Buying Antibiotics Online in the UK: What You Need to Know

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The online pharmaceutical industry is under scrutiny after a 2017 study showed that nearly half of 20 online pharmacies observed don’t ask for a prescription when selling antibiotics. This practice can seriously impact the effort of the medical community to prevent microbial resistance due to the improper use of antibiotics.

What is the legal requirement to sell medication online in the UK?

The law requires every online medicine dispensary to register with MHRA and GPhC. These agencies regulate the selling and distribution of drugs to consumers. Of course, anytime you want to buy antibiotics online, if the store isn’t registered with any of these agencies, it should be a red flag that warns buyers about unethical pharmaceutical practices.

Fortunately, it doesn’t appear to be dire for all consumers. There are plenty of online pharmacies that ensure to require buyers to present their prescription before selling any prescription medication. There are also several ways by which an online pharmacy can verify the suitability of selling antibiotic and other prescription meds to a consumer.

·         Some online pharmacies let customers choose the dosage, type, and treatment duration when buying antibiotics. This process is dangerous as it puts the consumers at risk. Without a doctor’s script, they could end up taking too much or too little of the right medicine.

·         There are online pharmacies that use a process where the consumer can click on symptoms, and the website will direct them to the type of antibiotic to buy before checking out. Once again, this process is dangerous and very subjective.

·         The right process involves allowing the consumer to fill out a questionnaire which will be evaluated by a doctor who will assess the consumer’s suitability to buy antibiotics.

In addition to a questionnaire, online pharmacies also need to educate the consumer about the proper and safe use of antibiotics. There needs to be detailed information on potential side effects, especially when taken along with other prescription medication.

What results from improper use of antibiotics?

Improper use of antibiotics results in microbial resistance. Microbes often mutate and develop resistance to a medication when the patient doesn’t take the right dosage or complete the recommended treatment period. We’ve all heard about superbugs which no longer respond to common antibiotics available today. Unfortunately, getting infected by antibiotic-resistant microbes is fatal as there’s no medication available to treat the patient. Also, it will take time for researchers to discover new antibiotics that can cure these new infections.

The problem with common infections is the misconception that when you’re no longer experiencing symptoms, you can stop taking medication. Also, many people today tend to self-medicate based on the limited information they find online.

The bottom line

Online pharmacies are available to provide consumers with a more convenient way to buy medication. But, consumers should exercise caution and be more conscious about protecting their health. Although it’s easy to research symptoms online, these aren’t as accurate as visiting a doctor and getting a thorough examination. If you want to buy antibiotics online, make sure to obtain a prescription first and buy from a pharmacy registered with health regulatory agencies.

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

Why face masks can prevent coronavirus spread

How well do face masks work in terms of minimizing coronavirus spread? The evidence is compelling if a person is infected and the right type of mask is worn (and worn correctly). Scientific data challenges the opinions of some leading politicians.

There's been lots of research about face masks, looking into the efficiency of surgical and respiratory masks, and ways hat people can attempt to make their own masks. In this edition of Essential Science we briefly look at where face masks have come from, how well they work , and what are the concerns with home-made face coverings.

Where did face masks come from?

Face masks have a long history. There is documentary evidence, for example, indicating that surgeons in the American Civil War (1860-1865) acknowledged the environmental risks from field surgery. For instance, army physicians speculated that the spread of pus-formation from one patient to another was probably airborne, which led to rudimentary face coverings being worn as well as the use of tent cloth to create divisions between infected patients who were believed to be contagious from others.

Do face masks slow down coronavirus spread?

There is scientific evidence that face masks reduce coronavirus spread. This is based on airborne transmission via respiratory aerosols representing the dominant route for the spread of COVID-19. Researcher based at Texas A&M University calculated that over 66,000 infections were prevented by using a face mask in little over a month in New York City. This research is published in the Proceedings of the National Academy of Sciences and it is titled "Identifying airborne transmission as the dominant route for the spread of COVID-19."

