Will they prove to be useful as this graphic suggests?
Pfizer/BioNTec has become well known for marketing a vaccine for coronavirus known as Cominarty or more simple the Pfizer vaccine. Personally I have lost count of how many I have made up (it’s bloody fiddly) and injected. I’ve even had a couple myself. And it seems to have worked, for two weeks I lived with my family who sequentially tested positive for coronavirus whilst my RAT persistently was negative. And more importantly, I remained fever-free, my nose persistently dry and my lungs breathing normal.
Pfizer now brings to the coronavirus toolbox, Paxlovid, an oral antiviral medication known as nirmatrelvir combined with ritonavir. Nirmatrelavir blocksSARS-CoV-2 3-chymotrypsin–like cysteine protease enzyme known as Mpro. Without Mpro processing viral polyproteins into functional units, viral replication is halted. If you need an update in viral replication, here is a graphic from an article by Robert Eastman.
Nirmatrelavir is combined with ritonavir, which although is a HIV protease inhibitor here, it interferes with metabolism of nirmatrelvir by blocking cytochrome P450 3A4, reducing the dosage frequency. This makes Paxlovid easier to take and cheaper.
The treatment is designed for those in the early stages of infection with an elevated risk of progressing to more serious illness. This includes patient who are
aged 65 or older, with two other risk factors for severe disease
aged 75 or older with one other risk factor
aged 50 and older and are of Aboriginal or Torres Strait Islander origin with two further risk factors for severe disease
moderately to severely immunocompromised.
Paxlovid on the PBS from May 1st 2022, will cost patients $42.50 or $6.80 for concession card holders. The actual cost of the medication will probably be around $720 for a five day course.
Now to the question of whether this money is well spent?
There is evidence from the EPIC-HR trial, a double-blind, randomized, controlled trial of 2246 symptomatic, PCR diagnosed, unvaccinated, non-hospitalized adults at high risk for progression to severe disease who were given either Paxlovid or placebo every 12 hours for 5 days. Treatment was started within 5 days of the onset of symptoms. In the final analysis, the relative risk reduction of progressing to severe disease was 88.9%. All 13 deaths occurred in the placebo group. Significant side effects more than placebo were altered taste (5%) and diarrhoea (3%). Other side effects were similar.
Oral antivirals for mild–moderate COVID‑19: a panacea or a logistical and clinical conundrum? The authors of this editorial point out a number of issues with the trials. None of these trials have been done in Australia, which in itself is not unusual. The trial did not study pregnant and breastfeeding women, children and adolescents and patients with renal impairment. The median age of subjects was 45 years of age. Interestingly, over 70% of the patients enrolled were defines as white. For thought provoking effect of race on coronavirus statistics in the US read this report by APM Research Lab.
More noteworthy in the trial sponsored by Pfizer, was done in the areas at a time when the majority of coronavirus was the more severe delta strain. The effectiveness may well be less obvious with the less severe Omicron strain.
There are number of significant drug interactions between Paxlovid and other medication including the direct-acting oral anticoagulants (apixaban and rivaroxaban), calcineurin inhibitors (tacrolimus and everolimus), lercanidipine, quetiapine and amiodarone. Building on their excellent HIV drug interaction checker, the University of Liverpool is a good place to check for details.
In the end as per Dr Mackay, illustration, oral antiviral agents are one component of protection we will have from getting severely ill from coronavirus. I am however not getting into a debate about where exactly this piece of swiss fits in his model.
Australia currently, like the rest of the world, is dealing with a coronavirus pandemic. Recently, Japanese encephalitis has edged into the media attention. Along with El Niño induced rainfall, there is a concern that with vast expense of water, mosquito breeding will likewise takeoff, and spread Japanese encephalitis. I have noticed this has stirred up internet algorithms with adverts for mosquito repellents cropping up.
Chemistwarehouse offers Mozziegear‘s silicone band which is DEET free containing only citronella as a mosquito deterrent. For $20 you get a pack of six silicone bands which are last 48 hours as per the website. Following that you get a colourful silicone band but little more. And when you get bored of them into the bin they go to landfill. Silicone can be recycled but not as easily as plastics.
So does citronella work?
Oh dear, maybe not….
“None of the bracelets we tested caused any significant reduction in mosquito attraction. Although the active ingredients in some bracelets may be mosquito repellents, we hypothesize that the concentrations that are emitted by all of the bracelets that we tested were too low to have an effect. Based on our results, we conclude that these bracelets in general do not offer adequate protection from mosquito bites.”
