Warning concerning accidental injection of Gudair sheep vaccine



Warning concerning accidental injection of Gudair sheep vaccine

Anastasia Tsirtsakis 24/11/2021 1:25:33 PM SPONSORED: GPs have been reminded about the potential medical implications following unintended exposure to the Gudair vaccine.

Even a small amount of vaccine fluid can result in intense swelling and a persistent granulomatous inflammatory reaction.

GPs working in sheep producing areas around regional Australia are being encouraged to be on high alert for adverse events in patients who are exposed to Gudair – a vaccine administered to sheep, primarily at lamb marking.

Gudair, a vaccine containing inactivated mycobacterium paratuberculosis combined with a mineral oil adjuvant, is used to control Ovine Johne’s Disease (OJD), an incurable wasting disease.

Zoetis undertakes an extensive education program for all rural stores and veterinary clinics that stock Gudair, to promote the safe use of Gudair that involves correct vaccine handling and vaccination using a specialised safety vaccinator, with a safe work environment for competent and experienced personnel.

Nonetheless, accidental injection into humans can still occur and even a small amount of vaccine fluid can result in intense swelling and a persistent granulomatous inflammatory reaction.

For example, if injected into a finger joint or tendon sheath, the product may track along the tendon and as a result the swelling and inflammation may compromise blood supply and result in necrosis, and in rare cases can result in amputation.

To avoid severe side effects, people are advised to seek prompt medical attention.

Every case is different, and the correct medical advice is a matter for the treating doctor.

‘Doctors have found that the treatment of a human accidental self-injection case may require prompt surgical attention to remove the vaccine,’ a letter issued to regional doctors by Zoetis, the Australian distributor of Gudair, reads.

Zoetis is aware of the following treatment strategies being frequently recommended where needle stick injury has occurred.

Needle-stick injuries without known injection of vaccine

Doctors have recommended that the wound be allowed to bleed freely and that the wound or injection site not be squeezed or otherwise interfered with. Doctors have recommended that the wound then be cleaned thoroughly with warm water and then kept clean and dry

Doctors have also considered that, following appropriate immediate local cleansing, corticosteroids may decrease the severity of any local reaction

Doctors have frequently determined the patient’s tetanus immunisation status and administered a booster or primary series, as appropriate

Commonly, if there is no pain or swelling 24 hours post exposure, doctors have continued to monitor for at least a month and treat any clinical symptoms accordingly

Needle-stick injuries with injection of vaccine

Doctors have observed that acute pain and inflammation is usually still evident 24 hours after the suspected injection occurred

In cases of self-injection, doctors have considered that prompt surgical attention has been required and, in those cases, the doctors have incised the wound to remove the vaccine, especially where there is involvement of finger pulp or tendon In the case of a lesion that has progressed to necrosis or granulomatous ulceration, doctors have performed surgical debridement to remove residual vaccine material

Doctors have stated that meticulous technique has been required to stop inadvertent spread of the product during surgery

If pain and swelling is present after 24 hours, doctors have considered that it is a case of accidental injection and have treated the injury as described below.Given the nature of this mineral oil-based vaccine, Zoetis recommends that any healthcare professionalspeak with a surgeon who has experience with the treatment.Similarly, if a person is exposed to Silirum, a vaccine that contains inactivated mycobacteria and a mineral oil adjuvant, it is recommended that GPs follow the same guidance.If presented with a case of accidental self-injection, GPs are advised to contact Zoetis on 1800 814 883 for further information.Log in below to join the conversation.

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New ‘targeted awareness’ approach for Medicare compliance



New ‘targeted awareness’ approach for Medicare compliance

Jolyon Attwooll 23/11/2021 4:31:22 PM The Department of Health has begun a new education campaign aimed ‘at the lowest levels’ of non-compliance to Medicare claims.

The first batch of ‘targeted awareness letters’ is expected to focus on aftercare items.

The Department of Health (DoH) has said it is adopting a new, lighter touch approach towards Medicare compliance, which will run in addition to its more hard-line measures.

