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Watch December 2000
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Women's Health Watch

edited by Sandra Coney

 

Selected articles from Women's Health Watch newsletters in December 2000

Contents

Issue 55 December 2000

Editorial- A dummy's guide to the new health act

Even seasoned health campaigners have been flummoxed by the horse-trading that went on during the passage of the New Zealand Public Health & Disability Act. The new Act abolished the Health Funding Authority and establishes 21 District Health Boards, with part elected members, but what else does it do?

So many changes took place as the Bill became law, with even National getting its spoke in, that there has been considerable confusion as to what happened and what it all means. I decided to find out.

Public health

There has been considerable anxiety about the future of public health under the new devolved health system. Previously public health dollars - 2% of Vote: Health - were ring-fenced with a discrete unit within the HFA funding services on a national, regional and local basis. During the period of the HFA's existence, it has innovatively reoriented funding that so that considerably more Maori and non-government organisation (NGO) providers have received a share of the pie. These providers have been fearful that if funds are devolved to DHBs, the money will either be gobbled up by GP groups, or re-routed to former HHS-providers. However, the Minister of Health has appeared very keen on totally devolved funding, and this was strongly recommended to Cabinet by Treasury as a means of ensuring DHBs could not shift costs to a national level.

The Health Select Committee flirted with the idea of a stand-alone public health agency. Memories of the demise of the former Public Health Commission prompted considerable misgivings about this model. In the final event, Annette King's office reports that there will be a Public Health Advisory Committee which reports both to Ms King and the National Health Committee, to advise on, promote and monitor public health.

The Ministry of Health will maintain its existing public health directorate, but there is nothing in the new Act about where public health money will sit. However, the Minister's Office reports that'the Minister flagged the ring-fencing of public health in her speech in the House'.

Just what this means and how deep this ring-fencing will go is not clear. Ms King's office said that'what's national and what's regional needs to be worked through.' There is no reassurance at this stage that 2% of the budget will be ring-fenced. I was told that was the'operating environment' and'the bill doesn't go down to that detail.'

'The Minister has flagged that unless there is good reason for money to be devolved, it will sit nationally, but we can't pre-empt things that are before Cabinet.'

It seems quite possible that public health money will be both ring-fenced and devolved. DHBs may still have considerable say about what is funded in their area, even if they are provided with money ear-marked for public health. If this happens it would undermine the intent of making decisions about public health spending at a national level.

All in all, there is still reason to be anxious about whether the public health money will stay nationally ring-fenced or whether the DHBs will mount a successful campaign to have it devolved to them.

New committees

There are a number of new national committees, and one beefed up committee.

  • Public Health Advisory Committee (see above)
  • National Ethics Committee

The Bill gave the Minister the option of using the Ethics Committee of the Health Research Council or establishing a committee but this is now not an option - or is it? The Minister must appoint a national ethics committee which must reports to the Minister or another entity and its role is wider than research ethics. The committee is to advise on'ethical issues of national significance in respect of any health and disability matters (including research and health services)' and it is required to consult with the public and people funding and providing services. It will be important to ensure the committee can initiate its own reports and advice, as a problem with the earlier national ethics committee was its dependence on the Minister requesting such advice. The Act also allows the Minister to use the HRC Ethics Committee for advice'on specific ethical issues of national, regional or local significance', which is very similar to the purpose of the new national committee, so there is still the potential for the Minister to side-step it.

  • National Health Epidemiology and Quality Assurance Advisory Committee This was added and is to advise the minister with a particular emphasis on morbidity and mortality prenatally, and for infants, children and adolescents.
  • Pharmac must in future have a Consumer Advisory Committee
  • Pharmacology and Therapeutics Advisory Committee (PTAC), formerly a committee of Pharmac, now has a statutory existence.
  • Health Workforce Advisory Committee

Role of Minister of Health

The Greens were successful in getting an addition: the Minister must now report to Parliament on progress on the New Zealand Health Strategy and the New Zealand Disability Strategy.

Strategy for standards and quality assurance

This is an entirely new bit added following campaigning by the Greens. It requires the Minister to determine a strategy for the development and use of nationally consistent standards and quality assurance programmes for health services and consumer safety, and ensure nationally consistent performance monitoring against the standards and programmes.

This will require a great deal of work as in many areas such standards do not exist and the Ministry of Health is not geared to performing such monitoring (note its performance with the National Cervical Screening Programme). However, it is a major advance, as it requires the Minister to actually monitor and measure health services against health standards, rather than performance measures that are related to throughput or financial measures.

Treaty of Waitangi

After a frenzy of catastrophising in the media, the Government watered down its Treaty clause. It went even further as the Act states that'to avoid any doubt' nothing in the Act'entitles a person to preferential access to services on the basis of race.'

I am not Maori but it must be galling for Maori to see the Treaty clause so easily traded off. Although the Act still requires DHBs to ensure they have Maori representation on committees, the Treaty clause could have enabled Maori to have a more secure seat at the table when DHBs are planning services and to be empowered as deliverers of services for their people. Given the parlous state of Maori health, this could only have been for the good. As Jane Clifton commented in a recent Listener column, she thought the Treaty was about equal rights, not preferential treatment, so what was the fuss? This retreat may come back to haunt Labour.

Additions to roles of DHBs

DHBs must now foster community participation in health improvement and planning in the provision of services. They must also promote integration of health services, especially primary and secondary health services. Is this a recipe for managed care? Maybe.

Delegation

There were concerns that the original Bill allowed DHBs to delegate all their authority to the Health Improvement Committee and Hospital Governance Committee, neither of which are to be democratically elected and could consist of external members. This is not changed in the Act, except that each DHB must develop a delegation policy and gain the Minister's approval for this.

Inquiries

The Bill gave the Minister more latitude to appoint inquiries which precluded cross-examination by parties and lawyers for parties. This was opposed by many consumer groups and lawyers, but it has survived unchanged into the Act.

Sale of assets

The Bill gave DHBs wide powers to sell endowed and other lands, subject to the Minister's permission. The Alliance fought to prevent this alienation of public assets, and in the Act, the Minister's permission is conditional on the DHB having consulted its'resident population' and there are conditions on the use of the proceeds.

Who's reading about me?

Developments in electronic patient record sharing have not been exactly put before the public. Penny St John reports on the latest moves in an area which keeps on keeping on, if behind the scenes.

