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Decision 99HDC03994
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Names have been removed to protect privacy. Identifying
letters are assigned in alphabetical order and bear no relationship
to the person's actual name.
General Practitioner
Complaint
The consumer complained to the Ministry of Health about the
service she received from a general practitioner. The
Ministry of Health forwarded the complaint to the Commissioner on
23 March 1999. The complaint is that:
- The consumer requested an oral contraceptive pill for her
painful periods during a consultation in mid-March 1999 with a
general practitioner, in which the general practitioner failed to
assess the consumer fully before prescribing an OCP or informing
her of the possible side effects of the OCP, in particular of
possible blood clotting.
Investigation Process
The complaint was received by the Health and Disability
Commissioner on 25 March 1999 and an investigation commenced on 4
April 1999. Information was obtained from:
The consumer / complainant
The provider / general practitioner
The practice manager, medical centre
Senior Adviser (Medical), Medsafe, Ministry of Health
The consumer's medical records were obtained and reviewed by the
Commissioner. The Commissioner sought advice from an
independent general practitioner.
Background
Since 1996, the Ministry of Health advice to doctors regarding
the third generation oral contraceptives has been to take a
history, disclose risks and gain informed consent. This
information has been stated publicly, in 'Prescriber Updates' sent
to doctors, in letters sent to doctors, and in patient
information.
The New Zealand Medicines and Medical Devices Safety Authority
(Medsafe), Ministry of Health, issued a publication entitled 'Oral
Contraceptives and Blood Clots' in February 1999 with an attached
letter outlining the risks of third generation oral contraceptives
and the link with blood clots. In the February 1999 covering
letter to health providers in New Zealand, Medsafe requested that
the publication be made available to women when being prescribed
oral contraceptives and the leaflet be widely distributed to ensure
easy access by women. The covering letter states, "A copy is
being sent to GPs, selected hospital doctors and specialists,
midwives and Maori and Pacific health workers. Bulk copies
are being sent to GP practices …".
Medsafe advised in its 1999 publication that a consumer should
discuss the risks and symptoms with her doctor: "You have a right
to expect your doctor to explain the risks and symptoms to you in a
way that you can understand".
Blood clots in association with oral contraceptives are described
as causing a blockage in the veins of the legs. The Medsafe
publication advised that:
"Blood clots occur rarely with oral contraceptives, and deaths
from blood clots are even more rare.
The risk of a normal healthy woman developing a blood clot in one
year is 1 in 30,000. The risk of blood clots is increased by
pregnancy. Taking oral contraceptives containing oestrogens
also increases the risk of blood clots, but not as much as being
pregnant. The risk depends on the type of oral
contraceptive."
Medsafe listed Marvelon as a combined oral contraceptive with low
dose oestrogen and progestogen. It is described as a third
generation oral contraceptive, containing the progestogens
desogestrel or gestodene. (Marvelon actually contains
desogestrel.) Medsafe advised that the risk of blood clots
per year is 2 in 10,000 women, "6 times the normal risk" compared
to non-use of any oral contraceptive pill, and twice the risk of
second generation oral contraceptives.
Information Gathered During Investigation
In mid-March 1999 the consumer went to a medical centre with a
sore throat, headache and blocked nose. She consulted with a
locum general practitioner (the provider).
The consumer advised the Commissioner that during the consultation
she explained to the provider that she also wanted a contraceptive
pill due to her painful periods. She advised that the
provider asked her whether she had any serious illnesses in her
family or whether she had any serious illnesses herself, but asked
her no further questions. The consumer stated that she
informed the provider there was nothing significant now or in her
past but advised that she was currently taking Roaccutane
(medication used for severe forms of acne). The consumer
stated that the provider, "then changed the type of contraceptive
pill to be prescribed without further questioning".
The provider advised the Commissioner that he suggested to the
consumer that due to her skin problem, Marvelon would be a suitable
contraceptive, "because it has anti-androgenic properties which
make it the oral contraceptive choice for women with acne".
The consumer advised that the provider described this pill as being
"a skin friendly oral contraceptive". The consumer
subsequently said that she did not know what Marvelon was before
she had gone to the consultation.
