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.