At
the JSMI 42nd Ordinary General Assembly held on May
9, the action programme and the budget plan for the
fiscal period of April 1, 2006/March 31, 2007 were
approved.
The
action programme consists of five pillars centering on
revitalization of OTC medicines. They are (1) Enlargement
of the scope of OTC medicines through introduction of new
OTC medicines such as Rx-to-OTC medicines and herbal medicines,
(2) Acceleration of launching the pharmaceutical products
having much better efficacy, (3) Enlightenment of consumers
on self-medication and extending supports to school education
on self-medication, (4) Improvement in the provision of
information to consumers and professionals through utilizing
Information Technology (IT), and (5) Building closer relationships
with the competent authorities, academic societies concerned,
and industrial associations involved.
In the international arena, JSMI conducts brisk exchanges of views and opinions
with the WSMI member associations and extensive marketing research in order
to promote self-medication in the WSMI Asia Pacific Region.
Following suit of the Ordinary General Assembly, the 32nd General Assembly
of JSMI Information Service was held and the actioin programme and the
budget plan for the same fiscal period were approved. The Information
Services issued the 10th edition of the "OTC Encyclopedia".
As the name speaks itself, the series of this directory has been utilized
and the latest up-dated edition contains new items such as "A list showing
the comparison of quantities of the active ingredients used in nonprescription
and prescription medicines", "<Diseases and the nonprescription medicines
for which precautions are necessary> designed for guiding the sufferers
of chronic diseases for compliance" and other various pieces of information.
The latest edition contains 2,850 items, classified by therapeutic
categories, which are manufactured and distributed by the JSMI member companies.
2.JSMI
submitted its petition to Minister of Health,
Labour and Welfare
On January 27, JSMI Chairman Ibe visited with Kazuo Fukui, Director General,
the Pharmaceutical and Food Safety Bureau, the Ministry of Health, Labour and
Welfare to hand over "The petition with regard to OTC medicines" addressed to
Jiro Kawasaki, the Minister of Health, Labour and Welfare.
Chairman Ibe explained that the OTC market in Japan continued to decline over
the past ten years and that the OTC industry desires to extricate itself from
the stagnancy by having the JSMI wishes outlined in the petition materialized.
Director General Fukui responded by commenting that he recognized the significance
of the OTC medicines and that the revision of the Pharmaceutical Affairs Law
envisioning the revision of the pharmaceutical retailing system was under contemplation.
The gist of the petition with regard to OTC medicines is as follows:
The petition with
regard to OTC medicines
Our country has seen a rapid shift from the aging society with
fewer children to the society of the decrease in population,
where it has become an issue of supreme importance for each
and every citizen to try to build and sustain an affluent society
by way of self-reliance. Self-medication, namely, a practice
to maintain one's health by oneself, not only plays a significantly
useful role for management of one's health but also contributes
to a reduction of the medical expenses borne by the entire
society.
Task Force To Study Revision of Pharmaceutical Retailing System,
Health Sciences Council, the Ministry of Health, Labour and
Welfare, conducted discussions to explore possibilities of
supplying OTC medicines which, in addition to their efficacy
and safety, are readily available and accessible so as to satisfy
the diversified needs of the nation and consumers. The results
of the discussions were summarized into a report on December
15 last year. We, as the suppliers of the pharmaceuticals,
would highly applaud the results and would be committed to
make every effort and to extend collaboration as much as possible
in order to materialize the results.
For the materialization, prerequisite are acceleration of launching
quality OTC medicines which are the major means to practice
self-medication and laying the groundwork for the acceleration.
The current business environment surrounding the OTC medicines,
however, keeps declining year by year over the past decade
despite the role played by the OTC medicines and their contributions.
The industries related to the OTC medicines have been struggling
against an uphill battle while, in many advanced nations, the
OTC medicines market has been expanding with the significance
of the OTC medicines having been recognized.
At this juncture when the revision of the Pharmaceutical Affairs
Law envisioning the revision of the pharmaceutical retailing
system has been under contemplation, in relation to the points
as outlined below, we would hereby cordially solicit the competent
authorities to grant their thoughtful consideration and the
bureau concerned to swiftly and appropriately cope with the
situation.
1: Clarification
of the status of the nonprescription medicines
in the framework of the Pharmaceutical Affairs
Law
2: Promotion
of launching new nonprescription medicines that
satisfy the needs of the nation and consumers
by way of promoting Rx-to-OTC switch and utilizing
herbs
3: Acceleration
of launching more efficacious medicines by way
of revising the approval standards for cold remedies
and other therapeutic categories
4: Simplification
and streamlining of the examination/approval
process for the nonprescription medicines
5: Introduction
of educational programme on the basics of medicines
into the curriculum at schools so as to provide
the necessary information adequately to the general
public
3."Revision
of the Pharmaceutical Affairs Law" submitted to
the Diet
In
response to the report compiled on December 15 last
year by Task Force To Study Revision of Pharmaceutical
Retailing System, Health Sciences Council, "the bill
of revision of the Pharmaceutical Affairs Law", drafted
by the Ministry of Health, Labour and Welfare (MHLW),
with an intention for building a new pharmaceutical
retailing system. Upon obtaining a decision at a Cabinet
meeting on March 7, the bill was submitted to the current
session of the Diet and granted an approval at the
House of Councillors on April 19.