The Ministry of Health intends consulting consumer groups over the next few months about the privacy of patient information transferred electronically and stored on electronic data bases. There has been considerable public interest in prescribing over the internet but little public debate about the rapid emergence of new technology allowing health professionals to access electronically-stored patient information and the push by governments to collect health information. The Ministry has drafted a Health Knowledge Strategy looking at a wide range of issues surrounding health information, including privacy and access issues, and it says it will seek public comment on this strategy over the next few months.
People in favour of collecting and storing health information argue the data can be used to improve health care. For example data on how many children have been immunised will increase New Zealand's low immunisation rates. They say considerable amounts of information are already collected and exchanged on paper systems which are even less secure than electronic systems.
Opponents say it is impossible to build secure systems and there are questions over who will have access to personal health information. There is the possibility for example of people selling information to health insurers. They say very little evidence has been produced to show that electronic systems improve health care, but there are risks if vulnerable patients, such as those with mental illness or sexual health issues, fear the confidentiality of their records. Access to paper records is limited by the existence of usually a single record. There is greater potential for very large numbers of people to access personal information when it is 'on-line'.

What's going on?

At the moment it is difficult to accurately document how much information is being stored. The privately-owned HealthLink Ltd runs a closed Value Added Network which allows hundreds of health providers to get laboratory results, radiology results and National Health Index (NHI) numbers. These are numbers which are now assigned to all people who use hospital or GP services and there has been debate about whether these numbers can be used to identify patients.
KidZnet is an initiative developed by the Rotorua GP Group and Health Waikato aimed at improving immunisation rates. KidZnet, which is about to be trialled in the Midland region, will store immunisation and Well Child data on all children seen by health professionals such as GPs, hospitals and Plunket nurses. Health professionals will be able to access KidZnet to check a child's immunisation status. The system is described as 'opt off' which means information about all children will be put on KidZnet unless parents elect to have data taken off.
Patient information will also be collected as part of the new free diabetes checks recently announced by the Health Funding Authority. Questions were raised about privacy resulting in two separate software versions. One system requires patients to give permission for their personal diabetes information to be forwarded to a database while the other system forwards non-identifiable patient data.

Circulating in cyberspace

One of the most intriguing developments is the Health Intranet, a shared information system under development for four years. The high-tech system has been developed by the Ministry of Health, five hospitals, Southern Cross and two IPAs but at the moment only appears to be used by providers to access NHI numbers.

New Zealand Doctor deputy editor Susie Hill has been following development of the Health Intranet and says it has been almost impossible to get information on the project, despite the fact that at least a million dollars has been spent on what some providers describe 'as wires that start nowhere and go nowhere.' Ms Hill reports the magazine has just submitted its third detailed Official Information request on the intranet. New Zealand Doctor reports South Auckland Health has made the most progress with the intranet with plans underway to open their files to East Health. However former New Zealand Health Information Service (part of MOH) group manager Paul Cohen has said the intranet will become mandatory for hospitals to exchange information.

Interestingly no-one appears to want to own this project. The Ministry of Health's NZHIS manager Debbie Chin says no-one owns the Health Intranet in the same way no-one owns the Internet. Ms Chin says the Ministry of Health has no asset on its books relating to the Health Intranet; Telecom has developed the system and providers have contracts with Telecom. The role of the NZHIS is to develop standards and protocols for the transfer of information on the intranet, according to Ms Chin. New Zealand Doctor reports being told by Health Minister Annette King's office that the minister did not know anything about the project.

An independent review of the security of the Intranet last year said this type of system is more secure than current methods such as fax, paper or telephone. The authors were worried about a growing trend for health practitioners to send information by email without understanding the privacy limitations of that system. Commenting on the Intranet, the authors expressed concern that there is no specific user authentication for people using the system within large organisations and raise the possibility of users circumventing security policies.

As private as your nearest hacker

So how do developers of these systems go about considering issues of patient confidentiality and privacy? Debbie Chin says developers must operate under the Privacy Commissioner's Health Information Privacy Code, although she says it is debatable whether this Code has been interpreted correctly. Projects must also be put before Ethics Committees. However the Privacy Commissioner has been scathing in his criticism of how government agencies are handling health information privacy issues. Bruce Slane has said that failure to take privacy issues into account will lead to a loss of faith by consumers in new health initiatives.
'This is a serious situation we have been warning Government about.'
Mr Slane has warned that in many cases GPs are not being equipped with enough information to inform patients what is going to happen to information that is collected. In some cases GPs are not certain why information is being collected, he has said.

Coming to a consultation near you

However the Ministry of Health's principal analyst who has drafted the Health Knowledge Strategy hopes the document will generate discussion about a range of issues, including privacy. Dean Alexander believes New Zealand has a good privacy framework but that framework needs better implementation. Meetings were held with the Privacy Commissioner during development of the strategy.
Mr Alexander believes health professionals also need more help with privacy issues, including the rights of patients to know when information collected by a doctor will end up in a data base. Doctors must not assume patients know about the Health Information Privacy Code and patients must be told what information is being collected and where this information will be sent. However unlike many sectors, health providers' codes of ethics are already towards privacy, according to Mr Alexander.
'Doctors do not discuss patients or leave patient notes lying around on the bus.'
Patients must have access to personal information stored on databases, according to Mr Alexander. He says patients have rights to correct information on patient records and this also applies to personal information stored on databases.
However Mr Alexander concedes it is impossible to claim databases will be secure. Apart from hackers, there will be debate about who should have access to the system and Mr Alexander says the Ministry has also considered the possibility of unscrupulous users selling information. He says all systems must have a privacy impact assessment and it is vitally important electronic systems are audited.
'You need to ensure people are obeying the policy. It is possible to track who has accessed information and where it has been sent but you must have systems in place to track.'
Children's health information is also of interest because permission is gained from guardians, according to Mr Alexander. He says there are questions about what age that authority is transferred to the child.
At the end of the day there are benefits and costs, Mr Alexander says. He believes there are trade-offs between having enough information to make good quality health care decisions and the privacy of the individual.