The consumer said that she asked the provider whether the pill
would be effective if she used it as a contraceptive while she was
taking Roaccutane. The provider advised the Commissioner that
he had been unsure as "it is not a drug I am thoroughly familiar
with", so he had consulted the pharmaceutical reference book, 'New
Ethicals Compendium'.
The consumer advised the Commissioner that the provider did not
see anything specific in the reference book about interactions
between Roaccutane and Marvelon. In his response to the
Commissioner, the provider stated, "so I was unable to give
specific advice at this point". The consumer advised the
Commissioner that the provider then informed her she would be
alright, but to use other contraceptive barriers "just in
case".
The provider advised the Commissioner that "since pregnancy is
very undesirable in women using Roaccutane, I suggested that
barrier methods would provide an extra method of security in this
situation, should the need arise". The consumer said that she
had left the medical centre feeling confused and unsure of "what
was 'O.K.' and what wasn't".
The provider documented in the consumer's notes:
"[Mid-] March 1999 at 15:53. [provider's initials]
Sore throat and blocked nose 2 days. Mild sinusitis.
Chest normal.
Temp 37.0
Also wants to go on the pill. LMP [last menstrual period]
19.2.99. Painful but regular periods over last few
months. Takes roaccutane for acne. Good general
health. No FH [family history] of serious illness.
Rx [prescription] Amoxycillin 250 mg caps [capsules]; 1 tds [three
times daily] - independent of food; 5 days
Rx marvelon 30; 1 od [once daily]; 90"
The Commissioner noted that there was no mention in the consumer's
notes of blood pressure or weight being taken by the provider or
any record of the information given to her about the oral
contraceptive pill.
The consumer confirmed to the Commissioner that the provider did
not take her weight or blood pressure or suggest that she get this
done the next time she went to the doctor, and did not perform or
ask her about a breast examination or cervical smear during the
consultation. She additionally advised that the provider did
not ask her whether she smoked or not.
The consumer stated that during the consultation, which was
approximately 15 minutes long, the provider did not inform her of
any of the risks of the contraceptive pill he had prescribed.
She advised that he did not give her any pamphlets on this form of
contraception or tell her where she could obtain further
information. Further, the consumer stated that the provider
had not told her how long she would be taking Marvelon for, or if
there was a review date to see how she was progressing on
Marvelon.
The provider stated that he had not informed the consumer of an
increased risk of blood clots in association with Marvelon as
compared with other contraceptives because "no such increased risk
exists, or if it does exist, for practical purposes it is
unmeasurably small". The provider stated that as the
manufacturers of Marvelon enclose a pamphlet on the side effects of
this pill in the packaging, "I usually don't read this list out
when prescribing the drug".
The practice manager of the medical centre advised the
Commissioner that there is a sign at the front reception of the
medical centre stating that information is available on the
contraceptive pill in relation to blood clots. Additionally,
she advised that the receptionists have the information fact sheet
produced by the Ministry of Health on blood clots, and the practice
nurses use a folder designed to help patients choose the most
appropriate contraception.
The consumer advised that following the consultation her friend
and flatmate told her that Marvelon, the contraceptive she had been
prescribed, was one known to cause blood clots.
The consumer advised the Commissioner that since that consultation
she no longer wanted to use this contraceptive pill, knowing the
risks associated with using it.
Independent Advice to Commissioner
The Commissioner sought advice from an independent general
practitioner who stated:
"I do not believe that [the consumer] was given enough
information. [The provider's] view of using a third
generation pill is not entirely in sync with the pamphlet that was
handed out by the nurses. The pamphlet itself states that if
a third generation oral contraceptive pill is used, the risk of
thrombo-embolism [blood clots] is 2 per 10,000 as opposed to 1 per
10,000 if a second generation pill is used. Thus there is a
difference in risk according to which pill is used and [the
consumer] needed to be informed that this issue was present.
I believe that [the provider] could well have then added to the
conversation what his opinion about the whole situation was, but
nevertheless [the consumer] needed to have the information that
there was a body of opinion in the community which said that third
generation oral contraceptive pills possibly carried a greater risk
than second generation ones.
