Thursday, 9 October 2014

PHSS bio-contamination monograph

The PHSS have produced a comprehensive monograph on bio-contamination in pharmaceutical and healthcare environments. The monograph examines bio-contamination characterisation, environmental control, environmental monitoring, deviations, and practices in GMP and classified areas.

The contents are:

Section 1. Introduction and scope includes a review of the challenges and requirements for Bio-contamination control and cross contamination control with a holistic approach to monitoring and proactive investigations in response to increased risk from changes in biocontamination profiles.

Section 2. Bio-contamination characterisation and risk profiling. Methodologies and strategies that profile bio-contamination through establishing control, in operations and holistic monitoring.


Section 3. Bio-contamination control principles and best practice guidance considering Quality by Design, different processes, control attributes, background environments and Barrier technologies.

Section 4. Bio-contamination monitoring including classical and Rapid Micro Methods (RMM).

Section 5. Bio-contamination Deviation management including considerations and guidance in completing investigations and undertaking corrective and preventative actions (CAPA).

The document was developed by James Drinkwater, Andrew Hopkins, Mike Davies, Ian Symonds, Tim Sandle, Tim Eaton, Una Hearty, Jim Filer, Malcolm Homes and Tim Triggs. Peer review was undertaken by a number of industry experts. The review included the U.K. regulatory inspection agency, the MHRA.

The document is reference is:

PHSS (2014) Bio-contamination, Technical Monograph No. 20, Pharmaceutical and Healthcare Sciences Society, Wiltshire, U.K.

For further details, see: PHSS

Posted by Tim Sandle

Wednesday, 8 October 2014

Origins of Tuberculosis in South America


Tuberculosis is one of the most widespread bacterial diseases on the planet. It is an infection that has plagued humans for over millennia. One line of bioarchaeological research is concerned with the origins and spread of the disease.

Conventionally, the spread of tuberculosis to South America is attributed to invading Europeans in the fifteenth century. However, some recent studies suggest a different vector: seals.

In a new paper, Tim Sandle considers the different theories relating to the spread of the disease. For a copy of the short review, please contact Tim Sandle.

The reference is:

Sandle, T. (2014) The Possible Origins of Tuberculosis in South America, Journal of Ancient Diseases &
Preventive Remedies, 2 (2): 1-2

Posted by Tim Sandle

Tuesday, 7 October 2014

Microbes are a rich source of drugs,

Bacteria that normally live in and upon us have genetic blueprints that enable them to make thousands of molecules that act like drugs, and some of these molecules might serve as the basis for new human therapeutics, according to UC San Francisco researchers who report their new discoveries in the September 11, 2014 issue of Cell.

With the research, the scientists purified and solved the structure of one of the molecules they identified, an antibiotic they named lactocillin, which is made by a common bacterial species, Lactobacillus gasseri, found in the microbial community within the vagina. The antibiotic is closely related to others already being tested clinically by pharmaceutical companies. Lactocillin kills several vaginal bacterial pathogens, but spares species known to harmlessly dwell in the vagina.

This example suggests that there may be an important role for many naturally occurring drugs – made by our own microbes—in maintaining human health.

For further details, see Phys.Org.

Posted by Tim Sandle

ECA events

The ECA are running two events of interest:

1. PharmaLab 2014, including the Endotoxin and Pyrogen testing Conference, on, 19/20 November 2014 in Neuss/Düsseldorf, Germany –www.phamalab-congress.com

2. RMM Conference and Mycoplasma Testing Conference fro 09-11 December, Heidelberg, Germany www.rmm-conference.org

The European Compliance Academy (ECA) was founded on the 1st of January 1999 as an independent membership association and is today the leading European association with regard to pharmaceutical Quality Assurance and GMP compliance. Close to 4.000 members from all over Europe and abroad represent more than 60 countries.

Posted by Tim Sandle

Monday, 6 October 2014

Sterile Ophthalmic Preparations and Contamination Control

Ophthalmic preparations (eye preparations) are sterile liquid, semi-solid, or solid preparations that may contain one or more active pharmaceutical ingredients. Ophthalmic products are intended for application to the conjunctiva, the conjunctival sac, or the eyelids. The course of treatment may extend during several days. Although eye preparations contain a preservative, there is a probability of microbial contamination after the package sterility seal has been broken during the period of use.

