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Dr Sanjay De Bakshi MS; FRCS (Eng; Edin{ad eundem}) Head of Division of General and GI surgery CMRI; C K Birla Hospitals. International Surgical Advisor & Examiner Royal College of Surgeons of Edinburgh.

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Page 1: Dr Sanjay De Bakshi...•WHAT ARE THE OTHER BENEFITS OF THIS THERAPY? 0 10000 20000 30000 40000 50000 60000 . , , , . . • Dr. Sanjay De Bakshi

Dr Sanjay De Bakshi MS; FRCS (Eng; Edin{ad eundem}) Head of Division of General and GI surgery CMRI; C K Birla Hospitals. International Surgical Advisor & Examiner Royal College of Surgeons of Edinburgh.

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• Credit must go to the Parisian pathologist and clinician

• Auguste François Chomel (1788-1858).

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WRONG SIDE SURGERY

• On May 26 1995, Rajeswari Ayyappan, the 59-year-old mother of the Indian actress known as Sridevi, underwent surgery for a malignant tumor on the left side of her brain. The tumor, however, was left intact because her neurosurgeon took another patient's X-rays into the operating room and operated on the wrong side of Mrs. Ayyappan's brain.

• Mrs. Ayyappan was transferred to New York Hospital-Cornell Medical Center, where another surgeon removed the tumor.

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• A spokeswoman for Memorial Sloan-Kettering, Christine Westerman, said that the neurosurgeon, whom she would not identify, had lost surgical privileges and that the case had been referred to the New York State Department of Health.

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MEDICAL ERROR • Medical error has been defined as an

– unintended act (either of omission or commission) or one that does not achieve its intended outcome,

– the failure of a planned action to be completed as intended (an error of execution),

– the use of a wrong plan to achieve an aim (an error of planning), or

– a deviation from the process of care that may or may not cause harm to the patient.

Patient harm from medical error can occur at the individual or system level.

Makary Martin A, Daniel Michael. Medical error—the third leading cause of death in the US BMJ 2016; 353. Johns Hopkins; Baltimore

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• A young woman recovered well after a successful transplant operation.

• However, she was readmitted for non-specific complaints that were evaluated with extensive tests, some of which were unnecessary, including a pericardiocentesis.

• She was discharged but came back to the hospital days later with intra-abdominal haemorrhage and cardiopulmonary arrest.

• An autopsy revealed that the needle inserted during the pericardiocentesis grazed the liver causing a pseudoaneurysm that resulted in subsequent rupture and death.

• The death certificate listed the cause of death as cardiovascular.

Makary Martin A, Daniel Michael. Medical error—the third leading cause of death in the US BMJ 2016; 353. Johns Hopkins; Baltimore

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CASE HISTORY

• Mr X, a 56 year old gentleman referred to Dr Gawande for a bile duct injury to the Harvard Medical Center in a very critical condition with incipient liver failure.

• Admitted in ICU and treated aggressively.

• On the eleventh day when it was being planned to take him off the ventilator, started spiking temperature and went into fibrillation.

• Lines ALL changed, ALL came back infected.

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REALITY OF ICU CARE

• 4% of lines in ICU become infected.

• 80,000 line infections a year.

• 5% to 28% FATAL.

• After 10 days on a ventilator 6% develop an infection.

• Death occurs in 40% to 45%.

• 10% of patients develop an infection after Urinary catherisation in American ICUs.

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REALITY OF ICU CARE

• It is estimated that each patient in ICU requires some 178 daily tasks!!

• In a 20 bed ICU it means some 3560 procedures EVERY DAY, each one having a potentiality for going wrong.

Bhatia N. “Manual of ICU procedures” edited by Mohan Gurjar. J Anaesthesiol Clin Pharmacol 2018;34:426-7.

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SIZE OF THE PROBLEM

• Medical error is not included on death certificates or in rankings of cause of death.

• NO ICD CODE FOR MEDICAL ERROR.

