||GUY K. ZIMMERMAN
ASSISTANT INSPECTOR GENERAL FOR AUDIT
OFFICE OF THE INSPECTOR GENERAL
||Harley G. Lappin, Director
||Response to the Office of the Inspector General's (OIG) report:
Audit of the Federal Bureau of Prisons Pharmacy Services
The Bureau of Prisons (BOP) appreciates the opportunity to comment on and respond to the recommendations from the OIG's report entitled Audit of the Federal Bureau of Prisons Pharmacy Services.
Twelve BOP institutions were selected for on-site visits as part of the audit. It was explained each was selected simply to ensure all types of facilities would be included (i.e., USP, FCI, FPC, FCC, MCC, MDC, and FTC), and that the institutions were not randomly selected. Although no major findings were identified it may not be appropriate to extrapolate the findings to all BOP institutions. The 12 selected institutions may not be a true representation of all BOP institutions in regards to institution type, region, size, Program Review findings, Joint Commission on Accreditation of Health Organization (JCAHO) review scores, American Correctional Association (ACA) findings, staffing levels, staffing shortages, etc. As such, selection bias may have a role in the findings.
Page iii of the Executive Summary states, "The BOP attributes the increase in its prescription medication costs to various reasons, including the: (1) increase in inmate population, and (2) increasing prices of prescription medications as shown in Figure 2." Other major and more specific contributing factors for increased medication costs, within and outside the BOP, should be referenced and include: new drug modalities for diseases such as HIV (e,g., FuzeonTM) and hepatitis C (e.g., interferon and ribavirin), atypical antipsychotics, advances in chemotherapy treatments; lack of community resources for persons with mental illness resulting in incarceration; increased vigilance and aggressive therapy by national guidelines such as the National Cholesterol Education Program (NCEP) and lipid levels, American Diabetes Association and glycosylated hemoglobin levels, and increased diagnosis and expanded treatment recommendations of chronic hepatitis C treatment; HIV patients are living longer and hence taking many medications for longer periods of time; need for the utilization of the newer HIV medications for BOP patients as these patients often come into the system heavily treatment experienced, accompanied with significant HIV resistance patterns; increased duration of release medications to improve continuity of care and transition into the community. It should be noted that appropriate medication therapy and monitoring, while possibly increasing medication expenditures, often play a role in reducing healthcare expenditures by improving overall patient outcomes.
OIG assessed the pharmaceutical per capita cost increase from 2000 to 2002 which BOP agrees is the most appropriate means to evaluate trends related to pharmaceutical expenditures. As noted, there was a 79 percent increase during this period which translates into a 15.8 percent per capita per year increase. This is consistent with the United States Department of Health and Human Services statistics for prescription medication cost increases of 15 to 16 percent from 1995 to 2002 represented by Figure 2, page 3 of the report. However, we do not concur with the appropriateness of the comparison between BOP prescription drug costs and the change in Consumer Prescription Drug Costs represented in Figure 2, page iii, and Figure 5, page 7. This comparison does not take into account any covariables between the data such as age, population growth, and gender. The BOP population is not identical to the U.S. population in relation to these covariables. Severely mentally ill and hepatitis C infected individuals are represented at a much higher prevalence within the BOP and correctional agencies in general, than in the population at large. As such, this comparison may graphically inflate any differences between BOP purchases and Consumer Prescription Drug Costs. We believe a better comparison is made by utilization of per capita costs as referenced above.
We have undertaken several initiatives to reduce overall healthcare costs, as well as improve patient care, which were not addressed in the report. One such initiative is the BOP National Formulary which was cited as a model program on pages 138 and 392 of the June 2002 publication Criminal Justice/Mental Health Consensus Project. Other initiatives include the BOP Clinical Practice Guidelines and the Inmate Copayment Program Policy. Please find the Bureau's response to each individual recommendation below:
Recommendation #1: Conduct a complete and accurate cost-benefit analysis of the Central Fill proposal before deciding whether to proceed with implementation.
Response: We agree with your recommendation. As pointed out in your cost adjustments, many of which were based upon differing assumptions between BOP and OIG, we realize that there will always be some variables. Taking into consideration your cost adjustments in relation to the BOP analysis and how Central Fill is inextricably linked to an overall pharmacy transformation, our final review of the entire process to include further analysis of our plan, has confirmed a need to centralize this function; and I have made the decision to move forward with our plans to implement Central Fill, Central Processing, and increased Clinical Pharmacy Services. We believe this is supported and consistent with ongoing initiatives within other government agencies as well as the private sector. We will keep you apprized of our progress in this endeavor and provide updates as we reach milestones in our strategic plans for this initiative.
Recommendation #2: Pursue efforts to request that Congress amend Pub. L. No. 102-585 (1993) to provide the BOP with eligibility for Big 4 pricing.
