. While the Receiver successfully implemented the first three objectives, the monitoring function was never fully implemented due to budget reductions eliminating the positions in 2009, midway in the implementation of the new pharmacy program. Elimination of these positions has contributed to the inconsistent oversight of non-approved medication expenditures. State of California • April 2010 Page 19 Finding 3 Unreliable computer inventories in prison pharmacies result in additional staff labor and increased costs. Concern over pharmacy inventories is not new to CDCR. In its 2006 review of CDCR pharmacies, Maxor noted significant inventory problems, noting that “based on a sampling of selected medications, it appears that millions of dollars of purchased medications are not accounted for in the prescription dispensing data.” In the same report, Maxor observed, “Such disturbing variances (in excess of 30%) indicate a serious lack of pharmacy management and inventory control, as well as a high level of waste and potential for drug diversion.” Maxor’s solution to the inventory problem is laid out as a goal in its pharmacy implementation plan, whereby Maxor proposed that “[a] computerized perpetual inventory system with integrated reclamation software will be utilized to achieve inventory control, monitor diversion, increase inventory turns, track returned medications, and re-circulate returns when possible to maximize inventory value.” The purpose of this goal was to “implement a perpetual inventory system in which dispenses are subtracted from inventory in real-time and daily inventory orders are automatically posted to the individual pharmacies’ inventory.” The GuardianRx computerized inventory system had been in use for at least six months in all nine prisons that we reviewed and it includes many useful tools such as drug interaction detection, readily accessible medication profiles, and medication utilization data. However, most pharmacy staff “The computer inventory is told inspectors that the new computer inventory system was not a useful tool for us.” not accurate and could not be trusted. While visiting one — Lead Pharmacist pharmacy, an inspector took a bottle of medication from a shelf and asked the pharmacist if anyone would notice if he removed the bottle. The pharmacist replied, “Probably not.” Pharmacy staff at three additional institutions gave similar answers. In order to test the accuracy of the computer inventory system, we selected 14 medications from the most expensive stocked in prison pharmacies, and compared the physical inventory to the 1 computer inventory at the nine prisons reviewed. The following chart illustrates the differences between the computer inventory and the actual stock on hand of these 14 medications at all nine prisons. The most significant disparity was in Risperidone 3mg., of which inspectors counted 5,191 actual tablets while the computer inventory indicated a stock of 24,360 tablets. This is a difference of 470 percent. The discrepancy between the computer inventory and the physical inventory of these medications demonstrates the unreliability of this system. 1 Narcotics are maintained in a separate, controlled environment and are not included in this data. Bureau of Criminal Investigations, Office of the Inspector General Page 20 Figure 4a: Comparison of computer inventory of 14 selected medications with the actual stock on hand at the nine prisons reviewed. Source: Office of the Inspector General Drug Name & Dosage Abilify 10mg 4,724 Physical Inventory Abilify 20mg 4,842 Abilify 30mg 4,483 Depakote ER 250mg 5,052 Depakote ER 500mg 14,634 Effexor XR 75mg 6,292 Effexor XR 150mg 4,663 Geodon 40mg 5,570 Geodon 60mg 4,473 Geodon 80mg 6,423 Risperidone 2mg 6,440 Risperidone 3mg 5,191 Zyprexa 10mg 3,911 Zyprexa 20mg 3,131 12,299 Computer Inventory 11,998 13,770 15,933 18,242 16,259 18,215 13,476 15,051 15,007 14,285 24,360 13,827 10,745 At $0.58 per unit, the difference between the cost of the actual stock of Risperidone 3mg. and the cost of the computer inventory for that medication is more than $11,000. As Figure 4b demonstrates, the cost difference between the computer inventory of the selected medications and the actual stock on hand at these nine prisons alone comes to more than a million dollars. When we inquired about the inventory disparity, pharmacy staff provided several explanations, including: • Medications are added to the computer inventory when ordered instead of when they are received. • If, for some reason, stocked medications are returned to the supplier, they are not consistently removed from the computer inventory. State of California • April 2010 Page 21 Figure 4b: Cost comparison of computer inventory with physical inventory for 14 drugs. Source: Office of the Inspector General Drug Name & Dosage Abilify 10mg Abilify 20mg Abilify 30mg Actual Total 4,724 4,842 4,483 Total Computer 12,299 11,998 13,770 Depakote ER 250mg Depakote ER 500mg 5,052 14,634 15,933 18,242 Effexor XR 75mg Effexor XR 150mg 6,292 4,663 Geodon 40mg Geodon 60mg Geodon 80mg Cost Per Unit $12.60 $17.81 $17.81 Total Cost Differential $95,445.00 $127,448.36 $165,401.47 10,881 3,608 $1.76 $3.23 $19,150.56 $11,653.84 16,259 18,215 9,967 13,552 $1.75 $4.49 $17,442.25 $60,848.48 5,570 4,473 6,423 13,476 15,051 15,007 7,906 10,578 8,584 $5.93 $7.19 $7.19 $46,882.58 $76,055.82 $61,718.96 Risperidone 2mg Risperidone 3mg 6,440 5,191 14,285 24,360 7,845 19,169 $0.52 $0.58 $4,079.40 $11,118.02 Zyprexa 10mg Zyprexa 20mg 3,911 3,131 13,827 10,745 9,916 7,614 $12.40 $24.80 $122,958.40 $188,827.20 Total Difference 7,575 7,156 9,287 Total for 9 institutions: $1,009,030.34 • Medications dispensed through a prison hospital are not automatically removed from the computer inventory. In addition to the explanations provided by pharmacy staff, we observed instances in which staff practices contributed to the inventory discrepancies: • In one pharmacy, we found medications that had been returned from prison yards were scanned back into the computer inventory and then discarded, thereby creating inaccuracies. • In another pharmacy, we found that staff were returning medications to stock without scanning them back into the inventory. Inventory counts are of no value We were informed that a physical count of each pharmacy’s inventory is taken once a year by an outside vendor; however, pharmacy staff explained that this yearly inventory is not a meaningful tool because the computer inventory system is not reconciled to the stock on hand. In an effort to perform a timelier inventory check in addition to the yearly inventory, Maxor implemented routine cycle counts, an inventory control procedure in which selected medications are periodically inventoried. Cycle counts can only be done when no orders are pending, which means they must be performed before or after the day’s work. Some pharmacy staff said that it is not feasible to conduct cycle counts because the high volume of prescriptions they process daily does not leave them enough time to complete this task. One pharmacist Bureau of Criminal Investigations, Office of the Inspector General Page 22 commented that Maxor had requested