Patients harming

A medication error is 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 labeling, packaging, and nomenclature compounding dispensing distribution administration education monitoring and use. 

Lack of access to medicines and inappropriate doses result in serious morbidity and mortality, particularly for childhood infections and chronic diseases, such as hypertension, diabetes, epilepsy and mental disorders. Inappropriate use and over-use of medicines waste resources - often out-of-pocket payments by patients - and result in significant patient harm in terms of poor patient outcomes and adverse drug reactions. Furthermore, over-use of antimicrobials is leading to increased antimicrobial resistance and non-sterile injections to the transmission of hepatitis, HIV/AIDS and other blood-borne diseases. Finally, irrational over-use of medicines can stimulate inappropriate patient demand, and lead to reduced access and attendance rates due to medicine stock-outs and loss of patient confidence in the health system. 

Most manufacturers provide a written response to the FDA-483, either disputing the findings or addressing how they will correct the issues and how problems are to be corrected. Negotiations typically proceed for months or years until the inspectional problems and issues are resolved or the FDA elects to pursue elevated enforcement. The agency retains discretion to pursue elevated enforcement if it concludes that there is a significant risk of harm to patients, with such action being more likely where patient harm is more likely or more serious. 

Cardozo s opinion concerned a case in which surgery was performed without the patient s consent, but the principle he expressed can be applied to any procedure that contains some risk of patient harm. Treatment may not be instituted without the patient s consent, and this consent cannot be legally secured without the patients being informed of the hazards, the possible complications, and both the expected and the unexpected results of treatment. In addition, practitioners must not make any misrepresentations, either by misstating known focts or by withholding pertinent information. This obligation to communicate forms the basis for the doctrine of informed consent. 

Ernst (2) projected that costs of 177 billion a year are attributable to medication misuse. Adverse drug events (ADEs) are instances when patient harm results from the use of medication. This includes both adverse drug reactions/ which were discussed in Chapter 25/... 

A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while medication is in the control of a healthcare professional/ patient/ or consumer (6). Not all medication errors reach the patient. These are often referred to as "near misses." They are not usually considered to be ADEs only because no harm was done. Preventable ADEs are a subset of medication errors that cause harm to a patient (7). Figure 26.1 depicts the relationship between ADES/ medication errorS/ and adverse drug reactions (8). Because adverse drug reactions are generally unexpected/ they are not presently considered to be a reflection of medication use quality in a classic sense. However/ as genetic variances become a more prominent consideration in drug selection and monitoring/ it may be possible to predict and avoid some of the reactions that have been previously unexpected. This offers an opportunity to improve the quality of medication use. 

There are several limitations that lead to potential for patient harm with the current regulation of herbals under the DSHEA. First, botanical nomenclature is not standardized. Common names for herbals may vary depending on the region of the country. A single herb may have more than a dozen common names (e.g., echinacea), or one common herbal name may refer to several different species (e.g., yellowroot and snakeroot). To avoid confusion, the American Herbal Products Association (AHPA) has published Herbs of Commerce, a text of more than 500 herbs with the preferred common name, Latin binomial, and appropriate synonyms. 

Harm attributable to drugs is a major reason for malpractice claims associated with medical proce-duresJ The average compensation for medication errors between 1985 and 1992 was almost 100,000. Most compensation for medication errors is for larger amounts that are agreed on in out-of-court settle-ments.f None of the costs cited above include the cost of patient harm or subsequent hospital admissions. ... 

The supply of medication to a patient is an important role for pharmacy. However, in addition to the actual supply, sufficient information needs to be given to the patient or the patient s representative to enable them to use the medicine safely and effectively. Although it is important to supply the correct medication to the patient, if it is not used correctly by the patient it may be ineffectual. In extreme cases, this can lead to patient harm or even death. 

A medication error happens when there is general agreement that a person should have done other than what they did and so the person is labeled as having committed a medication error. An ADE occurs when patient harm occurs as a result of a medication error (e.g., wrong me-... 

Systems which are poorly designed or sub-optimally implemented can add unnecessary complexity to the clinical environment. It is these ideas that lead Weiner and his colleagues [42] to coin the term e-iatrogenesis. They define this simply as patient harm caused at least in part by the application of health information technology . In this way two key challenges are presented by HIT one of security (who has access to which information ) and one of safety (can we trust the information we use for critical decisions ) [43]. It is the latter which is of primary focus in this book. 

The academic literature and popular media contain numerous other examples of HIT contributing to patient harm. Probably the most serious accident of this type was attributable to the Therac-25 radiation therapy machine in the 1980s. Six patients in the US were subject to massive doses of radiation resulting in serious... 

Of these 24 % had an observable impact on care, 4 % were categorised as near-misses and 3 % resulted in actual patient harm (including three deaths). 

An important property of the hazard is its impact or consequence (the two words being largely interchangeable). A true hazard will have a credible and clearly apparent effect on one or more patients. In other words it should be possible to draw a Une of cause and effect from the hazard to patient harm. Were it is not possible to draw this line, the existence of the hazard or the manner in which it had been described may need to be revisited. 

ISO/TS 25238 2007 (Health informatics - Classification of safety risks from health software) [9] proposes a framework for assigning HIT systems into one of five risk categories. The standard is aimed at HIT products which are not medical devices but could lead to patient harm - as with many other standards in this area financial and other types of risk are excluded from scope. 

The safety assurance of a system inevitably requires resources and in some cases the demand is not insignificant Failure to develop a CRM policy can deprioritise these activities at times when resources are challenged. All too quickly one can end up in a situation where CRM effort is completely omitted from a business case entirely leading to project risk, unexpected costs and potentially patient harm. 

If an issue could contribute to patient harm and it is unlikely to be imminently resolved, reflecting the problem in the hazard register can pay dividends to ensure that all stakeholder are aware and that the risk is formally assessed. One should consider ... 

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