CONTENTS President's Forum 2 Commentary 3 Reflections 4 Materia-Non-Medica 6 Letter to the Editor 8 Medical Students' Column 9 Classified Ads 10

EDITORIAL BOARD Editor A/Prof Goh Lee Gan

Assistant Editor Dr Wong Chiang Yin

Members Dr Au Kah Kay Dr Chan Kah Pone A/Prof Chee Yam Chang Dr Goh Jin Hian Dr Jon Goh Dr Tan Hooi Hwa

Ex-officio Dr Wong Chiang Yin Dr Cheong Pak Yean

Executive Secretary Ms Chua Gek Eng

Editorial Assistants Ms Tan Hwee Ping Ms Hazel Goh

The views and opinions expressed in all the articles are those of the authors. These are not the views of the Editorial Board nor the SMA Council unless specifically stated so in writing. The contents of the Newsletter are not to be printed in whole or in part without prior written approval of the Editor. Published by the Singapore Medical Association, Level 2, Alumni Medical Centre, 2 College Road, Singapore 169850 Telephone 223 1264 Facsimile 224 7827 Email sma_org@pacific.neLsg URL httpt//www.sma.org.sg

THESMANEWS Vol 30 NO 4 Aril 1998

I

Our challenge going forward is to balance the pursuit of medical excellence and affordability of healthcare to individuals, their families and the community.

■ SPEECH BY DPM LEE HSIEN LOONG AT OFFICIAL OPENING OF CHANGI GENERAL HOSPITAL

Ladies and Gentlemen, 1. I am happy to be here this morning to declare the opening on the new Changi General Hospital.

2. Changi General Hospital is the first of our new-generation regional hospitals. Developed at a cost of $380 million, it replaces two of our old hospitals, Changi Hospital which was built in the 1930s, and Toa Payoh Hospital which has been operating for 37 years. It will provide high quality medical care across a wide range of specialities, wider than what Toa Payoh Hospital and the old Changi Hospital used to provide. The types of medical care provided include general medicine, general surgery, orthopaedic surgery, geriatrics, rehabilitation medicine and psychiatry, ENT and eye, plus two sub-specialities: gastro-enterology and urology.

3. Changi General Hospital is part of the Ministry of Health's master-plan to build a modern hospital network of developed-country standards, to meet the needs of the Singaporean population for the 21st century. In the past decade, the Health Ministry has built or redeveloped 5 hospitals, 4 national centres and 8 polyclinics. The upgrading programme will continue. The Government is committed to provide Singaporeans with excellent and affordable health care. This is part of our vision of Our Best Home for Singaporeans.

4. Changi General will be the main hospital serving the eastern part of Singapore. We have decided to rename it Changi General Hospital rather than New Changi Hospital. The new name better reflects its role as a regional hospital offering a broad range of services, and also the main provider of hospital services for the 750,000 Singaporeans living east of Kallang Basin.

Acute Hospital Network 5. The national network of acute hospitals comprises of regional hospitals such as Changi General Hospital, tertiary hospitals such as Singapore General Hospital and National University Hospital, and national centres such as the National Heart Centre, the National Neuroscience

Institute, or the National Cancer Centre. These three levels of the hospital system serve different segments of the patient population according to different medical needs. Together, they enable patients to enjoy the best care possible at the best value.

Regional Hospitals 6. Regional hospitals like Changi General are the main providers of hospital care in the acute hospital network. We envisage three regional hospitals in Singapore: Changi General in the east; Tan -lock Seng Hospital serving the central sector; and eventually a new hospital serving the west. They have the appropriate levels and mix of medical, nursing and paramedical personnel. They are equipped with modern facilities and equipment. They have the resources and the professional capability to manage most patients efficiently and effectively.

7. For most medical conditions, Singaporeans should regard the regional hospital nearest them as the hospital of their first choice. For all but the most complex problems, regional hospitals will provide good quality and affordable care. Should they need to be referred to a tertiary hospital or a national centre because of their medical condition, the regional hospital will do so. Regional hospitals, tertiary hospitals and national centres will cooperate closely to handle referrals smoothly. They share the goal of quality service.

8. The Government encourages each regional hospital to excel in one or two specialities or sub-specialities. This will enhance the professional standing and public reputation of the hospitals. It will help them to attract and retain good staff. It will also encourage Singaporeans living in the vicinity to use regional hospitals as the hospital of their choice. For example, Changi General Hospital has capabilities in gastro-enterology and urology. The Government will also consider allowing Changi General to develop other clinical services, if there is high demand from the catchment population of the hospital, and if it can successfully do so.

► N5

38TH SMA COUNCIL

President 1st Vice President 2nd Vice President Honorary Secretary Hon Asst Secretary Honorary Treasurer Council Members

Dr Cheong Pak Yean Dr Lim Took Bong Dr Tan Kok Soo Dr Wong Chiang Yin Dr Tan Sze Wee Dr Goh Jin Hian Dr Lee Pheng Soon, A/P Low Cheng Hock, Dr Low Lip Ping, Dr W R Rasanayagam, Dr Tan Yew Ghee, Dr T Thirumoorthy, Dr Wong Tien Yin, Dr Wong Weng Hong, Dr Jason S K Yap, Dr Yue Wai Mun

Glaxo Wellcome plc IMPORTANT NOTIFICATION RELATING TO INTELLECTUAL PROPERTY PROTECTION ON RANITIDINE AND RANITIDINNE HYDROCHLORIDE

Glaxo Wellcome's ranitidine products for the treatment of ulcers and other gastrointestinal disorders are sold in Singapore by Glaxo Wellcome Singapore Pte Ltd under the registered trademark

ZANTAC These products continue to be an important part of Glaxo Wellcome's portfolio of healthcare products in Singapore and elsewhere.

The specific polymorphic form of ranitidine hydrochloride known as Form 2, which is the active constituent in Zantac• products, is the subject of Singapore Patent Registration No. 522/85, which remains in force until 1 October 2001.

Glaxo Wellcome also holds patents and other intellectual property rights in Singapore relating, inter alia, to processes for making ranitidine hydrochloride and certain intermediates, and to specific formulations and presentations, all of which remain in force until at least 2003.

It has come to the attention of Glaxo Wellcome that certain parties in Singapore have been involved in importing, offering for sale, selling and distributing "Urantac" 150mg tablets which are not manufactured by or with the consent of Glaxo Wellcome, and which contain Form 2 ranitidine hydrochloride, which is protected by the aforementioned Singapore Patent Registration No. 522/85.

Consumers and members of the public Ile advised that all genuine Glaxo Wellcome products are sold in Singapore under the Zantac trademark by Glaxo Wellcome's Sole Distributor, Inchcape Healthcare. Purchases of such products should only be made from the Sole Distributor or from authorised dealers appointed by the Sole Distributor.

TAKE NOTICE that Glaxo Wellcome will vigorously enforce its intellectual property rights in respect of ranitidine and ranitidine hydrochloride by commencing legal proceedings and seeking remedies including injunctions, delivery up of infringing products, damages and legal costs, as well as commencing criminal prosecution if necessary, in the event of infringement by authorised development sale, offer for sale, manufacture, importation, or stock-piling of ranitidine hydrochloride.

President's Forum

THE TASKS AHEAD

This is my third term as President of SMA and by constitution, this will be my last consecutive year as President. The AGM has returned al the candidates that I know will provide the leadership and the continuity ahead.

My first task in the third term is to list the tasks that some committees would tackle.

1. MEMBERSHIP COMMITTEE We have to look at the declining percentages of SMA membership in private practice over the past few years. Though we have not done detailed analyses, we suspect that the sectors least represented are either general practitioners practising alone or assistants working in group practice.

We also need to look at the question of spouse membership again. The constitutional amendment made last year to reduce the subscription for this group have not achieve any result. Also, lady doctors are under-represented at all levels. We are quite fortunate to have a lady council member this year after a hiatus of at least 5 years. Maybe this council would be able to increase participation by lady doctors.

2. ETHICS COMMITTEE The Ethics Committee has steadily made progress. This year, the committee ambit would be further enlarged and this would be reflected in the appointment of 3 vice-chairmen, one for each of the areas in ethical policy, special case management and publications.

The committee would look into pro-active case management and mediation in certain cases. The ethical policy group would be looking into the issue of media interviews and publications by doctors. More important, the Ethics and Practice Manual would be published before the end of this council's term.

3. PRIVATE PRACTICE COMMITTEE The subject of the clinic dispensary was discusssed at the AGM. A task force within an enlarged private practice committee would study the subject in depth and initiate necessary actions. The guideline for charges for medicine would also be published by the end of this council's term.

4. INVITATION TO PARTICIPATE We are enclosing the names and contacts numbers of the chairmen/vice-chairmen appointed to the various committees in an enclosure. Please response to indicate the area you are interested in. ■

DR CHEONG PAK YEAN

AGM NEWS

THE 38TH SMA COUNCIL The 38th Annual General Meeting of the SMA was held on Sunday, 19 April 1998. The following were elected as office bearers for the 39th Council for 1998/1999. President

Dr Cheong Pak Yean 1st Vice President

A/Prof Goh Lee Gan 2nd Vice President

Dr Lim Teck Beng Honorary Secretary

Dr Wong Chiang Yin Hon Asst Secretary

Dr Goh Jin Hian Honorary Treasurer

Dr Tan Sze Wee

The other newly-elected members of the 39th SMA Council are Dr Ang Peng Tiam, Dr Vivian Balakrishnan, Dr Chow Wan Cheng, Dr Chong Yeh Woei and Dr Yue Wai Mun.

Dr Cheong Pak Year, Dr Lim Teck Beng, Dr Tan Kok Soo, Dr Wong Chiang Yin, Dr Lee Pheng Soo, A/Prof Low Cheng Hock, Dr T Thirumoorthy and Dr Wong Wang Hong, who were elected to the 38th SMA Council, will continue to serve their second year on the 39th SMA Council.