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As well as with new York City, a global study found that regions with an early interest in face masks had milder COVID-19 epidemics compared with countries like the U.S. and U.K. that delayed asking their citizens to wear face masks.

Putting a mask on the infection source is up to 300 times more effective than putting a mask on the potential receiver of the infectious droplets. It stands that wearing a mask does not help all that much if a person is not infected (in terms of not contracting the virus), as masks do not filter out viruses from the air. However, the use of a mask does prevent viruses from being breathed out. In assessing this, the assumption that a person is not infected should not be a factor for consideration, since the majority of people with the virus show no symptoms (that this, they are asymptomatic).

In terms of how wearing masks slows down infection spread, University of Maryland researchers ran a series of laboratory experiments where it was shown that face masks significantly reduced the amounts of various airborne viruses coming from infected patients. This was as measured using the breath-capturing 'Gesundheit II machine.'

Time matters

How long a mask is worn for is an important consideration (masks tend to become less effective after four hours of wear). It also follows that the more time a person spends in an environment where the virus is present, the less effective a mask becomes. In other words, don't go to a bar for four hours and think you're risk free because you're wearing a mask.

The surrounding humidity is also a factor, according to scientists at the University of Arizona, as aerosol size can be affected by humidity,in that if the air is drier, then aerosols become smaller faster. If humidity is higher, then aerosols will stay larger for a longer period of time, dropping out faster onto surfaces, leading to high level of viral contamination.

These findings are set out in the Journal of Hospital Infection. See: "COVID-19 and non-traditional mask use: How do various materials compare in reducing the infection risk for mask wearers?"

Face coverings

Face coverings can help us protect each other and reduce the spread of the disease from someone who is suffering from coronavirus, but not showing symptoms. In many countries, people have to wear a face covering on public transport and in shops.This is what’s known as ‘source control’

However, the standard of face coverings isn’t all that high; most don’t fit properly; and people tend to re-use them. Aerosol visualization technology shows how loosely folded facemasks and bandanna-style coverings provide minimal stopping-capability for the smallest aerosolized respiratory droplets.

This means surgical masks are far more effective. However, if there is no other resort, then home-made cloth face masks can offer some protection. These need a minimum of two layers (and preferably three). This is necessary to prevent the dispersal of viral droplets from the nose and mouth.

The effectiveness of multi-layers with home-spun masks is outlined in a paper published in the journal Thorax, titled "ace coverings and mask to minimise droplet dispersion and aerosolisation: a video case study."

With the use of multi-layers, a separate research study finds that a combination of cotton with natural silk or chiffon can effectively filter out aerosol particles. This is presented in ACS Nano ("Aerosol Filtration Efficiency of Common Fabrics Used in Respiratory Cloth Masks").

Overall summary

The consensus of the science is where face masks are worn both in the home (particularly by the person showing symptoms) and outside the home in situations where meeting others is likely (for example, when shopping), masks do have an impact on transmission with a relatively small impact on a person's lifestyle. Evidence from mathematical models shows that routine facemask use by 50 percent or more of the population will reduce COVID-19 spread to an R-number less than 1.0, flattening future disease waves and allowing less-stringent lockdowns. The reproduction or 'R' number relates to the number of people an infected individual passes the virus onto. This needs to stay below 1.0 for the pandemic to slow.

It remains that face masks are the last line of defense. It still remains that do be safe, stay away; if you need to go, keep two meters apart from other people; and keep washing or sanitizing your hands.


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

Concern over COVID-19 test kit

The U.S. FDA has altered clinical laboratory staff of a risk of false results with ThermoFisher’s TaqPath COVID-19 Combo Kit. Thus is linked with two issues related to the test kit (imprecise instructions on sample preparation for the PCR plates and a concern with the positive contort); and one issue related to the Applied Biosystems COVID-19 Interpretive Software used to produce the test results.

TaqPath was fast tracked by the FDA and in Europe in March 2020.

