Non compliance

In the event of non-compliance with any limit in these Regulations 

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Needs Improvement The management systems audited provided limited protection from significant loss or non-compliance. Some required management systems may be... 

Other Titles - The Clean Air Act Amendments of 1990 continue the federal acid rain research program and contain several provisions relating to research, development and air monitoring. They also contain provisions to provide additional unemployment benefits through the Job Training Partnership Act to workers laid off as a consequence of compliance with the Clean Air Act. The Act also contains provisions to improve visibility near National Parks and other parts of the country. Strict enforcement of the Clean Air Act Amendments is the driving force behind pollution abatement. Non-compliance is simply not an option, since there are both financial and criminal liabilities that outweigh any benefits derived from a business. 

Based on the audit findings, the team typically issuesa report that summarizes the status of current management systems and identifies pacesetter programs and areas of non-compliance or exceptions. These findings should be provided both to the facility manager and to the PSM team, for consolidation into overall recommendations. A sample audit report is shown in Figure 4-5. 

Section 6607(c) of the Pollution Prevention Act provides enforcement autliority under Title 111 of the Superfund Amendments and Reauthorization Act (also known as the Emergency Planning and Community Right-to-Know Act). Civil, administrative, and criminal penalties are autliorized for non-compliance against a facility, USEPA, a Governor, or a SERC. The Act requires USEPA to... 

If the authority are of the opinion that magistrate s court action will not give an adequate remedy a complaint may be made to the High Court. This court will issue an injunction prohibiting the repeat of the nuisance. Non-compliance with an injunction constitutes contempt of court and penalties include imprisonment. 

D Non compliance with drug regimen related to indifference, lack of knowledge, other factors... 

Q Non compliance related to anxiety, difficulty in staying drug free, other factors (specify)... 

It should be noted that non-compliance with safety rules would be held strongly against a laboratory should there be a lawsuit as a result of an accident. 

Information on implementation of GMP inspection plans is available in only some of the countries. Where data exist, they indicate that plans were successfully followed or even exceeded their targets. This applies to Cuba, Malaysia, the Netherlands, Uganda, Venezuela and Zimbabwe. For Cyprus, however, inspections of domestic plants fell short of the planned values. Cyprus has 10 domestic manufacturers, and nine inspections were planned, but in 1997 only seven were carried out. The Netherlands has 86 manufacturers and 28 inspections were planned in 1998 all of them were carried out. Venezuela has 41 manufacturers and 23 inspections were planned in 1997, of which 35 were carried out. So a low implementation rate does not necessarily indicate a low inspection rate. Enforcement measures are available in case of non-compliance in Cyprus, Estonia, Malaysia, Tunisia, Uganda, Venezuela and Zimbabwe. In Cuba, no enforcement measures are specified for failure to comply with GMP standards. Comparatively speaking, there is less likely to be a workplan for inspection of distribution channels than there is for GMP inspection. Only four countries — Cyprus, Estonia, Uganda and Venezuela — carry out inspection of distribution channels based on such a plan. 

Non-compliance with the simple Langmuir adsorption model is indicative of violation under experimental conditions of certain assumptions used to derive the model. Therefore, while developing the theoretical models adequately describing experimental data one usually resorts to one of two approaches either introduces the notion of a inhomogeneous surface [36, 37] or accounts for various types of interaction developing between the particles absorbed [4, 38]. 

The patient has Medicare, but due to her fixed income, has difficulty paying for medications, leading to occasional periods of non-compliance. 

Evaluate the patient s stool patterns. Steatorrhea indicates suboptimal enzyme replacement or non-compliance. Infants should have two to three well-formed stools daily, while older children and adults may have one or two stools. 

Patients may remain infected with HP after the initial course of therapy because of reinfection, non-compliance... 

Initiation of a second HP treatment regimen after failure of the initial treatment regimen is usually associated with a lower success rate. Reasons for failure are often the same as those reported with failure of the initial regimen patient non-compliance and/or... 

Sexual dysfunction is common and challenging to manage and often leads to non-compliance with serotonergic medications. 

Lack of patient understanding concerning optimal antidepressant drug therapy frequently leads to partial compliance or non-compliance with therapy, thus, the primary purpose of antidepressant counseling is to enhance compliance and improve outcomes. 

Initial response to short-acting stimulant formulations (e.g., methylphenidate and dextroamphetamine) is seen within 30 minutes and can last for 4 to 6 hours.13,14 This short duration of effect frequently requires that short-acting stimulant formulations be dosed at least twice daily, thus increasing the chance of missed doses and non-compliance. Further, patients using any stimulant formulation but especially shortacting formulations can experience a rebound effect of ADHD symptoms as the stimulant wears off.14... 

If the patient is not responding to therapy after an adequate trial, assess compliance with the prescribed regimen. If the patient is not compliant, counsel the patient and caregivers and explore reasons for non-compliance. In some cases, switching to another stimulant formulation may improve compliance. 

Assess patient What precipitated the episode (non-compliance, infection, trauma, infarction, cocaine) Initiate appropriate work-up for precipitating event (cultures, CXR, ECG). 

An open-label study of paroxetine and fluoxetine (Alonso et al, 1997) in depressed Hispanic (Mexican descent, n = 13) and non-Hispanic females (n = 13) showed no differences in response rates. At variance with the tricyclic data, Hispanic subjects complained of fewer side effects (2.2 2.0 vs. 5.1 2.5 p < 0.005), but twice as many terminated participation prior to study completion due to non-compliance, intolerable side effects or pregnancy. 

Although non-compliance has not been consistently linked with any specific demographic it has been associated with numerous factors related to the illness, patient, clinician, and the medication itself as shown in Table 10.2. 

Inadequate discussion about potential side effects, and duration of treatment Lacking in flexibility to change regimen in response to side effects Lack of contingency planning in case of non-compliance... 

Non-compliance issues appear more prevalent in some non-Western cultures. One study in South Africa revealed non-compliance rates to oral neuroleptics in two-thirds of Black patients and one-half of colored patients compared to only one-quarter of Caucasians (Gillis.Trollip, Jakoet etal., 1987). Cultural and communication factors were considered to be significant barriers apart from those related to cost and social factors. Kinzie et al. (1987) reported that despite prescribing adequate doses of tricyclic antidepressants (TCAs) to depressed Asian refugees,... 

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