C/Prof Chao Tzee Cheng and Dr Wong Heck Sing elected as SMA Honorary Members The Singapore Medical Association is honoured that during the 38th SMA AGM held on 19th April 1998, C/Prof Chao Tzee Cheng and Dr Wong Heck Sing were elected to Honorary Membership in recognition of their services to the medical profession and the community. The official conferment of the Honorary Membership will be held on 25 April 1998, at the SMA Annual Dinner. ■

Medical Advisory Board Mount Elizabeth Hospital

CARDIOLOGY, THORACIC & CARDIOVASCULAR SURGERY

SPECIALTY GROUP

TALK Thursday, 28 May 1998

1.00 pm to 2.00 pm

TOPIC Current Issues in Cardiovascular Medicine

SPEAKER Dr Michael Lim

CASE PRESENTATION "Limb Salvage" — Dr C Sivathasan

CHAIRMAN Dr Lim Chin Hock

VENUE Seminar Room 1, Education Centre Mount Elizabeth Hospital #02-01

Singapore 228510

Lunch is sponsored by Mount Elizabeth Hospital and will be served at 12.00 pm

This talk has been accredited with one CME point

All doctors are welcome

The Last Whistle

When peer pressure fails

What remains?

The letter of the law

The rhetoric of ethics

And the whistle from our hearts

We whistled loud

We fought on

Is our cause forlorn?

Is our calling now. drowned

by the clang of cash registers?

But now the last whistle

Has reverberated

Through HDB and regal corridors

The albatross now hangs

on our necks and more

Should we all bother

When doctors can only prosper

By trading patients like fodder?

And whistle blowers should beware

Pounds of flesh prepare

Will this last whistle

Be the clarion of a new bidding

Or the knell of medicine's calling?

Will this whistle

Be the last of our pleading?

WHISTLE BLOWERS

Excellent, affordable healthcare is dependent on several elements. Defined delivery systems and a prevailing ethos of cooperation .are two of such elements. These are reflected in BG Lee Hsien Loong's address on the occasion of the opening of the Changi General Hospital. The text of his address forms the lead article in this issue of the Newsletter.

We have over the years developed a good healthcare infrastructure. This is however, not enough. There is a need for regional hospitals, tertiary hospitals and national centres to co-operate closely to handle referrals smoothly. Each must do what one is good at and appropriate for his level of care. For this to happen, we need a change of mindset. There is a need of a mental revolution to value working with one another. The credo of institutions have to change to what is their role in patient care, research and professional development of doctors. The organisation of seminars for GPs and public talks should not be for more market share. They should be aimed at reinforcing the notion of working together for good, affordable medical care.

Two other areas of cooperation are

necessary towards excellent, affordable healthcare. One is the patient. 130 Lee has also alluded to this. The patient needs to be discerning and to use the various elements of the health care delivery system appropriately. He or she should make use of the regional hospitals instead of tertiary hospitals where appropriate. Similarly, if the patient would make use of his primary care doctor, then the workload in the A & E and hospital walk-in clinic will be much reduced. The queue will be shorter and the service will be faster. All it needs is for every citizen to use it only for real emergencies.

The other area of cooperation is between the hospital and the primary care clinics. Doctors in the government polyclinics and private clinics can play a bigger role if their services are put to optimal use. The primary care doctor should be linked to the regional hospital of his district in more than one sense. He should be linked through patient care, through referrals and also in his professional development. He must have the confidence he will get his patient whom he has referred back to him again. He must have a

meaningful role in the patient management. He must know enough doctors in that hospital to be able to receive help and support professionally at the time he needs that.

Many hospitals have seen the merits of developing the doctors in their drainage areas. Perhaps, more primary care doctors should avail themselves of such linkages. Notwithstanding these linkages, there are still problems in the shared care programmes. Many patients in the shared care programmes return to hospital care because the primary care doctor can never provide the medicines at the cost that the hospital can. The hospital is able to get cheaper medicines because of quantity purchase. Perhaps, this advantage could be shared with the participating primary care doctors.

Excellent, affordable health care is possible in Singapore, if we seek out avenues to see how we can cooperate and enable each of us to do a better job. And this applies to the patient too. After all, he or she is the most important factor in the health care provision equation. Food for thought. ■

A/PROF G OH LEE GAN

Commentary

EXCELLENT, AFFORDABLE HEALTHCARE

N2 N3 1

Reflection]

Doctors are aware of the meaning of caring for the patient. They are also aware of the constant tussle between patient interest and self interest. The world has become commercialised. Money is increasingly seen as a symbol of success. The latest commercial arrangement to hit the profession is the profit guarantee. Is this a sign of the times?

The gut feeling among many doctors is this has gone out-of-bounds of what is acceptable to the medical profession. We are seduced by the charm of the so-called "free market forces" without balancing this with the long tradition of medical ethics that has been the guiding light to the profession. "Free market" is seen as a panacea. We have forgotten where our values should be anchored.

What is doctoring? Is it the age-old promise and commitment to the patient and the community that the doctor will use his healing hand to reduce suffering? Or is it a means to increase earning capacity?

The changing climate of medical practice has evoked different emotions. To some there is despair and a sense of helplessness. See Dr A's letter to the SMA President. Some get angry and resign from the SMA. See letter from B.

The SMA Council has decided that the profit guarantee puts the doctor at risk of unethical behaviour and discourages doctors from being a party to such commercial arrangements. Some doctors who are waiting to jump on the bandwagon may get angry and view this as whistle blowing. It is encouraging that the Singapore Medical Council has supported the resolution passed by the SMA Council.

To the doctor As and Bs in our medical profession, we need to move beyond despair and anger. These are emotions of futility. We need to encourage every thinking person in the medical profession, in the public, and in our Goverment to reflect on the increasing commercialisation of medical practice. Should we accept it as the sign of the times? Or should we remind doctors of their promise to society — to relieve suffering — as their manna and regard making money as a secondary concern? •

A/PROF GOH LEE GAN

Dr A's letter to SMA

14 April 1998

Dear President, I refer to your letter regarding the "profit

guarantee", dated 11 April 1998. After all have been said, what are you going to do about it?

Is the SMA going to recommend to the SMC to recommend to the government to pass laws to the effect that doctors cannot take part in profit making for themselves or for the health care organisations? Unless this is done, the resolution will just remain a resolution without any teeth, and nobody will be bothered and everybody will continue in their own happy ways. In fact, in a very short time, all will be forgotten and more doctors will jump onto the bandwagon. What wants to be left behind? Who is to be faulted?

It will be a very sad day indeed for the medical profession.

Is there any way to halt this onslaught on the medical profession when more and more numbers of the medical community see no way out but join in the fray?

Be that as it may, I like to give my whole hearted support to the resolution passed. As least SMA has taken a stand and I am in total agreement that ethical standards must be maintained. How to go about it other than through the Singapore Medical Council is always the problem facing the SMA.

Yours faithfully, Dr A

(Editor's note: For purpose of confidentiality, the doctor's name will not be revealed)

Dr B's letter to SMA

14 January 1998

Dear Sir, I have watched with dismay and

disappointment the inability of the SMA to stem the winds of change, from the practice of medicine to the marketing. of medicine.

I do not wish to be a member of the SMA.

Yours faithfully, Dr B

(Editor's note: For purpose of confidentiality, the doctor's name will not be revealed. The Secretary has accepted the member's letter of resignation hut hopes that he will continue to exert efforts on his own to stem the winds of change.

THE PROFIT GUARANTEE: THE GOVERNMENT'S POSITION

The Government's position on profit guarantee

was reported by the Straits Times and the

Business Times on 21 April 1998. The subject was

tabled by Mr Choo Wee Khiang, MP for Jalan

Besar GRC on 20 April 1998 at the Parliament.

He wanted to know how profit guarantee would

affect the standard of medical practice here. This

follows the recent Business Times report on the

deal struck in February between AsiaMatrix and

four specialists in private practice. The doctors

guaranteed AsiaMatrix a $4.36 million share of

the profits annually for five years beginning on

Jan 1, in exchange for it acquiring majority stakes

in their businesses.

In reply, the Health Minister, Mr Yeo Cheow

Tong said that "the Health Ministry supports the

strong stand taken by the Singapore Medical

Association (SMA) on the issue of doctors giving

profit guarantee". "These", said Mr Yeo, "will put

them at greater risk of unethical behaviour as

they are working under purely financial

imperatives imposed by a third party." The SMA's

resolution was also supported by the Singapore

Medical Council.

Mr Yeo said that the four specialists "do not

contravene any existing laws, and the parties do

not require the ministry's approval." But he added

that the Ministry is "very concerned with any

commercial transaction... which can lead to a

lowering of our high professional and ethical

standards of medical practice." "We must

remember that the doctor-patient relationship is

different from other consumer-provider

transactions, where the consumer has sufficient

knowledge of the service or product to make an

informed choice. It is therefore vital... that the

doctor remains professionally independent to do

what he believes is best for the patient."

He added that the Ministry of Health will

conduct more intensive audits on medical

establishments at greater risk of compromise of

professional or ethical standards, and will not

hesitate to act decisively to bring errant doctors

before the Singapore Medical Council when

needed.

"Doctors who enter into business

arrangements must be circumspect and avoid any

situation or arrangement, which would potentially

compromise their professional independence and

their patients' interests.", said the Minister. •

Food For Thought

JOURNAL SAYS AMERICANS LOSING FAITH IN DOCTORS

The Journal of the American College of Physicians, warned on Tuesday, 14 April 1998, that US society was losing confidence in the ability of physicians to curb their appetite for money. The Annals of Internal Medicine, which the doctors' group

publishes, said in its latest issue that a public

loss of faith in medical ethics could be seen in efforts by the Congress and the Clinton Administration to crack down on physician fraud.

"I hope that we in Singapore do not end up in the same boat..:' Professor SY Tan, Professor of Medicine and Adjunct Professor of Law of University of Hawaii

"That society should see a need for laws to protect patients from their physicians is disheartening:' an editorial in the journal by Dr

M Gregg Bloche, a medical doctor and legal expert at the Georgetown University Law Center in Washington said, "Physicians should heed the sobering message the laws send —that Americans have lost faith in their physicians' ability to restrain themselves when tempted by money."

The American College of Physicians, which represents more than 100,000 doctors, has joined the American Medical Association and other groups to seek new ways to root out abuse and

punish fraud while reducing unnecessary burdens on doctors.