cycle counts but had never followed up, so staff did not conduct them. Another pharmacist explained that his staff had originally performed the cycle counts, hoping to correct their inaccurate computer inventory; the inventory problem persisted, however, so they stopped doing the cycle counts. Ultimately, we question the value of the yearly physical counts and the cycle counts, since pharmacy staff are merely adjusting the electronic inventory to match the physical inventory without determining the causal factors for the disparity. Automated features “auto-refill” and “auto-reorder” require manual correction The failure to maintain an accurate computerized pharmacy inventory has also resulted in additional staff workload. Pharmacy staff explained that the computer inventory is tied to the daily “auto-refill” component of the dispensing system, an automated function which fills an individual’s ongoing prescriptions, such as blood pressure medication. These ongoing or maintenance medications are filled for 30 days at a time. Each pharmacy refills hundreds of these orders daily. Because the computer inventory is not accurate, the auto-refill’s functioning impedes the pharmacy staff, who manually override the computer system in order to accomplish their tasks. For example, the computer system will only allow prescriptions “The issue is the inventory to be filled if the computer inventory shows that there is stock control problem. Auto-refill available to fill the prescriptions. If the computer inventory shows less than is needed, the computer program will not allow cannot work with inventory as it is.” the prescription to be filled, even if there is actually a sufficient stock on hand. Pharmacy staff must then manually override — Lead Pharmacist the system to fill each of the prescriptions, or manually change the computer inventory to show a sufficient quantity to fill the prescriptions. Inspectors noted that this manual adjustment of the computer inventory also contributes to the disparity between the electronic inventory and the physical inventory. The computer system also includes an “auto-reorder” component, which, in theory, should track dispensed medications and create orders to replace those medications in the pharmacy inventory. In reality, however, an inaccurate computer inventory system also results in the need for pharmacy staff to manually track the dispensed medications so that they can order new stock. “We used the auto-reorder at first because Maxor insisted, but we got so much stuff we didn’t need that it would be dysfunctional to trust the system.” — Lead Pharmacist State of California • April 2010 Pharmacy staff described instances in which they had allowed the system to automatically place their medication reorder, only to receive unneeded items and/or excessive quantities. One staff member estimated that 70 percent of the items suggested by the auto-reorder function were not needed. For example, when staff allowed the auto-reorder system to place an order at one men’s prison, they received birth control pills; pharmacy staff who used the auto-reorder function at another men’s prison noted that they received a shipment of vaginal estrogen tablets. Page 23 Rather than relying on the automated system, pharmacy staff members keep a daily list, which they use to place reorders. In one pharmacy, inspectors observed a cardboard box with empty medication containers in it. Pharmacy staff told inspectors that the empty containers are placed in the box and later used to place an order at the end of the day. Because staff is unable to rely on the computer inventory system, they estimated that it took between thirty minutes to three hours of additional work daily to prepare the reorder to replenish their medications inventory. Bureau of Criminal Investigations, Office of the Inspector General Page 24 Finding 4 Inconsistent practices in handling medications for inmates who transfer between prisons result in waste and increased costs. CDCR transfers approximately 156,000 inmates a year among its various prisons throughout the state. Over 100,000 of those inmates are taking prescribed medications. Since each of the 100,000 inmates receives an average of five and a half prescriptions, the amount of medication involved in the transfer process is enormous. While the Receiver has the ultimate jurisdiction to ensure that inmates have access to their medications in an efficient and economic manner, a coordinated effort among medical, pharmaceutical, and custody staff at both the sending and receiving institutions is necessary to minimize waste and ensure that there is no interruption to an inmate’s drug therapy. As a result of the numerous staff involved in the process, our review into this area focused on six prisons. We found that four of the six prisons over-dispense medications when they transfer inmates to another institution. We also found that a high percentage of inmates arrive at the receiving prison without their prescribed medications. And we discovered that once inmates arrive at the receiving prison, all of their medications are refilled, regardless of the amount of medication sent from the previous prison. All extra medications are returned to the receiving prison pharmacy, where it is highly unlikely they are restocked. Photo 8: Incoming inmate transfer medication. Source: Office of the Inspector General. State of California • April 2010 Page 25 Our findings are similar to those referred to in the 2005 court decision to appoint a Receiver, in which the court found that prescriptions were not consistently transferred with the inmates, resulting in large quantities of medication being discarded, and that the receiving prisons routinely disregarded prescriptions from the sending prisons. Some pharmacies dispense more medication than is required for transfer To ensure the continuity of medical treatment when an inmate is transferred to another institution, the prison’s staff is required to ensure that a minimum three-day supply of all currently prescribed and essential medications is sent along with the inmate. When an inmate’s remaining supply is less than the prescribed dosage for three days, the nursing staff notifies the pharmacy, which dispenses the additional dosages. If an inmate’s prescription was recently filled, there may be several days or weeks’ worth of dosages already dispensed and available to be sent with the inmate. However, we found that pharmacies at four of the six prisons we visited dispense at least a three-day supply of each inmate’s prescribed medications, regardless of the number of dosages already available. A nurse at one institution said she routinely orders a three-day supply of medication to be sent with each inmate transferring as a safety precaution. One lead pharmacist’s reason for preparing a three-day supply of an inmate’s current medications is that he cannot be sure the remaining medications will be transferred. The fifth prison’s pharmacy staff explained that they only fill a three-day supply if the inmate’s medication record shows that less than five days’ doses remain, based on the date the medication was last dispensed. The sixth