In November last year, "Interim Report on Role of Over-The-Counter Medicines in Self-Medication - To encourage OTC Medicines to be needed, trusted and used with confidence" (commonly termed 'Interim Report') was compiled and publicized by "Expert Consultation for Streamlining Procedures to Approve and Examine OTC Medicines", an advisory task force for the Ministry of Health, Labour and Welfare (MHLW).
Among many steps proposed in the 'Interim Report', one entitled "Improvement in examining and approval process" specifically referred to the two steps sub-titled, "Exami-nation process" and "Review on application grouping and reduction in attachments".
The latter reads as follows:
"It is the government's mission to provide the public with the best available medicines as early as possible. In order to realize prompt, effective examinations, it is necessary to review and simplify the existing complicated application grouping at the time of application for approval.
It is also necessary to reduce the amount of data that must be attached with application, by making better use of existing medical data, both in terms of ethical considerations at clinical tests and of protecting animals."
Those concerned in the industry gladly welcomed the long-awaited realization of this step as recently as from October 1 this year.
Up until that date, "Data required for the applica-tion for approval of proprietary drugs" had been based on both Notification No. 481 issued on April 8, 1999 by Director General, Pharmaceutical and Food Safety Bureau (PFSB), MHLW and Notifica-tion No. 666 issued on the same day by Director, Evaluation and Licensing Division, PFSB, MHLW.
Now, Notification No. 0827003 issued on August 27 this year by Director General, Pharmaceutical and Food Bureau, MHLW, has partly repealed Notifications No. 481 and No. 666.
At the same time, Evaluation and Licensing Division, PFSB issued "Q and A concerning classification and data required for the application for approval of proprietary drugs" in order to facilitate applicants to properly file product registration dossiers with the competent authorities concerned.
On September 1, as a congratulatory event, JSMI, inviting a government official as an honorary lecturer, together with the major domestic four organizations related to the nonprescription medicines, co-sponsored a meeting in order to ensure that the streamlining measures are fully capitalized by all the interested persons and parties as well in the hope that such government-led measures could rejuvenate the stagnancy the non-prescription medicines business sector has been sighing about over the years.
OTC
Retailing Deregulation - Recent Movements
Although JSMI Newsletter No. 56, dated Septem-ber 30 featured, as the hottest topic, "Pharma-ceutical Retailing Outside of Pharmacy", we have ventured a guess that our overseas readers might want to be intrigued to learn how this highly controversial, sensitive, misleading and confusing issue has been developing itself from the previous news.
A brisk comment by the then Prime Minister Junichiro Koizumi, "To allow all the medicines with no safety concern be sold outside of pharma-cies by the end of this year" and a prudential counterstatement by the then Minister of Health, Labour and Welfare, Dr. Chikara Sakaguchi, "Those medicines whose safety has been established could be sold outside of pharmacies, yet, a careful consideration needs to be given to whether OTC to quasi-drug shifting similar to the current system be applied or new categorical naming be conceived" seemed to have blessedly produced a Government decision at its regular Cabinet meeting held in June.
The gist of the decision is "A thorough review of nonprescription medicines shall be carried out by the end of this year from the viewpoints of con-sumers' convenience and their safety so as to identify the nonprescription medicines presenting no safety concern" and "All those nonprescription medicines presenting no safety concern shall be sold not only at pharmacies and drugstores but also at general retail outlets".
Incidentally parliamentary elections held in late October gave a great loss of seats to the Japan's Social Democratic Party which had been the most powerful postwar opposition party and a staunch defender of the pacifist constitution and whose chairwoman had been considered to be a possible contender for the Prime Minister Koizumi.
On the other hand, Koizumi, with his ruling Liberal Democratic Party having won the nation's confidence, was reelected to the partyﾕs president and, consequently, to the Prime Minister.
The reelection has accelerated a flow of concrete actions including intensive discussions in line with the Government decision.
