Post-disaster Fukushima: Up to 30 mile Impact

It’s been more than two years since the Fukushima nuclear power plant experienced a meltdown after the earthquake and tsunami.  The environmental disaster resulting from the meltdown has received some publicity of late when solutions were being sought to contain the contaminated water leaking (or flowing) from the site.  We have heard very little about the impact of this on local residents.  Wednesday’s New York Times provided a glimpse at the effect of this disaster on residents more than 5 miles away.

Unfortunately residents up to 20 miles away from the plant were relocated and are unable to return to their homes – even now.  I think I imagined that people within a few miles of the plant were certainly affected – but I have to admit I had my head in the sand in terms of how many people were affected.  A total of 11 towns were evacuated.  Nearly 83,000 refugees evacuated from these areas are still not able to go home. We can see an uninhabitable area surrounding the plant for miles – I assume the shape of the area relates to weather and geographic features.  These residents are in ‘limbo’ regarding whether it will ever be safe to return.   Here is a link to the article with the zone affected surrounding the plant identified - (http://www.nytimes.com/2013/10/02/world/asia/japans-nuclear-refugees-still-stuck-in-limbo.html?smid=pl-share ) as you can see people up to 30 miles away have contamination levels in the ‘yellow’(20 to 50 millisieverts/yr) or ‘red’ zone (more than 50 millisieverts/yr). 

What does this mean? Public exposure is suggested by the International Commission on Radiological Protection (ICRP) of no more than 0.3mSv/year exposure from waste management and no more than 0.1mSv/yr for prolonged exposure.  For comparison - in homes with radon exposure, the remediation level is 3-10 mSv/yr and for occupational exposure the dose is 20mSv/yr.  Doses from 20mSv/yr to 100mSv/yr are considered ‘emergency exposure situations’.  (information on exposure rates can be found in  ICRP Publication 103, Annals of the ICRP, 37(2-4), 2007. Or try this link: http://www.icrp.org/publication.asp?id=ICRP%20Publication%20103  )

As we see here – disasters do happen – fortunately for most of us they are rare events and typically they affect us only a short amount of time – but unfortunately for a small few the impact is catastrophic. I have written previously that we don’t seem to expect that things like this could happen to us – but this example tells us – that yes, they do happen.  We expect that the power company and public officials have assured that regardless of natural or other type of disaster scenario the plants will be safe – yet we see failures and the devastating consequences.  While we learn much from disasters and apply it to preventing the next catastrophe, I do not believe we can ever imagine all the possibilities.  This of course leaves us open to being the next group with an unexpected or unprecedented disaster.

Recently we experienced an era where the business side of most operations (including health care, and utilities I am sure) decided that having ‘just in time’ inventory was enough – one replacement for parts or equipment would be enough – we decided not to stock up for the rainy day – but to better use that investment elsewhere to balance the books.  As we see with the massive power outages or transportation problems lately – not having needed supplies available to perform operations affects us regularly.  Luckily these problems are few and far between – but we are no less stunned and outraged when they occur.  

I imagine with the nuclear power plants you and I live near to – we tend to think a disaster of this sort couldn’t happen here – we have safety standards and safety or disaster planning that would limit the impact.  Unfortunately this may not be true – sometimes we really don’t have control over things – sometimes it is impossible to control things (like with the events in Fukushima or hurricanes or… ). 

We do have nuclear power here in CT.  I wonder how many of us could be impacted in a major disaster such as this?  If we drew a 20 or 30 mile circle around our plant (or our storage facility from our closed reactor), who would be impacted?  If I bought a home close to the plant I would knowingly be taking that risk – but how close? I did not choose to live within a few miles of a nuclear plant – but as we see many things can affect the plume of such a disaster.  Were we all aware that this could affect our ability to live freely in our own homes?  What do I or anyone else know of risks like this! 