prison’s pharmacy staff said that about one year ago, they stopped their practice of routinely filling a three-day supply for all inmates who were scheduled to transfer. Instead of relying on an inmate’s medication record, pharmacy staff at that prison rely on the nurses assigned to the transfer unit to advise them if an inmate has less than three days’ worth of medication on hand. This pharmacy has not filled a transfer order of medications in over a year because the nurses have not indicated a need for transfer medications. However, data from one receiving prison shows that in one month, over half of the inmates sent from this prison did not arrive with their required medications. Inconsistent practices result in some inmates arriving without their prescribed medications Some inmates do not arrive with their prescribed medications, even though medical staff at the transferring prison are supposed to pick up all medication from the inmate’s housing unit clinic, prior to the inmate’s departure, and transfer the medication. Inmates in possession of self-administered medications are supposed to give their medications to staff. The medications are then packaged with the inmates’ medical records and taken by transportation officers to the receiving prison. We spoke with some of the nurses screening new arrivals and learned the following: • One prison reported that of the total of 49 inmates arriving from other institutions in a week, only half came with their required medications. Bureau of Criminal Investigations, Office of the Inspector General Page 26 • At another prison, a review of inmates who arrived in a one week period showed that about a third arrived without their medication. • A nurse at a third prison reported that out of 20 inmates who arrived on one day, 15 had at least one prescription for medication, yet almost half of the 15 arrived without their medication. Upon arrival, inmates are prescribed additional medications whether they need them or not When inmates arrive with a supply of medications, those medications are not used up before a new prescription for the same medication is reordered by the medical staff at the receiving prison. At five of the prisons we visited, we were told that when inmates arrive with a supply of medication, that medication is sent to the housing units’ clinics, where it will be administered only until a new refill is dispensed from the pharmacy, which is usually the same day or the next day. The unused medication is returned to the pharmacy, but it can only be restocked under very specific conditions. The sixth prison’s lead pharmacist explained that their general practice is that only medications filled from their own pharmacy are sent to the housing units and that any medication coming from other prisons is destroyed. For inmates with self-administered medications, such as inhalers, new refills are also dispensed shortly after arrival. Pharmacy staff showed inspectors a bag full of inhalers found in the possession of one inmate. Photo 9: Overdispensed inmate medication. The inmate had been The inhalers shown have an approximate value of $1200 transferred between prisons Source: Office of the Inspector General. and had several unused inhalers he received from at least two prisons. The pharmacist stated that one inhaler was dispensed upon arrival at the receiving prison, which was two days after the inmate had last received one from the sending prison. State of California • April 2010 Page 27 Recommendations To address the deficiencies identified in this report, the California Prison Health Care Receivership Corporation should take the following actions: Medication Restocking • Establish and enforce procedures to maximize the restocking of usable drugs. • Develop guidelines to determine when to purchase unit dose versus loose tab medications to maximize the return of drugs to pharmacy inventory, and monitor purchases to ensure compliance. • Review existing staffing levels within pharmacies to ensure that adequate resources are available to restock drugs to inventory. Formulary Adherence • Monitor the prescribing of over-the-counter items that have a limited medical necessity and develop processes to limit prescribers’ ability to provide such items. • Identify institutions and individual prescribers that consistently do not adhere to the formulary and provide instructions to rectify the prescribing behavior. • Ensure that there is a strong clinical pharmacy presence at prisons to provide training and direction to reduce the use of non-formulary prescriptions, maintain accurate inventories, and promote efficiencies. Inventory control • Develop and implement procedures to ensure an accurate computer inventory system in order to monitor inventory shrinkage, reduce staff labor, provide accurate management reports, and provide accountability. • Provide guidance to pharmacy staff on how to use the computer inventory system to account for medications dispensed to prison hospitals. • Ensure that the auto-refill and auto-reorder systems work effectively without manipulating the electronic inventory. Inmate transfers • Monitor transferring inmates and identify any prisons that are not forwarding medications to the receiving prison; identify the cause of the failure to follow procedure and take appropriate action. • Ensure that prisons transferring inmates to other institutions take into account the quantity of previously dispensed medications before requesting a three-day supply from the pharmacy, and monitor for compliance. • Develop a procedure to ensure that the receiving institution’s pharmacy does not refill medication before it is necessary, and monitor for compliance. Bureau of Criminal Investigations, Office of the Inspector General Page 28 California Prison Healthcare Receiver’s response to the special report (page 1 of 8) J . Clark Kelso. Receiver STATE OF CALI FORNIA PRISON HEALTH CARE SERVICES <; ) April 7.2010 Mr. David R. Shaw Inspector General Office of In peelor General P.O. OON 348780 ,cramenlo. CA 95834-8780 Re: Response to O1G pedal Report - Lost Opportunities for B,·ings within California ~ L ,~tn'::' Pharmacies De~.'Mlaw: We have re" iewed tbe Office of the Inspeclor General draft report on California Prison \\'bi le \\e welcome nnd concur that there ruc opponunities for funher improvements in our phnrmacy operalion~ tremendous invesunenl and eITons ha\'e been undenaken 3S described in our enclosed response. Pharmacies. Again. we would like to thank you and your S13n~ for the \'alunblc review and recommendations, ineerely. Receiver Enclosure cc: Honorable Thelton E. Henderson Elaine Bush. Chief Depul)' Receiver. PII S Bonnie 'oble. Director, Allied Ile.lth ervices. CPHCS Wayne Goh l and Eugenc Roth. Chicf(A). Pharmacy Services. CPIIC Brenda Epperly· Ems. Director. Policy. I'lanning and E,aluation. CPHC Johnn) Hui. Cbief. Inlern.1 Audi t, CPI ICS P.O Box 4038 . Sacramento, CA 95812-4038 State of California • April 2010 Page 29 California Prison Healthcare Receiver’s response to the special report (page 2 of 8) R C$po nst t o OIG Audit SPECIAL REPORT LOSTOPPORTIJNITIES FOR SAVINGS \VJ TIHN CALIFORNIA PRISO PfiARMACIES As demonstrated in the history presented in the repon. !'tfoM of the COCR pharmacy program has reprtstnted a significant challenge. Transforming the sY$lem from one consisting of 33 separate and poorly perfonning phamlacy opcral~s. each of l,Jo·hich operated The following provides highlights of our rC$ponsc lind recent independently from one ahOltK.