 |
@CONTENTS@
| New
Year Greetings |
| for
2003 from Chairman, |
| Hachizaemon
Kazama |
I sincerely hope the first morning of the new year dawned bright
and prosperous for not only our dear colleagues at home and
abroad but all the parties and persons concerned.
Last year saw two landmarks in the 18-year history of our promoting
responsible self-medication since PAJ's foundation in 1985. |
 |
The one was compilation and release in early November by the
Ministry of Health, Labour and Welfare of "Interim Report on
Roles of Over-The-Counter (OTC) Medicines in Self-Medication
".
The other was that our association hosted the WSMI 14 General
Assembly and 5th Asia Pacific Regional Conference (commonly
called Tokyo Conference) under the theme, "Beyond the Conventional
Boundary of Self-Medication-Shared Vision, Common Under-standings
"for the first time jointly held in the long history of WFPMM
and WSMI.
The "Interim Report "with a sub-stile, "To encourage OTC Medicines
to be needed, trusted and used with confidence ", has its Foreword
which says "With the changes in disease structure such as the
rise in lifestyle-related illnesses, due to the rapid aging
of society and pursuit of quality of life, people are developing
an increasing interest in their own health ".
"The concept of self-medication, utilizing readily-available
OTC medicines with proper advice from the drugstores or pharmacists,
is spreading".
"Self-medication, according to the WHO, is 'For people to be
accountable for their own health and to treat minor illnesses
themselves '.
"The nature and functions of OTC medicines have been discussed
on a number of occasions. The percentage of elderly people continues
to rise and the public 's health needs are diversifying. There-fore,
in order to promote the effective use of OTC medicines as health
and medical resources in the future, it is necessary to develop
OTC medicines capable of responding to new public needs.
"The Expert Consultation for Streamlining Procedures to Approve
and Examine OTC Medicines has been discussing issues associated
with OTC medicines since June this year and has reached the
following conclusion ".
The report has included in its intensive discus-sions, inter
alia, scope and definition of OTC medicines, thus clearly setting
a goal for the industry to target as well as blessedly increasing
business opportunities for promoting responsible self-medication.
The report was introduced by the competent authorities themselves
during the Tokyo Confer-ence, successfully presenting itself
as "an eye-opener "specifically to those from abroad.
The Tokyo Conference - second time for us to host since we hosted
the then WFPMM 7th General Assembly in 1984 in Tokyo - was a
great success, made possible with the excellent and dedicated
help of all concerned, as we welcomed as many as 550 participants
from as many as 24 countries despite the uncertain international
situation both politically and economically.
Pre-Assembly Workshop under the title, "What is Self-Medication
? Self-Medication around the world ", was primarily conceived
to sensitize Japanese consumers, pharmacy students, and the
mass media to the importance of promoting responsible self-medication
by way of exposing them to the wide spectrum of self-medication
practiced around the world, in particular, in Europe, U.S.A.,
Australia and Japan. The Work-shop also was able to benefit
the overseas partici-pants as it provided an opportunity to
make "multi-center "comparative study on self-medication.
Conference Opening Session with a challenging title, "Building
Shared Vision from Mutual Under-standings ", was also a great
opportunity to widen our intellectual horizons since local as
well as international speakers of the possibly highest caliber
shared their frank opinions as viewpoints of doctors, pharmacists,
nurses and consumers.
Business Programme consisted of Four Plenary Sessions, namely,
"Information Technology - In search of effective sharing of
good information -Can it bring Opportunities or Challenges ?",
"Self-Medication- Public health implications - Can it really
deliver benefits?", "Dietary/Food Supple-2 ments - Looking for
a global framework - Neither fish nor fowl ?"and "Herbal Medicinal
Products-Identifying new roles in the new millennium -What can
they do ?".
Closing Session left a deep impression on the minds of the audience
with the business leaders telling their strategic experiences
in "Building a Global Self-Medication Market ".
Taking up this occasion, on behalf of the management and staff
at PAJ, I would like to thank you very much for inestimable
help and support you extended to us over the years.
