WHO interim guidance on the use of delamanid in the treatment of MDR-TB

28 Oct, 2014


Barcelona | 28 October 2014| A new TB drug with a novel mechanism of action – delamanid – is now available for treatment of adults with multidrug-resistant tuberculosis (MDR-TB), a form of tuberculosis resistant to at least isoniazid and rifampicin, the main first-line drugs. Delamanid was granted conditional approval by the European Medicine Agency in April 2014. Information about this new drug however remains limited, since it has only been through Phase IIb trial and studies for safety and efficacy. WHO is therefore issuing “interim policy guidance” that lists five conditions that must be in place if delamanid is used to treat adults with MDR-TB:

  • Proper patient inclusion: Special caution is required when delamanid is used in people aged 65 and over, in adults living with HIV, patients with diabetes, hepatic or severe renal impairment, or those who use alcohol or substances. Use in pregnant and breastfeeding women and children is not advised.
  • Adherence to WHO recommendations when designing MDR-TB treatment regimens: When delamanid is included in treatment, all principles on which WHO-recommended MDR-TB treatment regimens are based must be followed, particularly the inclusion of four effective second-line drugs as well as pyrazinamide. Delamanid should not be introduced alone into a regimen in which the companion drugs are failing to show effectiveness.
  • Effective treatment and monitoring: Treatment must be closely monitored for effectiveness and safety, using sound treatment and management protocols that have been approved by the relevant national authorities.
  • Pharmacovigilance and management of adverse events: active pharmacovigilance measures must be in place to ensure early detection and proper management of adverse drug reactions and potential interactions with other drugs.
  • Informed consent: Patients must be fully aware of the potential benefits and harms of the new drug, and give informed consent before embarking on treatment

WHO strongly recommends the acceleration of Phase III trials to generate a more comprehensive evidence base to inform future policy on delamanid. WHO will review, revise, or update the interim guidance as additional information on efficacy and safety become available. WHO has also developed an operational document to facilitate delamanid implementation and is working with partners to help ensure safe and effective introduction. More information about the practicalities of using delamanid alongside other old and new anti-TB drugs can be found in the updated WHO guidance “Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis”.

WHO estimates that about half a million new cases of MDR-TB occur worldwide, each year. Current treatment regimens for MDR-TB present many challenges: treatment lasts 20 months or more, requiring daily administration of drugs that are more toxic, less effective, and far more expensive than those used to treat drug-susceptible TB. Globally, less than half of all patients who start MDR-TB therapy are treated successfully. Wider availability of new drugs and shorter regimens will be essential if treatment outcomes of MDR-TB patients are to improve.

In 2013, another new drug, bedaquiline, was made available for use in the treatment of MDR-TB. Bedaquiline was the first new TB drug with a novel mechanism of action to be made available for more than 40 years and was granted accelerated approval by the United States Food and Drug Administration. It is still in Phase III trials and WHO urges caution in its use and strict adherence to conditions listed in the WHO interim policy guidance issued in June 2013.


Sierra Leone: for Ebola survivors the pain goes on

29 Oct, 2014


As the Ebola outbreak grows and spreads, a small but significant group of people is also growing – the Ebola survivors. Emerging shell-shocked from what one described as a “glimpse of hell”, the survivors have not found life easy on the other side of the Ebola ward.

Three woman that survived Ebola virus disease at the Survivors’ Conference in Kenema, Sierra Leone, 2014.

WHO/S. Gborie
Ebola survivors tell their stories at the Survivors’ Conference in Kenema, Sierra Leone.

Some in the community brand them as “witches” for surviving. For many, the faces they longed to see again while lying in the Ebola ward are no longer there. Husbands, wives, children, brothers, sisters, mothers and fathers have all been carried off to unmarked graves by Ebola virus disease.

“I am learning to live a new life in the home without my husband and my 2 children. Now there is so much emptiness in the house especially at night,” said Fatimata Gaima who clung to life in the hospital desperate to get home to care for her three year old.

However, as she recovered, her worst fears came true. Her last child was brought to the hospital ward, tested positive for Ebola, and died a few days later.

Survivors gather in Sierra Leone

Ms Gaima told her story to others in a small focus group at the first Ebola survivors conference organized by UNICEF and GOAL, humanitarian agency, in Kenema, one of the areas where the Ebola outbreak first exploded in Sierra Leone. The meeting aimed to identify the needs of survivors – physical, mental, social and economic – and help them to consider how they might contribute to battling the Ebola virus outbreak in Sierra Leone.