-r. to an achicyemenlS occompJi5hed for the pharmacy operation: effective c-cntralty eoon:linated pharmacy PharmIlCeutiC'.1 Cosu prognm has required sigllificam lime. CDCR dNg expenditures were increasing at double-digit rotd. reSQuI'CC$ and efTon " nd remains II work in Since implemrntins our progrnm impr-O\'eIT1cnl, ph:mnllCf progress, A s a pan of the Tumillound Plan e~lX"ndituft:5 have increased 2% or less each year. which i! 41 put in p~ by the Receivership, 8 frac:lion of the nationallrend of 6-7%. progrtss ion of carefully planned Steps an: This chllJlge is even more signiftC~' when one considers Ihm heln& laken to put in place " ccntrally man)' of the related medical eart improvement initiatives being adm inis tered, standardi7..ed 3pprooch to the im plemented eonc:umluty hll~·Ci increased the numbers of inmatedeli\'el')' of phannxy sel"\'iees thM is already pat ients being treated and Ihe level of lecess to care, resu lting in a more responsive lind costeffective pc-ogram. Wh ile there rtmains M«Iicalion MIOIll&l:'lIlrnt much work to IIchicve these goal.$. • S20,3 million in COSt avoidancc ttehicved in 2009 due 10 sj,nificant progress has b«n made. fonnulary management and UlrgcteO drug contracting efforts. This document rt:Pf"Cscms the California • 80% of the prescription drugs are filled u.$ing gen~rie medic~l1 ions . Prison Hea lth Care Strvices (CI' ..ICS) Receiver's response to the final droft of the S2,6 million per year in decre.ased U$C of non-formulary drugs "S~cial Report: Lo5.1 Opportunities for (S19.76 per inmlue in 2007 toS 18.38 in 2009), Savings \\ ithin Ca li fornia Prison Phtum"cies" reeeived o n March 30, 20 10 Rtfurn 10 Stotk and WIJtC' from the Office the Inspector General • S I} million in Return-to-Stock savinp \!tIC projecU:d for this (010). The following pages provide a fiscal year. summary rtsponst to the key findings and • $4.7 million in cmJil for retumed drugs have b«n recorded .since rec:ommencbtions noted in the report 2007 . prepared by the OIG ~gard in, the COCR prison ph.nnnacy program. Addition al benefiu with CC'nlr-a1 ri ll Pharmacy Standardittd bar code labeling and automation willllilow for or efficient and Itcc.ounlilble reclll.l1lBtion. ignifleant inventory bcrK'lilS by sh ifting most oflhe prescription p~si ng to a central faci lity wi lh etonomle! of scale and eentralized. automated controls. 1 Bureau of Criminal Investigations, Office of the Inspector General Page 30 California Prison Healthcare Receiver’s response to the special report (page 3 of 8) PhI m Ule, C~1t W hite- phunnaty ca:rl:!i hJl\'~ ris~n slightly mcr thr lasl Ihrf't' yttn. the rll tt or rist 15 dramatitall) IOVlc-r Ib1ln t hat eJpu irncrd p rlol'" to the Rttthtnhlp'5 e(roru to rerorm thc phll r ma~' prognln.. EfTons 10 comrol the cost.s Dr phllJ111l1cy I:;IUe hll,t resulted in 0. sianifN:ant fo\\ mn; or the annual i ncn=~ seen in prior )ean. These efforts. ~ b) an IIcthcly ~ngagro PhannKY 3nd '1"her3peuli Commitlet'. M \ t inclw;led such act ions 3...'> requiring the use of generic meditru ions "htnever pcmlble. actively fTWlBging the formulary. emp~) ing taf'l~ed ctrug contlDCting 5trDl~ie.s. uliliLing lhtn1pc.utic InierdmniC$, de\'elopin& dise3!C guiddines and opcimizing dO$inS in moo,ication Pl'fmrn lna.ma lll Dn.l1 EJIP*nOitu,.. fromPrwl/t.ow; t.llancbrY... C~~redUlH4ItIOMI ~fI(l\lNI'''· nih · alCl ..... _ • _ __ .to . . .... .~ ,,. -.- ..... _MIII' *'__ . _ __ thernpies. A.s illustrated in the odjaccn\ man. =:::-.=.===-too;.--~------ ~! the ~rcmmse increll.~ In drug expenditures fn 2009 (2.~.) is " ell belo" (he 23.4% and 13..2°. increasc:;: $Cen in 2006 and 2001 respttti\'ely. In addition. in comparing bmchrmut projcclif;tns., Lhe increase aboul ia tJurd of thaI (,Xpc'Cled n_tionall) . . - .' "'~ Thff cJJang~ iJ n'M mOre slgmflconl whf'n ~ cOn!dd~f3 thal ,"(1'/1)' oflhc n:./uled ntt.dietJ/ curt' Jmpro'"l!mr.m 'nJ1Jnti"~ belflg lmp(ememed roncurrcntl)" I,O\'~ I"creased 'hr lIumbu$ of inmalc-palu'nlS being Irt:utitd (V'fd ,hr Icvtl o/O«eSJ I() caN, For namplt. the Chltl.'Ilml follow lIIusU'~te: Ihe I~d casu expoienced in HIV and Hcp:uiLis C ml:dl~tionj r'Hptclivtl} resulting primarily from inc:~sed lCCess 10 tl'eO!tmenl for thcse condilion$.. By the end 0(1009. COCR " 35 5pCnding almo:;;1 double IhI! Ilmount or moncy each month rar IIiV medicmJotu than In 2006 before: the ~ronn cffom began. Over thai same time comparison. tlepatitis C medication spending hilS incnased almost eiQht(old. In dollM tc:r~ COCR ~pcnt SII.l million mo~ in 2009 than ID 2008 HCV rnedlcallon5 Md S3.1 million mort for HIV rot medicatlonJ. ........ '1__ ' 1 tOOOCIO I ....... .UQIiIOQO "00Cl0Cl) ...... .. ~;I .ooOClO ..., a.~QOO " .... _--.c'HI ' I~OI» - - - -_ _ _ _ _ __ _ _ _ _ _ __ ~ //'///,//,l//,f.//./// Ongoing program savings h.1\c also betn dWKlrlstnt.ttd due to di~ a li,iti relAled to fonnuhll') management Mel tttrgl!Lcd druB coolllctms,.. Through the P&!T committ~. certain drugs arc: tl!r.a.etcd (or ~p«ific purehaS(' agrc:ements .bat PfO,,;ck additior)31 dl5Counts in price through prtftrrtd rormulary !taluS;. These elTons resulted in S20,l mUlion in co!ot Ilvo'dance in :2009 alont, This $iunC inililaLI"e yielded II roSt lS"oidAnce 0($16.4 million 1n 2008 Faellit\ Pha rnlflC'\ OHrdg hl To add ress luue:s r..latlng 10 the ovt Nlgh' 0' 'ltellll) I~' el pharma<'-y opuulon!l. the R.tcth'er·" orne''" look Itpt In De('ember 2009 10 titftbll~h • ('lear line o( aU1horhy (or ph.rnUlC)' optriliionJ ¥I lIh Iht I.lppolnl melu 0' Iht Chltr or Phunulc)' ( ). Thi SI8te employee has direel line and disciplilW')' lIIuthoril), O\ C1' the pharmlllcies Ind Is charged "ilh enforumenl afsuut'" ide pharm~)' policies lind pracliccs. Regular oCommunit.Mions. ineludmg month ly 2 State of California • April 2010 Page 31 California Prison Healthcare Receiver’s response to the special report (page 4 of 8) meetings of 1511 Pharmacist.s· ln--Charge at eo.c-h rucility fIl'e being conducted (0 review and reinfon:e polidC$ and np«lalion$.. Rtd u£ing M edication \V_sid Retu rn 10 t oc k Thf rfducdon or m~d k;IIID n waslt' hRJ btrn a mK ltr,. of (n1i:oin& allt titiOIJ IhroughoUf Ihe phumac) Imp ro\,tmtnl InlllJu h'e. pro\'ldlng ror I.h ~ n~1 Hm. a ml!"ans of accouD l ill~ for Ihe JUIl Oli ntS I"tlurned . nd w!)sud. Tb i.l fi«:al )ea,., mort' Ibu n S IJ mll l,lon In rtlum IO ~I ~k Is projteled. † Anced idcnti(.rd early on "'1l$ tht' lac-k of a function.,l rerum! contracL Sub5equrntly, Ii conln1ct ",<as ntgtllliltt'd and approved b) lbe Receiver \\ itb Guamnu:ed rlrtum$ to pro.... ide a ~~ for \l;h~h medications lh::n could not be reclaimed CQuid be legal I)' retumed 'And credll otKained ~hc!n ~~ible. S.inct the COfIlrnC:t ",-as inllialed in 2007. re1"Ums credit ofapproxlmlltdy SoI.7 million hits been rewrded. Subsequent 10 that effQr1. 