Hospital pharmacists must get creative amid drug shortages

By TIMOTHY MAGAW 4:30 am, September 3, 2012 The medicine cabinets at Northeast Ohio's hospitals are sparse these days, and while it's no fault of their own, a nationwide drug shortage has forced pharmacists to come up with creative ways to make supplies of medications last. Although the federal government has offered a few tools to ease the burden, local hospital pharmacists say the shortages show few signs of easing. More than 200 drugs are in short supply or unavailable entirely; the bulk of these are generic injectable drugs. Alternatives, if they exist, often are sold at high markups. One hard-to-come-by pain medication typically costs the Cleveland Clinic 10 cents a dose. But, given the difficulty in securing the drug, the health system instead purchases an alternative that costs upwards of $10 a dose, according to Scott Knoer, the system's chief pharmacy officer. “Every hospital is working on this, and most of the public never even knows how much work goes into handling the problem,” said Mr. Knoer, who has a full-time staff mem-ber devoted to managing the issue. The reasons for the drug shortages are wide-ranging. Several drug manufacturers have closed or consolidated operations in the face of shrinking profit margins, a trend health care observers say has suffocated the supply chain. In addition, the U.S. Food and Drug Administration contends more than half of the shortages are a result of quality issues that forced regulators to shutter, either permanently or temporarily, drug manufacturing plants. That was the case at Ben Venue Laboratories Inc., which last year halted production operations at its headquarters in Bedford after multiple inspections turned up dozens of quality control issues. Ben Venue's shutdown led to a critical shortage of injectable methotrexate, a drug used to treat leukemia in children and rheumatoid arthritis in adults. “It's going to take a long time to figure this out,” said Dr. Michael Anderson, chief medical officer at University Hospitals Case Medical Center, in talking about how to address the shortage. “It'll take a long time to find the right balance between the needs of companies and the needs of patients.” A lobbying effort It wasn't until this summer — thanks to a lobbying effort in Congress led by the Cleveland Clinic — that larger health systems by law could repackage certain drugs into smaller doses and share them among hospitals within their system. Previously, the Clinic only could repackage drugs and share them on its main campus; it was barred, for example, from sharing them with Hillcrest Hospital, just 10 miles east in Mayfield Heights. Still, the Clinic's Mr. Knoer estimates the repackaging legislation will help extend the life of only about 10% of the drugs on short supply. The new provision doesn't apply to controlled substances. It's also unclear how the provision might affect hospitals loosely affiliated with one another, instead of those that are wholly owned. On the plus side, the FDA now requires drug manufacturers to provide six months' advance notice of decisions to discontinue certain drugs, so that hospitals and the market can react accordingly. Such disclosures in the past were voluntary. “This has been a problem that's been brewing for a while,” UH's Dr. Anderson said. “It's reassuring to me as a leader to see the FDA and Congress taking it seriously.” Locally, the Center for Health Affairs, an advocacy group for Northeast Ohio hospitals, has decided to step up its lobbying efforts at the state level after surveying its member hospitals to gauge the breadth of the problem. “The hospitals basically validated that they felt the shortage was somewhat severe,” said Lisa Anderson, a registered nurse and the Center for Health Affairs' vice president of member services. “Years ago, it was sporadic. Now it's more of a chronic problem.” The group is looking to ease restrictions on drug compounding — the method by which drugs are concocted from raw materials at hospitals' in-house pharmacies. At present, the Ohio State Board of Pharmacy permits hospitals to compound drugs on a patient-by-patient basis, rather than stockpile compounded drugs in anticipation of need. State regulations also limit the transfer of compounded drugs between a health system's member hospitals. The Center for Health Affairs also plans to lobby state lawmakers in support of legislation that would forbid pharmacies from selling drugs in short supply to wholesalers, who in turn resell them to hospitals at high markup. The new normal? Hospital officials say it's still too early to tell whether measures to curb the problem will have a lasting impact. Wiggle room, maybe, but a cure-all appears nowhere in sight. “It's bad,” said Stacey Zorska, director of pharmacy at Southwest General Health Center in Middleburg Heights. “It's a daily struggle, and we really can't anticipate what the next crisis is going to be. I think our team has gotten very good at what to do no matter what the shortage is, but it's a struggle.” Kevin Zupancic, director of pharmacy at Parma Community General Hospital, said he's reminded of the shortage daily. He has had to buy a second dry-erase board to keep track in his pharmacy of the mounting list of drugs on short supply. Local hospital officials acknowledge the drug shortages often force them to tweak patients' treatment plans. They said patients haven't been hurt, but the prospect of opting for backup drugs so regularly is a concern. Article found at Crain's Cleveland Business at this page.

