Conformity of Commercial Oral Single Solid Unit Dose Packages in Pharmacy
Conformity of Commercial Oral Single Solid Unit Dose Packages in Pharmacy
Background: There are limited published data on the labelling of single unit dose packages in hospitals.
Setting and Participants: The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada.
Objective: The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice.
Method: The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages.
Results: A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%.
Conclusion: This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.
In Canada and the USA, most hospital pharmacy departments provide a daily unit dose drug distribution system for inpatients. This distribution system has been in wide use since the 1970s, and most publications related to the implementation and evaluation of such systems were published in the 1970s and 1980s. A failure mode and effects analysis to improve drug distribution suggests that the percentage of opportunities during which any error occurred was significantly lower under the unit dose drug distribution system.
The Institute of Medicine recommends the implementation of a unit dose drug distribution system as a medication safety strategy to reduce errors in health care. The Medicines and Healthcare Products Regulatory Agency has issued guidelines for drug manufacturers. The International Pharmaceutical Federation, the Institute for Safe Medication Practices (ISMP), the American Society of Health-System Pharmacists (ASHP) and the Canadian Society of Hospital Pharmacists (CSHP) have published their statements and guidelines on unit dose drug distribution. According to an ASHP statement on unit dose drug distribution, 'the unit dose system may differ in form, depending on the specific needs of the organization. However, the following distinctive elements are basic to all unit dose systems: medications are contained in single unit packages; they are dispensed in as ready-to-administer form as possible; and for most medications, not more than a 24-hour supply of doses is delivered to or available at the patient-care area at any time'. Joint Commission on Accreditation of Healthcare Organizations standards require 'medications to be dispensed in the most ready-to-administer form possible to minimize opportunities for error'.
According to the ASHP Technical Assistance Bulletin on Single Unit and Unit Dose Packages of Drugs, drugs packages must fulfill four basic functions: identify their contents completely and precisely, protect their contents from deleterious environmental effects (e.g. photodecomposition), protect their contents from deterioration due to handling (e.g. breakage and contamination) and permit their contents to be used quickly, easily and safely. According to CSHP guidelines for drug packaging and labeling for manufacturers, a unit dose is a package that contains a particular dose of drug ordered for a patient, that is fully identified and that is ready for administration directly from the package. According to the guidelines, the mandatory label components of each unit dose package include the common or brand name for multiple active ingredient products, strength, lot number, name of the manufacturer and expiry date. Furthermore, the unit dose package must be able to be easily opened and the medication easily removed from the package to be administered directly to the patient. Push-through packages should not be used because the label is destroyed when the tablet or capsule is removed. Interestingly, Cohen says that the United States Pharmacopeia and Food and Drug Administration should standardize the terminology used on labels. Both 'single-use and single dose have been used on containers labels to mean the same thing'. He also says that 'regardless of a product's prescription or non-prescription status, the name and exact strength should be present on each pocket [referred to as a single unit dose package in our text] of the blister strip. Whether or not the manufacturer intends this, many nonprescription drugs are used in institutions as part of a unit dose dispensing system. [...] The blisters can be cut and separated from one another, or the drug name may be torn, making identification impossible and contributing to subsequent errors if the product is relabeled extemporaneously'.
Hospital pharmacists can buy drugs in bulk format or unit dose packages. Bulk format contains unpacked drugs that can be repacked by an automated medication dispensing system (Pacmed, Automed, etc.). Multiple unit dose packages are split (detached or cut) in single unit dose packages. In an unknown proportion of cases, the labeling of the detached single unit dose package is not complete for safe medication use in hospitals. Any missing information on a single unit dose package can lead to medication errors (wrong medication, wrong patient, expired medication, improper handling of a returned medication).
There are limited published data on the labeling of single unit dose packages in hospitals. The objective of this study is to evaluate the labeling of commercial oral single solid unit dose packages available in urban hospital pharmacy practice in Canada.
Abstract and Introduction
Abstract
Background: There are limited published data on the labelling of single unit dose packages in hospitals.
Setting and Participants: The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada.
Objective: The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice.
Method: The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages.
Results: A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%.
Conclusion: This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.
Introduction
In Canada and the USA, most hospital pharmacy departments provide a daily unit dose drug distribution system for inpatients. This distribution system has been in wide use since the 1970s, and most publications related to the implementation and evaluation of such systems were published in the 1970s and 1980s. A failure mode and effects analysis to improve drug distribution suggests that the percentage of opportunities during which any error occurred was significantly lower under the unit dose drug distribution system.
The Institute of Medicine recommends the implementation of a unit dose drug distribution system as a medication safety strategy to reduce errors in health care. The Medicines and Healthcare Products Regulatory Agency has issued guidelines for drug manufacturers. The International Pharmaceutical Federation, the Institute for Safe Medication Practices (ISMP), the American Society of Health-System Pharmacists (ASHP) and the Canadian Society of Hospital Pharmacists (CSHP) have published their statements and guidelines on unit dose drug distribution. According to an ASHP statement on unit dose drug distribution, 'the unit dose system may differ in form, depending on the specific needs of the organization. However, the following distinctive elements are basic to all unit dose systems: medications are contained in single unit packages; they are dispensed in as ready-to-administer form as possible; and for most medications, not more than a 24-hour supply of doses is delivered to or available at the patient-care area at any time'. Joint Commission on Accreditation of Healthcare Organizations standards require 'medications to be dispensed in the most ready-to-administer form possible to minimize opportunities for error'.
According to the ASHP Technical Assistance Bulletin on Single Unit and Unit Dose Packages of Drugs, drugs packages must fulfill four basic functions: identify their contents completely and precisely, protect their contents from deleterious environmental effects (e.g. photodecomposition), protect their contents from deterioration due to handling (e.g. breakage and contamination) and permit their contents to be used quickly, easily and safely. According to CSHP guidelines for drug packaging and labeling for manufacturers, a unit dose is a package that contains a particular dose of drug ordered for a patient, that is fully identified and that is ready for administration directly from the package. According to the guidelines, the mandatory label components of each unit dose package include the common or brand name for multiple active ingredient products, strength, lot number, name of the manufacturer and expiry date. Furthermore, the unit dose package must be able to be easily opened and the medication easily removed from the package to be administered directly to the patient. Push-through packages should not be used because the label is destroyed when the tablet or capsule is removed. Interestingly, Cohen says that the United States Pharmacopeia and Food and Drug Administration should standardize the terminology used on labels. Both 'single-use and single dose have been used on containers labels to mean the same thing'. He also says that 'regardless of a product's prescription or non-prescription status, the name and exact strength should be present on each pocket [referred to as a single unit dose package in our text] of the blister strip. Whether or not the manufacturer intends this, many nonprescription drugs are used in institutions as part of a unit dose dispensing system. [...] The blisters can be cut and separated from one another, or the drug name may be torn, making identification impossible and contributing to subsequent errors if the product is relabeled extemporaneously'.
Hospital pharmacists can buy drugs in bulk format or unit dose packages. Bulk format contains unpacked drugs that can be repacked by an automated medication dispensing system (Pacmed, Automed, etc.). Multiple unit dose packages are split (detached or cut) in single unit dose packages. In an unknown proportion of cases, the labeling of the detached single unit dose package is not complete for safe medication use in hospitals. Any missing information on a single unit dose package can lead to medication errors (wrong medication, wrong patient, expired medication, improper handling of a returned medication).
There are limited published data on the labeling of single unit dose packages in hospitals. The objective of this study is to evaluate the labeling of commercial oral single solid unit dose packages available in urban hospital pharmacy practice in Canada.
