Drug Products, Labeling, and Packaging

Marketing

Source: House of Delegates Resolution

To encourage federal agencies, the pharmaceutical industry, pharmacy and medical software providers, and purveyors of clinical data repositories and drug databases to explore the potential benefits of supplementing or modifying the National Drug Code with a coding system that can be effectively used across the medication-use continuum.

Source: Council on Pharmacy Practice

To advocate that manufacturers declare the name and derivative source of all excipients in drug products on the official label.

(Note: Derivative source means the botanical, animal, or other source from which the excipient is originally derived.)

Source: Council on Public Policy

To encourage continued research, development, and marketing of orphan drug products; further,

To urge health policymakers, payers, and pharmaceutical manufacturers to develop innovative ways to ensure patient access to orphan drug products; further,

To support public policies that ensure that the cost of orphan drug products does not preclude reasonable patient access to these agents.

Source: Council on Public Policy

To collaborate with others, including the United States Pharmacopeia and the Food and Drug Administration, in standardizing and defining the meaning of prefixes and suffixes for prescription and nonprescription drugs to prevent medication errors and ensure patient safety.

Source: Council on Professional Affairs

To advocate that pharmaceutical manufacturers eliminate surface contamination on vials of hazardous drugs; further,

To inform pharmacists and other personnel of the potential presence of surface contamination on the vials of hazardous drugs; further,

To encourage health care organizations to adhere to published standards and regulations to protect workers from undue exposure to hazardous drugs.

Source: Section of Inpatient Care Practitioners

To urge the Food and Drug Administration to mandate that manufacturers of medications and medication-device combination products include labeling information on whether any component of the product, including its packaging, contains natural rubber latex.

Source: Council on Professional Affairs

To advocate that pharmaceutical manufacturers provide all medications used in ambulatory care settings in unit-of-use packages; further,

To urge the Food and Drug Administration to support this goal; further,

To encourage pharmacists to adopt unit-of-use packaging for dispensing prescription medications to ambulatory patients; further,

To support continued research on the safety benefits and patient adherence associated with unit-of-use packaging and other dispensing technologies.

(Note: A unit-of-use package is a container--closure system designed to hold a specific quantity of a drug product for a specific use and intended to be dispensed to a patient without any modification except for the addition of appropriate labeling.)

Source: Council on Administrative Affairs

To advocate standardization of application criteria, processes, and forms for manufacturer-sponsored patient assistance programs (PAP); further,

To advocate the automation of PAP application processes through computerized programs, including Web-based models; further,

To advocate expansion of PAPs to include high-cost drugs used in inpatient settings.

Source: Council on Administrative Affairs

To advocate that pharmaceutical manufacturers provide all medications used in health systems in unit dose packages; further,

To urge the Food and Drug Administration to support this goal in the interest of public health and patient safety.

This policy was reviewed in 2007 by the Council on Pharmacy Management and by the Board of Directors and was found to still be appropriate.

Source: Council on Administrative Affairs

To declare that pharmaceutical manufacturers, distributors, group purchasing organizations, and regulatory bodies, when making decisions that may create drug product shortages, should strive to prevent those decisions from compromising the quality and safety of patient care.

This policy was reviewed in 2004 by the Council on Administrative Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To support efforts that stimulate development of pediatric dosage forms of drug products.

This policy was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To support the reading of drug product labels as the most important means of identifying drug products; further,

To oppose reliance on color by health professionals and others to identify drug products; and further,

To oppose actions by manufacturers of drug products and others to promulgate reliance on color to identify drug products.

This policy was reviewed in 2003 by the Council on Professional Affairs and the Board of Directors and was found to still be appropriate.

Source: House of Delegates Resolution

To support and actively promote the maximal extension of expiration dates of pharmaceutical products as a means of reducing health-care costs and to recommend that pharmaceutical manufacturers review their procedures to accomplish this end.

This policy was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Source: House of Delegates Resolution

ASHP should support the standardization and requirement of tamper-evident packaging on all topical products, including all dermatologicals and nonprescription products.

This policy was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Source: House of Delegates Resolution

To work with the FDA, USP, and pharmaceutical industry to assure that drug products are named in a manner that clearly and without confusion permits identification of ingredients' strengths and changes.

This policy was reviewed in 2003 by the Council on Legal and Public Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Legal and Public Affairs

To support efforts requiring manufacturers of solid dosage form prescription drug products to imprint a readily identifiable code indicating the manufacturer of the drug product and the product's ingredients; further,

To make information on translation of the codes readily available.