In a new paper for the Journal of GXP Compliance, Tim Sandle considers the key elements relating to the manufacture of ophthalmic products from the perspective of microbial contamination control. Its focus is upon the aseptic dispensing of the products and environmental and technological requirements including blow-fill-seal filling and container sealing systems.

The reference is:

Sandle, T.  (2014) Sterile Ophthalmic Preparations and Contamination Control, Journal of GXP Compliance, 18 (3): 1-5

Posted by Tim Sandle

French pharmacists meet to discuss medicinal safety

This week over five hundred pharmacists from across France, and a splattering from the U.K., Switzerland and Germany, have been meeting to discuss the safety of medicines and improvements in administration of healthcare products.

The event took was organized by the French pharmaceutical society Gerpac and it took place from October 1 to 3, at Presqu’île de Giens, located in Hyères-les-Palmiers. Digital Journal was in attendance.
The conference had a primary topic of simulation for pharmaceutical preparation and also on risks for operators, including risk exposure when preparing unit oral dose. There was also ample space given to hot topics on pharmaceutical sciences and technology.
With the running theme on the safety of medicines, this was particularly notable from the opening session, entitled "Evaluation of working practice and chemical contamination - Oncology day care units", which was delivered by Rudolf Schierl and Bettina Kopp. In the session the pharmacists discussed the risks of chemical contamination from some of the most potent anti-cancer drugs to healthcare workers, as well as environmental risks. The conference noted that in the U.S., the pharmacopoeia was being updated to reflect chemical risks.
On a related subject, Thomas H. Connor from the U.S. presented on the latest guidance for the safe Handling of hazardous drugs. Dr. Connor, who works at the National Institute for Occupational Safety and Health, broadcast his season from the U.S. The interactive medium allowed delegates to ask questions.
The integrity of containers was also addressed during the conference. While this may seem like a given, medicines transferred from one container may react with the container in an adverse way, or there could be issues with microbial contamination that can affect the sterility of the medicine. A way to ensure that syringes filled with product are secure was outlined by Alison Beaney.
A view of the Gerpac conference from the top of the stage  looking down as delegates assemble.
A view of the Gerpac conference from the top of the stage, looking down as delegates assemble.
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On day two, Dr. Tim Sandle addressed the conference with regard to effective cleaning and disinfection. In this talk, Dr. Sandle stressed to delegates that disinfectants only work effectively if all traces of dirt and protein have been removed from a surface. Dr. Sandle went onto present the key criteria for selecting disinfectants and biocides and the best ways to measure their efficacy.


Another key theme at the conference was training, especially in ensuring that pharmacy technicians do not commit errors and that they are well versed in avoiding the cross contamination of medicines. These themes were covered in presentations delivered by Pascal Bonnabry (Geneva University Hospitals) and Sylvie Crauste-Manciet (Université de Bordeaux, France).
As well as talks, there was plenty of time for pharmacists and healthcare workers to mix and discuss in more relaxed settings, including a lively and frenetic disco.
Conventioneers at the Gerpac 2014 event  held at Presqu’ile de Giens  Hyères  France
Conventioneers at the Gerpac 2014 event, held at Presqu’ile de Giens, Hyères, France
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All round it was a pleasant, informative and enjoyable conference. Even some of the local wildlife seemed to enjoy it.
A seagull lands on the balcony at the Gerpac conference 2014  at the Presqu’ile de Giens  Hyères ...
A seagull lands on the balcony at the Gerpac conference 2014, at the Presqu’ile de Giens, Hyères, France


Posted by Tim Sandle

The Ebola crisis: economic legacy and continuing social consequences



An essay by Tim Sandle.

The Ebola virus epidemic has been making headlines around the world both in relation to the rising death toll amongst hundreds  of people from four African countries and a handful of international aid workers who have contracted the disease. Behind these headlines, and associated reports of medical 'wonder-cures', there a legacy of post-colonial under investment and interference from Western governments; whereas, the post-crisis situation could lead to weakened countries at enhanced risk of multinational exploitation.