Dealing with sexual abuse by doctors

A plan of actions emerged from a Wellington meeting in late November at which medical groups and women's groups discussed preventing and dealing with doctors who sexually abuse patients. The meeting was called by Ron Paterson, Health & Disability Commissioner, to try and get some consensus on how to proceed. A range of actions and policies were emerging from different medical groups and there was a need to co-ordinate approaches. Groups who attended included the Medical Council, Medical Practitioners Disciplinary Tribunal, New Zealand Medical Association, Royal College of GPs, Doctors for Sexual Abuse Care, Ministry of Health, Women's Health Action, THAW from Christchurch, Federation of Women's Health Councils, National Council of Women and staff from the Commissioner's office.
The whole day meeting grappled with this difficult topic. Two types of doctors who abuse were discussed: the sexual 'predator' who seeks to abuse patients, and the 'naïve' doctor who does not provide effective professional boundaries and who does not communicate acceptably to patients. Because abuse is surrounded with secrecy and women can feel humiliated and uncertain about what to do, it can take some time to emerge. A particular problem is that abuse may be disclosed to other doctors, or suspected by them, but the woman does not want to take actions. Women's health groups reported the same dilemmas.

Screening and educating doctors

The meeting favoured a number of actions, ranging from how students were selected for the profession and the training they receive to how to get swift action when abuse comes to light. The Medical Council undertook to gather information about the training provided by colleges in New Zealand. The need for special training of doctors arriving from overseas was highlighted. This training would include New Zealand cultural aspects as well as issues around the status of women, women's roles, sexuality and reproductive issues. A Bill being put forward by ACT to prevent refusal of the registration of overseas-trained doctors for any reason was seen as an opportunity to raise these issues.
Sexual harassment policies within services provide an opportunity to educate staff and provide a culture of non-acceptance of crossing sexual boundaries. This may encourage colleagues to question a doctor about whom they are concerned.

Chaperons

The use of chaperons was intensely debated, both the NZMA and RNZCGP currently having chaperone statements. The term itself was deemed to be old-fashioned and there was acceptance that the role was more about 'witnessing' what happened to protect the doctor than protecting patients. The 'chaperon' role was not the same as a 'support person' who came with the woman. It was pointed out that abuse might occur at times other than during intimate examinations and that the concept implied distrust. Women's attitudes towards chaperones are not known, and WHA undertook to raise this as a useful area of study for nursing, midwifery, medical or legal students. The Medical Council will canvass the issues in a proposed discussion paper and the NZMA will revisit its statement in the light of the results of the Council's consultation.

Complaining and intervening

When women have been abused, a safe and sensitive process needs to enable them to formally complain. This may only occur after counselling and support. The HDC undertook to prepare a flowchart of options for counselling and support.
Where colleagues suspect abuse the need for colleague-to-colleague early intervention was stressed to prevent the conduct escalating. Models for referring or self-referring were discussed, but it was stressed that this would only be appropriate for low-level behaviour.
The Medical Council's competency review mechanisms could be used where issues were raised about a doctors' behaviour but the woman did not want to complain, although there were pitfalls in this approach as the Council cannot stop a person practising and the person making the complaint must be named.
The HDC undertook to find out whether cases of sexual abuse that go to ACC are reported to the relevant professional bodies.
The HDC undertook to establish a process that would ensure that cases of sexual abuse were treated as a priority and that a senior investigator be assigned to the case. HDC staff should ensure that woman was supported but the office could not act as counsellor or support person. Third parties, such as women's groups, can report cases and have them investigated, but if the consumer cannot be identified then the HDC may be hampered. However, the provider is on notice and there would be a record of that person for linking up were further reports to be received. The information could be shared with the Medical Council.
All in all, it was a useful meeting and a chance to hear a range of views. There were no instant answers, but many helpful suggestions that deserve to be pursued. Keep watching this space.
Sandra Coney

Facts and figures from breast screening in the UK

A recent study reported that the reduction in deaths among women in England and Wales attributable to breast screening was 6.4% by 1998. This is much less than the 25% predicted in the Forrest Report (1987) which led to the UK breast screening programme.
Reason given for not reaching the predicted benefit are that a benefit will appear more slowly in a population screening programme than in a research situation, and the time needed to build up expertise in the programme.
So far 1,699,727 UK women have been invited for screening and 75% have accepted.
In 1998/99 this resulted in the detection of 6.24 cancers per 1000 women screened, the performance of 2033 biopsies where no cancer was found and the detection of 1733 cancers less than 15 mm in size.
Ref: BMJ 2000; 321: 1101

RU486 - the medical abortion

In New Zealand medical abortions are not currently available but they may be coming to town if the application for their use is approved. Julie Newell reports on the issue and a Women's Health Action seminar on the topic.

Ishtar, the ancient Goddess of love and war, has given her name to the company which is trying to introduce RU486 medical abortions to New Zealand. Love, because abortion is about sexual relations, and war because the company's founders are ready for a battle. Dr Margaret Sparrow, one of the principals of Istar Ltd, told a recent WHA seminar that the company has made an application to the New Zealand Ministry of Health to approve RU486. The seminar was attended by over 30 women's groups and workers in the area of reproductive health.

At the moment Istar's application rests on a legal issue. According to the Contraception, Sterilisation & Abortion Act (CS&A Act) and Crimes Act, abortion must take place only in licensed premises, but there is a difference of legal opinion as to whether the foetus must be expelled in a licensed institution. Because women who have medical abortions often abort at home, an interpretation requiring completion of the abortion at licensed premises would make medical abortions not feasible in New Zealand without a law change.

Mifepristone, known as RU486 or Mifregyne(UK) or Mifeprex (USA) was developed in 1980 by a research team at Roussel Uclaf. In Europe, over 620,000 women have used mifepristone as an early option pill in combination with various prostaglandins which are needed to complete the abortion process in many cases.

Mifepristone become available in France in 1989 and since then was approved for use in the United Kingdom, Sweden, Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, Luxembourg, the Netherlands, Spain, Switzerland, Norway, Russia, the Ukraine and finally the United States in September this year. Roussel Uclaf donated to the Population Council US rights for all identified medical uses of mifepristone without any remuneration. The licensee to the Council is Danco Laboratories. The USA Food and Drug Adminstration approved Mifrex with the conditions that women must receive an approved medication guide and doctors must be trained to diagnose early pregnancy, exclude ectopic pregnancy and make advance arrangements for surgical back-up, in the event that the medical abortion method failed.