It has been a privilege and a great pleasure to have worked
with all of you. |
| @ |
|
| In
Deep Mourning for |
|
the Late Prince Takamado |
| @ |
While
we were still in a state of deep emotion and excitement
about the WSMI Tokyo Conference, we were greatly saddened
by the news of sudden demise of Prince Takamado who had
released his congratulatory address at the Conference
Opening in the morning of November 14 last year.
|
 |
|
| Sources
at the Imperial Household Agency said that Prince Takamado
had collapsed in the after-noon of the 21st, just a week after
his attendance at the Tokyo Conference. The sources reported
that he collapsed while playing squash tennis and demised
from ventricular fibrillation (a kind of abnormal cardiac
rhythm), remaining unconscious after collapsing. He was 47.
The Prince, seventh in line to the chrysanthemum throne and
a cousin to Emperor Akihito, was the honorary chairman of
the Japan Football Associa-tion and had attended various functions
in that capacity during the World Cup soccer finals jointly
hosted by the Republic of Korea and Japan earlier last year.
We all know that, unlike those in the higher echelons of the
sporting and nonprofit organi-zations the Prince had energetically
supported, he was never concerned with self-aggrandizement,
perfectly embodying the best of not only the Royal family
but also our country. With his untimely passing, Japan has
lost one of its finest repre-sentatives.
Please join with us in praying for the repose of his soul.
|
| @ |
|
| A
Logo for Self-Medication |
| |
| |
At the recently held Self-Medication Promotion Conference, it
was suggested and agreed that PAJ Public Affairs Committee should
beef up its efforts to more actively deal with the public campaign
on the self-medication.
The Committee has designed a logo as shown above, which reads
"Take charge of your own health "in Japanese and "Self-Medication
"in English, em-bodying "Healthy and bright family members "with
three cartoonish figures.
Constant uses of the logo on sales promotional leaflets, advertisements,
publicity materials and the like would considerably enhance
in the minds of the general public the image, impression and
importance of practicing self-medication responsi-bly, the Committee
expects so.
PAJ member companies are encouraged to use the newly designed
logo as much as possible for in-creasing awareness of the general
public towards responsible self-medication. |
|
|
|
| "OTC
GUIDEBOOK 2002 ""and "Approval |
|
Standards of Nonprescription Medicines |
|
(OTC Medicines) in Japan ""Published |
|
* With its first trial edition published in 1995, a revised
and enlarged edition of "OTC GUIDE-BOOK "was eagerly awaited
over the past seven years.
PAJ Information Science, an affiliated entity established exclusively
for publication, has signifi-cantly expanded the original version
so that it now contains 533 medicines-both nonprescription medicines
and the newly designated quasi-drugs in 15 therapeutic categories.
The latter were shifted from the OTC status to the new category
in 1999. A brief introduction to the regulatory climate which
resulted in the status shift was provided.
This guidebook will continue to find favour with visitors to
Japan who do not speak the Japanese language and who need to
communicate with pharmacists or other providers of self-medication
medicines or quasi-drugs.
It combines diagrams which considerably help communication between
people who do not speak the same language.
Besides the communication benefits, it should serve as a vehicle
for proper and accurate dis-semination of information on the
Japanese nonpre-scription medicines and quasi-drugs for which
safety, efficacy and quality have been firmly established by
the competent authorities. In addition, it lays emphasis on
"Precautions for Use " in line with the guidelines issued by
the Ministry of Health, Labour and Welfare.
At the Tokyo Conference, each and every regis-trant received
a copy, which was well accepted.
Now it is available for YEN 5,000 per copy plus postage. Contact
PAJ Secretariat for information and purchase.
* Publication by Asia Subcommittee, International Affairs Committee
of "Approval Standards of Nonprescription Medicines (OTC Medicines)
in Japan "deserves special mention here.
This booklet consists of Part I : Outline of Product Approval
of Nonprescription Medicines and Part II: Approval Standards
for 14 Therapeutic Categories.