This article briefly considers the Ebola viral disease and the extent of its destruction before considering how post-colonial actions have helped create weak healthcare systems and an infrastructure unable to cope with the unfolding crisis. While the article only provides some underdeveloped ideas for building an alternative way forwards, the text highlights areas where economists and scientists can provide analysis that could be of help to those seeking to build alternative political movements within the affected states.

The Ebola viral disease

Ebola virus disease (EVD) or Ebola hemorrhagic fever (EHF) (henceforth "Ebola") describes the human disease which is caused by any of four of five known Ebola viruses. The name of this grouping comes from Ebola River in Republic of the Congo, near to where the first case of the virus was detected in 1976. Ironically this is the British name for the river, and thus a somewhat a chilling reminder of the lasting legacy of colonial rule.

Ebola is an unpleasant disease. After an incubation time that can stretch to twenty-one days, one of the common signs of the disease is bleeding from mucous membranes and puncture sites. If the infected person does not recover, death due to multiple organ dysfunction syndrome occurs (1). Unlike many other of the major global diseases there is no vaccine, no accepted treatment and the disease can be up to 90% fatal, although this present strain seems to be fatal in around 60% of those patients who exhibit symptoms. New Scientist of 9 August  quoted the mortality rates as 74% in Guinea, 54% in Liberia and 42% in Sierra Leone. With no actual treatment, survival mainly seems to be a function of the quality of medical and nursing care of the symptoms, mainly of fluid and electrolyte replacement. The huge problem is that without rigorous precautions, it is precisely those providing the care who are most at risk of infection themselves. This only goes to show the heroism of the ordinary health workers of the West African nations, and some western volunteers, who are to be seen in protective gowns, masks and goggles, trying their level best to contain the virus. Reuters described a nurse in Sierra Leone, working for hours at a stretch in full protective gear in tropical heat, as she and others worked to raise the odds in favour of her patients’ survival. Sadly, she had to give a false name, such is the fear generated by the virus. There have been reports from Liberia of landlords refusing to rent to nurses. Yet without the efforts of these workers, and of the charity Medecins Sans Frontieres, the virus would already have spread far and wide.



The epidemic has ravaged the west African region since it erupted in the forests in the south of Guinea early in 2014, killing almost 1,500 people and infecting thousands more. The virus is deeply entrenched in Guinea, Liberia, Nigeria and Sierra Leone. Of these states, the worst hit is Liberia where Ebola has seemingly stretched into every corner. Deaths in Liberia account for around one third of the total.

The ongoing Ebola outbreak in West Africa is so serious that the World Health Organization (WHO) has declared the situation a "Public Health Emergency of International Concern" (PHEIC) (2). This is only the third time that such a status has been activated. The main focus in the mainstream media has been upon expensive potential pharmaceutical treatments, such as ZMapp, or upon more desperate sounding convalescent serum treatments. With drugs like ZMapp, even if they work on a large scale there is little chance of the medications being mass produced in time to deal with the current outbreak, even assuming that the African states or the people affected could afford them - which they cannot (3). The alternative treatment using convalescent serum -that is serum obtained from one who has recovered from an infectious disease and considered to be especially rich in antibodies against the infectious agent of the disease - was last tried in 1995 in an Ebola outbreak in Kikwit in the Democratic Republic of the Congo (4). However, the medical evidence pertaining to the success of this type of treatment is contested between scientists.

Ebola is a zoonotic disease. Exactly how the virus transferred to the human populace is linked to bats being the vector (5). This long-established fact that has led to some western-centric cultural critics deriding Africans for continuing to eat fruits bats whilst ignoring the evidence that this is not the primary cause for the viral spread (see, for example, The Guardian  - "Ebola risk unheeded as Guinea's villagers keep on eating fruit bats" (6)).

Economic legacy and weakened health systems

How viral diseases evolve, whilst of interest, is not the subject here. What is important for scientists to appreciate is how economic conditions can create conditions that allow a virus like Ebola to spread and how prevailing conditions affect the robustness of states to respond to such crises.