Makary Martin A, Daniel Michael. Medical error—the third leading cause of death in the US BMJ 2016; 353. Johns Hopkins; Baltimore

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SCREAMING HEADLINES

E.T.

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MORE OF THE SAME

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A REALITY CHECK

• 30th October 1935, in Ohio.

• Model 299 being tested for the first time, stalled and crashed, killing two of five crew members.

• The problem was “pilot error”.

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PILOT’S CHECKLIST

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2001

• Critical Care specialist Peter Pronovost, decided to give the doctors checklist a try.

• Steps when putting in a central line-

1. Wash hands with soap. 2. Put on a mask, cap and

sterile gown. 3. Prep the skin with

chlorhexidine. 4. Sterile drapes. 5. Sterile dressing over the

insertion site.

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2002

• The ICU nurses were auithorized to stop the doctors if any step was skipped.

• The results were collected for one year.

• The 10 day line infection went from 11% to ZERO!!

• Saving 43 infections, 8 deaths &

• Two million dollars!!!!

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DETROIT

Administrators also involved in this exercise. Within 18 months the following were observed:-

Most hospitals cut their quarterly infection rate to 0%. These ‘poor” hospitals outperformed 90% of hospitals USA-wide. Saved an estimated $175,000,000/- in costs!!!! Saved an estimated 1500 lives!!!!

Sinai-Grace Hospital Detroit Receiving Hospital

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SURGICAL SAFETY CHECKLIST

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SURGICAL SAFETY CHECKLIST

• SURGICAL SAFETY CHECKLIST

• Nursing staff trained to do it.

• SENIOR LEVEL NURSE – who is not going to be intimidated by an indifferent “senior surgeon”.

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CONTROLLING HEALTHCARE INFECTIONS

HEALTHCARE INFECTIONS

PERVASIVE

PROGRAMS

EQUIPMENT

PATIENT CARE

CLEAN & SAFE

ENVIRONMENT

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WHAT ARE YOU FISHING FOR? WHAT IS YOUR HOSPITAL’S INFECTIVE

ORGANISM?

?

The Surgical Infection Society Guidelines 2002

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AN ADDITIONAL BURDEN

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INCIDENCE

• Nosocomial (hospital-acquired) infections are a serious problem worldwide.

• According to WHO, at any given time more than 1.4 million people worldwide suffer from infectious complications acquired in hospitals (WHO, 2002) .

• Added expenditure in excess of $4.5 billion.

• 90,000 deaths a year in the United States from Hospital acquired infections.

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INDIAN SCENARIO (%)

Mustafa et al 2004

30

Meh

ta H

IS

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INCIDENCE OF NOSOCOMIAL INFECTION

• Wound infection rates as high as 38.8%.

• Among other parameters the duration of pre-operative stay as a predictor was quite significant.

0

20

40

60

80

100

Indian Journal of Community Medicine; Nosocomial Infections and Hospital Procedures

P.S. Ganguly, et al. Vol. 25, No. 1 (2000-3)

J.N. Medical College Hospital, Aligarh.

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Mr P.P. 56yrs; Male. A Rickshaw-puller

PRESENTING SYMPTOMS.

• Pain in the right groin for 1 week

EXAMINATION

• Elongated lump RIF

CT SCAN & FNA

• Right sided psoas abscess

• Gm+ve cocci; AFB –ve

TREATMENT

• Initally DRAINED, Catherised in OT

• Ampicillin-cloxacillin – GREAT Response

7TH POST-OP DAY

• Hectic fever –urosepsis

• Now had E.coli sensitive ONLY to Carbapenems (x7days)

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0

10000

20000

30000

40000

50000

60000

70000

ECONOMICS OF THE EQUATION

APPROXIMATE COST OF A SEVEN DAY COURSE OF ANTIBIOTICS IN INR

GNIx7days= Rs 10,150

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TIME TO BACTERIAL RESISTANCE

DRUG YEAR INTRODUCED

YEARS TO 1st REPORT OF RESISTANCE

YEARS TO 25% HOSP RESISTANCE

YEARS TO 25% COMM RESISTANCE

PENICILLIN 1941 1-2 6 15-20

VANCOMYCIN 1956 40 ? ?