California Senate Rules Committee: Proposed Law Regarding Compounding At Centralized Hospital Packaging Pharmacy

SENATE RULES COMMITTEE            |                   AB 377|
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                                 THIRD READING


          Bill No:  AB 377
          Author:   Solorio (D)
          Amended:  8/6/12 in Senate
          Vote:     21

           
           SENATE BUSINESS, PROF. & ECON. DEV. COMM. :  9-0, 6/13/11
          AYES:  Price, Emmerson, Corbett, Correa, Hernandez, Negrete 
            McLeod, Vargas, Walters, Wyland

           SENATE APPROPRIATIONS COMMITTEE  :  6-0, 8/13/12
          AYES:  Kehoe, Walters, Alquist, Lieu, Price, Steinberg
          NO VOTE RECORDED:  Dutton

           ASSEMBLY FLOOR :  70-0, 5/12/11 (Consent) - See last page 
            for vote


           SUBJECT  :    Pharmacy

           SOURCE  :     California Hospital Association


           DIGEST  :    This bill authorizes a centralized hospital 
          packaging pharmacy to prepare medications, by performing 
          specified functions for administration only to inpatients 
          within its own general acute care hospital, or one or more 
          general acute care hospitals under the same ownership and 
          located within 75 miles of each other.

           ANALYSIS  :    

          Existing law:
                                                           CONTINUED

 



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          1. Provides for the practice of pharmacy and the licensing 
             and regulation of 
             pharmacies and pharmacists by the Board of Pharmacy 
             (Board) within the Department of Consumer Affairs. 

          2. Defines "hospital pharmacy" as a pharmacy licensed by 
             the Board, located within any licensed hospital, 
             institution or establishment that maintains and operates 
             organized facilities for the diagnosis, care, and 
             treatment of human illnesses to which persons may be 
             admitted for overnight stay.

          3. Provides that "hospital pharmacy" also includes a 
             pharmacy that may be located outside of the hospital, in 
             another physical plant that is regulated under a 
             hospital's consolidated license issued by the Department 
             of Corrections and Rehabilitations or Department of 
             Youth Authority.  Specifies that the pharmacy in another 
             physical plant shall provide pharmaceutical services 
             only to registered hospital patients who are on the 
             premises of the same physical plant in which the 
             hospital is located.  Specifies that the pharmacy 
             services provided shall be directly related to the 
             services or treatment plan administered in the physical 
             plant. 

          4. State that any pharmacy that contracts to compound a 
             drug for parenteral therapy, pursuant to a prescription, 
             for delivery to another pharmacy, must report that 
             contractual arrangement to the Board within 30 days of 
             commencing that compounding.

          This bill:

          1. This bill allows a centralized hospital packaging 
             pharmacy to prepare medications for administration only 
             to inpatients within its own general acute care hospital 
             and one or more general acute care hospitals if the 
             hospitals are under common ownership and located within 
             a 75-mile radius of each other.

          2. Authorizes a centralized hospital to perform the 
             following specialized functions if each unit dose is 



 



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                                                                Page 
          3

             barcoded as specified:

             A.    Preparing unit dose packages for single 
                administration to inpatients from bulk containers.

             B.    Preparing compounded unit dose drugs for 
                parenteral therapy for administration to 
                inpatients.

             C.    Preparing compounded unit dose drugs for 
                administration to inpatients.

          3. Defines "common ownership" to mean that the ownership 
             information on file with the Board for the licensed 
             pharmacy is consistent with the ownership information on 
             file for the other licensed pharmacy or pharmacies.

          4. Requires, in addition to pharmacy license requirement 
             described in current law, a centralized hospital 
             packaging pharmacy to obtain a specialty license from 
             the Board prior to engaging in the functions authorized 
             by this bill.

          5. Requires the Board, before issuing and renewing the 
             specialty license, to inspect the pharmacy and ensure 
             that the pharmacy is in compliance with this bill and 
             regulations it has established.

          6. States a license to perform the functions described in 
             this bill shall only be issued to a pharmacy that is 
             licensed by the Board as a hospital pharmacy, and that 
             the license shall be renewed annually and is not 
             transferrable.

          7. Sets the fee for issuance or annual renewal of a 
             centralized hospital packaging pharmacy license at $600 
             and allows it to be increased by the Board to $800.

          8. Allows a centralized hospital packaging pharmacy to 
             prepare and store a limited quantity of the unit dose 
             drugs in advance of receipt of a patient-specific 
             prescription in a quantity as is necessary to ensure 
             continuity of care for an identified population of 
             inpatients of the general acute care hospital based on a 



 



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                                                                Page 
          4

             documented history of prescriptions for that patient 
             population.

          9. Requires any unit dose medication produced by a 
             centralized hospital packaging pharmacy to be barcoded 
             to be readable at the inpatient's bedside.  Upon reading 
             the barcode, the following information shall be 
             retrievable:

             A.    The date the medication was prepared.

             B.    The components used in the drug product.

             C.    The lot number or control number.

             D.    The expiration date.

             E.    The National Drug Code Directory lot number.

             F.    The name of the centralized hospital packaging 
                pharmacy.

          10.Requires the label for each unit dose medication 
             produced by a centralized hospital packaging pharmacy to 
             contain all of the following:

             A.    The expiration date.

             B.    The established name of the drug.

             C.    The quantity of the active ingredient.

             D.    Special storage or handling requirements.

          11.Requires all compounding and packaging functions be 
             performed only in the licensed centralized hospital 
             packaging pharmacy and that pharmacy shall comply with 
             all applicable federal and state statutes and 
             regulations, including, but not limited to, regulations 
             regarding compounding and, when appropriate, sterile 
             injectable compounding.