Link: https://www.mddionline.com/ivd/thermo-fishers-covid-19-test-could-have-inaccurate-results?ADTRK=InformaMarkets&elq_mid=14179&elq_cid=1077318

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

EN 17141 Cleanrooms and associated controlled environments. Biocontamination control

The standard for cleanroom contamination control has been issued. This is titled “Cleanrooms and associated controlled environments. Biocontamination control”.

What is EN 17141:2020 about?

This new European standard establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.

Replacing BS EN ISO 14698-1:2003 and BS EN ISO 14698-2:2003 , this new standard provides updated guidance and further information on best practice for establishing and demonstrating control of airborne and surface microbiological contamination in clean controlled environments.

The standard will help:

• Increase the effectiveness of risk management associated with microbiological contamination
• Improve efficiency
• Develop the risk management expertise of individuals who engage with its principles
• Where applicable, provide alignment with the regulatory authority’s expectations for continued compliance and process approvals

EN 17141:2020 describes requirements for microbiological contamination control, giving information on the qualification and verification of clean controlled environments. It includes considerations for medical devices and food applications.

Informative annexes give tables of cleanliness levels for monitoring of microbiological contamination in specific types of clean controlled environments and offer additional guidance on the choice of environmental monitoring sampling methods; the management and trending of collected data; and the role of alternative and real-time microbiological detection systems.

The standard retains and updates information relating to microbiological air sampler verification requirements that is included, and widely referenced, in EN ISO 14698–1:2003. 

EN 17141:2020 will provide users with the methodology and understanding to derive an effective formal system of microbiological control that identifies, controls and monitors microbiological contamination on an ongoing basis.

For regulated industries, the standard provides guidance which is consistent with the expectations of the regulatory authorities.

See: https://shop.bsigroup.com/ProductDetail/?pid=000000000030329442

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

Review of the causes of antimicrobial resistance

Antimicrobial agents particularly antibiotics have been critical in the fight against infectious diseases caused by pathogenic microorganisms including bacteria, fungi, viruses and protozoa (1). There usage in clinical medicine for treating infectious diseases has drastically leads to increase in the life expectancy of the human race over the past six decades. This is because the discovery and usage of antibiotics in infectious disease management has helped to reduce the rate of morbidity and mortality caused by infectious disease pathogens in human population. However, in recent years there has been a marked rise in the number and type of antimicrobial resistant organisms (2).

In relation to this subject, Tim Sandle has written an new article.

Here is the abstract:

Antibiotic resistance is one of the biggest challenges to the health sector worldwide, and this medical quagmire threatens our ability to effectively manage and treat some infectious diseases. Microbial resistance to antibiotics and/or antimicrobial agents has been documented not only against antibiotics of natural and semi-synthetic origin such as the penicillins, but also against some purely synthetic compounds (such as the fluoroquinolones) or those which do not even enter the cells (such as vancomycin). And unfortunately, the slow pace in the discovery and development of novel antibiotics have not actually kept pace with the emergence and rate at which bacteria develops and mount resistance to some available antibiotics (3).

Some infectious diseases including but not limited to tuberculosis, bacterial pneumonia, septicaemia, gonorrhoea, wound infections and otitis media are now becoming recalcitrant to treat with some available antibiotics because the causative agents of these diseases are fast becoming resistant to some available antibiotic therapy. These antibiotic resistant organisms have developed several novel ways and mechanisms that allow them to ward-off the antimicrobial onslaught of potent antimicrobial agents and/or antibiotics targeted towards them. This article reviews the primary resistance mechanisms.

The reference is:

Sandle, T.  (2020) Review of the causes of antimicrobial resistance, Microbioz India, 6 (3): 12-20

Access the article for free here: https://microbiozindia.com/microbiology-news/review-of-the-causes-of-antimicrobial-resistance/

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

Modern myth #6: Low endotoxin recovery affects all products

According to James Cooper, no one disputes that low recovery of lipopolysaccharide (LPS), as used for the LAL test control endotoxin, occurs in certain conditions, such as chelating buffers and detergents. However, this issue does not affect all products. 