The College Journal's Editorial also called on the medical community to recommit itself to the Hippocratic Oath, which embodies the essence of medical ethics. "Restoration of people's confidence in the medical profession's willingness to keep faith at the bedside should be a higher priority for physicians than criticism of the fraud

and abuse laws." it said. •

Source: David Morgan from Reuters, 14 April 1998

Editor's note: The Editor wishes to thank Professor SY Tan for sending this piece of news from Reuters

ccnt'd from N1 "SPEECH BY OPM LEE AT OFFICIAL OPENING OF THE CHANGI GENERAL HOSPITAL"

9. Regional hospitals can build closeness to the communities they serve, and can reach out more to the communities than a national-level institution can. Since moving into these new facilities, Changi General has been conducting health education talks, health screenings for common diseases, and training for residents in CPR and first aid. You have been running patient support groups and helping patients to learn self-care skills after being discharged from hospital for conditions such as diabetes, stroke and incontinence. You have also been working closely with other caregivers like general practitioners, and plan to establish links with nearby nursing homes and community hospitals, including offering them training and assistance. I commend the staff of Changi General on your efforts to make this the hospital of first choice for residents of the eastern part of Singapore.

10. Regional hospitals allow Singaporeans to enjoy good quality medical care at affordable prices. They should avoid competing head-on with tertiary hospitals and national centres. Their value lies in precisely that they can provide at lower cost the best care for a large proportion of medical needs, by referring the minority of cases needing more expensive facilities and complex treatment to tertiary hospitals and national centres. At the same time, tertiary hospitals and national centres should not expand into those areas which are better met by regional hospitals.

11. On their part, Singaporeans needing medical services should use the level of care appropriate to their needs. If they make unnecessary or excessive use of specialist services in the tertiary hospitals and national centres, they will drive up medical costs, It will also mean longer waiting times for appointments and hospital beds, physical overcrowding and long queues in these tertiary centres. Many patients now managed in the tertiary hospitals and national centres can be just as well managed in regional hospitals, and at lower cost.

12. it is understandable that Singaporeans who need medical treatment want the best treatment possible. But if everyone looks for a specialist to do an MRI scan every time he has a headache, we will never have enough specialists or MRI machines, nor are we able to afford them. I urge Singaporeans to use these expensive facilities only for complex medical conditions that cannot be adequately treated elsewhere. In many developed countries, patients must be referred by a general practitioner before they can see a specialist. Fortunately we do not need to do that yet. If we can convince Singaporeans that regional hospitals provide as good care as the tertiary hospitals, that should help reduce the problem.

Tertiary Hospitals and National Centres 13. Tertiary hospitals manage patients with more complex problems across a broad range of specialties. The two tertiary hospitals — SGH and

•

NUH — have the specialised expertise and facilities required to care for such patients properly: KK Women's and Children's Hospital is a specialist hospital, catering to the special needs

.of women and children.

14. We have 5 national centres of excellence: for skin, eye, heart, cancer and neuroscience. These cover the most important specialised areas to meet our present and future healthcare needs. Three of the centres — National Heart Centre, Singapore National Eye Centre and National Skin Centre are well established. The National Cancer Centre and. National Neuroscience Institute will open in 1999.

15. I understand that the regional hospitals are concerned that the tertiary hospitals will take patients away from them, and the tertiary hospitals are similarly worried about the national centres. They should not worry. The regional and tertiary hospitals will continue to manage the majority of patients within their capabilities, and refer only the difficult cases to the national centres. The different types of hospitals are meant to collaborate with and complement one another. Specialists with the appropriate qualifications, expertise and experience, no matter where they may be practising, should participate actively in clinical service, training and research activities at the national centres. Specialists in the relevant departments in the public hospitals will be offered concurrent appointments to the national centres. Those in the private sector will be invited to participate on a part-time basis.

Conclusion 16. We already have a first class healthcare system. Singaporeans have ready access to a wide range of preventive, curative and rehabilitative health programmes. We enjoy high quality medical care at affordable prices. We have managed to achieve this by complementing Government subsidies with our philosophy of promoting personal responsibility for one's own health, and requiring co-payment of at least part of the medical expenses when one falls ill.

17 Our challenge going forward is to balance the pursuit of medical excellence and affordability of healthcare to individuals, their families, and the community. We need to optimise the use of the acute hospital network. The regional hospitals will play a crucial role in providing high quality care to the large majority of patients.

18. It is now my pleasure to declare the Changi General Hospital open. •

I

Should we accept it as the sign of the times? Or should we remind doctors of their promise to society - to relieve suffering - as their manna and regard making money as a secondary concern?

• THE PROFIT GUARANTEE_LA_SIGN OF THE TIMES?

N5 N4

River crossing

Materia-non-medica

I

"Endless, the distant hills Blue upon blue, peak upon peak!'

■ GUNUNG TAHAN AND A HEALTHY LIFE-STYLE

Gunung Tahan, 2187 M, is the highest peak in Peninsular Malaysia. Situated on the main range in Taman Negara (Malaysia's national park), its challenge "lies not so much in its height nor the steepness of its sides, but rather in its remoteness and inaccessibility." The round trip from the park HO to the summit and back, a distance of about 110 Km, can be accomplished by the fastest trekkers in 5 days.

Someone once said that adventure is hardship recalled in the comforts of your sitting room. Thus, I tell my story.

Two months of "training" carrying 25 K packs up and down an HDB highrise block with week-end climbs on Bukit Timah hill and, mentally, we were ready.

A chartered minivan from Johor Bahru took us on an overnight ride to Jerantut, the town nearest to the ferry point for the national park, but the 3 hour ferry ride in a 12 seater narrow motor-boat up the picturesque Sungei Tembeling found us catching up with lost sleep.

Day 1 : 2.5.92 The Wildlife Department's office is situated in Kuala Tahan at the park HO. After obtaining our permits and declaring all tinned cans taken along (the empty tins had to be brought back at the risk of a penalty), we met Mohammed bin Hj Ibrahim, the guide assigned to us, and discussed our itinerary. William, our leader, had made a "secret" climb without a guide 5 years previously, but a guide was now compulsory.

Starting off at 8.45 am with myself (the slowest and oldest) to set the pace, we trekked 4 hours across undulating lowland jungle with many small streams and leeches a-plenty to reach Kem Melantai, where we cooked lunch by the river and buried our food for the return journey. The jungle protected us from the fierce sun. From Melantai, it was uphill all the way. For me, it was not the ultimate summit, but every step along the way, each step complete in itself, and every each moment, that made the journey. And as I began to experience our every movement, I began to enjoy the climb.

N6

On top of Tahan

Three-quarters way across the Malang Hills — a waterless ridge of 27 peaks between 300 —500 M high — we arrived at Kern Tengah, 379 M, at 6pm and camped for the night. At a hidden spring, 5 minutes down a steep slope, we drew water, precious living water, to wash ourselves and to cook rice for dinner, then settling down to a "happy hour" of brandy and retiring at Ilpm.

Day 2 : 3.5.92 A sleepless night — I always have difficulty trying to sleep in strange places, even in a 5-star hotel — and it was dry and comfortable within our two large 6-man tents. All were aroused by a "morning call" at 6.30 am and after breakfast we broke camp at 8.30 am.

We continued up the Malang Hills, climbing continuously, and in an hour reached Gunung Rajah, 576 M, the last and highest peak on the ridge. "Rajah is nothing!" Psychologically, we had triumphed.

Downhill all the way, we reached Kern Puteh, where we rested and cooked lunch from 11.15 am to 1.30 pm and again hid our food for the return journey. The scenery changed now from jungle treks to river crossings, and we crossed the Sungei Tahan — a fast flowing, thigh-deep river —8 times, with the assistance of a stout stick, in the strong current. The guide assisted me by holding my outstretched hand, to which Henry made a rude remark — something about "giving away the bride".

The sixth river crossing, on a tree trunk, was.

the easiest. Then, a difficult stretch along a high river embankment before arriving at Kern Teku, 168M, at 5.30pm. It has taken us 27 hills, one mountain, 8 river crossings and 2 days to arrive at the foothills of Gunung Tahan and still the mountain peak was out of sight.

Erected tents, cooked rice, bathed by the river, followed by "happy hour" and all our tiredness vanished.

Day 3 : 4.5.92 A late rising, and after a breakfast of porridge and tinned meats (energy needed for the climb) we broke camp and departed at 10 am. We also carried a cooked lunch of rice, sausage and dried prawns (our constant ration) because there was no water on the way.

"No great deal!" was the general sentiment, now that we had reached the top. But every mountain is its own, high or low, and to be reckoned with. To each his own mountain.

Uphill and uphill, "take 5", "take 10" at every half-hour, and we reached Pondok Dua ("Two Humps"), or Wray's Camp, 1100 M, by 3 pm, where we settled for the night. Water was available 10 minutes down a steep track, where we bathed and collected water in bottles tied around our necks, to cook rice and for the next day's journey.

We could have reached the next campsite further up, where there was prospect of a "beautiful sunrise", but there was no water up there.

Day 4 : 5.5.92 Each day the scenery changed, like someone changed the prop on stage. Departing Wray Kern at 9 am, we climbed an hour and reached Gunung Pankin, 1400 M, and after another 45 minutes, its upper reaches at 1463 M. We were now above the clouds and there were excellent views of the valleys below.

We continued our uphill climb and reached Gunung Tangga 15, 1539 M, at noon, where we stopped for a brief rest and resumed climbing. The terrain was steep and upwards almost all the way. The trail then ran along the top of a narrow ridge with breathtaking views (like from an aeroplane) on both sides.

We scaled up and down Gunung Reskit by ropes and paused for a dry lunch of biscuits in the rain. "Eat, for energy!", urged William, our leader, who was as shagged as anyone else. I laid on the ground. The whole world was my grave.

More vertical cliffs and rope-assisted climbs and, finally we made the shoulder of Gunung Gedong, which allowed a panoramic view of the Padang campsite below.

We pitched our tents on the grass at Padang and, because of strong winds, secured the fly-sheets firmly for our 2 nights stay. Our packs were hung on trees because rats were around the campsite at night. Bathed and collected water at the nearby stream whilst Bob cooked dinner in the rain, Bob always quietly cooking our meals.

The temperature was 16 degrees C in the evening, dropping to 12 degrees C at night. The Southern Cross showed the way whence we had come. The Plough pointed at Tahan, which was still out of sight, to the north. Then the mists came and blotted out the sky.

