Indian Journal of Anaesthesia  
About us | Editorial board | Search | Ahead of print | Current Issue | Past Issues | Instructions
Home | Login  | Users Online: 3935  Print this pageEmail this pageSmall font sizeDefault font sizeIncrease font size    




 
REVIEW ARTICLE
Year : 2008  |  Volume : 52  |  Issue : 4  |  Page : 373 Table of Contents     

Pharmacovigilance in Intensive Care Unit - An Overview


1 Senior Consultant, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
2 Professor & Ex Senior Consultant, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
3 Clinical Assistant, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
4 Senior Consultant and Chairperson, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
5 Senior Consultant and Chairperson, Department of Critical Care Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India

Date of Acceptance14-Mar-2008
Date of Web Publication19-Mar-2010

Correspondence Address:
Bimla Sharma
Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


Rights and PermissionsRights and Permissions
 

The drug related complications are on the rise warranting special attention towards patient safety in Intensive Care Unit (ICU) setup. Pharmacovigilance is the science about the detection, assessment and prevention of drug related problems. This review is aimed to highlight significant problems arising from medication errors with emphasis on special drugs used in ICU (oxygen, antibiotics, sedatives, analgesics and neuromuscular blocking drugs) and their risk reduction strategies in ICU utilizing practice of pharmacovigilance. Human error, lack of communication among various health providers, inadequate knowledge about drugs, failure to follow protocols or recommended guidelines are important causes of drug related problems in ICU. It is imperative that ICU administrators and medical directors of hospitals consider adverse drug events (ADEs) as system failures. Pharmacovigilance, an observational science is the need of the hour for patients admitted in ICUs. We need to give more emphasis on prevention rather than treating the potentially fatal complications arising from ADEs. Eternal vigilance is the key. Protocol based management, improvement of medication system, frequent audits, improved communication, good team work, a blame free environ­ment, inclusion of a pharmacist, leadership involvement and use of information technology in the ICU are possible solutions.

Keywords: Pharmacovigilance, Oxygen, Antimicrobial agents, Sedatives, Analgesics, Neuromuscular blocking agents, Medication errors in ICU.


How to cite this article:
Sharma B, Bhattacharya A, Gandhi R, Sood J, Rao B K. Pharmacovigilance in Intensive Care Unit - An Overview. Indian J Anaesth 2008;52:373

How to cite this URL:
Sharma B, Bhattacharya A, Gandhi R, Sood J, Rao B K. Pharmacovigilance in Intensive Care Unit - An Overview. Indian J Anaesth [serial online] 2008 [cited 2020 May 26];52:373. Available from: http://www.ijaweb.org/text.asp?2008/52/4/373/60651


   Introduction Top


Need for Pharmacovigilance in ICU

Intensive Care Units (ICUs) came into existence for patients with special needs and represent a mile­stone in the development of medicine. [1] The ICU envi­ronment is proactive, interventional, complicated, and hostile, making it prone to potential problems. [1] The chances of drug related complications are high here, requiring special attention towards patient safety. Pharmacovigilance, an observational science about drug safety is the study of the drug related injuries. [2] The WHO defines pharmacovigilance (WHO 2002) as the science and activities related to the detection, as­sessment, understanding and prevention of adverse ef­fects or any other drug-related problem. It helps us in warning or withdrawal of offending pharmaceutical product. The scope of pharmacovigilance has since been broadened to cover areas such as medical errors and medical devices.

An adverse event (AE) is an untoward medical occurrence, which may or may not have a causal rela­tionship with the treatment while medication errors, adverse drug events (ADEs) and adverse drug reac­tions (ADR) are related to the drug use. [3] ADE is de­fined as an injury resulting from medical intervention related to a drug. [4] It can be ameliorable or non­ameliorable. ADEs associated with medication error at any stage are considered preventable. Non-prevent­able ADEs are those not due to medication errors and are also known as ADRs. The International Confer­ence on Harmonisation defines ADR as any noxious unintended, and undesired effects of a drug, that occur at doses used in humans for prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function. [3] The objective of the practice of pharmacovigilance in ICU is to highlight:

A. Significant problems resulting from medication errors.

B. Various risk reduction strategies and their poten­tial impact on improving the patient outcome.

C. The research in the field of ADEs and medication errors in ICU.

This overview aims to underline the importance of pharmacovigilance in day-to-day practice in ICU set up. The critically ill and/or injured patients frequently need oxygen, antimicrobial agents, sedatives, analge­sics and neuromuscular blocking agents (NMBAs). Therefore, emphasis has been given to the problems associated with the sustained use of these drugs in ICUs. The current risk reduction strategies as a part of pharmacovigilance and their potential impact on im­proving patient outcome in the ICU is also delineated.

Data was obtained from peer-reviewed journals, textbooks, cross references, abstracts, conferences and symposia proceedings, expert informants, journal hand searching and Medline generated reference material (1970­2007) mainly in the English language. The keywords used for Medline search were pharmacovigilance, oxygen, an­timicrobial agents, sedatives, analgesics, neuromuscular blocking agents (NMBAs), medication errors and their risk reduction strategies in ICU.


