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CPE Activity Announcement: Safety & Cost - Are They Mutually Exclusive with Closed System Drug Transfer Technology?

Mike Johnston - noemail@statce.com — Sun, 15 May 2011 22:00:00 GMT

We are pleased to announce an upcoming CPE Activity.

Safety & Cost: Are They Mutually Exclusive with Closed System Drug Transfer Technology?
By James A. Jorgenson, RPh, MS, FASHP

This KNOWLEDGE-BASED activity is accredited for 1.5 contact hours.

ACPE UAN: 0384-9999-11-007-L04-P
0384-9999-11-007-L04-T

Release Date: June 1, 2011 Expires: June 1, 2014

Target Audience: The target audience is intended for all Pharmacists and Pharmacy Technicians who work directly with or around hazardous drugs.

Fees: FREE

Pharmacist Learning Objectives:
At the conclusion of this activity, participants should be able to:

• Investigate the presence of hazardous drugs in the workplace;

• Evaluate the health risk associated with long term exposure to small amounts of hazardous drugs;

• Review the application of closed system transfer device technology for enhanced protection from hazardous drug exposure;

• Evaluate reasons for not utilizing a closed system transfer device;

• Challenge the issue of closed system transfer device cost;

• Analyze the use of a closed system transfer device to extend the beyond use dating for high cost single use drug products.

Pharmacy Technician Learning Objectives:
At the conclusion of this activity, participants should be able to:

• Investigate the presence of hazardous drugs in the workplace;

• Evaluate the health risk associated with long term exposure to small amounts of hazardous drugs;

• Review the application of closed system transfer device technology for enhanced protection from hazardous drug exposure;

• Evaluate reasons for not utilizing a closed system transfer device;

• Challenge the issue of closed system transfer device cost;

• Analyze the use of a closed system transfer device to extend the beyond use dating for high cost single use drug products.

To obtain credit for this activity: Participants must read/study the journal article in its entirety, complete and pass the learning assessment quiz with a score of 70% or higher. Participants whom score 69% or below will be notified and permitted to retake the exam one time at no additional charge.

This program has been commercially supported by Carmel Pharma, Inc.

The National Pharmacy Technician Association, Inc. (NPTA) is accredited by
the Accreditation Council for Pharmacy Education (ACPE) as a provider of
continuing pharmacy education.

15-May-11 5:00 PM

Webinar Completion Page

Tue, 26 Apr 2011 21:40:43 GMT

Please choose your practice setting to print off your statement of credit:

Pharmacy

Nursing

Health Risk Management

ONS Congress Safe Handling CE Symposia Links

Fri, 14 May 2010 15:16:09 GMT

Thank you for attending the satellite symposia "Putting Safe Handling of Hazardous Drugs Into Practice" held in conjunction with ONS Congress in San Diego, CA. on May 13, 2010.

For those of you who did not receive a copy of the handouts, please download them by clicking here.

You may complete the evaluation form by clicking here.

Please Note: Your CE Statement of Credit will be mailed to you in approximately 2-3 weeks. We ask that you check your demographic information to ensure accuracy when mailing out your statements of credit.

If you have any additional questions, please feel free to contact Laura De La Rosa at laura@asyntria.com or 832-426-2728.

Thank you,

STAT Educational Services

2010 Confirmation

Tue, 20 Apr 2010 16:48:39 GMT

Thank you once again for registering for tomorrow's Safe Handling Awareness Day webinar, provided by an educational grant from Carmel Pharma. IF YOU ARE PARTICIPATING IN A GROUP VIEWING: Each participant MUST pre-register in order to obtain CE credit. Webinar Links Below you will find the links that will grant you access to this webinar: April 20, 2010 1:00pm EST viewing: http://www.stratosfour.com/programs/kp.cfm?a=98&b=4263&c=0 April 20, 2010 3:00pm EST viewing: http://www.stratosfour.com/programs/kp.cfm?a=98&b=4264&c=0 Handouts Please click on the following link to download copies of the presentation for each of your attendees. www.statce.com/shad-2010 CE Credit Important: At the end of the program, the moderator will provide you with a link to the evaluation form that you will complete online. You will need to make sure this is done as soon as possible, to ensure that your credit is mailed to you in a timely manner. Anyone who does not complete the evaluation form within...

Safe Handling - Recommendations and Best Practices

Tue, 16 Mar 2010 15:19:24 GMT

Accreditation This knowledge-based program has been accredited for 1.0 contact hour of continuing education credit for pharmacists and pharmacy technicians. STAT Educational Services, a division of Asyntria, Inc., is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. ® This knowledge-based program has been accredited for 1.0 contact hour of continuing education credit for pharmacists and pharmacy technicians. This program has been approved by ASHRM toward fulfillment of the requirements of ASHRM designations of FASHRM (Fellow) and DFASHRM (Distinguished Fellow) and towards CPHRM renewal. The University of Nebraska Medical Center College of Nursing Continuing Nursing Education is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. This activity is provided for 1.25 contact...

An Overview of Swine Influenza A (H1N1)

Tue, 28 Apr 2009 20:19:42 GMT

To take this FREE CPE program, click here Learning Objectives At the conclusion of this program, participants should be able to: 1. Define and describe swine influenza A (H1N1) 2. List the signs and symptoms of swine influenza A (H1N1) 3. Outline the pharmaceutical treatment recommendations for confirmed and suspect ill cases of swine influenza A (H1N1) 4. Outline information to provide and/or discuss with patients regarding swine influenza A (H1N1) Program Details ACPE 384-000-09-004-H01P 1.0 Contact Hour Release date: 04-28-09 Expiration date: 04-28-12 Cost FREE Target Audience Pharmacists & Certified Pharmacy Technicians (Technicians should take this program at www.pharmacytechnician.org)

Tue, 21 Apr 2009 16:11:05 GMT

Register is closed for the LIVE Safe Handling Awareness Day CE Webinar, however an archived version of this program is now available on-demand...just click on CE Courses...choose your profession...and select Safe Handling: Recommendations & Best Practices This program is accredited for 1.0 contact hours of CE for pharmacists and healthcare risk managers; 1.25 contact hours for nurses. For more details on the program, click here In preparation for the program, please note the following: To obtain CE credit, participants will need to complete and submit an official CE Evaluation Form. Please download a copy of this form at http://www.statce.com/attachments/files/13/SHAD%20Eval09.pdf. Forms should be faxed to 1-888-247-8706 following the presentation. We strongly encourage that you test your computer system for technical compatibility prior to joining the program by visiting...

Webinar Tech Support

Tue, 21 Apr 2009 15:54:56 GMT

To test your system beforehand to make sure it meets the below requirements - click here.

Minimum System Requirements & Plugin Downloads

PC with Microsoft Windows OS
Internet Explorer (IE) 6.0 or higher (Download Here)
Windows Media Player 7.0 or higher (Download Here)
Sound card and speakers
Internet connection (Broadband recommended)
MS Word or Adobe Acrobat Reader (Download Here)

Webinar FAQs/Tech Support - click here

Safe Handling CE Resources

Tue, 17 Mar 2009 22:04:19 GMT

Webinar FAQs

Thu, 19 Feb 2009 21:40:48 GMT

A webcast, otherwise known as a webinar, is an audio and/or video event broadcast over the Internet. All you need is a computer with Internet access, speakers and the free Windows Media player to see and hear the program. There is no need for additional software. It's that simple. For the StatCE Webinar you will be provided with a link from which to participate. About 10-15 minutes prior to the start of the webinar, simply click on the link provided and fill out the necessary information on the registration page. After submitting your registration a new window will pop-up containing the webinar. The course will be fully contained within the new Window. There is no need for dialing in on the telephone. Be certain your computer speakers are turned up, sit back and enjoy the presentation. To ask a question during the webinar, you can click on the Feedback button along the lower part of the page. A chat window will come up. From here simply type your question in the box provided...