35 a part or the GUllrdiilnflx pharmlc), operallng 5)Slem implementation. a Rt1:um'IOo lock CRT) function \\lIS dc:"elopcd 10 provide rQr the fil"$l tlm~ .. mtChilni!m 10 xcounl for and 1rack the rc:clamntion of medical,ion "ithin the system. Evidence of Jucb efforu can be found b) c'I(smining IhC! cha.n to the right which documenls lhe ina'Cluin, (np,;.emmt in IhC! RTS proctu by COCR facillli.es. Troc*mg if Ihu Lu-ue ,"'as first mllltl/~d ;n ScptemlNr 1008. ,"'lIh lbefir.fl month Teportlrlfl. abo!" 5Joo.000 in R1S By F,,"ruQl)· 1010. Ihe RTS amOltni.f htn'e more than qlloJnpftd t () (llmOSI 51.J hlilllon pu mOO/it. ~ ,..- -- -• /'////////'/////// In jusllhe first eight months ofthiJ FY. IIcnml RT amounts Ilre: on'r S7.8 milliQn_ We project that Ibc \1llue elf RTS alplUJ"td in the c:umnt fi5Cal )car will be over SI3 million. Thr: n-pon $usge$ts that the p1"6toce and discus.sKm$ by the OIG mspectot'S ""jlh three prisons resultcd in an immedillll! inaease in their RTS I'nults.. While not denyinll hllt the 010 discus$ians rna) ha\c had an implKt on the far:ilillc5. 10 53)' their presence \\as chI: dirttt rtaSOn for lhe incR!ase ignores the f8(1 thai othcr racililies. nol visited b)' Ihe 010 ll iso reflected Incrc:ase$ in RTS throughout the l;i$t 18 montbs since trocking of these actiyilieJ btgan In fact, during September 2009. (the montb refe.rcnctd in tbe report) the 0\('1'1;11 amount or RTS recorded incrcll$t:d b) S344.000. only about a third or "hleh i$ 3ccountt'd ror b) the Ihre~ facilities nllmtci. The report "Iso odmowledges thoU higher re510d.ing rale flK:ili lles ho\e b«n more: sutcmtUl by t'mpIQ)'ina; the vCI)' st.ralcs,iC$ tblll tune been pan or our ongoing training tnOns: incorpor:uing 1he restodr..ing dudes into !he reJ"lar workday rouli(1C$ i.1Ind UJini unit dose medication$ when a\"l.IIa.blc. l'be process oruunsrerring such "best prncticcs" from one facili1,. to 'the others is an ongoing part Qf die overnll \\ork iR\'ol"cd in lbc R~ivers.hip· s etTort to improve pharrnllcy opt"rMion. ''''hile the Retum·co-S«Ic:k process contin ue~ to sOO\\ impro\'emenl ond will be- a point of conlinucd emphasis.. it is a.1so imponnnt 10 lld:no\\ledg,e other R~eher iniliathes !limed Itt reducing the need for f1tdlhle~ to usc the return 10 stoc::k processes. There Are twO primal')' inilillli\' e~ of the Recei\·er's pharmacy impt()\Cmenl effortS 1M! will have substantiAl near term and lon,·term impacu on redudn, waste. These mo projects arc the t:Stablishmc.nl of II Central Fill Pharm3c), (near-rerm) and the de\ c lopmenl oran eMAR or c lectronic l00diclllion adminiSlnnion record (Io n &er~tcmn). The Central .. ill Pharmacy (erp) proj«t cnt:ails 1M construction and cquippin~ of 4 ((rHI'lIIud prescription packaging and automated disuibution system. The automllted centnllized phannac)' is designed 10 gain OOVAntages of scale rehilled 10 efficient pu!chasinc. imentOty control. volume: production. drug distribution. '¥>orkforcc- uulizalion. IlJ1d inr;retued pallen! safety. To achieve lhest advantages, Ihe new centralized phannacy building will Il~sume lhe- majority of lhe d.rug distribution fWKltons for 111 COCR filc:ili tie~. "ilh the e,,«priem of immediate netds fill. and suc:b items AS medk.uions requirina rdri,ennion and inlTB"etlOUll $OIUlions. The CF'P"iII order bulk pharnJQc~utirol." 10 be ckln'ua) 3 † Circled numbers correspond to OIG’s response (beginning on page 37) to CDCR’s response text. Bureau of Criminal Investigations, Office of the Inspector General Page 32 California Prison Healthcare Receiver’s response to the special report (page 5 of 8) to the CFP thereb), como/luming drug purcJraJing. decrclUlng .t)';Jt~m·",ldt ;m'rntory emd the current need to mamlam dlq»icalil'e i~nttH'ies at each/aeility. CFP automation wil l bc= used 10 package bulk pharmaceuticals intO 30-day dMt' blister packs: fulfi ll pre:seriplicm and $tock or-cIer-$ for.all COCR coJ1"eCliontal ftteilit icl: label medic.uions IS required 10 mcc=1 $ble and fe<kr.tI p~scrip l ion rtquirements; provide bar--(;od~ validalion matchins thc= drug 100 the speci fIc. pre$criplion; ..nd too $Ort the completed oorders foor shipping and nexl-da)' deliver)' 100 Ihe facilities. By u.tlng the CFP pr~pare.d blisler pacu for me.dication. Ihe am'antages ciwJ in Ihe r~porllor unil don: packaging will be adrit:'HQ for 01/ the dru~ (tNand and generic) that au ;~ued. ' tock al the facilities for immc=diate needs fill will also be p.acka,ged in this manner and provided by the CFP. The Central Fill Pharmacy will also be equipped with automalion 100 50rt and r« la im returned meditations eligible foor reuse. IlUtf!ad oj' having f!ac:h facility T(u:Jaim mf!uicatiOm. the ",tdlcations will be returned to 1M CFP ....here Ihe staMara;:ea bar code la~lins ana automation wiJI alit»!, lor ~fficif!.nI and (I(XOuntabfe redOMCJtlon. The CFP is scheduled 10 begin operation in May 20 10 and will be deployed to all facililiu oo\'er the substquent 18 moonth period. Equipment inslnllation:and tnllining of stuff ~&ins in April 2010, follc.we d by fi nal $)'5tC:m u:·sl ing ilnd i.nitial stock preparation activities in Ma)'. Beginning in June and July. respective I),. IWO facili tics \Viii be implemented as lest silts tOO valid31e the implemtnuuion prOCeSSd. ilc:giMing in Aus-wl 2010. IwO additicmal faci lities will be added 10 the CfP c:a<:h month until all facilities hav~ been converted. A long~r t~rm $Olution i$ lhe impJnnenlation oof an Eleclronic Medi~1ioon AdminiSU'l11 ion R«ord too nMsform Ihe medicalion administr.nion process and provide importanl bene-fits thou improve palient cate, incrC'l-5e .accounlabilily and re-sult in ra more COSI clTcclive medication admini:ilmtion prOCe$.$. Thc:$C bcnefil$ repre$Cnl $ign ifieanl improvements in access 100 ean: ..nd a decrease in Itle amount oof heakh care and eoorreclions sta ff lime required to ensure thai the right medication is administered to the ri&hl patient, in lhc ric.hl dosage, ill the right time . funhe r, lin eMAR assure$ continuity of care by making p'lIiem profiles ava ilable at any medicalioon administration area slatewide. 1M S}oslern would redflce WUlle and aduu~ mmaJe-patienJ mO~'~me'n1 by raing Jlanaard bar rod~d blisler card$ f()l' stock me.dicmioos. rather tha" palilml-specijic earth.. Th~ medication profil~$ would be a v aila bl~ fQf any paticnl at any authoorized cMAR I~rmina l. Thc= palic=nt pr-es~nts 3nd hisiheT $C'hedu lcd medic:;,.ions are displ .. yed :md can be immediately .dmini5lercd via a 5tock card. The in "enIOOry oof the medicllIlicm is d«rcmenled and the medk.alion ttctminislnuioon is recorded. The eMAR inilhnivc: wil l require 3n cXIC'nsi,'c effort and mus,1 be coordinat-c=d with other loong-term infrastructur~ and infonnation technOloogy proje(ts underway within the Recei\' ~tship. AI Ihis time. dc:velopmeflC or tbe eMAR system is anticipated 10 begin in aboul 24 m()nths.. No n~ f9rm ulary Mrdkaltoll Approval ProctS!I Mlln.J:tmCnl of bolh formulary a nd non-form ul ary el)j"l.tI Is an ongoing drort Il'd by Ihe COCR Ph a rnulCY li nd Therapeutic5 (P&l) Committee a nd clinical 'udership, The formu lae)' ml nlllgC'n1cn l proc:cs.sa: pUI in pl*CC" tbrou5th thc R~<:tinr·s erforlS arC" designed 10 push pre:serlblng Cow.rds Ihe most cos(.C!