   Magnitude of the problem Top


Medical injuries account for 44,000-98,000 deaths per year in the United States and over 7000 of the deaths are attributed to medication errors alone. [5] The data may be reported under various headings such as ADRs, ADEs, medication errors and adverse events (AEs). ADEs account for up to 7.5% of hospital ad­missions, 28% of all emergency department visits and 5% of hospital deaths. [6],[7],[8] In a comparative study of in­tensive care and general care units, Cullen et al. re­ported that the preventable and potential ADEs in ICUs to be nearly twice that of non-ICUs. [9] [Table 1] shows incidence of ADEs in ICUs by various authors. [9],[10],[11],[12],[13],[14],[15],[16]


   Epidemiology Top


The various factors contributing to ADEs and ne­cessitating the need for pharmacovigilance in an ICU are:


   A. Human error Top


Human error accounted for two thirds of ICU complications in one study while it was 73% in another study and 92% of these were avoidable. [17],[18] Other studies have concluded that errors are influenced by:

1. Staff characteristics: staff shortages, overwork, distractions, break in the continuity of the care, inexperienced staff, new residents, introduction of new medical techniques. [19],[20]

2. Communication breakdown among health pro­fessionals. [21],[22]

3. Errors by doctors: inappropriate indication, dos­ing and frequency of drug administration; choos­ing the wrong drug, prescribing incorrect dose and failure to recognize drug allergy in patients. [12],[21],[23]


   B. Co-morbidity and age Top


The patients most likely to experience ICU com­plications are at the extremes of age, the sick and pa­tients with two or more organ system failure. [24],[25] Length of stay, gender, altered renal and hepatic functions and drug exposure are other important factors affecting ADEs. [26],[27],[28] Children comprise a special group where the drug dosage has to be calculated on a weight basis and neonates, in particular, have limited room for er­rors. [29] Fortescue et al reported that medication errors occur at similar rates in paediatric age group as in adults but with thrice the potential to cause harm. [30] The rate of potential ADEs is significantly higher in neonates in the neonatal-ICUs. [30] Elderly patients experience higher incidence of ADEs because they are exposed to a greater number of medications, making them vulner­able to medication errors and drug interactions. The low therapeutic index of certain drugs narrows their safety margin in critically ill patients owing to altered pharmacodynamics and pharmacokinetic secondary to illness which may predispose to drug toxicity. [31]


   C. Drugs (number and class) Top


The potential for medication-related error in­creases as the average number of administered drugs increases. [32] Cullen et al, found that although ICU pa­tients had significantly higher rates of potential ADEs than non-ICU patients, after adjusting for the number of administered drugs, the rate was similar in both sec­tors. [9] Darchy reported that cardiovascular drugs ac­counted for 31%, anti-inflammatory and analgesics for 20% and antibiotics for 11% of ADRs. [33]


   D. Staging of errors in drug administration Top


Bates et al reported that preventable drug errors occurred in 28% of cases with physician ordering ac­counting for 56% and nurse administration for 34% cases. Dispensing (4%) and transcription (6%) errors resulted in a small fraction of preventable errors. [11] In another study, 57.9% of ADEs were avoidable and most of these were associated with inappropriate administration, drug-drug interactions, dosage error, drug not stopped despite the onset of ADEs. [34]


   Problems with commonly used drugs in ICU Top


Pharmacy accounts for about 10-23% of ICU budget, since ICU patients require more drugs than their non-ICU peers. [35] The drugs most likely to create prob­lems are oxygen, antibiotics, sedatives, analgesics and neuromuscular blocking agents. The implications of using these agents in ICUs are different from those seen in the immediate perioperative period. [36] The specific problems related to the drug are discussed with the drug itself, followed by discussion on the general pre­ventive measures.


   A. Oxygen Top


Oxygen is considered to be the commonest drug used in the ICU. There are indications, contraindications and certain guidelines for rational use of inhaled oxy­gen therapy. The efficacy of the inspired oxygen should be monitored to avoid its toxicity. [37] When oxygen is delivered to the airway in concentrations exceeding the usual 21%, the lung is the first organ to be exposed to it. When breathed in excess of 50-60% or for prolonged periods, secondary physiological changes and toxic effects can occur. There are only a few prospec­tive studies detailing this problem in ICU patients. [38],[39]

Pulmonary oxygen toxicity can present as ab­sorption atelectasis, tracheobronchitis, bronchopulmo­nary dysplasia, and acute respiratory distress syndrome (ARDS). The earliest adverse changes in pulmonary function or structure are; reduced oxygen-dependent respiratory drive (within minutes), substernal discom­fort from acute tracheobronchitis (up to four hours) secondary to breathing pure oxygen and decreased tra­cheal mucus velocity from consequent loss of ciliated epithelium. Moreover, an oxygen rich environment is a fire hazard. Extra pulmonary targets for O 2 toxicity in­clude:

Retina. Angiogenesis leading to reatrolental fibro­plasia occurs when a newborn is exposed to increased oxygen tension. Latest Cochrane Reviews do not pro­vide strong evidence for either the benefits or harms of early oxygen weaning in preterm/ low birth weight in­fants. [40] Future research and studies should be directed toward addressing the question of defining the most appropriate target levels of oxygenation in this particu­lar clinical setting.

Central nervous system: Hyperbaric oxygen therapy where pressure exceeds 200 kPa (2 atm) can result in CNS toxicity. Symptoms are seizures and vi­sual changes, which resolve when oxygen tension re­turns to normal values.


   B. Antimicrobial Agents Top


Majority of patients in ICU receive one or a com­bination of antimicrobial agents either empirically or based on evidence. The treating clinician should send cultures of blood and other body fluids before starting the drug therapy based on a presumptive bacteriologi­cal diagnosis. However, any empirical treatment has to be reevaluated after 48-72 hours. [41] Excessive use, misuse, inappropriate therapy and the development of re­sistance with antibiotics are global problems and add to the economic burden on health care system. Com­plying with current WHO or Centers for Disease Con­trol and Prevention (CDC) Hand Hygiene Guidelines are important tools to tackle the problems with antimi­crobial agents in an ICU. [42]


   1. Misuse and Excessive use Top


Inadequate treatment of nosocomial infections is associated with empiric use of certain antibiotics. [43] The other end of the spectrum is an overzealous and inap­propriate use of antimicrobials. Certain non-pharma­cological factors including cultural and economic fac­tors take the upper hand in dictating the antibiotic use. [44] According to the WHO report (2000) on infectious diseases, practicing physicians are the main culprits as the widespread use of antibiotics is of the major deter­minants in the shift toward resistant strains.


