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Safety in dispensing prescriptions

Note: This report represents information and AMA policy on this subject as of June 1998.

Full text

Resolution 506, introduced at the 1997 Annual Meeting by the Oregon Delegation and referred to the Board of Trustees by the House of Delegates, asks:

That the American Medical Association (AMA) encourage the United States Pharmacopeia and pharmaceutical manufacturers to consider adopting the following protocol relating to prescription labeling:

  1. Provide with wholesale stock containers a supply of self-adhesive labels containing the name of the product, the company name, the code that appears on the product and preferably a photograph of the tablet or capsule; and  
  2. Supply labels to pharmacists in sufficient quantity to allow two labels for each prescription from each stock container on hand, one which would be affixed to the prescription bottle by the dispensing pharmacist in the presence of the patient so as to confirm that the bottle contains the correct prescription; and  
  3. Pharmacists provide blank wallet cards to which to affix a second label in order to provide an accurate record of the medications the patient is taking to any physician the patient might have occasion to see; and  
  4. Encourage pharmacies to personally affix the labels on both the prescription bottle and the wallet card at each refill. 

This Council on Scientific Affairs (CSA) report responds to the referred resolution.

AMA Policy (June 1998)

The AMA has a number of policies on medication errors, drug product identification, and prescription labeling that are consistent with the intent of Resolution 506, which is to minimize errors associated with the dispensing of prescription drugs. 

Policy H-120.963 (AMA Policy Compendium) asks the AMA to continue its collaboration with the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP), along with its own ongoing initiatives, to identify and eliminate causes of medication errors. Policy H-120.968 (1) encourages individual physicians to minimize medication errors by adhering to a set of guidelines when prescribing medications (for specific guidelines, see Policy H-120.968). Policy H-120.965 encourages physicians to add a brief notation of purpose (i.e., for cough, for constipation) on prescriptions, when appropriate, to avoid confusion on the part of either the pharmacists or patients.

Policies H-115.984, H-115.992, and H-115.993 support a nationwide program of imprinting of all solid oral dosage forms (e.g., tablets and capsules), when feasible, as a coding system for the identification of all solid oral medication forms. In 1993, the FDA issued a Final Rule in the  Federal Register implementing such a program.

Policy H-115.974 recommends: (1) That when a physician desires to prescribe a brand name drug product, they do so by writing the brand name drug product and the phrase "Do Not Substitute" (or comparable phrase or designation, as required by state law or regulation) on the prescription; and when a physician desires to prescribe a generic drug product, they do so by writing the USAN-assigned generic name of the drug on the prescription whenever possible. (2) That, except where the prescribing physician has indicated otherwise, the pharmacist include the following information on the label affixed to the container in which the prescription drug is dispensed: 

In the absence of product substitution, (a) the brand or generic name of the drug dispensed; (b) the strength, if more than one strength of drug is marketed; (c) the quantity dispensed; and (d) the name of the manufacturer or distributor; and 

When generic substitution occurs, (a) the generic name (or, when applicable, the brand name of the generic substitute ["branded" generic name]) of the drug dispensed; (b) the strength, if more than one strength of drug is marketed; (c) the quantity dispensed; (d) the manufacturer or distributor; and (e) either the phrase "generic for [brand name prescribed]" or the phrase "substituted for [brand name prescribed]." 

Policy H-115.983 recommends that pharmacists place a beyond-use date on the labeling of all prescription medications dispensed to patients, and that the beyond-use date be based on the recommendations of the  United States Pharmacopeia-National Formulary (USP 23-NF 18) (official January 1, 1995). 

Background

In 1995, the USP invited some of the nation s leading health care and consumer organizations to collaborate in an effort to address the challenges regarding the safe use of medications. Fourteen national organizations American Association of Retired Persons (AARP); American Health Care Association (AHCA); American Hospital Association (AHA); the AMA; American Nurses Association (ANA); American Pharmaceutical Association (APhA); American Society of Health-System Pharmacists (ASHP); the FDA; Generic Pharmaceutical Industry Association (GPIA); Joint Commission for the Accreditation of Healthcare Organizations (JCAHO); National Association of Boards of Pharmacy (NABP); National Council of State Boards of Nursing, Inc. (NCSBN); Pharmaceutical Research and Manufacturers of America (PhRMA); and the USP-established the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) to address the growing concerns related to medication errors and help bring the health care community together in a unified problem-solving effort.

Each member organization of the NCC MERP has nominated a delegate with expertise in medication errors, and the delegates meet at the USP two or three times a year. Over the past two years, the NCC MERP has established a set of goals and objectives to improve the reporting, understanding, and prevention of medication errors; has developed a Medication Error Index for Categorizing Errors; has made recommendations to correct error-prone aspects of prescription writing; and has produced recommendations on labeling and packaging for industry, regulators/standards-setters, health care organizations, and health care professionals. 

In April 1997, Steven J. Schulte, RPh, a pharmacist employee of the Oregon Board of Pharmacy, requested an opportunity to present his proposal to eliminate errors associated with the dispensing of prescription drugs at the next meeting of the NCC MERP. The request was granted and, at the May 1997 meeting of the NCC MERP, Mr. Schulte presented his proposal to reduce dispensing errors where the wrong medication is dispensed in a correctly labeled container. In brief, Mr. Schulte would require all pharmaceutical manufacturers of solid oral dosage forms to provide a supply of detachable, self-adhesive labels with their bulk medications sold to pharmacies. Each label would contain the name of the product, the manufacturer's name, the imprint code of the product, and a picture of the product, i.e., the actual tablet or capsule. This label would be placed on the dispensed medication by the pharmacist and serve as a crosscheck with the pharmacy label and the actual contents of the container. Mr. Schulte indicated that the Oregon Medical Association had adopted his proposal and would be submitting it as a resolution at the 1997 Annual Meeting of the AMA.

