I’m a retired Radiation Oncologist who taught courses in undergraduate medical school for more than a decade. These courses were essentially the principles of “assessment.” At Western University’s Schulich School of Medicine and Dentistry, reviewing a patient’s medical history, interviewing patients and physical examination skills are taught in year-long courses over the first two years of medical school. These skills are further refined in clinical rotations, and later during residency training. They are assessed throughout undergraduate and postgraduate training via direct observation and written and oral examinations. Competency-based objectives are met to ensure physicians are ready to independently “assess” patients, formulate diagnoses and differential diagnoses (other possible diagnoses), order appropriate tests, interpret them and devise treatment plans. Shared decision-making, clear communication and ethics form the foundation of patient interactions.
These are the skills the province has summarily granted to Ontario pharmacists.
In January 2023, changes to the Pharmacy Act 1991 S.O., Ontario Regulation 202/94 S. 35(1), 2. Controlled Acts, included the addition of prescribing for 13 minor ailments: Allergic rhinitis, candidal stomatitis (thrush), conjunctivitis, dermatitis, dysmenorrhea, gastroesophageal reflux disease, hemorrhoids, herpes labialis, impetigo, insect bites and urticaria, tick bites, post-exposure prophylaxis, musculoskeletal sprains and strains and urinary tract infections.
In October 2023, the Pharmacy Act 1991 S.O., C36, Section 3, was amended to include the added skill of “assessment” to the scope of pharmacy practice:
“…(e) the assessment of conditions for purposes of providing medical therapies. 2009, c. 26, s. 21(1); 2023, c.4, Sched. 2, s.11.”
The list of minor ailments was increased to include: acne, aphthous ulcers, diaper dermatitis, nausea and vomiting of pregnancy, pinworms and threadworms and vulvovaginal candidiasis.
The Ministry had apparently realized that treatment wasn’t possible without a diagnosis and added “assessment” to the scope of pharmacy practice. This gift of “spot assessment” and treatment inherently undermines the practice of medicine and the quality of health care offered to Ontarians. Some conditions, such as nausea and vomiting of pregnancy, are beyond what pharmacists should manage. Pharmacists lack adequate training in obstetrical care, assessment for hypovolemia or when conditions warrant obstetrical referral. The wellbeing of the fetus must be the first concern. The focus of this amendment is on prescribing. That is not the focus of a physician-patient interaction. The terms “history,” “examination” and “diagnosis” were explicitly left out most likely because:
1) It would conflict with the definition of the practice of medicine in The Medicine Act 1991, S.O.,1991 C.30 and,
2) Pharmacists do not have the necessary training and education.
In The Medicine Act 1991, S.O. 1991, c.30, s 3, under “Scope of Practice,” a physician’s role is described as: “The practice of medicine is the assessment of the physical or mental condition of an individual and the diagnosis, treatment and prevention of any disease, disorder or dysfunction.”
It is obvious the province has conflated the practice of medicine and pharmacy. These changes have occurred without physician input or oversight. Online learning modules, necessary for pharmacists to prescribe, also have been created without apparent physician input. The Ministry of Health has provided caveats on the types of conditions that may be treated:
- “a short-term condition,”
- “lab results aren’t usually required,”
- “low risk of treatment masking underlying conditions,”
- “no medication or medical history red flags that could suggest a more serious condition,”
- “only minimal or short-term follow-up is required.”
To a physician, these caveats are short-sighted and perhaps even comical: Pharmacists lack clinical reasoning skills or the requisite education and clinical training to know if a particular presentation harbours a “red flag” for a more serious condition. It requires clinical knowledge, experience and judgment to know which problems require follow-up. While some conditions are reasonable for pharmacy consultation, others are concerning.
Proposed amendments to the pharmacists’ scope of practice – open for public comments until Oct. 20 – portend to further erode the safeguards initially placed by the province. These include:
- Treatment (i.e., prescribing) for additional minor ailments: acute pharyngitis, calluses and corns, headache (mild), shingles, minor sleep disorders (including circadian rhythm disorders), fungal nail infections, swimmer’s ear, head lice, nasal congestion, dandruff, ringworm, jock itch, warts, dry eye.
