Doctors in new turf war with pharmacists over ‘unlawful and unfair’ competition

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Proposed changes to the Pharmacy Guidelines are “unlawful, unfair and not in the patients’ best interests”, says the SA Medical Association , while the SA Private Practitioners Forum says it found the moves “deeply concerning”, with pharmacists possibly operating “far beyond their competency”, writes MedicalBrief. The dispute is part of a turf war between the two professions.

The dispute reflects increasing competition between pharmacists and medical practitioners, what Casper Venter, MD of independent health care consultancy Healthman described as “a turf war”, with medical practitioners alarmed at the erosion of the role traditionally played by GPs.

Last month, there was a similarly strong reaction from doctor organisations to the gazetting of proposals that pharmacists be allowed to manage patients for antiretroviral treatment, Pre-Exposure Prophylaxis (PrEP) and Post-Exposure Prophylaxis (PEP), in order “to increase the public’s access to health services”.

The most recent suggested changes, which will broaden the scope of practice of pharmacists, will also compromise patient care, says SAMA. In a statement, it says it is “deeply dismayed at the changes, which present “a clear conflict of interest in terms of diagnosis and treating patients, and the issuing of medicines and health products”.

SAMA has opposed the proposed amendments in a written submission to the South African Pharmacy Council (SAPC) in which it underscores its concern at what it deems an “over-reach” of pharmacists’ roles in broadening their scope.

The proposed changes allow pharmacists to provide therapeutic guidance, and give diagnoses, and prescribe medication to patients.  In its submission, SAMA argues that the rules broadening the scope of pharmacists contravenes the Health Professions Act, which makes it an offence to conduct acts described under any of the professions within its ambit while not being registered in that specific profession.

SAMA refers to the skills – “or lack thereof “– of pharmacists in performing a broadened scope of practice. “There is no way a pharmacist, by means of some ‘accredited course’ or CPD event, will be able to acquire the skills needed for diagnosis and treatment in the fields of reproductive and sexual health listed by the notice. What is being proposed, quite simply, falls far outside the scope of pharmacy and squarely within the scope of general and certain specialist medical practices” says Dr Angelique Coetzee, chairperson of SAMA.

SAMA said the public had a rightful expectation to be treated by persons “who are adequately qualified and experienced”. “It is also unclear how matters of medical negligence will be handled – are providers of pharmacist malpractice aware of this broadened scope of their clients and the implications thereof? And, what happens in cases of misdiagnosis, or the provision of incorrect treatment, care or non-referral?” questions Coetzee.

Apart from these concerns, SAMA has also raised the issue of conflict of interest. “The broadening of the scope of pharmacists includes the use of any product which can have a direct benefit to a pharmacy. In our view this creates a clear incentive to over-supply, over-service or inappropriately service patients and is a massive conflict of interest.

“Put bluntly: allowing pharmacists to compete with general practitioners and others, while not having the necessary qualifications, experience and registration – presumably at much lower rates – can only be described as unfair competition,” she says. SAMA says it will pursue meetings with all relevant stakeholders – including the SA Pharmacy Council and the National Department of Health, to protect the public.

 

SAPPF warns of “potential huge cost to quality of care”

The SA Private Practitioners Forum (SAPPF) said in a statement – echoed by the SA Society of Obstetricians and Gynaecologists – that it found it “deeply concerning” that pharmacists scope of practice might reach “far beyond their competency”. While SAPPF agreed that there was a clear need for more public clinical services, “improved access cannot come at a potential huge cost to quality of care”.

“We do not agree that the proposed extra training courses can amend the clear deficit in training, skills, infrastructure, and experience. The study of clinical medicine requires contact and prolonged exposure to patient care and clinical scenarios.

“As health practitioners, we have a duty of care to the public to ensure patient safety, best outcomes and that the quality of care is not compromised. It is our opinion that several factors associated with these amendments to the Pharmacy Act may severely compromise the safety and well-being of our collective patients and that these changes may drastically reduce the standards and quality of healthcare.”

 

Pharmacists involvement in first-line HIV treatment

Last month, reports IOL, there was resistance from some doctors to the gazetting of proposals that pharmacists be allowed to manage patients for antiretroviral treatment, Pre-Exposure Prophylaxis (PrEP) and Post-Exposure Prophylaxis (PEP), in order “to increase the public’s access to health services”. The initiative, Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART), meant South Africans would have increased access to HIV testing, first-line treatment and prevention through more than 3,600 community pharmacies.