Jobs

Wed, 06 Feb 2008 19:32:36 GMT

Coming Soon.

CE Evaluation

noemail@statce.com — Wed, 02 May 2007 00:00:00 GMT

Objectives:

Release Date: 1-May-07 7:00 PM
Expiration Date: 30-Jul-07 7:00 PM

NTI CE Evaluation

noemail@statce.com — Tue, 01 May 2007 15:00:00 GMT

Objectives: This survey allows us to evaluate, and better improve, the effectiveness of our continuing education programs.

Release Date: 1-May-07 10:00 AM
Expiration Date: 1-May-10 10:00 AM
Please answer each question.

Program Evaluation 07-006

noemail@statce.com — Mon, 23 Apr 2007 20:00:00 GMT

Objectives:

The goal of this program was to provide current information regarding USP <797> regulations, the NIOSH High Risk Drug Alert and implications for compliance decisions. This program was designed to educate healthcare professionals on the proper handling of hazardous drugs.

Release Date: 23-Apr-07 3:00 PM
Expiration Date: 23-Apr-09 3:00 PM
Please answer the following questions to evaluate this program and provide us with your feedback.

Safety and Cost: Are They Mutually Exclusive with Closed System Drug Transfer Technology?

2011-06-01T13:00:00Z

Instructor: James A. Jorgenson, RPh, MS, FASHP

Please click here to view this program content: Jim Jorgenson - Safe Handling Webinar 6.2011 from Laura De La Rosa on Vimeo.

Safe Handling Boot Camp - Nursing

2011-04-20T18:00:00Z

Instructor: Melissa A. McDiarmid, MD, MPH, DABT, Stephen F. Eckel, Pharm.D., M.H.A., BCPS, Kristie Howlett, MS,

Safe Handling Boot Camp - Pharmacy

2011-04-20T13:00:00Z

Instructor: Melissa A. McDiarmid, MD, MPH, DABT, Stephen F. Eckel, Pharm.D., M.H.A., BCPS, Kristie Howlett, MS,

Safe Handling Boot Camp - Health Risk Management

2011-04-20T13:00:00Z

Instructor: Melissa A. McDiarmid, MD, MPH, DABT, Stephen F. Eckel, Pharm.D., M.H.A., BCPS, Kristie Howlett, MS,