Day 5 : 6.5.92 It takes 3 hours from the Padang campsite to the top of Gunung Tahan. This was the day! We left at 10 am carrying only water, cooked lunch, medical kit (William's previous party was stung by hornets), the video and cameras.

The trail to the summit (minus the guide) was easy to follow. Over the Padang plateau, up along the dried-up river beds of quartz rocks, orchids, pitcher plants and stunted vegetation all around,

higher and higher up the ridge and we were at the top!

On top of Gunung Tahan, 2187 M at 1.30pm (a party from Kuala Lumpur arrived there before us) — the spot marked by a metal pylon with name-plates left behind by previous climbers. We took photos, hoisted the Singapore flag and the Seletar Hash pennant enacted the climb on video, and the rains came.

"No great deal!" was the general sentiment, now that we had reached the top. But every mountain is its own, high or low, and to be reckoned with. I shall never complain about Bukit Timah hill again. To each his own mountain. There was nothing more to do now other than to return.

Day 6 : 75.92 Coming down is always easier and this was the fun part. One step retrieved meant one step nearer home, one less obstacle to go, and so we made it down-hill (equal to our 2 days uphill climb) to Kern Tuku in about 8 hours.

Day 7 : 8.5.92 The return stretch from Kern Tuku to Kem Melantai (recovering the river crossings, Gunung Rajah and the 27 hills) was our longest, departing at 9 am and not arriving until after dark, in the rain, with torches, at 750 pm. It was only on the return journey that we could appreciate how far we had come. Like a reverse play on the cine, it was only now that I dared to look beyond my footsteps to realise the long stretches we had covered.

Day 8 : 9.5.92 This last day was the easiest. Departing Kern Melantai at 9.45 am we made our way swiftly on flat terrain back to the park HO by .1 pm, where chilled beers (prepared by our advanced party) and a shower at the HO awaited us. Time to throw away the dirty T-shirt I had worn for those 8 days and to inspect my two big toes, minus the nails, and the blisters over the heels.

Our return to Singapore was uneventful. We were now ready for our "National Big Walk", scheduled for 24.5.92. Shall we try? ■

DR LIM KUANG HUI OPHTHALMOLOGIST IN PRIVATE PRACTICE

Tel: 734 6666 Fax 734 6667

N7

G

L

In my opinion, gaining entry to the clinical school is akin to a lottery. How does a 10 — 15 minute interview allow one to judge if you are a suitable candidate to become a doctor?

For major corporations, interviewing job candidates is an intense and rigorous experience, consisting of two interviews and an assessment centre, with aptitude tests, personality inventories, report writing, practical tasks and exercises, group tasks, and giving presentations. By investing one to two days in this extremely thorough process, the companies attempt to ascertain your suitability for the job on offer. Then again, they are not always correct.

I have previously experienced a mock, but intense, assessment centre with Shell. We worked our way through real-life scenarios, and were given 40 minutes to prepare a 15-Minute talk. The talk was assessed on a one-to-one basis with a senior member of the corporation. During that time, I am positive that they elicited more about my personality and cognitive skills compared to a medical interview.

What are medical schools looking for when they evaluate candidates? According to Dr John Sear, head of the Oxford Clinical School, if one has consistently obtained distinctions preclinically, but has done nothing else but study, entry into the clinical school is not guaranteed. Most candidates are very similar when judged academically, therefore considerable emphasis is placed on the non-medical

Letter to the Editor

19 March 1998

Editor The SMA News Singapore Medical Journal

Dear Sir, I refer to Dr Lee Pheng Soon's article titled "Do doctors and pharmacists understand and trust each other enough?" published in the February 1998 issue of the Singapore Medical Journal.

I would like to commend Dr Lee Pheng Soon for bringing up cogent issues that affect the doctor-pharmacist relationship. It would be beneficial for the Pharmaceutical Society of Singapore (PSS) to clarify established and perceived misconceptions and assumptions with regards to pharmacists roles, responsibilities and training.

1. On the question of dispensing exactly according to prescription, pharmacists are professionally and ethically obliged to do so. This is clearly stated in the Code of Ethics For Pharmacists Section D(2) which states "A pharmacist who has accepted a prescription for dispensing will dispense the prescription exactly in accordance with the prescribers wishes and, in particular will not (except with approval of the prescriber or in an emergency) substitute any other product for a specifically named product even if the therapeutic effect and quality of the other product are identical." Hence fears that doctors may have with regards to therapeutic substitution are unfounded. Generic drugs are cheaper than branded ones. Therefore the question of generic substitution needs to be addressed by both doctors and pharmacists collaboratively in order to alleviate the economic burden on patients and reducing healthcare costs in the long run.

2. On the question of unregulated health products and herbal remedies being stocked in the pharmacies, the offer far sale of such products should not be construed as unethical. The main problem lies in the fact that these products are not medicines and therefore are not regulated except as food items. The other issue is the promotion of these health products and quasi-medicinal products as health-giving by the manufacturer. Medical advertisement on the label and insert of a quasi-medicinal product are controlled under the Sale of Drugs Act. Medical advertisements in general are regulated under the Medicines (Medical Advertisements) Regulations of the Medicines Act. Consumers, doctors and pharmacists should report to the Ministry of Health if they find any quasi-medicinal product making unwarranted medical claims. Pharmacists are also critical of products that have not been properly tested. In the same way consumers practise self-medication, the purchase of health products must be carried out responsibly with information and

advice from pharmacists and their doctors as safe-guards. Pharmacists are ethically bound to regard the health of their patients as their first consideration. Section A (3) of the Code of Ethics states that "A pharmacist should not encourage a member of the public to purchase or obtain more of a medicinal product than he may reasonably require". Therefore pharmacists have to exorcise their professional discretion in dealing with purchases of health products made by members of the public. I am certain that doctors fears that patients are more likely to try and self-medicate with health products if they were sent to a pharmacy is unfounded given the fact that such products are available in health food shops, supermarkets and even the grocers, places which the public is more likely to frequent. The answer to the issue about health products lie in public education and informed choices. As a public watch dog, the Consumers Association of Singapore (CASE) can play a more pro-active role. Members of the public should complain to CASE if they come across dubious claims being made on health products. The Advertising Standards Authority of Singapore (ASAS) is another body that can actively look at dubious claims and advertisements. The Pharmaceutical Society of Singapore's stand on health products is that the consumer should be given all relevant and unbiased information including scientific data (if any) about the products. The pharmacist should advice the consumer and make the relevant recommendations, including not to purchase a certain product (where applicable), putting the health of the consumer as his first consideration.

3. With regards to the undergraduate and professional training of pharmacists, they are well equipped to take on the complementary role as members of the healthcare team.

The pharmacy undergraduate course offered at the National University of Singapore is a 3-year Bachelor of Science (Pharmacy) and a 4-year Bachelor of Science (Pharmacy) with Honours (3 years B Sc. Pharmacy + 1 year Honours) degree course. Starting from the present academic year (1997/1998), it will move to a full 4-year structure with most students graduating with a B Sc (Pharmacy) Honours.

The objectives of the pharmacy undergraduate curriculum are two-fold: firstly, to establish a strong foundation in the pharmaceutical sciences and secondly focus on competencies in patient-oriented skills, based on the medical sciences, clinical pharmacy and pharmacy practice.

There are 29 essential modules and 10 elective modules in the course. One module is equivalent to 50 hours of instruction (lecturers, tutorials, practical). The essential modules are distributed as follows: Pharmaceutical Chemistry (medicinal chemistry and pharmaceutical analysis) = 7 modules,

Pharmaceutics (physical pharmacy, pharmaceutical technology, dosage form design) = 6 modules, Pharmacy Practice (pharmacy law, pharmacotherapy, therapeutic drug monitoring) = 9 modules, and Medical Sciences (taught by the Faculty of Medicine — anatomy, physiology, pathology and pharmacology), 7 modules. Doctors and pharmaceutical practitioners are invited to give some of the lectures in the modules mentioned.

Upon graduation, pharmacy graduates have to satisfactorily complete a one year pre-registration training (similar to housemanship for doctors) at an approved training centre (usually in a community or hospital pharmacy) under the supervision of a registered pharmacist based on an approved training syllabus before they can register as a pharmacist. During the one year period, pre-registration pharmacists also have to attend a series of compulsory lectures organised by the Pharmaceutical Society of Singapore for example: communication & presentation skills, community, hospital and industrial pharmacy, first aid, and therapeutic sessions. These lectures are delivered by pharmacy practitioners and doctors. At certain training sites, pre-registration pharmacists are attached to a GP clinic for interaction.

After registration, there are continuing pharmacy education (CPE) opportunities just as there are CME opportunities. The Pharmaceutical Society of Singapore has a CPE accreditation scheme which is voluntary. Pharmacists can choose to attend lectures which are accredited by the Society.

4. On the issue of patients being able to request prescriptions from doctors, it is very encouraging to note that the SMA encourages its members to oblige their patients if requested. It would be helpful to patients and lay public if SMA can make a public statement on this collaboratively through CASE or even with PSS. Most patients do not know they can request for such prescriptions.

In light of what has been said, as responsible health professionals, there should be greater collaboration between doctors and pharmacists at all levels which can only lead to better understanding, co-operation and respect between the two professions. Doctor's and pharmacist's roles are complementary and we need to work as a team for the ultimate benefit of patients. The goal must be to collaboratively provide a high standard of healthcare that is affordable to all Singaporeans through more interprofessional dialogues and collaboration. •

Thank you.

Yours sincerely,

MR WU TUCK SEND President Pharmaceutical Society of Singapore

Medical Students' Column

Letter from Oxford: Medical Interviews Miss Michelle Teo is a fourth year medical student in Oxford University. She was involved in helping the SMA collate a community service directory.

The Oxford medical course is clearly delineated into a pre-clinical and a clinical phase. Entry into the pre-clinical course requires at least 1 interview though two interviews are the norm for foreign students. It is well known that there is a quota of 3 foreign medical students each year. Usually one Singapore applicant is accepted though there are some years no Singaporean is accepted.

Entry to study pre-clinical medicine here does not automatically secure a place in the John Radcliffe Hospital in Oxford for the clinical years. Instead other applicants for example with B.A. or B.Sc. degrees are also enticed to join the keen competition. However, all applicants have to pass the first part of the B.M. examination. This does not exclude non-pre-clinical students from studying Medicine. I know law graduates, who proceed to do pre-clinical medicine for 2 years and then join in the rush for clinical school places.