“It was determined that the sticker, transdermal patch, wristbands and sonic device did not provide significant protection to volunteers compared with the mosquito attack rate on control volunteers who were not wearing a repellent device. “
“DEET proved more effective than the other synthetic and natural repellents marketed in Brazil for protecting against bites from the mosquito species investigated. All repellents studied exhibited satisfactory safety profile.”
This is a copy of a letter sent to local politicians and health bureaucrats expressing view opposing plans to expand the role of retails pharmacist. I think that most NQ GPs feel like minded.
I am currently working a general practitioner in Mackay Northern Queensland after moving from rural South Australia in 2015.
I have both a Bachelor of Pharmacy (1985) and Bachelor of Medicine and Bachelor of Surgery (2000). I made the change to career, after working for several years in retail pharmacy, more so in hospital pharmacy as a clinical and drug information pharmacist.
I think I am reasonable well placed to make a comment on the Pharmacy Guild plan to move beyond the normal scope of practice for retail pharmacists into the realm of General Practice and fellow medical specialists.
In a Forum reported by the Pharmacy Board of Australia, participants highlighted that a proposed model of pharmacist prescribing in Australia would need to:
• meet a public need or unmet demand
• achieve cost effective outcomes
• reduce adverse effects
• improve access to medicines for the community
• ensure collaboration between the health practitioners involved in the patient’s care
• ensure clear separation of prescribing and dispensing, and
• involve nationally consistent regulation and models of prescribing
There is a significant expansion of a retail pharmacists scope of practice. The full list of conditions are;
Acute nausea and vomiting
Oral health screening and fluoride application
Allergic and non-allergic rhinitis
Asthma and exercise induced bronchoconstriction
Chronic Obstructive Pulmonary Disease
Herpes Zoster (shingles)
Mild to moderate acne
Acute wound management
Uncomplicated urinary tract infections
Acute diffuse otitis externa
Acute otitis media
Type 2 diabetes
Musculoskeletal pain and inflammation
Weight management for obesity
The project documents presents no substantial evidence as to whether there is an unmet need in the North Queensland community for any of the 23 conditions noted.
The project does not discuss how this pilot will be assessed.
There are no criteria documented that would be used to objectively measure its success or failure or cost. I fear like the current Pharmacy UTI treatment project it will just be permitted to continue ad infinitum.
My concerns are many.
We all make errors. Currently, when I prescribe a medication, the dispensing pharmacist checks are a safety measure in the prescribing process. If a doctor has made an error, a pharmacist is ideally placed to identify this error and alert the prescribed to discuss their concerns. If a pharmacist is able to now prescribe scheduled four medications directly, this safety check is gone.
Fragmentation of patient care. As a GP, I have to keep abreast of a new medications prescribed in hospital and by specialist. I am uncertain how I will know what a pharmacist has prescribed. Unfortunately, some patients make for poor historians. Being told “I’m taking a new little blue tablet” could means digoxin or Viagra!
The proposal that with 120 hours, which could be squeezed a little more a little more than 2 weeks of supervised training will be sufficient for such a varied tasks seems to be surprising short. In addition, if there are no prescribing pharmacists currently, who exactly will be supervising this training? In the background paper from September 2021, there is recognition that the training requirement is not feasible within the time restrictions for development and implementation of the Pilot. Does that mean untrained pharmacists can what just have a go!
Indemnity for pharmacists. Currently I pay $7000 per year as a GP. My premiums are based on risk. I would expect that insurers may be reluctant to indemnify Pharmacists who have completed a only short course in prescribing.
Many pharmacies in my local area do not have a private area for the proposed consultations. Floor space in retails pharmacist costs money. I have seen some pharmacies which have a consulting room full of stock ready to go out shelves. If you walk into the average pharmacy, most transactions take place across a counter in an open space. I do not discuss a patient medical care in my clinic waiting room. It is not unusual to hear stories of conversations that really should be held in private being in an area where other shoppers can easily eavesdrop. You may test this by visiting local pharmacists in your electorate.
I am concerned how the average pharmacist working at the coal face will not actually have time to provide the level of care to provide quality expanded care. What tasks will they have to delegate to achieve the aims of the pilot. I do not believe that there is a capacity for retails pharmacy to take on this task. Do I have a reference for this, no, but I did see this report from the Australian Journal of Pharmacy which reported the difficulties of attracting workforce.
Importantly the Pharmacy Guild represent retail pharmacy owners not the coal face pharmacist who will be asked to provide this extra service. Speaking with my local pharmacist they were as surprised as myself about the project plans. I wonder when these stakeholders would be invited to discussion.