Our closed reactor, CT Yankee was disassembled and its contaminated fuel rods and irradiated enclosures are stored right here in CT.  The federal government was supposed to open a used fuel storage facility in 1998 (part of the Nuclear Waste Policy Act) – but still has not done so.  So we have one containment facility in CT.  I imagine this is a low risk for disaster site – but I really do not know.  We also have a working facility, Millstone in CT.  Over 100,000 people live within 10 miles of that facility (http://en.wikipedia.org/wiki/Millstone_Nuclear_Power_Plant) .  (The Nuclear Regulatory Commission identifies a 10 mile radius plume exposure zone within which breathing airborne contaminants would be dangerous and a 50 mile zone for ingestion of food or drink contaminated by radioactivity - that may be most of CT Wikipedia indicated nearly 3 million in this zone) (Here is a link to their info: http://www.nrc.gov/reading-rm/doc-collections/fact-sheets/emerg-plan-prep-nuc-power-bg.html).  That is a lot of exposure and a lot of people to relocate.  Imagining the evacuation required boggles my mind…  those who are still in the process of recovery from our recent natural disasters can probably still relate to what is involved when your home is destroyed or declared uninhabitable.

My hearts go out to the residents of these 11 towns in Japan – I imagine that like me – they never expected that their homes would be devastated in this way. 

Food Fraud: Counterfeit food products

The New York Times included an article about counterfeit food this week – similar to counterfeit designer bags – except consumable – and maybe even dangerous to your health.  Disturbing.

It seems any part of the food chain might be involved – from the oil in the baked product – whether bought pre-packaged at the store or fresh in a local bakery! 

The article was focused on fraud found in the UK and Europe, but the US is not immune.  Some examples:

• Counterfeit chocolate, olive oil, champagne – which may have water, vegetable oil, or other substitutes to increase profits.
• Shellfish that may be contaminated and we have heard about fish that is mislabeled as a more expensive type. 
• Vodka with perfect counterfeit labels and duty stamps (Glen’s Vodka in this case) – but the vodka was spiked with BLEACH to correct the color – and it had high methanol levels – which of course risks blindness if enough is consumed.  All of course sold at a bargain price – we do love a bargain don’t we?

My question is – how can we be sure we are getting the real thing – and that our food is really safe?

The FDA of course is the primary regulator in the US, and they do monitor and regulate food products for safety and truthfulness.  ABC News reported on these issues back in January, 2013 and identify several groups that provide some monitoring of these issues – 

• The US Pharmacopeial Convention (USP), 
• the Anit-Counterfeit and Product Protection Program (A-CAPPP), 
• the Grocery Manufacturers of America, 
• the National Consumers League.  

It appears the USP and the National Consumers league actually test products.  The USP  maintains a Food Fraud Database (here is the link: http://www.foodfraud.org/ )– which identifies a variety of risks associated with foods with references to studies that have been completed on various foods – however does not list direct information that would help you avoid certain brands on your shopping list.

My question remains – how can we be sure we are getting the real thing – and that food and drink are really safe?

References: 

Here is the link to the NY Times story by STEPHEN CASTLE and DOREEN CARVAJAL (Published: June 26, 2013)  http://www.nytimes.com/2013/06/27/business/food-fraud-more-widespread-than-suspected.html?smid=pl-share

And to ABC News Coverage by Jim Avila and Serena Marshall (Jan 22, 2013): http://abcnews.go.com/US/exclusive-group-finds-fake-ingredients-popular-foods/story?id=18281941&singlePage=true#.Uc2sdNi0SrM

Michael Douglas: Raising awareness about HPV and Oropharyngeal Cancer

Michael Douglas recently raised our awareness about the risk of Human Papillomavirus (HPV) infection leading to oropharyngeal cancer.  HPV is a common Sexually Transmitted Disease (STD) – here is a link to some information about HPV: http://www.cdc.gov/hpv/whatishpv.html.  HPV can lead to both minor and major health problems, including warts on the hands or feet, genital warts, and cancers.  There are more than 160 types of HPV – over 40 of which are transferred by mucosal or genital transmission, of these 40, two are responsible for most of the cancer risk, HPV 16 and HPV 18, including cervical, anogenital and oropharyngeal cancers (Saraiya,2013).  Information on HPV-associated cancers can be found here: http://www.cancer.org/ and on oropharyngeal cancer here: http://wwwnc.cdc.gov/eid/article/16/11/10-0452_article.htm.  