Hereafter, the bill will be reviewed at the House of
Representatives and it is anticipated that the bill
will be passed either in May or June.
In the bill, the definition of "OTC medicines" was
given for the first time in Japan. Article 25, under
the title of "The license for Tempo-hanbai-gyo", specifies
Tempo-hanbai-gyo as the business license to sell or
give, at the store, OTC medicines (OTC medicines are,
among the pharmaceutical products, those which work
mildly on the human body in their efficacy and indications,
and have the purpose of being used by the general public
at their own choice based on the information provided
by pharmacists or other professionals).
So far in the past, OTC medicines were included in
"Drugs" in the Pharmaceutical Affairs Law and were
given an extremely unstable status as "Other drugs"
in contradistinction to prescription medicines. It
is, therefore, expected that the clear positioning
of OTC medicines in the framework of the revised Pharmaceutical
Affairs Law would play a significant role in promoting
nonprescription medicines henceforth.
Tempo-hanbai-gyo
:
Ippan-hanbai-gyo
(Drug
store with a pharmacist)
+
Yakushusho-hanbai-gyo
(Drug
store without a pharmacist)
The major points of the bill other
than the foregoing are as follows:
(1)
Restructuring of Licenses for Selling Drugs
"The first-class license for selling drugs (Drug store with a pharmacist), The
second-class license for selling drugs(Drug store without a pharmacist), The
license for selling drugs by household distribution, and The third-class license
for selling drugs(Exceptional license)" were reclassified into "The license for
Tempo-hanbai-gyo , The license for selling drugs by household distribution, and
The license for wholesaling drugs"
(2)
Requirements for obtaining The license for Tempo-hanbai-gyo
Either a pharmacist
or a Toroku-hanbai-sha (a person who has passed the
tests conducted by the prefectural governments under
the newly established pharmaceutical retailing system.)
shall be kept in each store.
(3)
Requirements for obtaining The license for wholesaling
drugs
In the current
Pharmaceutical Affairs Law, the wholesaler is a special
sub-category of The Drug store with pharmacist. After
the amendment, the new independent category for the
license for wholesaling drugs shall be established.
The details were not mentioned in the proposal. And
the proviso regarding the exemption given by the
prefecture governor was deleted; therefore, the wholesaling
business was clearly cut off from retail business.
(4)
Classification into 3 Classes of OTC medicines
Class 1 OTC
medicines:
Either the OTC medicines designated by the Minister of Health, Labour and
Welfare as precautions for use are particularly necessary among the OTC medicines
whose side effects may possibly cause health hazards to the extent of disrupting
daily life, or the OTC medicines which the period specified by the MHLW Ordinance
has not elapsed since the approval has been granted, among the OTC medicines
considered to fall under Article 14, Paragraph 8, Item 1 at filing an application
for approval to manufacture and distribute, are Class 1 OTC medicines.
Class 2 OTC medicines:
Class 2 OTC medicines are the medicines designated by the Minister of Health,
Labour and Welfare whose side effects may possibly cause health hazards to
the extent of disrupting daily life (Class 1 OTC medicines excepted).
Class 3 OTC medicines:
Class 3 OTC medicines are the OTC medicines other than Class 1 and Class
2 OTC medicines.
(5)
Ascertainment of qualifications
The prefectural
governors, in compliance with the MHLW Ordinance,
shall conduct examinations to ascertain whether those
to be engaged in selling or giving drugs have the
appropriate qualifications to do the job.
(6)
Those engaged in sales of OTC medicines
It is required
that "a pharmacist for Class 1 OTC medicines" and
"either a pharmacist or a Toroku-hanbai-sha for Class
2 and Class 3 OTC medicines" be engaged in the job.
(7)
Provision of information
It shall be mandatory
for a pharmacist to provide written information on
Class 1 OTC medicines and it shall be obligatory
for either a pharmacist or a Toroku-hanbai-sha to
make effort to provide information on Class 2 OTC
medicines.
On the other hand, when there is an expression by a consumer that "I don't
need information", this stipulation shall not apply. This stipulation shall
apply mutatis mutandis to The license for selling drugs by household distribution
so as to impose similar obligations.
(8)
Matters to be indicated on the Immediate Container,
etc.