((«th'e mediC-ilion), Undc=r curnnl policie$., drugs are purthased in their generic fonn when ayailable and aUlomlllk.ally sub~iluted for Ihe COfTC$ponding mnd name producl. In CDCR. 8~ 0/ the pr~scriptl()n dru&1 ~ flNed using gentrfc rnedicallCIU. Prescribers may noc uSC' propridy product when" generic equiVlJent i$ 3"OIilable unless a non4formulary request is approved by Iheir superioor. Some med ications rare- also placed on n()n-formulary $tntus too force a scwnd-levC"1 re:viC"w or their use because ofsuc.h factors as thcir high C05I or their risk profile . It is imponant to uncle-rMand thlSt plKement of a drug on non-formulary SllIIU$ does nOOl mean the medication is nOOI me-dically nccC!'SS3ry, but ruther thlu a more careful I'C.'view of it$ U$e 1$ indicaled. When examining non-fonnulary c05l5, it is important 10 recognize thlll such eoslS conslrantly change ill the P&T Committee adds and deletes iterJU (rom the formulary each mcmlb. These: decisions, which nonnally take about 90 da)"s to be implemented. r~,ul arly shift COSIS belween the: form ullll)' and non -formuWy categories. For example, during the months ciled in the report, the P&T Coommitt~ converted from effexor XR to the newly ayailable gen~ric ER (orm oof the dru: . The spmdin, (shin to F) for Effex oor XR was S366,483 for the .six months from July-Dc:c:c-moo of 2009. This one example OCcoounLS for about SO.38 ~r inmale per month oflhe non· fOrmul ary COSls over this time period. As the shift 10 me g~neric: ER is fully realized. the eosts for the EffCJ(or XR version thai were shifted froom the fon1'lulary 10 non-formulary will &0 doo\'>n , Additionally. an examinatioon ornon-(ormulary CO$IS $hould also aecounl for llr'Iy ooutlier situalion$ thai can impact the COOSt For example. during the period from Jul)'*Ot"ctmber 2009, one SUlc prison hlKi a pOllient rcquirin, a highly expensive antihemophilic factor medication resulting in an unan1icip:aIC<l S1.31O.194 in costs, ull non· formulary , These COSlS contributC"d signifICantly too the higher non· formulary (;()$t$ foor this period. 4 State of California • April 2010 Page 33 California Prison Healthcare Receiver’s response to the special report (page 6 of 8) The repon cites a eakulation of S19,85 per inmzlle per month in non-rormulary C05l:50 for a three-month pcrioc:l in 2009 for 24 priwnl and rOm partS !.hose COSts 10 lh~ $)'st~m wide dala (for all 33 prisons) for 2001 and 2008. The system wide da13 is tracked Nsed on acrual purchases and reponed monthly to the PkT Committee, Th:lt ootfi s ho"'5lhllt th~ system wide CoSI per inmate pet mo nth for- n(tn-formulary med ications in 2009 was actually SI8,38. A ,llTee )'t(lr c()mpal'iS(m for all JJ !acilitiU SM'W:t non-/()rMulal)' com /xen I'edugdjrom an m'erag~ of S19. 76 in 1007 10 SI8 38 in 1009. withaMI oJiustmg!or ;""alion. r~pr~tnling mflre ,hen 51,6 m;tIi()ft in UN ngs per yt(U'". CPHCS le3det$hip h3$.. ov~r th~ lasl y~ar bcm actively cngagro in K'o·~r.ll ~ffort5 10 improve medication utilization, In recent months, (he: c linical Icadership (earn has idcn(if;ed and di5lribl.ll~d a Medication UrlCiency mid Quality Improvement (MEQI) initiative that has targeted several goals related to medic.Hion utilization including. reduction in non-formulary medications 10 thrtt perccnt or le$.$ o(totnl pf"C$(:riptions. Inilial re~lJll~ oflh~J~ 4/oru ar~ promi:s;ng. In January and February of 1010. non-/ormMltITy CMls ptr inmate P'" month (n'eraglNi S16,01, slgnlficomly lo~er 'han the 518.38 (n'erage!ol'Z0Q9. CPHCS dinicalleadership has also been acth'ely examining the use of o'o'er the.c:ounte1' (OTe) medical ions and has im p lem~nted II Slntt~gy to reduce Ih~ usc of non-modically necessary i t~ms. An initiatiyc ,,'M launched in February 2010 thai will remO\'e «I'lain pr()(iIJCI$ from the formulary that hsv~ been dt:t~nninC'd 10 bot: non·medically f\oC(cssa.I')'. Exa.mplH or ilems Ihat have been discontinued include fi$h oil, gIUCOS;Jm ine, mU$C1c rub, cert:lin vilamins ite/t15 hm'e iH!f!n matlftd 10 a non-formulary ~'alru requ iring Ihe prescribing provider 10 and vapor rub. Olhu documenl the medicl;ll need fOlthe items., including IOCions, digntive a id (Lact:lid) :lnd diphcMydrnmint:: (Benmdryl). 4 ore ore Ph . tm.tv Inventl) ry M.n.gement The cffe-ct in manBKemenl of pha,.macy Inn niory n :q uircs a n integra tcd set of s t,.s legits and is II work in prog r~$. The th ree primary $Inllegles ad opled by t he Rpce i'o'ership In'o'ol\le the de ployme nt o f t he C uard la nR x pha r m acy I)'Jle m; t he im ple nlenta Uo n o( a c-e nt r a liud ph . rm ~u:y. l ilt! the de\'elo p1ue nt o f a n e;'oo1,1\R .sY:50lem. Thne three componcnts pro\'ide a (ounda'ion ror a comprehensive invenlory manalem<"nl process, As th~$C :nn,caie.s are implemented, a1SOCiated improvements in invtntory management will be gained. The GuardianRx pharmacy operating .system provides for the fi~t (ime. a numbtf of (ools (or the pharmacies '0 use 10 manage their work_ The system include.s :I comprehensivc $CI o( loots for managing im'cnlories and th~ ordering process.. Addition.lly, unlike the prior ineffective data S)SlemS, the GuardianRx s)'ltem ensures compliance with established leg.;l l and regula10ry requirements and muintain.s data needed to manage the work effcctiYely. The chtm&eov~'t to this system hIlS ("nmi led e:l(lc(t5ive training, lind chan,gcs 10 pre:--c=xi.$tin.c workflow.s. The inventory s),stcm conlained within th~ GwudianR.x openuing 5)$tcm provides an cfT«"tive 1001 (or managing inv~ntory that is u$Cd ~ccessr\l lly to mltn~e ph;umacy inventories aeross the nation. Pharmacy mo.nagement hIlS recognIzed that effe<ti\'e use of the inyentor)' system requires additional trainin" especially in light of the prescriPlion workloads that must also be addrt:sscd each day as a fif$t priority. Management has responded with In ongoing eITOr1 (0 r~Yisil institutions 10 proyide them with the technic:41 a.ssisunc~ and tminin.; lools necessary to fully ulili7.e the: syste:m, including a scries of "so-oock" visits by phannacy operations teams. These "go-back" elTons are targeting .additional education on invefuory and rel.ted rUnC"1ions. s uch as.he RTS. auto refill and auto ord« funcrions. Implemenlation of Ihe Central 1-,11 Pharmacy will pruvide $ignljicanl im'enrory b~fil.l by shifting mO$1 of the prf'scr-ipHon pt"OCessing 10 a cenll'alfacilil)! 'lther~ tconomits of scaft and «.nlrali.:~d. automaltd COfIIrois CM bit pUI in place. Without this componau, cum~rn pharmacy operations would remain decentnllized., with duplicative inv~ ntol)' . By redirecting m\lch of the work~d from the: (xilities, the CFP inilialive: will .significantly ~duce the inY~ntorie$ needed at th~ fac ility Ie:vel and will allow the (acililY pharmacy sUlff to better utl1iu their lim ited .-esour«s to manl\g~ the: inventories. The final component in improvin& lhe management or medication [nventory is the long·tenn deployment o( Bn eMAR to providt:: accountability for mediell-lion:s rrOm the point o( purchase to the point o( administration. Th~ benefits of an eMAR arc di$(uS5ed earlier in this r~sponse. T nI" l!