Presently, numerous applicants for the Clinical School are readying themselves for a panel interview with 6 doctors. Needless to say, they are all fairly anxious, realising that success at the interview would enable them to train with some of the best doctors and surgeons in the world.

E DATE TOPIC S 7th

Localising Lesion with Eye Signs H 21st

Eye Trauma

Venue

Health Education Centre, Level 3, East Shore Medical Centre C Person

Ng Chieh Yun, 340 8750/736 3538

DATE

TOPIC 6th

Hospital-Acquired Pneumonia — Fact vs Fiction 13th

Erectile Dysfunction — New Treatments, including Viagra 20th

Update on the Management of Seronegative Spondyloarthropathy 27th

Photoaging

Venue

Lecture Theatre, Level 3, Gleneagles Hospital C Person

Sharon Yap, 470 5650/736 3538

• DATE

TOPIC E 8th

Broadening of Therapeutic Options for Asthma: Ant-leukotrienes Therapy H 15th

Towards a Pain-Free Surgery — An Update an Post Operative Pain Relief 22nd

Genetic Counselling in Obstetric Practice 29th

Effects of Radiocontrast on the Kidney: How Real is the Problem?

Venue

Doctors' Dining Room/Seminar Room 1, Education Centre, Level 2, Mt Elizabeth Medical Centre

C Person

Angela Tay, 731 2079

SPEAKER/CHAIRMAN Drs Yeow Yew Kim/Yea Poh Took Drs Marc Tay/S M Tahir

SPEAKER/CHAIRMAN Drs Amy Stebbings/Tan Tiong Har Ors I Swaminathan/Tan Hun Hoe Drs Koh Wei Howe/Leong Keng Hong Die Tan Kong Chong/Tham Siew Nee

SPEAKER/CHAIRMAN Drs Sally Wenzel (U of Colorado)/Cheong Tuck Hong Drs Boey Wah Keong/George Lim Drs Ivy Ng (KK Women & Children H)/Yeoh Swee Choo Drs Akira Wu/ Pwee Hock Swee

Parkway Group Healthcare Pte Ltd • East Shore Hospital • Gleneagles Hospital • Mount Elizabeth Hospital •

(1_00pm to 2.00pm) CME Monthly Calendar — May 1998

aspects of your life. I am fortuitous in that I can count myself among the few who were offered a place without an interview. Perhaps ail that time spent on a basketball court and an athletics track accomplishes much more than just self-fulfilment.

The interview serves as a means by which your future clinical tutors assess whether they would like to work with you. You have to know more about yourself, than about various rare clinical syndromes. They look for honesty and personality, not just candidates who are cardboard copies of an ideal prospect. One student was asked: "Which preclinical subject do you think will be most useful in your clinical years?". Instead of giving a textbook answer, he quipped: "I guess that I will find that out only when I begin clinical school:' He is currently a successful Oxford student.

One of the factors which interviewees cannot overcome is the prejudice which the interviewers may hold. The latter will always have a conception of what a medical student should look like, and how a medical student should act. If one doesn't fit into this profile, hard luck.

Mistakes will always be made because the selection process is not 100% accurate. 1 have some very good medic friends whose company I enjoy, but I know that I will never approach them for a medical consult. For all I know, there are friends out there who will avoid me at all costs when I graduate. •

MICHELLE TED

N8 N9

SNIA Classif ied Ads

Ak1 ■ FOR SALE/RENTAL

Mount Elizabeth Medical Centre Clinic to share with present occupant. A surgeon or anaesthetist preferred. Please call Mylene at Tel 734 3749.

Clinic space available for sharing in Gleneagles Medical Centre comprising personal office space of 220 square feet and common reception/waiting area. Available immediately. Please call 474 4677

Clinic space for rent at Mount Elizabeth Medical Clinic. Area approx. 1,100 sq feet. Contact 940 44016.

Clinic room available at Mt Elizabeth Medical Centre. Common reception, waiting area and OT to be shared. Please call Irene at 732 2334.

Clinic in Hounanq for taking over. Good returns. Interested parties please page 9312 8032. Assistant doctor also required. Those interested please page 9312 8032.

■ POSITIONS AVAILABLE

Full-time associate required for clinic in Kembangan Plaza. Please contact Rudolf at 9668 9242.

Female doctor required by clinic in HOB estate in Jurong East. Good remuneration and working hours. Fax 463 0541 of Tel 463 0540.

Young full-time Assistant Doctor needed in HDB practice at Chua Chu Kang. About 40-42 hour week only, including several evenings and weekends. Interested please write personally with full resume, expected salary & recent photo to: The Advertiser, 14 Jalan Ria, Singapore 359070.

GOH K. S. SKIN CLINIC

Dear Colleagues,

I would like to inform you that I have resigned as a Consultant Dermatologist from the National Skin Centre.

My new practice is at: Gob K.S. Skin Clinic 9 Penang Road #07-12 Park Mall Tel : 333 5626 Fax : 333 5623

Thank you for all your support in the past and I hope to be of service to you and your patients in the future,

With warmest regards,

DR GOH KIM SOON Consultant Dermatologist M.D., FAMS (Dermatology) American Board of Dermatology

A. B. JOHN Ear, Nose & Throat (ENT Clinic & Surgery) Mount Elizabeth Medical Centre 3 Mount Elizabeth #15-10, Singapore 2288510

A.B. JOHN EAR, NOSE & THROAT (ENT)

CLINIC & SURGERY PTE LTD

Dear Colleagues,

I have resigned my post as Head of the Ear, Nose & Throat Department at Tan Tock Song Hospital, with immediate effect.

My new clinic is located at: 3 Mount Elizabeth #15-10 Mount Elizabeth Medical Centre Singapore 228510

Tel :735 9654 Fax :737 5912 e-mail : johnent@mbox5.singnet.com.sg

Sincerely,

I orvi,4„1„...1,1

Consultant, ENT Surgeon MBBS (Singapore), FRCS (Glasgow), FAMS (Singapore)

NATIONAL UNIVERSITY HOSPITAL SINGAPORE

Excellence: Our Mission, A Commitment

The National University Hospital is a 900-bed multi-specialty teaching hospital. An opportunity exists td share in our mission of achieving excellence in patient care, medical education and research through the provision of quality patient care with state-of-the-art medical technology.

REGISTRAR IN GASTROENTEROLOGY.

Applicants must hold a basic medical degree registrable with the Singapore Medical Council and must possess an M Med (Int Med), MRCP (UK) or ARIM qualification or their equivalent and a good grounding in general medicine. Commencing salary will be competitive depending on qualifications and experience.

You have the opportunity to participate actively in the care patients with general medical, gastroenterological and liver-related (including liver transplantation) problems. Research is strongly encouraged. Commencing salary will be competitive depending on qualifications and experience.

Please give full personal particulars, professional qualifications, career history and expected salary together with medical testimonials, certificate of registration, recent photograph and telephone number to:

Chairman, Medical Board Medical Affairs Department National University Hospital

5 Lower Kent Ridge Road Singapore 119074

Fax: (65) 775 6757 Tel: (65) 772 5920/22 Website: http://www.nuh.com.sg Enquiries: leesmanuh.com.sg

Closing date: 4 May 1998

Dear Colleagues,

We wish to inform you that we have relocated from Specialist

Shopping Centre, Our new practice is at:

Mien, A. 41m ettftic 1, GRANGE ROAD, #10-03, ORCHARD BUILDING

SINGAPORE 239693 TEL : 2353280 (3 Lines) FAX: 7358319

Thank you for your support.

DR KHEW KHOON SHIN MBBS, AM, FICS, FRCOG (London)

DR THOMAS UM WEE HWA MBBS, (Syd) AM, FRCOG (London)

TEOH Colon, Rectum & General SURGERY

DR TEOH TIONG ANN MBBS (S'pore), FRCS (Fain), FAMS M.Med (Surgery) (Spore), FICS Consultant Colorectal Surgeon Consultant General Surgeon

Dear Colleagues, I would like to inform you that I have commenced private practice in Mt Elizabeth Medical Centre specialising in Colorectal Surgery, General Surgery and Laparoscopic Surgery.

I was previously Consultant Colorectal and General Surgeon at Tan Took Seng Hospital, where I am now a Visiting Consultant. Besides being a trained and accredited General Surgeon, my subspecialty training is in Colorectal Surgery.

I was a Fellow in Colorectal Surgery at the Cleveland Clinic Florida, USA. my specialty experience includes the surgical treatment of Colorectal Cancer, especially Sphincter-Preserving Surgery for Low Rectal Cancers (Reducing unnecessary Colostomies), Surgery for Inflammatory Bowel Disease, Reconnstructive Anal and Rectal Surgery and Proctology including the treatment of Hemorrhoids, Fistulae, Anal Problems, Fecal incontinence and Constipation.

I will also practice the full range of General Surgery. My other subspecialty interest is in Laparoscopic Surgery and this include

procedures like Laparoscopic Appendicetomy, Cholecystectomy and also Advanced Laparoscopic Procedures like Needlescopic Cholecystectomy and Laparoscopic Colorectal Surgery.

My clinic address is: TEOH Colon, Rectum and General SURGERY Suite 05-04, Mt Elizabeth Medical Center Tel: 738 9133 Fax: 738 7889 24-hr Answering Service: 535 8833 or 9802 5555

Please feel free to contact me if I can offer any assistance to your patients' surgical problems. I would also be most happy to accept referrals for Emergency Consultations and am available 24-hours via the answering service.

I look forward to being of service to you and your patients.

DR TEOH TIONG ANN

,Qs a*) Agape ray & Ultrasound Centre

60 Albert Street. 003-11 Atari Complex, Singapore 18096g. Ter, 339 9718 Fax: 339 1355

Of. Mtn: MON - : 9.00 ant - FOP 1.00 -.3.00

SAnJ000Y: 9 Mani -I Cap nt.

Dear Colleagues,

I wish to thank you for your kind support for the past 6 years while at Radiologic Clinic.

I will be commencing practice in April at Agape Imaging at #03-11, Albert Complex (opposite Sim Lim Square). We will be performing daily contrast (Barium and IVU) examinations, ultrasound, mammography as well as plain film facilities.

