Carbert Waite | Legal Risks for Family Practice & Responsibility for Potentially Harmful Drug Interactions
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Legal Risks for Family Practice & Responsibility for Potentially Harmful Drug Interactions

Legal Risks for Family Practice & Responsibility for Potentially Harmful Drug Interactions

By Michael Waite

 

Presenter Disclosure:

  • Faculty: Michael Waite. Partner, Carbert Waite LLP
  • Relationships with Commercial Interests: Carbert Waite LLP represents AHS and its insurer

Learner Objectives:

  • Identify key legal risks in Family Practice
  • Understand risks regarding drug interactions
  • Learn some methods for reducing risk

How Do General Practitioners Get Into Trouble?

  • Delay in diagnosis
  • Failure to diagnose or wrong diagnosis
  • Failure to refer to specialist
  • Insufficient information provided to specialist
  • Failure to follow up on referrals and diagnostic testing
  • Drug interactions

Overview of Seminar Topics

  1. Informed Consent in Family Practice
  2. Legal Risk Management
    1. Medical Negligence – General Principles
    2. Duty to Diagnose
    3. Duty to Follow Up on Diagnostic Testing and Referrals
  3. Drug Interactions

Informed Consent In Family Practice

Key Factors Regarding Informed Consent

  • Person consenting must have the legal capacity to do so
  • Consent must be voluntary
  • Consent must be informed
  • Consent can be express or implied
  • Consent can be withdrawn
  • Consent can be resumed

Legal Test: Was the patient informed of the risks, benefits and alternatives to treatment and consequences of non-treatment? If not, would a reasonable person in the patient’s circumstances have consented to the treatment had the patient been properly informed?

The case law establishes that the following must be done to obtain informed consent:

  • A Doctor must disclose the diagnosis, the nature of the proposed treatment, its chances of success /failure.
  • Not just an issue for surgeons:  applies to medications, prescriptions, diagnostic tests.
  • A Doctor must disclose those risks that are material, special or unusual.
  • A risk is material if a reasonable patient in the patient’s position would want to be informed of the risk.
  • A risk which is a mere possibility ordinarily does not have to be disclosed, but if its occurrence may result in serious consequences, such as paralysis or death, then it should be treated as a material risk and should be disclosed.
  • The evaluation of what is a material risk and a non-material risk is fact-specific.
  • A Doctor must answer any specific questions posed by the patient.
  • Consequences of non-treatment must be explained to the patient.
  • Consent is a process of communication and exchange of information, not a form.
  • While it is accepted that a patient has paramount right to refuse treatment, it does not follow that a patient is entitled to insist on provision of a particular medical treatment.
  • CPSA Standards of Practice: Informed Consent

Best practice is to have some documentation indicating that the patient understood the proposed treatment:

  • did the patient ask questions;
  • were diagrams or visual aids used;
  • could the patient restate what the physician had communicated;
  • whether the patient asked for a second opinion;
  • whether the information was put in writing and given to the patient to consider and then return with questions;
  • whether the time spent with the patient was realistic in terms of the patient’s ability to understand the complexity of the procedure;
  • whether the patient was dependent upon family members, translators or others for assistance in decision making or communication.
  • Document the discussion and keep a record of any documentation given to the patient.

Medical Negligence General Principles

Negligence – what does the Patient have to prove?

  • Existence of a Duty of Care
  • Breach of the Standard of Care
  • Causation
  • Damages

Standard of Care

  • Physician is bound to exercise that degree of care and skill which could reasonably be expected of a normal, prudent practitioner of the same experience and standing
  • Burden is on patient to prove breach of the Standard of Care on a balance of probabilities (more likely than not – 51%)

Common Breaches of Standard of Care by General Practitioners

  • Poor Charting
  • Failure to diagnose/Delay in diagnosis
  • Failure to keep an open mind/Revisit Diagnosis
  • Failure to refer
  • Insufficient information provided in referrals or diagnostic imaging
  • Failure to follow up
  • CPSA Standards of Practice: Patient Record Content

Duty to Diagnose

Scope of the Duty to Diagnose

  • Physicians have a duty to make a diagnosis and to advise the patient of the diagnosis.
  • If the physician cannot come to a diagnosis, he or she has a duty to refer the patient to others who can.
  • A physician is not expected to be infallible, only to exercise reasonable care, skill and judgment in coming to a diagnosis.
  • If this is done, the physician will not be held liable even if the diagnosis is mistaken.

