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At least 19 recordsLinked to original sources
PubMed1991

Performance-oriented packaging standards; revisions to transitional provisions--Department of Transportation. Final rule; partial response to petitions for reconsideration and revisions.

This amendment makes revisions to a final rule published in the Federal Register under Docket Nos. HM-181, HM-181A, HM-181B, HM-181C, HM-181D and HM-204 (55 FR 52402, December 21, 1990). That final rule comprehensively revised the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) with respect to hazard communication, classification and packaging requirements. The changes were based on the United Nations Recommendations on the Transport of Dangerous Goods (UN Recommendations) and RSPA's own initiative. The revisions contained in this document are in response to petitions for reconsideration addressing the transitional provisions contained in the final rule. This amendment also extends the effective date for certain quantities of infectious substances and incorporates all rulemaking actions issued under Docket HM-142A (56 FR 197, January 3, 1991, and 56 FR 7312, February 22, 1991) into Docket HM-181. RSPA will respond to other petitions for reconsideration in a forthcoming corrections document. The revision of the transition period will allow adequate time for persons subject to the HMR to evaluate domestic products for changes in classification, descriptions on shipping papers, product marking, labeling and vehicle placarding, to conduct package testing, and to provide sufficient time for the retraining of shipper, carrier, enforcement, and emergency response personnel in the new requirements.

Communication↗
PubMed1998

A European de facto standard for image folders applied to telepathology and teaching.

Since 1980, French pathologists at ADICAP (Association pour le Développement de l'Informatique en Cytologie et en Anatomie Pathologique) have created a common language code allowing the use of computers for routine applications. This code permitted the production of an associated exhaustive image bank of approximately 30,000 images. This task involved many specialists necessitating the definition of specific processes for security and simplicity of data handling. In particular, it has been necessary to develop image communication. To achieve that goal, it was necessary to define a folder, associating textual information to images. That was done through several industrial software providers contribution. Consequently, this folder, using a common packaging standard, allowed any pathologist access to images, codified data and clinical information. Accessing folders has been made easy by launching a Web server at CRIHAN under the supervision of ADICAP. An ADICAP software user may not only browse through the folder but may also import them into their own system and produce new folders. Today more than a hundred users in France and in foreign countries are able to provide diagnostic advice and also referential products useful for further education and quality control. The next challenge is the development of this preliminary de facto approach toward an internationally admitted standard suited for morphological image exchange.

Computer Communication Networks↗
PubMed2001

Naming, labeling, and packaging of pharmaceuticals.

The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

Drug Industry↗
PubMed1989

Information technology and the future of health services delivery.

This article examines the dramatic ways that information technology will influence clinical care, strategic management, and organization of the health care delivery system in the years ahead. Advancements in microprocessors, telecommunications, mass storage of data and images, and input-output devices will be accompanied by increased use of health-related software packages. Standardized patient record formats and coding systems will facilitate system integration and networking of computers. Clinical decision support systems will assist physicians in medical diagnosis and treatment. Computer-enhanced medical imaging and other noninvasive procedures will reduce surgery, patient pain and discomfort, and lower costs. Automation will get closer to the patient. Management information and decision support systems will be central to effective management in a highly competitive environment. Information systems will support strategic planning, cost control, productivity enhancement, quality improvement, and evaluation of products and services.

Delivery of Health Care↗
PubMedDate not supplied

Beyond the exchange--the future of B2B.

Using the Internet to facilitate business-to-business commerce promises many benefits, such as dramatic cost reductions and greater access to buyers and sellers. Yet little is known about how B2B e-commerce will evolve. The authors argue that changes in the financial services industry over the past two decades provide important clues. Exchanges, they say, are not the primary source of value in information-intensive markets; value tends to accumulate among a diverse group of specialists that focus on such tasks as packaging, standard setting, arbitrage, and information management. Because scale and liquidity are vitally important to efficient trading, today's exchanges will consolidate into a relatively small set of mega-exchanges. Originators will handle the origination and aggregation of complex transactions before sending them on to mega-exchanges for execution. E-speculators, seeking to capitalize on an abundance of market information, will tend to concentrate where relatively standardized products can be transferred easily among a large group of buyers. In many markets, a handful of independent solution providers with well-known brand names and solid reputations will thrive alongside mega-exchanges. Sell-side asset exchanges will create the networks and provide the tools to allow suppliers to trade orders among themselves, sometimes after initial transactions with customers are made on the mega-exchanges. For many companies, traditional skills in such areas as product development, manufacturing, and marketing may become relatively less important, while the ability to understand and capitalize on market dynamics may become considerably more important.

Commerce↗
PubMed1992

Functional versus standardized assessment procedures: implications for educational programming.

Teacher perceptions of the educational value of two distinct assessment procedures for assessing an 8-year-old student with severe to profound multiple disabilities were compared. Direct service providers (N = 38) from a public school system, randomly distributed into three groups, were asked to use an 8-item Likert-type survey to rate one of three assessment packages: standardized, functional-ecological, and a combined package. Results for four of the eight items were statistically significant. The functional-ecological approach was perceived to be most beneficial for educational intervention. Implications for greater emphasis on a functional-ecological assessment procedure versus standardized procedures were discussed.

Activities of Daily Living↗
PubMed1980

Regulatory considerations in the transportation of laboratory rodents.

The transportation standards of the Animal Welfare Act do not cover rats and mice, however, commercial carriers apply them to all species. These regulations, which outline such areas as packaging standards, terminal conditions and temperature parameters, are an example of governmental regulatory overkill. Air cargo deregulation also has had a negative impact on transportation of animals. We in the research community must work affirmatively within the legislative and regulatory process rather than responding defensively to proposed regulations.