RU486 - the good the bad and the maybe
Dr Sparrow was pragmatic about the positive and negative aspects of medical abortion. The known medical risks are haemorrhage requiring hospital admission (range 0-1.4%) and incomplete abortion, (range 1.3-4.6%).

If the method fails and the pregnancy continues there is a risk of foetal abnormality especially after the addition of prostaglandin. Disadvan-tages include heavy bleeding in approx 5% of cases and surgery in approx 5%. There may be may be more cramp-ing over longer period than surgery, especially after the prostaglandin. Analgesics are used in 16-68%of patients. There may be gastro-intestinal side-effects, especially after misoprostol prostglandin - nausea (50%) vomiting (20%) diarrhoea (15%). More uncommon is hypotension, skin rash, headache, vagal symptoms of hot flushes, dizziness, chills.

A minimum of three visits are needed for the whole procedure. Medical contra-indications to prostaglandin include cardiovascular disease (angina, Raynaud's disease, cardiac arrhythmia's, cardiac failure, severe hypertension). The method is not advisable for women over 35 years who smoke more than 10 cigarettes per day.

This is a sobering line up of reasons not to go the RU486 way, but wait, there are benefits. The method is effective early in pregnancy, there are no surgical risks to the cervix such as uterine perforation, or laceration, it is not dependent on the skill of the surgeon and there are no anaesthetic risks. Dr Sparrow believes the women feels more in control and that surgery is more intrusive. Also, surgical methods are certainly not drug free and employ medications, pre-op, during the termination and sometimes afterwards.

The Istar proposal
Istar proposes that restrictions on the availability of RU486 are the same as in the UK, namely that it is not available through pharmacies, and is not available for use as a post-coital contraceptive.

Informed consent must include an explanation of options, explanation of medical abortion's advantages versus disadvantages, the risks versus the benefits and the medical contra-indications.

The Istar protocol for early medical abortion up to 9 weeks is an early diagnosis by a GP with swabs, smear, blood tests and ultrasound. Counselling and certification are as required by the CS&A Act. There would be three mandatory visits. On day 1 with administration of Mifegyn, approx 3% will abort before the next treatment. On day 3 there is administration of prostaglandin (misoprostol or gemeprost). Observation takes place for 4-6 hrs, during which 60-80% of women will abort. Others will abort at home. The third follow-up visit will verify that expulsion is complete. In the unpleasant event of an incomplete abortion an ultrasound is arranged, and if a foetal heart is detected , the woman progresses to surgery. If there is a sac but no foetal heart the options of waiting or progressing to surgery are discussed.

Womens views vary
Women's views on medical abortion vary. When women do have a reasonable choice approximately 40% opt for a medical abortion as is the case in France and Scotland. Other studies indicate that women who have had both a medical and surgical procedure tend to favour the medical option. Although studies haven't particularly compared the emotional experiences between women having a surgical and those having a medical procedure, they have looked at whether women would have the same procedure again. One study found that there was substantial variation in acceptability among women who experienced different types of failure (requiring surgical interventions for any reason) , however: three quarters of the women who had ongoing pregnancies or incomplete abortions would choose this method again, and almost 90% would recommend it to others. Patients who requested surgical intervention were the least favourably disposed toward the method. The five most commonly reported best features of the method were: avoiding surgery and that the method was more natural, involved less pain, was easier emotionally, and was easier and simpler than surgical abortion. Its worst aspects were the pain, the amount and/or duration or bleeding, the nausea and vomiting, and the anxiety of waiting for the expulsion. Women of different races and ethnic groups reported different best features but similar worst features.

RU486 in the New Zealand context
At the RU486 seminar, Sandra Coney, executive director, Women's Health Action, explained why she is concerned at RU486's introduction and use in New Zealand.

'Although benefits might be demonstrated from the use of RU486 within particular populations, or within a research context, we need to examine RU486 in the ³real world² context, considering how it might impact on New Zealand women'.

Most of the available data on RU486 is on effectiveness, dosage regimes and safety. None of this work has been carried out using New Zealand women and none of the populations studied compare to the New Zealand ethnic mix. Most have been carried out on European women, Chinese, US and Afro-American women. Sandra Coney believes that we need to look at the context of New Zealand, the make-up of the New Zealand population, especially users of abortion services, and at how people use services.

In terms of information, there is very little on women's experiences. The information that does exist relates to a narrow range of issues. She asked the questions: What do we know about the cultural context for women around family knowledge, support, attitudes to sexuality and abortion? Do abortion services have the capacity to cope with communication issues when intepreter services are not well provided in NZ? Is there sufficient counselling time to inform women? RU486 is said to enhance privacy, but this contention has been criticised by some feminist groups because of the medical surveillance required. There would be issues arising for the many women who will abort at home such as their personal safety if disapproving family members learn of a secret pregnancy. Would there be a failure to complete the regime if women do not understand the implications of not doing so? Would women seek medical assistance if complications occur? Then there is the continued pregnancy where the method is unsuccessful leaving the possibility of damaged child.

Abortion ownership - who controls the services?
There was also the issue of ownership.

'Women don't own or control abortion services in New Zealand,' said Sandra Coney,'and have very little say in the organisation of the services which are organised as just another health service which have suffered from cut-backs in funds'.

She believes that this has led to a compromising of the ideals of service, particularly in the areas of support for women, counselling, giving women space/time to think, treating women with dignity and respect, privacy, and cultural issues. RU486 costs the same as or is more expensive than surgical abortion when used as recommended, but it provides more opportunities for cut-backs by administrators looking to save costs.

'Who owns abortion is important because this question determines how new technologies are introduced and used,' she said.' We need to see this new technique in the context of how abortion services might look in the future if RU486 introduced. Will it improve or undermine existing services? How much can women determine the standards, guidelines and protocols for use of RU486? Will the money be available to put in place the safeguards to prevent the method harming women?' Another big worry for Sandra Coney was the potential loss of choice as abortion services are organised around clinicians, not women's needs.'If many women choose medical abortion, surgical services might become scarce as short operating lists are uneconomic.' There was also the potential for a loss of skilled surgical operators.

The seminar speaks
Discussion from the audience at the seminar drew forth some critical issues. Questions were raised about whether medical abortions would still have to take place in approved and licensed facilities as happens now or whether a range of other options would be possible such as GPs, medical practices, Family Planning and so on. Concerns were expressed about the difficulty of controlling the standard and quality of a service and the way women were treated and counselled if RU486 could be got from a broad range of places and providers. A designated abortion service is probably more likely to carry out the service within a holistic framework with safeguards for women's physical safety and emotional wellbeing than a health service with a broader focus. Some people supported a wider range of providers being able to offer an abortion service so women in rural areas and places some distance from existing services would have better access.