It is laudable that Douglas would disclose this, particularly given the stigma related to STD’s.  He raises awareness of the risk of this STD to individuals (like middle aged and older adults) who may not consider themselves at risk from exposure to HPV decades earlier.  Unfortunately little can be done to detect this form of cancer early.  Here is a useful guide from the American Cancer Society related to oropharyngeal cancer: http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/index

Michael Douglas at the Vanity Fair party for the 2012 Tribeca Film Festival; by David Shankbone, 4/17/2012. (Use of this photograph does not imply endorsement of the author or the ideas shared)   Image from: http://en.wikipedia.org/wiki/File:Michael_Douglas_VF_2012_Shankbone.JPG

Douglas’ acknowledgement of the possibility of his cancer being linked to sexual activity and HPV transmission has naturally raised the question of what should be done about this risk? Men are at much higher risk of developing oropharyngeal cancer from HPV than women.  Should we screen all men for HPV like women are screened with pap smears to reduce cervical cancer risk?  Unfortunately there are difficulties to screening for this type of cancer.  Here is a video by the New York Times discussing some of these concerns: http://www.nytimes.com/video/2013/06/10/health/100000002273386/a-collective-gulp.html?smid=pl-share

While screening programs are common and they are usually viewed as only good – there are actually down-sides to screening – for example what happens when it is very difficult to detect the presence of the HPV virus (HPV-16 or HPV-18) that leads to throat cancer?  What if attempting to detect the presence of a virus to prevent its eventual turn to cancer actually has dangers to the individual?  Particularly in a situation where the rate of cancer development from this virus is low?  For example, although nearly everyone who is sexually active will acquire HPV, most virus types are not cancerous – and cancers are rare even in those infected with high risk HPV types (HPV 16 and 18), requiring persistent infection (Saraiya, 2013).  There were an average of approximately 32,000 new HPV-associated cancers identified between 2005 and 2009 in the US, of which 20,000 were identified in women (89% genital cancers), while 12,000 were identified in men (78% were oropharyngeal ) (Saraiya, 2013).

Similar to other screening programs, we should be judicious in use of societal resources to identify disease – it is difficult to weigh the risks and benefits of screening because not all diseases are simple to detect, and often our methods of detection are less than perfect – leading to many individuals who test positive for a disease by a not-so-good screening method to initially believe they have cancer only to find out later it was a false-positive result.  This of course is true in mammography where women often have lumps that require follow up ultrasound or biopsy – which then pushes the woman into a limbo of fear of actually having breast cancer – only to find out later it was an innocuous lump.  Depending on the type of lump found, some women undergo lengthy periods of heightened screening– leading to anxiety and greater exposure to ionizing radiation – however this screening is of great benefit when the risk of disease is high. 

While early identification and treatment of disease are important goals for our health care system, the actual ability of providers and detection methods to deliver this result is often limited by the lack of research and technology to accurately detect the disease.   In the case of HPV there are immunizations that prevent infection, however evidence is not yet available that these vaccines are effective in those who are already infected – this is one reason why the immunization focus is on youth who are not yet sexually active- it is hoped that most infections with HPV 16 will be prevented in the future, thus eliminating risk of cancer from this infection.  With continued research we will accumulate efficacy data from immunization.  Hopefully someday we will also better understand how to prevent cancer in those with acquired HPV infection  and also have better methods for early identification of the infection before the cancer occurs.

References & Links used to prepare this summary:

Saraiya, M. (2013). Public health importance of human papillomavirus infection and disease. CDC: Division of Cancer Prevention and Control. Accessed on 6/11/2013: http://www.cdc.gov/about/grand-rounds/archives/2013/pdfs/GR_HPV_Feb19.pdf

http://www.cdc.gov/hpv/whatishpv.html

http://www.cancer.org/

http://wwwnc.cdc.gov/eid/article/16/11/10-0452_article.htm

http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/index

http://www.nytimes.com/video/2013/06/10/health/100000002273386/a-collective-gulp.html?smid=pl-share