We look forward to your kind support and to be of assistance to you and your patients.

Thank you.

Warmest regards,

DR NG HWEENA

Dear Colleagues,

I wish to inform you that I have resigned from TanTock Seng Hospital as Consultant Rheumatologist. I have started my private practice at Mount Elizabeth Medical Centre.

Besides my special interest in the management of rheumatoid arthritis and seronegative spondyloarthropathy/ankylosing spondylitis, I am also keen to treat other rheumatological conditions such as difficult gout, osteoarthritis, psoriatic arthritis, soft tissue rheumatism, immune diseases eg. systemic lupus erythematosus, and osteoporosis.

I can be contacted at: Koh Wei Howe Arthritis & Rheumatism Medical Clinic 3 Mount Elizabeth #07-05 Mount Elizabeth Medical Centre Singapore 228510 Telephone 737 5255 Facsimile 732 5066 Answering service 9802 5555 Pager 9535 8075

Sincerely,

DR KOH WEI HOWE Consultant Rheumatologist and Physician Visiting Consultant, Tan Tock Seng Hospital MBBS, MRCP (UK), FAMS (Rheumatology)

1.11.919999d DP NO NWEEhla 1.19.138 PFICA

N10 N 11

9020301 VARIVAXTh

[Varicella Virus Vaccine Live (Oka/Merck)]

DESCRIPTION VARIVAX * [Varicella Virus Vaccine Live (Oka/Merck)] is a

preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with natural varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.

VARIVAX, when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 rnL dose contains the following: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes, approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg sodium chloride, 0.5 mg monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, 0.08 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of sodium phosphate monobasic, EDTA, neomycin, and fetal bovine serum. The product contains no preservative.

To maintain potency, the lyophilized vaccine must be kept frozen at an average temperature of -15°C (+5°F) or colder and must be used before the expiration date (see HOW SUPPLIED, Stability and Storage). Storage in any frost-free freezer (e.g. chest, frost-free) that reliably maintains with an average temperature of -15°C (+5°F) or colder and has a separate sealed freezer door is acceptable.

CLINICAL PHARMACOLOGY Varicella is a highly communicable disease in children,

adolescents, and adults caused by the varicella-zoster virus. The disease usually consists of 300 to 500 maculopapular and/ or vesicular lesions accompanied by a fever (oral temperature >100°F) in up to 70% of individuals.1,2 Approximately 3.5 million cases of varicella occurred annually from 1980-1994 in the United States with the peak incidence occurring in children five to nine years of age.3 The incidence rate of chickenpox is 8.3-9.1% per year in children 1-9 years of age.4 The attack rate of natural varicella following household exposure among healthy susceptible children was shown to be 87%.2 Although it is generally a benign, self-limiting disease, varicella may be associated with serious complications (e.g., bacterial superinfoction, pneumonia, encephalitis, Reye's Syndrome), and/or death.

Evaluation of Clinical Efficacy Afforded by VARIVAX Clinical Data in Children

In combined clinical trials5 of VARIVAX at doses ranging from 1,000-17,000 PFU, the majority of subjects who received VARIVAX and were exposed to wild-type virus were either completely protected from chickenpox or developed a milder form (for clinical description see below) of the disease. The protective efficacy of VARIVAX was evaluated in three different ways: 1) by comparing chickenpox rates in vaccinees versus historical controls, 2) by assessment of protection from disease following household exposure, and 3) by a placebo-controlled, double-blind clinical trial.

In early clinical trials,5 a total of 4142 children received 1000-1625 PFU of attenuated virus per dose of VARIVAX and have been followed for up to six years post single-dose vaccination. In this group there was considerable variation in chickenpox rates among studies and study sites, and much of the reported data were acquired by passive follow-up. It was observed that 2.1%-3.6% of vaccinees per year reported chickenpox (called breakthrough cases). This represents an approximate 67% (57-77%) decrease from the total number of cases expected based on attack rates in children aged 1-9 over this same period (8.3-9.1%).4.6 In those who developed breakthrough chickenpox postvaccination, the majority experienced mild disease (median number of lesions <50). In one study, a total of 47% (27/58) of breakthrough cases had <50 lesions compared with 8% (7/92) in unvaccinated individuals, and 7% (4/58) of breakthrough cases had >300 lesions compared with 50% (46/92) in unvaccinated individuals./ In studies of vaccinated children who contracted chickenpox after a household exposure, 57% (31/54) of the cases reported <50 lesions, while 1.9% {1/54) reported >300 lesions with an oral temperature above 100°F.

In later clinical trialss with the current vaccine, a total of 1164 children received 2900-9000 PFU of attenuated virus per dose of VARIVAX and have been followed for up to three years post single-dose vaccination. It was observed that 0.2%-1.0% of vaccinees per year reported breakthrough chickenpox for up to three years post single-dose vaccination. This represents an approximate 93% decrease from the total number of cases expected based on attack rates in children aged 1-9 over this same period (8.3%-9.1%).2.25 In those who developed breakthrough chickenpox postvaccination, the majority experienced mild disease.

Among a subset of vaccinees who were actively followed, 259 were exposed to an individual with chickenpox in a household setting. There were no reports of breakthrough chickenpox in 80% of exposed children; 20% reported a mild form of chickenpox .5 This represents a 77% reduction in the expected number of cases when compared to the historical attack rate of varicella following household exposure to

chickenpox of 87% in unvaccinated individuals? Although no placebo-controlled trial was carried out with

VARIVAX using the current vaccine, a placebo-controlled trial was conducted using a formulation containing 17,000 PFU per dose.4.5 In this trial, a single dose of VARIVAX protected 96-100% of children against chickenpox over a two-year period. The study enrolled healthy individuals 1 to 14 years of age (n=491 vaccine, n=465 placebo). In the first year, 8.5% of placebo recipients contracted chickenpox, while no vaccine recipient did, for a calculated protection rate of 100% during the first varicella season. In the second year, when only a subset of individuals agreed to remain in the blinded study (n=163 vaccine, n=161 placebo), 96% protective efficacy was calculated for the vaccine group as compared to placebo.

There are insufficient data to assess the rate of protection against the complications of chickenpox (e.g., encephalitis, hepatitis, pneumonia) in children.

Clinical Data in Adolescents and Adults Although no placebo-controlled trial was carried out in

adolescents and adults, efficacy was determined by evaluation of protection when vaccinees received 2 doses of VARIVAX 4 or 8 weeks apart and were subsequently exposed to chickenpox in a household setting.5 In up to two years of active follow-up, 17 of 64 (27%) vaccinees reported breakthrough chickenpox following household exposure; of the 17 cases, 12 (71 %) reported <50 lesions, 5 reported 50-300 lesions, and none reported >306 lesions with an oral temperature above 100°F. In combined clinical studies of adolescents and adults (n=1019) who received two doses of VARIVAX and later developed breakthrough chickenpox and reported numbers of lesions (42 011019), 25 of 42 (60%) reported <50 lesions, 16 of 42 (38%) reported 50-300 lesions, and 1 of 42 (2%) reported >300 lesions and an oral temperature above 100°F.5

The attack rate of unvaccinated adults exposed to a single contact in a household has not been previously studied. When compared to the previously reported attack rate of natural varicella of 87% following household exposure among unvaccinated children, this represents an approximate 70% reduction in the expected number of cases in the household setting,2

There are insufficient data to assess the rate of protection of VARIVAX against the serious complications of chickenpox in adults (e.g., encephalitis, hepatitis, pneumonitis) and during pregnancy (congenital varicella syndrome).

lmmunogenicity of VARIVAX Clinical trials with several formulations of the vaccine

containing attenuated virus ranging from 1000 to 17,000 PFU per dose have demonstrated that VARIVAX induces detectable immune responses in a high proportion of individuals and is generally well tolerated in healthy individuals ranging from 12 months to 55 years of age.4.5.5-25

Seroconversion as defined by the acquisition of any detectable varicella antibodies (gpELISA >0.3, a highly sensitive assay which is not commercially available) was observed in 97% of vaccinees at approximately 4-6 weeks postvaccination in 6889 susceptible children 12 months to 12 years of age. Rates of breakthrough disease were significantly lower among children with varicella antibody titers >5 compared to children with titers <5. Titers >5 were induced in approximately 76% of children vaccinated with a single dose of vaccine at 1000-17,000 PFU per dose. In a multicenter study involving susceptible adolescents and adults 13 years of age and older, two doses of VARIVAX administered four to eight weeks apart induced a seroconversion rate (gpELISA >0.3) of approximately 75% in 539 Individuals four weeks after the first dose and of 99% in 479 individuals four weeks after the second dose. The average antibody response in vaccinees who received the second dose eight weeks after the first dose was higher than that in those, who received the second dose four weeks after the first dose. In another multicenter study involving adolescents and adults, two doses of VARIVAX administered eight weeks apart induced a seroconversion rate (gpELISA >0.3) of 94% in 142 individuals six weeks after the first dose and 99% in 122 individuals six weeks after the second dose.5

VARIVAX also induces cell-mediated immune responses in vaccinees. The relative contributions of humoral immunity and cell-mediated immunity to protection from chickenpox are unknown.

Persistence of Immune Response Studies in vaccinees examining chickenpox breakthrough

rates over 5 years showed the lowest rates {0.2-2,9%) in the first two years postvaccination, with somewhat higher but stable rates in the third through fifth year. The severity of reported breakthrough chickenpox, as measured by number of lesions and maximum temperature, appeared not to increase with time since vaccination .5

In clinical studies involving healthy children who received 1 dose of vaccine, detectable varicella antibodies (gpELISA >0.3) were present in 98.8% (3775/3822) at 1 year, 98.9% (1057/ 1069) at 2 years, 97.5% (548/562) at 3 years, and 99.5% (220/ 221) at 4 years postvaccination. Antibody levels were present at least one year in 97.2% (423/435) of healthy adolescents and adults who received two doses of live varicella vaccine separated by 4 to 8 weeks. A boost in antibody levels has been observed in vaccinees following exposure to natural varicella which could account for the apparent long-term persistence of antibody levels after vaccination in these studies. The duration of protection from varicella obtained using VARIVAX in the absence of wild-type boosting is unknown. VARIVAX also induces cell-mediated immune responses in vaccinees. The relative contributions of hurioral immunity and cell-mediated immunity to protection from chickenpox are unknown.

