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Published on 25 March 2010

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Report of the Midyear Clinical Meeting of the American Society of Health-System Pharmacists

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Hollywood actor calls for adoption of new technologies
to reduce medication errors

Laurence A Goldberg
FRPharmS
Editorial Consultant
HPE

As the keynote speaker at the ASHP opening session, Hollywood actor Dennis Quaid began by telling the audience, “We can no longer let our caregivers take the hit when bad things happen.”

In 2007 Mr Quaid’s newborn twins received near-fatal heparin overdoses when a concentrated solution was mistakenly used for flushing of intravenous lines. This experience has led him to become a staunch advocate for changes in hospitals’ systems to protect patients from human error.

“Healthcare workers are overworked and underappreciated,” Mr Quaid continued. “They are also human and all humans make mistakes.” He called for more rapid adoption of technologies that have been shown to work well in reducing errors, such as barcoding and computerised physician order entry. Most importantly, new technologies should be interoperable, he added. He also called for the standardisation of medicines’ management activity and medical records. “Patients should carry (electronic) cards that hold their complete medical records, and they should be able to access them at all times,” he suggested.

Another useful measure would be story telling because this is core to living, learning and leading. Great leaders such as Gandhi and Churchill have all been good storytellers, he said. Good stories have a hero, a villain and a crisis. Pharmacists should cast themselves as heroes, with the status quo as the villain and the current situation as the crisis, he suggested.

Advancing pharmacy round the globe
By 2020, 80% of hospitals in Spain will be using the latest technological advances including automation systems and electronic prescribing, according to a strategic plan launched by the Spanish Society of Hospital Pharmacists (SEFH). Describing the SEFH 2020 initiative, Rosario Santolaya (vice-president, Spanish Society of Hospital Pharmacists; and specialist in hospital pharmacy, Hospital Principe de Asturias, Madrid, Spain) explained how six strategic goals had been defined. The first of these is to incorporate technological advances into hospital pharmacies to improve the quality of services. This could release staff to take on a bigger role in patient care and pharmacotherapeutics, she noted. The other goals were: to increase the use of evidence-based medicine; improve medication safety; increase pharmacists’ input into optimisation of individualised therapy; design individualised professional
development programmes for pharmacy staff; and to increase the number of scientific publications by hospital pharmacists. Dr Santolaya is also hoping to arrange clinical pharmacy rotations through hospitals in the USA for SEFH members.

The Canadian Society of Hospital Pharmacists has embarked on a “pharmacy excellence initiative”. Neil MacKinnon (associate professor, Dalhousie University, Canada; president-elect, Canadian Society of Hospital Pharmacists [CSHP]) explained how a list of objectives had been compiled and a baseline survey conducted to determine the current level of services. For example, one objective is to ensure that 75% of patients with complex and high-risk medication regimens have a medication history taken by a pharmacist at the time of admission. The survey showed that this currently occurs for 9% of these patients. One goal is to increase the extent to which pharmacy departments in hospitals and related healthcare settings
have a significant role in improving the safety of medication
use. A key objective is to ensure that hospitals have organisational programmes, with appropriate pharmacy involvement, to achieve significant annual, documented improvement in the safety of all steps in medication use. A total of 64% of hospitals had already achieved this at baseline while the target set by the CSHP is 90%.

Much discussion of “international pharmacy” actually refers to the developed world and its well established educational systems and literature, said William Zelmer (writer-in-residence, American Society of Health-System Pharmacists) in opening the Donald E Francke Medal lecture. Even within the developed world, differing concepts of the hospital pharmacy are rarely discussed and there is scant acknowledgement that these educational and practice standards are well beyond the grasp of the least economically-developed regions of the world.

He reminded the audience that, according to the World Health Organisation, at least one-third of the world’s population lacks access to essential medicines and even among those who do have access to medicines, they are often used inappropriately or wastefully. If the hospital pharmacy aspires to be relevant across the world, it must concern itself with these facts, he emphasised. Developed models of practice simply do not match the health problems in developing countries, said Mr Zelmer.

