Expect Grater Enforcement of USP 797 In Wake of NECC Compunding Tradgedy

Expect greater legislative enforcement of pharmacuitcal companies, specifically drug compounding centers, as the outbreak of contaminated drugs from The New England Compounding Center of Framingham, Mass expands nationally.


USP 797 refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

The standards in this chapter are intended to apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported). USP 797 requirements affect all disciplines involved in sterile compounding, including physicians, nurses, pharmacists, and pharmacy technicians. 

Winter Is A Great Time to Conduct Indoor Air Quality Testing

IndoorDoctor, a New England based indoor air quality testing firm, has seen a steady rise with indoor air quality concerns during winter months. Simply put, more people spend their times indoors when it’s cold outside. “As homes become more energy efficient indoor air pollution will accumulate with greater concentration,” says environmental engineer and company president Jeffrey Bradley. Major contributors of indoor pollution include combustible heating sources and fireplaces. These sources emit very small particles which penetrate deeply into sensitive parts of the lungs and can cause or worsen respiratory disease.  IndoorDoctor is able to measure and document fine particulate using a handheld particle scanner. 

     It’s not just people that spend more times indoors. Household pets are homebound during winter months. Many people will experience an increase in allergic symptoms due to the increased animal dander which is very difficult to remove. Other commonly associated irritants involve airborne fiberglass. Often people will exercise at home instead of outside or at the local health club. Bradley cautions people to place treadmills and other exercise equipment in a basement where the air quality is much worse than other areas in the home due to exposed fiberglass, fine particulates from the furnace, volatile organic compounds (VOCs) from stored chemicals, and higher mold spore levels.  

Carbon Monoxide (CO) is one of the most common pollutants IndoorDoctor detects during winter months. Homeowners will typically install carbon monoxide meters to detect the lethal colorless and odorless gas. Unfortunately, these detectors will only register CO levels around 5 or 10 parts per million (ppm) and not warn the homeowner of lower levels which may contribute to headaches, memory loss and fatigue. “We’ve had a number of clients experiencing long term acute carbon monoxide poisoning from CO levels around 2-4 ppm. Our specialized testing equipment will detect the trace carbon monoxide levels that a typical home detector will not”.  

IndoorDoctor recommends regular servicing and cleaning of the heating system and to schedule independent air quality testing.

The Cost of Asbestos Testing Vs. Product Value

Asbestos fibers—widely found in general industry materials prior to 1972, when OSHA began to regulate its existence—can lead to long-term health effects such as respiratory disease, asbestosis and at least the known cancers. When industry standards began to mandate monitoring of this problem after 1972, it was not only employers who listened: everyday Americans became concerned about the fibers they could be breathing as a result of airborne asbestos. Major occupational improvements such as a ventilation systems, wet processes, exposure assessment tests and air quality regulation efforts stirred the concern among average Americans. If workplaces were setting up hazardous waste removal sites for employees exposed to Asbestos, what did this mean for the airborne particulates within the walls they sleep? How was this airborne fiber damaging the clothes they wore every day?

The answer is still not clear. The only way to be sure about the presence of Asbestos, according to Environmental Engineer Jeff Bradley, is to test. Such procedures, however, are expensive: the OSHA-accredited testing materials, which measure both the rate of airborne exposure and the presence of particulate matter, can cost up to $750 per sample. A surface test, Bradley says, only measures up to four square inches of clothing—one-eighth the inseam on an average man’s pair of paints. Even then, these surface samples cannot be sure to detect every fiber present, leaving asbestos inspectors to often conclude the following: even after sampling, asbestos-contaminated clothing could be hazardous to your health. If the average American spends $50 on a pair of pants, the scientific process to rule out asbestos-contamination danger is fifteen times higher than purchasing a new pair of chinos.