Transmission In the placebo-controlled trial, transmission of vaccine virus

was assessed in household settings (during the 8-week postvaccination period) in 416 susceptible placebo recipients who were household contacts of 445 vaccine recipients. Of the 416 placebo recipients, three developed chickenpox and seroconverted, nine reported a varicella-like rash and did not seroconvert, and six had no rash but seroconverted. If vaccine virus transmission occurred, it did so at a very low rate and possibly without recognizable clinical disease in contacts. These cases may represent either natural varicella from community contacts or a low incidence of transmission of vaccine virus from vaccinated contacts (see PRECAUTIONS, Transmission).4.16 Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.

Herpes Zoster Overall, 9454 healthy children (12 months to 12 years of

age) and 1648 adolescents and adults (13 years of age and older) have been vaccinated with Oka/Merck live attenuated varicella vaccine in clinical trials. Eight cases of herpes zoster have been reported in children during 42,556 person years of follow-up in clinical trials, resulting in a calculated incidence of at least 18.8 cases per 100,000 person years. The completeness of this reporting has not been determined. One case of herpes zoster has been reported in the adolescent and adult age group during 5410 person years of follow-up in clinical trials resulting in a calculated incidence of 18.5 cases per 100,000 person years.5

All nine cases were mild and without sequelae. Two cultures (one child and one adult) obtained from vesicles were positive for wild-type varicella zoster virus as confirmed by restriction endonuclease analysis.5.17 The long-term effect of VARIVAX on the incidence of herpes zoster, particularly in those vaccinees exposed to natural varicella, is unknown at present.

In children, the reported rate of zoster in vaccine recipients appears not to exceed that previously determined in a population-based study of healthy children who had experienced natural varicella:5,181g The incidence of zoster in adults who have had natural varicella infection is higher than that in children 20

Reye's Syndrome Reye's Syndrome has occurred in children and adolescents

following natural varicella infection, the majority of whom had received salicylates.21 In clinical studies in healthy children and adolescents in the United States, physicians advised varicella vaccine recipients. not to use salicylates for six weeks after vaccination. There were no reports of Reye's Syndrome in varicella vaccine recipients during these studies.

Studies with Other Vaccines In combined clinical studies involving 1080 children 12 to

36 months of age, 653 received VARIVAX and M-M-R*11 (Measles, Mumps, and Rubella Virus Vaccine Live) concomitantly at separate sites and 427 received the vaccines six weeks apart. Seroconversion rates and antibody revels were comparable between the two groups at approximately six weeks post-vaccination to each of the virus vaccine components. No differences were noted in adverse reactions reported in those who received VARIVAX concomitantly with M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) at separate sites and those who received VARIVAX and M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) at different times (see PRECAUTIONS, Drug Interactions, Use with Other Vaccines).5

In a clinical study involving 318 children 12 months to 42 months of ago, 160 received an investigational vaccine (a formulation combining measles, mumps, rubella, and varicella in one syringe) concomitantly with booster doses of DTaP (diphtheria, tetanus, acellular pertussis) and OPV (oral poliovirus vaccine) while 144 received M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) concomitantly with booster doses of DTaP and OPV followed by VARIVAX 6 weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella, and varicella and the percentage of vaccinees whose titers were boosted for diphtheria, tetanus, pertussis, and polio were comparable between the two groups, but anti-varicella levels were decreased when the investigational vaccine containing varicella was administered concomitantly with DTaP. No clinically significant differences were noted in adverse reactions between the two groups.5

In another clinical study involving 307 children 12 to 18 months of age, 150 received an investigational vaccine (a formulation combining measles, mumps, rubella, and varicella in one syringe) concomitantly with a booster dose of PedvaxHlB` [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] while 130 received M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) concomitantly with a booster dose of PedvaxHlB followed by VARIVAX 6 weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella, and varicella, and geometric mean titers for PedvaxHlB were comparable between the two groups, but anti-varicella levels were decreased when the investigational vaccine containing varicella was administered concomitantly with PedvaxHlB. No clinically significant differences in adverse reactions were seen between the two groups.5

VARIVAX is recommended for subcutaneous administration. However, during clinical trials, some children received VARIVAX intramuscularly resulting in seroconversion rates similar to those

in children who received the vaccine by the subcutaneous route.22 Persistence of antibody and efficacy in those receiving intramuscular injections have not been defined.

INDICATIONS AND USAGE VARIVAX is indicated for vaccination against varicella in

individuals 12 months of age and older.

Revaccination The duration of protection of VARIVAX is unknown at present

and the need for booster doses is not defined. However, a boost in antibody levels has been observed in vaccinees following exposure to natural varicella as well as following a booster dose of VARIVAX administered four to six years postvaccination.s

In a highly vaccinated population, immunity for some individuals may wane due to lack of exposure to natural varicella as a result of shifting epidemiology. Post-Marketing surveillance studies are ongoing to evaluate the need and timing for booster vaccination.

Vaccination with VARIVAX may not muffin protection of all healthy, susceptible children, adolescents, and adults (see CLINICAL PHARMACOLOGY).

CONTRAINDICATIONS A history of hypersensitivity to any component of the

vaccine, including gelatin. A history of anaphylactoid reaction to neomycin (each dose

of reconstituted vaccine contains trace quantities of neomycin). Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Individuals receiving immunosuppressive therapy. Individuals who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Vaccination with live attenuated varicella vaccine can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressant doses of corticosteroids.

Individuals with primary and acquired immunodeficiency states, including those who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency virus;23 cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.

A family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.

Active untreated tuberculosis. Any febrile respiratory illness or other active febrile infection. Pregnancy; the possible effects of the vaccine on fetal

development are unknown at this time. However, natural varicella is known to sometimes cause fetal harm. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination. (See PRECAUTIONS, Pregnancy).

PRECAUTIONS

General Adequate treatment provisions, including epinephrine

injection (1;1000), should be available for immediate use should an anaphylactoid reaction occur.

The duration of protection from varicella infection after vaccination with VARIVAX is unknown.

It is not known whether VARIVAX given immediately after exposure to natural varicella virus will prevent illness.

Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of immune globulin or varicella zoster immune globulin (VZIG).24

Following administration of VARIVAX, any immune globulin including VZIG should not be given for 2 months thereafter unless its use outweighs the benefits of vaccination.24

Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX as Reye's Syndrome has

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been reported following the use of salicylates during natural varicella infection (see CLINICAL PHARMACOLOGY, Reye's Syndrome).

The safety and efficacy of VARIVAX have not been established in children and young adults who are known to be infected with human immunodeficiency viruses with and without evidence of immurtosuppression (see also CONTRAINDICATIONS).

Care is to be taken by the health care provider for safe and effective use of VARIVAX.

The health care provider should question the patient, parent, or guardian about reactions to a previous dose of VARIVAX or a similar product.

The health care provider should obtain the previous immunization history of the vaccinee.

VARIVAX should not be injected into a blood vessel. Vaccination should be deferred in patients with a family

history of congenital or hereditary immunodeficiency until the patient's own immune system has been evaluated.

A separate sterile needle and syringe should be used for administration of each dose of VARIVAX to prevent transfer of infectious diseases.

Needles should be disposed of properly and should not be recapped.

Transmission Post-marketing experience suggests that transmission of

vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.

Therefore, vaccine recipients should attempt to avoid, wherever possible, close association with susceptible high risk individuals for up to six weeks. In circumstances where contact with high-risk individuals is unavoidable, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural varicella virus. Susceptible high risk individuals include:

• immunocompromised individuals • pregnant women without documented history of

chickenpox or laboratory evidence of prior infection • newborn infants of mothers without documented history

of chickenpox or laboratory evidence of prior infection

Information for Patients The health care provider should inform the patient, parent

or guardian of the benefits and risks of VARIVAX. Patients, parents, or guardians should be instructed to report

any adverse reactions to their health care provider. Pregnancy should be avoided for three months following

vaccination.

Drug Interactions See PRECAUTIONS, General, regarding the administration

of immune globulins, salicylates, and transfusions.

Drug Interactions, Use with Other Vaccines Results from clinical studies indicate that VARIVAX can be

administered concomitantly with M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live).

Limited data from an experimental product containing varicella vaccine suggest that VARIVAX can be administered concomitantly with DTaP (diphtheria, tetanus, acellular pertussis) and PedvaxHlB using separate sites and syringes (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines).5 However, there are no data relating to simultaneous administration of VARIVAX with DTP or OPV.

Carcinogenesrs, Mutagenesis, Impairment of Fertility VARIVAX has not been evaluated for its carcinogenic or

mutagenic potential, or its potential to impair fertility.

Pregnancy Pregnancy Category Cr Animal reproduction studies have

not been conducted with VARIVAX. It is also not known whether VARIVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, VARIVAX should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).

Nursing Mothers It is not known whether varicella vaccine virus is secreted in

human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if VARIVAX is administered to a nursing woman.

Pediatric Use No clinical data are available on safety or efficacy of VARIVAX

in children less than one year of age and administration to infants under twelve months of age is not recommended.

ADVERSE REACTIONS In clinical trials,4.5.9-15 VARIVAX was administered to 11,102

healthy children, adolescents, and adults. VARIVAX was generally well tolerated.

In a double-blind placebo controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p<0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site.4

Children 1 to 12 Years of Age In clinical trials involving healthy children monitored for up

to 42 days after a single dose of VARIVAX, the frequency of fever, injection-site complaints, or rashes were reported as follows:

Table I Fever, Local Reactions, or Rashes (%) in Children

0 to 42 Days Postvactination

Reaction N Post Dose 1 Peak Occurrence in Postvaccinaton Days

Foyer 2102T (39°C) Oral 8827 14.7% 0-42

Injection-site complaints (pain/soreness, swelling and/or erythema, rash, pwritus, hematoma, induration, stiffness)

8915 19.3% 0-2

Varicella-like rash (injection site)

8916 3.4% 8-19

Median number of lesions 2

Varicella-like rash (generalized)

8916 3.8% 5.26

Median number of lesions 5

In addition, the most frequently (">1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, cough, irritability/ nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching.

Pneumonitis has been reported rarely (<1%) in children vaccinated with VARIVAX; a causal relationship has not been established.

