Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System
Abstract
:1. Introduction
1.1. Adverse Effects in CM
1.2. CM in the Tuscan Regional Healthcare System
1.3. Drug Surveillance in the Region of Tuscany
2. Aims
3. Materials and Methods
3.1. Significant Event Audit (SEA)
3.2. The Application of FMEA to Complementary Medicine Clinics
- (1)
- Selection of the significant process to be analysed;
- (2)
- Organization of a multidisciplinary group of experts;
- (3)
- Description of the different phases of the process;
- (4)
- Identification of FMs for each step of the process (i.e., anything that could go wrong, including rare and minor problems);
- (5)
- Definition of a numerical value (on a scale from 1 to 10) for frequency of the event, potential serious consequences, and probability that the healthcare providers will identify the failure. The Risk Priority Number (RPN) defined for each method of failure identified will help estimate the frequency, severity and detectability of the FMs (Table 3);
- (6)
- For each FM, calculation of the Risk Priority Number (RPN) considering on a scale from 0 to 10 the severity (S) of the effects, the possible occurrence (O) of the cause, and the likelihood of detection (D) of the cause: PRN = O × S × D;
- (7)
- Use of the results of PRN calculation (from 0 to 1000) to prioritise the improvement actions aimed at preventing the FMs.
4. Results
4.1. SEA in Homeopathic Practice
4.2. FMEA Application in the TCM Centre “Fior di Prugna”
- ◦
- activities and operators involved in these phases;
- ◦
- problems and criticalities that might arise during the activities;
- ◦
- main causes of such problems;
- ◦
- impact of these problems on the health of the patient and on the efficacy of the service and treatment.
- A long waiting list due to the high number of requests, causing delayed treatment (especially for those conditions where acupuncture is the first choice). This is due mainly to high demand; the consequence was a higher risk of aggravation of the disease and unsuccessful treatment, with loss of credibility of the healthcare service.
- Error in the diagnostic approach in the “energetic diagnosis” due to lack of knowledge, or the high complexity of the disease.
- Errors in the execution of the treatment by the health professional, and patient stress or hypersensitivity, which lead to a higher risk of leaving needles in situ, errors in needle insertion, application of contraindicated methods, possible infection in the case of accidental puncture, damage from erroneous puncture, and the occurrence of biliary or renal colic.
- Finally, there is excessive relaxation of the patient after the session of acupuncture and Chinese massage, and thus there is a higher risk of accident if the patient leaves the clinic immediately, driving for instance a car without waiting for the necessary rest time. To reduce this type of risk, an adequate time of rest (at least 20 min) must be considered and a dedicated room after the acupuncture session is required.
5. Discussion
6. Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
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TERMS | CONCEPTS |
---|---|
Adverse drug reaction (ADR) | A harmful effect suspected to be caused by a drug. The term is properly reserved for late-stage analysis when the association between a medicine and an adverse effect has moved beyond ‘unmeasurable’ or ‘uncertain’ |
Adverse effect | A negative or harmful patient outcome that seems to be associated with treatment, including total ineffectiveness |
Adverse event | Any negative or harmful occurrence that takes place during the process of care and that may or not be associated with a medicine. |
Benefit | (a) positive therapeutic effects of treatment in an individual; (b) positive health, social or psychological effects of treatment from the patient’s perspective. |
Benefit-risk or more accurately, benefit-harm | A description of positive and negative effects of a medicine and the likelihood of their occurrence, as far as they are known, as perceived by an individual. |
Harm | The damage or injury that is or might be caused by a medicine, including death. The concept extends to social and psychological damage, especially from the patient’s perspective. |
Hazard | The intrinsic chemical or biological characteristics of a medicine or its use that could cause harm. |
Individual case safety report (ICSR) | Reports sent by health professionals or patients when an adverse effect has occurred in a patient taking one or more medicines. See also Pharmacovigilance reporting systems. |
Risk | The statistical probability of harm being caused. |
Serious | An adverse event or reaction that results in death; requires hospitalization or extension of hospital stay; results in persistent or significant disability or incapacity; is life-threatening. |
Side-effect | Any unintended outcome that seems to be associated with treatment, including negative or positive effects. |
Pharmacovigilance reporting systems | The core data-generating system of pharmacovigilance, relying on healthcare professionals and patients to identify and report any suspected adverse effects from medicines to their local or national pharmacovigilance centre or to the manufacturer. |
Factor Types | Contributory Inluencing Factors |
---|---|
Patients Factors | Condition (complexity and seriousness) Language and communication Personality and social factors |
Task and Technology Factors | Task design and clarity of structure Availability and use of protocols Availability and accuracy of test results |
Individual (staff) Factors | Knowledge and skills Competence Physical and mental health |
Team Factors | Verbal communication Written communication Supervision and seeking help Team structure (congruence, consistency, leadership, etc.) |
Environmental Work Factors | Staffing levels and skills mix Workload and shift patterns Design, availability and maintenance of equipment Administrative and managerial support Environment Physical |
Organizational and Management Factors | Financial resources and constrains Organizational structure Policy, standard and goals Safety culture and priorities |
Institutional Context Factors | Economic and regulatory context National health service executive Links with external organization |