Services for survivors are gradually emerging. At one post-Ebola clinic, set up to deal with survivors’ psychological and social needs, it has become evident that physical after-effects of the disease are among the most pressing problems Ebola survivors face.

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“I am learning to live a new life in the home without my husband and my two children.”

Fatimata Gaima, Ebola survivor in Sierra Leone

“We are seeing a lot of people with vision problems,” says Dr Margaret Nanyonga, psychosocial support officer for the World Health Organization in Kenema. “Some complain of clouded vision, but for others the visual loss is progressive. I have seen 2 people who are now blind.”

Dr Nanyonga said that people with what she calls “post-Ebola syndrome” have a range of symptoms. These have been seen in survivors of previous outbreaks and cause long-term disability. Apart from visual problems which affect approximately 50% of Ebola survivors in Kenema, people complain of “body aches” such as joint, muscle and chest pain. They also suffer headaches and extreme fatigue, making it difficult to take up their former lives – especially if it involved manual work – as farmers, labourers and housewives.

Portrait image of Fatimata Gaima, Kenema, Sierra Leone 2014.

WHO/S. Gborie
Fatimata Gaima at the Survivors’ Conference,
Kenema, Sierra Leone.

Need for more information on post-Ebola syndrome

“We need to understand why these symptoms persist, whether they are caused by the disease or treatment, or perhaps the heavy disinfection,” says Dr Nanyonga who has developed an assessment tool that will be used to establish the most common and disabling symptoms and what can be done to help survivors with these problems.

Dr Andrew Ramsay, field coordinator for WHO in Kenema, says it is essential that potentially disabling physical and psychological problems be diagnosed and, where possible, treated as quickly as possible.

“Eye problems might be caused by damage to the cornea, to the nerves or something else. At this point we do not have enough information to know exactly what is going on. But we need to find out urgently so we can do whatever we can to preserve the eyesight for people who have to try to pick up their lives again.”

iBulletin 141017

17 Oct, 2014



Dear Members

We, at the Malaysian Pharmacists’ Family, are in a jubilant mood as we share our triumph of the recently concluded 25th FAPA Congress 2014 which was held from 9 – 12 October 2014. Words cannot fully describe the gratitude we feel about the HUGE contributions of pharmacists to the success of the Congress.

The biennial Congress held in Kota Kinabalu was hosted by The Federation of Pharmaceutical Associations and organized jointly by The Malaysian Pharmaceutical Society and The Pharmaceutical Services Division of the Ministry of Health with the Sabah Pharmaceutical Society as the Local Organizer. There were altogether 37 official meetings over the last four years with many side meetings. All sectors of the fraternity chipped in by way of financial, physical, emotional and spiritual support, amongst others.  As Organizing Chairman, I want to say a BIG THANK YOU to EVERYONE. Your valuable contribution will forever be cherished and appreciated.

Altogether over 1200 participants came from 23 Countries with 142 volunteers who helped. The young pharmacists and students gave us a lot of physical support. We are so proud of our younger generation of pharmacists. Our pharmacy profession has a bright future to look forward to with such quality pharmacists.

The entire Pharmaceutical Services Division, Ministry of Health including Sabah Health Department, the Universities including University Malaysia Sabah (UMS) the pharmaceutical industry including PhaMA, MOPI and MAPS, the Government Agencies including the Federal Ministry of Tourism and Culture, the State Government, the Sabah Ministry of Tourism, Culture and Environment, Sabah Economic Development and Investment Authority (SEDIA) Kota Kinabalu City Hall,  MOSTI, Sabah Ministry of Industrial Development, Sabah Foundation to name a few were solidly behind the Organizing Committee. The FAPA Member Countries, MPS, SPS, the MPS Secretariat and the local agencies like the event organizer Sri Pelancongan Sdn Bhd, Harry Sound and Lights, Angkatan Hebat Sdn Bhd the logistics specialists, Sabah Police, Immigration and Customs Departments and many others formed the formidable organizing team. All our sponsors, donors and exhibitors gave us the resources to organize.

The scientific papers were all of a very high standard with 23 notable speakers from Countries in Asia and was as far as United Kingdom and Iran. Our very own Health Minister, YB Datuk Seri Dr S Subramaniam gave an outstanding keynote address. We are lost for words as we relive our proud moments thinking of our Wonderful Country – Malaysia and its Beautiful People.

