RISK MANAGEMENT ISSUES IN POSTMENOPAUSAL HEALTH CARE

Aboubakr elnashar Benha University Hospital, Egypt

Aboubakr Elnashar

Outline

•Risk management (RM) •Postmenopausal health care (PMHC) •RM in PMHC: What could go wrong in PMHC? How can risk be reduced?

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Risk Management

(RM)

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Back ground

•Preventable errors in medical practice are frequent:

Much patient harm

Cost a tremendous amount of money.

•How

To protect doctors& hospitals from claims?

To immprove quality of care?.

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Managing Risk Definition •A process for improving the safety& quality of care through reporting, analyzing& learning from adverse incidents involving patients.

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Misconceptions I. RM is not primarily about avoiding or mitigating claims

It is a tool for improving the quality of care. II. RM is not simply the reporting of patient safety incidents. Incident reporting is on the reactive side of RM. Minimising the occurrence of patient safety incidents is the Proactive side, E.g. instead of ‘fire fighting’ after things have gone wrong, a scenario training (‘fire drill’) III. RM is not the business of service managers

It is the business of all stakeholders in the organisation, clinicians& nonclinicians.

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Basic Questions I. Risk Identification: What could go wrong?

II. Risk Analysis: What are the chances of going wrong

and what would be the impact?

III. Risk Treatment: What can we do to minimize

chances of happening or mitigate damage when it has gone wrong?.

IV. Risk Control, sharing& learning: What can we

learn from things that have gone wrong ?.

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Application At any level of an organisation •Hospital, unit, department or Process. • Investigation, Treatment, Surgery

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Requirements for implementing a departmental RM program Leadership:

Team:

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RM process I. Risk identification Looking at what went wrong

•Analysis of patient safety incidents, including near misses= Root cause analysis Looking at what potentially could go wrong Identifying prospective risk= Failure Mode& Effects Analysis (FMEA).

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Sources

1. Risk assessment conducted in all clinical areas (wards,

clinics, theatre, delivery suite, day assessment unit, etc.)

2. Incident reporting

3. Complaints& claims

4. Staff consultation – workshops, surveys, interviews

5. Clinical audit:

a quality improvement process to improve patient care&

outcomes through

systematic review of care against explicit criteria& the

implementation of change

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Reporting Each unit should have a list of reporting incidents (trigger list) 1. Near miss: A potential for harm or error which is intercepted prior to the completion of the incident/ event resulting in no harm to the patient.

2. Incidents: Any event that has caused harm, or has the potential to harm

patient or visitor

Any events which involves malfunction or loss of equipment

property or any event which might lead to a complaint.

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3. Adverse events •An unintended injury or complication, which results in disability, death or prolonged hospital stay and caused by health care management rather than the disease process.

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4. Sentinel events A subset of adverse events, occurs independently of a patient condition. Reflects deficiency in hospital system One who watches or guards

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II. Risk analysis& evaluation •Risk score: By multiplying the severity of the incident by the likelihood of its occurrence. •All reported cases should be entered into a database {permit examination and to generate audits of recurring topics}. • Confidentiality • No blame culture based feed back to clinician. • The review group may introduce a filtering mechanism in order to reduce the number of cases for detailed appraisal • Assessment of cases is often restricted to whether or not the outcome was substandard, and whether or not contributed to the adverse out come.

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III. Risk treatment •Action planes: Elimination Substitution Reduction or Acceptance of the risk •Depend on: 1. Risk rating 2. Resource implications. 3. Culture.

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IV. Risk Control, sharing& learning: What can we learn from things that have gone wrong ?.

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Postmenopausal health care (PMHC)

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Management of menopause symptoms or HRT Preventive& therapeutic management of osteoporosis, other degenerative conditions, postmenopausal bleeding, urinary symptoms psychological wellbeing.

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•Unintended harm to patients may occur in the course of PMHC, and measures to ensure patient safety should be actively promoted. •The magnitude of threat to patient safety varies with the setting.

