Safe Handling Awareness Month

Now in its third year, National Safe Handling Awareness Month (April) was petitioned to raise awareness of the occupational risks associated with handling hazardous drugs and educate healthcare providers on the U.S. guidelines and safety measures that may be taken to prevent hazardous drug exposure. As the highlight of National Safe Handling Awareness Month, National Safe Handling Awareness Day (April 20) brings together national and regional educational opportunities collectively aimed at preserving the health and wellbeing of the oncology healthcare professionals who devote their lives to helping others. National Safe Handling Awareness Month and Day are officially endorsed by the International Society of Oncology Pharmacy Practitioners (ISOPP) and are officially sponsored by Carmel Pharma, the maker of the PhaSeal® System – today’s only clinically proven closed-system drug transfer device (CSTD) for the safe handling of hazardous drugs. For additional details on National Safe Handling Awareness Month/Day, visit www.carmelpharma.com/safehandling or call 866-487-9250.

The Importance of Safe Handling

In 2004, the National Institute for Occupational Safety and Health (NIOSH) released an alert stating that “working with or near hazardous drugs in healthcare settings may cause skin rashes, infertility, miscarriage, birth defects and possibly leukemia or other cancers.” Further evidence to support the need to take action in this area may be found below:

  • The World Health Organization predicts a 50 percent increase of cancer cases over the next 20 years; this, combined with more potent chemotherapy drugs – as well as an increase in the use of hazardous drugs to treat non-malignant illnesses – will continue to elevate risk of exposure.
  • Two separate studies investigating the toxicity in healthcare personnel who handle cytotoxic (hazardous) drugs revealed a 40-50 percent increased risk for miscarriage. A total of 7094 pregnancies of 2976 pharmacy and nursing staff were examined.
  • A national survey conducted by the Environmental Working Group, the American Nurses Association, Health Care Without Harm and the Environmental Health Education Center at the University of Maryland School of Nursing showed that there are links between nurses’ occupational exposure to hazardous drugs and the health problems they develop such as cancer, asthma, miscarriages and children’s birth defects.

About Carmel Pharma (the maker of the PhaSeal System)

Carmel Pharma AB, headquartered in Gothenberg, Sweden, is the manufacturer of the PhaSeal System for the safe handling of hazardous drugs. PhaSeal is more than a system for the safe handling of hazardous drugs. It’s the only clinically proven closed-system drug transfer device (CSTD) available today and is validated by more than 15 independent, peer-reviewed, published clinical studies. Distinguished by prominent thought leaders as the “Gold Standard” in safe handling, PhaSeal’s airtight Expansion Chamber and leakproof Double Membrane connections prevent exposure to hazardous drugs, including aerosols and vapors, and make it the only system that meets the National Institute for Occupational Safety and Health (NIOSH) and International Society of Oncology Pharmacy Practitioners (ISOPP) definition of a true CSTD. Its streamlined design and universally-compatible components make the system easy to use from preparation and administration to waste disposal.

In the United States, PhaSeal is distributed by an U.S. affiliate office, Carmel Pharma, Inc., located in Columbus, OH.  The PhaSeal System has been in use in the U.S. since 1999 and implemented in more than 2000 cancer facilities, infusion centers and private practices, including M.D. Anderson and Texas Children’s in Houston, TX; City of Hope in Duarte, CA; Dana Farber Cancer Institute in Boston, MA; SwedishAmerican Hospital in Rockford, IL; and Johns Hopkins University in Baltimore, MD, just to name a few. For more information on Carmel Pharma or the PhaSeal System, please visit www.phaseal.com or email info@carmelpharma.com.


Speaker’s Forum

Safe Handling of Hazardous Drugs is Crucial to Nurses’ Safety

Kristie Howlett, RN, MS, CNS, AOCNS, oncology clinical nurse specialist at the Sutter Roseville Medical Center, will speak on the importance of safe handling of hazardous drugs in nursing during the live CE Webinar on Safe Handling Awareness Day, April 20th. Kristie recently spoke with Carmel Pharma about safe handling from a training perspective.