   2. Antimicrobial resistance Top


Antimicrobial resistance is several folds higher in ICU patients and the incidence of nosocomial infec­tions is high (25 to 33%) here. [41] However, resistance patterns vary widely among institutions, and make em­pirical choice of antibiotics increasingly problematic. Active surveillance programs, aggressive invasive di­agnostic techniques, use of agents in combination, anti­microbial cycling, follow up of practice guidelines and evaluation of the effectiveness of the practiced polices are some of the recommended measures for preven­tion of antibiotic resistance. [41],[45],[46],[47] The use of informa­tion technology can result in major reductions in the rate of complications associated with antibiotics, and can decrease costs and the rate of nosocomial infec­tions. [47]


   C. Sedatives and Analgesics Top


Anxiety, delirium, agitation and pain are common in ICU. Sun et al reported that in the surgical ICU, roughly 97% intubated patients and 92% nonintubated patients need analgesia and 87% patients are sedated with a benzodiazepine. [48] About 50% of seriously ill medical patients report pain. [49]

Benzodiazepines, praopofol, opioids, dexmed­etomidine, barbiturates, butyrophenones, clonidine, ha­loperidol and isoflurane have been utilized for sedation in ICU. Opioids like morphine and fentanyl and non­steroidal anti-inflammatory drugs (NSAIDs) with opioid sparing actions are the commonly used drugs for acute pain. Sedatives and narcotics may precipi­tate cardiovascular instability and respiratory depres­sion. Benzodiazepines should be administered intermit­tently rather than by continuous infusion as there is risk of accumulation and prolonged sedation with infusions. [50]

Continual monitoring of the respiratory rate and pattern may improve patient safety in those receiving neuraxial/ intravenous opiates. Gastrointestinal hypo­motility, masking of signs and symptoms of head injury, central depression, suppression of adrenal cortical axis, post paralysis myopathy, neuropathy in mechanically ventilated patients are other undesirable effects seen with opioids. [51] Progressive metabolic acidosis, rhabdomyolysis, hyperlipidemia, hepatomegaly, bradyarrhythmia, and unresponsive myocardial failure has been reported in children and adult head-injured patients receiving propofol infusion. [52],[53] Propofol is not approved for continuous sedation of paediatric patients in the ICU. Dexmedetomidine, alpha 2 adrenergic ago­nist in a dose of 0.2 - 0.7 mg kg -1 hr -1 causes less res­piratory depression than opioids. Infusions lasting more than 24 hours are not recommended to prevent re­bound hypertension. NSAIDs inhibit platelet aggre­gation, prolong bleeding time and may lead to renal toxicity or gastrointestinal tract ulceration with bleed­ing and perforation with long-term administration. In­duction of hepatic enzymes, drug interactions, and negative immunologic effects have also been reported. [54] Antipsychotic agents like droperidol have unique del­eterious effects such as tardive dyskinesias or the neu­roleptic malignant syndrome. [55]

Excessive sedation can lead to venous stasis, pressure ulceration, aspiration pneumonia, delayed weaning from ventilator and increased ICU stay and cost. [50],[56] The effects of sedative and analgesic drugs must be measured using a pharmacodynamic end point such as sedation score. The Joint Task Force of the American College of the Critical Care Medicine along with the American Society of Health -System Pharma­cists clinical practice guidelines (2002) for the optimal use of sedative and analgesics recommend use of Numerical rating scale or the Visual analogue scale to asses pain and response to analgesia in the ICU. [36] Ramsay scale, Riker sedation-agitation scale, Bispectral Index Sedation Score (BIS, Aspect Medical Systems, Newton, Mass) and bispectral analysis have also been used in ICU. [57],[58],[59] Delirium, an incredibly common problem in 50% to 80% of ventilated, severely ill pa­tients and 20% to 50% of other ICU patients has mul­tifactorial etiology which should be recognized and treated. [60],[61]


   D. Neuromuscular Blocking Agents (NMBAs) Top


NMBAs in the ICU are used to facilitate intuba­tion, reduce oxygen consumption, control harmful muscle activity in conjunction with sedation, permitting mechanical ventilation in patients undergoing permis­sive hypercapnia. [62] The use of neuromuscular monitor­ing to monitor the effect of NMBAs is desirable and may prevent the delivery of excessive drug dosages and may avoid long-term problems such as prolonged weakness or myopathies, polyneuropathy and drug in­teractions. [63],[64] Majority of adverse effects have been associated with the use of steroidal muscle relaxants (vecuronium, pancuronium) but the benzylisoqu­inolinium muscle relaxant, atracurium, has also been implicated. Awareness, unrecognized extubation, de­cubitus ulcers, nerve injury, corneal abrasions, venous stasis and venous thrombi are the other common problems seen with the use of NMBAs. The signs of car­diac ischemia, seizures, CNS abnormalities and ab­dominal pathologies may go unrecognized in patients receiving NMBAs. The Joint Task Force (2002) clini­cal practice guidelines for the use of NMBAs in ICU recommend that the patients must receive sedation and analgesia before the institution of NMBAs. [65]


   Risk reduction strategies and possible solutions Top


Pharmacovigilance by preventing errors, enhances the quality of care in ICU patients. Improvement of the accuracy of patient identification, the effectiveness of communication among caregivers, the safety of using medications and reduction of the risk of health care­associated infections are some of the several approved goals of the Year 2008 National Patient Safety Goals by the Joint Commission's Board of Commissioners. [42]


   Epidemiologic approach Top


Rigorous epidemiological approach to identify and prevent the problems by reactive as well as proactive means may be one of the best risk reduction strategies. Proactive methods like failure mode and effect analysis (FMEA) anticipate and preemptively implement changes to prevent errors. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) adopted a new leadership standard in 2001 that re­quires department heads in health care organizations to perform at least one FMEA every year. [66] Reactive or retrospective error analysis begins with the recognition of a serious, avoidable adverse event that has occurred and may happen again. Causes of a specific error of interest and preventive strategies can be identified after the fact by the process of root cause analysis.


   A. Identification of the problem Top


A vital step which can be implented by passive and active surveillance and audits.