Permitting retail pharmacists to repair wounds seems at odds with safe wound care practice. Currently, I have access to a clean area dedicated to medical procedures, sterile equipment and the training to identify whether I need to refer the patient to a surgeon for repair to nerves, tendons or deeper structures. I have access to a clinical nurse who can assist with wound care and repairs. My clinic uses a dedicated medical waste disposal service. The clinic is accredited to standards endorsed by the RACGP.
The model of care proposed focusses very much on the use of medications when the optimal interventions are lifestyle changes which take more than a short consultation and one-off visit.
When I first started in pharmacy, I worked for a pharmacist who was very keen on up selling to maximise profits. For example, for a cold it would be decongestant cough mixture, nasal spray, paracetamol and a box of tissues! Thankfully not all more bosses were like that, but there were enough for me to move into hospital based pharmacy practice. When the average GP considers starting a patient on metformin for diabetes, they do not have to think what else should I sell.
There is a common trope that doctors are the pocket of the pharmaceutical industry. I would ask where pharmacists profits come from but directly from the sale of medication. The more medication, the greater the profit.
The Medicines and Poisons (Medicines) Regulation 2021 currently precludes a pharmacist from prescribing schedule four medication.
Given there is access to bulk billing pathology services and some general practice, I am not sure how many people in north Queensland will be keen on engaging given the cost of the proposed pilot services. It is not likely to address the underserviced in the community given the costs involved. I am unsure how the Guild plan to engage Indigenous community with the pilot.
I have estimated the costs that a person who has diabetes type 2 may face should this pilot be permitted to continue. The illustration from the pilot document is used as a guide
Firstly, you have to work out which of the 100 people who walk through your door has diabetes. Does this mean screening people with urine or random finger prick tests, a point of care HBA1c or 2-hour glucose tolerance test. Who do your screen. Age, gender, weight, looks like they might have diabetes?
Moving on to the patient costs
Pharmacist Consult $55
Private lab tests FBE, LFTS, HBA1c, Urine ACR $220 (cost for o/s traveller without Medicare for 2 or more tests)
Metformin 500mg 100 tablets $5.80
Diamicron MR 60mg 60 $19.90
Sitagliptin 100mg 28 $47.99
Dapagliflozin 10mg 28 $52.69
Semaglutide 1.34mg injection $131.99
Insulin Levemir Penfill Cartridge 3mL 5 x 5 $359.95
Diabetic education or dietician initial consult $115
Podiatrist initial consult $80
Optician fees generally covered without a gap on Medicare, although more are charging a gap for their services.
Psychologist initial consult $180
Physiotherapist initial consult $110
Endocrinologist consult Up to $500
Ophthalmologist Up to $400
Cardiologist Up to $550
If a pharmacist charged $55 for every patient walking through their door then that looks like money for jam but I suspect people will stop walking through their door. I expect once the public balances “convenience” with the actual costs for non-Medicare referrals they will choose to attend their GP, or get one.
After reading the various documents I am perplexed as to how the pilot will be evaluated. Yes, they will report on the number of pharmacies enrolled, the number of pharmacists completing the training, and number of patients enrolled, the number of adverse outcomes and complaints, but what the objective measurable outcomes. How is its cost effectiveness be determined. Currently, most trials have a safety valve, if participants are harmed, it is halted. Where is the mechanism in this project?
The Pharmacy UTI trial alas is not a trial in the normal sense of the word. There is no control group to use to evaluate the outcome, and I understand it has been extended for another 6 months. Of note, this paper suggested 2/3 of women didn’t need antibiotics to resolve UTI symptoms.
This article from UK, comments on the fact that non-medical prescribing (mostly pharmacists and nurse practitioners) is contributing to antibiotics prescribing when antibiotic stewardship is becoming vital to minimise increased resistance.
The TGA has recently declared that oral contraceptive should be prescribed by medical practitioners not sold over the counter. There are missed opportunity for sexual health and general health screening. In particular the TGA notes “Consumers can identify when they require (oral) contraception, but consultation with a pharmacist is not sufficient to ensure safety, particularly over extended periods of time.”
I am in favour of maintaining the status quo. I am not convinced that a retail pharmacy will be able to meet unmet needs. I believe an accredited pharmacist who provide home and residential medication reviews provides an invaluable collaborative service.
I believe that having a dispensing pharmacist check my scripts and a discussion of the potential issues is invaluable.
I do believe that the lack of checks and balances with autonomous prescribing as detailed in this pilot will harm patients and fracture continuity of care provided by General Practice care.
