Rare Disease Day

Rare Disease Day is an observance held on the last day of February to raise awareness for rare diseases and improve access to treatment and medical representation for individuals with rare diseases and their families.

Every year, thousands of events are organised around the world during the month of February to mark the occasion of Rare Disease Day. Patient organisations, healthcare professionals, researchers, policymakers and other members of the rare disease community organise Rare Disease Day events.

Building awareness of rare diseases is so important because 1 in 20 people will live with a rare disease at some point in their life. Despite this, there is no cure for the majority of rare diseases and many go undiagnosed. Rare Disease Day improves knowledge amongst the general public of rare diseases while encouraging researchers and decision makers to address the needs of those living with rare diseases.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmacovigilance Inspection Metrics April 2017 to March 2018

The MHRA GPvP inspectorate published their latest inspection metrics for the period from April 2017 to March 2018.

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

See: https://mhrainspectorate.blog.gov.uk/2018/12/04/pharmacovigilance-inspection-metrics-april-2017-to-march-2018/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Effective training for cleanroom cleaning

A new article of interest.

Controlled environments are required for the manufacture of pharmaceutical products. Once a grade is assigned a number of physical and microbiological parameters need to be met. Controlled environments also need to be regularly cleaned and disinfected. While cleaning processes are defined, issues still arise with cleaning and disinfection effectiveness when undertaken by operators. E-learning provides an alternative approach to training. This article reviews the importance of cleaning and disinfection in cleanrooms; the importance of training; and the role that e-learning can play, centring on a new e-learning package from Pharmig.

The reference is:

Sandle, T. (2018) Effective training for keeping cleanrooms clean, Cleanroom Technology, 26 (11): 36-37

For details, contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Agrichemicals and antibiotics in combination increase antibiotic resistance evolution

"Agrichemicals and antibiotics in combination increase antibiotic resistance evolution". An interesting article was published in PeerJ during 2018, and it's worth revisiting.

The abstract reads:

"Antibiotic resistance in our pathogens is medicine’s climate change: caused by human activity, and resulting in more extreme outcomes. Resistance emerges in microbial populations when antibiotics act on phenotypic variance within the population. This can arise from either genotypic diversity (resulting from a mutation or horizontal gene transfer), or from differences in gene expression due to environmental variation, referred to as adaptive resistance. Adaptive changes can increase fitness allowing bacteria to survive at higher concentrations of antibiotics.

"They can also decrease fitness, potentially leading to selection for antibiotic resistance at lower concentrations. There are opportunities for other environmental stressors to promote antibiotic resistance in ways that are hard to predict using conventional assays. Exploiting our previous observation that commonly used herbicides can increase or decrease the minimum inhibitory concentration (MIC) of different antibiotics, we provide the first comprehensive test of the hypothesis that the rate of antibiotic resistance evolution under specified conditions can increase, regardless of whether a herbicide increases or decreases the antibiotic MIC. 

"Short term evolution experiments were used for various herbicide and antibiotic combinations. We found conditions where acquired resistance arises more frequently regardless of whether the exogenous non-antibiotic agent increased or decreased antibiotic effectiveness. This is attributed to the effect of the herbicide on either MIC or the minimum selective concentration (MSC) of a paired antibiotic. The MSC is the lowest concentration of antibiotic at which the fitness of individuals varies because of the antibiotic, and is lower than MIC. 

Our results suggest that additional environmental factors influencing competition between bacteria could enhance the ability of antibiotics to select antibiotic resistance. Our work demonstrates that bacteria may acquire antibiotic resistance in the environment at rates substantially faster than predicted from laboratory conditions."

See: PeerJ

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology