Clinical management plans

Every Monday in your oncology outpatient department, you run a pharmacist/ nurse-led oral capecitabine clinic, where patients are referred to you by oncologists for pretreatment counselling, drug history-taking and supplementary chemotherapy prescribing (under set clinical management plans) for the adjuvant treatment of colon cancer or treatment of metastatic colorectal cancer. 

You prescribe oral capecitabine on an approved preprinted prescription form according to protocol and the appropriate clinical management plan. The dosage prescribed is as follows ... 

A voluntary prescribing partnership between an independent prescriber and a supplementary prescriber, to implement an agreed patient-specific clinical management plan with the patient s agreement. 

Supplementary prescribers are able to prescribe from a range of medicines for a broad range of medical conditions under the terms of a clinical management plan (CMP). The plan will be drawn up, with the patient s agreement, in consultation with an independent prescriber (the independent prescriber is a doctor or (less commonly) a dentist). 

Supplementary prescribers (see Section 3.2.4) via clinical management plans ... 

Any supplementary prescriber may prescribe any controlled drug so long as it is in the clinical management plan specific to that patient and agreed between the independent prescriber, the supplementary prescriber and the patient. 

Any person can administer any controlled drug in accordance with the directions of a supplementary prescriber (acting under and in accordance with the terms of a clinical management plan). 

Chemicals (Hazard Information and Packaging for Supply) Regulations clinical management plan... 

The following case study is of a patient who might be seen in a podiatry clinic and who might be a suitable case for supplementary prescribing under a clinical management plan. 

You may need to refer to Chapter 14 for details of supplementary prescribing and the use of clinical management plans. 

Do you think this patient would be suitable for supplementary prescribing with a clinical management plan and why ... 

Certain analgesics can be accessed and supplied by podiatrists in the course of their professional practice, some of which are prescription-only medicines. Any health care professional who trains to be a supplementary prescriber could prescribe prescription-only analgesics if it was appropriate to the individual clinical management plan. 

Clinical management plan - written agreement between an independent prescriber, a supplementary prescriber and a patient for their care... 

In summary, currerrt trairring and education create another barrier to improving safety culture because they do not support the development of shared norms and behaviours across different professional groups. Rather they create professional silos. The net effect of the current training approach is that doctors and nurses carmot walk in each other s shoes. Handovers, where multi-disciplinary team input is needed to commimicate safety information across healthcare interfaces, illustrate this issue very well. All too often, nurses seek nursing information and doctors want to hand over a clinical management plan in which key information required by the nurses is not included. 

In order to reduce unnecessary data queries, the statistics group should be consulted early in the clinical database development process to identify variables critical for data analysis. Optimally, the statistical analysis plan would already be written by the time of database development so that the queries could be designed based on the critical variables indicated in the analysis plan. However, at the database development stage, usually only the clinical protocol exists to guide the statistics and clinical data management departments in developing the query or data management plan. 

A sponsor of a medical product entering the development phase must have a clinical development plan, which is created by experienced executives and consultants having expertise and experience in the disease state for which the product is intended. Once the plan is created, with appropriate input from regulators, the plan drives a clinical development budget, with consideration of the desired timeframe for projected producf approval. After the plan is created, the management team determines the "make vs. buy" strategy, which determines the elements of fhe plan that will be outsourced. 

Rapid and accurate diagnosis of a patient s condition is an essential part of clinical management. Laboratory tests are used to tailor individual treatment plans according to need, to monitor disease progression, to assess risk, to inform prognosis, and for population screening programs. 

In order to understand the clinical management of transient ischemic attacks (TIAs) and stroke, to plan clinical services or to design randomized controlled trials, and to measure the overall impact of treatments, it is important to understand the epidemiology of stroke. 

The clinical features of drug interactions are often non-specific, and therefore a high index of suspicion should be maintained if they are to be recognized promptly. When a new drug is started, a specific management plan should be made, which... 

Table 15.2 presents an example of a management plan for a pharmaceutical care practice located in an ambulatory care clinic. 

To develop a data management plan pertinent to the project, a checklist of the project material is necessary to enhance the planning. The items to be collected include the protocol, annotated case report forms (CRFs), literature, log-in and tracking forms, file structures, coding rules, CRF review conventions, query handling procedure, required edit checklist, central laboratory address/file format, laboratory normal ranges, clinically... 

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit the rules and special requirements from the statistician, clinician, safety officer, medical writer and regulatory associates. These project materials, rules and special requirements will be considered in conjunction with data management requirements to develop the data management plan. The CDC should prepare the following documents before the clinical trials are initiated ... 

What sorts of drugs and indications have special clinical hazards and need special risk management programs At the pan-European level, the EMEA now considers risk management plans more or less routinely prior to Marketing Authorization. But in general, the products for which detailed risk management plans will almost always be required are... 

Formulary systems are an essential tool used in a variety of settings including hospitals, ambulatory clinics, health plans, pharmacy benefit management companies, and government agencies. This tool, if used correctly, promotes rational, clinically appropriate, safe, and cost-effective pharmaceutical care. 

Prepare or review overall clinical development plan Management of clinical study conduct Protocol writing Site selection Investigator meetings Monitoring... 

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