METHICILLIN 1961 <1 25-30 40-50

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WORLDWIDE DISTRIBUTION OF CTX-M ESBL

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WORLWIDE DISTRIBUTION OF METALLO-b LACTAMASES

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IMIPENEM • The probabilities of achieving a

bacteriostatic/bactericidal target (20/40% of the time above minimum inhibitory concentration for 24 h) in the intraperitoneal fluid using a regimen of 500 mg every 8 h against the

• Bacteroides fragilis group, 97.3/89.1 • Escherichia coli 98.8/97.2 and • Klebsiella species 100/98.2%,

respectively. • However, a regimen of 1,000 mg

every 8 h was needed to achieve 96.7/89.3% against Pseudomonas aeruginosa.

• Ikawa K et al.Chemotherapy. 2008 Feb 27;54(2):131-139

CEFEPIME • The probabilities of attaining the

pharmacodynamic target (65% of the time above the MIC) were 92-99% in plasma (90% fraction unbound) and 93-100% in PF against Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae with a regimen of 1 g every 12 h.

• However, 1 g every 8 h or 2 g every 12 h was required for values of 94-95% in plasma and 95-96% in PF against Pseudomonas aeruginosa.

• Ikawa K et al. Int J Antimicrob Agents. 2007 Sep;30(3):270-3. Epub 2007 Jun 22.

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The basis of microbial resistance to antibiotics

RESISTANCE TO ANTIBIOTICS

INHERENT RESISTANCE

ACQUIRED RESISTANCE

Vertical evolution

DARWINIAN EVOLUTION

Horizontal evolution

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VERTICAL EVOLUTION- DARWINIAN THEORY

• Susceptible bacteria can acquire resistance to an antimicrobial agent via new mutations or selection.

1. Altering the target protein to which the antibacterial agent binds by modifying or eliminating the binding site.

2. Upregulating the production of enzymes that inactivate the antimicrobial agent.

3. Downregulating or altering an outer membrane protein channel that the drug requires for cell entry.

4. Upregulating pumps that expel the drug from the cell

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VERTICAL EVOLUTION- DARWINIAN THEORY

• Susceptible bacteria can acquire resistance to an antimicrobial agent via new mutations or selection.

1. Altering the target protein to which the antibacterial agent binds by modifying or eliminating the binding site.

2. Upregulating the production of enzymes that inactivate the antimicrobial agent.

3. Downregulating or altering an outer membrane protein channel that the drug requires for cell entry.

4. Upregulating pumps that expel the drug from the cell

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VERTICAL EVOLUTION- DARWINIAN THEORY

• Susceptible bacteria can acquire resistance to an antimicrobial agent via new mutations or selection.

1. Altering the target protein to which the antibacterial agent binds by modifying or eliminating the binding site.

2. Upregulating the production of enzymes that inactivate the antimicrobial agent.

3. Downregulating or altering an outer membrane protein channel that the drug requires for cell entry.

4. Upregulating pumps that expel the drug from the cell

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VERTICAL EVOLUTION- DARWINIAN THEORY

• Susceptible bacteria can acquire resistance to an antimicrobial agent via new mutations or selection.

1. Altering the target protein to which the antibacterial agent binds by modifying or eliminating the binding site.

2. Upregulating the production of enzymes that inactivate the antimicrobial agent.

3. Downregulating or altering an outer membrane protein channel that the drug requires for cell entry.

4. Upregulating pumps that expel the drug from the cell

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Horizontal Evolution

• We as Health Care Workers are often responsible for “Horizontal Evolution”.

• It is also very true that - We can also “Make a Lot of Difference” to the Horizontal Evolution Process.

HORIZONTAL

EVOLUTION

CONJUGATION

TRANSFORMATION

TRANSDUCTION

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Horizontal Evolution by CONJUGATION

• During conjugation, a gram-negative bacterium transfers plasmid-containing resistance genes to an adjacent bacterium, often via an elongated proteinaceous structure termed a pilus, which joins the two organisms.