Carmel Pharma: From your experience, what are the basics on safe handling of hazardous drugs?
Kristie Howlett:
First and foremost, know the medication you are administering and understand its properties. Is it a hazardous drug? Become familiar with the workplace practices at your facility, including policies, procedures and administrative guidelines. Wear personal protective equipment (PPE) such as gloves, gowns, safety shields and masks. Ideally, a closed-system drug transfer device (CSTD) is in place. Not all facilities use a CSTD, but thankfully we do at Sutter Roseville Medical Center.

Carmel Pharma: Why is safe handling so important?
Kristie Howlett:
Safe handling is important because healthcare workers don’t want to expose themselves to antineoplastic/hazardous drugs. They shouldn’t be the one receiving the chemo, the patient is. We know a lot of studies show healthcare workers suffer biologic effects when exposed to chemotherapy or a hazardous drug.

Carmel Pharma: When you present these studies in your training, do you also have to convince people that the hazards are real?
Kristie Howlett:
Absolutely. I have two camps: 1) younger nurses in their childbearing years and; 2) older nurses beyond childbearing years. The younger nurses, who really want to be proactive about safe handling, see the literature as a bit outdated or find themselves moving too quickly and think they don’t have time to put on all the PPE. “I’ll be fine,” they say. The older nurses think they don’t have to be as careful, because they don’t have pregnancy risks. Or they say, “I’ve been an oncology nurse for X amount of years and nothing has ever happened to me or someone I know.” Changing an attitude is difficult. I counter the arguments by emphasizing the conclusions in the studies are still relevant and their safety is worth slowing down just a little.

Carmel Pharma: Do you think nursing programs provide education on the safe handling of hazardous drugs?
Kristie Howlett:
No.

Carmel Pharma: Do you think safe handling of hazardous drugs should be included in nursing programs?
Kristie Howlett:
It should, to a certain extent. Not every nurse goes into an oncology setting. Even though cytotoxic drugs are present across the healthcare setting, most hazardous drug administration occurs in the oncology world. It’s important to realize, too, that most student nurses in an oncology unit are seeing clinical rotation patients and not administering hazardous drugs. Even though the student is on the floor, he/she might not be informed how hazardous these drugs are or why precaution is necessary.

Carmel Pharma: Carmel Pharma sponsors Safe Handling Awareness Month and Day, which focuses on the education of the safe handling of hazardous drugs. Do you think it’s valuable for students to listen to the live CE webinar?
Kristie Howlett:
I think it’s a great opportunity for student nurses to become more familiar with the information that’s out there. I know their pharmacology class exposes them to a little bit of information; however, it’s more on the mechanism of action of what those drugs are doing vs. the fact there are some important safety precautions healthcare workers need to take.

Carmel Pharma: How prevalent do you think good safe handling practices are in US medical facilities?
Kristie Howlett:
I can speak about my facility – we are a community setting. We are licensed for 319 beds, so we’re a decent size facility. Not everyone here practices safe handling all of the time; although, I can tell you my own personal practice is 100% of the time. Even in my facility with my constant reminders we are still striving for 100% adherence.

Carmel Pharma: What are some effective ways to overcome the misconception that nurses don’t need to use or are too busy for safety precautions?
Kristie Howlett:
The most effective method is continued education. I incorporate a lot of education into my training – constant reinforcement and constant reminding. Annual competency checks are also conducted at our facility to ensure everyone knows the proper use of PPE, including how to put everything on and how to actually administer the hazardous drug. Changing attitudes and ideas is important and when people have an ingrained belief such as, “This is how I’ve always done it,” it‘s hard to change that. When I teach the ONS Chemotherapy and Biotherapy course, I explain more than what is safe for the patient. This is about limiting your exposure or your potential of exposure to the hazardous drug. I want to make it real for them and stress that the PPE must be used in addition to a closed-system drug transfer device or you have the potential to be exposed.

Carmel Pharma: I had planned to ask, “What changes would you like to see made?” But it sounds like it’s for everyone to adhere to all the policies that are in place?
Kristie Howlett:
Absolutely. When I teach my class, I tell them this is not because I want to torture you, make more work for you, or make it difficult to provide patient care. Ultimately, my goal is to keep you safe. And I would hope that you would want to keep yourself safe as well.

