A recently added page identifies what tests might be included in an Iron Panel or a Thyroid Panel. While the phraseology of "ordering a panel" sounds very American, it has become ever so common. Yet the simplest level of knowing what that means is rarely explained.
And I keep adjusting the phrasing, adding some words, correcting typos, etc.
You might ask, why does helvella put things on a blog rather than on HealthUnlocked's Thyroid UK forum?
I can include much more information than in a reply on the forum.
I can include multiple graphics.
My replies on the forum can be tailored to the individual's actual question and circumstances. Putting a lot into a reply can feel overwhelming and confusing. And, if appropriate, I can add a link to my blog for more information.
Posting the same information repeatedly is tedious for other members.
I simply cannot write the information out every time someone asks. So I have to store it somewhere. By making that place a blog, it allows anyone to access my stored information at any time - at their convenience.
I can put more effort into a blog than into replies. That includes making the replies more comprehensive, including references, etc.
At the same time, this blog does not replace the forum. It is intended to add to it.
This
information is provided in response to your request. Resources may
contain information about doses, uses, formulations and populations
different from product labeling. See Prescribing Information above, if
applicable.
Can people take Mounjaro® (tirzepatide) with levothyroxine?
Levothyroxine is not contraindicated with the use of
tirzepatide; however, tirzepatide delays gastric emptying and thereby
has the potential to impact the absorption of concomitantly administered
oral medications like levothyroxine.
See important safety information, including boxed warning, in the attached prescribing information.
Use With Levothyroxine
Levothyroxine is not contraindicated with the use of tirzepatide.1
Tirzepatide delays gastric emptyingand thereby has the potential to impact the absorption of concomitantly administered oral medications.The impact of tirzepatide on gastric emptying was greatest after a single dose of 5 mg and diminished after subsequent doses.1
Monitor
patients on oral medications dependent on threshold concentrations for
efficacy and those with a narrow therapeutic index (NTI) when
concomitantly administered with tirzepatide.1
The Food and Drug Administration (FDA) has concluded that levothyroxine is a NTI drug.2-4
Eli
Lilly and company does not provide specific treatment recommendations.
We strongly encourage patients to go to their healthcare provider for
treatment advice because they know their patient's medical history the
best.
The prescribing information for levothyroxine includes a warning for worsening
of diabetic control: Therapy in patients with diabetes mellitus may
worsen glycemic control and result in increased antidiabetic agent or
insulin requirements. Carefully monitor glycemic control after starting,
changing, or discontinuing thyroid hormone therapy.4
3US
Food and Drug Administration (FDA). Real-world Evidence from a Narrow
Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic
Equivalence of Generic Drug Products. Updated November 19, 2020.
Accessed August 16, 2023.
4Synthroid [package insert]. North Chicago, IL: AbbVie Inc; 2017.
What I tend to do is post pages which are meant to be for reference - rather than the frequent blogs. Most blogs are intended to promote something or other. (And that is not in itself a criticism.) Or to provide an ongoing narrative.
Whereas my main aim is to maintain what could be pages on a website.
This sort of information is locked away by the USP so that we patients cannot access it!
However, searching found what claims to be a copy of the USP document and that says:
It may contain a suitable diluent such as Lactose, Sodium Chloride, Starch, Sucrose, or Dextrose.
My memory is claiming there might be one or two other substances are specifically permitted but I cannot find confirmation. I'll update if I can find out more. But as written, it seems to allow anything that is considered "suitable" without definition of that.
This blog post is a complete copy of a page on NHS England's Specialist Pharmacy Service website.
While I have copied it here, I actually encourage visiting the actual site - where it should remain and continue to be updated. However, in the past, useful pages like this have sometimes disappeared or been replaced or become inaccessible.
An understanding of the different types of unlicensed medicine will help in meeting patients' special clinical needs.
Quality, safety and efficacy
Any medicine that meets the definition of a medicine but does not
have a Marketing Authorisation valid in the UK, is an unlicensed
medicine.
Licensed medicines undergo full evaluation by the MHRA as part of the
licensing process. Pharmaceutical quality, safety and efficacy are
assured. Unlicensed medicines are outside the MHRA medicines licensing
process, so pharmacists and prescribers must take additional steps to
assure themselves of the quality, safety and efficacy of all the
unlicensed medicines that they prescribe, purchase, make and supply.
The most common types of unlicensed medicines are described below.
Specials
Specials are medicines manufactured in the UK by the holder of a
“Specials” Manufacturing Authorisation (MS) licence, or imported
medicines that do not have a GB Marketing Authorisation.
Specials may only be prepared and supplied (often referred to as
‘placed on the market’) under an exemption from the Human Medicines
Regulations 2012 (SI 2012/1916). This is further explained in MHRA’s Guidance Note 14.
Specials may only be supplied where there is no licensed medicine available to meet the special clinical needs of individual patients. They must be supplied only in response to a bona fide unsolicited order from an authorised person.
Special clinical need
Some patients have special clinical needs that cannot be met by the
administration of medicines with a UK Marketing Authorisation.
Cost saving, convenience or operational need are not special clinical
needs and Specials cannot be supplied for these reasons. Manufacturers,
importers and distributors must obtain documentary evidence that there
is a genuine special clinical need before they supply unlicensed
medicines.