Scale | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Occurrence | Never occurring | Always occurring | ||||||||||
Severity | No severity | Catastrophic | ||||||||||
Detection | Immediately detectable | Undetectable |
Care Delivery Problems | Contributory Factors | Recommendations for Prevention |
---|---|---|
Case 1—Newspaper | ||
The CM treatment was initiated early given the patient’s condition (failure to prevent deterioration) | Excessive confidence in a good doctor–patient relationship (patient CF) Underestimation or confusion/clinical error with respect to homeopathic aggravation and progression of the disease, as well as possible adverse events (individual CF) | Perform a risk–benefit evaluation before the decision to prescribe CM and share a strategy to prevent the risks of deterioration with the patient or the family. |
Case 2—Newspaper | ||
The doctor accepted the patients’ request to remove potential “life-saving” measures, but not well tolerated therapies (medication substitution) | Excessive trust in patients’ statements (individual CF) Lack of patient follow-up (task CF) Lack of communication with all the members of the family (individual CF) | Perform a risk–benefit evaluation before the decision to substitute an ordinary medication with CM and share with the patient AND the family a strategy to prevent deterioration |
Case 3—Newspaper | ||
The non-medical professional prescribed “alternative drugs”, eliminating conventional drugs in too short a time (medication substitution) | Insufficient professional training and authorization, either for conventional or unconventional treatments (institutional CF) | Prevent referrals to non-medical professionals. Patient and family education and counselling on treatment options |
Case 4—Personal Report | ||
The patient started homeopathic treatment at an inappropriate time: e.g., before the summer, during the holiday period (timing of CM treatment). | Lack of appropriate, specific, informed consent signed by the patient. (organizational CF) Limited availability, or difficulty in finding the homeopathic physician outside the working hours (organizational CF) | Consider service availability when prescribing CM and plan continuous follow-up, including patient advice to refer to a clinic in case of deterioration |
Case 5—Record Review and Personal Report | ||
The doctor performed the erroneous clinical evaluation of an acute illness by telephone. The doctor accepted the patients’ request to avoid particularly invasive diagnostic tests (diagnostic performance) | Limited guarantee of the effects of homeopathy practice on a particular disease, or unawareness of the risks of certain diseases (individual CF) Excessively rigid application of the homeopathic protocol (task CF) | Perform a general clinical assessment of patient conditions before initiating a CM treatment and provide follow-up visits or referral to the relevant specialists to diagnose and treat different diseases |
Case 6—Record Review and Personal Report | ||
The patient was not aware of the risks of dangerous interactions between her medications and herbal products (patient education) | Lack of a system of professional consultation and support both on the part of CM doctors and of conventional medicine specialists (institutional CF) | Provide medical doctors and patients with education and counselling on CM as isolated or integrated treatments to prevent dangerous interactions |
Activity | Actors | Failure modes | Causes | Possible Effects | O | S | D | PRN |
---|---|---|---|---|---|---|---|---|
Booking a medical examination | ||||||||
Booking a medical examination through the Central Booking Office (CBO) (normal procedure) | Patients; CUP operators | Many problems in booking a medical examination. The CUP schedules an appointment even if the condition is not treated by the FdP * (no selection) | High demand, reduced operator availability. Poorly informed CBO operators | Delayed treatment (especially for conditions where acupuncture is the first choice). Unsuccessful treatment. Loss of credibility of the healthcare service | 8 | 5 | 2 | 80 |
Energetic diagnosis | ||||||||
Energetic diagnosis | Medical doctor and physiotherapist | Error in the diagnostic approach | Lack of knowledge, complex disease | Unsuccessful treatment, complex disease | 3 | 5 | 4 | 60 |
Treatment execution | ||||||||
Treatment execution | Medical doctor and physiotherapist | Intolerance of the patient to some methods, onset of undesirable side-effects, possibility of the health professional to get pricked or to leave needles in situ, error in needle insertion, application of a contraindicated method | Patient hypersensitivity, lack of time, health professional tiredness | Health professional and patient stress, infection in the case of accidental puncture, damage from erroneous puncture, occurrence of biliary or renal colic | 5 | 4 | 3 | 60 |
End of the treatment | ||||||||
Treatment execution | Medical doctor and physiotherapist | Excessive relaxation of the patient after the treatment. | After the treatment, the patient is immediately dismissed without waiting for a necessary rest time | A higher risk of accident if the patient leaves the clinic immediately, using a car or a bike for instance. | 8 | 3 | 2 | 48 |
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Rossi, E.G.; Bellandi, T.; Picchi, M.; Baccetti, S.; Monechi, M.V.; Vuono, C.; Sabatini, F.; Traversi, A.; Di Stefano, M.; Firenzuoli, F.; et al. Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System. Medicines 2017, 4, 93. https://doi.org/10.3390/medicines4040093
Rossi EG, Bellandi T, Picchi M, Baccetti S, Monechi MV, Vuono C, Sabatini F, Traversi A, Di Stefano M, Firenzuoli F, et al. Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System. Medicines. 2017; 4(4):93. https://doi.org/10.3390/medicines4040093
Chicago/Turabian StyleRossi, Elio G., Tommaso Bellandi, Marco Picchi, Sonia Baccetti, Maria Valeria Monechi, Catia Vuono, Federica Sabatini, Antonella Traversi, Mariella Di Stefano, Fabio Firenzuoli, and et al. 2017. "Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System" Medicines 4, no. 4: 93. https://doi.org/10.3390/medicines4040093