That economic conditions have a causative role in the spread and response to the current epidemic has been featured in two recent reports. The first report, from Business Monitor, suggests that efforts to contain the outbreak have been hampered by weak state capacity, lack of public funding and poor health infrastructure (7). In essence, all affected countries do not possess the requisite state resources and capacity to adequately manage the outbreak. Although the report draws its arguments from a free-market perspective, the analysis describes institutional weakness, widespread corruption and weak government finances and capacity to act as factors that are constraining the ability of governments and foreign aid agencies to respond effectively to the situation. Moreover, a limited government ability to take command in rural areas, where the majority of cases originate, is further impeding efforts to slowdown the spread of the disease. An economic analysis may well identify similar factors, although the prescription measures would be very different.




The decades of under-investment in the health systems of West African states is also covered in a report issued by the medical charity, The Wellcome Trust. The Trust has announced that it is donating a multimillion pound sum to help establish a non-governmental organization called  "Enhancing Learning and Research for Humanitarian Assistance" (ELRHA). The primary purpose of ELRHA is to build a research community. The Trust argues that because of decades of under investment in medical research the affected countries do not have a viable scientific research community capable of developing home-grown potential drug treatments to Ebola and other diseases (8).
The poorly-conceived health systems and weak scientific culture are a consequence of the colonial legacy and trajectory of post-colonial development. Intermixed with some early flawed periods of state socialism; and followed by dictatorships, political corruption and military coups; and ending with  fragile capitalist democracies, the post-colonial years have ended with West African nations seeing Western governments and global monetary institutions impose an onerous debt regime. This has forced these countries to pay more in interest on debts to the World Bank and International Monetary Fund (IMF) than they spend on healthcare, education, or infrastructure (9). Furthermore, much aid has been in the form of Structural Adjustment Programmes (SAP), orientated towards projects that have not often been for the good of the populations; and where projects, both good or bad, have carried with them the price of debt servicing burdens and tie-ins into regressive international trade.

The effect of structural reforms on healthcare has led to a lack of primary care, few healthcare campaigns aimed at health protection or health promotion, systems that do not extend into the more economically deprived areas, and the chilling hold of private corporations.

In Guinea, for example, the Bamako Initiative of 1987 led to a shift towards a fee-paying healthcare system leading to many treatments being beyond the reach of ordinary citizens. The Bamako Initiative was drawn up in collaboration with the World Bank and led to the decentralisation of healthcare across Benin, Guinea and Nigeria (10). The decentralised system has arguably hindered the ability to formulate an effective national plan against Ebola. In Sierra Leone free healthcare only extends to pregnant and breast-feeding women and children under five (11).

Other health statistics indicate why the West African states have struggled to contain the Ebola. Guinea spends only $62 per person on health each year, compared with $3,364 in the U.K. Guinea has the lowest number of hospital beds per capita in the world. Sierra Leone has just two doctors per 100,000 people, compared with 245 in the U.S. Nigeria too has experienced a lack of medical personnel. It is estimated that as many Nigerian doctors are practising in the U.S. alone as there are working in the whole Nigerian public service (12).

Furthermore, post-colonial economic management by West African governments in thrall of western capital has led to decentralised health systems and collaborations with private multinationals. These reforms have further hindered the ability of the governments to respond effectively to the crisis. Moreover, the countries contain internal divisions and competing power blocks; without intending to oversimplify, the separations of language, religion, and ethnic groups have been exacerbated by post-colonial policies that have widened economic inequality and orientated healthcare towards the cities and away from the countryside. It is in the poorest regions, outside of the cities, where Ebola is most concentrated.



There is also a legacy of mistrust against health workers from the West. When much of the continent was under colonial rule, colonial powers used African outposts as their laboratories, and Africans as their test subjects. This accounts for a level of fear and suspicion, and an appreciation of this is important for the voluntary workers engaged in the affected countries. The extent that the populations feel helped or exploited at the end of the crisis will help modify whether this suspicion of the outsider is enhanced or attenuated.

