Bio-equivalentie en substitutie van generieke geneesmiddelen

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Gast1

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door Gast1 »

Kiek schreef: 29 sep 2017, 15:12 Ik las net dat ze in Frankrijk tijdelijk de Euthyrox van Merck uit Duitsland gaan invoeren, in reactie op het standpunt van de overheid.
Niet alleen Euthyrox, ook L-Thyroxin van Henning (ook uit Dld).
En een levothyroxine-drankje primair bedoeld voor kinderen onder de 8.
Vanaf maandag hebben de franse apothekers doosjes Euthyrox beschikbaar voor de mensen die de nieuwe formule van Levothyrox niet meer willen gebruiken.
Men schrijft dat de formule van Euthyrox identiek is aan de oude franse Levothyrox!
Onze Euthyrox, alsmede die uit Polen, Roemenie en ik vermoed zelfs Turkije *is* toch ook gewoon hetzelfde, want uit dezelfde fabriek etc; alleen een andere verpakking.
(Diepe zucht...'onze' Euthyrox zal dus vast ook wel veranderen....nog een diepe zucht..)
Dat is al een tijd de bedoeling ja. Lactose eruit en proberen te gaan voldoen aan die 95-105%-eis.
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laura
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Lid geworden op: 11 sep 2013, 22:42
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Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door laura »

Ook over Levothyrox. Een ingezonden bericht.
Ik ben een Franse patiente, onder behandeling voor m'n schildklier. Sinds de verandering van de samenstelling van Levothyrox, gefabriceerd door het laboratorium Merck ( dus niet Merck/Serono: manitol i.p.v. Lactose), hebben duizenden mensen last van serieuze bijwerkingen. De Franse autoriteiten op het gebied van de gezondheidszorg hebben eerst alle bijwerkingen ontkend, daarna gebagatelliseerd en uiteindelijk halve maatregelen genomen die ons niet gerust stellen. De minister van gezondheid heeft verkondigd dat alleen medicijnen met deze nieuwe samenstelling vanaf 2018 in heel Europa nog verkrijgbaar zullen zijn. Veel Franse zieken gaan momenteel indien mogelijk naar het buitenland, om het oude medicijn onder de naam Euthyrox of Eutirox te halen.

Help ons alstublieft door deze verandering in uw eigen land tegen te houden. U beschermt daarmee uw eigen gezondheid en steunt diegenen in Frankrijk die vechten voor hun gezondheid en hun leven.

Antwoord a.u.b. niet op dit bericht, vertaald door een vriendin, maar verspreid het in uw omgeving. HARTELIJK DANK voor uw hulp, dit is een noodkreet...
laura

Kijk voor meer informatie ook eens op Schildkliertje.

Raadpleeg altijd een arts als je twijfelt over je gezondheid.
Het Schildklierforum kan niet worden beschouwd als vervanging van een consult of een behandeling.
Kiek
Berichten: 6713
Lid geworden op: 12 sep 2013, 11:36

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door Kiek »

Nu worden we wederom geconfronteerd met gerommel over de status van onze pillen.
Volgend jaar de volgende wijziging.
Deze pillen zijn voor ons een primaire levensvoorwaarde.

Wie bepaalt de verkrijgbaarheid van 'onze' spullen?
De overheid, als hoeder, zou dit veilig moeten stellen.
Dat gebeurt niet vanwege het gebrek aan kennis bij de overheid.
Onze overheid realiseert zich niet meer dat ze de plicht heeft om de bevolking te beschermen.
Het gevoel van urgentie ontbreekt.

Daarom wordt het overgelaten aan de pharmaceutische industrie.
Die heeft geen hoederplicht.
Die heeft alleen maar een commercieel belang.

En zo is onze overheid ondergeschikt gemaakt aan de pharmaceutische industrie.
Het wordt tijd dat de overheid zelf kennis verzamelt en een farma opzet.
In Europees verband.
Dat doen ze nota bene in China ook.
Nuchter lab 8.00 uur - dosis pas slikken na het prikken - lees over schildklieren en ervaringen, want deze kennis geeft inzicht. Door Hashimoto een ervaren schildklierhormoongebruikster (geen arts).
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laura
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Rol hulp- en vulstoffen bij levothyroxine

Bericht door laura »

Vergeten lijkt wel eens dat een veranderde samenstelling van levothyroxine voor klachten kan zorgen.
Een bekend voorbeeld is Eltroxin waarvan de hulp- en vulstoffen veranderden.
Toen speelden twitter en facebook nog nauwelijks een rol. Maar toch meldden veel mensen klachten.