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Horizontal Evolution by TRANSFORMATION

• Transformation is the process whereby bacteria acquire and incorporate DNA segments from other bacteria that have released their DNA complement into the environment after cell lysis

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Horizontal Evolution by TRANSDUCTION

• During transduction, resistance genes are transferred from 1 bacterium to another via bacteriophage (bacterial viruses).

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Pathophysiology

• Within hours of admission, colonies of hospital strains of bacteria develop in the patient's skin, respiratory tract, and genitourinary tract.

• Risks factors for the invasion of colonizing pathogens can be categorized into 3 areas: iatrogenic, organizational, and patient related.

Risks Factors

Iatrogenic Organizational Patient related

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Risks Factors

Iatrogenic Organizational Patient related

Pathogens that are present on

1. medical personnel’s hands,

2. invasive procedures (eg, intubation, indwelling vascular lines, urine catheterization), and

3. antibiotic use and prophylaxis.

1. Contaminated air-conditioning systems,

2. Contaminated water systems, and

3. Staffing and physical layout of the facility (eg, nurse-to-patient ratio, open beds close together).

1. Severity of illness,

2. Underlying immunocompromised state, and

3. Length of stay.

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• Contact with health care system.

a. None

b. Medium < 5 years

c. Prolonged > 5 years

• Antibiotic treatment.

• Patient characteristic.

a. None

b. Old age

c. Immunosuppressed patient

Mazuki J E et al

Surgical Infections.

Volume 3, Number 3, 2002

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SO WHAT CAN BE DONE?

DE-ESCALATION THEORY

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DE-ESCALATION THEORY

1. SEND CULTURE.

2. HIT HARD -- IN ANTICIPATED TREATMENT.

3. STEP DOWN TO APPROPIATE ANTIBIOTICS WHEN CULTURE REPORTS AVAILABLE.

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DE-ESCALATION THEORY

• WILL MY PATIENT CONTINUE TO HARBOUR SEPSIS?

• WILL IT HARM MY PATIENT?

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GUIDE - guideline-treated versus National Nosocomial Infectious Surveillance (NNIS)

Guy W. Soo Hoo, MD, MPH;

West Los Angeles Healthcare Center

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DE-ESCALATION THEORY

• WON’T THE BACTERIA THEN DEVELOP RESISTANCE TO THE ANTIBIOTICS USED?

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INCIDENCE OF RESISTANCE TO IMIPENEM WITH DE-ESCALATION THERAPY

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DE-ESCALATION THEORY

• WHAT ARE THE OTHER BENEFITS OF THIS THERAPY?

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0

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NEO-ECONOMICS OF THE EQUATION

APPROXIMATE COST OF A SEVEN DAY COURSE OF ANTIBIOTICS IN INR

GNIx7days= Rs 10,150

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ANTIBIOTIC PROPHYLAXIS FOR SURGERY

1. Antibiotics alone are unable to prevent surgical site infections. Strategies to prevent surgical site infections should always include attention to: • Strategies including correct and compliant hand hygiene

practices

• Meticulous surgical techniques and minimization of tissue trauma

• Hospital and operating room environments

• Instrument sterilization processes

• Perioperative optimization of patient risk factors

• Perioperative temperature, fluid and oxygenation management

• Targeted glycemic control

• Appropriate management of surgical wounds

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ANTIBIOTIC PROPHYLAXIS FOR SURGERY

2. Antibiotic prophylaxis should be administered for operative procedures that have a high rate of postoperative surgical site infection, or when foreign materials are implanted.