Furthermore, the issue at hand is low lipopolysaccharide recovery rather than ‘low endotoxin’ recovery. Endotoxin is more sophisticated, being composed of a hydrophilic polysaccharide covalently linked to a highly conserved, hydrophobic lipid region. LPS and endotoxin do not behave in the same way (LPS activity varies due to the presence of various salts and detergents).

In addition, the use of a uniform screening test can reveal conditions of concern and legitimize the use of alternative naturally occurring endotoxin preparations for endotoxin challenge studies. However, to do required regulatory approval.

Reference: https://www.americanpharmaceuticalreview.com/Featured-Articles/181837-LER-Microbiology-s-Hottest-Urban-Myth/

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

New warning over ineffective hand sanitizers

Not all hand sanitisers are effective: How to spot a substandard or dangerous product. Many regulators have dropped some of the requirements for hand sanitisers in order to help to address supply problems. At the same time poor quality products have entered the market, including many containing toxic methanol. In this video, Tim Sandle explains what purchasers and members of the public need to watch out for:

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

Endotoxin Limits for Investigational Oncology Drugs and Biological Products

The U.S. FDA has issued an new guidance document titled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document is currently in draft form (dated July 2020).

This guidance describes FDA’s recommendations to investigational new drug sponsors for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two or more investigational drugs.

In keeping with the principles of facilitating drug development for serious and life-threatening diseases, this guidance outlines FDA’s current thinking on a risk-based approach to setting acceptance criteria for endotoxins during the clinical development of drugs intended to treat serious and life-threatening cancers.

For details see: https://www.fda.gov/media/140410/download

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

A Practical example of applying Quality Risk Management in GDP – Transportation Risks

The MHRA has issued some advice on the distribution of medicines and applying QRM.

This is about identifying and defining the risks. The MHRA write:

“Many companies present such summaries as a spreadsheet which assists communication, an essential part of QRM. The summary should be regularly re-evaluated and potential changes assessed during quality management review meetings. It is rare to find sound scientific justification for acceptance of a load subject to an excursion, and in the uncommon instances where a supplier or customer contacts the marketing authorization holder for stability information, it is often not directly comparable to the excursion experienced. Unfortunately, the most common reason for accepting a consignment with a temperature excursion is purely commercial, which may put patients at risk and undermines any risk management carried out by the company.

In some cases of quality risk management, attempts were made to inappropriately apply mean kinetic temperature to underestimate impact rather than develop good control and preventive measures.”

See: https://mhrainspectorate.blog.gov.uk/2020/07/15/a-practical-example-of-applying-quality-risk-management-in-gdp-transportation-risks/

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

Minimizing microbial contamination on cleanroom surfaces

One design aspect is with the incorporation of antimicrobial materials into surfaces as a means to reduce microbial numbers (or at least to prevent microorganisms from growing). This addition has become commonplace in many hospitals1 and within food factories;2 however, the adoption has been slower within pharmaceuticals (where the use of antibacterial materials used to coat cleanroom surfaces is sometimes referred to as “biotrunking”). A second design aspect lies with the selection of surface properties of materials, so that surfaces can reduce the possibility of microbial attachment, making disassociated organisms easier to kill by disinfection. Combined, antimicrobial surfaces with specific topography has the potential to reduce microbial survival in cleanrooms.

In relation to this, Tim Sandle has written an article. The reference is:

Sandle, T. (2020) Minimizing microbial contamination on cleanroom surfaces, American Pharmaceutical Review, 23 (2): 30-35

In this article, different antimicrobial technologies together with physical properties are considered together with a review of available literature to examine the efficacy of such surface materials.