Called ‘targeted awareness raising’, the approach is aimed at those demonstrating the ‘lowest levels of potentially non-compliant claiming behaviour’, and has been designed to complement existing measures such as targeted campaign letters, audits and practitioner reviews.

‘Targeted awareness raising involves the department writing to providers who are exhibiting lower levels of possible non-compliance to bring to their attention Medicare claiming rules,’ they wrote in a statement provided to newsGP.

‘It is the department’s expectation that providers will use this information to make any necessary changes to ensure their future claiming is compliant.’

The first batch of ‘targeted awareness letters’ focus on aftercare items, newsGP understands.

RACGP President Dr Karen Price described the new approach as ‘a step in the right direction’, after a highly criticised compliance campaign targeted GPs caught out by new Medicare Benefits Schedule (MBS) rules surrounding telehealth.

Dr Price wrote an open letter earlier this year to outline the college’s concerns and said the new approach is the result of the proactive stance taken by the RACGP towards the DoH and Professional Services Review (PSR).

‘They are listening to the feedback,’ Dr Price told newsGP. ‘There is certainly a desire to engage with the medical profession so that compliance targets only the people who are genuinely involved in deliberate acts.

‘If something happens that is not a lapse of professionalism but an outcome of a very complex system, then that can be managed in an educative way. We think that is a much better way to approach GPs.’

The DoH said it has been working with peak bodies including the RACGP on the approach, which is designed to provide GPs and other health providers with the relevant information required to lodge claims. MBS fact sheets and rules are included with the letters.

‘While recognising the impact of responding to COVID-19, the department has a legislative responsibility to address potential non-compliance with Medicare claiming rules and it is important that providers have access to this information early to avoid potentially non-compliant claiming continuing,’ the DoH said.

In contrast to the compliance letters that went out to GPs around telehealth billing last year, the DoH correspondence for the targeted awareness raising will not include a schedule of claims.

Dr Price said the complexity of the Medicare system often causes problems.

‘Just understanding the Medicare Benefits Schedule is becoming a discipline in itself,’ she said.

‘We are conscientious individuals delivering healthcare and are extraordinarily busy with the complexity of that, so to have audits and justifications is a very stressful situation.

‘Anything that can be done to lessen that for people who are not deliberately doing anything wrong is a good move.’

However, there are ongoing concerns that general practices with a particular specialty could be targeted unfairly.

‘We’re interested in making sure that ordinary practice doesn’t get caught up in this,’ Dr Price said.

‘You might have a practice that’s focused on refugee health or diabetes care, for instance, so your skew of Medicare items will be necessarily different.

‘Variation in practice shouldn’t mean that you should generate a Medicare audit.’

Dr Price said the new approach’s impact will be monitored carefully and any member concerns conveyed to the department. She believes that if the perception of the onerous levels of compliance required for general practice does not improve, it could compromise efforts to recruit and retain new GPs.

‘I hope we can continue to have the discussion about the bigger system issues around the complexity of Medicare,’ she said.

Webinar and Medicare survey

The RACGP is running a survey for doctors, aimed at assessing the value of current compliance resources and any other resources that could be introduced to help GPs bill Medicare.

An ‘Understanding Medicare compliance’ webinar is also being held for GPs in training on Wednesday 24 November at 6.30 pm (AEDT).

The webinar will use billing scenarios to look at problematic MBS item numbers, and provide information on note-taking requirements and compliance education resources to help GPs bill correctly.

Log in below to join the conversation.

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Changes to medicinal cannabis prescribing pathways



Changes to medicinal cannabis prescribing pathways

Anastasia Tsirtsakis 23/11/2021 3:42:45 PM The changes will improve patient access and reduce the administrative burden on prescribers, according to the TGA.

GPs prescribing medicinal cannabis products now have the flexibility to substitute an equivalent product without having to apply for a new permit.