How do you demonstrate reasonable care, skill and judgment?

  • Charting
  • Thorough history
  • Proper physical examination
  • Appropriate tests ordered
  • Consultations with colleagues and specialists where necessary
  • Developing a differential diagnosis and avoiding tunnel vision
  • Noting changes in the patients symptoms (improving with treatment or deteriorating?) and/or appropriately advising the patient of worrisome symptoms to watch for
  • Demonstrating diligence in reaching the correct diagnosis in a timely fashion

Case Study: Delay and Failure to Diagnose

Patient saw a GP for over 18 years. On numerous occasions in the last two years, the patient mentioned a lump on her neck. The GP was not concerned.

Patient moved away, saw a new GP, and the new GP immediately noted a lump on the right side of her neck, ordered a C-spine x-ray and referred the patient to a surgeon who requested an ultrasound and subsequently an MRI. The MRI indicated that the lump might be a malignant tumour and the patient was referred to an orthopaedic surgeon.

The Patient had surgery to remove the tumor. The Patient subsequently suffered a stroke.

Verdict? 

It was found that the delay in diagnosis was a breach of the standard of care and caused the patient injuries over and above what would have occurred in any event.

Case Study: Failure to Diagnose and Failure to Refer

Patient was concerned about blood in his stool, stomach pains, tiredness, dizziness and diarrhea so he went to see a Family physician on a few occasions

Doctor #1 gave the patient a physical exam with a glove and concluded that the patient’s rectal bleeding was probably due to hemorrhoids

Doctor #1 provided dietary advice and Preparation H as management plan.

Another Family physician in the same clinic, Doctor #2 saw the patient for the first time a few months later, and then three times more. The Patient did not complain of particular medical problems.

Subsequently, Patient was diagnosed with colon cancer, and subsequently passed away.

Verdict? 

Dr. #1 was liable in negligence for failure to diagnose as he failed to conduct a proper visual examination with proper instruments.

Additionally, he failed to refer the patient for testing which might either have confirmed his conclusion or made plain that more detailed inquiry was needed.

Moreover, he declined to refer the patient to a gastroenterologist.

Finally, the Court found that Doctor #1’s conduct discouraged the patient from following up on his recurrent health problem of rectal bleeding with Doctor #2.

The patient never complained of rectal pain or raised the issue with Doctor #2. Given that the cancer was at Stage IV at the time the patient saw Doctor #2, Doctor #2 was not found to be liable.


Follow Up on Diagnostic Testing and Referrals

Referral to Specialists and Diagnostic Testing

  • A physician who makes a referral to another health professional must:
    • discuss the purpose of the referral with the patient and confirm the patient’s agreement;
    • inform the patient about any fees that may not be covered by the Alberta Health Care Insurance Plan if aware such fees are likely to be charged;
    • evaluate and workup the patient within the regulated member’s scope of practice, including performing appropriate investigations; and
    • make a timely, written request for consultation that includes the following information:
      • patient’s name, Personal Health Number and contact information;
      • regulated member’s name and contact information;
      • name and contact information of the consultant or consulting service;
      • date of referral;
      • purpose of the referral, including but not limited to specifying if the referral is solely for the purpose of a third-party request;
      • pertinent clinical information, including but not limited to relevant investigation results; and
    • expected consultation outcomes (e.g., medical opinion only, possible transfer of care, other).
    • A regulated member who refers a patient for an urgent and/or emergent consultation must:
      • contact the consultant or emergency service directly to discuss the referral and provide pertinent clinical information; and
      • to the extent possible, provide relevant documentation.
    • Same relevant information should be provided as appropriate on a referral for diagnostic imaging or other diagnostic testing
  • CPSA Standards of Practice: Referral Consultation and Transfer of Care

Follow-up on Diagnostic Testing and Referral

  • A physician who orders a diagnostic test or makes a referral to another health professional must:
    • have a system in place for timely review of test results or consultations and arrangements for follow-up care when necessary,
    • have a system in place to contact the patient when follow-up care is necessary,
    • document all contacts and attempts to contact the patients, and
    • make arrangements for responding to “critical” diagnostic test results reported by a laboratory or imaging facility for urgent attention after regular working hours or in the absence of the ordering physician.
  • Provide for continuous after-hours care and inform patients how to access that care
  • A physician who orders a diagnostic test, and directs a copy of the result to another physician, remains responsible for any follow-up care required unless the physician to whom a copy is directed has agreed to accept responsibility for follow-up care.
  • CPSA Standards of Practice: Continuity of Care

Case Study: Failure to Refer and Follow Up

Patient underwent surgery for carpal tunnel syndrome in right hand.