This policy was reviewed in 2006 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To not advocate, at this time, adoption of the International System of Units (SI units) as the exclusive labeling for drug dosages and concentrations; further,

To urge labelers to include: (1) units of mass, volume, or percentage concentrations and (2) moles or millimoles in labeling until the health professions and the public can be educated and be comfortable with use of SI units in prescribing and labeling drug products.

This policy was reviewed in 2001 by the Council on Professional Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To recommend to all health professions and to the Pharmaceutical Manufacturers Association (PMA) (now the Pharmaceutical Research and Manufacturers of America, abbreviated "PhRMA") that the apothecary system be eliminated in referring to dosage quantities and strengths.

This policy was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Source: Council on Legal and Public Affairs

To approve the authority of manufacturers to copy the size, shape, and color of generically equivalent drug products as a means of promoting better patient compliance (rational drug therapy), but only when the source and identity of the product are readily ascertainable from a uniform mark or symbol on the product.

This policy was reviewed in 2006 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Marketing

Source: Council on Public Policy

To affirm support for the current system of drug distribution in which prescribers and pharmacists exercise their professional responsibilities on behalf of patients; further,

To acknowledge that there may be limited circumstances in which constraints on the traditional drug distribution system may be appropriate if the following principles are met: (1) the requirements do not interfere with the continuity of care for the patient; (2) the requirements preserve the pharmacist–patient relationship; (3) the requirements are based on scientific evidence fully disclosed and evaluated by prescribers, pharmacists, and others; (4) there is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care; (5) the costs of the product and any associated product or services are identified for purposes of reimbursement, mechanisms are provided to compensate providers for special services, and duplicative costs are avoided; (6) all requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients; and (7) the requirements do not interfere with the professional practice of pharmacists, prescribers, and others; further,

To advocate that the Food and Drug Administration (FDA) be granted the authority to consult with practicing pharmacists and others when the establishment of a restricted distribution system is contemplated for a drug product; further,

To advocate that FDA be granted the authority to require that manufacturers disclose all of the considerations that led to the establishment of a restricted distribution system for a specific product; further,

To advocate that FDA be granted the authority to require that manufacturers include in each restricted distribution system a mechanism that will ensure medication reconciliation and continuity of care as patients transition from one level or site of care to another; further,

To advocate that FDA be granted the authority to require manufacturers to conduct a follow-up assessment of the impact of a restricted drug distribution system.

This policy supersedes ASHP policy 0114.

Source: Council on Administrative Affairs

To support the principle that medications provided through manufacturer patient assistance programs should be stored, packaged, labeled, dispensed, and recorded using systems that ensure the same level of safety as prescription-based programs that incorporate a pharmacist-patient relationship.

Source: Council on Administrative Affairs

To support wholesaler/distribution business models that meet the requirements of hospitals and health systems with respect to timely delivery of products, minimizing short-term outages and long-term product shortages, fostering product-handling and transaction efficiency, preserving the integrity of products as they move through the supply chain, and maintaining affordable service costs.

Source: Council on Legal and Public Affairs

To support direct-to-consumer advertising that is educational in nature about prescription drug therapies for certain medical conditions and that appropriately includes pharmacists as a source of information; further,

To support direct-to-consumer advertising of specific prescription drug products only when the following requirements are met: (1) that such advertising is delayed until postmarketing surveillance data are collected and assessed, (2) that the benefits and risks of therapy are presented in an understandable format at an acceptable literacy level for the intended population, (3) that such advertising promotes medication safety and allows informed decisions, and (4) that a clear relationship between the medication and the disease state is presented; further,

To support the development of legislation or regulation that would require nonprescription drug advertising to state prominently the benefits and risks associated with product use that should be discussed with the consumer's pharmacist or physician.

This policy supersedes ASHP policy 9701.

Source: Council on Legal and Public Affairs

To oppose drug sampling or similar drug marketing programs that (1) do not provide the elements of pharmaceutical care, (2) result in poor drug control, allowing patients to receive improperly labeled and packaged, deteriorated, outdated, and unrecorded drugs, (3) provide access to prescription drugs by unauthorized, untrained personnel, (4) may encourage inappropriate prescribing habits, or (5) may increase the cost of treatment for all patients.

This policy was reviewed in 2006 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Source: Council on Legal and Public Affairs

To encourage pharmaceutical manufacturers to (1) extend their patient assistance programs to serve the needs of both uninsured and underinsured patients, (2) enhance access to and availability of such programs, and (3) incorporate the elements of pharmaceutical care into these programs.

This policy was reviewed in 2006 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.