Part
I further consists of 8 chapters;
1) Classification of Pharmaceuticals and Medicinal Products;
2) Approval Process of Nonprescription Medicines;
3) Approvals and Licenses for Nonprescription Medicines;
4) Nonprescription Medicines coming under Class 6;
5) Ingredients not acceptable for Nonprescription Medicines
and Ingredi-ents with limitations on quantities;
6) Handling of Nonpre-scription Traditional Chi-nese Medicine
(TCM) Preparations and Crude Drugs;
7) Switch OTC and Direct OTC Medicines;
8) Newly Designated Quasi-Drugs: |
 |
Part II includes 14 Therapeutic Categories;
1) Cold Remedies
2) Antipyretic Analgesics
3) Antitussives and Expectorants
4) Gastrointestinal Medicines
5) Laxatives
6) Antivertigo Medicines
7) Ophthalmic Medicines
8) Vitamin Preparations
9) Enemas
10) Anthelmintics
11) Nasal Drops for Rhinitis
12) Oral Preparations for Rhinitis
13) Antihemorrhoids (External preparations)
14) Athlete 's Foot and Ringworm Remedies
Each and every registrant also received a copy, which was very
much appreciated as it serves as a highly useful yardstick for
foreign-affiliated firms to apply for product registration.
It is available for YEN 3,000 per copy plus postage. Contact
PAJ Secretariat for information and purchase. |
| @ |
|
| Three
Major Topics of OTC |
| (Based
on the topics selected by |
| Pharmaweek
of ADecember 23, 2002 |
|
issued by JIHO Co., Ltd.) |
| |
(1) A strong tendency to promote self-medication
There is a worldwide trend for many people to take greater charge
of their own health. In the 1978 Alma-Ata Declaration, WHO stated
"People have the right and duty to participate individually
and collectively in the planning and implementation of their
health care ".
Subsequently, "Guidelines for Developing Nation-al Drug Policies
"by WHO stated "it is desirable to encourage self-medication
and every attempt should be made to ensure its appropriate use
and to guard against any unacceptable risks it may entail ".
In Japan, the year 2002 saw a growing tendency for major stakeholders
to promote self-medication or "self-care by the use of nonprescription
medi-cines as directed by the labeling ".
In February, "Self-Medication Summit "was hosted by Japan Association
of Chain Drug Stores (JACDS) in Chiba Prefecture, adjacent to
the Metropolis of Tokyo, where some 1,200 gathered "individually
and collectively "to share "Declara-tion of Summit "issued on
the last day.
Declaration recognized the need to (1) explore the establishment
of a climate where education and information are sufficiently
provided, (2) encourage potential collaboration among consum-ers,
health-care providers and educational institutions for furtherance
of self-medication and (3) foster partnership for forming a
platform to materialize self-medication.
Declaration paved the way for founding "Self-Medication Advocacy
Committee "(SMAC) in May, whose organizational structure consists
of 1 chairman, 3 vice-chairmen, 29 directors and 2 secretariats.
A wide spectrum of people from various sectors and circles include
academia, physicians, pharma-cists, nurse, representatives from
manufacturers, retailers and consumers, and health-care providers.
(2) Health hazards caused by the "so-called health foods "
Rampancy of so-called borderline products, in particular, dubious
products (ostensibly positioning themselves as foods and cunningly
making health claims), whose safety and efficacy have not in
any manner been established by the competent authorities has
been hampering the healthy growth of the self-medication market
which is placed under the very stringent control of the Pharma-ceutical
Affairs Law (PAL).
With body consciousness being almost an obsession, many Japanese
women, young and old alike, are taking those weight-reducing
products, some of which were found to contain a variant of Fenfluramine
and N-nitroso fenfluramine (both not authorized for use in Japan)
which cause liver failure.
In mid-August, Japan Pharmaceutical Association (JPA) filed
a Position Paper with the Ministry of Health, Labour and Welfare
(MHLW) strongly blaming the pharmaceutical administration for
the serious tragic events inflicted on as many as 708 people
(mainly women) including four deaths, as of August 9, caused
largely by untested, unregu-lated slimming products of quite
dubious efficacy from People 's Republic of China.