The dreaded cost cuts
There was concern that abortion services could be attractive to some providers for the wrong reasons. Cost-cutting could be easier to achieve with a service offering medical abortions. There was a feeling that when managers are looking to save money, the space and time required for activities such as counselling and the translating of information could be dropped off as likely to be considered not so important

The practical question of access
Although abortion services are well established in New Zealand, there are still issues of access for some women, particularly Maori. Access can relate to difficulties accessing information about services as well as difficulties getting to appointments. The requirement for three appointments to have RU486 treatment could be prohibitive for women who already find it difficult to get to two visits. Abortion services presently don't provide transport or assist women to attend the clinic as this could be seen as coercive, but medical abortion does raise different issues of access, as more appointments are needed and women leave the service in the middle of their treatment. What responsibility would a service have to a woman who was in the middle of treatment and didn't return after being given the RU486? There were differing views as to whether a provider should assist women in this situation. The privacy issues of following up a woman who did not attend an appointment were raised. Not all women have phones so some may not be able to be easily contacted. It is important women don't get abandoned in the middle of treatment if they are unable to continue.

Women want more information
The case for the development of national information resources for women was emphasised, as leaving it to providers can result in information of widely varying quality. Providers tend to underestimate what information women want. The attempt by the Abortion Supervisory Committee and later Ministry of Health to develop a national resource was spectacularly unsuccessful. There is the risk of the issue becoming politicised if it is developed nationally using a consultation process. This creates a dilemma of who does it and how it is done.

Trauma or relief
Abortion is very traumatic and difficult for some women whereas others have a different experience and find it a relief. For some women the medical option is an easier procedure than a surgical abortion. The potential effects of medical abortion could be that the emotional process would be drawn out over a number of appointments compared to the surgical procedure which is much quicker. There is also uncertainty over whether it has worked and whether a surgical abortion will also be needed if the medical abortion doesn't work. This period of time and uncertainty could be an emotionally traumatic experience for some. However for other women it would be better to have a medical abortion as it can be done so much earlier and the emotional stress of waiting around can be avoided. There were concerns that because RU486 is an early abortion service, abortion numbers could be boosted, as early abortions will include a number of pregnancies that would have naturally miscarried before the time surgical terminations would usually be carried out. This means that some women will have the procedure when they may not need it, and there may be a political risk around increasing abortion rates.

Keep talking
The difficulty of being able to freely discuss abortion issues continues to constrain and prevent opportunities for open dialogue. The sensitivity of the abortion issue means that matters such as the development of appropriate information and revision of the law are difficult to achieve in a wider forum whereas usually community support would be sought for important legal changes. Given the evidence for and against RU486, clear decisions based on the ability of groups to share information specific to the New Zealand experience will make the difference between a successful outcome and a fraught one.

Information packs are available from Womens Health Action at a cost of $8. You can see the notes from the seminar here.

Making mifepristone available in New Zealand

  • 1990 - FPA invites Prof Balieu to speak in Auckland
  • 1992 - FPA invited by WHO to participate in postcoital research
  • 1995 - method discussed at !st abortion providers conference
  • 1997 - Prof David Healy, Melbourne speaks at 2nd Abortion providers conference
  • 1997 - Prof David Baird, Edinburgh invited by RNZCOG
  • Feb1999 - Istar Limited incorporated as a company
  • March 2000 - Minister of Health, Annette King obtains legal opinion from Crown Law Office
  • May 2000 - Istar signs agreement with Exelgyn for Mifegyn
  • June 2000 - Istar makes application to Medsafe
  • Sept 2000 - Istar receives licence to sell medicine by wholesale

Medical Abortion- Quick check

Definition - Medical abortion is defined as the taking of medication as an alternative to a surgical procedure. It is currently used early in the pregnancy, although researchers are extending the time in which the method is used.

Surgical Abortion - The surgical procedure used to terminate pregnancy up to 13 weeks is referred to as a vacuum aspiration abortion or suction curettage abortion. It involves the dilation of the women's cervix and suctioning out the contents of the uterus. Surgical abortion has been acknowledged as one of the most scrutinised surgical procedures and one of the safest with a 0.5% failure rate. The chance of a complication occurring from the procedure is less than 1%.

The drugs - Currently the two drugs used for medical abortions are Methotrexate (a folic acid antagonist) and mifepristone (an antiprogesterone). Both are followed by a prostaglandin analogue to expel the foetus. Where available mifepristone is preferred because of greater effectiveness and safety.

How RU486 works - RU486, a synthetic steroid derived from 19-nor-testosterone, works by blocking the receptor for progesterone inside uterine cells. Without progesterone, the cells of the uterus are shed, prohibiting the establishment of an early pregnancy. RU486 also works to terminate pregnancy by increasing the body's natural production of prostaglandin (powerful stimulants of uterine contractions) as well as increasing the responsiveness of the uterus to these stimulants, either in their naturally occurring or introduced form.

Other applications - Other possible uses of mifrestone include a post-coital contraceptive or once-a-month contraceptive. It may also help with the medical conditions such as uterine fibroids, endometriosis, Cushings disease, meningioma, breast cancer etc.

Birth defects - There is a confirmed link between prostaglandin and gross birth defects should a pregnancy proceed to term when the abortion procedure fails. In the USA one study reported on 82 women internationally who continued on with their pregnancy after having had just the RU486. Thirteen of them carried to term and there were no foetal abnormalities as they had only had the RU486. It is the prostaglandin that has been linked to foetal abnormalities.

Privacy - There is a misconception that a woman pops a pill in the privacy of her own home and the pregnancy disappears. Physicians have been very explicit that RU 486 will never be available over the counter for do-it-yourself abortions. To begin, close medical supervision is necessary to establish the existence and length of the pregnancy; to monitor bleeding and possibly perform a blood transfusion; to administer narcotic analgesics if women experience severe pain; to use ultra sound to determine complete expulsion of the embryo and tissue after the final treatment protocol; to perform a conventional abortion if the medical abortion is incomplete and/or the pregnancy continues.