For details, see: https://www.qgdigitalpublishing.com/publication/?m=55362&i=654789&p=0

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

Mouthwashes could reduce the risk of coronavirus transmission

Sars-Cov-2 viruses can be inactivated using certain commercially available mouthwashes. This was demonstrated in cell culture experiments by virologists from Ruhr-Universität Bochum together with colleagues from Jena, Ulm, Duisburg-Essen, Nuremberg and Bremen. High viral loads can be detected in the oral cavity and throat of some Covid-19 patients. The use of mouthwashes that are effective against Sars-Cov-2 could thus help to reduce the viral load and possibly the risk of coronavirus transmission over the short term. This could be useful, for example, prior to dental treatments. However, mouth rinses are not suitable for treating Covid-19 infections or protecting yourself against catching the virus.

The results of the study are described by the team headed by Toni Meister, Professor Stephanie Pfänder and Professor Eike Steinmann from the Bochum-based Molecular and Medical Virology research group in the Journal of Infectious Diseases, published online on 29 July 2020. A review of laboratory results in clinical trials is pending.

Eight mouthwashes in a cell culture test

The researchers tested eight mouthwashes with different ingredients that are available in pharmacies or drugstores in Germany. They mixed each mouthwash with virus particles and an interfering substance, which was intended to recreate the effect of saliva in the mouth. The mixture was then shaken for 30 seconds to simulate the effect of gargling. They then used Vero E6 cells, which are particularly receptive to Sars-Cov-2, to determine the virus titer. In order to assess the efficacy of the mouthwashes, the researchers also treated the virus suspensions with cell culture medium instead of the mouthwash before adding them to the cell culture.

All of the tested preparations reduced the initial virus titer. Three mouthwashes reduced it to such an extent that no virus could be detected after an exposure time of 30 seconds. Whether this effect is confirmed in clinical practice and how long it lasts must be investigated in further studies.

The authors point out that mouthwashes are not suitable for treating Covid-19. "Gargling with a mouthwash cannot inhibit the production of viruses in the cells," explains Toni Meister, "but could reduce the viral load in the short term where the greatest potential for infection comes from, namely in the oral cavity and throat -- and this could be useful in certain situations, such as at the dentist or during the medical care of Covid-19 patients."

Clinical studies in progress

The Bochum group is examining the possibilities of a clinical study on the efficacy of mouthwashes on Sars-Cov-2 viruses, during which the scientists want to test whether the effect can also be detected in patients and how long it lasts. Similar studies are already underway in San Francisco; the Bochum team is in contact with the American researchers.

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

The latest revision of EU GMP Annex 1 signals a new regulatory paradigm

A new edition of GMP Review has been published (edited by Tim Sandle). In the new edition is a paper by Dr. Sandle, looking at the essential elements of the latest revision of Annex 1 of EU GMP.

The aim of Annex 1 is to set out the minimum standards for the manufacture of sterile products (both aseptically filled and terminally sterilised), which takes place within cleanrooms and barrier devices. There is a major focus within the Annex on the need for a contamination control strategy, purposefully designed for each facility; and for each manufacturer to be using the principles of quality risk management.

While there are several essential points to consider for the contamination control strategy, those that appear to be given the greatest weighting (from this author’s reading of the text) are:

• ·         Maintaining the critical processing zone.
• ·         The aseptic assembly of filling equipment.
• ·         Aseptic connections (these should be sterilized by steam-in-place whenever feasible).
• ·         Special focus on aseptic compounding and mixing.
• ·         The risks abound the replenishment of sterile product, containers and closures.
• ·         Concerns around the removal and cooling of items from heat sterilizers.
• ·         Staging and conveying of sterile primary packaging components.
• ·         Aseptic filling, sealing, transfer of open or partially stoppered vials, including interventions.
• ·         Loading and unloading of a lyophilizer.

It is unsurprising that each of these relate to aseptic processing, the highest-risk area of pharmaceutical manufacturing. 

The reference is:

Sandle, T. (2020) The latest revision of EU GMP Annex 1 signals a new regulatory paradigm, GMP Review, 19 (1): 4-6

For details, contact Tim Sandle.

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