Fifth Standing Committee on Delegated Legislation
Wednesday 24 January 2001
[Mrs Irene Adams in the Chair]
The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2000
Dr. Liam Fox (Woodspring): I beg to move,
That the Committee has considered the Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2000 (S.I. 2000, No. 3231).
The most important aspect of the debate is the quality of care given to the patient. There has been criticism of the availability of emergency hormonal contraception, with some patients finding it difficult to gain access to their general practitioner in sufficient time for its use. We understand the problem and have suggested that EHC could be partially deregulated with practice nurses able to prescribe it. That would allow greater flexibility for patients, yet keep EHC in the context of the general practice setting. It would allow access to patients' notes, enabling details of past medical history and any potential drug interactions to be assessed. It would give greater privacy for discussions about sexual contacts, sexually transmitted diseases, and so on, and allow detailed planning of future contraception.
The Government's plans to move straight to an over-the-counter status will increase the risk of problems being missed. There is no question about the competence of pharmacistsindeed, the Conservative party believes that they should have wider prescribing powersbut we would dispute whether a pharmacy is the most appropriate setting for dispensing this type of contraception. Pharmacists must satisfy themselves on several matters. Has there been unprotected sex in the past 72 hours? Is the client present in the pharmacy? Is the client 16 or over? Is EHC needed? Could the client be pregnant already? Is the client taking other medication that might interact with levonorgestrel? Does the client have any medical condition that might affect absorption of levonorgestrel? Does the client have liver problems? Has the client previously had an allergic reaction to levonorgestrel? Many pharmacists themselves have complained that the further training recommended has not yet been undertaken and that a busy pharmacy is not an ideal location for highly sensitive questioning.
In addition, we have already had cases where EHC has been available over the counter in a way that would not have been intended under the Government's proposals. An article from Saturday's Daily Mail reads:
To test how the guidelines, which state that the pill
The article goes on to quote Dr George Rae, chairman of the British Medical Association prescribing committee, about some earlier examples of this. He said:
The whole thing is turning into a hit of a hotchpotch and it needs looking at again. I do not think it is properly thought through.
Indeed, there have been numerous letters in the pharmaceutical press from pharmacists themselves. One pharmacist from Birmingham said:
A health professional dealing with unprotected sex in a teenage girl should be aware of their age and it is hardly a step forward for prescribing to proceed without asking it. There is the question of the mental and physical well being of these girls who may, as we now see, be going from pharmacy to pharmacy, using the drug as contraception.
We must avoid the fragmentation of health care which could be dangerous.
The most serious concern I have with the announcement that Levonelle-2 was to be deregulated was that it was made to the public before the profession was made aware of it. Also, it gave the public the view that it would be available from all pharmacies, which I do not think will be the case if pharmacists object to selling the product on religious or moral grounds. Pharmacists have not been consulted about whether they would like to see this deregulation and it would have made a lot more sense to have a vote for it by those pharmacists who are going to be in the front line of the supply chain.
Another pharmacist wrote from Cheshire to say:
I can foresee a situation where, because of their lifestyle, the same women will return time after time. I have witnessed this with ``patients'' on National Health Service prescriptions for EHC. So we have a potential medical time bomb waiting to explode as steroids are sold without control to girls and women of all ages. How, as a busy community pharmacist, can I check their medical history or age? What is there to prevent an over-16 purchasing the drug for an under-age girl? The Society's guidelines on supply of EHC would be hilarious if they were not intended as serious proposals!
Dr. Jenny Tonge (Richmond Park): As a fellow trained medical practitioner, will the hon. Gentleman explain how a dose of levonorgestrel will lead to a potential time bomb of steroids? I am confused, so will the hon. Gentleman provide some scientific background.
Dr. Fox: If the hon. Lady would let me finish, I am quoting from a letter written by a pharmacist in Cheshire. He continues:
We are supposed to obtain information and render advice and counselling in more than 20 areas in a totally private section of the pharmacy to ensure complete confidentiality for clients who may be under-age girls with parents who are regular customers of the pharmacy.
I am not aware of studies on the extensive and repeated use of EHC on girls under 16. If the hon. Lady is aware of such studies, perhaps she will tell me. It is important to assess the long-term effects of regular and repeated use of this new product among young girls. I suspect that we do not yet have that information.
Another issue is whether the Government's wider policy is sending out the right messages. The new product is not as effective as other methods of contraception. On average, it has an 85 per cent. success rate. I am worried about inadvertently sending out the message that there is less need to use barrier methods of contraceptiona serious public health concern in an age of sexually transmitted diseases.