[The provider] could simply have stated that there was a pamphlet
inside the box going through all the more minor side effects and
problems that the pill could have. [The consumer] … should
have been informed of the current debate in the medical and
scientific community about the relative risk of second and third
generation contraceptive pills.
[The provider] should have found out more information and if the
New Ethicals did not provide him with enough information to be able
to reassure [the consumer] about the contraceptive pill and
Roaccutane, he should have rung a dermatologist and asked whether
or not there was such an issue.
I believe that taking a woman's weight [and] blood pressure … is
mandatory before prescribing oral contraceptives.
Clearly the pamphlets that he has included as part of the
collection held by the nurses could have been handed to [the
consumer] at the time, but equally it might have been appropriate
for these to be handed to her at the end of the consultation.
Whether or not [the provider] obtained enough information from
[the consumer] regarding her personal and family history to
identify risk factors for thrombo-embolism is somewhat moot.
It is unclear to me whether this information was entirely
obtained. What is meant from the statement issued from the
Ministry of Health and published in the GP Weekly 25 February 1998
is simply that you need to ask the patient in some detail about her
family history regarding thrombo-embolism, namely has any member of
her family ever suffered a blood clot in their legs, or has any
member of the family suffered a pulmonary embolism or clot in the
lung. Also you need to ascertain from the patient concerned
whether she has any risk factors herself, namely, smoking, obesity
or past history of thrombo-embolism.
It is unclear to me whether or not [the provider] did indeed
obtain a sufficient level of information ….
[The provider] has a clear duty to inform [the consumer] of the
controversy about the third generation oral contraceptive pills
and, as mentioned before, even the pamphlet issued through his own
surgery states that there is a twofold increase in thrombo-embolism
if the third generation oral contraceptive pill is used.
Thus, in conclusion it does appear to me that [the provider] did
not entirely provide [the consumer] with care that complied with
professional standards."
Response to Provisional Opinion
The provider stated in response to the Commissioner's
provisional opinion:
"I do not seem to have made it sufficiently clear that the
consultation which took place [in mid-March 1999] was not for
contraceptive needs. This is however clearly stated in the
letter of complaint. I asked [the consumer] if she needed
contraceptive protection and she replied that she did not.
She specifically requested a pill for the relief of recent onset
dysmenorrhea which had not responded to simple analgesics.
Accordingly I prescribed what was intended to be a short term
therapeutic trial of a drug which I considered suitable for this
purpose, which also happened to be an oral contraceptive. If
[the consumer] had asked me for contraceptive protection, the
consultation would have proceeded along different lines, and I
would have asked her to make a second appointment at a later
date.
As it happened she did attend another doctor at the same surgery a
few months later for contraceptive needs. Your GP adviser
outlines a number of observations … which he/she feels are
important when initiating long term contraception, but which were
also omitted during the later consultation with the second
doctor. Your GP adviser has not seen [the consumer] who is
slim. Smoking is not a risk factor for venous
thromboembolism. I agree that it is important to take a
smoking history in older women who are being prescribed long term
oral contraceptives, because of the risk of peripheral vascular
disease and coronary artery disease. Neither of these
considerations apply to [the consumer] who is 20 years old.
Consequently I do not personally regard these as very serious
omissions. … I would however have recorded [the consumer's]
blood pressure as a matter of course if I had been commencing her
on long term oral contraceptive therapy. In this case I
intended to check this on review at 3 months, if she had wanted to
continue the treatment. In most cases of this kind short
courses of therapy are all that is required, as usually the
dysmenorrhea rights itself with time.