   1. Passive surveillance Top


Self-reporting by health professionals especially about incidents in inpatient settings is very useful. [11] However, the fear of punitive actions or the medico legal concerns are deterrents to self-reporting of the true incidence of the problem. Harris et al recently re­ported a voluntary anonymous card-based event re­porting system among healthcare workers across ICUs increased reporting significantly compared with pre-in­tervention web-based reporting. [67] Knowledge discov­ery in databases along with use of data mining tech­niques are more likely to detect signals earlier than the current methods. [68]


   2. Active surveillance Top


This can be done by reviewing medical records, bedside charts or interviewing patients and/ or physi­cians in a sample of sentinel sites. Direct observation approach can detect a large number of medication er­rors and is highly reliable for in the inpatient and long­term care settings. Computerized monitoring using trig­gers by automatic detection of abnormal laboratory values from computerized laboratory reports and drug event monitoring provide an efficient active surveillance system. Simpson et al have developed a checklist of care issues that must be addressed daily for every pa­tient in the intensive care unit to deter from omission and mistakes. [69]


   3. Frequent audits Top


Audit and retrospective analysis are simple ways to estimate the frequency and cost of ADEs. Morimoto et al have devised methods to collect incidents. [70] In one study, real time safety audits performed in ICU during routine work could detect a broad range of errors lead­ing to rapid changes in policy and practice. [71]

Following detection, subsequent classification should be done to find out the type and severity of er­rors to help in preventability and improvement of pa­tient safety. Regulatory authorities such as the FDA and the WHO maintain databases of adverse events and evaluate them for new safety signals. The problems of screening have been highlighted by Sanzaro and Mills. [72] Statistics have been used to address the problem of inter observer variability and a kappa score of 0.8 is considered near ideal. Despite the poor predictive value, the ICD-9 coding of medication errors and ADEs including drug and laboratory data may also be used. [73]


   B. Human factor engineering approach and non technical skills Top


An adverse event becomes an opportunity for im­provement once it is recognized that a significant prob­lem exists and needs remedial measures. Prevention includes system approach or human factor engineering approach where emphasis is laid on having foolproof systems and to the factors which can help in eliminating human errors such as; decreased work hours, better working conditions, use of information technology and the designing of tasks so that errors are difficult to make. [74] A recent review of contributory factors under­lying critical incidents in ICU stresses the need for non­technical skill competencies like good teamwork, situ­ation awareness, task management and decision-mak­ing skills for safe practice in ICU. [75] Further research is necessary on the non technical skill proficiencies for teaching and reliable assessment.


   1. Improvement of medication system Top


Prevention strategies should aim at improving medication systems [26] by paying attention to the follow­ing factors.


   a. Storage Top


Drugs should be kept free from contamination (blood, organic matter). Solvents and carriers are re­quired for lipophilic drugs may pose problems. The Anaesthesia Patient Safety Foundation has published guidelines for safe handling of parenteral medications used for anaesthesia and sedation. In the service areas, maintain a list of high alert medications e.g. narcotics, NMBAs. Store them at one place and remove them from patient care areas. A separate register can be kept where entries are made each time the drugs are used and signed by the consultant using them.


   b. Drug administration Top


Increased vigilance is required for delivery and monitoring of medication. [76] Correct identification be­fore administration is essential. Colour coding, proper labeling of syringes to avoid syringe swapping and proper packaging may check errors in drug adminis­tration. There can be chemical, bacterial or glass par­ticles contamination of the drug during administration. This can be avoided by changing the packaging in the case of glass ampoules. All solutions for infusions should be carefully labeled with the date of preparation, the concentration, and the amount of drug, the route of administration and the name of the individual who pre­pared the infusion. Similar tube connections for differ­ent drugs should be discouraged. Standardize the abbreviations, acronyms, and symbols used in an organi­zation, as this is one of the National Patient Safety Goals recommended by the Institute of medicine. [42]

Simple measures as the use of Electronic Medi­cation Administration Records, use of a zero before the decimal point (0.4) and no use of zero after deci­mal point (4.0) are helpful to prevent ten fold over­dose. [22]

Regarding the use of central neuraxial blocks in patients in ICU, there should be standardization and monitoring of the cleaning, wrapping, autoclaving and storing steps, and of sterile material distribution. [77] Rou­tine use of a 0.2 mm bacterial filter for aspirating drugs is recommended.

Careful marking of epidural or spinal catheters with legible and visible labels may reduce the likelihood of these catheters being mistaken for intravenous lines by anaesthesia/nursing personnel. In our hospital, we routinely label the catheters and follow a policy of keep­ing the central and the neuraxial catheters on opposite side of the patient.


   c. Drug and electrolytes monitoring Top


The effectiveness of antibacterials using pharma­cokinetic/pharmacodynamic relationships for drug moni­toring are important predictors of successful outcomes for quinolone and aminoglycoside. Monitoring of se­rum levels of certain drugs along with electrolytes may help prevent certain drug interactions and adverse ef­fects.




   2. Training, education and communication Top


Lack of knowledge (29-30%) about the drug and inadequate communication among health care givers are important causes of medication error. [78] Education, a simple and inexpensive modality should target all levels of organization. It is important that educational efforts should be ongoing and must provide continual feed­back on safety and quality improvement projects. After confirmation of the relationship of the drug and the ad­verse event, the information should be shared with other clinicians through various platforms. [79] Communication is cited as one of the major contributor to the quality of patient care. Improving communication between phy­sicians, nurses and pharmacists is a relatively cost ef­fective and easy to implement strategy to reduce medi­cation error rates. [80]


   3. Involvement of pharmacist Top


A pharmacist can bring down the prescribing er­rors and monitor the transcription process. With the help of computerized pharmacy systems, the pharma­cists can screen for duplicate drug therapies, potential allergies, drug interactions, drug/laboratory interactions and dose range. Nurses can be helped and supervised in monitoring of the drug preparation, distribution and storage systems. They may be engaged in various edu­cation programmes as well as actively participate in developing drug protocols. Individualized pharmaco­therapeutic care can be provided in addition to signifi­cant reductions in the drug costs. [81]