Bij verandering van merk kunnen dus eigenlijk logischerwijs ook de klachten komen door de andere samenstelling.
Een andere hoeveelheid levothyroxine hoeft de boosdoener niet te zijn.

Wat opvalt dat is dat bij Eltroxin net als nu bij Levothyrox de lactose verdwijnt.

Bron: Brief GSK

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laura

Kijk voor meer informatie ook eens op Schildkliertje.

Raadpleeg altijd een arts als je twijfelt over je gezondheid.
Het Schildklierforum kan niet worden beschouwd als vervanging van een consult of een behandeling.
marjoleta
Berichten: 225
Lid geworden op: 27 sep 2017, 08:03

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door marjoleta »

Goedemorgen,
Enorm geschrokken van alle informatie alhier betreffende verandering Euthyrox, vanwege schildklierkanker is mijn schildklier + 4 bijschildkliertjes verwijderd.
Ruim 4 jaar ging het best oké ,de vermoeidheid kon ik goed handelen.
Sinds Mei 2017 begon het te veranderen af en toe heftige hartkloppingen op dit moment iedere dag ,heel gek zo tussen 15.00 /16.00 uur begint het en kan uren aan houden.
Steeds aangegeven aan de internist maar volgen hem klopte alle waarden nu ben ik onder behandeling bij Rijnstate schildkliercentrum,(5 Dec. uitslag bloedonderzoek) nu krijg ik toch sterk het vermoeden dat de oorzaak is verandering Merck Serono.
Ik heb nog oude doosjes uit 2015 en dat is Merck Schiphol-Rijk.
Wat nu ??
Mvg.
Marjoleta
marjoleta
Berichten: 225
Lid geworden op: 27 sep 2017, 08:03

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door marjoleta »

Goedemorgen,

Vraag: zijn er al personen die Tirosint gebruiken als vervanging van Euthyrox?
Ik lees hier toch wel goede berichten over.

Mvg.
Marjoleta
Gast1

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door Gast1 »

marjoleta schreef: 03 dec 2017, 07:53 Goedemorgen,
Enorm geschrokken van alle informatie alhier betreffende verandering Euthyrox, vanwege schildklierkanker is mijn schildklier + 4 bijschildkliertjes verwijderd.
Ruim 4 jaar ging het best oké ,de vermoeidheid kon ik goed handelen.
Sinds Mei 2017 begon het te veranderen af en toe heftige hartkloppingen op dit moment iedere dag ,heel gek zo tussen 15.00 /16.00 uur begint het en kan uren aan houden.
Steeds aangegeven aan de internist maar volgen hem klopte alle waarden nu ben ik onder behandeling bij Rijnstate schildkliercentrum,(5 Dec. uitslag bloedonderzoek) nu krijg ik toch sterk het vermoeden dat de oorzaak is verandering Merck Serono.
Ik heb nog oude doosjes uit 2015 en dat is Merck Schiphol-Rijk.
Wat nu ??
Mvg.
Marjoleta
Euthyrox in Nederland is nog steeds dezelfde. De verandering van samenstelling is nog niet goedgekeurd (in Nederland). Er is dus enkel nog normale Euthyrox te krijgen. Al dan niet via parallel-import, maar ook die is exact hetzelfde, zelfde samenstelling uit dezelfde fabriek, enkel een ander doosje.

Doosjes uit 2015 lijken me "over de datum". Meestal is de houdbaarheid en daarmee voldoende stabiliteit gegarandeerd voor 18 maanden.
Dat is overigens een van de redenen waarom Merck Euthyrox lactosevrij maakt: de houdbaarheid (en daarmee de stabiliteit) zou toenemen.

Wat Tirosint betreft, die "hype" is al weer over. Tegenwoordig lees je vooral weer wonder-verhalen over mensen die terug zijn gegaan naar Thyrax (wat ze vaak al lange tijd gebruikten).
Tirosint is geen ander middel als alle andere levothyroxine. Het verschil is dat het capsules zijn, die kennelijk beter/stabieler opgenomen zouden worden in combinatie met een maaltijd of zelfs koffie. Al heb ik daarover ook tegenstrijdige onderzoeken gezien (en ook enkele onderzoeken gesponsord vanuit IBSA, de fabrikant).