Finally, I would like to point out the financial conflict of interest the Guild has in pushing this project. I believe that pushing the envelope of their scope is to increase profit for pharmacy owners not patient care.
As a doctor I have both an advantage and disadvantage.
I have a medical education (thanks Flinders University) and years of experience in various emergency department and general practices (such as Darwin, Nhulunbuy, Kangaroo Island and Mackay) to know when a child is sick. Apart from my own, I do not what your child normally does, acts and how he or she responds when stressed by illness or strangers (ie me). I have to rely on the parent to what is normal for their child.
There are some (maybe) universal fundamentals that I rely upon. It is a truism that a medical consultation begins as you watch the patient move from the waiting area to the consulting room. First impressions are important from the worried look on the parent’s face, to the way a child is held in their carer’s arms. A child who smiles and skips into your room is almost always reassuring. My heart sinks when a floppy pale child is carried in a frightened parents arms. We definitely need help for this child.
Thankfully most of the time I have the opportunity to sit and listen to the story, only sometimes do I have to start with taking vitals and sometimes reaching for the a vomit bag,
Watching how easily a child breathes is always easier with a layer of the child’s clothes off. The effort, noise, rhythm and rate are what I look at. Subconsciously, I sometimes I find myself breathing at the same rate as the sick child, my that’s fast!! A talkative child is reassuring. If …. a …. child…. has …. to …. breath …. between …. each …. word …. I worry. A pulse oximeter used to measure capillary oxygen levels can provide extra information, although it may take a bit of fuss to get it to work. Or be rejected outright by an irritable child. I had one flicked across the room once. Yep , stopped working, thankfully they are much cheaper these days.
A rough guide for normal breathing rate per minute is
birth to 1 year: 30 to 60
1 to 3 years: 24 to 40
3 to 6 years: 22 to 34
6 to 12 years: 18 to 30
12 to 18 years: 12 to 16
Non contact thermometers have made checking a temperature less disruptive and generally provides a reasonable estimate compared to traditional methods. I don’t use rectal, axillary or oral thermometers.
Assessing hydration comes from what I’m told about intake and outputs and what I can see. Are the eyes sunken, is the mouth dry, are there tears? How irritable or lethargic is the child. This along with pinching the skin testing turgor gives me an idea if dehydration is a problem. Dribbling, drooling and snotty noses are all taken into account.
Is there are rash, is skin colour normal and uniform. Is the rash a blanching red rash of a viral exanthem, the blisters of hand foot and mouth disease or the scary bleeding spots of sepsis.
A gentle hand on the belly can tell a lot, confirming an irritable and frightened child, reveal a source of pain, and confirm an elevated temperature.
How is the child interacting with me. Happy and chatting, screaming every time I look in their direction as though I have about to eat them for lunch, or a glazed far away look. Maybe they are sleeping comfortably, or is that unconsciousness. An acronym we use is AVPU. Short for Alert; eyes open and responding to Voice, eyes open to Pain (a finger squeezed or a rub on the chest) or not responding at all, Unconscious. For a parent, anything less than “A” may be an indication that extra help is needed.
Many illness may present in a similar way in children. For example, the list of things that cause vomiting varies from benign eating too much, posits after breast feeding, to more serious viral fever, gastroenteritis, a twisted testicle, to really serious things like poisoning, meningitis and sepsis. And it is alas true, children can get sick very quickly, but there are usually clues to found from a doctors examination.
Chris Stallman from MotherToBaby service regarding coronavirus exposure in pregnancy and while breastfeeding.
Good GP interviews obstetrician and gynaecologist Dr Robyn Aldridge on the impact of COVID-19 on pregnant women, pregnancy and the unborn child.
From Babytalk Alison McMillan the Chief Nursing and Midwifery Officer for the Commonwealth Department of Health and Adjunct Associate Professor Karleen Gribble from the School of Nursing and Midwifery, Western Sydney University.
2020 Baby – Caring for pregnancy women in the pandemic with Dr Pamela Douglas and Wendy Burton
Vertical transmission from mother to baby prior to birth
An early review of 31 cases and a smaller study of 9 cases reported in the Lancet found no vertical transmission found which is reassuring. But then a report of possible vertical transmission of COVID19 from mother to baby in utero. This was based on a baby having positive IgM which is not thought to cross the placenta. However PCR testing for the virus was negative. The accompanying editorial.