[The consumer] also asked me, in general terms, whether the pill
prescribed would also provide contraceptive protection should the
need arise in future, and I advised her on this to the best of my
ability. Your independent GP suggests that I should have
phoned a dermatologist to ask about possible interactions between
Marvelon and Roaccutaine. I did in fact phone the Family
Planning Clinic about this the following day to satisfy my own
curiosity. The doctor on duty was unable to give any specific
assurances, and concurred with my recommendation for barrier
methods as an interim method in case of need. I have since
consulted the specialist literature on this point, and find only
anecdotal evidence that there is probably not a major
problem. The literature also makes it very clear that
Marvelon is a drug of choice in women with acne. It is also
used in the treatment of acne. In retrospect I would not
change the advice I gave to [the consumer] at the time. I
think she needs to take particular care to avoid falling pregnant
while she is taking Roaccutane. I was seeing [the consumer]
for the first time, and was uncertain about her ability to comply
with the need for daily pill taking. This consideration, and
the known failure rate of oral contraceptives even when used
carefully, prompted my recommendation for the use of barrier
methods.
It is difficult to deal fully with all these matters, and to
anticipate all a patient's individual concerns, during a first
brief consultation at a walk-in clinic. That is why
continuity of care is important. [The consumer] consulted me
a month later about an unrelated problem, and this would have been
a good opportunity for further explanations, but she didn't say
anything about this.
Your adviser also thinks that I should have provided [the
consumer] with information published by the Ministry of Health 25
February 1999 […]. I am uncertain whether this pamphlet was
available at the surgery in early March, I was working there only 1
day a week at the time. The pamphlet deals mainly with the
risks of various oral contraceptives associated with long term use,
and is not immediately relevant to the purpose of the
consultation.
Your adviser states that 'a reasonable consumer would not
ordinarily expect to be told about the absolute risks of a
magnitude of 2 in 10,000'. He/she quotes a sixfold increase
in a relative risk of blood clots for women using third generation
oral contraceptives. This figure has been widely disputed,
and in any case refers to women much older than [the consumer], who
were most commonly obese, and had other risk factors which were not
present in this case. As an expert on … venous throboembolism
… I can inform you that [the consumer's] individual absolute risk
of dying of a pulmonary embolism is probably less than 1 per
million years of pill use, and is not much different from that of
non pill users. The risks associated with 3 months of pill
use in a fit and active 20 year old are immeasurably small.
After talking with her flatmate, [the consumer] was left with the
impression that I had carelessly prescribed a very dangerous
chemical. She understandably became quite angry about this,
and I agree that an apology and a fuller explanation of the facts
is required. I would be happy to provide this. I accept
that it was unwise of me not to have discussed these matters in
detail at the time. However since March last year there has
been ongoing sensationalism in the media on this issue. Like
most other practitioners, of necessity, I now routinely discuss
these matters at some length in all patients requiring oral
contraception, and this adds greatly to the consultation
times. I no longer prescribe Marvelon, unless there are
special reasons, as in this case."
Further Advice to Commissioner
The Commissioner sought further clarification from an
independent general practitioner in relation to the additional
points the provider raised in his response to the provisional
opinion:
"With reference to the further letter from [the provider]
concerning this consultation, there are a few points that need to
be made.
Firstly, I think that, irrespective of whether you are prescribing
an oral contraceptive for dysmenorrhoea or for the purposes of
contraception, the patient's blood pressure needs to be taken prior
to starting the oral contraceptive. This is known as a
baseline reading and is important because, if the subsequent level
is known to be high, it needs to be compared to the blood pressure
level prior to commencing the oral contraceptive. It could be
argued that perhaps weight or breast examination is not essential
but a blood pressure reading certainly is.
Secondly, it should be pointed out that the debate that is
currently before the media, and certainly was at the time of the
consultation, regarding the difference between second and third
generation pills, needed to be discussed and addressed with the
complainant.
As pointed out previously, the pamphlet that was given to [the
consumer] from the Health Department did state that there was a
doubling of the risk of venous thromboembolism between the use of a
second or third generation pill. I admit that the risk is
still very small but nevertheless this point needs to be discussed
with the patient.
Another point that needs to be made is that Marvelon is not the
only oral contraceptive that is appropriate for use by people with
acne. There is another pill called Diane 35 which is also
very appropriate for this condition as it uses second generation
hormones. So there is a choice and I feel, once again, it
would have been appropriate for [the consumer] to have had some
discussion about this.
I appreciate that [the provider] was not in fact prescribing the
pill for the contraceptive per se, but was prescribing it for
dysmenorrhoea; nevertheless the risks are no different irrespective
of the reason for prescribing it.
