more_vertWhen researching the progress of rheumatoid arthritis and related conditions, many rheumatologists will have used the Sharp/van der Heijde scoring system for measuring radiographically observed damage. The first half of that eponym denotes John Sharp, the American rheumatologist who devised and published the scale in 1985 with a view to measuring the effectiveness of disease-modifying drugs. Sharp died in 2008, but Désirée van der Heijde, the Dutch rheumatologist who modified Sharp’s original system, is alive and well and Professor of Rheumatology at Leiden University Medical Centre (LUMC) in the Netherlands.
Preference: Rheumatology
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What to do about low back pain … and it’s usually not drugs or surgery
Low back pain is the leading cause of disability worldwide and is becoming more common as our population ages. Most people who have an episode of low back pain recover within six weeks, but two-thirds still have pain after three months. By 12 months, pain may linger but is usually less intense.
Still, recurrence is common and in a small number of people it may become persistent and disabling. Chronic back pain affects well-being, daily functioning and social life.
A series on low back pain by the global medical journal The Lancet outlined that most sufferers aren’t getting the most effective treatment. The articles state that recommended first-line treatments – such as advice to stay active and to exercise – are often overlooked. Instead, many health professionals seem to favour less effective treatments such as rest, opioids, spinal injections and surgery.
So, here’s what evidence shows you need to do to improve your low back pain.
Risk factors for low back pain
The cause of most people’s low back pain remains unknown. But we do know of a number of risk factors that could increase the chance of developing low back pain. These include a physically demanding job that involves lifting, bending and being in awkward postures. Lifestyle factors such as smoking, obesity and low levels of physical activity are also associated with developing low back pain.
People with low back pain should see a health professional to rule out the more serious causes of pain such as fracture, malignancy (cancer) or infection.
Once patients are cleared of these, the current guidelines from Denmark, the UK and the US advise self-management and psychological therapies as the initial response for persistent low back pain. These include staying active, doing appropriate exercises and undertaking a psychological program to help manage the pain.
Exercises such as Tai Chi, yoga, motor control (to restore strength, co-ordination and control of the deep core stabilising muscles supporting the spine) and aerobic exercises (such as walking, swimming, cycling and general muscle reconditioning exercises) are recommended.
If any of these therapies fail or stop working, the guidelines point to manual and physical therapies such as spinal manipulation (Denmark, UK, US), massage (UK and US) and yoga and acupuncture (US) – particularly for low back pain lasting more than 12 weeks.
Exercise and psychological therapy
The guidelines are based on many studies that have shown the benefits of exercise and psychological therapies. For instance, a 2006 study compared pain levels across two groups of physically active people with chronic low back pain.
Participants who followed a four-week program using Pilates exercise equipment reported a more significant reduction in pain and disability than those in a control group who received usual care (consultations with a health care professional as needed). The benefit for the exercise group was maintained over a 12-month period.
Another, 2011 trial explored the benefits of Tai Chi for those with persistent low back pain. Participants who completed a ten-week course of Tai Chi sessions had less bothersome back symptoms, pain intensity and self‐reported disability, compared with a control group who continued with their normal medical care, fitness or health regimen.
Chronic pain is linked with chemical and structural changes at all levels of the nervous system. These include the level of neurotransmitter changes that alter pain modulation, and sensitisation of the nerves involved in transmitting pain signals. Incoming pain signals can be modified by our response to persistent pain.
Psychological treatments – such as mindfulness-based stress reduction – focus on increasing awareness and acceptance of physical discomfort, as well as challenging emotions often associated with chronic pain.
In a trial including 342 participants, around 45% of those who had completed eight sessions of cognitive behaviour therapy or mindfulness-based stress reduction had clinically meaningful improvements in bothersome pain at 26 weeks of follow-up. This was compared to only 26.6% of people who had received usual care.
from shutterstock.com
Manual therapy
In Australia, physiotherapists, chiropractors and osteopaths use manual and physical therapy to treat lower back pain. The treatments often include some form of spinal manipulation and massage, as well as advice to stay active and do exercises. This is consistent with The Lancet’s recommendations, also based on evidence from studies.
A 2013 trial of people with acute low back pain compared the effects of spinal manipulation with those of the non-steroidal anti-inflammatory drug diclofenac (Voltaren) and placebo on their pain. Spinal manipulation was found to be significantly better than diclofenac and clinically superior to placebo in reducing disability, pain and the need for rescue medication. It was also found to improve quality of life.