Carmel Pharma: In the upcoming webinar, you’ll be speaking to both nursing and pharmacy professionals. What are the main topics you plan to cover?
Kristie Howlett:
I will talk about the ONS guidelines and the safe handling of hazardous drugs for nurses. Many listeners will have a focus on oncology. That’s where the majority of hazardous drugs are administered. I will reinforce how to properly put on PPE. I’ve caught nurses wearing the gown with the opening in the front, which, of course, should be in the back. I will address how we adopted the practice of a closed-system drug transfer device in our facility. It was a 6 – 6 1/2 year process, and I am still looking at ways to improve how we are doing it. We have the basic system in place and that‘s a good start, but now I’m making sure all the other essential pieces are in place.

Carmel Pharma: Thank you, Kristie, for speaking with Carmel Pharma and taking time from your busy day to share your views on the safe handling of hazardous drugs and the importance of training. We look forward to hearing more about your education efforts during the live CE Webinar on April 20th.


Safe Handling of Hazardous Drugs is Essential to Best Practices

Stephen F. Eckel, Pharm.D., M.H.A., BCPS, assistant pharmacy director and residency program director at the University of North Carolina Hospitals, will focus on the safe handling of hazardous drugs during the live CE Webinar on Safe Handling Awareness Day, April 20th.  Stephen recently spoke with Carmel Pharma about his views on safe handling and the upcoming webinar.

Carmel Pharma: Could you tell us what you do and provide an overview of your experience with the safe handling of hazardous drugs?
Stephen Eckel
: I have been involved with leading the oncology pharmacies at UNC Hospitals. As we improved our methods of preparing chemotherapy products, we researched regulations and best practice standards to target what we wanted to incorporate and ensure we were providing the best quality. From this process, I learned much more about the standards and guidelines surrounding the safe handling of hazardous drugs and began implementing changes in our individual site areas to develop consistency in how we handled hazardous drugs.

Carmel Pharma: Could you please speak to the importance of the ‘safe handling of hazardous drugs’ to pharmacists?
Stephen Eckel
: I think it’s incredibly essential that, as managers, we not only provide a safe product for our patients but we create a workplace that is safe for our pharmacists and technicians. To me, safe handling of chemotherapy is one area where we can do that.  The data is pretty robust as it relates to hazardous drug exposure. Anything we can do to minimize that danger in the workplace, we should.

Carmel Pharma: How do you promote and monitor safe handling among your pharmacy staff?
Stephen Eckel
: Education. One of the things I’ll be talking about in my presentation is what UNC Hospitals has done to enhance our safe handling policy and the improved education of our employees.

Carmel Pharma: What do you believe are some misconceptions pharmacists have about the handling of hazardous drugs?
Stephen Eckel
: First, that the traditional methods used 10-15 years ago still work, or are still the practice standard. Second, the concept that if we don’t have data that directly suggests harm from exposure, then it must not exist. Third, that day in and day out, employees follow policies and procedures when preparing hazardous drugs.

Carmel Pharma: How do you combat these misconceptions?
Stephen Eckel
: Education, such as 1) answering employees’ questions about why they have to follow safe handling guidelines (especially healthcare workers that have come from different places); 2) explaining the reasons behind safe handling of hazardous drugs; and 3) keeping them abreast of the literature and what’s changing out there.

Carmel Pharma: Health effects from working with hazardous drugs have been known since the 1970’s. In your opinion, does your pharmacy do all it can to adhere to published safety guidelines?
Stephen Eckel
: We do our best. I think there is some ambiguity in some of the guidelines. For example, what are the reasons (evidence) behind the guidelines? To me, there still needs to be a continued discussion, as well as research into what are the optimal standards. How do we make sure that in every place where we prepare hazardous drugs we’re following those best standards?

Carmel Pharma: What do you think safe handling will look like five years from now?
Stephen Eckel
: I think a tremendous amount of research will continue to be published. Plus, the dangers and concerns associated with handling these hazardous drugs will be better understood.

Carmel Pharma: What were your initial thoughts when you read Johan Vandenbroucke’s microbial and economic impact studies?
Stephen Eckel
: That it was an interesting way – a different way – to look at hazardous drugs. It put a dollar sign around things that I had not thought through before. It forced me to reconsider our practices and understand the economics behind decisions that are sometimes made.

Carmel Pharma: So it changed your thinking – did it change your actions?
Stephen Eckel
: Yes. We began reviewing vial sizes we should purchase and we initiated research around that area to investigate it further.