One of the fruits was the formation of "Task Force on the selection of medicines presenting no major safety issues".
At its first meeting, "Task Force" agreed to form "Working Group" whose main role is to select non-prescription medicines that present no safety concern from the following two criteria:
* whether the medicines can be judged to have a mild action to the human body or not in terms of pharmacological profile
* whether provision of information by the professionals is essential or not
At its first meeting, "Working Group" agreed to comb approximately 17,000 OTC drug items carried in "Non-prescription Drugs in Japan" and "OTC Handbook" for selection of nonprescription medicines presenting no safety concern based on the above two criteria.
At its second meeting, "Task Force" organized a public hearing of seven interested parties, of whom two (Japan Chain Store Association and Japan Franchise Chain Association) were for the pharma-ceutical retailing deregulation while five (Japan Pharmaceutical Association, National Medicine Retail Association, All Japan Druggist Associa-tion, etc.) were against it.
At its second meeting held late in October, "Working Group" agreed, as its working proce-dures, to classify nonprescription medicines into five groups depending on the method of providing information, in accordance with the second criterion, as follows:
(1) Whether it is necessary for pharmacists to verbally explain to the consumers
(2) Whether it is necessary to prepare DIREC-TIONS to be handed over to the consumers at the time of purchases
(3) Whether it is necessary to indicate information on the outer containers/wrappers
(4) Whether it is sufficient to provide information stated on the package inserts
(5) Others
The selection in accordance with the first criterion is to follow after the above classification has been completed.
The
8th Health Forum by the Asahi Shimbun Dailies
On October 25, the 8th Health Forum was held under the sponsorship of Kanagawa Prefecture Pharmaceutical Association, Asahi Shimbun dailies and JSMI in the Hamagin Hall, Yokohama, Kanagawa Prefecture.
The Forum consisted of two parts; PART I (Speeches) and PART II (Panel Discussion).
PART I:
Hideaki Tanaka, Vice Chairman, Kanagawa Prefec-ture Pharmaceutical Association spoke about the role of community pharmacists under the title, "Let's be smart at utilizing community pharmacists !" and Cathy Nakajima, a TV personality spoke about her and her husband's health care under the title, "Try to know yourself; Try to understand your partner."
The gist of the speeches is as follows:
"Let's be smart at utilizing community pharmacists !"
Face-to-face sale by a pharmacist should be the principles when any drugs are sold and purchased. Drugs may be classified into two groups: Prescrip-tion and Nonprescription medicines.
As medical science advances and experience with newer medicines evolves, the reclassification or switch of active ingredients (or indications) from prescription to nonprescription status should be allowed if they are shown to be safe and effective for direct consumer use.
This is typically referred to as prescription-to-non-prescription (commonly termed Rx-to-OTC) switch, which has received a good deal of attention in our country like in many other countries and today approximately 50 switched products are available in the domestic market.
No drugs are free from interactions and side effects. Interactions can occur when you mix certain medicines with even ordinary foods, beverages or other medicines. Some interactions can produce unwanted side effects or make a medicine less effective. Therefore, always look for information on the medicine label or seek advice of a community pharmacist. In this context, you are encouraged to establish a good relationship with a pharmacy or pharmacist as your family pharmacy/pharmacist who acts as your good and liable partner in promoting and maintaining your health.
"Try to know yourself; Try to understand your partner"
As our children grew to manhood, we were able to have more time to spend together. After we both turned 40, once every year, we have been under-going complete physical examinations.
To know and understand the results of my own as well as my partner's examinations certainly serves as a yardstick for paying attention to the physical condition each other.
To exchange tender words each other between me and my husband works wonders as effective as medicines. Afterall, to be gentle to others and to improve one's point of excellence could enrich a flavour of life.
PART II:
The panelists were Yoko Araki (M.D., Ph.D. Director, Shutoken Health Administration Center, Tokyo, South Branch), Hideaki Tanaka, Takashi Kanda (President, Consumer Healthcare Company, Takeda Chemical Industries, Ltd.) and Cathy Nakajima.
