Despite the publicity given to the issues around 28-day prescribing, (see BTF News, issue 68, Spring 2009), there seems to be little sign of an abatement of the current prescribing practice. Our members report that many general practitioners in the United Kingdom are continuing to prescribe thyroid medication for only 28 days at a time for thyroid patients with stable, chronic disorders. As one member wrote, after moving recently from England to Wales and running into the same practice there: “I feel treated like a sick and untrustworthy child.”
As reported earlier, the Medicines, Industry and Pharmacy Group of the Department of Health issued a statement in December 2008 updating and clarifying its advice to prescribers. In its statement, the MIPG emphasised that ‘...where patients have stable long-term conditions, and can manage their stocks of medicines effectively, prescriptions for longer periods may be more suitable and more convenient to patients.’ But it seems the message is slow to get through.
The British Thyroid Foundation decided to find out about how thyroid medication is prescribed and dispensed in other countries. The representatives of national thyroid societies in France, Norway, Finland, the USA, and Australia, as well as BTF volunteers in Scotland and the Netherlands, kindly shared their experiences with us. We found considerable variations both in the length of prescriptions and other prescribing trends.
The strictest practice we found was in France, where thyroid medication is dispensed for 28 days at a time. The Association Vivre sans Thyro?de is however campaigning for thyroid medication to be packaged (and dispensed) in three-month quantities, as is the case for medication for other chronic conditions.
In several other countries, though, it seems to be far more usual for prescriptions to be written for one year, although they may be dispensed from the pharmacy for two or more usually for three months at a time. In some countries such as the Netherlands and Norway thyroid tablets are packaged and dispensed for three months (90-100 tablets) and in Australia for six months (200 tablets).
Even close to home, just across the Scottish border, there are considerable differences. The period covered by a prescription is a matter for the clinical judgement of the GP, but new systems just now being finalised will enable GPs to produce repeat prescriptions to be dispensed at intervals specified by the GP for 24 or 48 weeks.
BTF Director Janis Hickey commented: “The variations in practice, even close to home, are quite surprising. Nowhere did we find indications that other countries are looking at prescription length as a means to control costs or reduce wastage. To the contrary, dispensing medications for two, three or even six months seems to be seen as a sensible way to streamline costs and to make life more convenient for patients.”
Another difference we noted is that manufacturers of several brands of levothyroxine in other countries (the Netherlands, Norway, the USA, and Australia) have additional strengths, compared with the brands available in the United Kingdom, making it easier to fine-tune the daily dose.
Margaret McGregor, British Thyroid Foundation local coordinator for Edinburgh, writes: The period of time covered by a prescription is a matter for the clinical judgement of the GP at the moment. In my own case, as someone who has had thyroid disease for over forty years - first hyperthyroidism, then thyroid cancer and now, post-surgical hypothyroidism - I am prescribed levothyroxine (generic brand) for a period of eight weeks at a time. I am also on propranolol (a beta-blocker) to counteract the effects of being on a ‘suppressive dose’ of thyroxine. Again this is an eight-week supply. As a patient who has annual check-ups with my endocrine consultant, the dose is decided by him and then prescribed by my GP.
In Scotland almost all (99%) of GPs and community pharmacists are now enabled for the electronic transfer of prescriptions (ETP). Scotland has rolled out ETP in two phases, with acute prescriptions delivered via the electronic Acute Medication Service (eAMS), which is now completed; and repeat prescriptions delivered via its Chronic Medication Service (CMS), arrangements for which are being finalised. (See: http://www.scotland.gov.uk/News/Releases/2009/07/13111103.)
The CMS will mean that patients with long term conditions will be able to register with a pharmacist and have their pharmaceutical care needs assessed. It will also enable GPs to produce a repeat prescription for 24 or 48 weeks to be dispensed at intervals specified by the GP under a shared care agreement with the pharmacist. Each time a CMS prescription is dispensed, GPs will receive an electronic message and when the final instalment of the prescription is dispensed the pharmacist will send an electronic ‘end of care treatment summary’. GPs will also be able to cancel items electronically.
In my own case, at present, renewal of prescriptions is usually done by email, although I can drop off a repeat prescription form at the surgery if in the area.
The Scottish Government policy is that, wherever clinically appropriate, drugs should be prescribed generically. There is no national target for prescribing and the Scottish Government has said it considers the setting of a national target as both inappropriate and unlikely to achieve any significant increase in generic dispensing.
As regards the situation within the 14 Scottish NHS Area Boards, they are expected to regularly check on the unrealised potential savings from greater generic prescribing. Most Boards do have targets (of between 75% and 80%) where primary care generic prescribing is advised for all prescriptions except in special circumstances. Acute hospitals do not have generic prescribing targets as hospital doctors are instructed to use generic prescribing for everything written on in-patient prescription records.
Beate Bartes, President of the Association Vivre sans Thyro?de, France, writes: I had a thyroidectomy for cancer in 2000. I’ve been taking Lévothyrox 125mcg for the last two years.