          12.Requires a centralized hospital packaging pharmacy and 
             the pharmacists working in the pharmacy be responsible 



 



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          5

             for the integrity, potency, quality, and labeled 
             strength of any unit dose drug product prepared by the 
             centralized hospital packaging pharmacy.

           Background
           
          Existing law requires medications for a hospital's patients 
          to be prepared by a licensed pharmacy located on the 
          hospital's premises.  Automated processes implemented by a 
          hospital or health system have the potential to provide 
          additional patient protection through a reduction in 
          medication errors.  Many medication errors in hospitals 
          have resulted from inadequate and inconsistent labeling and 
          a lack of proper mechanisms to track medication through the 
          distribution process to the patient.  Recent reports show 
          that technology like bar-coding facilitates more efficient 
          medication administration and decreases medication errors.  
          According to a study published in the New England Journal 
          of Medicine, "Effect of Bar-Code Technology on the Safety 
          of Medication Administration," use of the bar-code 
          substantially decreased the rate of errors as well as 
          potential adverse drug events.  The report also concluded 
          that the bar-code electronic medication administration is 
          an important intervention to improve patient safety. 

           Food and Drug Administration (FDA).   Repackaging, 
          distribution, and compounding in advance of a patient 
          prescription are activities currently available only to 
          licensed manufacturers, which are regulated by the United 
          States FDA.  Last year, in an email pertaining to a 
          Virginia hospital using a model as proposed in this bill, 
          which is virtually identical to AB 2077 (Soloria, 2010), 
          the FDA stated that "Ýthe proposed health facility 
          pharmacy] system does not need to register as a 
          repacker/relabeler as long as they are servicing their own 
          hospitals within the state of California and repackaged 
          drugs are not commercially distributed and used only within 
          your hospital facilities."  While there has not been an 
          official change in FDA policy, it is clear in the FDA's 
          Compliance Policy Guide (460.200) as follows:  "FDA will 
          continue to defer to state authorities regarding pharmacy 
          compounding of human drugs."

           Board Compounding Regulations  .   New regulations governing 



 



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          6

          compounding took effect last summer.  According to the 
          Board, a Workgroup on Compounding was formed in 2004 
          comprised of board members, Board staff and industry 
          representatives.  The workgroup recognized that current 
          pharmacy regulations addressing compounding only govern the 
          physical circumstances, procedures and record keeping 
          requirements for general compounding and do not address 
          quality, strength or purity.

          The Board adopted regulations in Article 7 of Division 17 
          of Title 16 of the California Code of Regulations 
          (commencing with Section 1751) to implement provisions for 
          pharmacies that compound sterile injectable products as 
          required in statute.  As there were no similar provisions 
          in regulation for general compounding, the Board approved 
          the addition of language that will establish parameters and 
          provide uniformity for pharmacies that carry out 
          compounding in general (including sterile injectable).  
          Pharmacies that compound sterile injectable products must 
          go above and beyond the requirements for compounding in 
          general.

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes   
          Local:  Yes

          According to the Senate Appropriations Committee, minor 
          costs annually to the Board from the Pharmacy Board 
          Contingent Fund, offset by fees.  Potentially major costs 
          annually to the Department of Public Health from the 
          Licensing and Certification Program Fund.

           SUPPORT  :   (Verified  8/14/12)

          California Hospital Association (source)
          AmerisourceBergen
          Board of Pharmacy
          California Pharmacists Association
          California Society of Health-System Pharmacists
          Los Angeles County
          Mercy
          Sharp
          University of California, San Francisco School of Pharmacy





 



                                                                AB 377
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           ASSEMBLY FLOOR  : 
          AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill 
            Berryhill, Block, Blumenfield, Bonilla, Bradford, 
            Brownley, Buchanan, Butler, Charles Calderon, Campos, 
            Carter, Chesbro, Cook, Davis, Dickinson, Donnelly, Eng, 
            Feuer, Fletcher, Fong, Fuentes, Furutani, Beth Gaines, 
            Galgiani, Gatto, Gordon, Grove, Hagman, Halderman, Hall, 
            Harkey, Hayashi, Hill, Huber, Hueso, Huffman, Jeffries, 
            Jones, Knight, Lara, Logue, Ma, Mansoor, Mendoza, Miller, 
            Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan, 
            Perea, V. Manuel Pérez, Silva, Skinner, Smyth, Solorio, 
            Swanson, Valadao, Wagner, Wieckowski, Williams, Yamada, 
            John A. Pérez
          NO VOTE RECORDED: Alejo, Cedillo, Conway, Garrick, Gorell, 
            Roger Hernández, Bonnie Lowenthal, Mitchell, Portantino, 
            Torres


          JJA:do  8/14/12   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

                                ****  END  ****