...an educational memo from your Therapeutics Committee

February, 2000

The Pharmacy is making physicians, nurses and other health professionals aware of a potential shortage of the intravenous glucocorticoid methylprednisolone. This is a result of a manufacturing problem, and no alternative source is available. This shortage does not involve other dosage forms of methylprednisolone (oral MedrolÒ), nor does it involve other glucocorticoids such as prednisone, prednisolone, hydrocortisone or dexamethasone. Current supplies of I.V. methylprednisolone (Solu-MedrolÒ) should last several weeks.

Physicians and other prescribers who routinely order I.V. methylprednisolone (Solu-MedrolÒ) should immediately begin revising their prescribing practices AND PRE-PRINTED ORDERS in anticipation of this temporary shortage. It is reasonable to consider substituting either I.V. hydrocortisone (Solu-CortefÒ) or I.V. dexamethasone (DecadronÒ).

Methylprednisolone has intermediate glucocorticoid and mineralocorticoid potency with an intermediate duration of action (12 - 36 hours). Hydrocortisone is less potent as a glucocorticoid than methylprednisolone, has more mineralocorticoid effect and has a duration of action of 8 - 12 hours. Dexamethasone is more potent as a glucocorticoid than methylprednisolone, has less mineralocorticoid effect and has a duration of action of 36 - 72 hours.

The approximate conversion for glucocorticoid effect (anti-inflammatory effect) is:

hydrocortisone (cortisol, Solu-CortefÒ) 20 mg

methylprednisolone (Solu-MedrolÒ) 4 mg

dexamethasone (DecadronÒ) 0.75 mg

For example, if a physician wanted to substitute dexamethasone for methylprednisolone, he/she would divide the Solu-MedrolÒ dose by 5.3. Instead of giving 40 mg of Solu-MedrolÒ, give 7.5 mg of I.V. DecadronÒ, for example. If the physician desires some mineralocorticoid effect from the glucocorticoid, he/she needs to prescribe hydrocortisone (Solu-CortefÒ). The methylprednisolone dose would be multiplied by 5 to calculate the hydrocortisone dose. Instead of giving 40 mg of Solu-MedrolÒ, give 200 mg of Solu-CortefÒ.

Prepare for the possibility that I.V. methylprednisolone (Solu-MedrolÒ) will not be available. Choose whether to substitute dexamethasone or hydrocortisone.

The Therapeutics Committee is making additional efforts to keep you informed of shortages of critical drugs. A new publication, the STATGRAM will be published weekly, listing drugs that are in short supply. Not all drugs will be listed - only those deemed to be “critical” to the clinical practice of the physicians. These come from a list compiled weekly in the Pharmacy, because of the drug ordering process. The STATGRAM is sent to the Nursing Directors and physicians who are Department Chairpersons. It will not replace the PHARMAGRAM, but it will be published much more often. Nursing Directors and Department Chairpersons are asked to communicate this information to their departments as soon as it is received. Your cooperation will make this effort a success.

Why do we experience drug shortages? There is a variety of reasons. When investigated, the reasons for the shortages of some critical drugs range from “unknown” to a shortage of raw materials to regulatory (FDA) action to quality control problems. The pharmacy dispenses millions of doses of drugs a year. This, multiplied by the number of hospitals and outpatient “prescriptions”, adds up to a multibillion item production process. Companies control their manufacturing output carefully, to economize their use of expensive drug manufacturing materials. Internal factory controls and governmental inspections interrupt the manufacturing process. For these varied reasons and more, there are, at any time, about 50 drug products on “backorder” in our pharmacy. Many of these are temporary problems, or involve drugs for which logical substitutes are still available.

The manufacturer communicates information about the shortages to the wholesaler, who in turn lets our Pharmacy know details about the shortages. In most cases, the manufacturer knows an approximate date after which the drug will be available. However, a startup date is unknown to the manufacturer in situations. When this occurs with a drug for which there are no good substitutes, or for a drug which is critical to patient care, the Therapeutics Committee wants the Medical Staff to know promptly. Drug substitutions are usually left to the ordering physicians. The Drug Information Center, under the direction of Ruth Avelino, Pharm.D., as well as the pharmacists on staff, is available to answer questions about substitutions.

We greatly appreciate your patience and flexibility when you receive the telephone call informing you of a drug shortage. Remember that it is not the pharmacists’ fault, and they are here to assist you. It is also good to communicate information to your colleagues about drug shortages that might interfere with their clinical practices. Please be assured that when the drug is available from a reliable source, a FDA inspected manufacturing plant, that the Pharmacy will restock it. Drugs that are on the OSF SFMC inpatient formulary are stocked in anticipation of your orders.

Watch for the STATGRAM, coming to your department every week.