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(hepatitis A vaccine, purified inactivated, MSD)

PROTECTION PURE AND SIMP

Uniquely practical prefilled syringes

streamline administration and record keeping

Peel-off label for patient charts makes vaccination record keeping easier

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" "`""' "A` PEINORK/ADOLESUNT FORIYIURTION 03 rnl, 1--25511

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Color-coded plunger rod reduces the chance of product misidentification

Prefilled syringe reduces administration time

Rigid needle shield minimizes the risk of accidental needlesticks and avoids needle blunting

Demonstrated 100% protection against hepatitis A after a single dose in 519

susceptible children (ages 2-16) in a landmark protective efficacy trial (p<0.001)''

Highly immunogenic* after a single dose in healthy adults and children (95% - 97%)2

Generally well tolerated'

Indicated for both children (>_2 years) and adults - One primary and one booster'

• A high level of vaccine purity2

References 1. Werzberger, A. et al.: A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children, N. Engl. J. Med. 327(7):453-457,

August 13, 1992. 2. Data on file, MSD Singapore

# A double-blind, placebo-controlled triaLin an American community with recurrent outbreaks of hepatitis A (n.1037). Efficacy was evaluated 50 days or more (primary end point) and as early as 30 days (secondary end point)2 after vaccination In all studies conducted by Merck & Co., Inc., the minimum anti-HAV titer required for seroconversion using the "modified HAVAB" assay was >10 mill/mi. HAVAB is a registered trademark of Abbott Laboratories

Before prescribing, please consult the prescribing information on page 143

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Febrile seizures have occurred rarely (<0.1%} in children vaccinated with VARIVAX; a causal relationship has not been established.

Adolescents and Adults 13 Years of Age and Older In clinical trials involving healthy adolescents and adults,

the majority of whom received two doses of VARIVAX and were monitored for up to 42 days after any dose, the frequency of fever, injection-site complaints, or rashes were reported as follows:

Table 2 Fever Local Reactions or Rashes (%) in Adolescents and Adulls

9 to 42. D ars Posivaccination

Reaction N Post Dose

1 Days

Peak Occurrence in

Postvaccination

N Post Dose

2 Days

Peak Occurrence in

Postvaccinaton

Fever 100'F (37.7°C) Oral

1584 102% 14-27 956 9.5% 0.42

Injection-gee complaints (soreness, erythema, sailing, rash, pruritus, pyrexia, heinatoma, induration, numbness)

1605 24.4% 0.2 955 32.5% 0-2

Varicella-like rash (injection site) Median ouster of lesions

1600 3%

2

6-20 955 1%

2

0-5

Varicella-like rash (generalized) Median number of lesions

1606

5

5.5% 7.21 955

5.5

0.9% 0.23

In addition, the most frequently (31%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, rnyalgia, disturbed sleep, nausea, malaise, diarrhea, stiff neck, irritability/nervousness, lymphadenopathy, chills, eye complaints, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, constipation, lower respiratory illness, allergic reactions (including allergic rash, hives), contact rash, cold/canker sore.

As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.

The following additional adverse reactions have been reported since the vaccine has been marketed:

Body As A Whole Anaphylaxis.

Hemic and Lymphatic System Thrombocytopenia.

Nervous/Psychiatric Encephalitis; Bell's palsy; ataxia.

Respiratory Pharyngitis.

Skin Stevens-Johnson syndrome; erythema multiforme; herpes

zoster.

DOSAGE AND ADMINISTRATION

FOR SUBCUTANEOUS ADMINISTRATION Do not inject intravenously

Children 12 months to 12 years of age should receive a single 0.5 mL dose administered subcutaneously.

Adolescents and adults 13 years of age and older should receive a 0.5 mL dose administered subcutaneously at elected date and a second 0.5 mL dose 4 to 8 weeks later.

VARIVAX is for subcutaneous administration. The outer aspect of the upper arm (deltoid) is the preferred site of injection.

VARIVAX SHOULD BE STORED FROZEN at an average temperature of -15°C (+5°F) or colder until it is reconstituted for injection (see HOW SUPPLIED, Storage). Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15°C and has a separate sealed freezer door is acceptable for storing VARIVAX. The diluent should be stored separately at room temperature or in the refrigerator. To reconstitute the. vaccine, first withdraw 0.7 mL of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe, change the needle, and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid) or the anterolateral thigh. IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of VARIVAX because these substances may inactivate the vaccine virus.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

To reconstitute the vaccine, use only the diluent supplied, since it is free of preservatives or other anti-viral substances which might inactivate the vaccine virus.

Do not freeze reconstituted vaccine. Do not give immune globulin including Varicella Zoster

Immune Globulin concurrently with VARIVAX (see also PRECAUTIONS).

Parenteral drug products should be inspected visually tor particulate matter and discoloration prior to administration, whenever solution and container permit. VARIVAX when reconstituted is a clear, colorless to pale yellow liquid.

HOW SUPPLIED No. 4826/4309 - VARIVAX is supplied as follows: (1) a

single-dose vial of lyophilized vaccine, NDC 0006-4826-00 (package A); and (2) a box of 10 vials of diluent (package B).

No. 4827/4309 - VARIVAX is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00; and (2) a box of 10 vials of diluent (package B)

(6505-01-413-1331, Ten Pack).

Stability VARIVAX retains a potency level of 1500 PFU or higher per

dose for at least 16 months in a frost-free freezer with an average temperature of -15°C (+5°F) or colder.

VARIVAX has a minimum potency level of approximately 1350 PFU 30 minutes after reconstitution at room temperature (20-25°C, 68-77°F).

Prior to reconstitution, VARIVAX retains potency when stored for up to 72 continuous hours at refrigerator temperature (2-8°C, 36-46°F).

Storage During shipment, to ensure that there is no loss of potency,

the vaccine must be maintained at a temperature of -20°C (-4°F) or colder.

Before reconstitution, store the lyophilized vaccine in a freezer at an average temperature of -15°C (+5°F) or colder. Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature 01-15°C and has a separate sealed

freezer door is acceptable for storing VARIVAX. VARIVAX may be stored at refrigerator temperature (2-8°C,

36-46°F) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2-8°C which is not used within 72 hours of removal from -15°C storage should be discarded.

Before reconstitution, protect from light. The diluent should be stored separately at room temperature

(20-25°C, 68-77°F), or in the refrigerator.

REFERENCES 1. Balfour, H.H.; eiai.:Acyciovirheatment of varicella in otherwise healthy

children, Pediatr., 116: 633-639,1990. 2. Ross, A1-1.i. Modification of chickenpox in family contacts by

administration of gamma globulin, N. Engl. J. Med. 267: 369-376,1962. 3. Preblud, &R.: Varicella: Complications and Costs, Pediatrics, 78(4

Pt 2): 728-735,1985. 4. Weibel, R.E.; et al: Live Attenuated Varicella Virus Vaccine, N. Engl.

J. Med. 310(22): 1409-1415,1984. 5. Unpublished data; tiles of Merck Research Laboratories. 6. Wharton, M.; et al.: Health Impact of Varicella in the 1980's. Thirtieth

Interscience Conference on Antimicrobial Agents and Chemotherapy, (Abstract #1138),1990.

7. Bernstein, H.R.; et al.: Clinical Survey of Natural Varicella Compared with Breakthrough Varicella After Immunization with Uve Attenuated Oka/ Merck Varicella Vaccine. Pediatrics 92: 833-837, 1993.

8. Kuter, B,J.; et al.: Oka/Merck Varicella Vaccine in Healthy Children: Final Report of a 2-Year Efficacy Study and 7-Year Follow-up Studies, Vaccine, 9: 643-647, 1991.

9. Arbeter, A.M.; et al.; Varicella Vaccine Trials in Healthy Children, A Summary of Comparative and Follow-up Studies, AJDC 138: 434-438,1984.

10.Weibel, R.E.; Cl al.: Live Oka/Merck Varicella Vaccine in Healthy Children, JAMA 259(17): 2435-2439,1985.

11.Chartrand, D.M.; et al.: New Varicella Vaccine Production Lots in Healthy Children and Adolescents, Abstracts of the 1988 Inter-Science Conference Antimicrobial Agents and Chemotherapy: 237(Abstract #731).

12Johnscn, et al.: Live Attenuated Vaccine in Healthy 12 to 24 month old Children, Pediatrics 81: 512-516,1988.

13.Gershon, A,A.; et al.: Immunization of Healthy Adults with Live Attenuated Varicella Vaccine, Journal of Infectious Dseases, /58(11: 132-137, 1988.

14.Gershon, A.A.; et al.: Live Attenuated Varicella Vaccine: Protection in Healthy Adults Compared with Leukemic Children, Journal of Infectious Diseases, 161: 661-666,1990.

15.White, CU.; et al.: Varicella Vaccine (VARIVAX) in Healthy Children and Adolescents: Results From Clinical Trials, 1987 to 1989, Pediatrics, 87(5): 604-610,1991.

16.Asano, Y.; et al.: Contact Infection from Live Varicella Vaccine Recipients, Lancet 1(7966): 965, 1976.

17.Harnmerschlag, M.R.; et al.: Herpes Zoster in an Adult Recipient of Live Attenuated Varicella Vaccine, J Met Dis 160(3); 535-537,1989.

16.White, C.J.: Letters to the Editor, Pediatrics 318: 354, 1992. 19.Guess, RA.; et al.: Epidemiology of Herpes Zoster in Children and

Adolescents: A Population Based Study, Pediatrics 76(4): 512-517,1985. 20.11agozzino, M.; et al.: Population-Based Study of Herpes Zoster and

Its Sequelae, Medicine 61(5): 310-316,1982. 21.Morbidity and Mortality Weekly Report 34(1): 13-16, Jan 11, 1985. 22.Dennehy, P.R.; et al.: Immunogenicity 01 Subcutaneous Versus

Intramuscular Okailvlerck Varicella Vaccination in Healthy Children, Pediatrics 88(3): 604-607, 1991.

23.Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type Ill/Lymphadenopathy - Associated Virus, Annals of Internal Medicine, 106: 75-78, 1987.

24.Recommendations of the Advisory Committee on Immunization Practices (ACIP); General Recommendations on Immunization, MMWR 43(No.RR-1): 15-18, January 28, 1994.

25.Vaccine Adverse Event Reporting System - United States, MMWR 39(41): 730-733, 1990.

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