I feel that overall [the consumer] should have been fully informed
about the debate regarding this issue. Whether the health
professional feels that the risk is minimal or virtually
non-existent, the consumer has a right to know of the debate taking
place and that there are different opinions about it. Clearly
[the consumer] feels that she was not adequately informed of these
issues and did not have a chance to participate in any subsequent
decision making."
Code of Health and Disability Services Consumers'
Rights
The following Rights in the Code of Health and Disability
Services Consumers' Rights are applicable to this complaint:
RIGHT 4
Right to Services of an Appropriate Standard
1) Every consumer has the right to have services
provided with reasonable care and skill.
RIGHT 6
Right to be Fully Informed
1) Every consumer has the right to the
information that a reasonable consumer, in that consumer's
circumstances, would expect to receive, including - …
(b) An explanation of the options available,
including an assessment of the expected risks, side effects,
benefits, and costs of each option; …
2) Before making a choice or giving consent,
every consumer has the right to the information that a reasonable
consumer, in that consumer's circumstances, needs to make an
informed choice or give informed consent.
RIGHT 7
Right to Make an Informed Choice and Give Informed Consent
1) Services may be provided to a consumer only
if that consumer makes an informed choice and gives informed
consent, except where any enactment, or the common law, or any
other provision of this Code provides otherwise.
Opinion: Breach - General Practitioner
In my opinion the provider breached Right 4(1), Right 6(1)(b),
Right 6(2) and Right 7(1) of the Code of Health and Disability
Services Consumers' Rights.
Right 4(1)
The consumer was entitled to have medical services provided to her
with reasonable care and skill. In my opinion, the services
provided by the provider did not meet this standard.
History and tests
Before prescribing an oral contraceptive for the consumer, the
provider had an obligation to ask her details of her family medical
history, specifically regarding thrombo-embolism, and to clearly
document these matters. Information provided to general
practitioners by the Ministry of Health requires that a general
practitioner obtain background medical information prior to the
oral contraceptive being prescribed. The provider should also
have checked the consumer's blood pressure. The fact that the
provider intended to review the consumer's use of Marvelon after
three months does not justify a failure to take her blood
pressure.
Although I recognise that the provider was seeing a patient, who
appeared to be a healthy young woman, for the first time during a
brief consultation in a walk-in clinic, I do not accept that these
facts justified his failure to undertake a standard history and
blood pressure check. Nor is it relevant that the consumer's
needs related to her dsymenorrhoea, rather than
contraception. The fact remains that the medication the
provider prescribed was an oral contraceptive with associated
risks.
In my opinion, in omitting to take an adequate history and blood
pressure, the provider failed to provide medical services with
reasonable care and skill.
Roaccutane
I am advised that Roaccutane is a very powerful medication and
that its use is contraindicated in women who are pregnant or who
may become pregnant, given the near certainty of a major congenital
abnormality in the event of a pregnancy. I am further advised
that in practice virtually all women are started on an oral
contraceptive before commencing Roaccutane and that continued use
of Roaccutane is dependent on continuing use of the oral
contraceptive.
The provider was unable to find sufficient definitive information
regarding the interaction between Roaccutane and the oral
contraceptive pill during his consultation with the consumer and
simply advised her to use other barrier methods "just in
case". I accept the advice of my medical advisor that the
provider should have consulted a dermatologist if he was uncertain
about potential drug interactions between Roaccutane and
Marvelon. It is no answer that the provider consulted a
Family Planning director, and the specialist literature, after he
had prescribed Marvelon, although I accept that it was better than
making no inquiry.
For these reasons, in my opinion the provider breached Right 4(1)
of the Code.
Right 6(1)(b) and Right 6(2)
In my opinion, a reasonable consumer in the consumer's
circumstances would expect to receive, or be directed to, general
information about the side effects of the contraceptive pill, such
as the risk of blood clots occurring when taking an oral
contraceptive. She would also expect to receive specific
information about the particular contraceptive pill that she was to
be prescribed. Although the provider was aware there was
written material concerning the risks associated with the oral
contraceptive pill, and he himself was well versed in the issues
surrounding the oral contraceptive pill, he did not use any of the
written material available at the medical centre. Nor did the
provider inform the consumer of the increased risk of blood clots
from Marvelon.