Bij alle goede berichten, bedenk dat het voor het overgrote deel vooral gaat om het vinden van de voor jou, jouw lichaam, situatie, levenswijze juiste en best passende dosering; de meest-optimale hoeveelheid levothyroxine. En die werkzame is in al die pillen en capsules exact gelijk. Hulp- en vulstoffen veranderen dar niks aan, hebben hooguit een (beperkte) rol bij de hoeveelheid levothyroxine die je lichaam opneemt.
marjoleta
Berichten: 225
Lid geworden op: 27 sep 2017, 08:03

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door marjoleta »

Dag Mark,

Hartelijk dank voor de reactie, ik begrijp dat ik geen medicatie uit 2015 moet innemen, ik wilde alleen maar aangeven
dat mijn huidige Euthyrox een ander land van herkomst had.
Tirosint las ik zeer goede berichten over, maar je hebt gelijk ook te lezen dat sommigen er van terug komen.

Bedankt !
Mvg.
Marjoleta
Gast1

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door Gast1 »

marjoleta schreef: 03 dec 2017, 13:21 Dag Mark,

Hartelijk dank voor de reactie, ik begrijp dat ik geen medicatie uit 2015 moet innemen, ik wilde alleen maar aangeven
dat mijn huidige Euthyrox een ander land van herkomst had.
Tirosint las ik zeer goede berichten over, maar je hebt gelijk ook te lezen dat sommigen er van terug komen.

Bedankt !
Mvg.
Marjoleta
Oké! Dan had ik het niet helemaal goed begrepen.
In de geneesmiddeleninformatiebank kun je ook zelf de informatie vinden. Zoek op <Euthyrox> en je ziet bijvoorbeeld 3 registraties voor 100mcg.
https://www.geneesmiddeleninformatiebank.nl/nl

Als je de 3 bijsluiters naast elkaar legt, dan zie je dat ze alle 3 dezelfde fabrikant hebben: Merck KGaA
In het ene geval is de vergunninghouder (degen die het op de markt brengt) Merck, de andere is van EuroRegistratieCollectief en de 3e is Eureco-Pharma. De laatste 2 importeren naar Nederland Euthyrox uit andere landen (die info staat óók op de bijsluiter).

De fabrikant (de maker) is hetzelfde, de samenstelling ook. Ik heb zelf overigens ook de Roemeense buisluiter, en als je die ernaast legt, is het óók dezelfde samenstelling.
ineke
Berichten: 484
Lid geworden op: 08 nov 2014, 17:53

Re: Bio-equivalentie en substitutie van generieke geneesmiddelen

Bericht door ineke »

Nieuw - volledig - artikel

Open Access - Springer Link
AAPS PharmSciTech April 2019,
White Paper Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model
First Online: 12 March 2019
Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence


In dit artikel over levothyroxine:
THERAPEUTIC EQUIVALENCE OF LEVOTHYROXINE TABLETS


For generic and biosimilar medicinal products, pharmaceutical equivalence can be the “Achilles heel” in concluding sameness, biosimilarity, and interchangeable biosimilarity.
“Achilles heel” is a metaphor for a weakness in apparent strength or confidence. Shifting the mindset from “pivotal” (one-time) bioequivalence or clinical trial to the integrated “weight of evidence” or “totality of evidence” for assessing and concluding therapeutic equivalence is a significant need.
Education and communication, with the goal to provide patients, their care providers, and the public at large assurance in “weight of evidence” or “totality of evidence,” is an urgent need and is a more significant challenge.

Reduction of quality failures, product recalls, regulatory violations, and FDA enforcement actions (e.g., Warning Letters) and effective communication and education are essential to prevent erosion of trust. The case example of continued challenges in assuring therapeutic equivalence of levothyroxine tablets is a useful reminder of this need and provides useful insights.


The paper entitled “New Insights on Solid-State Changes in the Levothyroxine Sodium Pentahydrate during Dehydration and its Relationship to Chemical Instability” published in this Theme Issue provides a great example of NPK.
It identifies a new failure mode in drug substance chemical stability.
That levothyroxine remains stable at higher humidity and is unstable at low humidity raises questions on recommended stress-inducing conditions for stability testing in regulatory guidelines.
Over the past several years, regulators across the globe responded to the concern, expressed by both physicians and patients, of apparent variability and therapeutic inequivalence upon switching between manufacturers of products deemed to be therapeutically equivalent.
They tightened potency specification and bioequivalence goalposts. The reported failure mode and the questions it raises on the appropriateness of the recommended stress-inducing conditions for stability testing in ICH guidelines should remind and speak loudly to the community on residual uncertainty despite efforts to improve confidence in bioequivalence methodology and tightening potency specifications and it is yet another voice calling for “dire need” for NPK (21).


