News in 1 Shot (June 2012)

Summary of WPPF News Update

Topic News

*

WPPF in the Asia Pacific Conference on National Medicines Policies (5/26~29)

1.

2012 Vol. 1 Edition of the IPJ is now online

2.

PAC12 opportunity for rural pharmacists

3.

[WHO]: Update June

4.

[NPS]: Updates June

5.

Pharmacists: the vital role

News

1.

[Publication – Forefront]: Issue 20~23

2.

Counselling guide for non-prescription medicines

3.

The Legislative Yuan Passed the Third Reading for Partial Amendment of Provisions in the Pharmaceutical Affairs Act, Strengthening Our National Drug Management System and Gearing It to the International Standards

4.

When the going gets tough…

5.

MPA website to foster clarity on the PBS

6.

[Youtube]: Why you should be at the Pharmacy Business Network

7.

Mackay pharmacist wins PSA QUM in Pain Management Award

8.

Obese people can seek help via phone

9.

[Publication -PSS eBulletin]: Issue No 81

 

 

International

1.

WHO-The future we want: a healthier planet

2.

WHO-WHO gives countries tools to help stop abuse of people with mental health conditions

 

 

Publication

1.

FIP – 2012 Vol. 1 Edition of the IPJ

 

 

Upcoming Event

1.

01.07.2012 – 31.08.2012
PSA-National Intern Training Program course

2.

03.07.2012 07:00 – 09.07.2012 23:30
11th APPS in Taiwan

3.

05.07.2012 – 07.07.2012
WPPF 2012 2nd Executive Meeting

4.

07.07.2012 – 09.07.2012
12th ACCP Conference

5.

16.07.2012
National Gathering of Pharmacy Students NOGAPS

 

 

Public Health

1.

N/A

 

 

PharmacyEducation E-learning

1.

NPS News 79: Headache – Diagnosing, managing and preventing

2.

NPS RADAR April 2012 

3.

NPS Prescribing Practice Review 58: Depression  

4.

eLearning @ NPS

5.

Australian PrescriberVolume 35 Number 3 – June 2012

 

 

 

WPPF in the Asia Pacific Conference on National Medicines Policies (5/26~29)

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From left, Dr Andrew McLachlan, Chairman of the Conference, Mr John Ware, President, WPPF and Executive member Mrs Myung Suk Park, Dr Klara Tisocki (newly appointed Regional Adviser in Pharmaceuticals, World Health Organization, Manila) and Executive member Mr Nobuo Yamamoto.

 

The Asia/Pacific National Medicines Policies Conference was held in Sydney, Australia 26-29 May 2012. The meeting was held under the auspices of WHO, Australian Government Department of Health and Ageing, supported by NPS Better Choices – Better Health, Australia’s independent quality use of medicines implementation body and the University of Newcastle, Australia.

 

Some 400 participants from right across the Asia/Pacific region attended and were given a wonderful opportunity for practising health professionals representing their non-government associations to meet and discuss problems and experiences with representatives of government. It represented a wonderful opportunity to –

 

Ø             Share knowledge, skills and experiences delegates have gained as they have moved to implement elements of their national medicines policy (NMP).

 

Ø             Determine the current priority elements of NMPs for implementation in participating countries

 

Ø             Understand the major enablers and barriers to NMP implementation

 

Ø             Consider an evaluation framework to monitor implementation of NMPs for the region

 

Ø             Strengthen networks and collaboration across the region.

 

The participants were welcomed by Dr Hank Bekedam, WHO, representing the Regional Directors of both South East Asia and Western Pacific regions of WHO.

 

Dr Budiono Santoso of WHO, Western Pacific, gave an overview of the state of implementation of National Medicines Policies both globally and in the Asia/Pacific region.

 

Professor Lloyd Sansom from Australia, introduced the discussion by describing the Australian experience in establishing and supporting a National Medicines Policy.

 

Speakers from China, Japan, South Korea, India, Indonesia, Malaysia, Thailand, Laos, Bangladesh, Sri Lanka, Vietnam and the Philippines, presented their national experiences in developing and supporting National Medicines Policies.

 

The meeting included workshops where all participants both organisational and government had the opportunity for input. These included medicine supply and distribution, generic medicine policies, antimicrobial resistance, monitoring medicines, monitoring medicine safety, advertising and promotion of medicines and the rational and quality use of medicines.