According to the most recent Asbestos Regulations Manual put forth by the Institute for Environmental Education, “Asbestos-containing material (ACM)” (p. B-1) must be treated as hazardous, which includes, but is not limited to, the following: proper laundering after initial clothing assessment (as Bradley stated, up to $750 per sample for a small area of clothing), inspection of cleaned clothing, disposal of clothing that does not unequivocally meet the OSHA standards. Such actions are monitored closely due to risks of releasing asbestos. “If the asbestos-containing material is damaged or deteriorated, the professional may recommend that it be removed or repaired. Planned or unplanned renovation activities may also require removal if asbestos-containing material will be disturbed as a result of the renovation. If materials are intact, but have a high potential for being damaged or disturbed, it may be desirable to remove these materials to avoid inadvertent exposures,” James Fite of the White Lung Organization reports.

Even if the area said to contain asbestos passes visual inspection, aggressive air sampling should be performed to test for asbestos fibers, according to Fife. Such samples, Bradley adds, are a minimum of $80 each and must be conducted after the initial assessment. Bradley’s company, IndoorDoctor, charges a travel fee of $350 per visit. The U.S. Department of Labor’s Daniel Walker makes note of an additional cost: “…The  laundry provider should have analytical procedures in place to verify that the decontamination process was effective.” Additional costs mandated by the EPA might include hiring a consultant to develop a management plan.

While Bradley understands that cost often drives health-related decisions, he concludes that the exhaustive testing, remediation and re-resting of ACM in a single-family home would be more extreme than proper removal of potentially-affected materials. “Considering the lack of certainty and the probability that future testing would need to be conducted on laundry exposed to asbestos, I recommend that my customers properly dispose of their clothing and start with a fresh peace of mind,” Bradley concludes. In short, a new wardrobe not only prevents asbestos fibers from becoming airborne, but won’t burn a hole as deep as the testing required to eliminate the fibers from used clothing.

How the Economy Compromises Indoor Air Quality in Rental Property, Schools and Small Businesses

Everyone relates to the visible effects the economy has one their lives: gas prices rising, home values plummeting, and even the rise of grocery bills. But what we cannot see might have one of the most consequential effect of our poor economy. In a series of three op-eds, environmental engineer Jeff Bradley will tell us how the current market affects the everyday, indoor environments of rental properties, schools, and small business.

 

People who rent their homes, and even those who rent commercial space, detect more indoor environmental issues than before the economy went sour. Because the financial burden on property owners often causes them to turn a blind eye to non-essential costs such as proper air testing.

Even further, landlords are not as quick to respond to complaints about a flooded basement, a leaky pipe or an area of visible mold growth. If these property owners are working just to pay the mortgage on the building, they are more likely to ignore tenants’ requests that do not seem to carry the same financial significance as skimping on bills. Renters, in turn, are tentative to request assistance with what seem to be less timely concerns. Living with a water mark on the bedroom ceiling, or mold growth in the bathroom, for example, present far fewer immediate consequences than complaining to the point of eviction. Landlords’ financial frugality in the current market, then, creates hesitant tenants who become sick from breathing poor indoor air.

The problem is that there is no bad guy in this scenario. The property owner wants to accommodate his renters but cannot afford to do so and the tenant wants an environmentally sound living or work area but does not want to risk eviction based on persistent requests.

The solution? Property owners must address environmental concerns as soon as possible: an asthma-inspired trip to the Emergency Room costs quite a bit more than an air purifier or even a professional mold test. If an environmentally-rooted health issue arises, tenants need to contact their landlords to request environmental consulting. Once the problem has been identified, all parties benefit from the prevention of further damage.

Harmful Cell Phone Raditation

The World Health Organization (WHO) announced yesterday that radiation from cell phones increases users’ risk of getting cancer. According to the WHO's International Agency for Research on Cancer (IARC), radiofrequency electromagnetic fields (EMF) have been classified as possibly carcinogenic to humans.