Nursing the Mentally Ill in Soweto, South Africa

I am pleased to introduce readers to Carmen Rivera, a nurse with interest in forensic nursing and violence prevention.  Carmen has a BS in Nursing and has discovered a love for writing... and is currently a freelance writer who is passionate about issues concerning mental health and how they affect communities worldwide.  Please email if you ever want to discuss the article:

Nursing the Mentally Ill in Soweto, South Africa  by Carmen Rivera

Nearly 20 years after the end of apartheid, the Soweto neighborhood of Johannesburg, South Africa, remains a striking relic of the country’s unequal, separatist past. Originally established as an urban district for mining workers and blacks evicted from the city, many Soweto residents still live in poverty, suffering from the remnants of institutional racism imposed by apartheid government.

Recently, two sexual assaults occurred in Soweto, which shed light on an alarming kind of discrimination and something not typical discussed outside of the confines of forensic nursing programs: discrimination against the mentally disabled. In April of 2012, seven Soweto teenagers were accused of gang raping a mentally disabled girl. Video of the attack was recorded on a cell phone then posted on the Internet. Shortly after that, two Soweto females were arrested and accused of raping a mentally disabled 17-year-old boy.

This disturbing trend illuminates a larger problem of sexual abuse rates and the historical oppression of the mentally disabled in South Africa. These attacks also highlight systemic problems that plague forensic investigations, education programs and ensuring victims’ allegations are adequately heeded by authorities. While forensic school programs are advancing with every class of students, there are still areas in which they can improve, something prevalent in these cases.

A 2009 study conducted by South Africa's Research Council concluded that one in four South African men admit to having sex with a woman without her consent, while 46% admit that they have done it more than once.

Until 2002, many of South Africa’s mentally disabled were involuntarily committed in psychiatric facilities as per apartheid-era legislation. Their treatment dates to the Mental Health Act of 1973, which was enacted after a mentally ill gunman assassinated Prime Minister Hendrik Frensch Verwoerd. The mobilization of this Act relied heavily on the precepts of fear to strip the South African mentally disabled of the rights given to other South Africans.

Legislation enacted in 2002 aims to right the care of the mentally disabled by drastically reducing the amount of involuntarily committed patients, essentially downsizing state-run mental hospitals. To accommodate discharged patients, the legislation seeks to provide mental health screening and treatments as part of primary care, as well as implement community-based mental health programs, both of which emphasize the role that nurses play in caring for the mentally disabled. An additional provision of the bill seeks parity in providing black and low-income South Africans, many of them based in Soweto, with better access to mental health care.

As of a 2007 study conducted by the World Health Organization, the outcome of the deinstitutionalization of mental health treatment has achieved few of its initial goals. Poverty, lack of transportation and the social stigma associated with mental disorders has all provided a serious challenge for nursing the mentally disabled.  The two rape cases previously discussed provide further insight into the intolerance of the mentally disabled culled from 30 years of indignity.
Sexuality in Africa magazine links the high instances of sexual assault in South Africa to nationwide gender discrimination and a history of violence. The Soweto rapes further illustrate the use of sexual violence as a means of asserting dominance against a marginalized group, the mentally disabled.

In addition to health care reform, the South African government has taken steps to address the high rates of sexual assault within the country. The Domestic Violence Act 116 and the Bill on Sexual Offences both seek to more strictly define and prosecute perpetrators of sexual assault. Additionally, several South African-based non-governmental organizations—many of them staffed by volunteer nurses—have been established to assist victims of sexual assault while promoting prevention. Still, the reporting rate of sexual abuse remains low, and many victims do not receive the care that they need.

Nursing Soweto’s mentally disabled provides a necessary step to the prevention of sexual assault and other violent acts against South Africa’s mentally disabled. As access to community-based health care and stricter prosecution of perpetrators of sexual abuse progress in South Africa, Soweto’s mentally disabled will be better protected from these disturbing acts of aggression and violence.