 

The meeting was a wonderful experience, both socially and workwise, enabling the rare opportunity for NGO health professionals to directly interact on an international basis with their government peers.

 

The Western Pacific Pharmaceutical Forum would like to express its appreciation to NPS and Dr Andrew McLachlan, Chairman of the Conference Committee, for facilitating such a worthwhile meeting.

 

Some of the speakers’ presentations are already available on the internet and may be accessed at   www.apcnmp2012.com.au/scientific-program

 

Further presentations made at the meeting will be advised when available and the full official report will be published on our website when completed.

[WHO]: Updates in June

Reference:

1. http://www.who.int/mediacentre/news/statements/2012/rio20_20120619/en/index.html

2. http://www.who.int/mediacentre/news/notes/2012/mental_health_20120615/en/index.html

1). The future we want: a healthier planet

Statement
19 June 2012

The United Nations Conference on Sustainable Development (Rio+20) offers the world an important opportunity to both acknowledge, and benefit from the inextricable links between human health and sustainable development.

Good health contributes to the achievement of sustainability goals

WHO estimates that 150 million people suffer severe financial hardship each year because they fall ill, use health services and have to pay for them on the spot. Many have to sell assets or go into debt to meet the payments. 100 million people are pushed below the poverty line for these reasons. Lack of access to health services impoverishes people because they cannot work; using health services impoverishes people because they cannot pay.

Protecting people from catastrophic expenditure and ensuring access to essential services through universal health coverage is thus an essential element of any strategy to reduce poverty and build resilient societies. Health has the potential to increase economic development, improve educational opportunities, empower women, reduce impoverishment and foster social cohesion.

Health is a beneficiary of sustainable development

A healthy environment is a prerequisite for good health. Reductions in air, water and chemical pollution can prevent up to one quarter of the overall global burden of disease. Cleaner energy policies could halve the number of childhood deaths from pneumonia and substantially reduce the one million people who die each year from chronic lung disease caused by indoor air pollution. Replacing biomass or coal stoves with cleaner stoves and fuels could help improve the health of up to three billion of the world’s poorest people.

As the world seeks to address the challenges posed by ageing populations, growing cities, increasingly mobile populations, competition for scarce natural resources, financial uncertainty, and a changing climate, it is no longer viable to think of solutions in terms of individual sectors. This calls for a greater policy coherence: for a move to address not only health in all policies, but environment in all policies too.

Health is a way of measuring the impact of sustainable development policies

Monitoring progress towards sustainable development means being able to evaluate the economic, environmental and social dimensions of policy. Investment in health alone cannot solve the problems of sovereign debt, volatile food prices or the environmental impact of climate change. But for those aiming to promote a fairer, greener and more sustainable approach to globalization, people’s health remains vitally important as a measure of the impact of policies in all these areas. Not only are health outcomes readily measurable, health concerns are immediate, personal and local.

The original Rio Declaration of 1992 described “human beings as the central concern of sustainable development … living a healthy and productive life in harmony with nature”. It is vital that those attending Rio+20 reaffirm this fact, and take concrete action to optimize the interactions between human health and sustainable development.

For more information, please contact:

Fadela Chaib
Telephone: + 41 22 791 32 28
Mobile: + 41 79 475 55 56
E-mail: chaibf@who.int

Gregory Härtl
Telephone: +41 22 791 4458
Mobile: +41 79 203 6715
E-mail: hartlg@who.int

2). WHO gives countries tools to help stop abuse of people with mental health conditions

Note for the media

15 June 2012 | Geneva – WHO urges countries to protect the rights and dignity of people with mental health conditions as it launches a new tool for countries to assess and eventually stop, these violations. The WHO QualityRights Tool Kit aims to ensure that quality of care and human rights standards are put in place in mental health and social care facilities around the world.

“Poor quality services and human rights violations in mental health and social care facilities are still an everyday occurrence in many places, especially in low- and middle-income countries,” says Dr Shekhar Saxena, Director of WHO’s Department of Mental Health and Substance Abuse. “Decrepit buildings, overcrowding and unhygienic living conditions are a reality for many people living in psychiatric institutions. In many facilities, people are exposed to violence, abuse, harmful treatment and neglect. Many are locked up against their will, overmedicated, put in seclusion cells or restrained, sometimes for years.”

