FDA Bites the E-cigarette Regulation Bullet

April 24th, 2014 by Will Humble 6 comments »

E-CigIt’s no public health secret that tobacco use continues to be a dominant cause of preventable disease and death in the US.  While the trend has been encouraging (Arizona’s smoking rate is down to 17%), there’s still much work to be done- and continued efforts to provide creative and effective ways to help adult smokers kick the habit are a key public health intervention strategy.

The flurry of electronic cigarettes that have come on the market recently have thrown us a tobacco cessation curve ball.  Over the last couple of years the public health community has been asking itself “… do the risks of electronic cigarettes outweigh their potential benefit as a smoking cessation tool?”.   The answer to that question depends on whether and how electronic cigarettes are regulated by the FDA.  Today, we got some information to help answer this key question.

Today the FDA released proposed new regulations that (when finalized) would: 1) ban selling of e-cigarettes to minors (it’s already illegal in AZ); 2) prohibit the distribution of free samples to anyone; 3) ban selling e-cigarettes in vending machines unless they’re in places where kids can’t come; 4) require e-cigarettes to have labels stating that they contain addictive nicotine; 5) require e-cigarette manufacturers to disclose the ingredients in their products; 6) require current e-cigarettes to provide  justification for remaining on the market…  and require new e-cigarettes to get FDA approval before being sold; and 7) only let e-cigarette claim that their product reduces risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health.

The  proposed new regulations wouldn’t restrict or ban the sale of fruit and chocolate flavored e-cigarettes that some believe are designed to attract and hook young people.  They also wouldn’t restrict TV advertising or online sales.

The FDA will begin accepting public comment on the proposed new regulations tomorrow.

Abortion Clinic Inspections Bill

April 24th, 2014 by Will Humble 1 comment »

inspectionsbillWe license and inspect abortion clinics in AZ.  Due to a court settlement agreement (unlike other health care institutions we license) we’re currently required to get an administrative search warrant before conducting an unannounced inspection of an abortion clinic.   For a routine compliance inspection, we need to give them 10 days-notice.

On Tuesday, the Governor signed HB 2284, which (when it becomes effective later this Summer) will make our abortion clinics inspection authority more consistent with our authority for the other health care institutions we license.  Basically, we’ll have the authority to conduct an unannounced inspection when we have reasonable cause to believe the clinic isn’t adhering to licensing requirements or any other law or rule concerning abortions without getting an administrative search warrant.  We’ll start a rulemaking shortly to adjust our rules so they’re consistent with the new statute.

Novel Group B Strep Intervention for Babies

April 23rd, 2014 by Will Humble 2 comments »

groupbstrepGroup B Streptococcus bacteria is a leading cause of infection and death within the first week of life. Each year about 40 infants less than 1-week old get early-onset group B strep disease in Arizona.  The bacteria can cause life-threatening infections like sepsis (infection of the blood), pneumonia (infection in the lungs), and meningitis (infection of the fluid and lining around the brain).

A couple of months ago the CDC developed an app to provide clinicians with on-the-spot recommendations to reduce the number of bad outcomes from Group B Strep.  The app asks a series of simple questions.  Based on the responses, health care providers get patient-specific prevention recommendations within seconds.

The app was developed to be consistent with the 2010 Guidelines for the Prevention of Perinatal GBS Disease.  Folks can Download “Prevent Group B Strep” free from the CDC iTunes App Store or Google Play.

5 Years of Behavioral Health Innovation Paying Dividends (Part II)

April 22nd, 2014 by Will Humble 1 comment »

dividendsOver the next couple of weeks I’ll continue reflecting about some of the innovative strategies that we’ve implemented with our behavioral health community partners over the last several years to improve the health status of folks with a serious mental illness. Last week I wrote about the Integrated Health Homes initiative.

Another success has been improvements in our Crisis Response System.  In Maricopa County, Magellan, with providers and partners, restructured and overhauled the system to reduce congestion at emergency rooms- decreasing the amount of time first responders spend processing an admission to behavioral health acute care service from 2.5 hours to 7 minutes.  A strong performance by any standard.  Next week, I’ll cover improvements to the kids system of care.

Compliance v. Enforcement

April 21st, 2014 by Will Humble No comments »

compliancevenforcementThose of you in Public Health Licensing have heard me talk about the difference between compliance and enforcement more than once.  They’re 2 different things. Compliance means that a licensed healthcare, residential or childcare facility meets our standards and expectations.  Enforcement is an action that we occasionally take in order to get a facility into compliance.

In other words, our goal is always compliance- not enforcement.  The most cost effective way to achieve compliance is to provide clear and understandable customer assistance, provide education during on-site surveys, set clear expectations, and work effectively with our licensees and associations to make sure they understand what we expect.  When customer assistance, education and clarity aren’t enough to get compliance, we sometimes need to resort to enforcement actions to move a licensee into compliance.

The bottom line is that while we sometimes need to take enforcement actions to incentivize a facility to become and/or stay compliant- it’s usually the least cost-effective tool in our toolbox.

Regulatory Reform Improves Health & Wellness in AZ

April 18th, 2014 by Will Humble No comments »

web regulatoryreform Three years ago we made the commitment to overhaul the way we regulate Arizona’s 5,500 licensed healthcare facilities.  Our goal was to move from the existing prescriptive regulations to a new set of outcome-based rules.  The idea was to shift from the former 2-dimensional standards to a deeper set of 3-dimensional regulations.