All the panelists were in full agreement that, while the term, "Self-Medication" has been gradually understood and recognized in the country as there is a worldwide trend for people to take greater charge of their own health, one should be re-sponsible for one's own health by way of deciding whether to take nonprescription medicines or to consult a physician when one feels sick.
They were also unanimous in reaching the con-clusion that, for properly practicing responsible self-medication, it is advisable for the general public to bear in mind three basics, namely,
(1) To regularly undergo a medical checkup:
(2) To constantly check the medicine chest:
(3) To identify a pharmacist as one's family pharma-cist.
Perhaps the most valuable key learning from the Health Forum is the fact that the consumers are seeking much more precise and detailed infor-mation on the proper use of medicines.
Some examples are shown below:
* Many consumers know pretty well that interactions can occur when a certain type of hypertension drugs and slices of grapefruits are concomitantly taken, but, they do not know whether they can safely take slices of grapefruits after a lapse of time or not.
* Those who have long been on medication (laxatives) keep worrying if such a long use might adversely affect their physical condition or if they should change the medication to other medicines.
* They know taking a medicine with water is the ABC, but, they are less sure as to the quantity of water to be taken.
Since there has been strongly expressed a desire for uniform guidance as to disposal of the leftover medicines, the industry is urged to standardize the directions for disposal.
Handbook on Self-Medication compiled
The Public Affairs Committee printed 200,000 copies of a pam-phlet for consumers entitled anew "Self-Medication Handbook - Promotion and maintenance of health through proper use of non-prescription medicines".
The Data Subcommittee of the Public Affairs Committee attempt-ed to significantly renovate this annual campaign of public relations not only by changing the title from "A Master Guide to OTC Drugs" to the above mentioned "Self-Medication Handbook - Promotion and maintenance of health through proper use of non-prescription medicines" but also by increasing the number of copies from 160,000 to 200,000.
Corresponding to the "Week of Medicines and Health" annually sponsored by MHLW and Japan Pharmaceutical Association for promoting proper use of medicines, the Committee distributed the copies to 47 prefectural pharmaceutical author-ities, Consumer Centers, 12 Public Health Centers in Tokyo, Osaka, and 10 other major cities designated by the Cabinet Order, Prefectural Pharmaceutical Associ-ations, and Pharmacy Universities.
Distribution was done in a much wider scope as compared with the precedents, covering many more institutions throughout the country.
The contents of the pamphlet featured, among others, the 8-page articles to enlighten the readers on the basic knowledge of self-medication, using consumer friendly words and phrases such as “Why is self-medication necessary ?", "How should I practice self-medication ?", "Check your own health.", "Check your life style.", and the like.
International
Drug Price Comparison issued by MHLW
In late
August, Economic Division, MHLW issued a report, "Results
of International Survey on Prices of Medicines and Medical
Devices - 2002", of which key findings concerning nonprescription
medicines are shown below:
1: SURVEY RESULTS
Comparison by exchange rate(With Tokyo taken as 100)
A
B
C
D
E
F
G
Cold remedies
100
101
110
81
86
72
57
Antacids
100
53
57
70
51
97
37
Antipyretics and Analgesics
100
81
91
136
131
173
84
A : Tokyo B
: New York C : Los Angeles
D : London E
: Paris F : Dusseldorf
G : Singapore
Exchange Rate(Tokyo Foreign Exchange Market: March 31,2003)
New York/Los Angeles
1US＄
YEN120.15
London
1Pound sterling
YEN189.72
Paris
1Euro
YEN130.96
Dusseldorf
1Euro
YEN130.96
Singapore
1Singapore＄
YEN68.09
2: SURVEY OBJECTS
Most ideally, such a survey comparing the prices of nonprescription medicines should be conducted with the items having the same specifications (types of active ingredients, their quantities, and other properties) for ensuring fair and accurate comparison of the survey objects that are easily available and accessible throughout the world.