UN work on Human Rights

I was lucky enough to visit the United Nations yesterday with a group of colleagues and students from Sigma Theta Tau.  We toured the building (which I haven't been in since I was in 7th grade!) and also attended two briefings. I am thankful to my colleague Dr. Jerri Marrocco (here is a link to her faculty web page) http://nursing.yale.edu/marrocco who arranged the visit for our group.  I am so pleased to have met Dr. Holly Shaw who leads Sigma Theta Tau's program that is working on global human rights issues. This link provides an overview of our Honor Society's work in this area, which has developed under Holly's leadership. http://www.nursingsociety.org/GlobalAction/UnitedNations/Pages/STTIandtheUN.aspx  This project is one excellent example of why I really like STTI as an organization.  Their perspective is broader and less myopic than many organizations which often seem to have a myopic focus on nurses only.  This is very important work and I am hoping to offer service related to these issues in the future. Here is a summary of ways we all can make a difference in these efforts:  http://www.nursingsociety.org/GlobalAction/UnitedNations/Pages/MakeaDifference.aspx

Dr. Shaw arranged a briefing on the status of women globally and one on work to eradicate child labor.  We had wonderful and knowledgeable speakers who shared their global perspective and experiences on working in these areas.  It was inspiring.

In addition it was disturbing.  Despite the fact that we are among the leaders of developed nations, I realized that even we will not meet the UN's millenium goals... the first of which is to eradicate poverty and hunger.  here is a link to the goals so you can learn more about them.  http://www.un.org/millenniumgoals/poverty.shtml
I hope they inspire you to work for change in these important worldwide problems.

Respect for the Rights of Individuals with Mental Health Problems

Just left a very interesting class discussing psychiatric advanced directives...
We discussed an article by Swanson (2008) evaluating whether individuals with Psychiatric Advanced Directives (PAD's) had reduced risk of coercive crisis interventions.  (here is the reference to the article: Swanson, J., Swartz, M., Elbogen, E., Van Dorn, R., Wagner, H.R., Moser, L., Wilder, C., & Gilbert, A. (2008) Psychiatric advance directives and reduction of coercive crisis interventions.  Journal of Mental Health, 17, 255-267.)  The short answer was yes... completing the psychiatric advanced directive may reduce coercive interventions... you may want to read the article.

This article also finds at baseline high rates of lifetime prevalence of being placed in handcuffs (41.8%) or transported by police to treatment (67.8%).  Rates of involuntary commitment were 61% and use of physical restraints was 37.7% in their population...  Nothing to be very happy about there.  (reminds me of my last post...!)

More importantly, what is your experience with PAD's?  Do your patients come to you with them?  Do you ask if they have one?  Many states require them and some have very specific requirements.  I would love to hear more about the 'reality' of them.

In my view they set a frame for partnership of individuals with their care providers.  What an important discussion to have.  It seems setting the stage for this kind of work together is very important and provides a sense of respect and dignity to individuals we work with.

Tell me what you think!

Traumatic Experiences in Psychiatric Settings

A colleague shared an article with me this week which reports that a large proportion of patients experience trauma or traumatic events from psychiatric care in the public setting. The study looked at a sample of 142 randomly selected patients in a day hospital program.  It asked them what kinds of experiences they had during their treatment in the public mental health system. The study used the Psychiatric Experiences Questionnaire (PEQ) which was designed to query about experiences specific to psychiatric settings such as aggression, seclusion, restraint, sexual assault, and forced medication.  Some interesting results:
-65% had been handcuffed and transported in police cars (an average of 3.4 times!)
-54% reported having been around other patients who were very violent or frightening  (an average of 7.2 times!)
-39% witnessed one patient being physically assaulted by another patient
-34% had been put in some kind of restraint (an average of 2.9 times)
-24% had been strip searched (an average of 2.7 times)

This is very disturbing.  However I can't say it is surprising.  We tend to follow tradition of a variety of practices over time in the psychiatric setting.  These practices (seclusion, restraint for example) may or may not be therapeutic.  I believe they are carried out to maintain safety (or I want to believe that).  But unfortunately we see that in fact they are traumatizing the people we are actually intending to treat!

How do we change this?  For example, is it really necessary to strip search patients? Might we either use some other method, or distinguish when or if searching is needed?  Aren't wands available to detect weapons?  If you aren't a suicide risk must we search for pills, razors and other contraband?  Or if we do search people, how can we do it in the most sensitive, private and non-intrusive manner?  I do realize that people do attempt to 'smuggle in' a variety of things.  But it seems in the majority of cases this is not a problem.  I think over 3 years working inpatient, I found only 1 or 2 situations that this happened out of hundreds. 