Key quality standards for all facilities

To address this, WHO has developed the WHO QualityRights Tool Kit – assessing and improving quality and human rights in mental health and social care. The tool kit, which is based on the International Convention on the Rights of Persons with Disabilities, establishes key standards that need to be met in all facilities. These include the need for:

  • living conditions to be safe and hygienic and the social environment to be conducive to recovery;
  • the provision of evidence-based care for their mental and physical health condition, on the basis of free and informed consent;
  • gearing services towards enhancing people’s autonomy enabling them to engage in their own recovery plans;
  • reporting and halting all inhuman treatment; and
  • linking health services with employment, education, social and housing services in order to promote independent living in the community for mental health service users.

“The Tool Kit has been developed with major inputs from people from civil society organizations which specialize in mental and psychosocial disabilities, as well as other mental health and human rights experts, which is why it is so comprehensive and practical,” explains Dr Michelle Funk, who led the WHO team which developed the Tool Kit. “It can be applied in low-, middle- and high-resource settings. It is unique because it can be implemented in both inpatient and outpatient facilities and allows for a comparison between mental health and general health care services.”

Guidance on quality of care assessments and recommendations

In addition to establishing quality and human rights standards, the QualityRights Tool Kit provides specific guidance on how to conduct a comprehensive assessment of services, how to report findings and make appropriate recommendations to improve quality of care and human rights at the health facility and at national level.

The Tool Kit is a critical first step in a larger WHO QualityRights Project which aims to improve the quality of mental health care and human rights conditions in mental health and social care facilities. Future priorities will be to gather evidence on the state of mental health and social care facilities and use the tool to help address and correct deficiencies and research further means of improving conditions at the service level.

For more information please contact:

Dr Michelle Funk
Coordinator, Mental Health and Substance Abuse Department
WHO, Geneva
Telephone: +41 22 791 3855
Mobile: +41 79 475 5458
Email: funkm@who.int

Ms Natalie Drew
Technical Officer, Mental Health and Substance Abuse Department
WHO, Geneva
Telephone: +41 22 791 3206
Mobile: +41 78 654 2102
Email: drewn@who.int

Dr Shekhar Saxena
Director, Mental Health and Substance Abuse Department
WHO, Geneva
Telephone: +41 22 791 3625
Mobile: +41 79 308 9865
Email: saxenas@who.int

Mr Tarik Jasarevic
Communications officer
WHO, Geneva
Telephone: +41 22 791 5099
Mobile: +41 79 367 6214
Email: jasarevict@who.int

[NPS]: Updates in June

Reference:

1. http://www.nps.org.au/health_professionals/publications/nps_news

2. http://www.nps.org.au/health_professionals/publications/nps_radar

3. http://www.nps.org.au/health_professionals/publications/prescribing_practice_review

4. http://www.nps.org.au/health_professionals/publications/e-learning

5. http://www.australianprescriber.com/

1). http://www.nps.org.au/__data/assets/pdf_file/0009/143829/News_79_Headache_0612.pdf

Title Date
NPS News 79: Headache – Diagnosing, managing and preventing June 2012

2). Download the NPS RADAR April 2012 complete issue in PDF

3). http://www.nps.org.au/__data/assets/pdf_file/0003/142986/PPR_58_Depression_0512.pdf

Title Date
NPS Prescribing Practice Review 58: Depression May 2012

4).

Title Date
eLearning @ NPS May 2012

5). http://www.australianprescriber.com/upload/pdf/issues/169.pdf

Volume 35 Number 3 – June 2012

Major Reforms of the Review for Registration and Market Approval of Drugs

Reference: http://www.fda.gov.tw/eng/news.aspx?newssn=8817&key_year=2012&keyword=

The Department of Health of Executive Yuan promulgated the partial amendment of the “Criteria Governing the Review for Registration and Market Approval of Drugs” on May 8, 2012. The original criteria required that the application of the review for registration and market approval of new drugs should be submitted along with the Permit for Manufacturing and Sales from Country of Origin/Certificate of Pharmaceutical Product in addition to relevant administrative and technical data. This provision was set because there were no legal as well as scientific standards in compliance with the then international requirements in the domestic pharmaceutical industry in the past, and regarding the nature of the aforementioned provision, the aforementioned permit/certificate issued by the then ten most medically advanced countries was expected to prove that the quality, safety and effectiveness of the said new drug had been approved in those countries and serve as reference during the review for registration and market approval of the new drugs in Taiwan.