3. Antibiotic given as prophylaxis should be effective against the aerobic and anaerobic pathogens most likely to contaminate the surgical site i.e., Gram-positive skin commensals or normal flora colonizing the incised mucosae

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ANTIBIOTIC PROPHYLAXIS FOR SURGERY

4. Antibiotic prophylaxis should be administered within 120 minutes prior to the incision. However, administration of the first dose of antibiotics beginning within 30- 60 minutes before surgical incision is recommended for most antibiotics (e.g. Cefazolin), to ensure adequate serum and tissue concentrations during the period of potential contamination. Obese patients ≥ 120 kg require higher doses of antibiotic.

5. A single dose is generally sufficient. Additional antibiotic doses should be administered intraoperatively for procedures >2-4 hours (typically where duration exceeds 2 half-lives of the antibiotic) or with associated significant blood loss (>1.5L)

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ANTIBIOTIC PROPHYLAXIS FOR SURGERY

6. There is no evidence to support the use of post-operative antibiotic prophylaxis.

7. Each institution is encouraged to develop guidelines for the proper surgical prophylaxis.

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CASE CAPSULE

• A 16 year old boy with leukaemia was receiving chemotherapy with intravenous vincristine and intrathecal methotrexate after a relapse. A lumbar puncture was performed and a junior doctor passed two syringes to his colleague.

• The contents of both syringes were injected intrathecally without being checked. It was subsequently realised that the patient had been given intrathecal vincristine, and an attempt was made to lavage the theca through a cisternal needle. This punctured the brain stem and the boy died.

• The two doctors were convicted of manslaughter. At the trial the judge said, “You are far from being bad men. You are good men who . . . were guilty of a momentary recklessness.” The conviction was quashed on appeal because the trial judge had not directed the jury to consider whether each doctor was grossly negligent, taking into account the possible excuses and mitigating circumstances.

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DEFINITION of MEDICATION ERRORS • The United States National Coordinating Council for Medication

Error Reporting and Prevention defines a medication error as: • “any preventable event that may cause or lead to inappropriate

medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to – professional practice, – health care products, – procedures, and – systems, including

• prescribing, • order communication, • product labelling, • packaging, and

– nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use”

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Factors associated with health care

professionals • Lack of therapeutic training

• Inadequate drug knowledge and experience

• Inadequate knowledge of the patient

• Inadequate perception of risk

• Overworked or fatigued health care professionals

• Physical and emotional health issues

• Poor communication between health care professional and with patients

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Factors associated with patients

• Patient characteristics (e.g., personality, literacy and language barriers)

• Complexity of clinical case, including multiple health conditions, polypharmacy and high-risk medications

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Factors associated with the work

environment

• Workload and time pressures

• Distractions and interruptions (by both primary care staff and patients)

• Lack of standardized protocols and procedures

• Insufficient resources

• Issues with the physical work environment (e.g., lighting, temperature and ventilation)

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Factors associated with medicines

• Naming of medicines

• Labelling and packaging

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Factors associated with tasks

• Repetitive systems for ordering, processing and authorization

• Patient monitoring (dependent on practice, patient, other health care settings, prescriber)

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Factors associated with computerized information systems

• Difficult processes for generating first prescriptions (e.g. drug pick lists, default dose regimens and missed alerts)

• Difficult processes for generating correct repeat

• prescriptions

• Lack of accuracy of patient records

• Inadequate design that allows for human error

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Primary-secondary care interface

• Limited quality of communication with secondary care

• Little justification of secondary care recommendations

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Practical next steps

1. Educating health care providers and patients • Educating primary care providers about common

causes of medication errors; • Providing simple tools to assist primary care

providers in safe medication prescribing and use process;

• Considering how patients can be actively involved in medicine management;

• Providing patient engagement tools to address non-adherence.

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Practical next steps

2. Implementing medication reviews and reconciliation

• Ensuring that pharmacists actively review prescriptions;

• Encouraging and supporting use of medication reconciliation by clinicians.

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Practical next steps

3. Using computerized systems

• Strengthening electronic prescribing and alert systems. Computerized provider order entry with decision support may be particularly effective when targeted at a limited number of potentially inappropriate medications and when designed to reduce the alert burden by focusing on clinically-relevant warnings.

