Drug Distribution and Control

Drug Distribution and Control

Source: Council on Professional Affairs

To foster increased pharmacist and public awareness of drug product counterfeiting; further,

To encourage pharmacists to purchase and handle medications in ways that enhance the transparency and integrity of the drug product supply chain; further,

To encourage pharmacists to identify instances of drug product counterfeiting and to respond by assisting the patient in receiving appropriate treatment and monitoring, documenting patient outcomes, and notifying the patient, prescriber, and appropriate state and federal regulatory bodies (e.g., the Food and Drug Administration's MedWatch system); further,

To provide consumers and health professionals with information on how to avoid counterfeit drug products and how to recognize, respond to, and report encounters with suspicious drug products; further,

To foster research and education on the extent, methods, and impact of drug product counterfeiting and on strategies for preventing and responding to drug product counterfeiting.

Source: House of Delegates Resolution

To support the development of policies and guidelines for health-system pharmacists designed to deter drug product theft and thereby enhance both the integrity of the drug distribution chain and the safety of the workplace; further,

To encourage the development of systems that limit the diversion and abuse potential of medications, including high-cost drugs and controlled substances, and thereby reduce the likelihood that these products will be targets of theft.

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 Professional Affairs

To affirm the pharmacist's expertise and responsibility in the procurement, distribution, surveillance, and control of all drugs used within health systems; further,

To encourage the Joint Commission on Accreditation of Healthcare Organizations, other accreditation bodies, and governmental entities to enhance patient safety by supporting the pharmacist's role in drug procurement, distribution, surveillance, and control.

(Note: For purposes of this policy, drugs include those used by inpatients and outpatients, large- and small-volume injectables, radiopharmaceuticals, diagnostic agents including radiopaque contrast media, anesthetic gases, blood-fraction drugs, dialysis fluids, respiratory therapy drugs, biotechnologically produced drugs, investigational drugs, drug samples, drugs brought to the setting by patients or family, and other chemicals and biological substances administered to patients to evoke or enhance pharmacologic responses.)

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 Administrative Affairs

To urge health-system pharmacists to assume leadership, responsibility, and accountability for the quality, effectiveness, and efficiency of the entire medication-use process (including prescribing, dispensing, administration, monitoring, and education) across the continuum of care; further,

To urge health-system pharmacists to work in collaboration with patients, prescribers, nurses, and other health care providers in improving the medication-use process.

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

Procurement

Source: Council on Legal and Public Affairs

To support existing laws and legitimate practices that ensure product integrity and allow organized health care settings to purchase drug products and related supplies at prices that minimize health care costs; further,

To support the principle of purchase of pharmaceutical products and related supplies by public and private entities using appropriate professional practices to achieve that end; further,

To encourage government acknowledgement of existing local professional activities (e.g., drug-use review, formulary systems, pharmacy and therapeutics committees, and patient counseling) already practiced in organized health care settings that are methods of promoting quality and cost-effective pharmacist patient-care services.

This policy supersedes ASHP policy 0014.

Source: Council on Professional Affairs

To minimize the patient safety consequences and public health impact of inappropriate disposal of patients' home medications by working collaboratively with other interested organizations to (1) develop models for patient-oriented medication disposal programs that will minimize accidental poisoning, drug diversion, and potential environmental impact, (2) advocate that the pharmaceutical industry and regulatory bodies support the development and implementation of such models, and (3) educate health professionals, regulatory bodies, and the public regarding safe disposal of unused home medications.

Source: Council on Professional Affairs

To affirm that extemporaneous compounding of medications, when done to meet immediate or anticipatory patient needs, is part of the practice of pharmacy and is not manufacturing; further,

To support the principle that medications should not be extemporaneously compounded when they are commercially and readily available in the form necessary to meet patient needs; further,

To encourage pharmacists who compound medications to use only drug substances that have been manufactured in Food and Drug Administration-approved facilities and that meet official United States Pharmacopeia (USP) compendial requirements where those exist; further,

To support the principle that pharmacists be adequately trained and have sufficient facilities and equipment that meet technical and professional standards to ensure the quality of compounded medications; further,

To encourage USP to develop drug monographs for commonly compounded preparations; further,

To educate prescribers and other health care professionals about the potential risks associated with the use of extemporaneously compounded preparations.

This policy supersedes ASHP policy 0225.

Source: Council on Professional Affairs

To encourage unaccredited facilities where extemporaneous compounding of medications occurs to seek accreditation by a nationally credible accreditation body.

Source: Council on Professional Affairs

To work closely with regulatory bodies and appropriate organizations to develop standards that address pharmaceutical hazardous waste as defined in the Resource Conservation and Recovery Act, for the purpose of simplifying the disposal of these substances in health systems; further,

To encourage pharmaceutical manufacturers and the Environmental Protection Agency to provide guidance and assistance to health systems in their pharmaceutical waste-destruction and waste-recycling efforts; further,

To promote awareness of pharmaceutical waste regulations within health systems; further,

To encourage pharmaceutical manufacturers to streamline packaging of drug products to reduce waste materials.

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.

Distribution

Source: Council on Legal and Public Affairs

To support the use of new and emerging medication ordering and distribution systems (e.g., via the World Wide Web) when such systems (1) enable pharmacists to provide patient care services, (2) ensure that patients will not receive improperly labeled and packaged, deteriorated, outdated, counterfeit, or non-FDA-approved drug products, (3) provide appropriate relationships among an authorized prescriber, pharmacist, and patient, (4) enhance the continuity of patient care, (5) support the pharmacist's role as a patient care advocate, and (6) provide for data security and confidentiality.

This policy supersedes ASHP policy 0008.

Source: Council on Administrative Affairs

To advocate technician-checking-technician programs (with appropriate quality control measures) in order to permit redirection of pharmacist resources to patient care activities; further,

To advocate state board of pharmacy approval of these programs.

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 Legal and Public Affairs

To support, with appropriate changes in federal statutes and regulations, the establishment of an intermediate category of drug products that do not require a prescription but are available only from pharmacists and licensed health care professionals who are authorized to prescribe medications; further,

To base such support on the following facts:

1. Some drug products that are potential candidates for switching from prescription-only to nonprescription status raise concerns about patient safety as nonprescription products; these products could be better controlled, monitored, and evaluated by making them available only from pharmacists and licensed health care professionals who are authorized to prescribe medications; and

2. Pharmacists have the education, training, and expertise to help patients make appropriate therapeutic decisions associated with the use of such drug products; further,

To support that the regulatory system for this intermediate category of drug products contain the following features:

1. Drug products appropriate for this intermediate category would be identified through the advice of pharmacists, physicians, and other licensed health professionals who are authorized to prescribe medications, on the basis of the medical conditions to be treated and potential adverse effects (as indicated in FDA-approved labeling);
2. Pharmacists would be able to provide drugs in this intermediate category directly to patients without a prescription, on the basis of appropriate assessment and professional consultation;
3. Licensed health professionals who currently have prescribing authority would continue to have the ability to prescribe medications in this intermediate category; and
4. Data from postmarketing surveillance, epidemiologic studies, and adverse-drug-reaction reporting would be collected to help determine a drug product's eventual movement to nonprescription status, return to prescription-only status, or continuation in the intermediate category.

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 reaffirm the position that all medication dispensing functions must be performed by, or under the supervision of, a pharmacist; further,

To reaffirm the position that any relationships that are established between a pharmacist and other individuals in order to carry out the dispensing function should preserve the role of the pharmacist in (a) maintaining appropriate patient protection and safety, (b) complying with regulatory and legal requirements, and (c) providing individualized patient care.