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Avomeen Blog

Wednesday, September 25, 2013

Dr. Thanedar Shares Insight on J&J Recall

When Dr. Shri Thanedar, CEO of Avomeen Analytical Services, heard news of the recent Johnson & Johnson recall, he had a word of advice to offer. The company just recently announced the recall of Motrin Infant Drops due to the possibility that the medication may be contaminated with plastic particles. Dr. Thanedar advised the following:

“The first practices any company should introduce are ways to protect their products. Preventative measures should be put in place to avoid product defect or contamination. However, it is also imperative to know what steps to take if a product failure should occur. Johnson & Johnson responsibly removed the medication for sale that had even a chance of contamination. The question for them now is – what’s next?”
Dr. Thanedar suggests J&J should consult a laboratory that can conduct both a failure analysis study as well as provide method development and validation. These services can assist Johnson & Johnson in determining the precise origin of the contaminant as well as identifying any future issues they might have. Mitigating risk before it happens is the best defense any company can have against recalls. However, issues do arise and that is when having the right resources makes all the difference.

Avomeen Analytical Services is well versed in testing for product defects. Using techniques such as FT-IR, SEM/EDXA, GC/MS and LC/MS, contaminants in formulated products can be precisely isolated and identified. With services ranging from comprehensive deformulation to litigation support we are the resource for even the most difficult cases.

Wednesday, September 18, 2013

Overseas Pharmaceuticals - Avoiding Wrong Medications & Counterfeits

Those who frequently travel overseas more than likely have purchased or will at some point have the need to purchase medication while abroad. There are multiple reasons one might purchase drugs while traveling. Whether due to forgetting daily prescription drugs or becoming ill while traveling, the probability of buying drugs abroad has greatly increased, and with it multiple risks have surfaced. Every country, and sometimes even individual pharmacies, operates in a different manner.  Due to these differing standards and protocols one must be aware of potential hazards such as receiving the wrong, counterfeit or even contaminated medication.

The first preventative measure to take is to refill prescriptions before leaving on a trip and to bring extra medication in case of sickness. This will elevate many of the problems you might otherwise face. Sometimes, however, despite all precautions things go amiss. Lost luggage or illnesses caught en route can quickly put you in a predicament while visiting a foreign country.

General guidelines for purchasing medications while abroad:
  •          Brand names vary – know the generic name to ensure receiving the right medication. Similar sounding drugs such as “Ambien” and “Ambyen” treat completely different health problems and could be dangerous if mistakenly taken.
  •          Dosage matters – make sure the medication you buy is the same dosage you are used to taking.
  •          Active ingredients mean everything – double check that the active ingredients are the same as what you have taken and in the same proportions.
  •          Doctors are the best resource – go see a local doctor if you are unable to purchase your medication or need a physician’s help. Also, make sure to have your physician’s contact information on hand in case of an emergency.

Preparing beforehand alleviates many common pitfalls and helps you avoid purchasing the wrong medication. Unfortunately, purchasing incorrect medicine is not the only risk; counterfeit and contaminated medicines pose just as much, if not more, of a hazard when seeking prescription drugs abroad.

Counterfeiting prescription drugs has been on the rise since the early 2000’s and are thought to make up between 1-30% of the total medication sold in some countries. Some may think that purchasing counterfeit pills simply wastes money on buying fake medication, when in fact it means much more. It’s true that counterfeit pills many times are just highly diluted versions of the true medication making them ineffective for treatment. Often though, the ingredients applied to stretch the counterfeit batches are actually harmful ingredients that could lead to severe side effects or death in extreme cases. Though without contamination and product analysis it is impossible to be completely sure of what you have purchased there are guidelines that you can follow to enact your due diligence and have more confidence in your purchases. (Note: These guidelines apply to all medication your purchases whether at home or abroad.)

Ways to check medication for counterfeiting:
  •          Branding makes the product – most brands have unique packaging for marketing purposes, verify the packaging as a first defense against counterfeit medication.
  •          Packaging with purpose – verify that the packaging has not been tampered with in any way and if it has do not buy the product.
  •          Taste, touch, and sight – your senses are some of your best defense systems against counterfeiting. Check if the medication itself is the right shape, color, and taste that you are accustomed to. If it seems like something is off, it is not worth the risk.
  •          Source – refer to the manufacture’s information to see if it corresponds to the manufacture listed on your common medication.

With these pointers remember when traveling to plan ahead, fill prescriptions before you leave, and thoroughly check any medication bought overseas. If you believe that any medication you purchased could be counterfeit, alert the FDA by call the Medwatch program at 1-800-332-1088. For litigation services involving counterfeit or contaminated medication have your legal representative contact Avomeen for contamination analysis and other litigation services.

Tuesday, September 10, 2013

Supreme Court Ruling on DNA Collection Raises Concerns of Contamination

Contamination is always a concern in scientific research, but the new ruling on DNA-collection has both analysts and the general public abuzz with unanswered worries.

With DNA-collection now allowed at time of arrests the number of samples collected will skyrocket. Researchers voice concern that with such a large number of samples the possibility for contamination increases exponentially. Other concerns such as ease of contamination during collection or storage have brought the process under needed scrutiny.

Scientists urge the government to take extreme caution by setting strict guidelines for DNA-collection and processing to ensure protection of the samples and the individuals concerned. While scientists worry how to protect the samples’ purity, individuals argue over Fourth Amendment rights. Voices also give warning that the classification of DNA-collection as equivalent to fingerprinting is misguided and DNA results should be treated as a piece of confidential evidence, not be abused or used lightly.

There is obviously an increased need for the establishment of processes to accurately account and document DNA-samples and results. Researcher Greg Hampikian of Boise State University has recently developed a way to us nullomers as a sort of DNA bar code. These smallest of DNA sequences can be used to permanently mark samples to prevent contamination. Whether new inventions such as this will be used in the standardization of DNA-processing or not is still to be seen.

As with most testing, human error is an element that must be taken into serious consideration. Contamination can easily occur in any laboratory setting by negligent actions as simple as touching multiple samples without changing gloves. As the outcomes of these particular tests will play a part in deciding the innocence of individuals accused of crimes, it is even more necessary for us to take measures to be taken to minimize the possibility of mistrial through use of contaminated evidence.

Tuesday, September 3, 2013

Color Coding Molecular Environment

Shigehiro Yamaguchi and a team of scientists from Nagoya University have created a molecule which when hit with 365 nm ultraviolet light will emit various colors of light depending on its environment. The basic design of the molecule consists of a flexible π moiety and two rigid wings. The flexibility and rigidity combined in this molecule’s skeleton is what makes this system so remarkable.
There are two characteristics of this system which makes it outstanding. First is the ability to change from nonplanar V-shape to a planar form in excited state, allowing for dual fluorescence. Secondly the nesting ability of the V-shaped molecules is unique and provides the necessary structure to emit the third color.
In a basic sense the molecule will maintain one of three forms, the V-shape, flat, or stacked V-shape. The form the molecule takes depends entirely on its environment. It will bend into the V-shape and emit a blue light when trapped in a polymer, lie flat and glow green when dissolved in organic solvent, and stack multi-layers and emit a red hue when crystalized.

Temperature and pressure also affect the molecule’s change in shape and so the colors can serve to identify many aspects of their environment. This bio-molecule invention is so unique that it may be used as the groundwork strategy for future molecular sensors.

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