Similar results came from another study of 192 people with low back pain that lasted around two to six weeks. Participants were randomly allocated to one of three groups: chiropractic manipulation with a placebo medication; muscle relaxants with sham manipulation; or placebo medicine with sham manipulation. All subjects improved over time, but the chiropractic group responded significantly better, with a bigger decrease in pain scores, than the control group.
Physiotherapists, chiropractors and osteopaths are required by law to be registered with the Australian Health Practitioner Regulation Agency (AHPRA) to practise in Australia. To be registered, a person must complete a minimum of four years’ study at a university in a degree that includes a focus on non-pharmacological (drug-based), non-surgical management of musculoskeletal conditions, including low back pain.
Under the government’s Chronic Disease Management Plan patients with persistent low back pain may be referred to physiotherapists, chiropractors or osteopaths for evidence-based therapies such as spinal manipulation and massage. If patients are unfamiliar with these therapies, they can discuss referral with their GP.
Physiotherapists, chiropractors and osteopaths can also be consulted without referral. Their services are usually covered by private health insurance. The AHPRA website lists registered practitioners in your area.
One thing to look out for when you see a practitioner is the number of treatments they recommend. Patients usually start with a short course of two to six treatments to see if the treatment helps. It shouldn’t take many treatments for a change in symptom pattern to become obvious.
The message to the public and to health professionals is clear. People with non-specific low back pain need to learn how to independently manage their pain while remaining active, staying at work and maintaining their social life as far as possible.
Sandra Grace, Associate Professor in Osteopathy, Southern Cross University; Roger Mark Engel, Senior Lecturer, Department of Chiropractic, Macquarie University, and Subramanyam R Vemulpad, Associate Professor, Macquarie University
This article was originally published on The Conversation. Read the original article.
The best diet for arthritis: what the latest research tells us
Osteoarthritis is the most common of the more than 200 forms of arthritis, affecting more than 20% of the population. Unfortunately, there are currently no effective treatments or approved drugs for this disabling condition, which causes the joints to become painful and stiff. Some new drugs are in the pipeline, but it will be years before they are tested in clinical trials and approved by regulators.
Many people with osteoarthritis take a bewildering variety of dietary supplements, the favourites being glucosamine and chondroitin sulphate, but the evidence doesn’t actually support their use. However, we are happy to report that our recent review of published evidence shows that eating the right foods, combined with moderate low-impact exercise, can benefit people with osteoarthritis.
Firstly, losing weight and exercising are the most significant things that osteoarthritis patients can do to ease their symptoms. Weight loss reduces the load on the joints and lowers the level of inflammation in the body, reducing arthritis pain. Exercise helps you to lose weight while keeping your muscles strong, which helps protects the joints and makes it easier to move around. So overweight and obese people with osteoarthritis should find ways to lose weight that include exercise aimed at increasing their muscle strength and enhancing their mobility.
Oily fish
Eating certain foods can also help improve patients’ symptoms and reduce their daily joint pain. Evidence shows eating more oily fish such as salmon, mackerel and sardines can improve pain and function in arthritis. This is because the long-chain omega-3 fatty-acids they contain reduce the amount of inflammatory substances the body produces. Fish-oil supplements of 1.5g per day may also help.
But eating fish oils alone may not be enough. It is also important to reduce the long-term consumption of fatty red meats and replace saturated animal fats with vegetable oils such as olive and rapeseed.
Lower cholesterol
Osteoarthritis patients are more likely to have raised blood cholesterol, so eating in a way that reduces blood cholesterol can help, as well as improving general cardiovascular health. Reducing the amount of saturated fat you eat and increasing the amount of oats and other soluble fibres will help to reduce cholesterol.
Other specific ways to reduce blood cholesterol include eating 30g a day of nuts, 25g a day of soy protein from tofu, soy milk or soy beans, and eating 2g a day of substances called stanols and sterols. These are found in small amounts in plants but the easiest way to consume them is in fortified drinks, spreads, and yogurts that have these substances added to them.