- Ordering specific laboratory and point of care testing to support assessment, management and treatment. Feedback is being sought as to the appropriate tests to add and required training.
- Communicating a diagnosis for specific minor ailments (“The ministry is seeking feedback to determine whether communicating a diagnosis is required to support pharmacist assessment and prescribing.”)
- Identifying barriers for pharmacists in hospital settings.
- Expansion of Schedule 3 vaccines with the addition of a number of vaccines, including shingles and rabies.
Beyond the pitfalls of treating pharyngitis, headache and shingles, which are definitely in the realm of a physician and not a pharmacist, one can see the vision that the Ford government has for pharmacists – ordering and interpreting laboratory tests and communicating diagnoses. It knows or accepts little distinction between doctors and pharmacists, raising the question of whether private industry ties are driving these changes?
The impetus is certainly not the health-care professionals involved in patient care.
There appears to be a belief that relying on lay diagnoses for most of these interactions is suitable. But do pharmacists intend to examine genital rashes or to simply prescribe antifungals for tinea cruris (jock itch)? Will they miss diagnoses of inverse psoriasis in doing so (most certainly)? Will they examine shingles rashes and recognize the “red flags” of an immunocompromised patient with an underlying diagnosis of acute or chronic leukemia, or lymphoma? Are they able to proceed with a “red flag” medical history and physical examination. Extremely unlikely. Will they know that facial shingles eruptions may cause blindness?
Will they know that facial shingles eruptions may cause blindness?
I can raise these concerns with a number of the listed “minor ailments.” The truth is many are not necessarily minor. Some pharmacists will be more skilled than others. However, the public should be made aware that pharmacists do not have adequate clinical training to diagnose and prescribe. A 70-per-cent pass rate on an informal, online, multiple choice exam based on several required online learning modules is all that is required. Is that a satisfactory method for an evaluation of competency to this level? It’s not acceptable for physicians.
Taken together, these successive legislative changes to the Pharmacy Act are akin to the practice of medicine being added piecemeal, amendment by amendment, to pharmacists’ scope of practice so as not to be so flagrant a breach of the Medicine Act all at once. But how can one practice as a physician and yet not be a physician? It’s a bit bewildering that the Ontario Medical Association hasn’t launched a legal challenge.
I have been in full support of adding vaccinations to pharmacists’ scope of practice. It is a skill easy to learn, has dramatically improved influenza vaccine uptake and certainly has supported COVID-19 vaccinations. However, some vaccinations are best administered by a physician. Rabies for one. The ramifications, counselling and necessary follow-up are beyond a pharmacist’s scope of practice.
Reviewing the objectives from the “Sample Objectives from the Association of Faculties of Pharmacies of Canada Educational Outcomes (2017) for First Professional Degree Programs,” we can see the lack of clear language to support the requirements for a medical assessment, i.e., “taking a medical history,” “physical examination skills,” “diagnosis or diagnostic skills” and “clinical reasoning skills.”
Likewise, it is difficult to find language to support further expansion of pharmacists’ roles within the 2023 Accreditation Standards for Canadian Educational Programs leading to the Doctor of Pharmacy Degree. Ontarians should therefore understand pharmacists are not completing medical histories or performing the requisite physical examinations required by physicians who assess the same problems in their offices.
Learning about the assessment and treatment of a list of “minor” ailments within a vacuum does not permit one to carry out clinical reasoning. In my opinion, pharmacists are not adequately trained to discern “red flags,” when seemingly “minor issues” are related to a complex medical problem that if missed may lead to serious consequences. They lack sufficient breadth of training and experience to know when diagnostic testing is required, which lab test to order; how to interpret the results and when to refer to a specialist. One of the Ministry’s guiding principles for pharmacist prescribing was to avoid assessments that included lab tests, yet this appears to be soon abandoned.
Justin Bates, the Chief Executive Officer of the Ontario Pharmacists Association, has called out physicians for “hysteria” over their voiced concerns about unilaterally expanding pharmacists’ role in medical care and “gaining their … appropriate scope of practice.”
Is it hysteria? Is it crazy that physicians want the best care for Ontario patients?