Before surgery, the patient visited her family physician for second opinion.

Following surgery, the patient complained of extreme pain and the Doctor advised the patient to start motion exercises. However, the chart did not indicate that the Doctor had sent patient to physiotherapy until four months after surgery.

Approximately six months after the surgery, the Doctor advised the patient to return to the surgeon as the report indicated that surgery was not successful.

Nine months after the surgery, the patient saw a specialist who made a diagnosis of chronic debilitating condition and made arrangements for further surgery.

Verdict?

The Court found that the Doctor breached the standard of care once it was observed that the patient was not recovering as expected by failing to refer her promptly to a surgeon or a neurologist who would have been better able to diagnose the cause of her continued pain and limited mobility.

The Court also found that the Doctor breached the standard of care by failing to effectively advise the patient to maintain active use of the hand notwithstanding the pain, that the physiotherapist could assist her with this and for failing to follow up on the advice he did give her in this regard.


Drug Interactions

CPSA Standards of Practice: Drug Interactions and Prescribing

Pharmacist Standards of Practice

  • STANDARD 6:
  • Each time a pharmacist or a pharmacy technician dispenses a Schedule 1 drug or blood product pursuant to a prescription:
  • a) the pharmacist must determine that the prescription is appropriate; and
  • b) the pharmacist or the pharmacy technician must determine that the prescription is current, authentic, and complete.

Case Study: Drug Interaction

Patient was being treated for pulmonary disease and had been under treatment after having a blood clot. Despite this, patient was prescribed Biaxin while already on Warfarin notwithstanding that there is a known interaction between the drugs that can cause increased bleeding.

The patient suffered a fatal hemorrhagic stroke.

Verdict?

The plaintiffs alleged that the Doctor failed to meet the requisite standard of care by failing to warn of the potential interactions, including an increased bleeding risk, between Biaxin and Warfarin and by failing to instruct him to have his INR checked more frequently.

While there was some discrepancy amongst the experts, our expert was of the opinion the Doctor had a duty to advise the patient to watch for signs of bruising, bleeding etc and to repeat his INR in 2-5 days.

Case settled.

The bulk of the exposure clearly rested with the Doctor, some risk did exist for the pharmacy and its pharmacists given the fact there was no documentation with respect to the counselling provided to the patient regarding the potential drug interaction and the pharmacists did not follow up with the Doctor to confirm the Biaxin prescription in light of the potential interaction (as had been done by another pharmacy previously when Biaxin had been prescribed to the patient).

Case Study: Drug Prescription

Family Doctor prescribed Gentamicin to patient for 14 days for a UTI until the patient was admitted to the hospital for prostate surgery. After surgery the Gentamicin is stopped.

The patient saw his Family Doctor with problems of inability to stand or walk and Family Doctor admits the patient to hospital.  Notwithstanding these symptoms the Family Doctor prescribes Gentamicin for a second period.

The patient sees a second physician, who advised the Family Doctor to stop the drug after receiving it for 4 days.

Two known side effects of the drug were kidney damage and inner ear damage leading to impairment of balance. Testing during both drug use periods showed evidence of kidney impairment.

The patient brought an action in negligence for prescribing the drug for both time periods, without disclosing the risk of permanent impairment.

Verdict?

Action was allowed. The patient’s condition was caused by the administration of the drug.

The Doctor was not negligent for the initial administration of the drug. During the first period, the Doctor adequately monitored the drug for any signs of side effects in accordance with the standard required of the average general practitioner. Reasonable patient would have consented to administration of the drug in the first period.

However, the Court found that the Doctor was negligent in prescribing and administering the drug in the second period. The patient’s complaint of loss of balance was not similar to his prior urinary tract complaint. The Doctor should have diagnosed on this visit that the patient was suffering from induced ototoxicity.

Prior to starting the patient on the drug again, he should have conducted a number of tests which would have alerted him to the possibility that the patient was suffering from something other than a urinary tract infection. It was also reasonable for the Doctor to have sought the advice of a specialist before administering the drug the second time.

A reasonable patient adequately informed of the risks would not have agreed to the second administration of the drug.


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