   4. Protocol based management Top


Effort should be made to standardize and limit the number of drug concentrations in an organization. More stringent safeguards, such as, protocol driven order­ing, dosing tables, independent versus professional double checks of the syringe pump settings and the dose/ volume/concentration to be administered are indicated for high risk medications. A clearly defined system must be in place to alert clinicians to patient's allergies and this information must be readily available to the ICU staff. Though the use of selected guidelines and proto­col based management, very helpful, but these are not alternatives to vigilance or knowledge. It has been found that physicians and nurses do not always follow the guidelines and may be reluctant to use them. [82] Patients medicated according to drug guidelines have signifi­cantly shorter lengths of stay in the ICU, have improved sense of well-being and mechanically ventilated patients have lower rates of self-extubation. [22],[36] It is cost effec­tive and helps in cutting down the excessive use of drugs.


   5. Use of information technology Top


Computerized physician order entry, clinical de­cision support systems, automated dispensing, bar cod­ing of drugs and patients, smart intravenous devices for performing dilutions; automated bedside dispensing devices; and unit-based dosing and computerization of the medical records and of discharge prescriptions and instructions are the different ways in which information technology can be used. Information technology pre­vents and decreases errors by improving communica­tion thereby making knowledge more accessible, and assists with calculations and clinical decision-making. Smart monitors highlight signals, which indicate the early detection and aid in taking timely corrective measures. [83] Computer systems to detect critical conditions and au­tomatically notify the responsible physician via the hospital's paging system has also been used. [84] Various studies have shown that the application of information technology can prevent up to 95 percent of ADEs. [4],[19],[28],[34] The specificity of the computer monitoring sys­tem can be improved by the implementation of 'trend monitoring' in laboratory values (delta ALS). [85] Infor­mation systems to display drug and patient data may also produce long-term reduction in errors. [86]


   Conclusion Top


A patient admitted in an ICU needs continuous monitoring, oxygen therapy, multiple diagnostic or therapeutic interventions, and is dependent upon complex pharmacological regimens using sophisticated delivery and other organ support systems. Multidisciplinary strategies involving physicians, pharmacists, and other health care professionals with a special focus on communica­tion and education should be targeted. Pharmac­ovigilance incorporating information technology can be of great help in improving the patient care in the ICU. Pharmacovigilance must be integrated into public health programmes as recommended by the WHO for pro­motion of safe and rational use of medicines. However its application should not be limited to ICU alone rather quality and safety should become second nature to all health care professionals.