The myth of international aid


It could be taken from some  reported news stories that money is flooding into West Africa as a result of the Ebola epidemic. While some funding has been sent through, the level of support and aid going into the west African nations is not as great as the global media implies. With the WHO, for example, the United Nations body's budget for outbreaks and crises has declined by 35% since 2010. In July 2014, WHO estimated that $103 million was needed to continue the fight against Ebola. Nevertheless, the Agency only has a fifth of that available and it faces a gap of $79 million. Moreover, a decline in aid and support in the years leading up to the current Ebola epidemic have arguably laid down some of the foundations for sluggish ability of the African governments to respond.

Whilst a number of aid agencies have sent out health workers and charities have transferred donations, the levels of money provided by the governments of the West and the major global institutions fall far short of what is needed. Again the veneer of rhetoric needs to be stripped away. The World Bank has stated that it will devote up to $200 million to fight Ebola; however, most of this will be drawn from funds already allocated to the affected countries. It also stands that this aid comes with a string of policies that must be applied (continuing with the SAP initiatives, as discussed above).

Economic impact and the continuing hold of the multinational

The economic impact of Ebola on the affected states is considerable. With the internal economy, a combination of cases of infection and a fear of the virus  appear to have had an equivalent impact to that of an environmental disaster. Crops rot in the fields, mines are abandoned and goods cannot get to market. In quarantined zones in Sierra Leone and Liberia, key cash crops such as cocoa and coffee have been left rotting in the fields as farmers fear to stray far from home. Agricultural issues are not only confined to exports. In township markets, supplies of staple commodities such as rice are already dwindling, with only the bravest traders willing to venture far afield to buy stocks.

Rather than address the fall-out, several of the actions of the African governments have been directed to appeasing international capital management. This is the basis of a charge made by Amadou Soumah, a trade union official in Guinea. It was only during mid-August that Guinea declared Ebola to be a national emergency. This is despite the country being at the epicentre of the outbreak, with the first cases reported in March 2014.  Soumah argues that the government played down the crisis "to stop investors fleeing" (13).

Despite of the attempts by some African government to micro-manage the crisis, the economic response from the multinational firms has been to protect their interests.  Several multinational companies have suspended operations. For example, Steel giant ArcelorMittal, headquartered in Luxembourg, has halted work at its iron ore works in Liberia and has withdrawn its executives. Having exploited the region for decades, the company seems to have no inclination to offer economic support. To take a different example, several international airlines have halted their flights to West Africa. These reactions are likely to have a long-lasting impact on the national economies, a point noted recently by the president of the African Development Bank, Donald Kaberuka (14).




In other cases, the multinationals are staying put. There are no signs that the epidemic has affected the economically vital oil industry, mainly because the African governments and multinationals are working hard together to ensure continuity. Taking Nigeria, where the multinational oil companies have for many years collaborated with the government to exploit a region in southern Niger Delta that lies about 600 miles from Lagos. In this region, there have been as many cases of Ebola as they have been in areas where agricultural commodities predominate. However, with these oil rich areas the Nigerian government has provided support, in terms of supplies, resources, and it has erected barriers to create a quarantine zone, protecting the oil drilling activities of Royal Dutch Shell and Chevron Corporation from the main parts of the country. West Africa sits atop 15 percent of the world’s oil (15) and this is far too profitable an operation to be interrupted by illnesses afflicting the local populace.

The crisis also carries with it the risk of further liberalisation of the economies of the affected countries and thus more opportunities for multinationals to move in once the crisis is over. The African Development Bank, which is locked into the global financial system, has provided loans and is proposing a greater injection of capital to West Africa. The problem is that these are tied loans in a similar way to money advanced by the World Bank. Here capital is orientated towards particular projects aimed at diversifying the economy and cementing damaging public-private partnerships.

On the political front the crisis presents opportunities for governments to strengthen authoritarianism. For example, in the worst affected country Liberia, President Ellen Johnson Sirleaf, of the right-wing Unity Party, has ordered night time curfews and quarantine zones in the most economically deprived areas in the country, including Monrovia's West Point slum and Dolo Town, to the east of the capital.