Physicians know the potential for poor health outcomes and strive to avoid misdiagnosis and/or mistreatment. Ontarians may be lulled into a belief that their issue was adequately managed by a pharmacist when it was not.
And then there is the obvious strong bias to prescribe.
Physicians are unable to own pharmacies in Ontario because of the significant conflict of interest that would exist. Why not embellish diagnoses or err on the side of over-treatment than under-treatment, especially when one earns more money with the latter approach? This bias may be so strong as to occur even among those with the best intentions, i.e., implicit bias.
One colleague via social media, Lindy Smith, reported her patient presented to a local pharmacist with symptoms of an upper respiratory tract infection (a cold). That individual left the pharmacy with a seven-day prescription of oral antibiotics, a two-week prescription for a nasal steroid spray, a prescription for inhaled potent corticosteroid/long-acting bronchodilator and a short-acting bronchodilator. A physician would have taken a history and completed physical examination that included auscultation of the lungs with a stethoscope (often to rule out pneumonia, though colds are often clear before that step). Pharmacists lack that clinical training. Not only was this over-treatment gross and inappropriate, the introduction of long-acting bronchodilators and short-acting bronchodilators poses the risk of serious arrhythmias in some individuals. It’s the kind of error medical students might make in their second or third year of medical school. I worry for more of the same.
Finally, what’s to stop managers at pharmaceutical conglomerates from requiring a quota of authored prescriptions filled per shift? So, Minister of Health Sylvia Jones, where’s the regulation and oversight? Why didn’t the province instead require nurse practitioners be hired to work with pharmacists should an individual pharmacy elect to provide “assessments?” Why hasn’t this government required physicians audit pharmacist practices to ensure over-prescribing and patient harm was minimal? That seems only logical.
Ontario physicians could have collaborated with Ontario pharmacists and this government. Diagnostic algorithms could have been devised to assist with diagnosis of truly minor problems. Some inappropriate problems could have been identified and prevented from reaching the pharmacist assessment and prescribing.
Why recognize the need to increase the number of family physicians accessible to Ontarians and simultaneously exclude physicians from consultations on expanding the scope of pharmacy practice? Who is best positioned to advise how to take a history, diagnose and treat common ailments? Whose interests are this government serving?
More than 2 million Ontarians are without family physicians. Where’s the focus on improving family physician recruitment and retention?
Why not increase the number of funded family health teams, add an Office of Physician Recruitment and Retention, provide recruitment and retention bonuses and/or offer student loan forgiveness for a five-to-seven-year family physician contract?
Ontario’s physicians have ideas to boost family physician numbers. Premier Doug Ford only need ask.
Dr. Leighton,
I am a practicing pharmacist who has worked in retail, hospital and regulatory environments. Your article shows an inherent lack of understanding of Pharmacy curriculum. Pharmacists are absolutely trained to identify ‘red flags’ during their 4 years of pharmacy training. They are extensively trained to conduct complete patient assessments and thorough medical histories. As they have been doing for over the counter (OTC) and schedule 2 products for years. In fact, Pharmacists have been primary prescribers in Alberta since 2007. Alberta has integrated Pharmacists into their healthcare system better than any other province. In Alberta, Pharmacists have access to Connectcare, a comprehensive electronic healthcare record which supports a larger circle of care through sharing of hospital admissions information as well as laboratory values. I would argue that a radiologist has less exposure to minor ailments than a frontline pharmacist does. My father in law, a radiologist, has asked for my recommendation on multiple minor medical conditions as I have greater requisite knowledge than his very limited pharmacology training in medical school. Any pharmacist who has spent time working in a hospital environment has experienced a July with first year medical residents, who do not know drug doses, common side effects or what therapeutic drug monitoring is required. Most residents learn the vast majority of their drug knowledge after medical school, which they are able to do because of the foundation school provided them.
Pharmacists have the foundational knowledge to enhance their skill sets and learn additional training following pharmacy school, similar to residents graduating medical school. Expanding the scope for pharmacists is intended to assist general practitioners by reducing their workload. This liberates GPs from managing minor conditions, so that they may focus on complex patients who require more time and diagnostic efforts. Rather than looking for all the reasons this is a bad idea, focusing on how to leverage this to improve the healthcare system is much more constructive. There is potential for corporate interests to negatively impact the professionalism and autonomy of pharmacists, however, this can be mitigated through incorporating pharmacists into primary care networks and family medicine teams. Pharmacists do not need to be restricted to the dispensary. Attacking the ethical sincerity and professional integrity of pharmacists makes physicians appear petty and protectionist.
