Compliance problems

A system checklist is useful to identify compliance problems and also tliose areas of die system diat require furdier hazard evaluation. The niediod is easy to use and can be applied to any component of a given system such as equipment, instrunientation, materials, and procedures. Tliis mediod, which produces qualitative results, must be prepared by an engineer dioroughly experienced with die system once die checklist is prepared, however, it can be used by engineers or managers who may have less tecluiical experience widi die system. ... 

In the treatment of chronic diseases, a long term zero order release dosage form is highly desirable as it reduces fluctuations of drug levels, reduces toxicity and increases patient compliance. Problems in the treatment of both hypertension, a lifetime disorder, and opiate addiction are associated with compliance. The goal of this research is to develop a subcutaneously injectable system which can release drug at constant rates over a long period of time. 

Laengrich, A.R. and Cameron, W.L. "Tail-Gas Cleanup Addition May Solve Sulfur-Plant Compliance Problem," The Oil and Gas Journal, March 27, 1978. 

The risk-based approach merges science-based policies and standards with an integrated quality system. This is to ensure that the FDA s resources are directed to address those areas that are considered to have higher risks for example, companies with previous compliance problems, new companies with unknown history, and processes requiring aseptic procedures. 

Naltrexone is prescribed at a dose of 50 mg once per day for at least 12 weeks as part of a comprehensive alcohol treatment program. Like all treatments for substance use disorders, it works only as well as the addict allows it to work. This is why it is important to use it as a component of an overall treatment plan. Otherwise, poorly motivated alcohol abusers will seldom remain adherent with naltrexone and it will have little chance of providing benefit. A long-acting depot formulation of naltrexone currently in development might improve these compliance problems. 

This situation provided the opportunity for the decision maker to consider many other factors when the control decision was made. The predominant factors driving the control decision were judgmental and unquantifiable. They included the essentiality of the disinfection process in the control of waterborne disease (which is a large risk), the desire to optimize drinking water quality so as to avoid unnecessary risks, and the consideration of the unique compliance problems of small underfinanced and marginally operated water systems. Ultimately, the decision was driven by the feasibility and costs of treatment process improvements. 

During my tenure with the Center for Medical Devices, I was part of several injunctions that were referred to as corporate or corporatewide injunctions. These actions were intended to address what the agency believed to be a corporate culture that permitted, and possibly encouraged, company noncompliance. Corporate injunctions were invoked when compliance problems were found in different facilities of the same company. A pattern of noncompliance and negligence on behalf of the parent company led the agency to consider a corporate injunction as the regulatory enforcement tool. Corporate injunctions typically include the corporate parent, its senior officers, and all of its facilities around the world. It usually requires that some of those facilities cease operations for some period of time until compliance is achieved. Its characteristics are similar to the traditional injunction, with the exception that this particular enforcement targets the corporate umbrella. 

Technology transfer specialists, in contrast, are more focused on business aspects. They need to be able to work closely with and understand the work of the industrial property people, to help them check on the patent applications filed by the institution. But they also, and more importantly, must follow market trends involving the portfolio of patents and applications, orient the preparation of technical cooperation, detect and contact potential partners for future technology transfers, negotiate and draft contractual instruments applicable to each case, monitor the partnerships formed, deal with external law offices specializing in intellectual property, and act in cases of breach of contractual clauses. In relation to this last item, when a contractual infraction or other compliance problem is noted, a choice must be made as to what action to take. Will it be by judicial action or some form of alternative dispute resolution ... 

According to FDA compliance executives with the Center for Drug Evaluation and Research (the division that regulates drugs), recent GMP compliance problems include ... 

Tlie short duration of action of Ritalin can also lead to problems. Because the beneficial effects of the drug wear off in about 4 hours, children often experience a midday loss of ftinctioning and have to be given another dose. This entails a visit to the schtx)l nurse or other school staff and can lead to compliance problems. An extended-release methylphenidatc preparation (Concerta) with a 12-hour duration of action has now been developed to solve this problem and is in widespread use (PcUiam ct al., 2001). 

One factor to keep in mind when evaluating disulfiram is that its effects may be enhanced considerably if its u.se is combined with a behavioral program that in part consists of supervised administration of the disulfiram (e.g., by the patient s spouse) to the patient (Hughes Cook, 1997). This apparently addresses a major practical problem with using disulfiram clinically It typically requires daily administration of the prescribed dose, and patients tend to show poor compliance with such a regimen. Disulfiram implants have been tried as another w ay to solve the compliance problem, but their effectiveness has not been shown clearly, and the bioavailability of the implanted disulfiram has not been demonstrated in clinical trials. Additional well-controlled studies of supervised disulfiram therapy would allow us to specife the conditions under which its administration is most likely to enhance outcomes. 

Direct instillation is most frequently used in clinical practice. It is cheap and, in most circumstances, relatively easy for handlers to carry out, particularly where ointments are used. However fractiousness or head shyness on the part of the horse may lead to significant compliance problems and therapeutic failure. 

Lavage systems overcome the compliance problems associated with instillation of solutions in some horses. However, they involve increased expense arising from the costs of the system and from the relatively high drug volumes required, much of which may be wasted in the dead space... 

Parenteral administration of NAC eliminates compliance problems associated with oral therapy (very bad taste and odor due to the sulfhydryl groups) and circumvents the problems associated with acetaminophen-induced vomiting. 

How might the pharmacist have identified that there may be a compliance problem with Mrs Akhurst What coping strategies could the pharmacist suggest to solve the non-compliance problem ... 

Once a compliance problem has been identified, pharmacists can use patient education to help patients to... 

Corticosteroids also may be delivered by injection. The intramuscular route is preferable in patients with compliance problems, since a depot effect is achieved. Depot forms of corticosteroids include triamcinolone acetonide, triamcinolone hexacetonide, and methylprednisolone acetate. This provides the patient with 2 to 8 weeks of symptomatic control. The depot effect provides a physiologic taper, avoiding withdrawal reaction associated with hypothalamic-pituitary axis suppression. It should be noted that the onset of effect via this route may be delayed by several days. Intravenous corticosteroids may be used to provide the patient with large amounts of drug during a steroid burst to control severe symptoms. Intra-articular injections of depot forms of corticosteroids can be useful in treating synovitis and pain when a small number of joints are affected. The onset and duration of symptomatic relief are similar to those of intramuscular injection. The intra-articular route often is preferred because it is associated with the fewest number of systemic adverse effects. If efficacious, intra-articular injections may be repeated every 3 months. No one joint should be injected more than two to three times per year because of the risk of accelerated joint destruction and atrophy of tendons. Soft tissues such as tendons and bursae also may be injected. This may help control the pain and inflammation associated... 

Is the compliance problem a static phenomenon or a dynamic process ... 

There are no apparent reasons for the combination of technologies in the WHEAT process to lead to unusual permitting or compliance problems. 

As discussed above, pharmacy data can provide insight into a patient s pattern of medication use and reveal compliance problems. Because many patients non-compliance takes the form of underuse of anti-inflammatory therapy and overuse of bronchodilators, a bronchodilator/prophylactic ratio which is inconsistent with the guidelines may indicate poor asthma control, and possibly poor compliance. Some clinics have an electronic automatic alert facility that alerts the clinician when this ratio becomes too imbalanced, and the ratio is also an important aspect of asthma audit. However, there are a number of reasons why the bronchodilator/prophylactic ratio should be treated with caution. 

Despite these disadvantages, the bronchodilator/prophylactic ratio can be useful as a system of alerting the clinician to possible compliance problems. The rule is that if the bronchodilator/prophylactic ratio is poor, then there is probably... 

---