In France, the prescription length is for one month, but for long-term treatments like levothyroxine, once the treatment is correctly adjusted, the physician generally marks ‘renewable five times’ on the prescription, which means that we have to return to the doctor once every six months.
Many patients consult an endocrinologist, especially in the beginning (the GP refers them once the thyroid condition has been diagnosed), but later on, many are followed by their GP.
The most frequently prescribed medication is Lévothyrox (Merck) (which is presently the ONLY available type of levothyroxine drug available in France, next to L-Thyroxine drops which are mostly used for small children. Apparently a generic levothyroxine will become available soon.
Lévothyrox is supplied in packs of 28 pills (two 14-pill blisters with the days printed on it), which means that the patient has to go to the pharmacy every 28 days (and to the doctor every six months) for their entire life, which seems unacceptable. Our association has recently written to the French Drug Administration authorities to request their authorisation for tablets to be packaged for three months (90 or 100 pills), as is the case for medication for many other chronic conditions such as high blood pressure, cholesterol and diabetes. Contraceptive pills are also supplied for three months.
I am not aware of any discussion about changing the prescription length or renewal procedure.
Judith Taylor, former BTF News Editor, who has lived in The Netherlands for more than thirty years, writes: I have medication for several chronic conditions. All of these, including Thyrax (Organon), are dispensed for three months at a time after a trial period, and I have not come across any discussion about changing it. I see my endocrinologist annually and he gives me a prescription for 12 months that I drop off at the apotheek (pharmacy), which gives me a three-month supply and enters the prescription details in the computer. I re-order every three months, usually when the supply at home is down to about 28 days, via the apotheek website, and pick up my tablets a day later after my GP has signed off on line.
The high degree of automation means that the apotheek staff can spend more time on patient education. When I re-ordered calcium tablets after a long break I was given a trial supply and told to re-order after two weeks and to contact my doctor if there were any side effects or problems. And there was a note reminding me to take them at least four hours after my thyroid medication. When I re-ordered I received a three-month supply.
I have been taking thyroid medication for over forty years, and as a thyroid cancer survivor I need to take it diligently to avoid a recurrence. As I travel a lot, and am outside the country frequently for weeks at a time, I just cannot imagine being restricted to a 28-day supply and having to go in person to get each and every prescription and then get it filled 13 times a year!
Thyrax (Organon) is dispensed in bottles of 90 tablets. There are three strengths - 25mcg, 100mcg and 150mcg - and there is a deep groove so that they can be cut in half, making three additional strengths.
I asked Dr Foppe van Mil, consultant and pharmacist and specialist in the field of international community pharmacy, who explained the dispensing policy in the Netherlands as follows:
“In order to avoid wastage, there is a general consensus measure in the Netherlands that medication for chronic conditions may be dispensed (and will be remunerated) for a maximum period of three months, but the first time all medicines are dispensed for only 14 days. Benzodiazepines can only be dispensed for 30 days maximum. We no longer need repeat prescriptions at all for contraceptives (which are dispensed for a maximum of one year after the first three months) or insulin, unless the prescriber changes the therapy.
Since doctors indicate on the prescription the amount to be dispensed, it is they who make the ultimate decision, but if they prescribe for too long a period, we cut the excess in the pharmacy and give a repeat prescription for the remaining amount(s).
So, for thyroid hormones, once the therapy has been established, doctors prescribe and we dispense for three months, as for all other chronic conditions like hypertension and other cardiovascular diseases, rheumatism, diabetes etc.
This rule used to be official and legal under the previous health care law in the Netherlands when everything was organised centrally. Since the de-regulation of the health service, health insurance companies have now taken over the ruling for their insured, but the three-month limit for chronic medication has been maintained by all (30 or so) health insurance companies.”
Bente Bakke, President of the Norwegian Thyroid Association, writes: Norwegian doctors usually write prescriptions for levothyroxine for one year. Only in the beginning of the treatment, in the titration phase, do they prescribe the medicine for shorter periods.
There are very few thyroid endocrinologists in Norway. Therefore most patients are treated and getting their prescriptions by their GP. The prescription is usually renewed at an appointment, where the GP also will arrange a blood test to check that the dose is appropriate.
As levothyroxine treatment is normally life-long, it is very unlikely that the length or procedures for renewing prescription will be changed in Norway. Patients often have to wait before they can get an appointment with their GP. If they would have to see the doctor every 28 days to get their medicine, the pressure on the health system would be further increased.
The brand name of the medicine is Levaxin (Nycomed) and it is supplied as 100 tablets which are packed loose in small plastic boxes. The strengths are 25, 50, 75, 100, 125, 150 and 200mcg. Nycomed also produces Liothyronin (T3). This tablet comes only in a strength of 20mcg. Many Norwegian patients use a small supplement of T3 for better cognitive function, usually 5mcg twice a day. We have therefore asked Nycomed to produce tablets with 5mcg strength, but so far with no success.