Many tropical diseases including malaria, trachoma and onchocerciasis are amenable to drug treatment but what is needed is a remodelling of pharmaceutical care. In sub-Saharan Africa, for example, problems such as inadequate facilities for training, low numbers of trained pharmacy personnel and handling of medicines by untrained workers are commonplace. In this type of situation, using hard-pressed resources to train pharmacists as in the developed world is definitely not the way forward, commented Mr Zelmer.

Hospital pharmacy leaders in economically-developed countries have multiple competencies that should be of value in developing countries. They could help in designing and implementing efficient and effective national systems for acquiring and distributing medicines and for fostering appropriate use of medicines, and also in identifying the most appropriate ways to handle medicines for patients, suggested Mr Zelmer.

Hospital pharmacy groups might be able to “open the door to deeper engagement” if they acknowledged the difficulties and drew on the histories of their own early development to identify what is needed. Critically, they needed to approach the situation with humility and respect for the health-related self-determination of the people of other countries, he said.

Mr Zelmer concluded that pharmacists should include an international dimension in their professional lives and, in the process, foster tolerance, understanding and harmony in the world.

Safe handling of hazardous drugs
Some 5.5 million healthcare workers are potentially exposed to hazardous drugs according to Byron Peters (director of pharmacy, Siteman Cancer Center, St Louis, Missouri). Speaking at a satellite symposium sponsored by Carmel Pharma, Mr Peters explained that pharmacy and nursing staff who are involved in mixing and administering the drugs are at the highest risk. Healthcare staff are exposed to low doses of multiple drugs over long periods. “It is not uncommon to work with 50 different drugs in a week,” commented Mr Peters. Moreover, four studies had reported the presence of antineoplastic drugs in the urine of workers who were in the environment but not handling the drugs, he added.

Occupational exposure to antineoplastic agents is associated with reproductive toxicity, including increased risks of miscarriage, low birthweight and congenital malformations. The danger is greatest during the first trimester, and there is conflicting opinion about the importance of exposure during the second and third trimesters. The best recommendation is to protect healthcare workers from these agents throughout pregnancy, said Mr Peters.

About 30 antineoplastic agents are classified as carcinogens by the International Agency for Research on Cancer. There is therefore a risk of carcinogenicity among those handling the drugs and a risk of secondary malignancies among those receiving antineoplastic treatment. Occupational exposure occurs as a result of dermal contact, oral ingestion and by breathing in vapours and aerosols. This latter route has received least attention because it is most difficult to track, document and manage, said Mr Peters. The problem arises because some drugs, such as cyclophosphamide and ifosfamide have high vapour pressures and therefore vapourise readily. The vapours can pass through HEPA filters, which are designed to remove particles. If filtered air is recirculated into the working area, then staff can be exposed to the vapours. “Unlike the situation in radiology departments, we do not have the luxury of personal dosimeters for cytotoxic exposure,” commented Mr Peters.

Chapter 797 of the US Pharmacopoeia requires that hazardous drugs should be prepared under conditions that protect healthcare workers and others from exposure. This includes working in cabinets that are vented to the outside and the use of closed system drug transfer devices that contain the drugs. Both the National Institute for Occupational Safety and Health and the International Society of Oncology Pharmacy Practitioners (ISOPP) call for the use of a drug transfer device which: “Mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system,” said Thomas Carey (director of pharmacy services, Swedish American Hospital, Rockford, Illinois). In addition, ISOPP points out that a system cannot be considered ‘semi-closed’. Either it is closed or it is not, added Dr Carey.

A transfer device can be described as a containment device if it is both leakproof and airtight. The PhaSeal device (CarmelPharma) satisfies these criteria, commented Dr Carey. Published studies using titanium tetrachloride smoke showed that it was airtight and studies using fluorescein showed that it was leakproof. He recommended that pharmacists purchasing
transfer devices should ask for published evidence that devices meet the required specification. “If a device uses a vented filter to equalise pressure then it is not a closed system,” he added.

The chairman of the session, Firouzan Massoomi (pharmacy operations coordinator, Nebraska Methodist Hospital, Omaha, Nebraska) suggested that pharmacists should challenge their hospital administration departments by saying that they would be unwilling to buy closed system transfer devices if the hospital were unwilling to purchase lead shielding for radiology staff.