Compliance - Any medical treatment involving multiple steps is fraught with non-compliance. This is particularly true for abortion where the added moral, legal and physical barriers make it more difficult for women to obtain even a one-step abortion procedure. It has been found that a significant proportion of women do not come back for a follow-up visit. In France, 10% of service users do not attend follow up while in Scotland it is a staggering 20%.

New Zealand elderly surveyed on health care

New Zealand has a high percentage of elderly people who report serious problems with long waits for surgery, according to a report into medical care of the elderly in five countries.
The Commonwealth Fund 1999 International Health Policy survey includes results from interviews of elderly people carried out in Australia, Canada, New Zealand, the United Kingdom and the United States.
In New Zealand 16 percent of the elderly report serious problems with waiting times for surgery, compared to four percent in the United States, nine percent in Australia, 11 percent in Canada and 13 percent in the United Kingdom.
However 39 percent of New Zealanders rank the care they received as excellent; the highest result among the five countries surveyed.
New Zealand had the highest percentage of elderly (16%) who had not visited a doctor in the past year but also the highest number (51%) who ranked their doctor's visit as excellent.
New Zealand and Australia had the highest number of elderly people hospitalised in the past year (29%) while only 21 percent of the elderly in the United Kingdom received hospital care. Hospitalised New Zealanders rated the standard of care and the availability of nurses more highly than the elderly people in the other countries surveyed.
The United States stood out in its large percentage of elderly people who had difficulty getting prescription drugs. Thirty two percent of the elderly in the United States say they have no insurance coverage for prescription drugs. This rate is twice that of the next highest country, New Zealand, where 16 percent of the elderly lack prescription drug coverage. Sixteen percent of the elderly in the United States say they pay more than $100 out-of-pocket each month for prescription medicines.
Elderly New Zealanders believe they are reasonably healthy. About 18 percent rate their health as fair or poor compared to 26 percent in the United Kingdom, although 31 percent of New Zealand elderly have a disability or health condition limiting full participation in daily activities.
New Zealand also has the highest percentage of elderly who often receive help from their children when they are ill (37%) compared to 26 percent in Canada.
The elderly in all five nations live on limited budgets and struggle to make ends meet. Many elderly, especially in New Zealand and the United States, are very concerned about how a deterioration in health could affect them and their family. New Zealand elderly are the most concerned they will not have enough money or insurance to pay for the long-term care services they will need.
New Zealand was the only country of the give surveyed in which a greater percentage of the elderly felt the health system needed to be completely rebuilt compared to people who felt that the system worked well and required only minor changes.
Ref: Findings from the Commonwealth Fund 1999 International Health Policy Survey, May 2000

Health prosecutor: the role of the Director of Proceedings

In this article, Tania Davis, Director of Proceedings for the Health & Disability Commissioner, talks about her work. Ms Davis' role is to prosecute cases to the Complaints Review Tribunal, which has the ability to award compensation to complainants. or to health professional disciplinary bodies.

It is sometimes suggested that the Health and Disability Commissioner is a'toothless tiger'. The implication is that errant health professionals cannot be held to account. This overlooks the statutory role of the Director of Proceedings, an independent prosecutor who may bring a case before disciplinary tribunals and/or the Complaints Review Tribunal. Where the Commissioner finds that a provider has breached the Code of Rights, the matter may be referred to the Director for further action. In 1997-2000, approximately 15% of breach cases were referred to the Director. The Commissioner effectively acts as a gatekeeper in referring more serious cases to the Director for possible further action.

Before taking any action against a provider, the Director must follow the statutory steps set out in the Health and Disability Commissioner Act 1994. The provider must be given an opportunity to be heard. This usually involves a meeting with the provider, his or her counsel, sometimes a relevant expert, and a stenographer. Providers are advised of their right to legal advice and representation, and that anything said will be recorded and may be used as evidence in later proceedings.

The Director is required to consider the wishes of the consumer, and to have regard to "the need to ensure that appropriate disciplinary proceedings are instituted in any case where the public interest (whether for reasons of public interest or public safety or for any other reason) so requires". In practice, other considerations are relevant: is there sufficient admissible evidence to prove the charge? does the conduct reach the threshold for discipline? Not all shortcomings call for disciplinary sanction, even though a breach of the Code may have occurred.

The option of proceedings before the Complaints Review Tribunal (CRT), where damages may be awarded, is not available where the parties have reached a settlement. A much more significant barrier to damages is the fact that where a consumer has personally suffered physical injury (medical misadventure) covered by ACC, there is a bar on damages claims for compensatory damages, although exemplary damages — for'flagrant disregard' of a consumer's rights — may still be available.

Sometimes the ACC bar will not apply, for example where a mother sues for damages, not for her baby's injury (which has been covered by ACC), but for her own "humiliation, loss of dignity and injury to feelings". In one such case, where a baby was born with severe brain damage, and died six weeks later, the Commissioner found that the midwife had failed to exercise reasonable care and skill (in breach of Right 4), and referred the matter to the Director, who prosecuted the midwife before the Nursing Council. The Council found her guilty of professional misconduct and ordered that her name be removed from the register of midwives.

The Director also brought a claim for damages before the CRT. The Tribunal accepted that the mother was suffering from enormous and debilitating grief, but that technically such feelings did not amount to "injury to feelings" (Director of Proceedings v O, 21/5/99), since that phrase had to be read narrowly, in light of the preceding words, "humiliation" and "loss of dignity". On appeal, the High Court adopted a wider definition of the phrase "injury to feelings" (Director of Proceedings v O, 11/8/00). In Justice Gendall's words: "The feelings of human beings are not intangible things. They are real and felt, but often not identified until the person stands back and looks inwards. … [I ]t is clear that some feelings such as fear, grief, sense of loss, anxiety, anger, despair, alarm and so on can be categorised as injured feelings. They are feelings of a negative kind arising out of some outward event. To that extent they are injury to feelings". An award of $20,000 damages was upheld. (The Tribunal had awarded damages, but on a different basis: that "there was significant humiliation and loss of dignity for the mother knowing that her levels of discomfort during labour may have caused the [midwife] to unwittingly sacrifice the interests of the baby for the interests of the mother".)