IOL reported that Vincent Tlala, Registrar and chief executive of SAPC said that this would help in ensuring that people who test positive for HIV were placed on treatment as soon as possible. “Pharmacies, due to their longer operating hours, accessibility and affordable professional fees, would also ensure that those persons who were likely to default due to cost and inability to collect treatment at specific times of the day would continue to stay on treatment,” he said.

“Persons with the risk of contracting the virus will also be able to access HIV prevention medication PrEP and PEP much easier than before. Given that South Africa has the highest number of HIV-positive people in the world, expanding access to treatment through pharmacies will also reduce the number of people dependent on the public health system, as there is an average of 15 community pharmacies per municipality in South Africa.

However, Dr Norman Mabasa, practising general practitioner and former chair  of SAMA told IOL that there was “vehement” opposition to the move. Patients who were HIV-positive still needed a medical expert to manage the disease, requiring a holistic understanding of a patient’s anatomy, physiology and pathology. “It is a risk also for medical negligence and exposure to litigation.”

“It takes seven years and an additional two years of community service to master how to diagnose and treat HIV. Whilst pharmacists are so protective of their training, such that they would wish they were the only creatures on earth who know how to treat all ailments under the sun, they go on to wish to annihilate competition,” said Mabasa.

Jackie Maimin, chief executive of the Independent Community Pharmacy Association, told IOL that Mabasa’s concerns were misplaced. The PIMART curriculum aimed to expand access to PrEP and reduce over 200,000 young women and men being exposed to HIV in the first place and to prevent either government or private health being forced to carry the burden of the cost of chronic care.

Maimin added that during the 60-day consultation period for the gazette doctors and clinicians specialising in HIV care had widely welcomed the gazette. “Doctors are not going to be losing their role. The pharmacists will counsel, test, and dispense the life-saving medicine. Where needed they would then refer the patient to a doctor for long term care.”

“A pharmacy is a neutral ground, we have resistance from men to go to clinics but a pharmacy is a discreet place to reach men who often don’t want to be seen going to a clinic for testing for HIV.”

 

Expanded access to medicines needed

Healthman MD, Casper Venter, told MedicalBrief that the emphasis should be on expanding access to all medicines.

“There are many parts of the country where there is no medical practitioner around but a pharmacy still operates. There’s no doubt that pharmacists have the professional training and skills to provide for many treatments.”

 

This week’s SAMA statement in full:

Proposed changes to the Pharmacy Guidelines, which will broaden the scope of practice of pharmacists, are unlawful, will compromise patient care. It present a clear conflict of interest in terms of diagnosis and treating patients, and the issuing of medicines and health products. The South African Medical Association (SAMA) has opposed the proposed amendments in a written submission to the South African Pharmacy Council (SAPC) in which it underscores its deep dismay at what it deems an over-reach of pharmacists’ roles in broadening their scope.

The proposed changes allow pharmacists to provide therapeutic guidance, and give diagnoses, and prescribe medication to patients. Pharmacists are not educated, trained or experienced in treating patients, and their focus is on medicines only. Diagnosis and treatment choices are within the domain of healthcare professionals registered as such. In its submission SAMA notes that the rules broadening the scope of pharmacists contravenes the Health Professions Act which makes it an offence to conduct acts described under any of the professions within its ambit whilst not being registered in that specific profession.

Whilst the financial pressure pharmacies have been under since the regulation of medicines prices and their dispensing fees are understood, this reduction in income cannot be address by venturing in the scope of practice of other healthcare professionals. In addition, the SAMA submission refers to the skills – or lack thereof – of pharmacists in performing a broadened scope of practice, which includes aspects of mental health (counselling in cases of for example gender-based violence), complex medical- and social fields such as infertility, amongst others.

“There is no way a pharmacist, by means of some ‘accredited course’ or CPD event, will be able to acquire the skills needed for diagnosis and treatment in the fields of reproductive and sexual health listed by the notice. What is being proposed, quite simply, falls far outside the scope of pharmacy and squarely within the scope of general and certain specialist medical practices” says Dr Angelique Coetzee, Chairperson of SAMA.