Recent publications had suggested that the PhaSeal device provided good protection against microbiological contamination and that this might make it possible to implement a more economical way of preparing cytotoxic doses. Further evidence is expected from a forthcoming US study, concerned with maintaining sterility of drugs over extended periods while using the PhaSeal system, said Dr Carey.

Pharmacogenomics
Pharmacogenomics offers the potential to optimise drug therapy in ways that could maximise effectiveness, minimise toxicity, reduce pharmacokinetic and pharmacodynamic variations and avoid unnecessary treatment, Joseph Ma (assistant professor of clinical pharmacy, University of California, San Diego) told the audience. There are numerous challenges in pharmacogenomic testing and currently the Food and Drug Administration (FDA) lists 66 drugs with valid genomic biomarkers in labels of approved drugs (see Resources).

One key area is oncology. Dr Ma gave the example of the human epidermal growth factor receptor (HER2), which is over-expressed in some breast cancers. Positive HER2 status is associated with reduced disease-free time and overall survival. Dosing of trastuzamab is not affected by pharmacogenomic testing but drug selection is affected and treatment (in combination with chemotherapy) should be started in those with positive results. Genomic testing is required prior to initiation of trastuzumab and this is set out in the prescribing information. There are two types of FDA approved tests for HER2 status �’ Fluorescence In Situ Hybridisation (FISH) and an immunohistochemistry test. Positive results in each test indicate expression of HER2. A report from a National Comprehensive Cancer Network Task Force (see Resources) provides guidelines about appropriate use of the two methods
to determine HER2 status, noted Dr Ma.

Studies have shown that in metastatic breast cancer, treatment with trastuzumab plus chemotherapy is associated with increased time to disease progression and longer median survival time. Adjuvant trastuzumab given with paclitaxel also increased disease-free survival and reduced the risk of death when compared to chemotherapy alone.

Anticoagulation with warfarin is another key area in the application of pharmacogenomics, explained Grace Kuo (associate professor of clinical pharmacy, University of California, San Diego). Warfarin metabolism involves cytochrome p450 2C9 (CYP2C9) and vitamin K epoxy reductase complex subunit 1 (VKORC1), both of which have several alleles. Two of the CYP2C9 alleles-CYP2C9*2 and CYP2C9*3- are associated with 50% and 90% reduction in activity, respectively. These alleles are present in 3-20% of Caucasians. A total of 10 different single nucleotide polymorphisms for VKORC1 have been shown to determine nine different haplotypes, some of which require lower doses of warfarin (‘haplotype A’) and some of which require higher doses (‘haplotype B’).

Genomic tests are available. These are 95% accurate and can provide results in one to three days. The FDA has updated labelling of warfarin to include information about pharmacogenetic testing to encourage its use to guide dosing of warfarin, although it is not a prerequisite for prescribing.

Knowing a patient’s genotype will affect the starting dose of warfarin, for example someone with the CYP2C9*2 or CYP2C9*3 alleles would require a lower dose. Someone with two CYP2C9*3 alleles would need to have the starting dose reduced by 60%, said Dr Kuo. Haplotype A patients would also require a smaller starting dose whereas Haplotype B patients would need higher doses, typically 5-6mg/day, she continued. One study that compared methods of dosing showed that pharmacogenomic dosing was the most effective when compared to a clinical algorithm and a fixed dosing method. Testing may decrease the risk of serious bleeding events but increase the risk of clotting events and, therefore, the risk must be carefully weighed against its benefit, concluded Dr Kuo.

Resources
Food and Drug Administration: Table of valid genomic biomarkers in the context of approved drug labels: http://www.fda.gov/ Drugs/ScienceResearch ResearchAreas/Pharmacogenetics/ucm083378.htm

The National Comprehensive Cancer Network (NCCN) is a
not-for-profit alliance of 21 of the world’s leading cancer centres dedicated to improving the quality and effectiveness of care provided to patients with cancer.http://www.nccn.org

Pharmacogenomics Education Program. Free CPD modules on
basic concepts and clinical applications of pharmacogenomics. Registration required. http://pharmacogenomics.ucsd.edu/about-us/pharmgened-objectives.aspx



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