Response: We agree with this recommendation. This proposal was one of the BOP's internal legislative initiatives prior to the commencement of the OIG audit. Our intentions, to coordinate with the Department of Justice and pursue this initiative, were shared with the OIG at the beginning of the audit. The BOP will continue to work with the Department regarding this proposal.
Recommendation #3: Ensure BOP pharmacy staff search for the lowest possible prescription medication prices within the FSS.
Response: We agree with this recommendation. The following statement is now included in the 2005 BOP National Formulary: "The least expensive generic equivalent is to be utilized when available, otherwise non-formulary approval is required." Additionally, page 6 of the Pharmacy Services Program Statement 6360.C1, dated January 15, 2005, states: "All institutions will use the least expensive A/B rated generic when possible." The Health Services Program Review Guidelines will be revised to incorporate a review step to assess pharmacists compliance with this requirement by December 31, 2005.
Recommendation #4: Implement a system that would ensure that prescription medications are transferred with the inmates, by taking into account security issues.
Response: We agree with this recommendation. There have been generalized discussions concerning this specific issue for some time. It should be recognized that application of any such policy is extraordinarily difficult because of security and safety concerns of the staff assisting with transfer, as well as the inmate. This was most recently discussed during the Health Services Division and National Union's policy development workgroup. Appropriate Union concerns and security issues were discussed including the fact inmates are not aware of when they are moving, so medications cannot be obtained from their possession prior to preparing for transfer. This is imperative for the safety of BOP staff. Inmates are often prepared for transfer after normal working hours when a pharmacist is not onsite to verify appropriateness or identity of medications. This can risk patient safety as the potential exists for adulteration or mislabeling of medications by the inmate while they are in their possession. Lastly, this creates a mechanism for the potential smuggling of contraband. We will revise policy by June 30, 2006.
Recommendation #5: Ensure that prescription medication confiscated from an inmate is returned to the pharmacy for reissuance to the same inmate or is disposed of properly.
Response: We agree with this recommendation. It is agreed, we should always strive to reissue chronic medications when appropriate and not confiscate them when inappropriate. It should also be noted some waste is unavoidable due to therapy changes, patient non-compliance, non-use of "as needed" medications, or medications associated with treatment of an acute condition which are not taken as directed. The current Pharmacy Services Program Statement 6360.01, dated January 15, 2005, page 22, includes the following direction:
- Medications for Inmates in Special Housing Units
- Local procedures will be developed and negotiated to retrieve the inmate's confiscated medication. Health Services staff will determine if the medication should be administered or redistributed to the inmate, if appropriate.
- Under no circumstances will medication be locked up with the inmate's property, thrown in "hot trash," or distributed or administered to an inmate by anyone other than a health care provider.
Additionally, on page 7 it states, "Discontinued and outdated drugs and containers with worn, illegible, or missing labels will be returned to the pharmacy for proper disposition.”
We will revise policy by June 30, 2006. In addition, the Health Services Program Review Guidelines will be revised to incorporate a review step to evaluate compliance with this procedure by December 31, 2005.
Recommendation #6: Ensure that all BOP institutions comply with the OTC policy.
Response: We agree with this recommendation. Since completion of the audit this specific issue has been addressed through revision of the Health Services Program Review Guidelines. The revised steps are 1.5.11.d and 1.7.14. (See attached.) We request this recommendation be closed.
Recommendation #7: Ensure all documentation related to controlled substances is accurate and complete.
Response: We agree with this recommendation. We understand OIG is evaluating us based on our own policy; however, the acceptable compliance rate or threshold of OIG is unclear. The Bureau has much higher standards regarding accountability of controlled substances, per our policy, than expected in the community or as required by law. While we strive for an error rate of zero, this may not be realistic in a paper driven or even electronic medium as human administrative errors will always exist. The report insinuates only a 100 percent compliance rate is acceptable. Pages iii and 40 of the report refer to 402 unaccounted for doses, which represents less than a 1 percent error rate (402 doses/42,125 doses = 0.95 percent). There were no trends or outliers identified within the report.
Documentation and accountability of controlled substances within an institution are thoroughly reviewed through the BOP Program Review process. Several steps (1.7.l.a - e, 1.7.4 through 1.7.12) within the Health Services Program Review Guidelines address this specific issue. (See attached.) We will continue to review potential electronic processes to assist in decreasing documentation and accountability errors. Based on our own internal review process and the extremely low percentage of non- compliance identified by OIG, we request this recommendation be closed.
Recommendation #8: Require all controlled substances, including those in the substock, crash cart, and other locations, are included in the quarterly inventories.