To place the noted “dire need” in the real-world context considers the massive backlash following the introduction of an improved formulation of levothyroxine in France and other European countries. Recently, the European Thyroid Association and Thyroid Federation International issued a joint position statement on the interchangeability of levothyroxine products in EU countries (22) which listed the following four concluding statements:

1. Several European countries have seen major health issues after a switch from one levothyroxine brand to another, as well as following the introduction of several levothyroxine formulation changes.

2. Although it is not possible to ascertain what proportion of these health issues are biologically related to the formulation change, the issues include increased prevalence of side effects as well as increased prevalence of biochemical signs of inadequate dosing and result in increased healthcare consumption and healthcare expenses.

3. Testing bioequivalence does not guarantee continued euthyroidism after a formulation change of levothyroxine.

4. In at least 3 European countries, formulation changes have been introduced by manufacturers without adequate communication with healthcare professionals and patient organizations.”


A similar experience in New Zealand is also worth noting. ***)
The introduction of a formulation deemed to be bioequivalent to the old formulation resulted in a sharp increase in the reporting of adverse reactions to this drug. Initial interpretations were attributed to a combination of factors, including mistrust of state drug-subsidizing agencies and media attention could have provoked anxiety in patients. An alternate explanation posits a change of formulation and accompanying media attention may provide patients a reason to pay attention, leading to uncertainty and anxiety, and triggering the amplification of reporting of adverse drug effects (22).

In the USA, the report on the University of Pennsylvania Health System’s efforts to promote generic substitution is also worth mentioning. They implemented a default opt-out checkbox labeled “dispense as written” in their Electronic Health Record system. If left unchecked, the generic-equivalent medication is the default (automatic). The opt-out default resulted in the overall generic prescribing rate to increase (in 7 months post-intervention) significantly for all drugs except levothyroxine. The opt-out rate for generic levothyroxine was 22.1% after the intervention, compared with less than 2% of other drugs; indicating the continued lack of confidence in generic levothyroxine among many physicians (23).


Fig. 1
Current challenges in approval of ANDA’s. A For 10% of all FDA-approved NDA’s (100%), no ANDA has been submitted despite expired patents and exclusivities (6). B Quoting an FDA issued Federal Register notice—“The drugs described in more than half of all FDA-approved ANDAs are never marketed, marketed only after a substantial delay after approval, or marketed only intermittently. Such failures to market contribute to drug shortages and hinder consumer access to approved products” (7). C Percentage of approved and commercialized ANDA’s
https://link.springer.com/content/pdf/1 ... 1347-6.pdf

Gerelateerd
Abstract artikel:
New Insights on Solid-State Changes in the Levothyroxine Sodium Pentahydrate during Dehydration and its Relationship to Chemical Instability

https://link.springer.com/article/10.12 ... 018-1264-0



***) Dit rapport?
Medicines Adverse Reactions Committee: 13 September 2018
5.0 ELTROXIN FORMULATION SWITCH (33)
Hypothyroidism is a common medical disorder that is easily managed by replacement treatment with synthetic thyroxine. About 70 000 New Zealanders have hypothyroidism and are treated with thyroxine replacement medication. Since 1973 the only thyroid hormone replacement drug approved and funded by the government for use in New Zealand was the Eltroxin brand, made by GlaxoSmithKline. In 2007 the company moved the manufacture of Eltroxin from Canada to Germany. This resulted in a change in the tablets’ inert ingredients: the new formulation differed in markings, size, and colour and—according to some reports—also in taste and rate of dissolution on the tongue. The active ingredient (thyroxine) remained unchanged and continued to be made in Austria. The new formulation was approved by Medsafe (33).
In 2007 and 2008 New Zealand pharmacies changed to the new formulation of Eltroxin. The old formulation had been used for more than 30 years without problems; but after the new tablets were introduced the rate of adverse event reporting rose nearly 2000-fold—from 14 reports in 30 years to more than 1400 in 18 months (33).