No success can be attributed to any single entity. Do ask for a copy of Programme Book from the MPS Head office to see the long list of heroes and heroines behind the success.

The Malaysian Pharmaceutical Society is very proud of you all.

May you be richly blessed.

Yours in MPS

(Datuk Nancy Ho)
President Cum Organizing Chairman of 25th FAPA Congress 2014

– See more at: http://www.mps.org.my/newsmaster.cfm?&menuid=37&action=view&retrieveid=3946#sthash.UHnuzYBT.dpuf

iBulletin 141003

3 Oct, 2014



Dear Members,

The “Final Countdown” for 25th FAPA Congress 2014 has now JUST began! We are counting our days before the curtain rises on the Congress. The “red carpet” is being rolled out to welcome all delegates.

Thanks to the Pharmaceutical Services Division under the Ministry of Health and all in the Pharmacy fraternity, we have surpassed our target of 1200 registration!. The support rendered is truly amazing! A big “THANK YOU” to everyone. Our corporate leaders’ from the pharmaceutical industry have also lent a helping hand in the sponsorship. Many have come forward to offer a word of encouragement and volunteered their help. The members of the Organizing Committee have gone on the overdrive to ensure that the stage is set and that no STONE is unturned.

The “World Pharmacists Day” was celebrated with the limelight turned on the Pharmacists throughout the Country. Thank you for doing us proud!

Pharmacists, let us keep the banners flying high and our head held high.

See you at 25th FAPA Congress 2014!

Yours in MPS

(Datuk Nancy Ho)

– See more at: http://www.mps.org.my/newsmaster.cfm?&menuid=37&action=view&retrieveid=3943#sthash.sfZcMMtP.dpuf

Campaign highlights services provided by pharmacists

28 Oct, 2014


The launch of a public advertising campaign highlighting the range of professional services being delivered by Australia’s pharmacists has been welcomed by the Pharmaceutical Society of Australia.

The Pharmacy Guild of Australia campaign, “Discover more. Ask your pharmacist” encourages Australians to learn more about the services provided by pharmacists.

National President of the PSA, Grant Kardachi, said the campaign higlighted the need for a greater emphasis to be placed on professional services in the next Community Pharmacy Agreement.

“As detailed in the PSA 6CPA discussion paper released a few weeks ago, pharmacist professional programs funding, as a proportion of total CPA funds has actually declined from 4.9% (4CPA), to 4.1% in the current CPA,” Mr Kardachi said.

“If we are to see more of the services detailed in the advertising campaign, then this amount will need to significantly increase.

“Some of the services focused on in the advertising campaign are among the areas which PSA has long advocated, and are critical to improving patient health outcomes.

”I’m pleased to see the campaign picks up on PSA’s previous Federal Budget submission on the need for transitional care from hospital to after-hospital care to provide better care for patients during this critical time.

Mr Kardachi said that not every pharmacy currently delivered all the services detailed in the advertising campaign, and that an urgent focus was needed to help pharmacies transition to a health-focused and more financially stable model of pharmacist care.

“PSA has developed a solution to help pharmacies move toward this “health hub” model through the Health Destination Pharmacy program pilot.

“The Health Destination Pharmacy pilot showed significant professional and business improvements for the pharmacies involved, and most importantly, improved patient satisfaction and health outcomes.”

The next stage of Health Destination Pharmacy program, incorporating results and lessons from the pilot, would be launched in the near future.

“This program will offer great advantages for the pharmacist and consumer and I look forward to the next Community Pharmacy Agreement providing adequate and sustainable funding for professional service provision which is the basis of the program.”

Media contact:     Peter Waterman Public Affairs Director 0419 260 827

PSA Code of Ethics underpins consumer confidence in pharmacists

17 Oct, 2014


Pharmacists continue to rate highly with consumers and the latest customer satisfaction survey shows up 91 per cent of customers are happy with the service they receive from pharmacists.

The latest findings from Roy Morgan Research reinforce its survey earlier this year on the image of the professions which rated pharmacists second only to nurses in terms of ethics and honesty. Pharmacists received an 86 per cent rating against a 91 per cent rating for nurses.

In its customer satisfaction survey, Roy Morgan Research said: “In the year to August 2014, 50% of Australians 14+ (or 9,675,000 people) made at least one purchase from a chemist/pharmacy in an average four-week period. That’s a whole lot of customers – and for so many of them to be satisfied with the service they received speaks volumes for the high standards of this particular retail category.