Aircraft↗
PubMed1997

How important are airfreight rates and vaccine packaging in cost-saving efforts for the Expanded Programme on Immunization?

Vaccines constitute the single most important cost factor in the Expanded Programme on Immunization (EPI) in Mozambique and in view of future new disease-control initiatives, the proportional expenditure on vaccines will only increase. Airfreight may contribute up to at least 25% of the total cost of delivered vaccine. Air transport of vaccine provided by UNICEF was arranged by the vaccine supplier. As a result of a lack of control mechanisms, airfreight rates were unnecessarily high and showed considerable variation. By negotiating rates directly with the airlines, the EPI management team in Mozambique succeeded in reducing them from an average of about US$ 12 per kg to US$ 4 per kg, equivalent to an annual saving of US$ 100,000. Vaccine vials are typically packaged in one of the following types of boxes: small colourful boxes containing 5-10 vials or bigger more functional boxes containing 50-100 vials. The packaging of vials in smaller boxes can double airfreight costs compared with bigger boxes. The EPI management team for Mozambique recommends that UNICEF should take over from suppliers the arrangements for shipping vaccine and negotiate airfreight rates centrally; further, WHO should tighten current vaccine-packaging standards for net packaging volume per dose, so that packaging in uneconomical small boxes can be eliminated.

Aircraft↗
PubMed1997

Intravenous potassium predicament.

In 1991, United States Pharmacopeia (USP) required modification of the nomenclature and packaging standards for potassium chloride injection following reports of deaths that occurred due to inadvertent medication administration errors. The following article taken from USP Quality Review provides a brief history of the revised standards and a current Medication Errors Reporting (MER) Program database analysis of potassium chloride misadministrations. Also included is an errors table that compiles and abstracts all actual and potential errors of potassium chloride for injection concentrate that were received through August 1996. Because errors continue to be reported, USP Practitioners' Reporting Network would appreciate continual communication about the potential for error when administering potassium chloride for injection concentrate. Reprinting of this review is encouraged. A camera-ready format also is available by contacting USP Practitioners' Reporting Network at 800-487-7776.

Humans↗
PubMed1991

Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?

Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives and brand-name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, oral contraceptive packaging is unique to each manufacturer, and any change in brands (and therefore packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons proposed for placing oral contraceptives in the critical drug category, in which generic substitution and interchangeability of products should not be allowed.

Biological Availability↗
PubMed1996

Latex rubber condoms: predicting and extending shelf life.

Condoms from five manufacturers were subjected to controlled exposures of heat, humidity, and air and to different natural environments in five countries. Under aerobic conditions (condoms in permeable packages or unpackaged), stress properties declined. The relationship between rate of decline as a function of temperature was quadratic. Under oxygen-restricted conditions (foil-wrapped packages) at average storage temperatures of 30 degrees C and lower, strain properties declined with little or no significant change in stress properties. The effect is to cause condoms to become stiffer; high-breakage rates in use have been correlated with product stiffening. A new rationale for accelerated-aging tests to predict condom shelf stability is suggested, including a test to control the trend of condoms to stiffen. Silicone lubricant, impermeable packaging, and inclusion of antioxidants in the condom formulation can prevent or minimize aerobic breakdown of latex condoms. Specifying low-modulus condoms can prevent excessive stiffening.

Air↗
PubMed1994

Labeling emergency contraception.

According to the signers of a November 28 citizens' petition filed with the Food and Drug Administration (FDA), unintended pregnancies and abortions could be reduced significantly if the FDA would require the relabeling of several oral contraceptives as emergency or postcoital contraception, also known as "morning after pills." It has long been established that within 72 hours after unprotected intercourse or contraceptive failure, a specified combination of pills taken at specified intervals can reduce the risk of pregnancy by an estimated 75%. Although physicians at university health clinics, in hospital emergency rooms treating rape victims, and at some family planning clinics prescribe emergency contraceptives, other physicians are reluctant to do so without relabeling, and most women taking the pill do not know the correct dosage. Calling this a "critical public health issue," attorneys at the Center for Reproductive Law and Policy petitioned the FDA for a labeling change on the grounds that manufacturers are in fact "misbranding" pills by suppressing emergency contraceptive information. If pill makers rewrite their patient packet inserts, women undoubtedly would have far greater control over the occurrence of an unintended pregnancy, the attorneys said.

Americas↗
PubMed1995

Special report: the truth about condoms. Restrictive label could impede plastic condom sales.

You walk into a drugstore to buy a package of plastic condoms. You happen to notice the label says that no one's sure how well they protect you from pregnancy or sexually transmitted diseases (STDs) like AIDS. Then, the label indirectly points you in the direction of latex condoms. What would you do? Some observers familiar with the condom industry speculate that the restrictive labeling carried on each package of the new plastic condoms for men will not interfere with consumers' purchasing decisions. Other predict an instant replay of the situation faced by makers of the polyurethane Reality female condom: A lack of data on pregnancy rates and STD rates resulted in a label touting latex as a superior product, which in turn caused an onslaught of negative press about the first plastic condom. The US Food and Drug Administration, finding itself in a similar position with approving plastic condoms for men, recently released interim labeling to be followed by all manufacturers who want to sell the new male condoms. Essentially, the manufacturers must point out on the front of the condom box that the product is "for latex-sensitive condom users," and on the back of the box must tell a potential buyer that risks for pregnancy and STDs are not known for the product. Upon reading this disclaimer, the consumer then reads that "latex condoms for men, if used correctly with every act of vaginal intercourse, are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection)."

Condoms↗