(rr of Mloclisal inn't M a n age m ~nt of (he: ttll OSret of med ications 15 II to mplex Issue th.t invo lvr:s m on)' m o't~ d isdplin~ Ihan simply pharm llcy. Custody, tra nsporta t Ion, n ursi n$:. nlfdiea l a nd pharmllcy sia n at~ All in'o'ol'o'ed in t he prOCf s. E J:l c nsi \'C~ dfol1 b underwa), 10 Idd rtu: ch en lu uu, but much M"o r k re ma ins. Policies and procedures havc been 5 Bureau of Criminal Investigations, Office of the Inspector General Page 34 California Prison Healthcare Receiver’s response to the special report (page 7 of 8) developed th~l require the sending tIJcility 10 lriln$ter remllining patient medication to the receiving fadlif)' , It the remaining quantity is less than 3 da)'S, the sending pharmacy is requ ired to fill 3 th~e-dlly s upply_ The reeei",ing facility is expected to accept and usc the transferred medicat ions. Policies have also been developed to address the issues relaled to inmates with multiple keep on person medica.l ions, s uch 8.5 inhaler$:. To pre·.-ent hoarding and for safety reasons, medical polides state thai patients arc: cxPC!;ted 10 complete a. "'one for ooe" exchange or such item5 when they are i$.5ued (e.g.• in order to obtain a new inhaler, the inmilte is expected to tum in tbe old one). Edu('8tion effol'U relaued 10 these: processes are ongoing, A$ a result r;( the impleml!nlation ojlhe. Central Fill model, Ihl! JfondardizOliOn of I~ling wrd packaging should help 10 millgatt ' his issue, One point or res i.stanee to allowing pre$Criptions from otMT prisons hilS bttn concem over their legitimacy, given the '""ide v&-iance in pa<kilgin& and labeling. As noted e-arlier, me long tenn resolution of this com plex issue rem: with the deployment oran eMA R system that wou ld vlrtulIlI)' cJ iminate the need to transfer nurseadministered medictll,io ns. The inmtllc's e lectronic medication profile would be available lit any facilify throlJghoutthe system and could be filkd using stock cards with no wmled doses_ BUODll'llendfliioni CPHCS genern lly concurs with the recommendations of the 010 related to the recommendations an: already underway. as sum m a,iz~ below, In many C8SC"S, activities Esfablish and enforce pro«rirlTU to maximr:e! Ihe restocldng of UJablc drugs, Steps 10 C$tIlblish a nd enror-ce proccdures 10 maximi~ the: restock ing or drugs are: already underway_ As documented in o ur response, t!'lese steps are a lready resulting in Tecli.lmlUion $~lVi ngs cl)Ch month. With the recent appointment by the Re«h'e:r or the Chier Pllarmacy (A). who has dirett line and diseiplinary authoriry over the phllnnllCies, enforcement or these dYorts will be ('nhanced_ As the CFP corne1 online: inc.-e.:tMd opponunities for recl;Jmation will be realized through the use of standud iud bli.stcr packal;inl; and mllf:h or the restock.ing .[I(tiviry "ill shift 10 the and be automated, O \'er the long tenn, the eMA R solution proposed ror the COCR .sY5tCm " ill e liminate m uch of the need for restocking. or crr • • De\'elop gllidelines 10 determin' when 10 PII,chase IJn;1 dos, 1"~11J,J loole lab medico/10m 10 Mll:tlml:e lite return of drug,J t i) pharMacy im'f!nlory. and Mcmitor purdJases 10 el'lfllrt! compliance. Through the P&T commil1ee. pharmacy admini5U1tion will review and upd.B.le relevant policy and pTOCedure.s to provide more guktMce relating '0 the purchase of unit dose versus loose tablet medications. As tile new CFP Imumes responsibi lity for processing me majority of the prescriptions, the use of blister packaging will resolve this issue and maximize the o pponunitie.s to rec laim med ications eligible ror reissue, Rn'/rw ~I ling stofling I~ls 'Wllhln phormaciu 10 ensllre thot DdeqlJQle r"owcu (Ire Q\'oilDbJe 10 rUlodt. drugs 10 inWtnlor),. Stamn, levels are and wil l continue to be ~ on II quanerly ~is and re:c;:ommendlit ions ror adjustmCflIs madc IJS nec;e.ssary. A staffing pattem for lhe CFP Implementation includes the responsibility for inventory oversight as a primlU')' dUly of prison leve l phannacy SlnO"_ Pharmacy administration wi[1 continue 10 wort with Pharm.[1f:ist~ [n ~ barge·s on prioritiz.ing inventory and ~5toeki ng tasks within daily phamuu;;y work flows, • Monitor the pt"ucrlbing of cn~r. 'lr'·COUnl~r Items thot h(Il,"/t a ('mired medical nect!$3ify olld de\'t!lop procaUJ 10 limit prescrlbt:rs' ability 10 provide such Ilems.. The R«e h'er's clinica.! leadership team hll$ a lready developed and has sent OUt ror implementation a program tarat-ting OTC uti lil-3lion . Oeveloped by a multidisciplinary clinical team, the initiatl\'e is desig.nc-d to rtduce the use of non·mtdically nef:essary OTC pTodUf:t$. Phannacy Services is suppon ing the initiative wilh the production ofmonthty OTC data as a pan of the: rnanaged care report SCtS, This data will assist regional and local clintC'.a1 leadership to manage OTe uS3se. • Identify InstJluliont and mdMdual prescribers thai consistenlly do not adhere 10 Ihe formulary and provJde ulJ' ruCl;OfI$ IOrectify Ihflt pruCf'ibmg behavior including duclplinary OCIU}n if warramed. Thb recommendation is alrelld), being addressed_ Monthl)' medical utilh:lltion rcpons provide tools Ihat Ihe regionalmediet l director and service chiefs f:an u.sc to review and evaluate prescribing patterns, These rtpOrIs dri ll down 10 the prescriber hwel. In addition. the monthly Med ication EflicienC)' and Quality Impro\'emc:nt Ilnd 6 State of California • April 2010 Page 35 California Prison Healthcare Receiver’s response to the special report (page 8 of 8) medkal program miUlagcmcnl reports provide data for the be:h,wior, • s.upCrvi ~ing ph),siciMs 10 use to influence presc:ribing £H.Jure thal there i$ a strf)llg Clinical Pharmacy $peciaJi$II"l!Si!flU at prUIJnS to pro\lide 'raining and di,(!ctitm t() ,erJ,u:e thl: use ofrro"..fOrmlllary pr~-sCTip"()ns, maintain ac~ur(JJe im'trrloriu, (lnd prom(;JI~ ef/iciencJu. In lieu of placing clinical pharmacists at prison si lC:~. the clinktr.1 phanniXy foeus has shifted (0 providing and educating clinicallcadcrship on the managed ean!" tools avai lable to them . Pharmacothernpy I"iltdicltion conS'UlIs have betn init~ted at a number of racililies. providing !pKific recommendalion~ (0 address i»ue5- 5-uch Il5- nl;Kl' fonn ulal')' utilitation , In the kIn&er tenn, the u:nlltivc CP~ICS phannac)' adminimation :nl'ueture calls for thl'« regional phmnacists who wi ll exercise operational and c:linical oversight. In addition, the imptemenlalion of CFP is inltnded 10 IIUOW (!)Cility leve l pharmads" 10 spend more time intcractin, wi1h pre.s.cribcrs to o-p(imi;tc pharmacotherapy and reduce COSIS. • Qe\.'tfop and Impft menl pt"oudllru 10 C11Sllre an actu,al~ COtnp"/~r Im'enlOl)' S}'Slem In ()I'd" to monll()l' JmwlIOI)' slrrinkagt:. redu« sltlfflubor. provide accurale managrmrnl rtports, and prrwide Qccountabiliry. Ph nu:.cy admini:nration will rtview and d~v~ lop as nc«s$ill)' IIddiliooal pr(K~dure5 oUllining the we of the c:ompuu:rized invc:ntory S)'st~m. The policiC$ and prt)CCdures will provide morc .$pcdfic guidance with clemr rt!5PQft5-ibi1itit"$ and CXp«1~lion~ outlined. Pharmacy adminiSlration " ,ill require: lbu.t the: PICs nm invmt~ adjU5tment repons regularly to enwre the im'cntory i.s being maintained. With the rt'Ctnt appoinlmenl by Ihe Receiver o( the Chief o( PharmlK)' (A), who has direct !inc and diseiplinary authority over the: pharml.