“Pharmacies are heavily regulated by a range of codes and guidelines designed to ensure the customer’s wellbeing when buying pharmaceuticals. This no doubt contributes to the generally high customer satisfaction ratings across the main chemist chains, as well as the widely held perception of pharmacists as trustworthy and ethical.”

National President of the PSA, Grant Kardachi, said the high perception consumers had of pharmacists was reinforced by their operating to the PSA Code of Ethics.

“This Code is a very important body of work for the profession in that it articulates the values of the pharmacy profession and expected standards of behaviour of pharmacists to consumers and society,” Mr Kardachi said.

“The Code is made up of a number of principles covering five areas of focus which are core to pharmacists and pharmacy practice. These areas are the consumer, the community, the pharmacy profession, business practices and other health-care professionals.

“These principles apply to every pharmacist irrespective of their role, scope, level or location of practice. The application of ethics is not discretionary and I think the application of the code is being reflected in the latest Roy Morgan findings.”

Mr Kardachi urged pharmacists to display the code in their practices so that consumers could examine it.

“Transparency and pride in operating to the principles of the code can only further increase the stature of the profession as a whole and to individual practices that display the code,” Mr Kardachi said.

The code can be accessed at http://www.psa.org.au/membership/ethicsu

Media contact:     Peter Waterman Public Affairs Director 0419 260 827

PSA welcomes reappointment of George Tambassis as National President of Pharmacy Guild

16 Oct, 2014


The Pharmaceutical Society of Australia has welcomed the announcement by the Pharmacy Guild of Australia that George Tambassis has been re-elected as the organisation’s National President for a further three-year term.

National President of the PSA, Grant Kardachi, said the re-election of Mr Tambassis came at an important time with the Guild, PSA and the pharmacy profession now in the preparation phase of the next Community Pharmacy Agreement.

“This is a critical time for the pharmacy profession as a whole and to have a person of George’s stature remain at the helm of the Guild gives stability and future direction to the profession,” Mr Kardachi said.

“This stability is also necessary to ensure that the collaborative approach to the agreement produces the best outcomes for the profession and the community that pharmacists serve.

“PSA is an integral part of that collaborative process and we have always found George’s leadership to be pivotal in guiding the discussions forward in a positive and achievable manner.

“In my professional and personal dealings with George I have been impressed by his great passion for community pharmacy as well as his ongoing pragmatism as to the challenges the profession is facing.

“He has a very realistic approach as to what we as a profession need to do to work towards securing a sustainable and viable future.”

Mr Kardachi said Mr Tambassis was always open to discussion, collaboration and a whole-of-profession approach.

“PSA’s initiatives and ideas sit well with George’s enthusiasm and together I am confident we will continue our collaborative and cohesive approach to putting the profession in a strong position as we move forward,” Mr Kardachi said.

Media contact:          Peter Waterman Public Affairs Director 0419 260 827

PSA welcomes recommendations of Vic Govt committee inquiry into community pharmacy

14 Oct, 2014


The Pharmaceutical Society of Australia has welcomed the findings of a Victorian Government committee inquiry in community pharmacy which has formally recognised the role of the pharmacist in the community, while pointing to the potential for pharmacists to play a much greater role in improving health outcomes.

The report of the Legislative Council Legal and Social Issues Legislation Committee Inquiry into Community Pharmacy in Victoria found a proportion of general practitioner visits were for ‘less complex’ conditions, some of which could potentially be treated within a community pharmacy.

In particular, the committee made recommendations for pharmacists to administer adult vaccinations, triage minor ailments and continue to expand their role within the allied health team to improve the health outcomes of Victorians.

Victorian President of the PSA, Michelle Lynch, said the committee’s findings and recommendations support PSA’s view that pharmacists are currently under-utilised.

“Pharmacists have a wealth of skills and knowledge that can be better used within the health system,” Ms Lynch said.

“The committee recognised this and has made 17 recommendations which all incorporate better uses of pharmacists’ expertise.

“The committee has recommended that the Victorian Department of Health establish a pharmacy immunisation trial targeting adults and ideally commencing in time for the 2015 influenza season.

“PSA already has conducted a very successful pilot in Queensland which saw more than 10,000 people immunised by pharmacists and we look forward to assisting in implementation of such a pilot in Victoria.”