Antioxidants
Osteoarthritis occurs when the joints become inflamed by increased amounts of oxygen-containing reactive chemicals in the body. This means that eating more antioxidants, which can neutralise these chemicals, should protect the joints. Vitamins A, C and E are potent antioxidants you should make sure you get the guideline amounts of them to maintain healthy connective tissues throughout the body. However, the evidence that they improve osteoarthritis symptoms is debatable.
Vitamin A is abundant in carrots, curly kale and sweet potato. Fresh fruits and green vegetables are rich in vitamin C, especially citrus fruits, red and green peppers and blackcurrants. Nuts and seeds are a great dietary source of vitamin E and oils derived from sunflower seeds are rich in vitamin E.
Evidence suggests that increasing the intake of vitamin K sources such as kale, spinach, broccoli and Brussels sprouts may also benefit people with osteoarthritis. We also know vitamin D, which your body makes when exposed to sunlight, is important for bone health and many people don’t produce enough. But more evidence is needed before vitamin D supplements can be recommended for osteoarthritis patients.
Though several popular diet books on arthritis advocate avoiding certain foods, there is no clinical evidence that this benefits osteoarthritis patients.
With the help of dietitian colleagues, we have summarised our findings in a food fact sheet on diet and osteoarthritis endorsed by the British Dietetic Association
Ali Mobasheri, Professor of Musculoskeletal Physiology, School of Veterinary Medicine, University of Surrey and Margaret Rayman, Professor of Nutritional Medicine, University of Surrey
This article was originally published on The Conversation. Read the original article.
[Comment] Mentoring women in medicine: a personal perspective
About half of the medical students in the USA and European Union are women,1,2 but leadership in medicine globally does not reflect this gender balance. In a survey by the Association of American Medical Colleges (AAMC), women comprised half the instructors and assistant professors in 2015–16, but only 20–33% of full professors and only 15% of chairs and deans were women.1 Women are also under-represented as journal authors, on editorial boards, and as speakers at medical meetings.3,4 However, in a large survey by the Canadian Rheumatology Association women were found to work fewer hours and see fewer patients per week than men, which could partly explain less promotion to leadership roles.
[Perspectives] Mary Crow: leader in research on systemic lupus erythematosus
Mary “Peggy” Crow was not one of those people who always wanted to be a doctor. “I absolutely was not on a track toward either medicine or research”, Crow, Physician-in-Chief at the Hospital for Special Surgery (HSS), New York City, USA, and a past President of the American College of Rheumatology, told The Lancet. She took biology in 7th grade and loved it, Crow says, but at her private high school in Westchester County, NY, girls didn’t get to take science—she “was not even offered science courses”, recalls Crow.
[Perspectives] Gerd Burmester: enduring leader in rheumatoid arthritis
Having been Professor of Medicine at Berlin’s Charité University Clinic for the past 23 years, Gerd Burmester is among the university’s longest-standing full professors. He leads a 100-strong Department of Rheumatology and Clinical Immunology, and is as committed to research in the laboratory as to work in the clinic. His team is collectively researching how to reprogramme the human immune system, with an emphasis on the molecular pathways that underpin autoimmunity across many diseases, but especially in rheumatoid arthritis (RA).
[Editorial] A platinum age for rheumatology
On June 14–17, over 14 000 rheumatologists, health-care professionals, and patients will gather in Madrid, Spain, for the European League Against Rheumatism (EULAR) Annual Congress. 2017 is a particularly special year for the organisation as EULAR celebrates its 70th anniversary. Since our inception, The Lancet has been pleased to have shared in the rich history of rheumatology research, including The “Rheumatic Disease”, coauthored by the founding President of EULAR, Mathius Pierre Weil, in 1928 and today’s issue, which highlights recent and innovative developments in therapeutics and management strategies for rheumatic diseases.
Hip arthroscopy for femoroacetabular impingement: use escalating beyond the evidence
There is a concerning lack of data comparing surgical with non-surgical management of femoroacetabular impingement
Femoroacetabular impingement (FAI) is a common cause of groin pain in physically active young adults, accompanied by limited hip movements. It occurs when bony anatomical abnormalities of the femoral head-neck junction (cam deformity) and acetabular rim (pincer deformity) result in abnormal contact between the two joint surfaces during hip motion. Radiological evidence of FAI is present in about 25% of asymptomatic young adults in the general community.1 FAI increases the risk of end-stage hip osteoarthritis (OA) in later life and is a long term risk factor for joint replacement;2 it may be very disabling. The quality of life of young adults with FAI is comparable to that of older adults who had a total hip replacement for OA.3
No effective treatment for FAI currently exists. However, there has been a very rapid increase in the use of hip arthroscopy for this condition, a procedure that aims to correct hip bone shape and improve symptoms. Hip arthroscopy rates have increased almost four-fold from 2004 to 2009 in the United States4 and over seven-fold from 2002 to 2013 in England,5 with FAI being the most common indication.4 This has resulted in escalating health care costs, despite the uncertainty about its effectiveness.