Chemotherapy Safety Guidelines: Why We Need Them

2010-05-28T13:00:00Z

Instructor: Kerry Mahar, RN, MSN, AOCN

Background The risks of exposure to hazardous drugs have been documented for over 4 decades. Guidelines to protect patients, staff and the environment have been in place for more than 25 years. Despite the fact that this information has been incorporated into numerous versions of guidelines and institutional policies and procedures, there still remains incomplete understanding of risk and inconsistent application of the standards. Introduction Since the 1970’s it has been reported that the very agents used in the treatment of cancer can incur unwanted effects on those preparing and administering them. In particular, a study in Finland revealed that nurses who handled chemotherapy had that agent in their urine. (Falck, 1979) Subsequent reports revealed nurse complaining of many of the symptoms their patients, who had received full doses, experienced. These symptoms included nausea, vomiting, hair loss and mouth sores. Through the 1980’s and 1990’s numerous studies have confirmed the genotoxic effect on nurses and pharmacists exposed to antineoplastic agents (National Institute for Occupational Safety and Health, NIOSH, 2004). Fetal loss, abnormalities, and low birthweight have been related to length of maternal exposure (Hemminki, 1985). The risk of cancer in nurses who have handled chemotherapy was reported from leukemia data collected among Danish oncology nurses between 1943 and 1987. In addition, there seemed to be a relationship between leukemia rates and physicians working in the same department at that time. (Skov, 1992) The 2004 NIOSH Alert cites several examples of healthcare provider symptoms and injuries related to direct exposure. Skin contact and fume inhalation of carmustine led to severe GI distress in a nurse a few hours after exposure. Another nurse appeared to have developed allergic asthma after 3 years of work-related exposure to hazardous drugs. Lastly, a nurse’s aide, who had worn personal protective equipment (PPE) while handling urinals of patients who had received chemotherapy, developed skin irritation and a rash. The term hazardous drug was first used by the American Society of Health-System Pharmacists (ASHP) in 1990. A hazardous drug is defined as any chemical that is a physical hazard or health hazard. A physical hazard relates to combustibility or reactivity (i.e. solvents, some cleaning agents, etc.). A health hazard, the focus of this report, is a chemical that has shown to incur acute or chronic health effects in exposed individuals. (NIOSH, 2004.) Hazardous drugs are identified by having one or a combination of the following characteristics: genotoxic, teratogenic, carcinogenic, which cause fertility changes and result in organ toxicities even at low levels of exposure. (NIOSH, 2004) The International Agency for Research on Cancer (IARC) has identified numerous agents as either carcinogenic, probable carcinogenic and possible carcinogenic to humans. Alkylatings agents including cyclophosphamide and melphalan are some of the most carcinogenic agents. Other established carcinogens include arsenic trioxide, tamoxifen and thiotepa. Probable carcinogens include azacitadine, cisplatin, carmustine, etoposide and doxorubicin. Examples of possible carcinogens are dacarbazine, bleomycin and daunorubicin. Opportunity for Exposure The risk of a healthcare worker’s exposure to hazardous drugs (HDs) begins from the time a delivery arrives at the loading dock to the time the IV materials, syringes, and related safety equipment are discarded in the hazardous waste receptacle. The highest risk is related to the amount of drug one can be potentially exposed to and the amount of time one is open to exposure. Therefore, the highest rates of exposure are related to preparation and administration of antineoplastic agents. Exposure to HDs most often occurs from ingestion or inhalation of aerosolized prepared medication, dust or powder (pure drug or dried prepared medication), and less commonly accidental injection. Other mechanisms of exposure include contact with contaminated surfaces, and improper disposal or spill management. It is important to consider that improper handling at any point can lead to exposure to those who are unaware of the exposure at all. Preparation of antineoplastic agents involves the reconstitution and withdrawal of drug from vials, and transferring the drug to a syringe or IV bag. Administration involves connecting (and disconnecting) syringes or IV tubing to patient IV access. Any of these activities can result in an accidental spill or splash, splattering, spraying or aerosolization. Once an agent is outside of a closed system (aerosolized, spray, etc.) it can be ingested or inhaled or come into contact with skin or mucous membranes. Once ingested, inhaled or in contact with membranes, absorption can and does occur. Less obvious, and many may argue, far more prevalent, is contact and repeated exposure to minute amounts of drug in the treatment area. Such surfaces include desks and tables where chemotherapy may briefly be placed, keyboards used with gloved hands that handled a syringe or bag, patient treatment chairs, bedside tables, urinals and bed pans that have contained waste that may have excreted drug in it. After an individual exposure, measures must be taken to remove any product from skin, clothing and the immediate environment. Material Safety Data Sheets (MSDS) should be available to allow the best management of an exposure and the subsequent cleanup. Personal management usually involves removal of contaminated clothing and washing with soap and water. Mucosal contact must be dealt with immediately. Eye rinsing or use of an eyewash station is necessary for even the slightest exposure to the face. If ingestion occurs, it is not recommended that vomiting be induced. Emergency treatment should be sought immediately. Unfortunately, any drug that is absorbed by ingestion, inhalation or mucosal exposure cannot be removed. The amount of agent absorbed will most likely be very small, but the individual must be prepared to experience some type of effect (either local or systemic). In general there are no defined safe limits of exposure to hazardous drugs, according to NIOSH, the Occupational Safety and Health Administration (OSHA) or the American Conference of Government Industrial Hygienists (ACGIH). Guidelines In 1986, OSHA published guidelines for antineoplastic drugs. US Environmental Protection Agency (EPA) standards for the handling of hazardous waste have been in existence since 1976. OSHA (1999) and ASHP (1990) recommend hazardous drug waste be handled in the same fashion. Hazardous drug waste includes partially filled vials, undispensed products, unused IVs, needles and syringes, gloves gowns, underpads, contaminated materials from spill cleanups, and containers such as IV bags or drug vials that contain more than trace amounts of hazardous drugs and are not contaminated by blood or other potentially infectious waste. In 1998, the Department of Labor established the following hierarchy of hazard controls. Eliminate the hazard – not necessarily achievable as the drugs need to be prepared and administered Substitute – utilizing a less toxic substance Engineering controls – isolate the hazard by using equipment that is designed to protect from exposure Administrative controls – this includes educational and training standards, limiting personnel who come into contact with hazardous agents Personal Protective Equipment (PPE) – the individual’s use of the available barriers to protect oneself In 2004, NIOSH issued an alert identifying specific recommendations for the handling of antineoplastic agents. Keeping in mind the US Department of Labor’s hierarchy, the recommendations include practices related to: Receiving and Storage Drug Preparation and Administration Ventilated Cabinets Routine Cleaning Decontamination Housekeeping Waste Disposal Spill Control Additional guidelines that address hazardous drugs or the equipment in which they are manipulated have been developed by The Centers for Disease Control (CDC), National Institute of Health (NIH), International Society of Oncology Pharmacy Practitioners (ISOPP), ASHP, Oncology Nursing Society (ONS), United States Pharmacopeia (USP), and The National Sanitation Foundation. Profession-based guidelines like USP, ONS and ISOPP are all based on the recommendations of the 2004 NIOSH Alert. Each group has expanded on those practice areas pertinent to their roles. First and foremost, education and training that is required is outlined in all of these guidelines. Any worker who may be at risk of exposure to a hazardous drug must receive the appropriate amount of training to both perform the tasks correctly and to protect themselves. For instance, ISOPP, outlines the training required for anyone preparing or administering chemotherapy. In addition, the preparation of parenteral cytotoxic drugs should be undertaken only by pharmacy personnel. ONS guidelines address in detail the use of PPE during handling, administration and disposal of waste products. The following table summarizes the recommendations, components and implementation guidelines of the 2004 NIOSH Alert. Recommendation Components Guideline Implementation Assess the hazards of the workplace 1. Evaluate the workplace to identify and assess hazards before anyone begins work with hazardous drugs. Physical layout Equipment Decontamination process Potential points of exposure 2. Regularly review the current inventory of HDs, equipment, and practices Institutional Safety Committee 3. Conduct regular training reviews with all potentially exposed workers Include employees in discussions related to effectiveness or issues concerning the program Handle drugs safely 1. Implement a program for safely handling HDs at work and review this program annually on the basis of the evaluation Policies and Procedures for: labeling, storage, spill control 2. Establish procedures and provide training for handling HDs safely, cleaning up spills, and using all equipment and PPE properly Make spill kits and PPE available and easy to access. 