The committee also recommended that the Department of Health work with the Commonwealth Government and healthcare providers to pilot a minor ailments scheme in rural Victoria for selected and suitably trained community pharmacists.

Ms Lynch said pharmacists had long been involved in treating minor ailments and the PSA welcomed the suggestion that a formalised scheme be trialled for rural areas.

“These are all very targeted recommendations by the committee and PSA in Victoria looks forward to working with the Government, health authorities, stakeholders and consumers to help implement these recommendations and ensure the best possible outcomes for all consumers.” Ms Lynch said.

Media contact:   Peter Waterman
Public Affairs Director
0419 260 827

Pharmacist guide to cultural responsiveness with Aboriginal and Torres Strait Islander people

12 Oct, 2014


The importance of pharmacists and pharmacy staff being responsive to the health beliefs, practices, culture and linguistic needs of Aboriginal and Torres Strait Islander people, families and communities has been highlighted in a new guide officially launched at PAC14 in Canberra today.

The Guide to providing pharmacy services to Aboriginal and Torres Strait Islander people suggests all people working in this area undertake cultural responsiveness training.

National President of the PSA, Grant Kardachi, said a culturally safe environment was one in which people felt comfortable and respected.

“To make a pharmacy more culturally safe for local Aboriginal and Torres Strait Islander people, pharmacists should seek the advice of local community members as to how the pharmacy can be made more welcoming,” Mr Kardachi said.

“A culturally safe pharmacy may include such things as a sign that welcomes Aboriginal and Torres Strait Islander people or flags and local artwork.

“It might also have health resources specifically written for Aboriginal and Torres Strait Islander people and perhaps a private area to discuss medicines.”

Mr Kardachi said that often it was the pharmacy assistants who engaged most frequently with patients and so all pharmacy staff should undertake cultural awareness training.

These principles apply in any situation where pharmacists and staff provide services offsite, including visiting Aboriginal and Torres Strait Islander communities, health centres and remote locations.

”Staff should be trained in cultural responsiveness and it should be an important component of staff performance management reviews. Staff should also be encouraged to attend community events such as NAIDOC (National Aboriginal and Islander Day Observance Committee) events,” he said.

Mr Kardachi said The Guide to providing pharmacy services to Aboriginal and Torres Strait Islander people was an invaluable resource which covered cultural awareness and responsiveness, communication skills and relationship building.

Media contact:   Peter Waterman
Public Affairs Director
0487 922 176

PSA welcomes Dutton call at PAC14 to better utilise skills and expertise of pharmacists

12 Oct, 2014


Calls by the Minister for Health, Peter Dutton, for the health professionals to work together to improve patient outcomes have been echoed in a discussion paper released by the Pharmaceutical Society of Australia at the weekend.

In a message to delegates at PSA’s annual conference, PAC 14, Mr Dutton said the role of pharmacists, particularly around primary care, was evolving.

“PSA has been advocating for an enhanced role for pharmacists in primary healthcare and this is an area in which we all have a very keen interest,” Mr Dutton said.

“Pharmacists are already key players in coordinating and integrating care to improve patient health outcomes… the skills and expertise of pharmacists need to be better utilised and I am pleased there is a similar view across the health sector.”

Launching a Sixth Community Pharmacy Agreement discussion paper, entitled, Better health outcomes through improved primary care: Optimising pharmacy’s contribution, PSA National President Grant Kardachi called on all health professional organisations to join in the discussion.

Mr Kardachi said the next Agreement needed a strong focus on evidence-based pharmacist services focussed on meeting patients’ needs.

“Mr Dutton has strongly supported this approach and this paper provides an opportunity for health professionals and the public to comment on how pharmacists can help achieve this goal in a pragmatic and sustainable manner,” Mr Kardachi said.

“The Minister also commented on the positive approach taken by PSA in joining with the AMA to develop a more integrated role for pharmacists in primary health care, with particular reference to PSA’s talks with the AMA to integrate pharmacists into GP clinics as part of primary health care teams.

“Our paper is an important document that should be examined and commented on by health professionals across all sectors in Australia

“I urge all health professional to examine the paper and provide PSA with feedback and suggestions. We need to ensure this Agreement meets the expectations and needs of the health-consuming public and we can only achieve this by all sectors of the health profession working together with a common goal of improving the health of consumers.”

Media contact:   Peter Waterman

Public Affairs Director
0487 922 176