Conservative proposals for retaining EHC as a prescriptions only medicine, but with availability through the practice nurse as well as the doctor, provide the best way forward. Our policy maintains safeguards and provides enhanced access to patients. Making it an entirely over-the-counter medicine would provide too few safeguards and be inappropriate in such a sensitive and complex clinical domain.
The Minister for Public Health (Yvette Cooper): I am disappointed that the Opposition decided to pray against the order and make it a political issue. Levonelle is a licensed medicine that is assessed by the Medicines Control Agency and the Committee on Safety of Medicines as safe and effective for the purpose of emergency contraception.
When the company Medimpex UK applied to change its legal classification to pharmacy status, all the standard procedures were followed and there was widespread consultation. The medical, safety and public health arguments all support the change and the arguments in favour of the order are strong. The arguments of the hon. Member for Woodspring (Dr. Fox) are not based on an accurate assessment of the facts.
Let us start with the facts. We amended the Prescription Only Medicines (Human Use) Order 1997 to allow 0.75mg of levonorgestrel for emergency contraception to be sold in pharmacies without a prescription to women aged 16 years and over. For pharmacists knowingly to supply the product to women under 16 is an offence the Medicines Act 1968.
Levonorgestrel, a medicine used for emergency contraception, has been assessed by the Medicines Control Agency and the Committee on Safety of Medicines as both effective and safe. It works prior to implantation and prevents pregnancy. The accepted legal and medical view is that emergency contraception is not a method of abortion. It is more effective the sooner it is taken, reaching 95 per cent. effectiveness if it is taken within the first 24 hours after unprotected sex.
Under United Kingdom and European Community law, the sale and supply of all medicines, including emergency contraception, is regulated to protect public health and medicines are legally classified as prescription-only if the medicine needs to be supplied under the supervision of a doctor to ensure that it is used safely. It can be sold in pharmacies only if the legal criteria for listing medicines for prescription-only no longer applies.
Mr. Desmond Swayne (New Forest, West): The hon. Lady may recall the then headmaster of Westminster school, Dr. John Ray, describing sexual intercourse while wearing a condom as similar to the experience of eating a Mars bar with the wrapper on. Does not it occur to the hon. Lady that there will now be a means of avoiding such barrier methods? If the product is sold over the counter what safeguards will there be to enable any restraint on young girls habitually having recourse to morning-after contraception, and what will be the long-term consequences?
Yvette Cooper: The hon. Gentleman was not listening to what I said earlier. This is an application for the product to be given to women over the age of 16. It is an offence under the Medicines Act 1968 for pharmacists knowingly to supply the product to women under 16. The chance of the measure having the effect of increasing the amount that young women use emergency contraception is highly unlikely. I shall deal with the safety issues, and matters of age, later.
The standard procedure was followed after Medimpex UK applied for the product to have pharmacy status. First, the Medicines Control Agency assessed the safety of the medicine in the light of the legal criteria for prescription-only status. Then it was referred to the Committee on Safety of Medicines for advice. That committee recommended that the Prescription Only Medicines (Human Use) Order should be amended to allow the non-prescription supply of the product. The matter then went to public and professional consultation; 138 organisations were consulted and the Medicines Control Agency posted a consultation letter on its website. All the main medical and pharmaceutical bodies that responded were in favour of pharmacy supply. The matter was referred to the Medicines Commission, which advised that it was appropriate to reclassify the product for emergency contraception for women aged 16 years and above from prescription only medicines status to pharmacy status.
The Committee on Safety of Medicines and the Medicines Commission carefully considered all the available evidence on safety and effectiveness. They advised that Levonelle can be safely supplied under the supervision of a pharmacist for emergency contraception.
There has been considerable experience of world-wide use. In the UK the active ingredient has been available in other contraceptive and hormone replacement therapy products for 30 years, though only more recently as an emergency contraceptive. However, it has already been used for emergency contraception in other parts of the world since the 1980s. In France, it has been available from pharmacists since 1999.
The side effects of the medicine are usually mild and short-lived. The committees therefore considered that the medicine had an acceptable safety profile for supply under the professional supervision of a qualified pharmacist and that women would be able to use the product correctly.
In support of that change, the Royal Pharmaceutical Society set professional standards and developed comprehensive guidance for pharmacists on the retail supply of emergency contraception. That guidance is detailed and clear. Although pharmacists are already familiar with the product, through prescription supply, additional training is being provided. A distance learning programme is being sent to pharmacists ahead of the product launch and workshops are available. Although pharmacists are expected to deal with requests personally, pharmacy staff will also receive training to ensure that they respond appropriately.