\cics, oversight of this arta will be sU'tngme-ned . Prmid~ gllidanc~ tflSpelJ$~d 10 10 pharmacy staff on fN'isf)ll ho$pita~. ~, To account for medications dispensed to (0 t4(! t~ pri~on compule,. In~enttJl)l system 10 QCC"Ounl l or medlC(llions hospital -settings. pharmK)' adminLstr4tion will eontinue 10 encourage the com'ersion to a 1 db)' till process that ~liminates the need 10 make mrlnuill adjustments. This proc~ss has bet-n successfu ll)' ~mplo)'~d in .severnl facili1ies within COCR ~ Irelld)' . In ~ddition, $upplemcnlallraining wi ll be: provided to allow singJe day fill siles to accoun1 for inventory. • ellfUTe Ihotthe (J"IIto-rejifl and aUle>-reordtr 1)'slems work tJJtClillely willwu, m(mipu{uling 'he th'cJronic im't/t/Ol")'. The Reeeiver's pbannac)' consultant will conduct an applicalion lo,ic r~Yiew of Ihe au10 rerill and muto rcorder SystClnS 10 ~nsurc that 1hey work as intended and to document how the)' do so. Written procedure-s and ooclitional lmining material deUl ilin& the comel mc:lhods of maintain ing and adjusting inyentory in the compuler s)',stem wi ll Ix' d~ve loped and di$$cminatcd by phllrnl-llC)' administration. • Momlor Irunsft"ing inmates and identify any pris()l1S Ihal a,.~ l1{)l/on...arding m(!diC(IJions 10 1hl/! "«eMrr8 pri3on,' idenlify 1M cause ofthelailure to lollow fN'OCf.durl/! end ,oJ.e approp,;ore oClion £Mur~ Ihol prisonJ Ir(lns/~rring mmales cui take ;"'0 account Ihe quanlity of pret/ioudy di3pellJf-d medfcollons Wore reqlluJing (I Ihrf:1t day supply from 'he pharmacy. ami monftor lOT compliance. {)c\.-efop a procedure to 4'.fUUr~ tna' Ihi! r«eiving institution's ph(Jrm(lC)' dod nol n:/1I1,,,.:dl(;Ollo,, b.:forlJ il is necenary. and m onilor for compliance. To monitor inmate transfCll and iclenlify prisons that Ire not rorwarding medic:otions, (he Receiver and COCR Executive teams will appoinl an interdisciplinary work group to n!"view the medication lrans(er issue. The work Grou p will include: medical. menial health. dentaL. nursina. phllrmacy. custody and transportat ion representatlyes and be charged with the goal o( stondardil ing 1he processes involved in transfer of medieodons. Addilionally. this work &roup would be charged with establiShing responsibilities ror rcponina. rollowing. up and cOITeCtin& (Ilcililies who (a il 10 follow the ~t3ndardi7.ed processes. • • 7 Bureau of Criminal Investigations, Office of the Inspector General Page 36 The Office of the Inspector General’s Comments on the Receiver’s Response Although we are not responding to all of the Receiver’s statements as outlined in their response, we are commenting on the following specific issues to provide clarity and perspective: ‡ The Receiver points out that since 2007, there has been a $4.7 million offset to the reported $7.7 million annual loss resulting from what the Office of the Inspector General reported as the lack of an effective usable medications restocking policy. The offset was a credit received from a contract with Guaranteed Returns for medications returned to the pharmacy and subsequently destroyed through the program. However, we found that pharmacists used the Guaranteed Returns program inappropriately by destroying drugs that could have been restocked. Although the Guaranteed Returns program provided partial credit for drugs that met specific criteria, pharmacists used this program as a quick and easy way to process the returned drugs out of the pharmacies instead of taking the time to identify the drugs that were eligible for restocking. Consequently, pharmacies likely received pennies on the dollar and had to purchase drugs to replenish drug inventories. The Receiver noted that return-to-stock (RTS) reports initiated in September 2008 reported a total savings for that month of $300,000. Returns since that date have reportedly quadrupled, so that by February 2010 the amount of savings was nearly $1.3 million per month. However, it is important to note that when the report was initially generated in September 2008, only 15 prisons were on the GuardianRx inventory system. By February 2010, there were at least 29 prisons on GuardianRx, almost twice the number of prisons that were reporting in September 2008. Therefore, it is unclear whether the dramatic increase in RTS figures is the result of a more effective restocking program or is merely the result of more prisons using the GuardianRx inventory system. In response to our finding that not ensuring the use of approved medications costs California taxpayers an additional $5.5 million annually, the Receiver asserts that nonformulary costs decreased from $19.76 per inmate per month in 2007 to $18.38 per inmate per month in 2009. However, we note that the non-formulary costs were reduced in 2008 to $14.98 per inmate per month. The basis for our report’s finding was the difference between the failure to maintain this lower 2008 rate of $14.98 and the resulting significant increase (almost a third) in 2009. As we reported in our finding, the consequence of this lack of oversight was an additional cost to California taxpayers. ‡ Circled numbers correspond to CDCR’s response text beginning on page 30. State of California • April 2010 Page 37 Even though we found that the GuardianRx inventory system was unreliable, resulting in increased staff labor costs, the Receiver believes that the “GuardianRx operating system provides an effective tool for managing inventory that is used successfully to manage pharmacy inventories across the nation.” The Receiver does acknowledge the need for additional training on the system. However, the Receiver’s response did not address our findings that inventory counts were of no value, and that the auto-refill and auto-reorder processes lacked functionality. Clearly, in the manner currently being used by the Receiver in California, the GuardianRX system is an ineffective management tool. This unreliable system results in increased costs. The Receiver also believes that the Central Fill Pharmacy project will provide significant inventory benefits. However, it is yet to be determined what effect this will have in maintaining an accurate automated inventory system. We further note that the Central Fill Pharmacy project, developed by the Receiver and originally scheduled for operation in February 2009, has been delayed until May 2010. Bureau of Criminal Investigations, Office of the Inspector General Page 38 SPECIALREPORT REPORT SPECIAL INMATE CELL PHONE USE ENDANGERS PRISON SECURITY AND PUBLIC SAFETY Lost Opportunities for Savings Within California Prison Pharmacies OFFICE OF THE INSPECTOR GENERAL OFFICE OF THE INSPECTOR GENERAL DAVID R. SHAW INSPECTOR GENERAL STATE OF CALIFORNIA David R. Shaw MAY 2009 INSPECTOR GENERAL Samuel Dudkiewicz CHIEF DEPUTY INSPECTOR GENERAL (a) Kerry McClelland DEPUTY INSPECTOR GENERAL, IN-CHARGE (A) Rusty Davis Deputy Inspector General Chris Eagle Deputy Inspector General Anna Galvan Deputy Inspector General Sueann Gawel Deputy Inspector General Debra Maus Deputy inspector general STATE OF CALIFORNIA April 2010 WWW.OIG.CA.GOV