The High Court ruling in the O case indicates that there is a real prospect of recovering modest damages for consumers who, although not physically injured, have suffered emotional injury. Where consumers experience grief and anger as a result of the actions of a provider whose conduct is found to have breached the Code, and the matter is referred by the Commissioner to the Director, a claim for compensation from the CRT may be appropriate, in addition to any disciplinary proceedings.

New registration and disciplinary processes for health professionals proposed

Around 600 groups and individuals made submissions in response to a discussion document on the Health Professionals Competency Assurance Bill. If passed by Parliament, the new act will bring most health professionals under one set of standards.
Under the current system, the Ministry of Health administers 11 occupational regulation statutes covering 18 health and disability sector professions. The discussion paper says many of these statutes are old, inflexible, overly restrictive and do not meet the needs of the relevant profession or consumers.
The discussion paper says benefits of having a single act include consistency, flexibility, transparency, simplification of regulating new professions and economies of scale through combining the disciplinary functions of different professions. The Health Professional Competency Assurance Bill would include concepts such as:

  • Lay representation in both registration and disciplinary functions
  • Registering authorities being responsible for ensuring practising practitioners maintain ongoing competence
  • Registering authorities being empowered to establish detailed requirements for registration
  • Separation of the registration and disciplinary functions
  • Quality assurance activities

The discussion document asks for responses to six key questions, including whether colleagues should be required to report practitioners they believe to be working below an acceptable standard Notifying practitioners will be protected from civil and criminal liability as long as they have acted in good faith. The Medical Association supports doctors reporting colleagues who are not practising safely but points out the legislation is unclear on whether doctors would have to report incompetence in other health professionals.
All health professionals should have quality assurance programmes, according to the Ministry document. Doctors are currently required by statute to carry out quality assurance programmes but the discussion paper points out health services are provided by multidisciplinary teams.
The discussion paper also questions how complaints should be investigated and whether disciplinary and registration functions should be separated If separation occurs, should there be a separate disciplinary tribunal for each occupation or should there be a single multidisciplinary group?
Registration is another issue raised in the paper. It says registration imposes costs on both society and health professionals and the degree of risk may not always warrant the potential costs involved. However the Medical Association argues for protection against low standards and for any act to ensure the government and its agencies are not easily able to interfere with the setting of these standards.
An area of concern for consumer groups is that the Medical Practitioners' Act is presented as the model for future disciplinary tribunals, whether these are based on a single profession, or a single tribunal for all professions. This is the Act that has failed fairly spectacularly in the cases of Drs Fahey and Parry.
The Medical Practitioners Disciplinary Tribunal established by the Act has a single lay person when it sits, and retired health professionals are used as 'lay' people. The discussion paper also proposes to continue the system of Complaints Assessment Committees (CACs) established under the Medical Practitioners Act. These consist of three persons, two of whom are doctors, appointed by the chair of the Medical Council. They vet complaints and can prevent them going forward. There is little oversight of the committees or information about how they work and there is no right of appeal of their decisions.
All in all, Women's Health Action argued in its submission that this was not a good model for disciplinary processes for other professions. There should be 50/50 consumer and health professional on any disciplinary bodies.

Adverse medical event reporting

Medico-legal expert Helen Cull has been appointed to review processes for reporting and investigating adverse medical incidents. Health Minister Annette King says the review is designed to ensure agencies can identify patterns of adverse medical events and take timely action. The review stems from recent publicity about Northland doctor Graham Parry where it was suggested concerns could have been brought to light and acted on earlier. Mrs King says she wants to ensure the new legislation covering the occupational regulation of health professionals better protects the public so patterns of adverse outcomes can be quickly identified and responded to in a co-ordinated way.

Ms Cull has been asked to review relevant legislation concerning the Health and Disability Commissioner, the Medical Council of New Zealand, the Medical Practitioners Disciplinary Tribunal and the ACC Medical Misadventure Unit. Ms Cull's terms of reference anticipate the need for her to interview patients in the Northland region and to examine how each of the agencies responded and interacted and whether their actions were coordinated and timely.

ART bills in limbo

Two bills on assisted reproductive technology &endash; the Assisted Human Reproduction Bill introduced by National in 1998 and Dianne Yates Private Member Human Assisted Reproductive Technology Bill (1996) &endash; are languishing in select committee with no apparent date for them to be reported back to the House. The National bill was due back this month, but WHA has been told that this will be deferred. Written submissions on both bills closed early in 1999, and WHA indicated it would want to make an oral submission in addition to providing its report Protecting Our Future. While the bill vastly improved access to information for children born through ART, and for donors, other aspects were unsatisfactory. The Bill excludes surrogacy and there is no intention to establish a strong overseeing body.
WHA has long called for an authority, similar to the Human Fertilisation & Embryology Authority in the UK, to govern ART practices in New Zealand.
In the meantime, fertility clinics continue to push the boundaries with subjects under discussion including the use of family members from other generations to provide gametes.

Lump sums for ACC back

The Government is promising the return of lump sum payments, abolished by National, but only for loss of bodily function. The cap on payments would be $100,000, and payments would be tied to a formula for physical losses. Impairment must reach 10% before any payment would be made and 80% impairment must be reached before the full $100,000 payment could be made.
Examples given include loss of one eye, 24% impairment or $10,000. Loss of both eyes, 80% receiving the full
$100,000.
The amount to be paid to sexual abuse victims has yet to be quantified.
Unlike the old legislation, there will be no payments for pain and suffering and loss of enjoyment of life, despite this being part of Labour's election promises.

Call for repetitive strain injury investigation

The Council of Trade Unions wants an independent medical panel to draw up criteria for diagnoses of repetitive strain injury. The call comes after a District Court judge upheld an ACC decision to revoke cover for a Wellington switchboard operator, even though her claim had been approved and paid out five years previously. Her payments were stopped after ACC ordered a specialist review that found a work cause for her injuries unproven. The judge chided ACC for giving the woman cover in the first place, saying it should have made proper inquiries about the nature of her injuries.
Union president Ross Wilson says the decision highlights the need for an independent medical panel to analyse international evidence and put together criteria for diagnosing repetitive strain-type injuries. He says the decision puts a substantial onus on claimants to prove the cause of their injury and new legislation being introduced should address issues such as criteria for repetitive strain injury.
Ref; New Zealand Herald; 27/9/2000