The Position Paper by JPA stressed two points:
* It is fairly assumed that majority of those Chinese-made products
in question have been imported through petty import agents into
Japan under the food category which is subject to a much less
stringent import procedure as opposed to drugs.
Investigation of the illnesses linked to the products (in most
cases, pills or capsules) has shown that the products, although
declaring as foods at time of import, clearly claim on the labeling
"Slimming or Weight Reducing ".
Before April 2000, pills and capsules were strictly limited
to pharmaceuticals in order to prevent the consumers from being
misled in distinction between medicines and foods.
A series of relaxation of the regulations after then, however,
has rapidly and randomly allowed foods to take shape of pills
and capsules, thus considerably confusing and misleading the
innocent public to believe in some therapeutic efficacies of
foods.
Those who suffer from the health hazards inflicted by those
Chinese-made products are nothing less than the victims of the
relaxation of the regulations imprudently effected by MHLW.
In the light of the seriousness of the health hazards, it is
imperative that, in order to control "so-called Health Foods
", new regulations be established after reviewing appropriateness
to allow foods to take shapes of pills and capsules.
It is also imperative that labeling of "borderline " health
therapeutic claims such as "Slimming "or "Weight Reducing "by
the foods be examined.
* Obviously, "imports for personal use ", namely, the products
imported through petty import agents are the culprit of these
tragic events.
The Internet is glutted with advertisements of medicines approved
in Japan, those not approved, "Neither fish nor fowl "dubious
products cunning-ly claiming as miracle aids or panacea, and
the like, presenting a lucrative business to those agents.
Those petty import agents are quite skillful in giving evasive
answers to the governmental inves-tigation, most of them saying
they are merely helping "imports for personal use ".
According to the book, however, they are virtually to be classified
as "License holders for import of pharmaceuticals "who are subjected
to various rigid requirements as specified in PAL.
JPA hereby urges MHLW to tighten the control and inspection
of petty import agents so as to prevent reoccurrences of such
tragedies.
To openly blame a government agency for social issues by an
industry representative has been quite unprecedented in the
Japanese climate. In that sense of the meaning, the Position
Paper by JPA has attracted a keen attention from many con-cerned,
who carefully watch how this social irony (some of those women
who are dying to be slim and thin have actually died after using
Chinese-made killer weight-reducing pills and capsules) develops
in the future.
(3) Interim Report on Roles of Over-The-Counter (OTC) Medicines
in Self-Medication issued by MHLW
As this topic was covered in depth by the New Year Greetings
for 2003 from Chairman, Hachizaemon Kazama, to avoid redundancy,
only Contents will be given here as below:
I. Foreword
II. Necessity of OTC Medicines to Respond to People 's Needs
III. Changes in Roles of OTC Medicines
1: Changes in roles of OTC Medicines
2: Attributes required of OTC Medicines
IV. Appropriate Use of OTC Medicines and Roles of the Parties
Concerned
1: Roles of pharmaceutical companies and the pharmaceutical
industry
2: Roles of pharmacists
3: Roles of the government
V. Recommendation - Specific Measures
1: For OTC Medicines "to be trusted "
(1) Review of scope of OTC Medicines to reflect public needs
(2) Rx-to-OTC switch
(3) Utilization of Chinese Medicines & Tradition-al Medicines
(4) Expansion of dose forms
2: Safety measures; Post Marketing Surveillance (PMS)
(1) Re-evaluation
(2) Provision of information
3: Improvement in examination/Approval process
(1) Evaluation system
(2) Review on application grouping and reduction in attachments
For our foreign readers, the following Home Page may not be
so much useful as it is to the Japanese readers, but the editors
are pleased to provide it for any one of our dear colleagues
to venture to wander deep into the forest of crabbedness.
http://www.mhlw.go.jp/shingi/2002/11/s1108- 4.html |
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