Practically speaking, however, there are no such nonprescription medicines as could meet these comparison criteria. Consequently, three thera-peutic categories (Cold remedies, Antacids, and Antipyretics & Analgesics) and five top brands in the categories sold in the seven cities were chosen as a yardstick for comparison.
REFERENCE TABLE 1
Comparison by PPP on GDP base (With Tokyo taken as 100)
(UNIT:YEN)
A
B
C
D
E
F
Cold remedies
100
123
135
96
105
84
Antacids
100
81
87
83
62
113
Antipyretics and Analgesics
100
99
111
161
159
202
A : Tokyo B
: New York C : Los Angeles
D : London E
: Paris F : Dusseldorf
PPP : Purchasing Power Parity
A type of currency exchange rate obtained by calculating so that the goods and amount of services which can be purchased by the currency of one country and the currency of another country become equal.
GDP : Gross Domestic Product
GDP base : PPP in each country was calculated by OECD using, in lieu of effects of exchange rate,
price data for goods and services which make up GDP of the OECD member countries, for the purpose of assessing the actual purchasing power.
Singapore was not included in the comparison by PPP on GDP base because data of GDP base were not available.
PPP (GDP base)
U.S.A
Dollar
YEN147.00
London
Pound sterling
YEN224.77
Paris
Euro
YEN158.92
Dusseldorf
Euro
YEN152.97
REFERENCE TABLE 2 Comparison of cost for daily dose of
the top five brands
(Calculated on exchange rate) (UNIT:YEN)
A
B
C
D
E
F
G
Cold remedies
185
186
204
150
160
134
105
Antacids
205
108
117
144
105
198
75
Antipyretics and Analgesics
152
123
138
207
199
263
127
A : Tokyo B
: New York C : Los Angeles
D : London E
: Paris F : Dusseldorf
G : Singapore
REFERENCE TABLE 3
Comparison of cost for daily dose of the top five brands
(Calculated on PPP base) (UNIT: YEN)
A
B
C
D
E
F
Cold remedies
185
186
204
150
160
134
Antacids
205
108
117
144
105
198
Antipyretics and Analgesics
152
123
138
207
199
263
A : Tokyo B
: New York C : Los Angeles
D : London E
: Paris F : Dusseldorf
REFERENCE TABLE 4
Average number of active ingredients contained in the top five brands (UNIT: YEN)
A
B
C
D
E
F
G
Cold remedies
4.5
2.4
2.4
1.6
2.8
1.5
1.8
Antacids
5.4
1.4
1.4
1.8
2.2
2.4
2.0
Antipyretics and Analgesics
3.8
1.3
1.3
1.8
2.2
2.0
1.8
A : Tokyo B
: New York C : Los Angeles
D : London E
: Paris F : Dusseldorf
G : Singapore
Aging
and Less Birthrate continue
On August 20, Ministry
of Management and Coordination issued the findings of
the census of the population as of March 31, 2003 as follows:
The total population:
126,688,364
Live births:
1,151,507
Deaths:
1,007,966
Natural increase:
143,541
While the number of deaths marked the highest record,
that of natural increase registered the lowest record
in the year 2002.
Incidentally, the number of persons aged 65 and over increased
0.57% to 18.8% of the total population.
Tightening
Advertising Control on Health Foods
As of August 29, the revised Health Promotion Act went into effect.
Before the enforcement of the Act (promulgated in 2002), Safety Division, Pharmaceutical and Food Bureau, MHLW urged, through the Internet for three weeks from July 3 to 23, interested persons and parties to send their opinions and comments concerning the revisions.
The revised Health Promotion Act clearly bans false or exaggerated statements in the advertise-ments regarding health maintenance and promo-tion effects claimed by the "so-called"health foods.
Notably, penal provisions have been incorporated in the revised Act so as to penalize any violations.