How many of these experiences would be prevented if we turned the system upside down and instead of treating everyone as if they cannot be trusted we actually treated people with a sense of trust? It seems we are attempting to control for the very rare events that occur by controlling everyone and everything (i.e. a patient swallows a staple from the bulletin board, so no staples allowed; or a patient tries to break a light bulb to electrocute themselves so we encase all lights - and end up with a dim environment).  You only have to look at research on what is considered 'contraband' on units to see how variable and really ineffective many of these practices are.  All patients suffer/are treated as if they are not able to be safe and responsible because a few are unsafe. 

As for handcuffing patients, I can't imagine when or why this is really needed.  Must we treat people as if they are criminals and cannot be trusted?  I have seen patients transported by law enforcement in this way.  It is often justified by a concern that the person will jump out of the vehicle and try to escape or kill themselves.  Again, how many cases really involve this risk?  Don't the vehicles have locks you cannot open?  Can't we come up with a better way?

Unfortunately the violence in the setting - patients assaulting one another, staff and patient physical altercations -which judging from this study patients perceive as staff assaulting them - is a major problem.  This will not be easily tackled.  Maybe culture change is in order.

Recently we have seen the growth of the 'comfort room'.  This is a fine idea and way to replace the seclusion room... but why aren't entire units 'comfort units'?  Must it only be one room where you can find quiet, privacy, relaxation.  Why wouldn't we design the entire unit around this concept? Isn't that truly what our patients need?

I was in Europe recently and in the UK patients now have private rooms.  This allows them some space and privacy when needed.  What a brilliant idea!  If a patient is grossly psychotic and responding to internal stimuli must they be in the middle of the busy day room?  Wouldn't we expect this to make them worse and more overstimulated?  Is it surprising that others would find them frightening and fear their presence at times? 

Of course some will say if we did any of these things all kinds of unsafe mayhem would prevail.  I can't say that there would not be risk.  We would need to do our job of assessing and therapeutically working with patients very well.  Would any of us complain about that?  

However I suspect that in many settings unsafe events occur regardless of the rules promulgated on how searches are done, where patients can and can't be, etc.  Isn't that how we come up with new rules... and so the cycle goes on.

Maybe we need a better separation of settings in terms of who is safe to be where with what and then a system of procedures that follows this...

It just seems to me that if we had a truly comforting and therapeutic environment we would be starting from a basis of treating people more humanely.  From there we might find we are more able to appeal to the healthy aspects of the individual who does have some wish to get better.  Maybe those most unsafe and immediately at risk are managed in a 'safer' area - with greater degree of environmental controls (but still comfortable and comforting- not a cell)- this would create a dynamic of wanting to be out in the more comforting less controlled areas... which if managed carefully and therapeutically would encourage patients to be more responsible for keeping themselves safe... And just imagine instead of assigning people to run around and get patients belongings that we keep locked up or simply denying use of (and making them angry and frustrated... which then starts that cycle...), we could spend those extra minutes talking with our patients so we are aware of and in touch with the individual needs of each one.  Spending more time on 'controlling things' does result in less time to be therapeutic.  I do think we have a lot of work to do in mental health settings.  I know a lot of
clinical workers who agree with this and would love to be engaged in redesigning how inpatient mental health care is provided.  Why aren't we doing that?  If you are, tell me and tell us how you got there and what you are doing?!

If we start by wanting to treat our patients as equal human beings, and respecting their needs, I think we would be moving in the right direction. I sincerely believe that most workers totally agree with this and in the majority of cases follow through on this in their day to day work... The problem is that our unit and organizational cultures do not support this.  That is a difficult problem to solve... but one that we desperately need to address. 

That study shows how inhumane treatment can really be.  Unfortunately it strikes home that it is not uncommon.  I encourage you all to review the article (it is not new - although I have never seen or heard of this study previously).  You would think this study would have called for a tidal wave of change in how things work in the inpatient psychiatric setting... (as well as all psychiatric settings...)  I can't help but think that stereotype and stigma again victimize our most vulnerable patients and that is why there wasn't a tidal wave of action on learning these results.