3. Establish work practices related to both drug manipulation techniques an to general hygiene practices. Policy on food items in the work area. Use and maintain equipment properly 1. Develop workplace procedures for using and maintaining all equipment that functions to reduce exposure. Policy on use of ventilated cabinets, closed system transfer devices, closed IV systems, PPE The Resource Conservation and Recovery Act - commonly referred to as RCRA - is the primary law governing the disposal of solid and hazardous waste. Congress passed RCRA on October 21, 1976 to address the increasing problems the nation faced from our growing volume of municipal and industrial waste. RCRA, which amended the Solid Waste Disposal Act of 1965, set national goals for: Protecting human health and the environment from the potential hazards of waste disposal. Conserving energy and natural resources. Reducing the amount of waste generated. Ensuring that wastes are managed in an environmentally-sound manner. The following sections highlight the detailed recommendations for preparation, administration and disposal of chemotherapy. These guidelines were selected from the ISOPP Journal of Oncology Pharmacy, Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings Practice by the NIOSH and the 2009 Oncology Nursing Forum. Preparation All cytotoxic medications should be prepared in a central location within a sterile environment. A Biologic Safety Cabinet (BSC) must be used for all reconstitution and preparation of cytotoxic medications for administration. Personal protective equipment (PPE) will include a non-linting and non-absorbent polyethylene gown with cuffs gripped at the wrist. Disposable sleeve covers may also be used to protect the wrist and lower arm. If in a cleanroom, hair covering, overshoes and surgical mask must be worn. Gloves should be powder-free and proven resistant to chemotherapy. Latex, nitrile and neoprene are the only materials validated for handling of chemotherapy. Double gloving is recommended and gloves should be changed after 30 minutes of use. The use of special devices to protect the handler, preparer and administrator of cytotoxics should be implemented. This includes a closed system transfer device that prevent spraying and aerosolization (ISOPP 2007). Use of a Closed System Transfer Device (CSTD) NIOSH defines a CSTD as a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system (NIOSH 2004). ISOPP further states that the devices need to be leak proof and airtight. While there are numerous marketed devices currently, there is a paucity of published literature supporting their benefits. One of the early studies demonstrated the reduction of both surface contamination and urinary presence of chemotherapy six months after the implementation of a closed system transfer device. Another study evaluated five different marketed devices to determine if they met the NIOSH and ISOPP definitions of a CSTD. Following a two-part evaluation, only one of the devices was successful in meeting these definitions of a CSTD. Many hospitals are either currently using or evaluating the CSTD products on the market. It is recommended to undertake your own evaluation to ensure that it meets the NIOSH and ISOPP definitions and has peer-reviewed data to supports its claims. Administration (ONS 2009) It is recommended that a pharmacist attach and prime IV tubing to the cytotoxic agent to be administered. All chemotherapy should be labeled to indicate its hazardous nature. Storage of these agents should be in specified containers in a location that limits exposure (i. e. on a specific shelf in the medication preparation area). IV set up should be closed and all connections should be luer-locked. Utilization of closed system transfer devices is recommended. PPE will include a non-linting and non-absorbent polyethylene gown with cuffs gripped at the wrist. Gloves should be powder-free and proven resistant to chemotherapy. Double gloving is recommended. If there is a risk of splash, eye and face protection should be used. A respirator (such as a non-powered, air-purifying, particulate –filter respirator) should be worn when administering an aerosolized HD. PPE should be worn for administration of HDs by any route, spiking IV bags containing HDs and changing IV tubing, priming IV tubing, handling leakage from tubing, syringe and connections sites. PPE should also be worn when disposing of HDs and items contaminated by HDs. (ONS 2004) Dispose of the gown after each use or if it becomes soiled. Remove the gown and outer gloves and place into the hazardous waste receptacle. Then remove the second pair of gloves and dispose. (NIOSH, 2004) Wash hands with soap and water. Disposal of Waste (NIOSH 2004) Waste Disposal Trace waste (those that contain less than 3% of the original quantity of HD) which consists of used syringes, IV tubing, gowns, gloves, empty vials should be placed in a yellow chemotherapy waste container. Disposal of arsenic trioxide and any bulk amounts (3% original quantity) should be in an RCRA-rated container. Housekeeping Wear two pairs of gloves and a disposable gown when handling soiled linen, stool or urine from patients who have received HDs within the last 48 hours. Wear a face shield if a splash risk (NIOSH 2004). Linen may be placed in a leak-proof laundry bag for usual cleaning (ONS, 2009). Dispose of the gown after each use or if it becomes soiled. Remove the gown and outer gloves and place into the hazardous waste receptacle. Then remove the second pair of gloves and dispose. Wash hands with soap and water. Do not use a hand sanitizer (NIOSH 2004). Spill Management All institutions should have a specific policy and procedure for spill clean up. Spills and the clean up is considered high risk for aerosolization and splash. In addition to double gloving and gowning, face shield and respirator use is required (NIOSH 2004). Most recently, in 2009, ONS and the American Society of Clinical Oncologists (ASCO) developed a joint set of Chemotherapy Administration Standards. The joint ASCO/ONS guidelines are a unique and comprehensive approach to standardizing the entire process of chemotherapy treatment. Multidisciplinary standards were developed regarding the flow of chemotherapy administration: The review of clinical information and regimen selection Treatment planning and informed consent Order/prescription writing Drug Preparation Treatment compliance Administration and monitoring Response and toxicity monitoring There are eight standards. They include staffing, planning, practice, ordering, preparation, administration, patient consent and education, and monitoring/assessment (Jacobson et al., 2009). There is no specific standard related to safe handling but these standards speak to adequate training of personnel, education of patients and monitoring and re-assessment of the plan of care and response to treatment. Discussion The availability and specificity of the guidelines for safe handling of chemotherapy are undisputed. Unfortunately, there are many who do not have enough knowledge of the risks or of the guidelines which has resulted in less than optimal adherence to the recommendations. Barriers to adherence include lack of clear institutional policies, denial or dismissal of risks and inconvenience (Mahar, 2008). Raising the awareness of risks and how to protect oneself is one way to improve adherence. The establishment of practice-based organization position statements and creating a Safe Handling Awareness Day has certainly raised awareness, but has there been a change in practice? Increasingly, non-providers or indirect caregivers are also at risk of exposure. Oral chemotherapy is taken by the patient or administered by a family member. These therapies are also taken for extended periods of time, so that bottles and pills are more commonplace outside of the clinical area. Family, assistive personnel and pets can be exposed. As more agents are used in the clinical setting for non-oncology diseases (i.e. neurology, rheumatoid arthritis, organ transplant) clinicians who may not have the education and training that oncology nurses receive. Ensuring this group of clinicians receives that education and training is the responsibility of the employer. References American Society of Health-Systems Pharmacists. ASHP Guidelines on Handling Hazardous Drugs. 2006, 63:1172-1191. Cass, Yaakov and Setton, Isaac. 25 Years of Safe Handling of Cytotoxics (Antineoplastics) in Israel. Journal of Oncology Clincal Practice. 2006, Vol 12, pp. 83-90. Falck K., Grohn P, Sorsa M. et all Mutagenicity in Urnine of Nurses Handling Cytostatic Drugs. Lancet. 1979. 1:1250-1251. Gambrell, J and Moore, S. Assessing Workplace Compliance with Handling of Antineoplastic Agents. Clinical Journal of Oncology Nursing. 2006,Vol 10, No. 4. Pp 473 – 477. ISOPP, ISOPP Standards of Practice: Safe Handling of Cytotoxics, Journal of Oncology Pharmacy Practice (Suppl) Vol 13, pp. 1-81. Jacobson, J. O., Polovich, M., McFiff, K. K., LeFebvre, K. B., Cummings, C., Galioto, M., Bonelli, K. R., and McCorkle, M. R.. Ameirica Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administratin Safety Standards. Oncology Nursing Forum. Vol. 36, No. 6, Nov 2009. Martin, S. and Larson E. Chemotherapy Handling Practices of OUtpaitent and Office-Based Oncology Nurses. ONF, 2003, Vol 30, No. 4. Pp 575-581. Mahar K. Practical Applications: Overcoming Barriers to Chemotherapy Safety in Nursing. The Oncology Nurse. Vol. 1 No. 5, Oct/Nov 2008. (suppl). National Institute for Occupational Safety and Health. Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Sept 2004. Polovich, Martha. Safe Handling of Hazardous Drugs. Online Journal of Issues In Nursing. Sept 30, 2004. US Pharmacopeial Convention, USP 797. Guidebook to Pharmaceutical Compounding Sterile Preparations, 2008. United States Department of Labor, OSHA Technical Manual, Section 4, Chapter 2 Vanchieri, C., Health Hazards to Community Practice Nurses: The Big Worry, Community Oncology, 2005, May/June Vol 2,, No 2. Pp 277-279 Valanis, B. G, Vollmer W. M., Labuhn K. T, et al. Acute Symptoms Associated With Antineoplastic Drug Handling among Nurses. Cancer Nursing, 1993, 15:288-295. Martin S., The Adverse Health Effects of Occupational Exposure to Hazardous Drugs Community Oncology, 2005. 2: 397-400. Ritchie, MA, McAdams C, and Fritz, N. Exposure Risk in the Handling and Administration of Chemotherapy Agents: A Review and Synthesis of the Literature. Online Journal of Knowledge Synthesis in Nursing, 2000,Vol 7, No. 4