IndoorDoctor LLC, a leading New England-based environmental engineering firm specializing in indoor air pollution, can measure this harmful electromagnetic frequency (EMF) exposure from cell phones. Jeffrey Bradley, President and CEO of IndoorDoctor, likens the uncertainty of EMF exposure to how cigarettes were once viewed fifty years ago.  Bradley is also concerned that the combination of radio frequency and other indoor air chemicals may trigger an allergic condition known as Electromagnetic Hypersensitivity (EHS).  A wide variety of physical illnesses such as headaches, migraines, insomnia, neurological illness, cancer, leukemia, tumors, muscle aches and pains, fibromyalgia, neuromuscular disease, and heart disease have also been associated with EMF.

Unlike other indoor pollution such as mold, radon, asbestos, and chemicals, there is no easy fix to EMF other than avoidance. As with any indoor air pollution concern, the most effective plan is to first have your home, car and place of work tested for EMF to understand your exposure. People who are interested in assessing their risk should contact IndoorDoctor at 800-466-1522 to schedule an EMF evaluation. Bradley or one of his environmental engineers will travel to your home for consulting and testing services based on sound engineering principals. Visit www.indoordoctor.com for complete information.

Test Your Home For Radon Every Two Years

Radon is a colorless and odorless gas that can have very serious health effects. According to the Surgeon General, radon is the second leading cause of lung cancer within the US. Radon levels fluctuate throughout the year, but often go undetected by homeowners, sometimes placing residents at risk without any detectable air quality changes. Environmental Engineer Jeffrey Bradley explains that it is not unusual for radon levels to be higher in the winter months. Snow cover creates a blanket effect that can trap radon in soil, allowing the gas to escape through the frozen ground and leak into houses at a higher concentration than during other seasons. 

The EPA has set a national action level of 4 pCi/L (picoCuries of radon per liter of air).  Bradley’s New England-based Environmental Engineering firm, IndoorDoctor, specializes in indoor air quality investigations to measure such levels. They recommend radon testing in different seasons at least every two years. Most homebuyers conduct a radon test as part of their purchasing agreement and neglect to test further down the road. “I’d say nearly half of the homes we test have radon levels higher than their initial test when they purchased the home,” Bradley says. He warns, too, that over-the-counter tests can be poor indicators of radon. “The only reliable way to be sure that your home has a safe level of radon is to test your home tested on a regular basis.”

To avoid the dangerous health risks associated with radon, IndoorDoctor engineers strongly urge homeowners to have their home's indoor air quality tested for radon along with other indoor air quality pollutants. Contact IndoorDoctor to schedule unbiased and independent air quality testing

Newer Homes Vulnerable to Airborne Fiberglass

Newer homes are more vulnerable to aerosolized fiberglass insulation, says environmental engineer Jeffrey Bradley, President of the New England-based air quality testing firm IndoorDoctor LLC.  “We’ve seen a substantial increase in air quality concerns from homeowners with young children experiencing chronic coughing and eye irritation,” says Bradley.  “The majority of these homeowners live in newly constructed homes. Once the insulation issue is resolved then the symptoms tend to go away.”

There are many reasons for the increase in fiberglass levels. One such reason is that more people are air conditioning their homes by adding duct work in their attic; the resulting exposed insulation can then filter through the seams in areas such as recessed lighting. The jagged, microscopic fiberglass particles stay airborne longer than a typical dust particle and can penetrate the eyes, throat and lungs, causing irritation and sometimes chronic respiratory distress.  Bradley urges homeowners to seek alternatives to fiberglass insulation, such as safe non-toxic, foam-based lining, and to avoid installing the duct work in the attic.  

Bradley notes that homeowners are also looking to expand their homes by finishing their basement, where there is often exposed insulation. The fiberglass particles in the insulation have the potential to become airborne every time a fan turns on, a door opens or shuts or the room's interior pressure changes due to temperature, leading to respiratory distress, among other conditions.

To avoid the dangerous risks associated with airborne fiberglass, Bradley strongly urges homeowners to have their home's indoor air quality tested for such particles and, if high levels are detected, to take professional restoration action to reduce the dangerous counts. To have Bradley or one of his team members test the air in your home, you can contact him at: jeff.bradley@indoordoctor.com or by calling 800-466-1522.