Although surgical correction of hip bone shape provides a biologically plausible approach for reducing hip pain and slowing the incidence and progression of hip OA, the evidence supporting the use of hip arthroscopy in the management of FAI is limited.6
Evidence for symptom benefit of hip arthroscopy for pain in femoroacetabular impingement
While there is some evidence that hip arthroscopy results in short to medium term symptomatic improvement in FAI,6–8 these conclusions are based on examining patients only treated surgically, and no study has compared surgical with non-surgical therapy. Although one systematic review concluded that symptom outcomes with hip arthroscopy were superior to non-surgical management of FAI,7 this conclusion may be misleading since the systematic review was largely based on case series with no head-to-head comparisons between surgical and non-surgical groups. Such claims must be tempered by the lack of clinical trials with non-surgical control groups.
Evidence for structural benefit of hip arthroscopy for correcting hip bone shape
Evidence shows that bone shape abnormalities in FAI increase the risk of hip OA in later life.2 One rationale for correcting hip shape abnormalities in FAI is based on the premise that this will reduce future structural damage at the hip. Most hip arthroscopies that aim to correct bone shape have focused on reducing the alpha angle,6 a measure of cam deformity associated with the 20-year risk for developing radiographic hip OA.2
Although hip arthroscopy can improve alpha angles,6 there is no evidence that this modifies the risk of incident or progressive hip OA. Indeed, the only available data, albeit over a short follow-up period (1–2 years), showed radiographic progression of disease following arthroscopy.6 One recent systematic review showed excellent hip survival rates following hip arthroscopy: 90.5% of arthroscopic procedures did not require total hip replacement after an average follow-up of 4 years.8 However, it is important to note that of the 16 studies examined, the mean age of the participants was less than 40 years in 14 studies, and less than 20 years in two studies. It therefore stands to reason that the young age of participants is likely to have precluded progression to hip joint replacement, and that these results have limited generalisability. Since FAI is predominantly seen in younger participants, a relatively long follow-up is required when joint replacement is the outcome of interest.
Rationale for non-surgical therapy in femoroacetabular impingement
The data on non-surgical therapy for FAI is limited, although a recent systematic review suggested that physical therapy and activity modification were effective for symptom reduction.9 While the lack of high quality studies in the systematic review was acknowledged, observational data showed that surgery was avoided in at least 39% of patients and in up to 89% of young patients when non-surgical management comprised exercise avoidance, activity modification, non-steroidal anti-inflammatory drugs, intra-articular steroid injection and physiotherapy.6 Nevertheless, these observational studies provide low quality evidence, and head-to-head comparisons between surgical and non-surgical groups for the management of FAI are urgently required.
There is evidence for an effect of physical activity on the development of FAI. Bone is a dynamic tissue with the capacity to remodel across the various life stages. The prevalence of cam abnormalities in skeletally mature, non-athletic men is 9%, but 89% in basketball players who have practiced their sport from childhood.10 The mechanism is thought to be due to either new bone formation or changes in the growth plate shape due to high shear forces at the growing hip. This highlights the importance of activity modification, particularly in early childhood and adolescence, in order to reduce the prevalence and severity of FAI in early adulthood. We have recently shown that obesity in adulthood is associated with pincer deformity in community-based middle-aged adults,11 suggesting that adult hip bone shape may be modifiable. Such data provide a rationale for exploring non-surgical management for FAI across the lifespan.