Carmel Pharma: What do you plan to cover during the live CE Webinar on April 20th?
Stephen Eckel
: I will cover education around safe handling policies and procedures. There are a couple of things I want to demonstrate: 1) the reason why safe handling of hazardous drugs is important, and 2) the different ways that hazardous drugs can be introduced into the work environment. However, just knowing the information is not enough. I will speak about the strategies at UNC we have employed to adhere to policies and procedures surrounding the best practices of handling hazardous medications. Finally, what should we expect in the future? Where is research going?

Carmel Pharma: What type of dialogue are you hoping to create?
Stephen Eckel
: My goal is to get people talking about safe handling and what they should consider when evaluating practices at their organization.

Carmel Pharma: Thank you for talking with Carmel Pharma and we look forward to listening to you on the live CE Webinar scheduled for Safe Handling Awareness Day.


Study Finds Chromosomal Changes Take Place in Professionals Who Handle Hazardous Drugs

Dr. Melissa A. McDiarmid, MD, MPH, DABT, scheduled to participate in the live Safe Handling Awareness Day Webinar, will speak specifically on the results of her chromosomal study titled, Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. McDiarmid recently spoke with Carmel Pharma about the findings from the study along with observations she has noted over the years.

Carmel Pharma: What motivated you to undertake the study?
Dr. Melissa McDiarmid: I’ve been studying acute and chronic exposure to antineoplastic drugs since I was an occupational medicine physician. In the early 1980’s I received a phone call from an employee who said that our oncology nurse had spilled an entire infusion on herself the day before. Although she went to the ER – now called EDs – they didn’t decontaminate her correctly. She vomited all night and went to the emergency room the next day, presuming her vomiting was from her exposure. So ever since then, I have had a special interest in both acute and chronic exposures to antineoplastic drugs. Because I was a young internist, I knew what the side effects of hazardous drugs were and of course I thought her symptoms were related to the spill the day before, but there were people actually saying it could be food poisoning. I laughed out loud then, just as I do now. That was, obviously, an unusual event and wasn’t the type of exposure people usually have, but it got me very interested in the topic and I started collaborating with colleagues in the oncology pharmacy performing wipe sample studies, as well as air sampling studies.

Carmel Pharma: Since understanding the effects of working with hazardous drugs has become a more popular topic over the years, why do you think more has not been done until now?
Dr. Melissa McDiarmid: Because they are drugs. People think of them as drugs and not chemicals. People think of healthcare as a clean and safe place to work. People think the amount of exposure a worker gets is so much less than what a patient is exposed to, they have trouble wrapping their minds around the fact that this could still be important. Chronic exposures, albeit a very low dose, can still have health effects.

Carmel Pharma: Is your study on chromosome abnormalities changing people’s conceptions on the safe handling of hazardous drugs?
Dr. Melissa McDiarmid: Those who wanted to believe this were already on board because of the wipe sample studies, but I think there are still people who think we should be conducting epidemiology studies to actually show excesses of cancer in nurses and pharmacists. I don’t think we need to wait for that, because I think we have the “chain of evidence” that one would like to see and I think there is sufficient data for us to make a public health action. Of course, there has been some work in that direction. OSHA wrote their first safe handling guidelines in the mid-1980’s. Other professional organizations have safe handling guidelines such as NIOSH, ASHP and ONS. Help me understand why we are still arguing about this? Even though there is quasi compliance, there still has been a lot of denial.

Carmel Pharma: What impact do you hope the results of your study will have?
Dr. Melissa McDiarmid: I hope there will be more compliance. I hope people take this all more seriously. I really think the right place to start is with the current NIOSH guidelines, which is very similar to the OSHA guidelines. I think we have harmonization and agreement between professional organizations like ASHP and ONS and the public health agencies like OSHA and NIOSH. I don’t know whether pristine adherence to those guidelines is good enough. We don’t know that yet because frankly, I haven’t seen pristine adherence. We have a lot of people doing work arounds, which are shortcuts taken when people are in a hurry. I think one of the reasons this has been such a tough nut to crack is because healthcare workers are committed to their patients and there has always been this dichotomy that it is either/or. It’s either excellent care for your patient or watching out for yourself. The idea that we can give both competent, compassionate care to our patients and still protect ourselves is still a new one.