The matters are
specified by the MHLW Ordinance for each Class. The
drugs such as insecticides, etc. designated by the
Minister of Health, Labour and Welfare should indicate
"CAUTION - Do not use on human body".
(9)
Displays, etc.
A proprietor or
a seller of drugs is required to "Store or display
drugs by clearly separating them from other merchandise.
Also it is stipulated that "OTC medicines shall be
displayed, in compliance with the MHLW Ordinance,
by separating from each other Class 1, Class 2 or
Class 3 OTC medicines". (Also, the particulars regulating
the displays for each Class are scheduled to be specified
in the MHLW Ordinance.)
(10)
Enlightenment on the proper use of OTC medicines
It has been stipulated
that the national government, the prefectural governments,
and cities and special wards where public health
centers are located shall, with collaboration from
the agencies concerned and the related industrial
associations, make effort to enlighten consumers
and develop their knowledge on the proper use of
drugs and medical devices.
(It is assumed that promotion of and enlightenment on self-medication have
been incorporated in the Pharmaceutical Affairs Law.)
(11)
Date of enforcement
The Government
Ordinance stipulates that Date of enforcement shall
be set within three years from Date of promulgation.
The designation of Classification of the OTC medicines
shall be made on April 1, 2007 and the particulars
relating to the tests conducted by the prefectural
governments shall be issued on the date set by the
Government Ordinance within two years from Date of
promulgation.
(12)
Interim measures for those professionally engaged
in the sales of drugst
Interim measures
shall be established so as to avoid unnecessarily
confusing purchasers and business sectors and to
allow the new system to begin functioning smoothly.
The second-class license for selling drugs: Those who
are currently doing business with the license shall
be deemed as Toroku-hanbai-sha.
The license for selling drugs by household distribution:
Those (business corporations included) who are currently
doing business with the license shall be allowed to
do business by household distribution the way they
have been doing the business.
The third-class license for selling drugs: Those who
are currently doing business with the license shall
be allowed to do business the way they have been doing
the business.
Concerning nomenclature and symbols to feature each of
the three Classes of OTC medicines and new naming of
quasi-drugs which are also classified into three groups,
comments have been sought after from those concerned.
Major supplementary resolutions include the following:
(1)
It is required that the
classification of the risks
associated with OTC medicines
be continuously reviewed.
(2)
In addition to the efforts
to make the new pharmaceutical
retailing system known
to everyone without exception,
it is essential to improve
and expand the measures
for disseminating knowledge
and enlightening consumers
in order to enable them
to fully understand the
properties of drugs and
to properly use them.
Furthermore, school education
shall make every effort to
disseminate knowledge and enlighten
students on the proper use
of drugs.
(3)
It
is also essential to take
measures to streamline
the examination/approval
process in order to offer
highly effective and safe
OTC medicines to respond
to the public's health
needs.
At the same time, for developing
switch OTC medicines, careful
consideration shall be given
for assuring safety and proper
use of them.
4.The
30th Report on Consumer Awareness of Nonprescription
Medicines
This report summarized the
results of the consumer awareness survey conducted by
means of a questionnaire in an advertorial in the Asahi
Shimbun dailies on December 24, 2005. Following suit
of the previous survey, JSMI conducted a survey on the
consumer awareness of self-medication. The survey also
covered how deeply consumers are interested in the revision
of the pharmaceutical retailing system, what is their
preferable naming of the OTC medicines and how consumers
take care of themselves when they do not feel well.
Of the 1,491 respondents, 1,000 respondents were chosen,
with the plural replies by the same respondents being eliminated.
BREAKDOWN OF
THE RESPONDENTS
(A)
Gender and Age
The respondents
consisted of approximately equal number, with male
(51.7%) slightly outnumbering female (48.3%).
1,000 respondents
(B)
Occupation
"Salaried men/women"
showed the largest percentage (38.4%), followed by
"Jobless and Others" (29.7%) and "Housewives" (26.8%).
1,000 respondents
RESULTS OF THE
SURVEY
(1)
Awareness of Self-Medication
The term,
"Self-Medication", is defined as self-treatment of
minor illnesses and injuries by use of OTC medicines
.
Do you know this term ?
1. Yes, I know it pretty well.
2. Yes, I know it to some extent.
3. I have heard only the term.
4. No, I don't know it.
5. Unanswered
1,000 respondents
Awareness of the concept of "Self-Medication"
was 33.3% with "Yes, I know it pretty well" (7.6%)
and "Yes, I know it to some extent" (25.7%) combined.
Awareness of the term was 65.5%, exceeding 60%
of the respondents, with adding "I have heard only
the term" (32.2%) to those two answers. Those who
answered "No, I don't know it " indicated 34.5%.
(2)
Understandability of Package Inserts (Directions
to use the medicines)
Package Inserts
(Directions to use the medicines) are attached to
the OTC medicines. Recently, Package Inserts have
been designed to ensure readability.
