Sunday, March 24, 2013

Proposed Requirements for Pharmacies that Compound Medications--Petition to Be Sent to California Board of Pharmacy

Re: Proposed Requirements for Pharmacies that Compound Medications

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Board of Pharmacy
Attn: Karen Cates (Proposed Compounding Regulation)
1625 N. Market Blvd. N219
Sacramento, CA 95834
Fax: (916) 574-8618

Re: Proposed Requirements for Pharmacies that Compound Medications

Dear Board of Pharmacy Members:

The Sacramento Valley Society of Health-System Pharmacists(SVSHP) represents the local Sacramento Valley Pharmacist members of the California Society of Health-System Pharmacists (CSHP).

We, the undersigned SVSHP members support CSHP in its message to the Board of Pharmacy and its concerns regarding sections of the proposed compounding regulations that pertain to new labeling and pharmacy record requirements with regard to certain compounded IV medications that would inevitably delay treatment to the direst of patients.

It is common practice for a pharmacy in an acute care facility to prepare emergency compounded medications for the treatment of heart attack, stroke, and other life-threatening situations. Such patients require one-time and immediate-use (STAT) medications, such as alteplase, epinephrine, or diltiazem for treatment. CSHP members are concerned that the added documentation requirements for both the label and pharmacy log will delay the preparation and delivery of these one-time and immediate-use medications; therefore, placing the patient at risk without any additional benefit to patient safety and care.

CSHP fails to see the advantage in delaying treatment for patients with critical conditions to record the pharmacy reference number or lot number on the label of each dispensed IV and the additional information in the pharmacy log when such labeling and recordkeeping requirements are primarily intended to be used in the event of a medication recall. CSHP believes that such information would be obsolete in situations where patients are in need of one-time and immediate-use compounded products as any future recall of these products would be moot as the IV would be already administered to the patient.

As the proposed regulations stand now, every STAT compounded medication with life-saving potential prepared by a pharmacist during cardiac resuscitation, in the emergency department, in the operating rooms, or in other critical care areas would be delayed a few minutes longer to assure logging, assignment, and labeling of the IV bag with a pharmacy lot number.

Exempting immediate-use and one-time sterile products from some regulations has been done before. The recently updated United States Pharmacopeial Convention (USP) Chapter 797 has a special section related to Immediate-Use Compounded Sterile Products as the immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a compounded product.

As it relates to the preparation of one-time and immediateuse injectable products in acute care facilities, CSHP requests all proposed additional pharmacy record requirements be exempted from the pharmacy records. CSHP also requests an exemption of having to record the pharmacy reference number or lot number on the label for one-time and immediate-use IV medications. CSHP believes that an exemption from additional record keeping requirements would be best to ensure that patients in acute care facilities with one-time and immediate-use needs are treated in a safe and appropriate timeframe.

These exemptions in STAT situations will certainly benefit and prolong patients lives as they receive compounded medications urgently. CSHP hopes the following suggestions will help to meet our shared goal of better and safer patient care, and appreciate the boards willingness to consider our requests. 

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