 
   References Top

1.Donchin Y, Seagull FJ. The hostile environment of the intensive care unit. Curr Opin Crit Care 2002; 8: 316-20.  Back to cited text no. 1  [PUBMED]  [FULLTEXT]  
2.Anne Trontell. Expecting the Unexpected - Drug Safety, Pharmacovigilance, and the Prepared Mind. N Eng J Med 2004; 351: 1385-7.  Back to cited text no. 2      
3.Clinical Safety Data Management: Definitions and Stan­dards for Expedited Reporting. London: European Agency for the Evaluation of Medicinal Products, Hu­man Medicines Evaluation Unit; 1995. [cited 2005 March 27]. Available from; http://www.emea.eu.int/pdfs/human/ich/037795en.pdf.  Back to cited text no. 3      
4.Bates DW, Leape LL, Petrycki S. Incidence and pre­ventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993; 8: 289-94.  Back to cited text no. 4  [PUBMED]    
5.Kohn L, Corrigan J, Donaldson M, eds. The Institute of Medicine Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health Sys­tem. Washington, DC: National Academy Press; 1999.  Back to cited text no. 5      
6.Baker GR, Norton PG, Flintoft V, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004; 170: 1678-86.  Back to cited text no. 6  [PUBMED]  [FULLTEXT]  
7.Patel P, Zed PJ. Drug-related visits to the emergency department: how big is the problem? Pharmacotherapy 2002; 22: 915-23.  Back to cited text no. 7  [PUBMED]    
8.Juntti-Patinen L, Neuvonen PJ. Drug-related deaths in a University central hospital. Eur J Clin Pharmacol 2002; 58: 479-82.  Back to cited text no. 8  [PUBMED]  [FULLTEXT]  
9.Cullen DJ, Sweitzer BJ, Bates DW, Burdick E, Edmondson A, Leape LL. Preventable adverse drug events in hospi­talized patients: a comparative study of intensive care and general care units. Crit Care Med 1997; 25: 1289-97.  Back to cited text no. 9  [PUBMED]  [FULLTEXT]  
10.Giraud T, Dhainaut JF, Vaxelaire JF, et al. Iatrogenic com­plications in adult intensive care units: a prospective two-center study. Crit Care Med 1993; 21: 40-51.  Back to cited text no. 10  [PUBMED]    
11.Bates DW, Cullen DJ, Laird N, et al. Incidence of ad­verse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA 1995; 274: 29-34.  Back to cited text no. 11      
12.Mc Donnel PJ, Jacob MR. Hospital admissions result­ing from preventable adverse drug reactions. Ann Pharmacother 2002; 36: 1331-6.  Back to cited text no. 12      
13.Pronovost PJ, Thompson DA, Holzmueller CG, Lubonski LH et al. Toward learning from patient safety reporting systems.J Crit Care 2006; 21: 305-15.  Back to cited text no. 13      
14.Valentin A, Capuzzo M, Guidet B, Moreno RP, Dolanski L. Patient safety in intensive care: results from the mul­tinational Sentinel Events Evaluation (SEE) study. In­tensive Care Med 2006; 32: 1591-8.  Back to cited text no. 14      
15.Buckely MS.Erstad BL, Kopp BJ, Theodorou AA, Priestley G. Direct observation approach for detecting medication errors and adverse drug events in a pediatric intensive care unit. Pediatr Crit Care Med 2007;8:145-52.  Back to cited text no. 15      
16.Chacko J, Raju HR, Singh MK, Mishra RC. Critical inci­dents in a multidisciplinary intensive care Anaesth In­tensive Care 2007; 35: 382-6.  Back to cited text no. 16      
17.Donchin Y, Gopher D, Olin M, et al. A look into the nature and causes of human errors in the intensive care unit. Crit Care Med 1995; 23: 294-300.  Back to cited text no. 17  [PUBMED]  [FULLTEXT]  
18.Graf J, Von den Driesch A, Koch KC, Janssens U. Iden­tification and characterization of errors and incidents in a medical intensive care unit. Acta Anaesthesiol Scand. 2005; 49: 930-9.  Back to cited text no. 18  [PUBMED]  [FULLTEXT]  
19.Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. ADE Prevention Study Group: JAMA 1995; 274: 35-43.  Back to cited text no. 19      
20.Young JS, Stokes JB, Denlinger CE, Dubose JE. Proactive versus reactive: the effect of experience on performance in a critical care simulator. Am J Surg 2007; 193: 100-4.  Back to cited text no. 20  [PUBMED]  [FULLTEXT]  
21.Brennan TA, Herbert LE, Laird NM, Lawthers A, Thorpe KE et al. Hospital characteristics associated with adverse events and substandard care. JAMA 1991; 264: 3265-9.  Back to cited text no. 21      
22.Phillips J, Beam S, Brinker A, et al. Retrospective analy­sis of mortalities associated with medication errors. Am J Health -Syst Pharm 2001; 58: 1835-41.  Back to cited text no. 22  [PUBMED]  [FULLTEXT]  
23.Weingart SN, Wilson RM, Gibberd RW, Harrison B. Epi­demiology of medical error. Br Med J 2000; 320: 774-7.  Back to cited text no. 23      
24.Prelipp RC and MacGregor DA. The Intensive Care Unit. In: Robert C Morell and John H Eichhorn, editors. Pa­tient Safety in Anesthetic Practice. New York: Churchill Livingstone Inc.; 1997. p . 353-87.  Back to cited text no. 24      
25.Geoffery J Dobb and Geoffery Knight. In: Extremes of Age. Gilbert R Park, Robert N Sladen, editors. Sedation and Analgesia in the Critically Ill. London: Blackwell Science Ltd.; 1995. p . 145-69.  Back to cited text no. 25      
26.Bates DW, Miller EB, Cullen DJ, et al. Patient risk fac­tors for adverse drug events in hospitalized patients. ADE Prevention Study Group. Arch Intern Med 1999; 159: 2553-60.  Back to cited text no. 26  [PUBMED]  [FULLTEXT]  
27.Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5.  Back to cited text no. 27  [PUBMED]  [FULLTEXT]  
28.Cullen DJ, Bates DW, Leape LL, et al. Prevention of adverse drug events: a decade of progress in patient safety. J Clin Anesth. 2000; 12: 600-14.  Back to cited text no. 28      
29.Kaushal R, Bates DW, Landrigan C, McKesnna KJ, Clapp MD, et al. Medication errors and Adverse drug events in Pediatric inpatients. JAMA 2001; 285: 2114-20.  Back to cited text no. 29      
30.Fortescue EB, Kaushal R, Landrigan CP, et al. Priortizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics 2003; 111: 722-9.  Back to cited text no. 30  [PUBMED]  [FULLTEXT]  
31.Duncan Michel A, McMahon Niamh, Carton Edmund G. Application of pharmacokinetic and pharmacodynamic principles in critically ill patients. In: Murray MJ, Coursin DB, Pearl RG, Prough DS, editors. Critical Care Medicine Perioperative Management. Philadelphia: Lipincott Wil­liams& Wilkins, 2002.p.186-91.  Back to cited text no. 31      