Hip arthroscopy for femoroacetabular impingement: lessons from arthroscopic partial meniscectomy
The evolution of hip arthroscopy for FAI shares a number of similarities with the evolution of knee arthroscopy. Arthroscopic management of knee pain in OA was commonplace until a randomised controlled trial (RCT) showed a lack of efficacy for arthroscopic intervention.12 This has resulted in a transient reduction in the rate of knee arthroscopy for knee OA in Australia (although it was not sustained), a pattern mirrored by practice in the United Kingdom and the US.13–15
There is now significant debate about the role of arthroscopic partial meniscectomy (APM) in those patients with symptomatic knee OA and meniscal tears.16 The rationale for this procedure is that meniscal pathology may have a significant role in knee pain. However, recent RCTs have shown no superior symptom benefit of APM when compared with non-surgical management,16 although there may be a subgroup of patients who benefit. These results are not surprising because it is now clear that knee OA is a disease of the whole joint, and thus targeting one structural abnormality does not address the whole joint nature of the disease and may not address the genesis of knee pain. It is important to note that about 30% of patients crossed over from non-surgical to surgical management with improved symptom outcomes.16 It may be that certain subgroups of patients with knee pain and meniscal pathology benefit from APM. However, further efforts are required to characterise the individuals who may benefit. Moreover, there is no evidence that APM reduces structural progression of knee OA. Indeed, available evidence suggests an adverse effect of APM on knee structure.17
Meniscal repair has been postulated as a viable alternative to APM for pain reduction. This is technically and theoretically analogous to labral preservation at hip arthroscopy. However, when comparing meniscal repair and APM, meniscal repair was exclusive to young patients (eg, ≤ 35 years), while APM was the mainstay of management among older patients.18 This is likely because the two groups represented different pathologies: one group had an isolated tear easily repaired in the young, and the other group had part of a wider degenerative process observed in older people. Likewise, although labral preservation may be important for improving hip symptoms,7 it is unclear whether this is because preservation surgery was biased to a population with isolated, rather than whole joint disease. There is some evidence to support this possibility, as factors such as degeneration, complex tears, calcification and ossification reduce the potential for labral repair and debridement is necessary.19 Labral debridement may, therefore, be a marker of more widespread hip degeneration, which is a worse prognosis.
It is concerning that the increasing trend toward hip arthroscopy for FAI is following a similar pattern to the history of APM. Lessons learned from the knee strongly support the need for an evidence-based approach to examining the role of hip arthroscopy for FAI. It is well accepted that there is a direct correlation between the invasiveness of an intervention and the placebo effect it can exert. While studies have shown that hip arthroscopy for FAI improves hip pain in the short to medium term,6–8 it is unclear how much of this symptomatic improvement may be driven by a placebo effect. Moreover, the percentage of pain improvement achieved by hip arthroscopy for FAI6 is similar to that achieved by sham surgery for degenerative meniscal tears.20 There is a pressing need for head-to-head RCTs with adequate control arms before definitively advocating hip arthroscopy for FAI. Such studies are also important to ensure that arthroscopic surgery is not associated with harm, such as accelerated disease.
Conclusions
Despite the increasing use of hip arthroscopy for FAI, there have been no RCTs comparing the efficacy of hip arthroscopy with either non-surgical management or sham surgery. There are no data available to help the clinician determine which, if any, patients may benefit from surgery for either improving symptoms or preventing development of hip OA. Lessons learned from knee arthroscopy should be heeded. High quality evidence is required to optimise the management of FAI.
Spotlight on rheumatology
Gout is in the news this week, with a new study from the BMJ demonstrating that eating well can downgrade your risk of developing this inflammatory condition.
The so-called DASH diet, designed to reduce blood pressure, is also good for lowering uric acid levels, US and Canadian study involving 44,000 people has found. The diet is rich in fruit, vegetables, nuts and whole grains, and low in salt, sugary drinks, red and processed meats.
Gout is also the subject of an ongoing battle in the rheumatology community, reports Health Professional Radio. New guidelines from the American College of Physicians advise doctors against urate-lowering therapy in most patients, in stark contrast to both EULAR and ACR recommendations. It’s angered many gout specialists who have set up two new professional bodies to advocate use of urate-lowering drugs.
New fibromyalgia guidelines have also come under fire. The EULAR recommendations, write two Maltese rheumatologists, underplay the importance of severe anxiety and depression in the debilitating condition.
Meanwhile, biosimilars are making news at the Digestive Disease Week held in Chicago this month. The question of whether they are interchangeable with biologics has been troubling many Australian rheumatologists since the recent PBS listing of the etanercept biosimilar Brenzys for a number of rheumatology conditions.