Response: We agree with this recommendation. It should be noted the intent and type of data collected for the quarterly inventory for substock is different from what is needed for the quarterly inventory for main stock. The Quarterly Controlled Substance Inventory for Main Stock is a mechanism for trending controlled substance use by Central Office. The purpose of the DEA biennial inventory is different than that of the Quarterly Controlled Substance Inventory for Main Stock. The DEA biennial inventory is required by the DEA to obtain a snapshot of all controlled substances within the institution. This results in a reference point which can be analyzed against all invoices, administrations, substock transfers, etc., in the event the DEA audits a DEA licensed institution.
As a trending tool, the Quarterly Controlled substance inventory is concerned with movement through the main stock. Adding substocks to the Quarterly Controlled Substance Inventory would add no value for this trending by Central Office. Having a separate substock quarterly inventory, however, could potentially provide further control and oversight at the institution level above those already in place by the required perpetual substock inventory and shift inventories.
It is hopeful the Electronic Medical Record (EMR) Pharmacy Module initiative will eventually result in the ability to completely automate the controlled substance main stock, substock, administration disposition sheets, and the medication administration records. This would create the ability to monitor controlled substance activities by tying an electronic inventory system with the administration of the medication. This may result in the ability to monitor electronically, negating the need for the labor intensive Quarterly Controlled Substance reports. Discussion with the EMR vendor in this regard is ongoing.
In the interim, we will revise the pharmacy policy to address completion of a separate Quarterly Controlled Substance Inventory for Substock. We anticipate completing the policy revision by June 30, 2006.
Recommendation #9: Develop and implement policies and procedures requiring the Health Service Administrator or an authorized designee to approve each prescription medication purchase order and verify the items received to each vendor invoice.
Response: We agree with this recommendation. We are hopeful the EMR Pharmacy Module initiative will result in the ability to assist with medication monitoring activities by tying an electronic inventory system and the dispensing activity through the pharmacy module. This has been discussed with the EMR vendor. However, we believe this would be best accomplished by someone other than the Health Services Administrator (HSA). As administrators, many HSA's will not know formulary status, or be familiar with medication names to provide appropriate oversight.
It should be noted our current system does not vary with the standard mechanism found within the community. Additionally, if one or more pharmacy personnel are present, peer oversight would be inherent because of the physical proximity, overlapping duties, and oversight of the Chief Pharmacist.
Central Fill and associated centralized inventory will greatly assist in this area.
We will review potential processes for inclusion in policy until such time as the EMR Pharmacy Module can accommodate this function. We anticipate completing revisions to the pharmacy policy by June 30, 2006.
Recommendation #10: Develop and implement policies and procedures requiring adequate segregation of duties for ordering and receiving prescription medications.
Response: We disagree with this recommendation. This recommendation is in essence a redundancy of recommendation #9. If a new procedure is appropriately found and implemented, this recommendation will not be necessary. Segregation of duties would be very difficult as this is a primary responsibility of the pharmacy department with little knowledge by anyone outside of the pharmacy department. Central Fill and associated centralized inventory will greatly assist in this area. We request this recommendation be closed based on the planned corrective actions identified for recommendation #9.
Recommendation #11: Implement a policy that requires pharmacist reviews for contraindications are documented in the inmates' files.
Response: We agree with this recommendation. The pharmacy policy will be revised to require a pharmacist's signature indicating the review of contraindications. We anticipate the policy revision will be completed by June 30, 2006.
Recommendation #12: Ensure that written prescriptions include all required information.
Response: We agree with this recommendation. Pharmacy Services Program Statement 6360.01 dated January 15, 2005, on pages 27-28 states, "Medication orders written in the health record and inpatient record, must be complete and will include:
- drug name;
- route and site of administration;
- dosage form;
- frequency of administration;
- duration of therapy; and
- prescriber's name."
On page 19 it states, "DEA Controlled Substances. The physician or dentist will initiate or countersign the medication order in the health record which will include:
- controlled substance;
- DEA number;
- directions; and
- duration of therapy."
The Health Services Program Review Guidelines will be revised to evaluate compliance with this requirement by December 31, 2005.
Recommendation #13: Ensure that non-formulary waivers are obtained and required to be renewed annually.
Response: We agree with this recommendation. We agree the clinical status of patients may change which may necessitate further evaluation of a non-formulary medication.
Efforts are underway to ensure implementation of annual review with the EMR Pharmacy Module application. It is hopeful the EMR Pharmacy Module will electronically force formulary compliance through the electronic Prescriber Order Entry and Non-Formulary Request moieties rather than relying on manual tracking and audits.
It should be noted only 31 out of 1107 prescriptions reviewed did not have non-formulary approval (2.8percent) and that 23 of these instances were for the same drug for the same inmate.
We will revise the pharmacy policy, by June 30, 2006, to require all non-formulary waivers be renewed annually.
If you have any questions regarding this response, please contact Michael W. Garrett, Senior Deputy Assistant Director, Program Review Division, at (202) 616-2099.