The final regulations that we’re publishing at the end of April are tied to outcomes.  The model puts more responsibility on the facility’s managers to ensure that they’ve developed policies and procedures to ensure they’re meeting the needs of the people they serve.

The new model basically sets some prescriptive minimum standards- and then requires facility operators to develop an additional set of policies and procedures to ensure patient and resident health & safety.  Facilities are also required to measure patient and resident outcomes.  If they have bad (preventable) outcomes- our survey teams will determine whether they weren’t following their policies and procedures, had inadequate policies and procedures, or both.

The new final regulations aren’t the finish line.  Our next task is to educate and train our survey teams and regulated healthcare facilities on the new regulations.  Because the final rules depend largely on outcomes and solid policies and procedures rather than just static standards- this effort won’t happen overnight.  It’ll probably take about 18 months to get everybody up to speed on the new expectations.

Congratulations to our committed Stakeholders and Team ADHS for collaborating on the development of regulations that’ll be improving Health and Wellness for all Arizonans for years to come.

ADHS SWAT Team Strikes

April 17th, 2014 by Will Humble No comments »

ASH recheckLast week the ASH Pharmacy began having problems with the computer system that the medical staff use to order prescriptions for patients.  Orders weren’t consistently showing up on the pharmacy computer screen or printing out.  We implemented our back-up system right away, but the temporary work-around was time consuming.  Our Information Technology team made this their highest priority to figure out what was wrong and fix it.

Our I.T. team and our vendor (Netsmart) found a creative solution and the the system is up and running again.  A million thanks go out to Raghu Ramaswamy, Chris Long, Robert Cooprider, Nita Surathu, Desi Grosso, Daryl Hall, Eric Hill, Chris Peak, Dave Gilbert, Janet Slawinski, Paula Mattingly for the creative technology solution and the Hospital leadership team; our pharmacy team (especially Brianna Englett) for their diligence in working out the emergency back-up process to ensure patient safety; and our nursing and medical staff for ensuring that patient safety was priority #1.

 

5 Years of Behavioral Health Innovation Paying Dividends (Part I)

April 15th, 2014 by Will Humble 3 comments »

MPeople with a serious mental illness die more than 30 years earlier than people without those challenges.  Over the next few weeks, I’ll be reflecting about some of the innovative strategies that we’ve implemented with our behavioral health community partners over the last several years to improve the health status of folks with a serious mental illness.

I’ll start with a project that began with modest funding from SAMHSA, through a grant meant for small pilots to test concepts in our community.  In 2009, we and AHCCCS jointly applied for and got a Transformation Transfer Initiative grant which was used to initiate a peer-based whole health program Maricopa and Pima Counties.  The goal of the program was to help transform the behavioral health system into one that applies a holistic approach to consumer health.

Magellan Health Services of Arizona launched the first phase of Integrated Health Homes as part of this initiative- bringing together mental health and physical health care.  The model was a partnership between Magellan, Maricopa Integrated Health System, and CHOICES Network, Partners in Recovery, People of Color Network and Southwest Network.  By 2013, there were 10 Integrated Health Homes in Maricopa County that have been providing coordinated care for members.  Thousands of people have received coordinated care and achieved better outcomes through these health homes.  Here are some additional typical health home participant vignettes that profile service recipients who can benefit from the initiative.

In the coming weeks, I’ll cover improvements in the Crisis Response System, the kids system of care, children’s substance abuse, coordination with the correctional system, and performance dashboards.

FDA Approves Painkiller Overdose Field Treatment

April 14th, 2014 by Will Humble 3 comments »

EIt’s no secret that misuse and abuse of opiate painkillers like OxyContin and Vicodin are a large and growing public health threat in Arizona-  misuse and abuse of these medicines are now killing more Arizonans than car crashes.

Last week the FDA approved a prescription treatment called Evzio that can be used in medical emergencies caused by prescription opiates or heroin.  It’s approved to approved to rapidly deliver a single dose of the drug naloxone using a hand-held auto-injector.  The goal is to put this in the hands of non-medical folks who might encounter overdose patients.  Our EMS agencies and hospitals have used naloxone for decades- but this new approval potentially opens administration opportunities to other first-responders as well.

There’s some concern in the medical community about using naloxone in the field because it can cause some pretty bad side effects in folks that have been using opiates for a long time…  but given the increase in deaths related to overdoses, the FDA has taken a pretty bold move.

More Arizona Parents Choosing Not to Vaccinate their Kids

April 11th, 2014 by Will Humble No comments »

Vac2_031.jpgAs I mentioned in a blog post last year, more AZ parents are choosing not to vaccinate their kids- using “personal exemptions” when they enroll their kids in school.  This has jeopardized our immunization rates enough that this week’s measles case in Maricopa County could spread.  We’ll know in a couple of weeks.

Vaccinating yourself and your kids is more about community protection than personal protection.  We need just about everybody to participate and get vaccinated in order to get the herd immunity we all need to prevent the spread of diseases like measles.   It’s a social contract that we have with each other to keep all of us healthy- just like it’s everyone’s responsibility to be a Good Samaritan when you see a car crash.

Last year we asked the UA’s Mel and Enid Zuckerman’s College of Public Health to conduct a Study Summary and provide Recommendations to overcome the trend toward increased vaccine exemptions.  Using the study results, we developed and implemented an Action Plan to Address Vaccine Exemptions last year.  Here’s a link to our Action Plan Summary with the details of the key interventions we’ve conducted over the last year.