Three new studies (here, here and here) suggest Inflectra, an infliximab biosimilar that was PBS-listed last year, can be switched with its originator Remicade without any effect on safety or efficacy.
And in other biologics news, abatacept has been found in a phase 3 study to be effective in psoriatic arthritis. In the study of over 400 patients, around 40% of those randomised to the biologic showed improvement compared with 22% in the placebo group.
How common is hand arthritis? A large study from the US crunches the numbers: it finds that one in two women will develop the condition at some stage in their life, while only one in four men will do so.
Hand arthritis affects Caucasians more than African-Americans and is more prevalent among obese people.
But people with any kind of arthritis should go easy on some kinds of painkillers, Canadian researchers say. The BMJ study involving 450,000 people found that taking any dose of an NSAID even for only a week significantly increases the risk of myocardial infarction.
And finally, a US study has found that squeaky knees are a better predictor of osteoarthritis than knee pain.
The study looked at 3500 people at high risk of developing OA and found that 75% had radiographic evidence of the disease despite the absence of pain.
Among those not experiencing pain, crepitus was more common in those who developed OA within a year.
Need some fast facts on osteoarthritis? Buy our OA handbook at the Doctorportal bookshop. This comprehensive resource includes:
- a clear and concise description of the normal joint;
- a detailed overview of the pathology of osteoarthritis;
- expert guidance on well-established diagnostic criteria and investigations;
- up-to-date, practical information on drug therapy, non-pharmacological treatments and surgical options;
- joint-specific treatments for the hand, hip and knee, including intra-articular corticosteroid injections.
Controversy over arthritis biosimilar listing
The first biosimilar to be sold in retail pharmacies has been listed on the PBS amid criticism from Australia’s peak rheumatology body.
Brenzys, an etanercept biosimilar for the treatment of several rheumatology conditions, was listed on April 1st with an “a-flagging”, which means pharmacists can substitute it for the originator biologic, Enbrel, without consulting the prescribing doctor.
Brenzys is the second rheumatology biosimilar to get a PBS listing, behind Inflectra (infliximab), which was a-flagged a year ago.
Dr Mona Marabani, chair of the Australian Rheumatology Association’s biosimilars working group, said the new listing was concerning because unlike Inflectra, a hospital-dispensed infusion product, Brenzys is a self-injected medication available at retail pharmacies.
“Pharmacists may stock only the originator or the biosimilar, which means there is potential for the patient to receive a different drug every month,” she said.
And yet multiple switching between biosimilars and their originator drugs is an “evidence-free zone”, she said.
Dr Marabani said responsibility for determining whether a biosimilar is interchangeable with its originator drug was quietly switched last year from the TGA to the PBAC, creating a conflict of interest.
“The funder is making the decision as to whether the drug is interchangeable, and not the regulator. My position is that the regulator should regulate and the funder should look at cost-effectiveness,” she said.
She said one PBAC criterion for determining interchangeability is “absence of proof” to suggest differences in safety and efficacy between a biosimilar and reference drug.
“This is clearly concerning as it reverses the onus of proof. Absence of evidence is not the same as evidence of absence,” she said.
“The powers that be keep asking rheumatologists what’s going to make us confident in prescribing biosimilars. What makes us confident is data. We recognise that biosimilars represent an opportunity. We are all for reducing the cost to the community. But there are data gaps at the moment; there are things we don’t know.”
Dr Marabani said the ‘a’ flagging of biosimilars is the “wrong mechanism”, adopted by only one other country in the world, Venezuela.
The Department of Health has launched a Biosimilar Awareness Initiative to address the lack of information surrounding biosimilars and boost confidence in their use. But a CPD accreditation program for biosimilars won’t be up and running until later this year.
Meanwhile MSD, which is marketing Brenzys in Australia, is pushing back against criticism from the Australian Rheumatology Association.
The company said it had consulted widely on the introduction of the biosimilar.
It said that in Europe, rheumatology biosimilars have been used for a number of years with no reports of enhanced immunogenicity or unexpected adverse events.
It noted that the pharmacy substitution process allows for prescriber and patient choice and is not automatic.
“For any individual prescription, a prescriber may choose not to permit brand substitution. If on the other hand, substitution has been permitted by the prescriber, the patient may choose which brand they wish to receive from the pharmacist,” the company noted.