Prescribing GuidelinesRx

Last updated: November 24, 2014

In this book, a listing in the Indications section does not imply that a particular drug has been approved by the FDA for a particular indication. In rheumatology, because many conditions are rare, trials for FDA approval may not have been performed and many patients are treated “off label”. In addition, because responses to established therapies for many conditions are often unsatisfactory, new drugs are sometimes tried, although there is only preliminary evidence to support their use, in patients who have failed other therapies.  Hence, there are many conditions wherein the standards of therapy are defined by clinical research or experience.   “Off-label” use is common and expected in rare diseases, pediatric disorders and when treatment options are very limited.  It is the physician’s duty to treat each patient in the most effective and safest manner possible (which may include off-label prescribing), with treatment choices given in the best interest of the patient and for a well defined clinical indication.

Pregnancy Risk Category
The use of any drug in pregnancy represents a therapeutic decision reached after evaluating the potential risks and benefits to the mother and fetus. Drugs are classified into FDA-designated categories representing the risk of a particular drug being teratogenic. The pregnancy risk increases through categories A to D. Category X indicates drugs that are absolutely contraindicated in pregnancy. These categories are explained in Table 1.

Table 1: Pregnancy Risk Increases
Category Drugs Effects on Fetus
A Controlled studies show no risk to the fetus, and possibility of fetal harm appears remote
B Either (a) animal studies have not demonstrated a fetal risk, but there are no controlled studies in pregnant women or (b) animal studies have shown an adverse effect in pregnancy that was not confirmed in women in controlled studies
C Either (a) animal studies demonstrate adverse effects on the fetus and there are no controlled studies in women or (b) studies in women and animals are not available
D Positive evidence of human fetal risk but potential benefit may justify potential risk in certain circumstances
X Contraindicated in women who are or may become pregnant

Cost of Medication

The following key is used to indicate the relative cost of medication to the patient. The relative scale used is not meant to indicate an accurate monetary cost but rather to portray the range of possible cost of treatment to the individual. Unless otherwise noted, the cost represents the average cost of generic medication using an average effective dose.

$: Inexpensive (e.g., $10-20/month):affordable even for those with limited financial resources.
$$: Affordable to many patients (e.g., less than $100/month): cost concerns are limited with such a drug.
$$$: Expensive (e.g., low hundreds of $/month): less expensive agents should be considered; agent may only be affordable when the cost of medication is subsidized by insurance programs.
$$$$: Very expensive (e.g., high hundreds of $/month): cost limits use of this agent to those able to afford the high price of medication or those with “liberal” prescription programs.
$$$$$: Extremely expensive (e.g., more than $1000/month): should only be used if (a) the agent is absolutely indicated, (b) anticipated therapeutic benefits are sufficiently great, and (c) less expensive therapeutic options have been exhausted or are contraindicated; some such agents are not covered by medical insurance programs and many have pre-authorization programs.

Pitfalls in Prescribing
The clinician should be careful to avoid the following common mistakes in prescribing:

1. Prescribing a drug when no drug is needed. Alternative, nondrug methods of symptom control may be the appropriate intervention.
2. Prescribing no drug when a drug is indicated. Therapeutic nihilism or therapeutic ignorance may deny patients effective and necessary treatment.
3. Prescribing a poorly chosen drug for the disease. A drug that is ineffective, expensive, and potentially harmful (e.g., methotrexate to treat gout) should be avoided. Also common is the mistake of choosing a drug that has similar efficacy but is more expensive or has more side effects than the treatment of choice.
4. Prescribing a poorly chosen drug for the patient. The patient is a major determinant of rational prescribing. Children, the elderly, pregnant or lactating women, patients with renal or liver disease, and patients receiving other drugs all require special consideration.
5. Prescribing a drug incorrectly. A correct drug for the patient and the illness may be chosen, but the drug may be prescribed incorrectly. The dose, dose interval, duration of therapy, and route of administration must be considered. An example of this is the prolonged use of high-dose corticosteroids in RA (which should be tapered as soon as possible). Last, the prescriber should be familiar with the drug’s indications, contraindications, proper dosing, common and uncommon side effects, precautions, drug interactions, mechanism(s) of action, and the drug’s cost to the patient.
6. Not providing a patient with essential information. This is particularly important in long-term therapy with potentially dangerous drugs (e.g., cyclophosphamide) and drugs that must be taken in a particular way (e.g., alendronate).
7. Failing to monitor appropriately. Many drugs are potentially toxic, and appropriate long-term monitoring is essential. Assessing the patient’s clinical response and modifying therapy appropriately, in addition to laboratory monitoring, is important.
8. Polypharmacy. Many patients require long-term therapy with multiple drugs. Nonetheless, the requirement for ongoing medications should be thoughtfully reviewed.
9. Illegibility. Tragedies have occurred because of illegibility. Printing is preferable. Avoid abbreviations (e.g., MTX for methotrexate) when prescribing. Electronically generated prescriptions may lessen prescribing errors by both physicians and pharmacists.

Therapeutic Aims
Primary aims in the treatment of musculoskeletal illness are

1. To relieve pain and stiffness
2. To maintain and restore function and strength
3. To maintain or improve the quality of life
4. If possible, to prevent recurrence or progression of disease
5. If possible, to induce remission

Formulation of a Therapeutic Plan
Treatment of the various musculoskeletal conditions depends on the diagnosis, the severity of disease, and the individual patient’s response to different forms of therapy. All these need to be evaluated before and during treatment. Treatment generally takes three major forms: (a) rehabilitation (including physical therapy, occupational therapy, splints), (b) drug therapy, and (c) surgery. A rational management plan is outlined below.

Key Steps in a Therapeutic Plan
Establish a diagnosis: A diagnostic consultation with a rheumatologist is more cost-effective than ordering numerous radiographs or an extensive rheumatology panel of laboratory tests.
Evaluate: Disease severity, aggravating factors, modifiable contributors, functional status, psychosocial status, and comorbidities must be evaluated.
Initiate the treatment plan: The plan should include patient education, appropriate physical and/or occupational therapy, appropriate drug or combination of drugs, and surgery, if indicated.
Monitor: Monitor the clinical status, complications, response to therapy, and toxicity from therapy. Employ measures to prevent toxicity.
Modify the treatment plan: Change therapy if unacceptable toxicity occurs or after an appropriate trial with inadequate efficacy; if the response is acceptable, evaluate maintenance doses or need for continued therapy.
In some rheumatic diseases (e.g., osteoarthritis, fibromyalgia) the efficacy of drug therapy may be modest, and nondrug therapies play an important adjunctive role. Few rheumatic diseases are cured by treatment; thus, the therapeutic plan for an individual patient is based on realistic treatment goals and may change over time as the illness evolves and new data become available.
Seek expert advice: Management of RA, SLE, dermato-/ polymyositis, and vasculitis is complex. Diagnostic and therapeutic issues may be clarified and complications or toxic­ities minimized by consulting a rheumatologist expert in a particular area.

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