Also of concern to SAMA are the rights of patients who have an expectation to be treated by persons who are adequately qualified and experienced. Medical practitioners spend years in hands-on care for patients, from their third year in medical school, two years of formal internships, and gain additional experience during community service. “It is also unclear how matters of medical negligence will be handled – are providers of pharmacist malpractice aware of this broadened scope of their clients and the implications thereof? And, what happens in cases of misdiagnosis, or the provision of incorrect treatment, care or non-referral?” asks Dr Coetzee.

Apart from these concerns, SAMA has also raised the issue of conflict of interest. A key principle of the relationship between prescribers (doctors) and dispensers (pharmacists) is that there should be no incentive to prescribe or dispense any product. It is for these reasons that medical practitioners are prohibited from owning any direct or indirect stake in any pharmacy. “The broadening of the scope of pharmacists includes the use of any product which can have a direct benefit to a pharmacy. In our view this creates a clear incentive to over-supply, over-service or inappropriately service patients and is a massive conflict of interest. As medical professionals with patient care as our main priority, we cannot abide by such a suggestion,” notes Dr Coetzee. Part of SAMA’s submission also focuses on the issue of unfair competition.

“Put bluntly: allowing pharmacists to compete with general practitioners and others, whilst not having the necessary qualifications, experience and registration – presumably at much lower rates – can only be described as unfair competition,” says Dr Coetzee. SAMA says it will pursue meetings with all relevant stakeholders – including the SA Pharmacy Council and the National Department of Health, in order to protect the public.

 

Full SAPPF statement:

SAPPF OBJECTS TO AMENDMENTS TO PHARMACY ACT:
POSITION STATEMENT REGARDING PROPOSED AMENDMENTS TO THE PHARMACY ACT, 53 of 1974

Government Gazette No: 44305 Board Notice 17 of 2021 – Pharmacists who provides Pharmacist- Initiated Management of Antiretroviral Therapy (PIMART) services in South Africa
Government Gazette No: 27112 Board Notice 71 of 2021: Rules relating to good pharmacy practice: Minimum standards for sexual and reproductive health services provided by pharmacists
The South African Private Practitioners Forum (SAPPF) is a voluntary association of private specialists working in the South African private health sector. The organisation has a membership base of approximately 5500 specialists representing most specialist disciplines as well as 2000 healthcare providers in other fields. Importantly our membership groups include The Gynae Management Group (GMG), the Faculty of Consulting Physicians of South Africa and the Paediatrician Management Group.

As a representative body for healthcare specialists SAPPF object to the proposed amendments by the South
African Pharmacy Council to the Pharmacy Act, 53 of 1974, namely:
i. Board Notice 17 of 2021 – Pharmacists who provide Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) services in South Africa (Board Notice 17); and
ii. Board Notice 71 of 2021 – Rules Relating to Good Pharmacy Practice (Board Notice 71)

We find it deeply concerning that pharmacist’s scope of practice may reach far beyond their competency when the proposed amendments are implemented. We do not agree that the proposed extra training courses can amend the clear deficit in training, skills, infrastructure, and experience. The study of clinical medicine requires contact and prolonged exposure to patient care and clinical scenarios. As health practitioners, we have a duty of care to the public to ensure patient safety, best outcomes and that the quality of care is not compromised. It is our opinion that several factors associated with these amendments to the Pharmacy Act may severely compromise the safety and well-being of our collective patients and that these changes may drastically reduce the standards and quality of healthcare.

Minimum standards for sexual and reproductive health services provided by pharmacists

SAPPF acknowledges the intention to improve patient’s access to reproductive health services for women and to improve access to anti-retroviral medication. We agree that there is a clear need for more public, free or affordable clinical services, but improved access cannot come at a potential huge cost to quality of care. We strongly disagree that pharmacists are “better placed” to provide therapeutic guidance to women of all ages on matters of contraception, fertility, pregnancy, menopause, sexually transmitted disease, abortion services and sexual and gender-based violence.

The main reason for our position is that pharmacists lack the infrastructure, equipment, skills and trained staff to provide what is needed for such services.