GPs will now have a more streamlined process for prescribing medicinal cannabis following changes introduced on 22 November by the Therapeutic Goods Administration (TGA).

Special Access Scheme (SAS) and Authorised Prescriber applications for ‘unapproved’ medicinal cannabis products can now be made by active ingredient, under one of five categories based on cannabinoid content, rather than by trade name.

‘This approach allows flexibility in brand substitution when needed, ie in the event of product shortage or discontinuation,’ the TGA website states.

Prior to the change, prescribers who wished to change the product being prescribed had to obtain a separate permit each time.

GP and integrative medicine practitioner Associate Professor Vicki Kotsirilos became Australia’s first authorised GP prescriber of medicinal cannabis in 2018. She told newsGP the changes, which came into effect on Monday, are a ‘fantastic result’ for prescribers and patients.

‘This means that as prescribers we will be able to freely switch from one product to another similar product, with equivalent cannabinoid content, without the need to apply for a new SAS approval,’ Associate Professor Kotsirilos said.

‘This is good news for the doctor as it saves time.

‘We don’t have to make a new application for a permit for … the patient who would like to switch to another equivalent product that might, for example, be cheaper or when their product is not available.’

The Melbourne GP also noted that being able to prescribe based on active ingredients rather than by a particular brand is more ethical.

‘It reduces any conflict of interest, so we don’t align ourselves with just one sponsor and their products,’ Associate Professor Kotsirilos said.

Medical cannabis products will now be categorised by cannabinoid content:

Category 1 CBD medicinal cannabis product (CBD ≥98%)

Category 2 CBD dominant medicinal cannabis product (CBD ≥60% and <98%)

Category 3 Balanced medicinal cannabis product (CBD <60% and ≥40%)

Category 4 THC dominant medicinal cannabis product (THC 60-98%)

Category 5 THC medicinal cannabis product (THC >98%)

Associate Professor Vicki Kotsirilos became Australia’s first authorised GP prescriber of medicinal cannabis in 2018.

For products that contain THC, which is classified as a Schedule 8 drug under the Australian Poisons Standard, prescribers are still required to apply for authorisation following the relevant state or territory jurisdiction. In Queensland, however, this is only required if the patient is known to have drug dependency issues.As part of the change, the TGA has also simplified its requirements around becoming an authorised prescriber.As products listed under categories 1–3 have been included in the Authorised Prescriber ‘Established history of use’ pathway, to become an authorised prescriber, approval from a Human Research Ethics Committee (HREC) or specialist medical college endorsement will no longer be required before applying to the TGA.Associate Professor Kotsirilos says this change helps to recognise the experience of doctors who have an established history of prescribing medicinal cannabis for chronic refractory pain and chronic refractory anxiety in adults.‘This is also positive as it reduces administrative burden and makes it easier to prescribe, as well eliminating the cost for obtaining Authorised Prescribing through the HREC or an institution,’ she said.However, GPs who want to become an Authorised Prescriber for conditions other than chronic refractory pain and chronic refractory anxiety in adults will require approval from an HREC or a medical specialist college endorsement.An October newsGP poll found 24% of respondents cited the difficult prescribing process as the main barrier GPs face when prescribing medicinal cannabis, while 26% said a lack of knowledge was also a barrier.While Associate Professor Kotsirilos says the latest streamlined process is largely good news, addressing any knowledge gaps remains an issue.Where the former requirement for prospective authorised prescribers to go through an ethics committee or institution required GPs to demonstrate their understanding, that is no longer the case.‘While this is a really exciting space for GPs – it broadens our ability to provide patients with choices of treatments – we still need to educate,’ she said.‘While it can help in some cases, it does need to be prescribed cautiously as a last resort treatment when all other Australian-registered products have already been trialled, based on the principle of “start low, go slow” to ensure we do not cause any harm.‘GPs need to be aware of how to prescribe it safely, how to monitor patients, what side effects to look for, to report any side effects, and also when to stop if it’s not effective for the patient.‘So education is the key here.’Log in below to join the conversation.

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