The situation in Finland is similar to that in Norway. Dr Ulla Slama, President of the Thyroid Foundation of Finland, writes: In Finland the doctors prescribe levothyroxine for one year, but the patients get the social security money back only if they take it out from the pharmacy every three months. A check-up by the doctor is recommended once a year if everything is stable in hypothyroid patients, in Graves’ a check-up is often recommended twice a year depending on the stage of the disease.
Nancy H. Patterson, RN, PhD, Founder and Chairman of the Graves’ Disease Foundation, USA, writes: I developed Graves' Disease in 1987. I take Levoxyl (King Pharmaceuticals), 150mcg, as it is considered to be the equivalent of the Synthroid I took for many years. That has been my dose for at least ten years. Before that, the dose fluctuated between 125 and 175mcg. At this moment, it is prescribed by my nurse practitioner (in a family practice). Prior to that, it was prescribed by my endocrinologist (specialist).
The prescription is for at least six months. I telephone the pharmacy for refills, and pick them up. If it were a mail-in prescription, it would be for one year, and I would get three months’ supply at one time. That prescription has to be mailed (or faxed) and has to have either a check or credit card with it. The cost to me would be exactly the same. I choose to have it filled at a local family-owned pharmacy, because they know me, know my medications, and I want to give them the business. If I had them filled at a large chain, I would probably choose to have the three-month supply via mail.
I’m not aware of any discussions about changing the prescription length or procedures for renewing prescriptions. It doesn't make sense to prescribe 28 days. There is only one month that has only 28 days! All that does is create more work for the doctor's office staff.
Synthroid (Abbott Laboratories), Levothroid (Forrest Pharmaceuticals) and Levoxyl (King Pharmaceuticals) come in bottles with loose tablets, and they have twelve separate doses ranging from 25mcg to 300mcg. Unithroid (Jerome Stevens Pharmaceutical/Watson) is available by mail. These are the only products in the USA that have Food and Drug Administration (FDA) approval.
Beverly Garfield, President of the Australian Thyroid Foundation (ATF) Ltd, writes: I had a thyroidectomy 18 years ago, as I had Hashimoto's, Graves and a multi-nodular goitre; and I have been on 150mcg of Oroxine (Sigma) since.
A prescription is valid for 12 months in Australia. A prescription for levothyroxine will usually be given for 200 tablets (there are 200 tablets in each box) with one repeat. The patient needs to have both dispensed within a 12-month period. Either my GP or specialist endocrinologist can prescribe the medication. It depends if I need a script and who I see at the time. I have not heard of any talk of changing the system in Australia.
In Australia, all patients can apply for a PBS Safety Net Card. This card covers less expensive (generic) medicines for general patients to the amount of AU$1,264.90 per calendar year. Once you have reached this amount, you only pay AU$5.30 per prescription. Once Pensioner/Concession Card holders reach the amount of AU$318.00, their prescriptions are free of charge, per calendar year. If your doctor prescribes a medication that is not covered by PBS, or is not available on PBS, a general patient or pensioner/concession card holder has to pay the full price for the medicine prescribed. The cost of these medications is not covered under the PBS threshold.
Generic brands are advertised in the media and on radio, encouraging patients to buy generic brands instead of the original. When your prescription is dispensed at the pharmacist, the assistant always asks if you would prefer the cheaper or generic brand of the medication you have been prescribed. I always say no, I want the original, Oroxine.
Sigma Pharmaceuticals Australia produces both of the brands of levothyroxine available in Australia: Oroxine (original) and Eutroxsig (generic). They are both packed the same. There are 200 tablets in each box. The doses are, 200mcg, 100mcg, 75mcg (a recently introduced dose which the ATF lobbied), and 50mcg. They are packed in blister strips, plastic and foil. Because of the climate in Australia, the tablets must be kept in the refrigerator and are stored in the refrigerator at the pharmacist. The ATF has recently designed a ‘medication travel pouch’ to keep the blisters cool for hopefully up to 30 hours. This pouch will be available to our members, once government approvals have been granted and production has completed.
Beate Bartes, President of the Association Vivre sans Thyroide, France writes: "according to members of the German discussion forum Ohne Schilddruse Leben, there are many different brands in Germany. Most of these drugs are packaged in amounts of 50 and 100 tablets-once the patient is correctly adjusted, the doctors generally prescribe the package with 100 tablets. And some doctors even prescribe a "double dose" so that the patient can then cut the pills, and make the tablets last twice as long (for example, precribe 200 mcg instead of 100). But in most cases, the prescription is for 100 pills, so that the patient has to return once every three months."
It seems there are no less than 13 brands of levothyroxine available in Germany. Of these, L-thyroxin Henning (Sanofi-Aventis), L-thyroxin beta (Betapharm) and Duthyrox (Merck Pharma) are all available in tablet strengths of 25, 30, 100, 125, 150, 175, and 200 mcg. There are also two brands of combination T4 and T3: Novothyral (Merck Pharma) 100mcg (100mcg T4 and 20mcg T3) and Prothyrid (Sanofi-Aventis) 100mcg (100mcg T4 and 10mcg T3).
This article first appeared in BTF News Autumn 2009, Issue no 70 and BTF News Winter 2009/2010, Issue no 71.