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•PMHC is delivered in a variety of settings: 1. General or special-interest clinics in general practice, 2. Community menopause clinics, 3. Hospital- based menopause clinics 4. General outpatient clinics. •Each centre should conduct its own risk assessment& have measures in place to contain risk.

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RM in PMHC

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I. What could go wrong in PMHC? Patient safety incidents& near misses may occur as a result of: 1. Error in diagnosis 2. Error in treatment 3. Failure of communication.

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1. Error in diagnosis

a. Inadequate medical history:

Full history before presceibing HRT e.g.

Symptoms may direct the physician to the climacteric, but

the possibility of an undiagnosed endocrine, CV, mental

health or other problem should be considered

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b. Misinterpretation of symptoms

E.g.

VMS& tiredness may be due to thyroid over- or

under-activity, respectively.

Mental illness may be misdiagnosed as a

perimenopausal phenomenon.

Self completed climacteric questionnaire:

facilitate history taking within time constraints,

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C. Failure to examine the patient. E.g. Routine examination of the breasts. Controversy. Breast examination should be performed only where

there is a clinical indication (The Committee on Safety of Medicines)

•Many clinicians feel it is safer to perform a routine examination of the breasts. •Breasts are not always examined when there is a clinical indication: delayed diagnosis.

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2. Error in treatment a. Failing to screen or treat an at-risk woman E.g. •With an intact uterus: E should not given alone This principle is not always followed: endometrial cancer (Rees & Purdie, 2006)

Contraception for the perimenopausal woman is not prescribed { Fertility rate is low, Age Medical conditions} The consequences of an unwanted pregnancy are profound.

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b. Inadequate monitoring of long term therapy •Not all postmenopausal are suitable for management in a general primary care facility •Referral to specialist at the appropriate time : Diabetes Previous breast cancer HRT with abnormal bleeding

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c. Inadequate follow-up arrangements. •More careful assessment with a pre-existing medical condition (Rees & Purdie, 2006)

•Refer to: breast disease, cardiology, rheumatology, haematology& urogynaecology

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3. Failure of communication

I. Between doctor& patient.

Consent: Vital in clinical practice Avoiding litigation.

Involving patients in their care Facilitated by the provision of oral& written information for patients.

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Discussion Risks, benefits& alternatives of the intervention e.g. HRT Documented esp if controversy e.g. HRT with history of DVT or Breast ca Checklist

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Investigation e.g. cervical smear, mammogram or US. Ordered Follow up the results Inform the women

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II. Between doctors particularly when a woman is transferred from one doctor to another

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II. How can risk be reduced? Patient safety is enhanced by quality-oriented organization of menopause services.

I. Proactive identification & management of risk Prospectively identifying ‘red flags’

II. Incident reporting III. Clinical audit that assures optimal standards of

care. IV. Oral & written information to patients V. Good practice in relation to patient consent VI. Good documentation

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VII. Nominated guidelines & Care pathways Each unit should have

•The British Menopause Society has published care pathways for

menopause& osteoporosis (Rees & Purdie, 2006).

•Care should be standardized through EB guidelines& protocols

E.g.

HRT:

Risk assessment at commencement,

Follow-up visits.

Advice when there is uncertainty

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VIII. Education & training of the staff (Mander & Edozien, 1998)

•Quality standards in postmenopausal care (Gray , 2007)

•Stick to safe practice: Guidance from the General Medical Council (GMC, 2006) Medico legal pitfalls in prescribing HRT, 2006

•Safety alerts In 2006, an alert on hepatotoxicity associated with black cohosh, used to treat menopausal symptoms

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Conclusion

Patient safety incidents& near misses may occur as a result of: Error in diagnosis Error in treatment Failure of communication. A proactive approach to RM: Help reduce errors in diagnosis& treatment Facilitate communication Enhance patient safety.

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