Monday, 29 August 2022

5 Signs Of A Trustworthy Medical Supply Distributor


 Image by L. Weakley

Whether you are a diabetic who relies on test strips and other supplies to keep your blood sugar under control, a person who relies on oxygen to help you breathe better, or one of the many people who need various prescription medications, you realize how important it is to have what you need when you need it most . But as you know, not all medical supply distributors are alike. If you want to make sure you don't get stuck relying on a company that rarely gets things right the first time, here are five signs that will indicate a medical supply distributor is trustworthy.


By Lizzie Weakley


Take Care of the Paperwork

First, a trustworthy medical supply distributor will always handle all the necessary paperwork in a timely manner. This includes knowing your insurance plan's coverage requirements, verifying your insurance, and collecting all necessary paperwork from your doctor.

 

Excellent Customer Service

Next, a medical supply distributor that provides expert customer service can be trusted. This often includes insurance specialists who can explain your coverage, product experts to help you determine what you need, and knowledgeable customer service reps who can answer your questions and solve problems in a matter of minutes.

 

They Don't Let You Run Out

Whether it's lateral flow test assembly kitting or other essential medical supplies, a trustworthy distributor will never let you run out of your supplies. Instead, they will keep track of your monthly supply quantity, know when you need more supplies, contact you to remind you about reordering, and ship your orders in a quick and discrete manner.

 

Make the Ordering Process Easy

When a medical supply distributor is committed to excellent customer service, it will have as one of its top priorities making the ordering process as easy as possible. This should include letting you order your supplies online in a manner that takes you no more than 10 minutes from start to finish, as well as letting you order your supplies 24/7.

 

You Have Peace of Mind

If you are always worried about how things will go with your medical supply distributor, you need to find a new distributor. A trustworthy distributor will always give you peace of mind, since you will know they will rarely if ever make a mistake. If you never find your health being jeopardized by your supplier's lack of service and knowledge, you've got a great medical supply distributor.

If you keep these tips in mind when searching for a medical supply distributor, you will eventually find one that will make good on its promises and ensure you always have whatever you need.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 27 August 2022

Revised Annex 1 is out - and here is the link

Here is the link to hge revised Annex 1 (The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf

The implementation date for most parts is August 2023.

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday, 23 August 2022

Explaining how highly resistant strains of fungi emerge


 

Antibiotic resistance is a matter of common knowledge. And the same phenomenon also occurs with drugs against pathogenic fungi. What causes it is still not very well understood.

   

An international research team has deciphered the mechanism by which the fungus Cryptococcus neoformans is resistant to fungus-specific drugs. It is a yeast-like fungus that can infect humans. Specific drugs, named antifungals, are available for treatment, but they don't always work -- a phenomenon similar to antibiotic resistance. A team from Duke University in the USA and Ruhr-Universität Bochum (RUB) has used genetic, bioinformatic and microbiological techniques to decipher the mechanism underlying this resistance.

 

In the western hemisphere, the number of people with a lowered immune defence is increasing, because life expectancies are rising rapidly and treatment with immunosuppressants after organ transplants is becoming more common.

 

Cryptococcus neoformans is one of the most significant human pathogenic fungi responsible for so-called cryptococcosis. It triggers acute infections in immunocompromised patients; and the mortality rate may be as high as 70 per cent. This is because fungal strains that are resistant to the drugs often evolve in hospitals, which makes treatment more difficult. So far, it was unclear which cellular and genetic mechanisms lead to this resistance.

 

 

So-called transposons, however, were known to play a role in the resistances. Transposons are jumping genes, i.e. DNA segments that can change their position in the genome and thus affect the function of genes. If a transposon jumps into a gene that's critical for susceptibility to a drug, it's possible for resistance to emerge. The mobility of the transposons is controlled by regulatory RNAs, so-called small interfering RNA, or siRNA for short.

 

In their current study, the researchers discovered gene mutations in resistant isolates that led to siRNA control being switched off. By introducing an intact copy of the gene, it was possible to restore siRNA control; as a result, the researchers were able to prevent the transposons from jumping and shed light on the cause of resistance. Due to their small size, the gene segments that code for siRNAs are not easy to find in the genome.

 

See:

 

Shelby J. Priest, Vikas Yadav, Cullen Roth, Tim A. Dahlmann, Ulrich Kück, Paul M. Magwene, Joseph Heitman. Uncontrolled transposition following RNAi loss causes hypermutation and antifungal drug resistance in clinical isolates of Cryptococcus neoformans. Nature Microbiology, 2022; DOI: 10.1038/s41564-022-01183-z

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 22 August 2022

3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations

                                                            Image: Tim Sandle

 

Over the past decade, implementation of single-use technologies for pharmaceutical and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage, relating to areas like sterilization and cleaning. Within pharmaceuticals, these technologies introduce a new way of thinking in terms of the design space and process flows.

 

Advances in 3D printing have led to novel developments in biomedical science, such as the 3D printing of thick, vascularized, and perfusable cardiac patches to serve as functioning hearts.4 Areas of application in pharmaceuticals include drug delivery systems, such as controlled release and microneedles; pharmacy dispensing aids and drug-eluting devices, including for patients who require special personalized medications for long-term care; and single-use disposable technologies.

 

 

Thus article provides a primer for 3D printing applications and associated risks.

 

Sandle, T. (2022) 3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations, Pharmaceutical Online at: https://www.pharmaceuticalonline.com/doc/d-printing-for-pharmaceuticals-medical-devices-a-primer-with-risk-considerations-0001

 

Also:

 

Outsourced Pharma: https://www.outsourcedpharma.com/doc/d-printing-for-pharmaceuticals-medical-devices-a-primer-with-risk-considerations-0001

Bioprocess Online: https://www.bioprocessonline.com/doc/d-printing-for-pharmaceuticals-medical-devices-a-primer-with-risk-considerations-0001

Medical Device Online: https://www.meddeviceonline.com/doc/d-printing-for-pharmaceuticals-medical-devices-a-primer-with-risk-considerations-0001

Biosimilar Development: https://www.biosimilardevelopment.com/doc/d-printing-for-pharmaceuticals-medical-devices-a-primer-with-risk-considerations-0001

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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