First case of mother-to-child transmission of vCJD

United Kingdom newspapers have reported that doctors suspect an 11-month girl has variant CJD which she may have contracted from her mother. The child, whose mother died from the disease in May, has brain damage, is unable to swallow and has convulsions and stiff limbs. Doctors have not been able to give other explanations for her symptoms but cannot definitely confirm vCJD which requires a brain biopsy. Paediatric neurologists from Addenbrooke's Hospital in Cambridge stress the need for caution before drawing conclusions from the case. They say there are many reasons why children have developmental problems.
Ref: Lancet 2000; 356: 1085

Study questions value of mammography

Careful physical breast examination is as effective as screening mammography in reducing mortality from breast cancer in women aged over 50, according to a controversial new randomised controlled trial published in the Journal of the National Cancer Institute.
The second Canadian national breast screening study found that mammography detected breast cancers earlier than physical breast examination but that detection did not translate into a survival advantage. The researchers from the University of Toronto followed 39,405 women aged 50-59 who were recruited into the study between 1980 and 1985. 19,711 women received both mammography and physical breast examinations by nurses or doctors and 19,694 women received physical breast examinations alone by trained nurses. The women were followed via record linkage with the Canadian national cancer registry and the national mortality database to 31 December 1993. Women with breast cancer were followed until 1996.
The study found that, although mammography clearly detected cancers earlier than physical examination alone and was more sensitive in finding smaller cancers and in situ cancers, some of these advantages disappeared with longer screening.
Moreover early detection did not translate into a reduction in mortality. At the initial screening, mammography plus physical examination found almost twice the number of cancers compared with physical examination alone &endash;7.3 breast cancers per 1000 patients compared with 3.45 breast cancers per 1000 with physical examination alone. Overall mammography plus physical examination yielded a 2.1 year lead time advantage over physical examination alone. However, this advantage disappeared with longer follow up; by which time 622 invasive breast cancers were found in the mammography group and 610 in the physical examination group.
In situ carcinomas continued to be picked up more readily with mammography, with 71 in situ carcinomas compared with 16 in the physical examination group.
By the end of the study, 107 women had died of breast cancer in the group receiving mammography plus physical examination compared with 105 in the group receiving physical examination alone.
The researchers surmised advances in treatment may have equalised the survival curves for both groups of paper. They suggest careful physical breast examination may be a viable alternative to screening mammography in women aged over 50 who find mammography painful, unaffordable or inaccessible or who fear the cumulative effects of radiation to the breast.
However they say mammography does clearly give women a survival advantage and they acknowledge the breast physical examination given to women in the study was much more thorough than is usual.
Discussing this paper in the British Medical Journal, several authors, including the outspoken Professor Michael Baum, discussed whether clinical breast examination might provide an acceptable alternative to mammographic screening. They point out that the point at which a lump becomes palpable is at 1cm but which time the tumour will have doubled 30 times. The difference between this and the size at which the same tumour can be detected by x-ray (0.5cm) only one doubling. They question whether this difference can confer a significant advantage in terms of survival.
They point out studies that show that mammographically detected lesions have more favourable characteristics than clinically detected lesions. In other words screening is good for detecting lesions with low malignant potential.
Changing to clinical examination instead of mammographic screening, say the authors, would shift the emphasis from picking up cancers that pose less risk to the survival of the woman.
They urge that women be given accurate information about breast screening, especially 'numbers needed to treat' rather than raw incidence figures for breast cancer which are frightening but not especially relevant.
Ref: Journal of the National Cancer Institute 2000;92:1490-9; BMJ 2000; 321: 1071-3

Hormones and autoimmune disease

Why are women so much more likely than men to develop autoimmune diseases? Women are two to three times more likely to develop multiple sclerosis and rheumatoid arthritis and women make up 75 percent of cases of myasthenia gravis. In fact in the United States 80 percent of people with autoimmune diseases are women.
One answer may be that in general women produce a more vigorous immune response to infection, according to the chair of the Department of Molecular Virology, Immunology and Medical Genetics at Ohio State University College of Medicine. Caroline Whitacre is a leading researcher into the autoimmune gender gap and she says an antibody response known as the Th-2 predominates when men's immune systems are challenged by an antigen. On the other hand women's immune systems generate a more pro inflammatory mix of cytokines, known as the Th-1 response.
In pregnancy Whitacre says a woman's immune system shifts towards the milder Th-2 response. This may explain why some women with MS and RA experience an improvement in symptoms while pregnant. Within a few weeks of delivery the symptoms return. For this reason Whitacre is studying what goes on during the last trimester and post-partum that causes these great changes in disease severity, as well as focusing on how changes in sex hormone concentrations during this time affect immune function.
A considerable amount of attention is being focused on the effects of the oestrogens and in particular oestriol. During menses, the primary oestrogen is oestradiol but during pregnancy oestriol predominates. In animal studies researchers from the University of California have shown doses of oestradiol similar to those seen in late pregnancy lessen symptoms, shifting animals' immune response towards the Th-2 profile. These researchers suspect oestrogen and other sex-related hormones probably modulate the immune system, raising and lowering a threshold above which the combination of genetic and environmental risk factors trigger the disease.
However other researchers are not convinced hormones are the key to understanding the autoimmune gender gap. They question why autoimmune diseases do not peak in young adults, when concentrations of these hormones are highest in women. Researchers agree there are many other differences between men and women that might explain why women are more likely to develop autoimmune disease. The obvious place to look are in the sex chromosomes, according to Whitacre.
Ref: The Lancet 2000, 356;1088

New information booklet on breast implants

About one in ten women who has breast implants will experience hardening and pain, according to a new UK government booklet on breast implants. The booklet, which has been written for women considering having breast implants, summarises the issues in breast implant surgery and includes questions to ask before undergoing surgery.
The UK Department of Health says the information in the booklet has been prepared by women who have had breast implants, health professionals and representatives of interested organisations. The booklet's content is based on the recommendations of the report of the Silicone Gel Breast Implants Independent Review Group and the material is evidence-based and reflects current scientific knowledge about breast implants.
Information in the booklet covers four types of breast implants available in the United Kingdom; Silicone Gel, Saline, Hydrogel and Polyvinyl pyrolidine solution.
Maxine Heasman from the Breast Implant Information Society says the booklet is essential guidance for women who need to know exactly what they are letting themselves in for.
The booklet can be found at http://www.doh.gov.uk/bimplant/
Ref: Independent; 5/10/2000