The Ministry of Health (Medsafe) publication dated February 1999
clearly advises that a consumer should discuss the risks and her
symptoms with her doctor and that the information needs to be given
in a way that is understood. Additionally, the letter dated
February 1999 from Medsafe, requests that its new publication
titled 'Oral Contraceptives and Blood Clots' be made available to
women. It was widely distributed to health professionals
throughout New Zealand, and followed up advice that had first been
issued in 1996. The provider did not provide this information
to the consumer.
In my opinion the consumer had the right to be provided with
information about the benefits and side effects of oral
contraceptive pills and the increase in relative risk of blood
clots if a third generation contraceptive pill is used. It
was not sufficient to rely on an information leaflet in the packet
of pills. The provider needed to discuss the relevant issues
with the consumer.
The fact that the provider intended to review the consumer's use
of Marvelon after three months does not justify a failure to
disclose and discuss the risk of blood clots. I am advised
that there is no evidence that the risk of blood clots in oral
contraceptives users increases with duration of use. Nor did
the consumer's age (20 years) excuse the provider's
nondisclosure. I am advised that the median age of New
Zealand women who have died of a blood clot when taking an oral
contraception pill is under 30 years.
I accept that a reasonable consumer would not ordinarily expect to
be told about absolute risks of a magnitude of 2 in 10,000.
However, in circumstances where there had been extensive publicity
about the sixfold increase in risk of blood clots for women using
third generation oral contraceptive pills, compared to non-use of
every oral contraceptive pill, it is my opinion that fuller
disclosure by the provider was required.
I am aware that there is continuing debate about the true extent
of the risk of blood clots associated with the third generation
oral contraceptive pills. However, in accordance with the
Ministry of Health (Medsafe) advice, and in keeping with the
reasonable expectations of consumers in such circumstances, health
professionals in New Zealand are required to inform women about the
debate and the heightened risk of blood clots.
In my opinion, by not fully informing the consumer of the side
effects of Marvelon, the provider breached Right 6(1)(b) and Right
6(2) of the Code.
Right 7(1)
The consumer had not received sufficient information to enable her
to make an informed choice and give informed consent to the
provision of the contraceptive pill in general and of Marvelon in
particular. Without this information she was unable to make
an informed choice and give informed consent. In my opinion
the provider breached Right 7(1) of the Code.
Opinion: No Breach - Medical Centre
Right 6(1)(b), Right 6(2) and Right 7(1)
Vicarious liability
Employers are vicariously liable under section 72(2) of the Health
and Disability Commissioner Act 1994 for ensuring that employees
comply with the Code of Health and Disability Services Consumers'
Rights. Under section 72(5) it is a defence for an employing
authority to prove that it took such steps as were reasonably
practicable to prevent the employee from doing or omitting to do
the thing which breached the Code.
In my opinion the medical centre did not breach the Code of Health
and Disability Services Consumers' Rights. The Centre had a
system in place whereby pamphlets about the oral contraceptive pill
were readily available at the reception desk and accessible to
patients. Additionally, the Centre's practice nurses had
further pamphlets available. In my opinion, the medical
centre had taken reasonably practicable steps to ensure that
patients were adequately informed about oral contraceptives, and is
not vicariously liable for the provider's breaches of the
Code.
Actions
I recommend the provider takes the following actions:
- Apologises in writing to the consumer for his breach of the
Code of Rights, and refunds the cost of her consultation and
prescription ($25.00). This apology, together with a cheque
for $25.00, is to be sent to the Commissioner's office and will be
forwarded to the consumer.
- Reviews his practice in relation to prescribing oral
contraceptives for patients.
Other Actions
A copy of this opinion will be sent to the Medical Council of
New Zealand. A non-identifying copy of this opinion will be
sent to the Ministry of Health, the Royal Australian and New
Zealand College of Obstetricians and Gynaecologists, and the Royal
New Zealand College of General Practitioners.