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Practical next steps 4. Prioritizing areas for quick wins

• Target use of injections as a key source of errors;

• Target interventions related to the care of children and the elderly;

• Implement multicomponent interventions with a mix of education, health informatics, medication reviews and involvement of community pharmacists;

• Consider specialist outpatient clinics for the prescription of selected medications that require routine monitoring, such as warfarin;

• Conduct further research on medication errors to develop a better understanding of the causes, generate evidence for interventions impacting on adverse outcomes, and to help bridge knowledge gaps in low- and middle-income countries on injection use and the specificities of the paediatric population.

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FUTURE SHOCK SYNDROME

• “Millions of ordinary, psychologically normal people will come into an abrupt collision with the future.”

Alvin Toffler - 1970

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If the entire 5 million years is divided into 62 year lifetime periods, the maximum change occurred in

the last 4 and the fastest in the LAST!!!!

0

200

400

600

800

SPEED OF CHANGE

LIFETIMES @ 62 years

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REMEMBER THE

ANGELCHIK

A new surgical procedure

for the treatment of

gastroesophageal reflux

and hiatal hernia.

Angelchik JP, Cohen R.

Surg Gynecol Obstet. 1979 Feb;148(2):246-8

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Treatment of symptomatic gastroesophageal reflux using the Angelchik prosthesis.

The Angelchik prosthesis in this series has been safe, simple, and reproducible, and can eliminate the symptoms and signs of gastroesophageal reflux.

Ann Surg. 1982 Jun;195(6):686-91 Starling JR, Reichelderfer MO, Pellett JR, Belzer FO.

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Angelchik prosthesis revisited.

Varshney S, Kelly JJ, Branagan G, Somers SS, Kelly JM.

World J Surg. 2002 Jan;26(1):129-33.

Between October 1983 and January 1994, 65 patients (45 men and 20 women)

aged between 29 and 84 years (mean 52 years) had an AP inserted for

gastro-oesophageal reflux (GOR) with or without hiatus hernia (HH).

0%

5%

10%

15%

20% 15%

12%

17% 20%

8%

COMPLICATIONS

Removal

Tr Dysphagia

Perm dysphagia

Distal slip

Prox slip

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RESULTS

53%

20% 20%

7%

0%

10%

20%

30%

40%

50%

60%

I II III IV

VISICK GRADING

In view of poor long-term results and high incidence of complications as compared to other conventional operations for GOR, we cannot recommend the continued use of the AP

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MISSION ASI 2019

• Enhancing Safety of Patients

– Reduce Hospital Acquired infections

– Reduce Complications in Surgery

– Reduce Medication Errors

– Reduce Antibiotic Misuse

– Enhance Patient Satisfaction

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What makes an Excellent Surgeon?

Sir Barry Jackson was the Serjeant Surgeon to the Queen from 1991 to 2001 and President of The Royal College of Surgeons of England from 1998 to 2001.

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What makes an Excellent Surgeon? 1. Very good technical skill. 2. First-class judgement. 3. One who knows when not to operate. 4. Calmness of the mind and bearing in an emergency. 5. Humility and moral courage, by the need to call for

further skilled assistance when faced with an emergency.

6. Team working. 7. Critical analysis of one’s personal outcomes should be

second nature throughout a surgeon’s career. 8. Need to be able to adapt to the new and learn

continuously. 9. Communication skills are vitally important. 10. Golden Rule, “do unto others as you would have done

unto yourself”.

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ASI GUIDELINES

• ASI Whitepaper on Guidelines for Emergency Management of Surgical Conditions under the aegis of the Department of Health and Family Welfare. Govt of India.

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Makings of an Excellent Professional

• Years of training and support helps- when situations go beyond the book.

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“SULLY” - MIRACLE ON HUDSON Makings of an Excellent Professional

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PRIMUM NON NOCERE • “Every surgeon carries within

himself a small cemetery, where from time to time he goes to pray – a place of bitterness and regret, where he must look for an explanation for his failures.’

• René Leriche, La philosophie de la chirurgie, 1951”