Adverse reaction reports relating to the new formulation were first received in October 2007 by New Zealand’s Centre for Adverse Reactions Monitoring, CARM. By July 2008, 294 incidents of adverse reactions had been reported—most (251) reports were received after the Eltroxin formulation change hit the press. The number of adverse reaction reports peaked in September 2008 (at 492). The number fell in October that year to 177 and even further in November to 21, after an announcement that an alternative thyroxine brand was being approved.
About half of all the symptoms reported—such as weight gain, lethargy, muscle pain, joint pain, and depression—can be features of hypothyroidism, but other commonly reported symptoms are not: conjunctivitis, eye pain, headache, itching, skin rash, abnormal or blurred vision, nausea, and indigestion. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) consulted with local endocrinologists and sought information from the 30 countries in which the new formulation of Eltroxin is used. Some countries reported a small increase in the number of adverse reports, but none had such a dramatic increase as in New Zealand. Medsafe also had independent tests conducted, which found that the new formulation contained the ingredients listed by the ompany, had the same levels of thyroxine as the old formulation, and was bioequivalent to the old tablet.


Medsafe issued a press releases to clarify misinformation being spread through the media and internet sites about the new Eltroxin formulation. This misinformation included rumours that the new formulation was being manufactured in India and contained genetically modified ingredients and monosodium glutamate.
In response to public pressure two additional brands of thyroxine were approved for use in New Zealand in October 2008, enabling patients to switch brands without additional expense. Although these alternatives were provided as soon as they could be, the public perception was that Medsafe’s response to the adverse reactions reporting was too slow, as reflected by demands for immediate action from politicians in a press release headed “How long will Eltroxin sufferers have to wait?” By April 2009 the level of adverse reaction reporting had dropped back to nearly that before the formulation change and has remained low since. There have been very few media stories about the formulation change since November 2008. Despite the negative publicity about Eltroxin, data from Pharmac indicates that as of June 2009, many patients had gone back to the drug and about 80% of patients using thyroxine were taking the new formulation of Eltroxin.

The following two studies investigate this change from psychological and sociological viewpoints. Although this was not a brand switch, the studies provide an interesting perspective on the role that media, public reactions and governmental agencies play. These studies provide valuable insight from a different lens and also draw parallels to brand switches, highlighting areas that can be targeted for future improvement. 5.1.1 Gardner & Dew, 2011 (34)

This study uses the Eltroxin formulation switch to investigate the use of the Actor-Network Theory (ANT) in sociological studies. Although ANT is not relevant to this paper, the observations this study presents on the Eltroxin switch can be utilised to understand different forces in play during a brand switch, and how that can affect ADR reporting and patient outcomes.


The paper follows the events, noting when important changes occur and how they affect future events and the end outcome.
1. A sufferer of hypothyroidism, Lyn, made a link between her new symptoms and her new medicine after listening to people with the same problems discussing this on talk back radio. The radio provided the initial means for an otherwise discrete collection of individuals to form a group bound by the belief in the ill-effects caused by the new formulation.

2. The Southland Times published a story on this potential link, further disseminating the nascent groups rendering of the medicine to a wider audience. The article included discussions about Medsafe, Pharmac and GSK’s role. The newspaper drew a series of associations between bodily symptoms of Lyn, Eltroxin, and GSKs manufacturing processes in Germany.

3. Due to Lyn’s phone number being published in the article, she claimed to have received “hundreds” of complaints from people having the same symptoms. This prompted The Southland Times to publish another article which elaborated on the alternative medication (Goldshield brand) taken by Lyn that doesn’t cause any side effects. This article reaffirmed to the readership the series of associations made in the first article.

4. The article prompted patient’s to report their adverse reactions to CARM. It provided instructions to Eltroxin users, attempting to channel one series of actions into another series of actions. It encouraged the translation of anecdotal complaints of a group of dispersed individuals into coordinated and homogenous action by contacting CARM.


5. The Waikato Times also published an article after someone in the Waikato region experienced problems, exposing the controversy to 40,000 more people. Media coverage continued and increased, exposing the problems to more people.

6. A massive flow of reports was received by CARM, of which 40% were consumer reports. CARM became a voluntary passage point, where the actions of dispersed individuals were coordinated into a series of formal reports. They essentially acted as an inscription device, translating scattered action among members of the population into a format that could be subject to various statistical analyses. It produced an official appraisal of risk.