A number of NCC MERP delegates raised concerns with Mr. Schulte's proposal, but the NCC MERP did not take formal action on the proposal at the May 1997 meeting.

Resolution 506 contains all of the elements of Mr. Schulte's proposal and, in addition, asks that the pharmacist also provide the patient with a wallet card and affix a second (duplicate) manufacturer-produced, self-adhesive label on the wallet card. During the discussion of Resolution 506 in Reference Committee E at the 1997 Annual Meeting, expert witnesses from the USP, the FDA, and PhRMA raised concerns about the resolution and recommended that the AMA ask the NCC MERP to evaluate and offer its position on the merits of the proposal. 

In the absence of evidence-based research on the merits of Mr. Schulte's proposal, and consistent with AMA Policy H-120.963 that asks the AMA to continue to collaborate with the FDA and the USP to identify and eliminate causes of medication errors, the CSA recommended that the AMA make a formal request of the NCC MERP to evaluate and offer its position on the merits of Mr. Schulte's proposal and on Resolution 506. A letter of request was sent to the NCC MERP on October 2, 1997. The NCC MERP accepted the Council's request to formally discuss these items at its next regularly scheduled meeting on October 27, 1997.

Results of the October, 1997 NCC MERP discussion

The NCC MERP believed it was premature to endorse Mr. Schulte's proposal (and Resolution 506) without further study and without the collective opinion from a broad range of health care practitioners. This conservative approach was due to the fact that the proposal has the potential to dramatically change the packaging, labeling, and dispensing process. Thus, the NCC MERP believed that changes of this magnitude should be further studied and pilot-tested before requiring sweeping changes. The NCC MERP raised a number of areas of concern that need to be addressed. Among the concerns were:

  1. There is no evidence currently to support the proposal's conclusion that it will reduce dispensing errors.  
  2. Given the concerns with current pharmacy workloads, the introduction of an additional step into the dispensing process must be carefully evaluated. Potentially, this could lead to more (rather than fewer) errors.  
  3. It would be difficult for manufacturers to estimate how many detachable, self-adhesive labels are adequate when medications, such as antibiotics, range from single doses for certain treatments to 30-day supplies. Thus, calculating how many prescriptions could be filled from a stock bottle and the appropriate number of auxiliary labels would be challenging.  
  4. In current drug distribution channels, repackaging of drug products between the manufacturer and the retail pharmacy has become common. It was unclear to the NCC MERP who would be responsible for auxiliary label production when manufacturers sell to repackagers. For example, would manufacturers also have to "repackage" labels and would these labels still be accurate for the repackaged product?  
  5. The large number of detachable labels created by this proposal potentially could lead to a number of problems regarding storage, loss of labels, mixing of labels, etc. Pharmacy inventory systems might need to be redesigned to accommodate the sheer volume of labels needed for this initiative.  
  6. Accurately reproducing tablet/capsule colors can be problematic, and only one side of the tablet or capsule could be shown  
  7. Specific to Resolution 506, the proposal is unclear as to what happens when a patient forgets his/her wallet card that is to be updated by the pharmacist. There appears to be a very real potential for incomplete patient records (at least in terms of the card). Also, the confidentiality of patient information on the card would be jeopardized when someone other than the patient would pick up the prescription. Finally, the proposal fails to address issues, such as medications that are discontinued, and whether a patient should maintain a file box of cards over time.  
  8. The proposal only addresses the ambulatory setting and solid, oral dosage forms. At a minimum, the cost/benefit ratio of requiring manufacturers to create packaging for this specific area needs to be evaluated. Similarly, can the increased regulatory burdens on both industry and retail pharmacies be justified?  
  9. The proposal would result in a change in FDA-approved labeling of drug products and as such would require further FDA review before the proposal could go forward.  
  10. The proposal only addresses one aspect of medication errors, the dispensing of the wrong product. However, errors can occur because verbal orders are misunderstood, when dosage instructions are misread, or for a variety of other reasons. The NCC MERP believes that the root cause(s) of dispensing errors needs further study. 

The Chairperson of NCC MERP sent a letter to the AMA stating these concerns and the NCC MERP's lack of endorsement for the proposal at this time. The NCC MERP believed that a more complete analysis of the cost/benefit ratio is needed; that a pilot study is needed to address the impact of the proposal on the dispensing process versus the potential of the proposed system to reduce errors; and that an opportunity for broad comment on this proposal needs to occur.

Recommendations

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy at the 1998 AMA Annual Meeting.

  1. That Resolution 506 (A-97) not be adopted, because there is no evidence that the proposal will reduce dispensing errors and, based on the judgment of the National Coordinating Council for Medication Error Reporting and Prevention, there may be an increase in medication errors. Furthermore, the technical problems associated with the proposal may be difficult to overcome, and the additional costs to the pharmaceutical industry and regulatory burdens to pharmacists may not be offset by a reduction in dispensing errors.  
  2. That this report be provided to the National Patient Safety Foundation. 

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Last updated: Sep 24, 2007
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