Regulations and Recommendations of Safe Handling

2010-04-26T13:00:00Z

Instructor: Stephen Eckel, PharmD, MHA, BCPS & Scott W. Savage, Pharm.D., M.S.

In 1917, mustard gas (CH2ClCH2)S was a feared chemical weapon that caused a myriad of symptoms frequently resulting in death. However, by the late 1920s a topical form of mustard gas showed promising effects alleviating pain associated with superficial tumors.(1) By 1946, nitrogen mustard (also known as chlormethine or mechlorthamine) , an agent once intended to end life, had become a pivotal agent in lymphoma cancer treatment. (2) Although surgery and radiation continue to be a mainstay in the cooperative efforts of the mulitdisplanary healthcare team to treat cancer, medicinal treatment options continue to expand available treatment modalities. With continued scientific advances, chemotherapy and biologic therapy is now commonly administered with curative intent, as adjuvant or neoadjuvant therapy, or palliative symptom relief in advanced disease.(3) In the United States, the American Cancer Society estimates almost 1.5 million new cancer cases and roughly 600,000 deaths from cancer in 2009.(4) The National Cancer Institute forecasts a doubling of this figure by 2050 with the growing and aging population.(5) With treatment not only is the patient at risk, but the health care professionals caring for the patient have a high risk of being exposed to these hazardous drugs. Considering this risk, coupled with growing patient volumes, it is paramount to have a clear understanding of the exposure risk, the national recommendations and standards related to hazardous drugs, and strategies to reduce exposure risk. Hazardous Drugs and Exposure Effects: Hazardous drugs are drugs that possess qualities presenting the risk of unwanted health effects to those handling these drugs. The term hazardous drug, first used within the American Society of Health-System Pharmacist (ASHP)’s “Technical Assistance Bulletin (TAB) on Handling Cytotoxic and Hazardous Drugs”, was further expanded in 2004 by the National Institute for Occupational Safety and Health (NIOSH).(6) In the NIOSH Alert, drugs considered hazardous are identified by exhibiting one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicities at low doses in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity. (Table 1).(7,8) Health care workers are at an exposure risk throughout the medication use process, not only during the preparation, distribution, and administration phases, but also during the subsequent disposal process of the used hazardous drug. Potential routes of exposure include inhalation, dermal contact, ingestion, or injection. In fact, it is estimated that roughly 5.5 million U.S. health care workers, including physicians, nursing, pharmacy, environmental services, research, and shipping/receiving personnel, will be exposed to hazardous drugs annually at some point throughout the process.(7) Health hazards associated with hazardous drug exposure were initially reported in the 1970s, when patients were diagnosed with secondary malignancies post-treatment with hazardous drugs for their primary neoplasm. Additionally, historical laboratory data compiled by the International Agency for the Research of Cancer (IARC) supported these observations and lead to the classification of certain hazardous drugs as human carcinogens (Group1) and probable human carcinogens (Group 2A). (Table 2)(9,10) Falck et al., first reported occupational exposure to hazardous drugs. Nurses caring for patients receiving a cyclosphosphamide based regimen had higher mutagenic markers in their urine. The mutagencity measure was less remarkable after a “duty-free” weekend indicating potential correlation of exposure frequency to cumulative occupational exposure.(11) From a pharmacy perspective, personnel preparing hazardous drugs in a horizontal, laminar airflow work bench (LAFW) had detectable mutagenic markers. However, personnel using a vertical, biological safety cabinet (BSC) had non-detectable mutagenic markers.(12) Additional evidence has validated acute health effects associated with hazardous drug exposure in nursing and pharmacy personnel including hair loss, hypersensitivity, headaches, adverse reproductive effect, increased risk of neoplasm, and chromosomal abnormalities.(13-19) Table 1: NIOSH Alert Hazardous Drug Classification (7,8) Characteristic Result Carcinogenicity Causes cancer Teratogenicity Damages developing fetuses Reproductive toxicity Impairs fertility Organ toxicity Impairs organ function Genotoxicity Damages DNA Mimic existing hazardous drugs in structure and toxicity Any of the above Sources of Exposure: Exposure of health care professionals to hazardous drugs is varied in route as previously mentioned. Surface contamination is evident in all phases of the medication use process. During the preparation, administration and distribution phase, contamination has been documented within pharmacy and nursing areas.(20-22) Dermal contamination can be a direct result of the external contamination of hazardous drug vials which can subsequently lead to surface contamination of other areas. In 1999, six cancer treatment centers in Canada and the United States were evaluated for the level of contamination of hazardous drugs. Measurable amounts of contamination were detected in 75% of the pharmacy area samples and 65% of the administration area samples.(20) Additional studies have presented consistent results to other published data showing surface contamination within primary engineering controls (e.g. LAFWs, BSCs, compounding aseptic isolators, and cleanrooms), equipment used for preparation and administration of hazardous drugs (e.g. intravenous bags and tubing), and general work surfaces (e.g. desk, floors, countertops, and cabinets).(10,22-24) Such diverse contamination of work surfaces only increases the risk of personnel exposure. Measureable indicators of hazardous drug exposure in the urine of health care workers are documented in over 19 studies worldwide. A majority of these studies detected one or more hazardous constituent. Additionally of the 19 studies, four of them described secondary exposure to health care personnel that had no direct contact with the patient.(10) Based on the expected excretion of some of the measured hazardous drugs, in particular cyclophosphamide, inference was possible correlating an increased risk of cancer in those with systemic exposure.(20,25) Inhalation and ingestion exposure are also a potential risk. Although minimal data supports a complete understanding of the effects of these types of exposure, studies report little to no detectable contamination to significant contamination indicated by particulate air sampling. Ingestion serves as an alternative route to dermal absorption due to the combination of surface contamination transferring from the hands to the mouth.(10) This exposure data validated the incidence and risk of hazardous drug contamination and has garnered a response from governmental and health care professional bodies. These efforts, as detailed in the next section, all intend to reduce the occupational exposure risk of personnel. Safe Handling Guidelines and Standards: Guidelines to minimize exposure to hazardous drugs were first published by the Society of Hospital Pharmacists of Australia in 1981.(26) Today, there are multiple guidelines or references that guide the management of hazardous drugs.(7,27-31) Occupational Safety and Health Organization (OSHA) OSHA, whose mission is to assure safe and healthful working conditions for working men and women, first released guidelines for safe handling of hazardous drugs in 1986. Under OSHA standards, material safety data sheets (MSDS) for any hazardous drug must be available to the health care worker. Subsequent updates, reinforced prior findings that personnel exposure to hazardous drugs is an increasingly serious health concern promoting updated guidelines in 1995.(27,28) National Institute for Occupational Safety and Health (NIOSH) Although guidelines had been released from both governmental and professional organizations prior to 2004, data indicated that contamination and exposure to hazardous drugs within the workplace continued.