Another fall-out from the crisis that could have longer-lasting repercussions is the effect on pan-African unity for some underlying historical fractures have been re-opened. Several West African nations have sealed their borders with their neighbours in attempts avoid cross-infection. This could lead to countries leaning more towards the international capital rather than engaging in cross-national trading, getting further indebted in the process. An alternative would be to build a pan-African union based on greater self-sufficiency and less dependence upon the invasive multinationals.

The way forwards

There are no immediate solutions to the Ebola crisis other than supporting the work of aid agencies and health care workers. Once the epidemic has declined, and hopefully the risk of pandemic does not rise, then what matters is helping the West African nations to build effective healthcare systems on a central model and free from interference from global finance. These healthcare systems need to be properly staffed, with well-supplied clinics, and free at the point-of-use. Behind this a scientific foundation is needed so that African nations can develop appropriate medicines and become less reliant upon global pharmaceutical companies. For instance the only reason why there is any treatment at all in the pipeline, Tekmira’s TKM trial drug, is that the US Department of Defense funded the work. There is little profit for big pharmaceutical corporations in a drug to treat intermittent virus outbreaks, especially in the world’s poorest countries. There is a lot more money in drugs, like Simvastatins, that people will take for decades for less serious conditions in the richer countries of the world. Even New Scientist was moved to comment on ‘market failure’. Home grown science and infrastructure would help these countries handle not just outbreaks of Ebola, but more common diseases such as malaria, cholera and HIV. To do so requires governments willing to consider central solutions and to steer economies in alternative directions from capitalism.

Summary

This article has attempted to place the Ebola crisis into a historical and economic context. Part of the reason for the deficiencies in containing the spread of the disease is a consequence of a failure during the post-colonial years to have built up a strong socialised health care system, and where the elements of it existed, to dismantle it; a secondary reason is the bias of major programmes to attract investors rather than developing the infrastructure necessary to build up the affected countries .

Scientists need to analyse the events of the past and examine the internal and external influencing  factors on post-colonial development; and then to use this inquiry as a means to help develop an alternate socio-economic trajectory. The very real risk is, with a crisis still unfolding and the death toll rising, that governments will extend their hands further out to the multinationals and international capital will increase its hold on West African states even more tightly than before.

In the short term we should insist that the resources necessary to contain Ebola are found. Instead of voting for $225 million to fund the Israeli state’s ‘Iron Dome’, the US Congress should have sent that money to West Africa . The health workers of West Africa must be honoured and supported not feared and taken for granted. The UK health unions must find a way to get money to their west African colleagues to ensure they are looked after and have full trade union rights

References

1. Heymann, D.L. et al (1980) Ebola hemorrhagic fever: Tandala, Zaire, 1977-1978, J Infect Dis. 142(3):372-6
2. WHO Statement on the Meeting of the International Health Regulations Emergency Committee Regarding the 2014 Ebola Outbreak in West Africa, issued on 8th August 2014: http://www.who.int/mediacentre/news/statements/2014/ebola-20140808/en/
3. Sandle, T. (2014) Ebola, experimental drugs, and human ethics, Digital Journal, 9th August 2014: http://www.digitaljournal.com/science/ebola-experimental-drugs-and-human-ethics/article/395978
4. Mupapa, K. et al (1999) Treatment of Ebola Hemorrhagic Fever with Blood Transfusions from Convalescent Patients, J Infect Dis. 179 (Supplement 1): S18-S23
5. van der Poe, W.H., Lina, P.H. and Kramps, J.A. (2006) Public health awareness of emerging zoonotic viruses of bats: a European perspective, Vector Borne Zoonotic Dis. 6(4):315-24
6. Anon. "Ebola risk unheeded as Guinea's villagers keep on eating fruit bats", Guardian Online, 4th August 2014: http://www.theguardian.com/global-development/2014/aug/04/ebola-risk-guinea-fruit-bats
7. Business Monitor International (2014) "Economic Analysis-Full Impact of Ebola Yet To Be Felt", issued on 7th August 2014: http://msgfocus.com/files/amf_bmi/workspace_18/Full_Impact_of_Ebola_Yet_to_be_Felt.pdf
8. Statement by The Wellcome Trust, issued 21st August 2014: http://www.wellcome.ac.uk/News/Media-office/Press-releases/2014/WTP057171.htm
9. Bond, P. (2006) Looting Africa: The Economics of Exploitation, London: Zed Books, p2
10. World Bank. "Spotlight on the Bamako Initiative", World Development Report 2004, pp76-77. At: http://dx.doi.org/10.1596/082135468X_Spot_Bamako
11. USAID (2013) Post-Conflict Health Sector Reform. At: http://www.healthsystems2020.org/section/where_we_work/liberia
12. Anekwe, M.C. (2003). "Brain Drain: The Nigerian Experience",. Niger Delta Congress. At: http://www.nigerdeltacongress.com/barticles/brain_drain_the_nigerian_experie.htm
13. Business Report "Ebola taking toll on west Africa’s economy", 24th August 2014: http://www.iol.co.za/business/news/ebola-taking-toll-on-west-africa-s-economy-1.1740059#.U_od8fmwJcQ
14. African Development Bank Fund. "$210 million response: AfDB steps up efforts to curb Ebola outbreak in West Africa", 19th August 2014: http://www.afdb.org/en/news-and-events/article/210-million-response-afdb-steps-up-efforts-to-curb-ebola-outbreak-in-west-africa-13437/
15. KPMG (2013) "Oil and Gas In Africa" https://www.kpmg.com/Africa/en/IssuesAndInsights/Articles-Publications/Documents/Oil%20and%20Gas%20in%20Africa.pdf