32.Brennan TA. The Institute of Medicine report on medi­cal errors-could it do harm? N Engl J Med 2000; 342: 1123-5.  Back to cited text no. 32  [PUBMED]  [FULLTEXT]  
33.Darchy B, Mie're E Le, Figue're'do B, Bavoux E, Domart Y. Iatrogenic Diseases as a Reason for Admission to the Intensive Care Unit: Incidence, Causes, and Conse­quences. Arch Intern Med 1999; 159: 71-8.  Back to cited text no. 33      
34.Peyriere H, Cassan S, Floutard E, et al. Adverse Drug Events Associated with Hospital Admission. Ann Pharmacother 2003; 37: 5-11.  Back to cited text no. 34  [PUBMED]  [FULLTEXT]  
35.Cheng DCH, Karski J, Peniston C, Asokumar B. Mor­bidity outcome in early versus conventional tracheal extubation after coronary artery bypass surgery: a pro­spective randomized controlled trial. J Thorac Cardiovasc Surg 1996; 112: 755-64.  Back to cited text no. 35      
36.Nasraway SA, Jacobi J, Murray MJ, et al. Sedation, an­algesia and neuromuscular blockade of the critically ill adult: Revised clinical practice guidelines for 2002. Crit Care Med 2002; 30: 117-8.  Back to cited text no. 36      
37.Michael Beers F. Oxygen therapy and Pulmonary Oxy­gen Toxicity. In: Alfred P. Fishman, editor. Fishman's Pulmonary Diseases and Disorders. New York: Mc Graw­Hill; 1998.p. 2627-42.  Back to cited text no. 37      
38.Singer MM, Wright F, Stanley LK, Roe BB, Hamilton WK. Oxygen toxicity in man: a prospective study in patients after open-heart surgery. New Engl J Med 1970; 283: 1473-8.  Back to cited text no. 38  [PUBMED]    
39.Davis WB, Rennard SI, Bitterman PB, Crystal RG. Pul­monary oxygen toxicity. Early reversible changes in human alveolar structures induced by hyperoxia. New Engl J Med 1983; 309: 878-83.  Back to cited text no. 39  [PUBMED]    
40.Askie LM, DJ Henderson-Smart DJ. Early versus late discontinuation of oxygen in preterm or low birth weight infants. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD001076. DOI:10.1002/14651858.CD001076.  Back to cited text no. 40      
41.Eggimann P, Pittet D. Infection control in the ICU. Chest 2001; 120: 2059-93.  Back to cited text no. 41  [PUBMED]  [FULLTEXT]  
42.Joint Commission International Center for Patient Safety [homepage on the Internet]. Illinois America, USA: Na­tional Patient Safety Goals 2008 [updated 2007 Jun 01; cited 2008 Jan 01]. Available from: http://www.jointcommision.org/patientsafety/nationalpatientsafetygoals2008.html  Back to cited text no. 42      
43.Kollef MH, Ward S, Sherman G, et al. Inadequate treat­ment of nosocomial infections is associated with cer­tain empiric antibiotic choices. Crit Care Med 2000; 28: 3456-63.  Back to cited text no. 43      
44.Avorn, J and D Solomon. Cultural and Economic Fac­tors That (Mis) Shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics. Ann Intern Med 2000; 133: 128-35.  Back to cited text no. 44      
45.Dettenkofer M, Ebner W, Els T, et al. Surveillance of nososcomial infections in a neurology intensive care unit. J Neurol 2001; 248: 959-64.  Back to cited text no. 45  [PUBMED]  [FULLTEXT]  
46.Fagon JY, Chastre J. Diagnosis and treatment of noso­comial pneumonia in ALI/ARDS patients. J. Eur Respir J 2003; 42: S77-83.  Back to cited text no. 46      
47.Evans RS, Pestotnik SL, Classen DC, et al. A computer­assisted management program for antibiotics and other antiinfective agents. N Engl J Med 1998; 338: 232-8.  Back to cited text no. 47  [PUBMED]  [FULLTEXT]  
48.Sun X, Quinn T, Weissman C. Patterns of sedation and analgesia in the postoperative ICU patient. Chest 1992; 101: 1625-32.  Back to cited text no. 48  [PUBMED]  [FULLTEXT]  
49.Desbiens NA, Wu AW, Broste SK, et al. For the SUP­PORT Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment investigators: Pain and satisfaction with pain control in seriously ill hospitalized adults: Findings from the SUPPORT research investigations. Crit Care Med 1996; 24: 1953-61.  Back to cited text no. 49  [PUBMED]  [FULLTEXT]  
50.Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous IV sedation is asso­ciated with prolongation of mechanical ventilation. Chest 1998; 114: 541-8.  Back to cited text no. 50  [PUBMED]  [FULLTEXT]  
51.Bosscha K, Nieuwenhuijs VB, Vos A, Samsom M, Roelofs JMM, , Akkermans LMA. Gastrointestinal motility and gastric tube feeding in mechanically ventilated patients. Crit Care Med 1998; 26: 1510-7.  Back to cited text no. 51      
52.Bray RJ. Propofol infusion syndrome in children. Paediatr Anaesth 1998; 8: 491-9.  Back to cited text no. 52  [PUBMED]  [FULLTEXT]  
53.Cremer OL, Moons KG, Bouman EA, Kruijswijk JE, de Smet AM, Kalkman CJ. Long-term propofol infusion and cardiac failure in adult head-injured patients. Lancet 2001; 357: 117-8.  Back to cited text no. 53  [PUBMED]  [FULLTEXT]  
54.Galley HF, DiMatteo MA, Webster NR. Immunomodulation by anaesthetic, sedative and anal­gesic agents: Does it matter? Intensive Care Med 2000; 26: 267-74.  Back to cited text no. 54  [PUBMED]  [FULLTEXT]  
55.Gurrera RJ. Sympathoadrenal hyperactivity and the eti­ology of neuroleptic malignant syndrome. Am J Psy­chiatry 1999; 156: 169-80.  Back to cited text no. 55      
56.Kress JP, Pohlman AS, O'Connor MF, et al. Daily inter­ruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med 2000; 342: 1471-7.  Back to cited text no. 56  [PUBMED]  [FULLTEXT]  
57.Ramsay MAE, Savege TM, Simpson BRJ, Goodwin R. Controlled sedation with alphaxalon-alphadolone. BMJ 1974; 2: 656-9.  Back to cited text no. 57      
58.Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med 1999; 27: 1325-9.  Back to cited text no. 58  [PUBMED]  [FULLTEXT]  
59.Song D, Joshi GP, White PF. Titration of volatile anes­thetics using bispectral index facilitates recovery after ambulatory anesthesia. Anesthesiology 1997; 87: 842-8.  Back to cited text no. 59  [PUBMED]  [FULLTEXT]  
60.Ely E Wesley, Inouye Sharon K, Bernard Gordon R, Gor­don Sharon, Francis Joseph, May Lisa, Truman Brenda, Speroff Theodore, Gautam Shiva, Margolin Richard, Hart Robert P, Dittus Robert. Validity and Reliability of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) JAMA.2001; 286: 2703-10.  Back to cited text no. 60      