(20-22) The NIOSH Alert, representing the recommendations of governmental and non-governmental thought leaders, intended to increase the awareness among the employers and the front-line health care workers. It applies to all workers who handle hazardous drugs and provides tools for preventing exposure that can be implemented by the employee or employer in their daily activities. ASHP Guidelines on Handling Hazardous Drugs Originally published in 1990, the updated guidelines intend to characterize the reoccurring and new concerns associated with the handling of hazardous drugs.(6) Additionally, it discusses specific recommendations concerning development of a safety program, general work practices, processes related to labeling and packaging, benefits of protective equipment, and containment and disposal of hazardous drugs.(29) American Society of Clinical Oncology (ASCO) and Oncology Nursing Society (ONS) The Oncology Nursing Society (ONS), originally established by nurses working in research settings involved with medical oncologist, released guidelines in 1982.(30) Updates to ONS’s guidelines, focuses on the knowledge base necessary to reduce risk associated with hazardous drugs including safe handling and administration.(31) Additionally, ASCO released guidelines intended for application at physician’s offices, infusion centers, free-standing cancer-centers, and any other treatment site, except a hospital outpatient department.(32) The updated ASCO guidelines include minimum level of services necessary to provide hazardous drug therapy.(33) Recently, ASCO and ONS jointly released standards encompassing seven domains of which preparation and administration practices are discussed. ASCO and ONS intend adoption should be the goal for best practice implementation in ambulatory care setting.(34) United States Pharmacopeia The Food, Drug, and Cosmetic Act of 1938 recognized the United States Pharmacopeia-National Formulary (USP-NF) as the official compendia of drug standards with the Food and Drug Administration (FDA) responsible for enforcement. USP Chapter <797>, based on its chapter number, is considered an enforceable regulation; however, the FDA looks to individual states to regulate pharmacy practice.(35,36) Within the most recent version, hazardous drugs as compounded sterile preparations has a distinct section with specific details related to the engineering and facility controls along with personnel training and attire required to prevent injury and illness associated with hazardous drug exposure. United States Environmental Protection Agency (EPA) The discovery of pharmaceuticals in surface, ground, and drinking waters around the United States has been a direct way for the everyday citizen to have an awareness of the risk associated with hazardous drugs. Established in 1976, the Resource Conservation Recovery Act (RCRA), sought to address the disposal of hazardous chemicals. The list of regulated chemicals include a variety of commonly used hazardous drugs. Failure to comply with the RCRA regulations can result in potential EPA violations and associated monetary fines.(37) The Joint Commission Created in 1951, this accreditation body is the oldest and largest health care standard-setting and accrediting body in the United States. In order to earn and maintain, The Joint Commission’s approval, an organization must undergo on-site survey. Within the Hospital Accreditation requirement, Medication Management and Environment of Care standards related to hazardous drugs. These standards and associated Elements of Performance (EP) guide the management, disposal, and minimization of risk associated with hazardous drugs. Non-compliance with these standards can result in non-accreditation for an organization.(38) Strategies to Reduce Potential Exposure: Knowing that there is a potential for exposure in your workplace to chemotherapy products is not enough. It is important to develop strategies for reducing contamination for employees. Some recommendations are easy to achieve and many places already complete them. However, others will require time to develop, resources to purchase, and organizational approval to implement. Determining and classifying medications as hazardous – NIOSH recommends a written inventory of all hazardous medications that will be used to be developed(7). This list needs to also come with a process to keep it updated and active, as new medications are added to the formulary. While the IARC provides carcinogenicity classifications of hazardous medications (table 2), this information is not current with all of the existing medications in the workplace. This table provides a good start for an organization in determining classification for medications they use, it should not be an end of itself. Medications that need to be reviewed for hazardous includes biologics, oral cancer medications, and medications that are teratogenic (but not used for the treatment of cancer). Another required recommendation is to have MSDS sheets available to all employees who could come into contact with the medication. These provide needed information to employees. Table 2: International Agency for the Research of Cancer Hazardous Drug Classifications (9) Group 1: (Carcinogenic to Humans) Group 2: (Probably Carciongenic to Humans) Arsenic trioxide Azathioprine Chlorambucil Chlornaphazine Cyclophosphamide Myleran Melphalan Semustine Tamoxifen Thiotepa Terosulfan Mustarge-Oncovin-Procarbazine-Prednisone (MOPP) Etoposide-Cisplatin-Bleomycin Azacitidine BCNU CCNU Chlorozotocin Cisplatin Doxorubicin N-Ethyl-N-nitrosurea Etoposide Mechlorethamine N-Methyl-nitrosourea Procarbazine Teniposide Implement policies and procedures for handling chemotherapy – After the list is determined, explicit policies and procedures need to be developed surrounding the handling of these medications. Each employee that has the potential for interacting with the chemotherapy needs to be evaluated for risk potential. This evaluation should start all the way from the receipt of medications to the administration of them. It has been studied that the outside of chemotherapy vials have trace contamination on them(22). This develops through the manufacturing process and could pose a concern for those handling medications on the loading dock. Issues to be discussed revolve around whether they should handle these medications while wearing gloves and should chemotherapy be stored in a separate area so as to not contaminate other medications. After the medication is in the pharmacy, USP <797> recommends that the medications be stored in a negatively pressured room. Another overlooked employee group is housekeeping. Many times they will enter the pharmacy to clean and not take the appropriate steps to protect themselves. Training employees – all employees need to be educated about the concerns with handling chemotherapy products. This should be done at the point of orientation, but should not end there. Continual education should be implemented as a part of the culture of the workplace. Part of the training should include the various steps that the organization uses to protect the worker. Simple steps include double-gloving with chemotherapy-approved gloves, use of a lint-free gown, hair nets, masks, shoe protection, and when needed, an eye shield. Other required steps in the training are the utilization of the appropriate environmental controls: either a barrier isolator or a biological safety cabinet. These procedures should both be taught and explained to the employee, but also observed to ensure compliance. Environmental controls – NIOSH and USP 797 have recommendations on the appropriate environmental controls that need to be used in the pharmacy. These are established to protect both the product from microbial contamination and the employee from exposure to hazardous drugs. Many of the recommendations are associated with airflow, hood placements and selection, and filtration of the air. Monitoring chemotherapy contamination – USP <797> recommends that an organization undertakes a surface wipe study to detect contamination of chemotherapy every 6 months(35). This will allow you to monitor over time the level of chemotherapy on surfaces in order to determine if exposure levels increase or decrease. In addition, there is also a recommendation from NIOSH to undertake medical surveillance of your employees(7). Cleaning