Here is the reference if you are interested in reviewing the article for yourself...
Frueh, B.C., Knapp, R.G., Cusack, K.J., Grubaugh, A.L., Sauvageot, J.A., Cousins, V.C., Yim, E., Robins, C.S., Monnier, J., Hiers, T.G. (2005). Patients' reports of traumatic or harmful experiences within the psychiatric setting. Psychiatric Services, 56, 1123-1133.
Here is a link - I hope it works!  http://www.annafoundation.org/Patients%20rpts%20of%20trauma%20or%20harm%20in%20psychiatric%20setting.pdfh
 or try this one...
http://ps.psychiatryonline.org/article.aspx?volume=56&page=1123

Defective equipment and worker safety

I received a letter today from Janssen pharmaceuticals regarding problems that have been identified with the syringes used with risperdal consta.  The problem is that the needles can detach during use.   I was pleased to be notified of the problem, and naturally thought the rest of the letter would identify how they had re-engineered the syringe to eradicate the problem. 

I was initially pleased that the company had even gone so far as to be transparent in informing healthcare professionals about the problem.  The problems include:

• the needle could fall off before, during, or after administration, 
• the needle may remain in the arm after withdrawal of the syringe. 
• detachment resulted in several workers being stuck with a contaminated syringe.  

Luckily none of these needle stick injuries have resulted in transmission of HIV or hepatitis... At least not yet.

Imagine my dismay when I read the rest of the letter, which explained the procedure to follow to avoid or reduce the chance of needle disengagement during preparation or administration of the injection! 

There is something wrong with this picture!

Why not package the shot with a safer more reliable syringe-needle attachment?!  The best way to deal with an occupational safety problem is to universally protect workers... in this case by re-engineering of the needle-syringe (remember that hierarchy of controls?).  

I am deeply disturbed that hundreds or maybe thousands of nurses everyday place themselves at risk of a needle stick injury while doing their job.  Isn't there something wrong with this? I think these types of syringes are used in many settings.  What are they thinking?  (by the way - I recognize that it may not be Janssen that manufactures the syringe/needle used -but they are requiring us to use the system to be able to reconstitute and prepare the injection)

I have actually read and re-read their directions several times in the past.  I have always been left to wonder whether this new safety covered needle is really worth the effort?  If you look at the drug information leaflet (http://www.janssencns.com/shared/pi/risperdal/risperdalconsta.pdf) you can see the 'simple' 17 steps involved in preparing the injection!!!  

Doesn't the addition of this new risk move the equation to the side of not worth the effort? 

Am I alone in thinking this was a misguided attempt to use the current technology despite evidence of a problem?  Is the device really that much better than others available?

Am I supposed to inform my patient that there is a risk of the needle remaining in his arm after I withdraw the syringe? This is a risk of the procedure, should it be part of consenting?  Unfortunately that may not happen often given that the reason we use injectable depot antipsychotics is to improve adherence in that group of patients who are not as interested in staying on the medication or don't actually want to take it every day.

Again, what are they thinking?  Can anyone provide a reality check for me on this subject?

If HIV had been transmitted would that change things and promote the withdrawal of a poorly designed and manufactured syringe-needle product? 

Could they perhaps try a little harder to fix the needle disengagement issue?

Actually, I remember using similar needles in the past, with detailed directions on how to 'correctly use' the  syringe.  I think I recall a flu shot clinic many years ago as well as other pre-filled type syringes where this can happen.

I have had the experience of the needle remaining behind in the patients arm... Not a very happy moment in my practice experience. I am pretty sure that was the last flu shot that person ever came in for.  Luckily I did not get stuck while removing the needle from the patient's arm - and miraculously the patient allowed us to perform the procedure again (with a different syringe and needle). 

So if this is both a patient and worker safety problem, why isn't it being fixed?  I would think the risk of HIV or hepatitis transmission would be a great enough risk that someone would push for recall of the device?

I would love to hear what all of you think about this!