  1. A safe, confidential and quiet environment where the patient can provide a history and feels comfortable to discuss personal matters.
  2. A detailed physical examination, including intimate examination must be performed
    before recommendations regarding best contraception and other reproductive health issues can be made.
  3. All contraceptive methods must be available to the patient, including those requiring invasive procedures to fit (intra-uterine devices, implants) which creates further infrastructure and skills needs.
  4. The gestational age must be accurately determined before providing recommendations regarding termination of pregnancy or drugs that will result in abortion – the infrastructure, skills and ultrasound equipment needs are specialized.
  5. An essential part of the termination of pregnancy service is having a facility available to perform an evacuation of the uterus for women who require that as part of their management. Neither the facilities nor the skill required to perform an evacuation of the uterus could be provided by pharmacists.
  6. The management of peri- and post-menopausal women and appropriate steroid hormone replacement choices is a highly complex matter that requires a clinical estimate of risk and benefit based on an intimate knowledge of the patient, her health history, risks and status, and the products available.
  7. Basic disease screening belongs in this domain and is essential to provide optimal care such as female cancer screening, breast examination and Pap smears, imaging such as transvaginal or transabdominal ultrasound scans, bone density, mammography, etc.

Pharmacists who provide Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) services in South Africa

We believe that the proposed Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) oversimplifies comprehensive HIV management and ignores the complexities that go with managing a patient infected with HIV. If patients are not optimally managed according to best practice with appropriate clinical experience, then the safety, comorbidity and death rates will inevitably increase.

Similar to the needs of reproductive health care, the correct treatment of patients infected with HIV also require:

1. A taking of a comprehensive patient history detailed physical examination, accurate diagnosis, appropriate ordering of and interpretation of investigations (pathology and radiology).

  • These patients frequently have comorbidities and any level of clinical examination skill has to be backed up by an extensive knowledge of disease pathophysiology so as to fully appreciate the whole illness and disease process.
  • These services can only be provided by someone with qualified clinical expertise, infrastructure, equipment and experience, as opposed to dishing out ARV medication on a positive HIV test.
  • Holistic treatment includes monitoring compliance, identifying and managing psycho-social matters, co-morbidities, opportunistic infections including TB and cancer risk.
  • The above level of competence above competency cannot be achieved by non-clinicians who have only participated in a short period of supplementary training. This competence requires prolonged exposure to patients through medical student years followed by supervision during internship and then clinical community service as a medical officer.
  • The delivery of patient care requires the clinician to be available for emergencies and after-hours work. Not only will pharmacists not be available for these emergencies but they are also not equipped to diagnose and treat the emergencies or side effects that arise from the disease process or the treatment.

Conclusion

SAPPF acknowledges that pharmacists do play a role in the provision of some primary health care services in collaboration with general and specialist practitioners. It is our position that services should be limited to those that are within the competency of the provider.

Services in female reproductive and HIV care which in our view could reasonably be provided by pharmacists, include:

  1. Counselling and provision of oral emergency contraception and short-term oral contraception
  2. Extended provision of previously prescribed contraceptives and menopausal hormonaltreatment to 12 months
  3. Counselling and provision of rapid HIV testing, PEP and PrEP, male and female condoms orbarrier contraceptives.
  4. Counselling and provision of nutritional support for HIV infected people, pregnant women andmenopausal women
  5. Screening for gender-based violence and referral for further assessment or assistance
  6. Ovulation and pregnancy testing and referral to antenatal care, abortion services or fertilityservices
  7. Basic health screen for pregnant women including weight, urine analysis and blood pressure
  8. Basic health screen for older women including bone health, cholesterol test and blood pressure

It is essential that pharmacy facilities providing such services must collaborate with medical practitioners and develop referral pathways. If pharmacist-initiated contraception and PIMART involves referral of all patients for comprehensive assessment and confirmation of the selected drug regimen, the initiative may provide improved access without a loss of quality of care.

Services such as antiretroviral treatment, treatment of HIV co-morbidities and opportunistic infections, treatment of menopause, abortion services, syndromic STI diagnosis and treatment, and intra-uterine and implanted contraceptives are beyond the scope of a pharmacist even if the supplementary training is provided as recommended.

 

Full story on IOL – Mixed views on pharmacies dispensing ARVs (Open access)

 

See more from MedicalBrief archives:

 

SA's private pharmacies are Gollums, not trusted gatekeepers

 

Pharmacists concerned over 'limited dialogue' on NHI Bill

 

Black pharmaceutical industry wants 30% of tenders, it tells NHI hearing in Parliament

 

 


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