procedures – at the end of the shift or day, the organization needs to develop a plan for cleaning the work surfaces of both the preparation and the checking areas. One area to discuss is the use of a decontamination product as a part of this process. There is currently one marketed for use that uses sodium hypochlorite. This product would be used in addition to the routine sterilization that occurs. Handling chemotherapy spills – it is imperative that each location that prepares and administers hazardous medications to store a chemotherapy spill kit. Each employee working in those areas should be knowledgeable about location and how to use it in the event of a spill. Disposal of hazardous medications – this is an area that is receiving significant national attention. The RCRA regulation provides some direction on disposal of medications(37), but each organization needs to develop policies that provide for disposal of chemotherapy vials and for chemotherapy infusions. Use of a closed system transfer device (CSTD) – over the past few years, there has been a significant growth of technology in this area. NIOSH defies a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system(7). ISOPP further states that the devices need to be leak proof and airtight(39). While there are numerous marketed devices currently, there is a paucity of published literature supporting their benefits. One of the early studies demonstrated the reduction of both surface contamination and urinary presence of chemotherapy six months after the implementation of a closed system transfer device(21). Another study evaluated five different marketed devices to determine if they met the NIOSH and ISOPP definitions of a CSTD(40). Following a two-part evaluation, only one of the devices was successful in meeting these definitions of a CSTD. Many hospitals are either currently using or evaluating the CSTD products on the market. It is recommended to undertake your own evaluation to ensure that it meets the NIOSH and ISOPP definitions and has peer-reviewed data to supports its claims. Conclusions: Chemotherapy and hazardous drug preparation is not without risk. While these medications have been demonstrated to be effective at treating cancer and other disorders, they also have side effects not only for the patient, but also for the healthcare worker. The most important issue is to be aware of the concerns and risks present with handling hazardous drugs. There are also many regulations and guidelines to assist in providing recommendations on how to protect healthcare workers from exposure to chemotherapy. Reviewing these statements and instituting a few processes have been demonstrated to reduce the exposure to hazardous drugs. Bibliography 1. Joensuu G. Systemic chemotherapy for cancer: from weapon to treatment. Lancet Oncol 2008;9:304. 2. Goodman LS, et al. Nitrogen mustard therapy. JAMA 1946;132:126-32. 3. Medina PJ and Fausel C. Cancer treatment and chemotherapy. In Dipiro JT, eds. Pharmacotherapy: A Pathophysiologic Approach , 7th ed. New York, 2008: 2085-119. 4. Jamel A, et al. Cancer statistics, 2009.CA Cancer J Clin 2009;59:225-49. 5. Edwards BK, et al. Annual report to the nation on the status of cancer, 1973-1999, feature implications of age and aging on U.S. cancer burden. Cancer 2002;94;2766-2792. 6. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-49. 7. National Institute for Occupational Safety and Health. NIOSH alert: preventing occupational exposure to anti-neoplastic and other hazardous drugs in health care settings. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf (accessed 2010 Mar 9). 8. Power L and Jorgenson J. Safe handling of hazardous drugs: video training program. American Society of Health-System Pharmacists. Maryland, 2006. 9. International Agency for the Research of Cancer. IARC monographs database on carcinogenic risks to humans. http://monographs.iarc.fr/ENG/Classification/index.php (accessed 2010 March 9). 10. Connor TH and McDiarmid. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J Clin 2006;56;354-365. 11. Falck K, et al. Mutagenicity in urine of nurses handling cytostatic drugs. Lancet 1979;1:1250-1. 12. Anderson RW, et al. Risk of handling injectable antineoplastic agents. Am J Hosp Pharm 1982;39:1881-87. 13. Valanis BG et al. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nurs 1993;16:288-95. 14. Dranistsaris G , et al. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systemic review and meta-analysis of the literature. J Oncol Pharm Pract 2005;11:69-78. 15. Selevan SG, et al. A study of occupational exposure to antineoplastic drugs and fetal loss in nurses. N Engl J Med 1985;313:1173-78. 16. Valanis BG, et al. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharmacy 1993;50:455-62. 17. Skov T, et al. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. Lancet 1990;336:1446. 18. Sessink PJM, et al. Drugs hazardous to healthcare workers, a review article. Drug safety 1999;20(4);347-59. 19. Sessink PJM, et al. Urinary cyclophosphamide excretion and chromosomal aberrations in peripheral blood lymphocytes after occupational exposure to antineoplastic agents. Mutation research 1994;309:193-99. 20. Connor TH, et al. Surface contamination with antineoplastics agents in six cancer treatment centers in Canada and the United States. Am J Health-Syst Pharm 1999;56:1427-32/ 21. Wick C, et al. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health-Syst Pharm 2003;60:2314-20. 22. Connor TH, et al. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies. Am J Health-Syst Pharm. 2005;62:475-84. 23. Harrison BR, et al. Comparison of surface contamination with cyclophosphamide and flurouracil using a closed-system transfer device versus standard preparation techniques. Am J Health-Syst Pharm. 2006;63:1736-44. 24. McDevitt JJ, et al. Exposure of hospital pharmacists and nurses to antineoplastic agents. J Occup Med. 1993;35:57-60. 25. Bos RP and Sessink PJM. Biomonitoring of occupational exposure to cytotoxic anticancer drugs. Reviews on environmental health. 1997;12(1):43-58. 26. Harrison BR. Developing guidelines for working with antineoplastic drugs. Am J Hosp Pharm. 1981;38:1881-87. 27. United States Department of Labor, Occupational Safety and Health Administration. Hazard Communication. 29 CFR Part 1910.1200. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 (accessed 2010 March 10). 28. United States Department of Labor, Occupational Safety and Health Administration. Controlling occupational exposure to hazardous drugs. OSHA technical manual, TED 01-00-15. Section VI. Chapter 2. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html (accessed 2010 March 11). 29. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health Syst Pharm. 2006;63:1172-93. 30. Oncology Nursing Society: Outcome standards for cancer nursing education. Pittsburgh, 1982. 31. Polovich M, et al. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. 3rd edition. Pittsburgh, 2009. 32. American Society of Clinical Oncology: Criteria for facilities and personnel for the administration of parenteral systemic antineoplastic therapy. J Clin Oncol. 1997;15:3416-17. 33. American Society of Clinical Oncology: Criteria for facilities and personnel for the administration of parenteral systemic antineoplastic therapy. J Clin Oncol. 2004;22:4613-15. 34. Jacobson JO, et al. American society of clinical oncology/oncology nursing society chemotherapy administration safety standards. 2009;99:1-7. 35. USP General Chapter <797>. The current United States Pharmacopeia and the National Formulary and Supplements. Rockville, Md: The United States Pharmacopeial Convention, 2007. 36. US Food and Drug Administration. Compliance Policy Guides Manual; CPG Sec. 460.200 Pharmacy Compounding. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074398.htm (accessed 2010 March 11). 37. US Environmental Protection Agency. Hazardous Waste Regulations. http://www.epa.gov/epawaste/laws-regs/regs-haz.htm (accessed 2010 March 12). 38. The Joint Commission E-dition. Hospital Accreditation Requirements. http://amp.jcrinc.com/Frame.aspx (accessed 2010 March 12). 39. Special devices. J Oncol Pharm Pract.2007;13:27-30. 40. Jorgenson JA, Spivey SM, Au C, et al. Contamination Comparison of Transfer Devices Intended for Handling Hazardous Drugs Hosp Pharm—2008;43:723–727