How do you rate them ?
1. Easy to understand.
2. Hard to understand.
3. Neither easy nor hard to understand.
4. Unanswered
"Easy to understand" (44.1%) exceeded 40%, indicating
the largest portion, followed by "Neither easy nor hard" (34.7%) and
"Hard to understand" (21.2%).
(3)
Points hard to understand in Package Inserts (Directions
to use the medicines)
To those who answered,
"Hard to understand", to the question (2) 2, what
are the points you find hard to understand ?
"The letters are too small to be legible" (122 respondents)
by far outnumbered the other answers, being followed by "Explanations
are too lengthy to the extent of making me sick of reading", namely,
"Lengthy explanations" (44 respondents).
52 respondents with these 44 respondents plus "To simplify the explanations
by itemizing" (8 respondents) expressed dissatisfaction with the lengthiness.
This was followed by "Too much use of technical terms, rendering the
explanations hard to understand" (28 respondents).
A total of 17 respondents, with "Insufficient explanations on side-effects"
(11 respondents) and "Insufficient explanations on how to use/take the
medicines and interactions of the medicines" (6 respondents), felt the
explanations on both side-effects and directions to use were not sufficient.
Other answers included "More device is desirable so as to indicate the
important matters in colours" (11 respondents) and "More device is desirable
so as to indicate the important matters by use of tables and graphic
charts" (5 respondents).
Points hard
to understand in Package Inserts (Directions to use the
medicines)
N = 198 *
ORDER
POINTS
HARD TO UNDERSTAND
RESPONDENTS
1
The letters are too small to be legible
122
2
Explanations are too lengthy
44
3
Too much use of technical terms to understand
28
4
Insufficient explanations on side-effects
11
5
More device to indicate important matters in colours
11
6
Simplification by itemizing
8
7
Insufficient explanations on how to take medicines
and interactions
6
8
More device to indicate by use of tables and graphic
charts
5
Hard to understand because ways of
indicating
vary from manufacturer to manufacturer:
"Features" and "Efficacy and indications" overlap
with each other:
Desirable to indicate whether the medicines are
"Generics" or not:
10
* As the plural answers are all added, the total exceeds 198.
(4)
Awareness of the revision of the OTC medicines
retailing system
At present, the
revision of the OTC medicines retailing system has
been under review among the Ministry of Health, Labour
and Welfare.
Do you know about this ?
1. Yes, I know.
2. No, I don't know.
3. Although I don't know, I am interested.
4. I neither know nor am interested.
"I know" (28.8%) is close to 30%.
71.2% respondents or a total of "I don't know" (22.1%), "Although I don't
know, I am interested" (47.5%) and "I neither know nor am interested"
(1.6%) answered they do not know that the revision of the retailing
system has been under review.
(5)
How to take care of oneself when one does not feel
well
How do you take
care of yourself when you do not feel well (symptoms
such as a common cold or stiff shoulders which you
can diagnose by yourself) ?
1. First of all, I will go to a pharmacy /a drugstore, buy an OTC drug and
use it.
2. First of all, I will go to a clinic to consult with a physician.
3. Depending on my symptoms, I will decide whether I go to a pharmacy/ a
drugstore or to a clinic.
4. I will watch the development of the symptoms for a little while.
Unanswered
The respondents who answered "Depending on my symptoms,
I will decide whether I go to a pharmacy/a drugstore or to a clinic"
(48.7%) were the largest in number, being close to 50%.
Combining the 48.7% and "First of all, I will go to a pharmacy/a drugstore,
buy an OTC drug and use it" (22.1%), the 70.8% respondents indicated
their intention to use OTC medicines.
These respondents were followed by "I will watch the symptoms for a little
while" (17.9%) and "First of all, I will go to a clinic to consult with
a physician" (11.3%).
(6)
Comparison of the costs in time-wise and economy-wise
To the respondents
who answered, in Question (6), "1: I will go to a
pharmacy/a drugstore"
or "2: I will go to a clinic" or "3: I will decide depending on the symptoms";
Have you made a comparison of the costs in time-wise and economy-wise ?
1. Yes, I have done.
2. No, I have not done.
3. Unanswered
821 respondents
To the respondents who answered "I will go to a pharmacy/a
drugstore", "I will go to a clinic", or "I will decide depending on the
symptoms" when they do not feel well, the question as to whether they
have made a comparison of the costs in time-wise and economy-wise, a
fairly large number (61.8%) of the respondents answered "Yes, I have
done".
(7)
Comments on OTC medicines
Your comments or
dissatisfaction on OTC medicines are welcomed.
"The prices of OTC medicines are high" scored the highest,
followed by "Pharmacists' professionalism is not adequately demonstrated",
"OTC medicines do not work well", "There are too many items to choose
", "There are anxieties about the safety and side-effects" and the like.