July 2021: Abstract: The ongoing coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global public health problem. The SARS-CoV-2 triggers hyper-activation of inflammatory and immune responses resulting in cytokine storm and increased inflammatory responses on several organs like lungs, kidneys, intestine, and placenta. Although SARS-CoV-2 affects individuals of all age groups and physiological statuses, immune-compromised individuals such as pregnant women are considered as a highly vulnerable group. This review aims to raise the concerns of high risk of infection, morbidity and mortality of COVID-19 in pregnant women and provides critical reviews of pathophysiology and pathobiology of how SARS-CoV-2 infection potentially increases the severity and fatality during pregnancy. This article also provides a discussion of current evidence on vertical transmission of SARS-CoV-2 during pregnancy and breastfeeding. Lastly, guidelines on management, treatment, preventive, and mitigation strategies of SARS-CoV-2 infection during pregnancy and pregnancy-related conditions such as delivery and breastfeeding are discussed.\
April 2021 Conclusion: A systematic review of published studies confirm that the course of COVID-19 in pregnant women resembles that of other populations. However, there is not sufficient evidence to establish an idea that COVID-19 would not complicate pregnancy.
Jan 2021 Abstract: There are many unknowns for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Clinical experience of pregnancies complicated with infection by other coronaviruses e.g., Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome, has led to pregnant woman being considered potentially vulnerable to severe SARS-CoV-2 infection. Physiological changes during pregnancy have a significant impact on the immune system, respiratory system, cardiovascular function, and coagulation. These may have positive or negative effects on COVID-19 disease progression. The impact of SARS-CoV-2 in pregnancy remains to be determined, and a concerted, global effort is required to determine the effects on implantation, fetal growth and development, labor, and neonatal health. Asymptomatic infection presents a further challenge regarding service provision, prevention, and management. Besides the direct impacts of the disease, a plethora of indirect consequences of the pandemic adversely affect maternal health, including reduced access to reproductive health services, increased mental health strain, and increased socioeconomic deprivation. In this review, we explore the current knowledge of COVID-19 in pregnancy and highlight areas for further research to minimize its impact for women and their children.
Conclusion: In mothers infected with coronavirus infections, including COVID-19, >90% of whom also had pneumonia, PTB is the most common adverse pregnancy outcome. Miscarriage, preeclampsia, cesarean, and perinatal death (7-11%) were also more common than in the general population. There have been no published cases of clinical evidence of vertical transmission. Evidence is accumulating rapidly, so these data may need to be updated soon. The findings from this study can guide and enhance prenatal counseling of women with COVID-19 infection occurring during pregnancy.
One of the early medical student days, hidden by the mists of time, I was taught by an Infection Control nurse how to wash my hands. Of course I “knew” how to wash my hands. My Mum had been making me doing it since I learnt how to wipe my bottom. In fact, I had a reasonably good idea from the years of preparing total parenteral nutrition and cytotoxic infusions in hospital pharmacy but that’s a different story.
Back to the mist, as a test we had to wash as normal, and then plate out the hand on an agar filled petri dish. It was shocking to see what grew!
Remember that virus are far too small to be seen and won’t grow as visible colonies amongst the bacteria and moulds on the on agar plate.
Imagine shaking that hand. So maybe a simple social hand wash is not enough to prevent spread of infection. With the imminent pandemic of coronavirus, everyone is telling you to wash your hands, but do you know how and what to use?
This helpful guide from the World Health Organisation describes the essence of a good hand wash.
In most cases soap and water is preferable, but if there is none, the alcohol hand rub that contains at least 60% alcohol, is a suitable alternative, especially if it increases the likelihood that something will be done.
Although, soap and water is better at removing Clostridium spores and non-enveloped viruses such as Norovirus and Rhinovirus. However, 60% alcohol does is effective against enveloped virus like Coronavirus.
Just remember, not to mix your alcohol gel with water!
Now when do you wash your hands? These times seem pretty sensible to me.
Before and after examining a patient makes sens for me as a doctor. But this list also seems pretty sensible.
Before, during, and after preparing food
Before eating food
Before and after caring for someone at home who is sick
Before and after treating a cut or wound
After using the toilet (especially if the world runs out of toilet paper)
After changing a nappy and cleaning up a child who has used the toilet
After blowing your nose, coughing, or sneezing, especially if you sneeze or cough into your hand. This about using the cubital fossa (doctor speak for the inside of your elbow)
After touching an animal, animal feed, or animal waste
After handling pet food or pet treats
After touching garbage
and maybe even
Before or after shaking someone’s hand
This article from The Conversation explains why I’m not being rude by not shaking your hand, just protecting you and me from possible infection.