Looking at the Safe Handling of Drugs a Whole New Way

2009-12-08T17:30:00Z

Instructor: Byron Peters B.S. Pharm., R.Ph., E. Thomas Carey, Pharm D

Risky Business: Understanding & Preventing Hazardous Drug Exposure

2009-11-13T14:00:00Z

Instructor:

Risky Business: Understanding & Preventing Hazardous Drug Exposure

2009-11-13T12:00:00Z

Instructor:

An Overview of Swine Influenza A (H1N1)

2009-04-28T13:00:00Z

Instructor: Wendy Meigs RPh/ Mike Johnston, CPhT/

Important Note: The development of this continuing pharmacy education program was expedited with approval of the Accreditation Council on Pharmacy Education (ACPE) in response to a nationally declared public health emergency by the US Department of Health and Human Services (HHS). This program was developed with the latest information available as of April 26, 2009, but since this topic is undergoing constant updates and revisions by the CDC and HHS, some information provided could possibly be outdated or revised. We strongly recommend that you obtain the latest information available directly from the CDC or HHS in addition to, and as a verification of, the information presented. The majority of this program utilizes content developed and originally published by the CDC, with permission. INTRODUCTION Swine Influenza A (H1NI), known as swine flu, is a respiratory disease of pigs caused by type A influenza viruses that causes regular outbreaks in pigs. Over the years, different strains of swine flu viruses have emerged. At this time, there are four main influenza type A virus subtypes that have been isolated in pigs: H1N1, H1N2, H3N2, and H3N1. However, most of the recently isolated influenza viruses from pigs have been H1N1 viruses.U.S. cases of human infection with swine influenza A (H1N1) viruses were first reported in Southern California and near San Antonio, Texas, in late March 2009. The Centers for Disease Control and Prevention (CDC) has determined that swine influenza A (H1N1) is contagious, but is unsure how easily the virus spreads between people. Like seasonal flu, swine flu in humans can vary in severity from mild to severe. According to the CDC, 12 human cases of swine flu were detected in the U.S. with no deaths occurring between 2005 and January 2009. Swine flu infection, however, can be serious and even fatal. In September 1988, a previously healthy 32-year-old pregnant woman in Wisconsin was hospitalized for pneumonia after being infected with swine flu and died 8 days later. A swine flu outbreak in Fort Dix, New Jersey occurred in 1976 that caused more than 200 cases with serious illness in several people and one death.Certain groups might be more likely to develop a severe illness from swine flu infection, such as persons with chronic medical conditions. Additionally, bacterial infections may occur at the same time as or after infection with influenza viruses and lead to pneumonias, ear infections, or sinus infections. SWINE INFLUENZA A (H1N1) Human cases of swine influenza A (H1N1) virus infection have been identified in several states, as well as in other countries. This is a novel influenza A virus that has not been previously identified in humans, and human-to-human transmission of the virus appears to be ongoing. Unlike the experience in Mexico, the United States is currently observing a less severe clinical spectrum of disease with infection by the identical virus strain. As of April 26, 2009, of the confirmed cases of swine influenza A (H1N1) virus infection, only two confirmed case-patients were hospitalized and there had been no reported fatalities in the United States. Mexican health officials have reported several hundred suspect cases, including several deaths associated with confirmed swine influenza A (H1N1) virus infection. In Mexico, many patients have experienced rapidly progressive pneumonia, respiratory failure requiring mechanical ventilation and acute respiratory distress syndrome (ARDS). Therefore, the impact of this virus on the two countries has been strikingly different to date. Novel influenza A virus infections in humans, including swine influenza A (H1N1) virus, represent a pandemic threat. Recognizing the historical precedent for the emergence of a pandemic influenza virus, which could have waves of disease with different morbidity and mortality and epidemiologic profiles, public health departments in the United States must remain vigilant. Swine influenza A (H1N1) virus is thought to spread in the same way as seasonal influenza. The virus is spread mainly from person to person through coughing or sneezing of infected individuals, however some people may become infected by touching a contaminated object and then touching their mouth or nose. Infected individuals may be able to infect others as early as 24 hours prior to the onset of symptoms and up to 7 or more days after becoming infected. SIGNS & SYMPTOMS The symptoms of swine flu in people are similar to the symptoms of regular human influenza and include: ·Fever · Cough · sore throat · body aches · headache · chills ·fatigue · diarrhea · vomiting DIAGNOSIS Official diagnosis of swine influenza A infection requires a respiratory specimen, collected while the infected person is still shedding virus, typically within the first 4 to 5 days of illness. Some individuals, especially children, may shed virus for 10 days or longer. Identification as a swine flu influenza A virus requires sending the specimen to CDC for laboratory testing. The infectious period for a confirmed case of swine influenza A (H1N1) virus infection is defined as 1 day prior to the case's illness onset to 7 days after onset. SWINE INFLUENZA A (H1N1) VIRUS DEFINITIONS A confirmed case of swine influenza A (H1N1) virus infection is defined as an individual with an acute febrile respiratory illness with laboratory confirmed swine influenza A (H1N1) virus infection at CDC by one or more of the following tests: · real-time RT-PCR · viral culture A probable case of swine influenza A (H1N1) virus infection is defined as a person with an acute febrile respiratory illness who is: · positive for influenza A, but negative for H1 and H3 by influenza RT-PCR, or · positive for influenza A by an influenza rapid test or an influenza immunofluorescence assay (IFA) plus meets criteria for a suspected case A suspected case of swine influenza A (H1N1) virus infection is defined as an individual with acute febrile respiratory illness with onset: · within 7 days of close contact with a person who is a confirmed case of swine influenza A (H1N1) virus infection, or · within 7 days of travel to community either within the United States or internationally where there are one or more confirmed swine influenza A(H1N1) cases, or · resides in a community where there are one or more confirmed swine influenza cases. Close contact is defined as within about 6 feet of an ill person who is a confirmed or suspected case of swine influenza A (H1N1) virus infection during the case's infectious period. VACCINATIONS There is no vaccine currently indicated for swine influenza in humans. The seasonal influenza vaccine will likely help provide partial protection against swine H3N2, but not swine H1N1 viruses.The H1N1 swine flu viruses are antigenically different from human H1N1 viruses and, therefore, vaccines for human seasonal flu would not provide protection from H1N1 swine flu viruses. PHARMACEUTICAL TREATMENT There are four different antiviral drugs that are licensed for use in the US for the treatment of influenza: amantadine (Symmetrel), rimantadine (Flumadine), oseltamivir (Tamiflu) and zanamivir (Relenza). While most swine influenza viruses have been susceptible to all four drugs, the most recent swine influenza viruses isolated from humans are resistant to amantadine and rimantadine. At this time, CDC recommends the use of oseltamivir or zanamivir for the treatment and/or prevention of infection with swine influenza viruses. Suspected Cases Empiric antiviral treatment is recommended for any ill person suspected to have swine influenza A (H1N1) virus infection. Antiviral treatment with either zanamivir alone or with a combination of oseltamivir and eitheramantadine or rimantadine should be initiated as soon as possible after the onset of symptoms. Recommended duration of treatment is five days. Recommendations for use of antivirals may change as data on antiviral susceptibilities become available. Antiviral doses and schedules recommended for treatment of swine influenza A (H1N1) virus infection are the same as those recommended for seasonal influenza. (Table 1) http://www.cdc.gov/flu/professionals/antivirals/dosagetable.htm#table Confirmed Cases For antiviral treatment of a confirmed case of swine influenza A (H1N1) virus infection, either oseltamivir or zanamivir may be administered. Recommended duration of treatment is five days. These same antivirals should be considered for treatment of cases that test positive for influenza A but test negative for seasonal influenza viruses H3 and H1 by PCR. Special Considerations for Pregnant Women Oseltamivir, zanamivir, amantadine, and rimantadine are all Pregnancy Category C medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. Only two cases of amantadine use for severe influenza illness during the third trimester have been reported. However, both amantadine and rimantadine have been demonstrated in animal studies to be teratogenic and embryotoxic when administered at substantially high doses. Because of the unknown effects of influenza antiviral drugs on pregnant women and their fetuses, these four drugs should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus; the manufacturers'' package inserts should be consulted. However, no adverse effects have been reported among women who received oseltamivir or zanamivir during pregnancy or among infants born to such women. Special Considerations for Children Aspirin or aspirin-containing products (e.g. bismuth subsalicylate Pepto Bismol) should not be administered to any confirmed or suspected ill case of swine influenza A (H1N1) virus infection aged 18 years old and younger due to the risk of Reye syndrome. For relief of fever, other anti-pyretic medications such as acetaminophen or non-steroidal anti-inflammatory drugs should be recommended. ANTIVIRA CHEMOPROPHYLAXIS For antiviral chemoprophylaxis (pre-exposure or post-exposure) of swine influenza A (H1N1) virus infection, either oseltamivir or zanamivir are recommended. Duration of antiviral chemoprophylaxis is 7 days after the last known exposure to an ill confirmed case of swine influenza A (H1N1) virus infection. PATIENT CONSULTATIONS Pharmacy technicians should refer any patient considered a suspected case or describing any of the previously mentioned signs and symptoms to the pharmacist for consultation. According to CDC recommendations, pharmacists should consult confirmed cases to stay home and avoid contact with other people as much as possible to keep from spreading your illness to others. Suspect cases should be advised to contact their physician to report illness, by telephone or other remote means, before seeking care at a clinic, physician's office, or hospital, with the following exceptions for when immediate medical attention required. Immediate Medical Attention Required Persons who have difficulty breathing or shortness of breath or are believed to be severely ill should seek immediate medical attention Individuals who become ill and experience any of the following warning signs, seek emergency medical care. In children emergency warning signs that need urgent medical attention include: · Fast breathing or trouble breathing · Bluish skin color · Not drinking enough fluids · Not waking up or not interacting · Being so irritable that the child does not want to be held · Flu-like symptoms improve but then return with fever and worse cough · Fever with a rash In adults, emergency warning signs that need urgent medical attention include: · Difficulty breathing or shortness of breath · Pain or pressure in the chest or abdomen · Sudden dizziness · Confusion · Severe or persistent vomiting For More Information Pharmacy professionals or patients needing additional information should contact The Centers for Disease Control and Prevention (CDC) Hotline (1-800-CDC-INFO), which is available in English and Spanish, 24 hours a day, 7 days a week. References & Resources http://www.cdc.gov/swineflu/ http://www.hhs.gov/ http://www.who.int/csr/disease/swineflu/en/