Individual needs
Individual patients sometimes need custom preparations, for example
those with an intolerance or allergy to a particular ingredient.
Group needs
There may be whole patient cohorts for which a suitable licensed formulation is not available. Examples include:
children who cannot swallow a tablet or capsule and therefore require an oral liquid
those receiving oral medicines via a nasogastric tube
the need for a smaller dose than is achievable using the required licensed medicine
Medicines supply disruption
In the case of disruption to supply of a licensed medicine, there may
be a temporary special clinical need. For example, a patient group
whose usual licensed medicine becomes temporarily unavailable, and where
there is no suitable licensed alternative.
The Medicines Supply Notifications (MSNs) published on the medicines
supply tool may include information about availability of unlicensed
medicines. Unless specifically stated otherwise, these have not been
evaluated for pharmaceutical quality or suitability to meet patients’
needs, so organisations must follow their local unlicensed medicines
policies in the usual way.
UK manufactured specials
UK manufactured Specials are manufactured in the UK by the holder of a
“Specials” Manufacturing Authorisation (MS) licence. UK manufactured
Specials may either be supplied directly by the manufacturer or via the
holder of a Wholesale Distribution Authorisation (WDA).
Although the MS holder is regulated and inspected by the MHRA, the
products themselves are not independently evaluated for quality, safety
and efficacy.
the holder of a Wholsesale Distribution Authorisation that allows
imports of medicines. Such importers are permitted to import medicines
from specified authorised countries, such as those within the EEA
the holder of a MS licence that allows imports of medicines. Such
importers are permitted to import medicines from the rest of the world
Imported medicines may have a marketing authorisation from another
country, or in some cases they may be unlicensed medicines in their
country of manufacture.
The importer must notify the MHRA of the intention to import a
medicine. The MHRA may object to any importation, for example, if there
is concern it has not been manufactured following standards equivalent
to Good Manufacturing Practice, or if they are not satisfied there is a
genuine special clinical need. However, the lack of objection is not
equivalent to approval of the medicine by the MHRA.
Investigational Medicinal Products (IMPs) are a pharmaceutical form
of an active substance or placebo being tested or used as a reference in
a clinical trial. These may be novel products, or may be medicines
already with a UK marketing authorisation but:
assembled (formulated or packaged) in a different way from the authorised (licensed) form
used or administered in a different way from the authorised form
used for an unauthorised indication
used to gain further information about the authorised form
Although many IMPs are not licensed medicines they do undergo a
formal assessment by the MHRA as part of their acceptance into the
trial. This means that pharmaceutical quality is assured.
Some medicines made by the holder of a Manufacturing Authorisation
(MIA or MIA(IMP)) are made available to patients as part of the Early
Access to Medicines scheme.
EAMS
medicines, although not yet licensed (authorised), do undergo a formal
assessment of quality, safety and efficacy by the MHRA as part of their
acceptance onto the scheme. This means that pharmaceutical quality is
assured.
All medicines with a current positive EAMS scientific opinion are listed on the MHRA’s website.
Regulation 174
Regulation 174 of the Human Medicines Regulations enables the MHRA to
temporarily authorise the sale or supply of a medicinal product in
response to the suspected or confirmed spread of pathogenic agents,
toxins, chemical agents or nuclear radiation which may cause harm to
human beings. To date, the only example of this is the supply of the
first COVID-19 vaccines before they were granted marketing
authorisations.
Medicines made under Section 10 exemption
Pharmacists are exempt from licensing requirements pertaining to the provision of medicines if the medicines are prepared:
in a registered pharmacy, hospital or healthcare premises
by or under the supervision of a pharmacist
in response to a prescription from an appropriate practitioner
Aseptically prepared medicines
Many hospital pharmacies prepare ready to administer injectable
medicines for supply to their wards and clinics under Section 10
exemption from the Medicines Act 1968.
Aseptic preparation is a critical activity undertaken according to
national quality standards. The governance and regulatory arrangements
are explained by NHS England’s Assurance of Aseptic Preparation of Medicines
When members post links on HealthUnlocked, the platform itself changes their colour to blue/cyan and shrinks the links. It ends up that, except for the very shortest of links, you cannot see where the link is pointing. Any characters beyond about 24 change to an ellipsis (three dots - ...)
If you post just the link, then members might have little or no idea why they should click on it.
I've produced a simple image below which shows what you can do to help members.
First example, just a few words which can provide some sort of content.
Third, the same words, but with some added formatting. In this example, I have formatted them all as italic. And then also emboldened some of them.
You can format by selecting the text you want to format and then clicking on the letters at the bottom of the post/reply box - B for bold, I for italic or U for underscore - or combine them.
The link examples as they appear when posted. In all three, the link has been truncated.
Don't worry. Nothing awful will happen if you do not do this (or your interpretation of this). But we'd probably find more members who are interested do click on the links if they are made more obvious. And fewer who really are not interested will feel frustrated that they have clicked on another link and wasted their time and effort.
Also, you don't have to confine yourself to the heading. Sometimes it can be helpful to include the first paragraph, or the abstract, or the summary.
Once you have done this once or twice, it really shouldn't take much time or effort to add these helpful features.