Carmel Pharma: It would be understandable for nurses and pharmacists to become desensitized to the dangers of hazardous drugs. But it sounds, from what you just described, that the issue is more the conflict between caring for the patient or for themselves.
Dr. Melissa McDiarmid: I think conflict is part of it. I think the other part is people get PhD’s in this stuff. The ‘risk communication’ people will tell you there is a whole list that describes the hierarchy of fears/respect that we have for agents that could possibly hurt us. I think one of the problems is that these chemicals, these carcinogenic, hazardous chemicals, are substances we call drugs. People are not used to attributing all of the same types of suspicion to an agent we call a drug as they would to an agent we call a chemical.

Carmel Pharma: When you say people, do you mean nurses and pharmacists?
Dr. Melissa McDiarmid: I mean the public in general and yes, nurses and pharmacists. I think that is one part – it’s sort of like a wolf in sheep’s clothing. You would think that professional people would better understand and yet there’s this other belief that competes with the common sense approach that one would hope you’d take if you just look at the toxicological profile of these drugs.

Carmel Pharma: Let’s dive back into the specifics of your study. Could you speak about the highlights the study unveiled?
Dr. Melissa McDiarmid: This study was done in collaboration with colleagues in NIOSH and Tom Connor was the lead on the NIOSH piece of it. We tried to do what we called a comprehensive approach. We didn’t want to do just one more study. We wanted to conduct a study that would address the gaps in the existing studies. Most of the other studies either focused on environmental contamination separately or biologic measures of exposure to genotopic substances separately. So we tried to combine those two outcomes in real time. We tried to have a very comprehensive environmental assessment of exposure – air samplings, wipe samples, etc. Combine that with state-of-the-art outcome measures of ‘exposure to drug’ that would document the ‘uptake of drug’ taking place – this meant measuring drugs in the urine of oncology workers. This is the piece that is really different; no one has done this before. We used the same genotoxic markers – chromosomal abnormality markers – and looked for the exact same lesions (abnormalities) in workers as reported in cancer patients who are treated with these drugs. So we tried to minimize the argument that non-specific increases in genotoxic markers could be attributed to say diet, second-hand smoke, etc. We used the specific markers that allowed the epidemiologists to tell us 20 years ago that specific drugs caused specific secondary cancers in specific secondary leukemia’s that wounded specific parts of specific chromosomes. I said specific about 12 times. But I think that’s the kicker of our study.

Carmel Pharma: Are the results from the study what you anticipated they would be?
Dr. Melissa McDiarmid: I was really surprised. I know, as an investigator and a clinician, that hazardous drugs are causing significant exposure opportunities to workers that I have studied and taken care of my entire professional life. I know that. But I was surprised that we got a dose response in the frequency of abnormalities of the chromosomes – a function of the drug handling that the workers in our study reported.

Carmel Pharma: Is there anything else you would like to address?
Dr. Melissa McDiarmid: The people in our community who understand the risks involved with handling hazardous drugs think this study is really important work, but there are a lot of people that are still in denial about the risks and I guess you might say, “Why hasn’t more been done?” On the one hand, this study was just published about 3-4 months ago so I think it’s taken awhile for people to know about it.

Some of my colleagues have said, “Why don’t people get this?” I think it’s because even in the medical world, people don’t understand what raw data looks like. We show there is a dose response. By that I mean, as your frequency of drug handling goes up, your frequency of chromosome abnormalities also goes up. That’s called a dose response. That’s one of the really critical lynchpin examples of evidence that we need in public health in order to say there is an association between an exposure and an effect. For example, 35 years ago when it was proven that cigarettes cause lung cancer, researchers showed an epidemiology study that the more one smoked, the more likely one is to develop lung cancer. Again, that’s called a dose response. The more you smoke, the higher your risk. I really think that people, including medical professionals (unless they are in research) are not used to seeing what raw data looks like – i.e., types of tables – so they fail to fully grasp what a dose response means. I think people are more used to seeing pre-packaged results that somebody else has already validated.

We still have all these lingering doubts about, “How can this be possible? It’s just a little bit of drug. It’s not as much as patients get.” So, I think we’re still walking around in this haze of how drugs that are supposed to be good are possibly bad. How drugs in a small amount, compared to what a patient would get, can cause chromosomal abnormalities. They are very significant.

Carmel Pharma: Thank you for talking with Carmel Pharma and we look forward to listening to you on the live CE Webinar scheduled for Safe Handling Awareness Day.

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