Nowadays, the review and administration for registration and market approval of new drugs have reached the level equal to that of medically advanced countries, and the Center for Drug Evaluation (CDE) has been established to offer professional reviews on the technical data provided by the application of the review for registration and market approval of new drugs. Therefore, the review on the new ingredients of the imported new drugs is conducted only on the scientific basis and non-scientific factors (the requirement for the Permit for Manufacturing and Sales from Country of Origin/Certificate of Pharmaceutical Product) are discarded. However, the Permit for Manufacturing and Sales from Country of Origin/Certificate of Pharmaceutical Product (CPP) is considered as an auxiliary document now. Besides, in accordance with the risk level of drugs, the corresponding risk management system and review requirements are established. Hence, the “Criteria Governing the Review for Registration and Market Approval of Drugs” are amended and the major amendment is listed as follows:

1. The provision stipulating that the application of the review for registration and market approval of the new ingredients of new drugs should be submitted with the CPPs issued by more than two countries can be relaxed on condition that the said application should provide information regarding the domestic clinical trials or the multinational and multicenter trials with the involvement of Taiwanese people.
2. A drug policy management system based on risk classification is established, and the aftermarket risk management of drugs is reinforced by actions such as requiring the pharmaceutical factory to submit a drug risk management plan.
With the aforementioned amendment, it is expected that the public can take advantage of the safe and effective new drugs developed abroad earlier and the public interests and health, therefore, are enhanced.

The Legislative Yuan Passed the Third Reading for Partial Amendment of Provisions in the Pharmaceutical Affairs Act, Strengthening Our National Drug Management System and Gearing It to the International Standards

Reference: http://www.fda.gov.tw/eng/news.aspx?newssn=8861&key_year=2012&keyword=

To enhance the quality of pharmaceutical development and drug safety in Taiwan, Food and Drug Administration (FDA) amended the related provisions in the Pharmaceutical Affairs Act (PAA) for the purpose of perfecting the management system of drug manufacturing facilities and strengthening the control over the quality of imported drugs. The drafted amendment passed the third reading in the Legislative Yuan on June 5, 2012. The amended provisions will not only contribute to the promotion of the development of biotechnology industry in the future, but also reassure the drug quality and safety of all compatriots.

The current amendments of the PAA are summarized below:

(1)At present, due to the lack of legal grounds against drug manufacturers seriously violating the Good Manufacturing Practice (GMP) standards, our legal system is unable to ban such manufacturers from continuing to manufacture drugs that pose safety and quality concerns. Under the current amendments, the management of “manufacturing” and “products” is separated, and the amendments clearly state that drug manufacturers must pass the competent authority’s inspection for compliance with the GMP standards and obtain the “pharmaceutical manufacturing license” before the manufacturing process can be initiated. If there is a major violation of GMP, appropriate measures can be taken to terminate or invalidate the item under the original manufacturing license without abolishing the “drug permit license”. Such measures can prevent the violating manufacturer from continuing to manufacture or sell drugs with safety concerns, thus achieving the purpose of effective supervision of drug manufacturers for their continued GMP compliance. In addition, only logistics providers performing drug packaging and some emerging biotech industries are not required to apply for a factory registration after the current amendments take effect. The fact that these companies are allowed to manufacture drugs immediately after passing the inspection for GMP compliance will greatly boost the development of related industries.

(2)The current amendments also empower the central health authorities to deny entry of any disqualified drugs by undertaking sampling inspection at the border customs to ensure the quality and safety of imported drugs.

(3) In addition, to expand and effectively utilize the inspection resources, the revised PAA empowers the central health authorities to delegate the sampling inspection and laboratory testing businesses to their subordinate agencies or commission relevant institutions for the businesses, while the quality and credibility of test can be ensured by accreditation of the professional laboratories.