61.Meagher David J, Moran Maria, Bangaru Raju, Gibbons Dympna, Donnelly Sinead, Saunders Jean, and Trzepacz Paula T. Phenomenology of delirium: Assessment of 100 adult cases using standardized measures. Br J Psychia­try 2007; 190: 135-41.  Back to cited text no. 61      
62.Bidani A, Tzouanakis AE, Cardenas VJ Jr, Zwischenberger JB. Permissve hypercapnia in acute respiratory failure. JAMA 1994; 272: 957-62.  Back to cited text no. 62  [PUBMED]    
63.Latronico N, Fenzi F, Recupero D, et al. Critical illness myopathy and neuropathy. Lancet 1996; 347: 1579-82.  Back to cited text no. 63  [PUBMED]    
64.Hund EF, Fogel W, Krieger D, DeGeorgia M, Hacke W. Critical illness polyneuropathy : clinical findings and outcomes of a frequent cause of neuromuscular wean­ing failure. Crit Care Med 1996; 24: 1328-33.  Back to cited text no. 64  [PUBMED]  [FULLTEXT]  
65.Murray MJ, Cowen J, DeBlock H, Erstad B, et al. Clini­cal practice guidelines for sustained neuromuscular blockade in the adult critically ill patient. Crit Care Med 2002; 30: 142-56.  Back to cited text no. 65  [PUBMED]  [FULLTEXT]  
66.Duwe B, Fuchs BD, Hansen-Flaschen J. Failure mode and effects analysis application to critical care medi­cine. Crit Care Clin 2005; 21: 21-30.  Back to cited text no. 66  [PUBMED]  [FULLTEXT]  
67.Harris CB, Krauss MJ, Coopersmith CM, Avidan M. Pa­tient safety event reporting in critical care: a study of three intensive care units. Crit Care Med 2007; 35: 1068-76.  Back to cited text no. 67      
68.Wilson Andrew M, Thabane Lehana, Holbrook Anne. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol 2004; 57: 127-34.  Back to cited text no. 68      
69.Simpson SQ, Peterson DA. Development and implemen­tation of an ICU quality improvement checklist. AACN Adv Crit Care 2007; 18: 183-9.  Back to cited text no. 69      
70.Morimoto T, Gandhi TK, Seger AC, Hsich TC, Bates DW. Adverse drug events and medication errors: de­tection and classification methods. Qual Saf Health Care 2004; 13:306-14.  Back to cited text no. 70      
71.Ursprung R, Gray JE, Edwards WH, Horbar JD et al. Real time patient safety audits: improving safety every day. Qual Saf Health Care 2005; 14: 284-9.  Back to cited text no. 71      
72.Sanazaro PJ, Mills DH. A critique of the use of generic screening in quality assessment. JAMA 1991; 265: 1977-­81.  Back to cited text no. 72  [PUBMED]    
73.Honigman B, Lee J, Rothschild J, Light P, Pulling RM, Yu T, Bates DW. Using computerized data to identify adverse drug events in outpatients. J Am Med Inform Assoc 2001; 8: 254-66.  Back to cited text no. 73  [PUBMED]  [FULLTEXT]  
74.Reason JT. Human error: models and management. BMJ 2000; 320: 768-70.  Back to cited text no. 74      
75.Reader T, Flin R, Lauche K, and Cuthbertson B.H. Non­technical skills in the intensive care unit. Br J Anaesth 2006; 96: 551-9.  Back to cited text no. 75      
76.Philips DP, Christenfield N, Glyan LM. Increase in US medication-error deaths between 1983 and 1993. The Lancet 1998; 351: 643-4.  Back to cited text no. 76      
77.Cardo DM, Sehulster LM. Central Sterile Supply. In: Mayhall CG, editors. Hospital Epidemiology and Infection Control. Philadelphia: Lippincott-Williams& Wilkins, 1999. p. 1023-30.  Back to cited text no. 77      
78.Leape LL, Brennan TA, Laird NM, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991;324: 377-84.  Back to cited text no. 78      
79.Dickerson LM, Mainous AG III Carek PJ. The Pharmacist's Role in Promoting Optimal Antimicrobial Use. Pharmacotherapy; 2000: 20: 711-23.  Back to cited text no. 79      
80.Manojlovich M, Decicco B. Healthy Work Environ­ments, Nurse-Physician Communication, and Patients' Outcomes. Am J Crit Care 2007; 16: 536-43.  Back to cited text no. 80  [PUBMED]  [FULLTEXT]  
81.Montazeri M, Cook DJ. Impact of a clinical pharmacist in a multidisciplinary intensive care unit. Crit Care Med. 1994; 22: 1044-8.  Back to cited text no. 81  [PUBMED]    
82.Bair N, Bobek MB, Hoffman-Hogg L, Mion LC, Slomka J, Arroliga AC. Introduction of sedative, analgesic, and neuromuscular blocking agent guidelines in a medical intensive care unit: Physician and nurse adherence. Crit Care Med 2000; 28: 707-13.  Back to cited text no. 82  [PUBMED]  [FULLTEXT]  
83.Bates DW, Gawande AA. Improving Safety with Infor­mation Technology. N Engl J Med 2003; 348: 2526-34.  Back to cited text no. 83  [PUBMED]  [FULLTEXT]  
84.Dormann H, Criegee-Rieck M, Neubert A, et al. Imple­mentation of a computer-assisted monitoring system for the detection of adverse drug reactions in gastroen­terology. Aliment Pharmacol Ther 2004: 19: 303-9.  Back to cited text no. 84      
85.Kuperman GJ, Teich JM, Tanasijevic MJ, et al. Journal of the American Medical Informatics Association 1999; 6: 512-22.  Back to cited text no. 85      
86.Kaushal R, Bates DW. Information technology& medi­cation safety: what is the benefit? Qual Safety Health Care 2002; 11: 261-5.  Back to cited text no. 86      



 
 
    Tables

  [Table 1]



 

Top
 
  Search
 
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

 
  In this article
    Abstract
    Introduction
    Magnitude of the...
    Epidemiology
    A. Human error
    B. Co-morbidity ...
    C. Drugs (number...
    D. Staging of er...
    Problems with co...
    A. Oxygen
    B. Antimicrobial...
    1. Misuse and Ex...
    2. Antimicrobial...
    C. Sedatives and...
    D. Neuromuscular...
    Risk reduction s...
    Epidemiologic ap...
    A. Identificatio...
    1. Passive surve...
    2. Active survei...
    3. Frequent audits
    B. Human factor ...
    1. Improvement o...
    a. Storage
    b. Drug administ...
    c. Drug and elec...
    2. Training, edu...
    3. Involvement o...
    4. Protocol base...
    5. Use of inform...
    Conclusion
    References
    Article Tables

 Article Access Statistics
    Viewed2608    
    Printed81    
    Emailed0    
    PDF Downloaded475    
    Comments [Add]    

Recommend this journal