Posted by Tim Sandle

Sunday, 5 October 2014

One in 25 Patients End Up with Hospital-Acquired Infections

According to a Health Grades Hospital Quality in America Study, the incidence of medical harm occurring in the United States is estimated to be over 40,000 harmful and/or lethal errors each and every day.

Hospitals have become particularly notorious for spreading lethal infections. According to the most recent report by the US Centers for Disease Control and Prevention (CDC), hospital-acquired infections now affect one in 25 patients.

In 2011, an estimated 722,000 patients contracted an infection during a stay in an acute care hospital in the US, and about 75,000 of them died as a result of it.

That amounts to just over 205 deaths from hospital-acquired infections every day of the year! More than half of all hospital-acquired infections were contracted outside of the intensive care unit. The most common hospital-acquired infections include:
  • Central line-associated bloodstream infections
  • Catheter-associated urinary tract infections
  • Surgical site infections after surgery
  • Clostridium difficile infections

For further details see: “Multistate Point-Prevalence Survey of HealthCare–Associated Infections”.

Posted by Tim Sandle

Saturday, 4 October 2014

Bacteria harbour secret weapons against antibiotics

In the paper, researchers from Princeton University in New Jersey describe how they observed two similar strains of E. coli bacteria quickly developing similar levels of antibiotic resistance using surprisingly different genetic mutations. Developing different solutions to the same problem shows the bacteria have a diverse arsenal of genetic "weapons" they can develop to fight antibiotics, potentially making them more versatile and difficult to defeat.

The research team used a custom-made microfluidic device that contains approximately 1,000 connected microhabitats in which populations of bacteria grow. The device generates complex gradients of food and antibiotic drugs similar to what might be found in natural bacterial habitats like the gut or other compartments inside a human body.

By sequencing the genomes of wild type and GASP bacterial colonies that has been exposed to the antibiotic ciprofloxacin (Cipro), the researchers found different genetic mutations could lead to similar levels of antibiotic resistance. For example, two different mutant strains emerged: one of the antibiotic-resistant GASP strains evolved in such a way that it no longer needed to make biofilms in order to survive stress. It did so by "borrowing" a piece of leftover DNA from a virus that infects bacteria. The other strain did not do this excision, indicating that in evolution the strains can hedge their bets.

Viruses routinely inject their own DNA into bacteria and sometimes DNA sequences remain that no longer seem to have any function in terms of viral replication. Under normal circumstances the leftover DNA may neither help nor hinder the bacteria, but in times of stress the bacteria can use the new DNA to rapidly evolve antibiotic resistant mutations.

The results demonstrate the diversity of the tools that bacteria have to fight stress.