7. Medsafe issued statements saying the formulation had been retested and GSK ordered to issue information concerning the medicine directly to consumers. The statements also suggested that poor patient compliance should be considered as a possible cause of adverse effects. In doing this, Medsafe became delineated and engaged in action that induced other actors to delineate themselves.

8. Allan Campbell, a Temuka-based pharmacist, claimed that Medsafe, along with other government agencies has failed to react with sufficient haste. Support groups formed which criticised the government and requested subsidies of the Goldshield brand of levothyroxine. Opposition MPs also claimed ineffectiveness of the Government and Medsafe.
These actions strengthen the viewpoint that the new Eltroxin formulation was the cause of the adverse reactions. As more individuals, groups, and agencies become enrolled in this viewpoint, it becomes more factual and has a greater ability to induce entities to delineate themselves and act, as well as becoming more durable and difficult to dismiss.

9. As more politicians became entwined, only one out of the two viewpoints that had been originally expressed, had been disseminated with any success. Very few people and groups had taken the position that Medsafe was correct, regardless of the absolute truth. CARM and Medsafe were restricted to a monitoring role. The success of the anti-Eltroxin group is best indicated by the media coverage.

10. Medsafe and CARM provided information to MARC. The recommendations from the Committee meeting represented a further translation of action: the summary of adverse reaction reports composed by CARM, and the worldview constructed by Medsafe have prompted the Committee to act and to initiate activities that will put other actors into motion.


The media was vital: it disseminated the rendering of Eltroxin as the cause of adverse reactions, the risk, to a very large readership. Importantly, it enabled an otherwise diverse heterogeneous collection of dispersed individuals to group together behind various spokespeople. It also coordinated this group by illustrating a conduit for action: the media provided details of CARM and encouraged sufferers to report their symptoms. It therefore facilitated a widespread, concerted response to risk.
By reporting directly to CARM, sufferers could bypass the usual channel for reporting to GPs, who may be both placating and dismissive. Consequently, CARM received a large quantity of reports which were standardised through CARMs various ordering and sorting practices. Politicians acted as another conduit for action: the complaints of the worried, anxious individual became the basis for political sound bites and rhetoric.


5.1.2 Faasse, Cundy & Petrie 2009 (33)
The authors of this study discuss four major factors which they believe had roles in causing the massive amounts of reports received by CARM.

External factors – at the time of the formulation switch, Pharmac was under intense scrutiny due to decisions made around rationing the availability of Herceptin to only early stage breast cancer. Patients saw the formulation change as a cost cutting strategy by Pharmac,
despite the newer formulation being more expensive.
The negative perception and distrust of Pharmac from this are likely to have contributed to the problems.  C

hampions – Alan Campbell, a pharmacist from Temuka, publicised patients’ concerns by giving media interviews. This brought the issue to the attention of the public, but also created fear and dissatisfaction that may have made the situation worse. There was also appeal in his position as a small town health professional taking on the “medical establishment”. 


Media coverage –
Media coverage of the issue was widespread, but varied between regions. The intensity of the coverage was related to the rates of ADR reporting, showing the strong effect the media can have on ADR reporting rates and potentially the development of nocebo-based symptoms. In the Auckland region, where the news media did not particularly focus on the story, is home to around 31% of the New Zealand population but accounted for only 16% of all adverse reactions reported. In contrast 41% of all adverse reaction reports came from the Bay of Plenty, Canterbury, and Southland regions, which together have only 22% of New Zealand’s population. The Eltroxin story was covered extensively in local newspapers in these regions. 


Patient factors –
Hypothyroid patients, even those taking thyroxine replacement therapy, had been found to have higher levels of emotional stress and more physical symptoms than people without hypothyroidism. Because of this, they are more likely to attribute physical symptoms to a medical intervention or illness. It is likely that patients taking Eltroxin misattributed unrelated physical symptoms to the new formulation. Additionally, they may have misattributed indications that they required a re-evaluation of their dose as instead being harmful adverse effects. 


Although the authors did not consider this a separate factor, social media attention is discussed. Internet support groups and chat forums provided channels for false rumours to be spread about the drugs manufacture, ingredients, and the agenda of the “medical establishment”. The misinformation may have influenced patients’ beliefs and expectations about the likelihood of experiencing physical symptoms in response to the formulation change and also to the spread of physical symptoms in these patients.
https://medsafe.govt.nz/committees/marc ... ealand.pdf

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