In recent years, FDA has been committed to the promotion of international mutual accreditation of GMP, and actively applying for membership of the “Pharmaceutical Inspection Co-operation Scheme (PIC/S). The system for pharmaceutical manufacturing license is a key criterion for the qualification for PIC/S application. The passing of the third reading for the amendment of provisions of the PAA happened to coincide with the visit of PIC/S delegation (June 4 – 8) to Taiwan for an on-site evaluation of our application. This will greatly and positively help our application for PIC/S membership. After becoming a PIC/S member and signing the Mutual Recognition Arrangement (MRA) with other member countries, Taiwan’s drug exports will not need to undergo repeated factory inspections. This would facilitate the expansion of overseas markets, enhance the international competitiveness of the industry and stimulate the development of the bio-medicine industry in Taiwan.

Obese people can seek help via phone

Reference: http://www.mps.org.my/newsmaster.cfm?&menuid=36&action=view&retrieveid=3634

PETALING JAYA: It does not matter if you are a senior citizen or teenager – when it comes to weight issues, all are deeply affected.

This is shown by the response to a recently launched helpline for weight management, which sees callers from below 21 to those aged above 60.

According to the helpline call centre, more than half of the callers are below 21 and at least 10 are above 60.

As at last Friday, about 50% of the centre’s 140 callers were found to be obese while some 30% were overweight and the rest has normal weight.

The helpline was set up by the Malaysian Pharmaceutical Society to help combat the worrying increase of obesity in the country.

“We are keeping a close watch on the progress of the programme. We hope that we will be able to see whether it is possible to make an impact on the prevalence of obesity in the country,” said its president Datuk Nancy Ho.

According to the latest Health Ministry statistics released in December last year, about 15% of Malaysians are obese – a 1% increase since 2006 – and almost half of all adult Malaysians are either overweight or obese.

Ho said the programme to assist and counsel people who were overweight or obese was a combination of diet, nutrition, lifestyle modification and, if necessary, a spectrum of medication.

“We have a group of pharmacists, nutritionists and dietitians who will hold the participants’ hands and walk them through the whole process,” she said, adding that it would take about four months.

She said the option of calling the helpline might also appeal to those who might be too shy to come forward to seek help for their weight issues.

“The information shared with the helpline staff is confidential. It would help if someone shares their details with us, but it is also okay if they do not wish to do so,” said Ho.

Although the society hoped that more would seek help from the helpline, it said it would continue to monitor the progress of the programme and publicise it accordingly.

The toll-free helpline number is 1-300-800-373 and it is open from 8.30am to 5.30pm on weekdays.

PAC12 opportunity for rural pharmacists

Reference: http://www.psa.org.au/archives/12536

20 June 2012

Pharmacists travelling from some rural and remote areas to attend PAC12 may be eligible to claim travel and accommodation expenses under the Rural and regional allowances scheme.

Pharmacists who work and reside in rural and remote areas classified as PhARIA 2-6 are eligible and the event must be accredited Group 2.

Applications for allowances must be accompanied by a completed record of expenditure within two calendar months of completion of the activity.

The PAC12 program will present more than 50 hours of CPD from which delegates will be able to select topics of their choice. More than 20 Group 2 points and in excess of 20 additional Group 1 points will be available.

PAC12 has a wide range of clinical, practice, and business and management sessions of interest to rural and regional pharmacists which are incorporated under the Congress umbrella theme of From Vision to Reality which will focus on the changing nature of the pharmacy profession.

The sessions will help all pharmacists, including those in rural and regional areas, to prepare to meet and make the most of the challenges and opportunities these changes present.

PAC12 will provide an unprecedented opportunity to broaden skills and learn from researchers, practitioners and consumers about   developments that will help shape the future of the profession and its part in the changing health-care environment.

From Vision to Reality will look to the future of pharmacy as this relies upon the profession’s ability to discover new practice knowledge, develop new skills and systems to improve practice, and to diversify into new practice areas to better the health and wellbeing of the population.

PAC 12 will continue the Congress’s tradition of providing a topical and comprehensive program covering a wide range of therapeutics, management and practice subjects which will increase delegates’ specific knowledge, attitudes, skills and behaviours in support of their expanding roles as pivotal professionals in the multi-disciplinary health-care model towards which Australia is rapidly moving.

The PAC12 program now includes the annual AACP Consultant Pharmacist clinical program, the now hugely popular Great Debate and thePSANational Forum.

The Congress will be held at the Melbourne Exhibition and Convention Centre from Friday 19 October 2012 to Sunday 21 October 2012.