It is crucial that someone has to be responsible for seeing that these procedures carried out by pharmacists are effective in helping people. Most pharmacists will agree that one pill won’t cure anything but many have been quick to jump on board promoting a single prophylactic dose of doxycycline following a tick bite for the prevention of Lyme disease (LD).
Pharmacists are going astray when they say they use guidelines but openly admit that no one is actually keeping statistics on whether these guidelines are helpful. In future pharmacists may be identified and held responsible if the guidelines fail to be helpful and have caused harm because pharmacists failed to investigate the scientific and medical evidence and why there are reputable researchers and a medical society that hold diametrically opposed opinions on LD based on the same science but interpreted differently.
It’s all based on a single underpowered 2021 (Nadelman/ Wormser) study) that was designed to see if a single or double dose of doxycycline would prevent the EM or Lyme rash. Canada’s leading self-appointed LD experts, who neither see or treat cases of complex disseminated (chronic) LD , tell their audiences that there is no need to check the references because it has all been done for them and it’s all based on top notch, peer reviewed, blinded, published science. We tend to believe our professors, particularly when they can have us investigated if we stray from the regimens they endorse.
The conclusions of the May 1999 Quebec INESSS report still stand. A balanced committee concluded that the evidence for use of single dose prophylactic treatment to prevent LD was low level and sparse. The committee concluded that the procedure should only be undertaken after properly conducted trials were completed and the results analyzed. No such trials have been held in Canada.
Patients weren’t followed to see if anyone actually became ill. The only thing one dose has been shown to do is prevent the rash, the acute symptom, not the disease. There were only 9 EM rashes in the Nadelman study. Nadelman and colleagues were able to reduce the number of rashes from eight to one by prescribing a single 200 mg dose of doxycycline. The IDSA guidelines adopted the single, 200 mg dose of doxycycline despite the fact that 3 previous prophylactic antibiotic trials for a tick bite had failed. ILADS guidelines note that the evidence supporting a single dose of doxycycline to prevent LD was “sparse, coming from a single study with few events, and, thus, imprecise.” Several problems that suggest this single dose of doxycycline may not be the best prophylactic for LD.
Nadelman’s study had several other limitations:
1. The recommendation is based on a questionable conclusion. The study claimed to show the effectiveness of a single dose of doxycycline to prevent LD. The study actually shows a reduction in the appearance of erythema migrans [“bull’s-eye”] rashes, a possible symptom of LD – but not the disease itself. The absence of an EM rash does not indicate the absence of LD.
2. It was not designed to detect LD if the rash were absent.
3. The 6-week observation period was not designed to detect chronic or late manifestations of LD.
4. It was not designed to assess whether a single dose of doxycycline might be effective for preventing other tick-borne illnesses such as Ehrlichia, Anaplasmosis, Babesiosis or Borrelia miyamotoi.
5. Taking a prophylactic dose of doxycycline prevents sero-conversion which could later result in a false-negative blood test for LD causing delays in diagnosis and treatment.
AMMI Canada and the Nadelman study fail to mention the evidence, as put forth by the International Lyme and Associated Diseases Society (ILADS), which finds that a single dose is ineffective in warding off LD.
Lyme is a low abundance disease and Borrelia burgdorferi, the spirochete responsible, is a very slow growing, slow dividing organism with many sophisticated defensive systems. This is a multi-staged, multi-system disease and it can take 12 to 24 months before the severe debilitating symptoms of late complex disseminated can take people out of the work force or out of school. Researchers and patients have different end points. Patients want to ward off future complications of disease. The end point for researchers was to prevent the Lyme or erythema migrans rash which is a poor objective sign of the disease, occurring in less than 50% of patients. This procedure might work if you believe that the rash is the disease.
Patients know they should be allowed to make choices where those exist for not to do this is unethical.