For further details see:

Qiucen Zhang, Julia Bos, Grigory Tarnopolskiy, James C. Sturm, Hyunsung Kim, Nader Pourmand, and Robert H. Austin. You cannot tell a book by looking at the cover: cryptic complexity in bacterial evolution. Biomicrofluidics, 2014 DOI: 10.1063/1.4894410

Posted by Tim Sandle

Friday, 3 October 2014

FDA: List of Guidance Documents



FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. This document provides a concise overview of the status of various guidelines that are currently in process: 
  • CDER List of Guidance Documents
  • CDER Guidances new, revised, withdrawn (January 1 - June 30, 2014)
For details, see FDA

Posted by Tim Sandle

Thursday, 2 October 2014

Study finds reduced hospital-acquired infection rates with ultraviolet disinfection

In a retrospective study, rates of hospital-acquired infections caused by multidrug-resistant organisms (MDRO) or Clostridium difficile decreased when an ultraviolet environmental disinfection (UVD) system was used after routine discharge cleaning of contact precautions rooms and other high-risk hospital areas.

A 20% decrease in hospital-acquired MDRO and C difficile rates was observed during the 22-month period of UVD use compared with the 30-month pre-UVD period (2.14 vs 2.67 cases per 1,000 patient-days; P < .001.

Hospital-acquired infections are caused by viral, bacterial, and fungal pathogens; the most common types are bloodstream infection (BSI), pneumonia (e.g., ventilator-associated pneumonia [VAP]), urinary tract infection (UTI), and surgical site infection (SSI).

For further details, see:

Nierengarten M. Ultraviolet Disinfection Cuts Hospital-Acquired Infections. Medscape Medical News.

Haas JP, Menz J, Dusza S, Montecalvo MA. Implementation and impact of ultravioletenvironmental disinfection in an acute care setting. Am J Infect Control. Jun 2014;42(6):586-90

Posted by Tim Sandle

Wednesday, 1 October 2014

New antifungal: isavuconazole

A newly developed antifungal, isavuconazole, is as effective as an existing drug, voriconazole, against invasive mold disease in cancer patients with less adverse effects, according to phase 3 clinical data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology.

Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed by Astellas and Basilea Pharmaceutica International Ltd. for the treatment of life-threatening invasive fungal infections.

For further details, see ASM

Posted by Tim Sandle

Tuesday, 30 September 2014

New ISO 14644 Part 2 – draft



A new draft of the international cleanroom standard ISO 14644 Part 2 has been produced. The draft is open for public comments. The title of the standard is: “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration”.

ISO 14644-2 specifies the requirements of a monitoring plan, based on a risk assessment of the intended use. The data obtained provide evidence over time of continuing cleanroom or clean zone performance related to air cleanliness by particle concentration (ACP).

Copies of the draft are available from national standards agencies.

Posted by Tim Sandle

Monday, 29 September 2014

Quality Control of Hospital Water Systems

Water quality in hospitals, whether for haemodialysis, decontamination washers, clean sterilizer reuse, floor cleaning, analyser equipment, food service, or the boiler room, is of great importance as the water carries a microbiological risk. Certain microorganisms in hospital water can cause nosocomial infection.

In relation to this subject, Tim Sandle has written an article for The Clinical Services Journal in relation to the quality control of hospital water systems.

The reference is:

Sandle, T. (2014) Quality Control of Hospital Water, The Clinical Services Journal, 13 (8): 47-51

For further details, see Clinical Services Journal.

Posted by Tim Sandle

Sunday, 28 September 2014

EU Commission publishes revised EU GMP Guide Chapters 3 and 5

The EU Commission has revised versions of chapter 3 "Premises and Equipment" and 5 "Production". The new chapters are effective from 1 March 2015.

With chapter 3, the stated change is: “Reasons for changes: The only change is to section 6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5.”

With chapter 4, the stated change is: “Reasons for changes: Changes have been made to sections 17 to 21, including adding a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment. Changes were also introduced in sections 27 to 30, including adding a new section, on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Sections 35 and 36 are inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section 71 introduces guidance on notification of restrictions in supply.”

For chapter 3, see: Chapter 3
For chapter 4, see: Chapter 4

Posted by Tim Sandle

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