Navigation Links
Consumer and Healthcare Groups Call for Clear, Concise Single Document From Pharmacy
Date:7/29/2008

Patients Need Information to Take Medicines Safely

WASHINGTON, July 29 /PRNewswire-USNewswire/ -- The National Consumers League has asked the Food and Drug Administration to issue a guidance for a combined and simplified document for patients when they receive their prescription drugs. In a petition filed on June 30, NCL was joined by several national healthcare organizations including the National Association of Chain Drug Stores, the National Community Pharmacists Association, the National Alliance for Hispanic Health, the National Alliance for Caregivers, the Food Marketing Institute, Healthcare Distribution Management Association, and Catalina Health Resource.

"It is very important that patients receive clear, useful information in plain language with their prescription drugs. They should be able to talk to their pharmacist about potential interactions, how to take their medicine and what side effects to expect. Patients do not need to receive multiple and lengthy pieces of paper that are often redundant and may even contain conflicting information," said Sally Greenberg, Executive Director of the National Consumers League. "The present jumble of documents ill-serves the patient who simply needs enough information to take a prescription drug safely and effectively."

The multitude of documents delivered to patients in pharmacies arises from different FDA legal requirements or unwritten, informal interpretation of those requirements from offices within FDA. Some of the legal requirements were established long ago, and were intended to regulate communications directed to healthcare professionals and not directly to consumers.

The FDA-mandated documents for patient communications can be just "too much information," said Greenberg. For example, a person refilling a prescription for an anti-depressant could, theoretically receive:

-- Consumer Medication Information (CMI) describing how to take the prescribed drug, its risks, and other information including risk information from the Medication Guide.

-- A Patient Package Insert from the manufacturer with a Medication Guide.

-- A Medication Guide provided by the pharmacy.

-- Full professional labeling if the patient receives a sponsored message about the anti-depressant from the drug manufacturer describing, for example, the importance of adhering to the doctors' orders.

The National Consumers League and other petitioners believe that it makes more sense to provide a single, clear, patient-friendly document with information for the patient that reinforces the communications between the patient, the pharmacist, and the prescribing healthcare professional. This single patient document would consolidate the many documents now in use and replace them with one that is easy to read, in plain language, in a consistent format, with plain instructions informing the patient where he or she can reliably obtain additional information.

"Many of these documents were never designed for, nor intended to apply, to the unique pharmacy environment," said Greenberg. "The risks of patient confusion, conflict, redundancy, and pharmacy burden would be eliminated if FDA permitted a 'single document solution' for all patient-directed information disseminated in the pharmacy."

Founded in 1899, the National Consumers League is America's pioneer consumer organization. Its mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. NCL is a private, nonprofit membership organization. For more information, visit http://www.nclnet.org.


'/>"/>
SOURCE National Consumers League
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Consumers Offer to Pay More to Satisfy Health Demands
2. CIGNA Group Insurance Shows Consumers Theres More to Life Through a New Consumer Education Toolkit
3. Draxis Health selected by Johnson and Johnson Consumer Companies, Inc. for major contract manufacturing relationship
4. Naked Juice Brings Consumers Happiness by the Billions With First 100% Juice Smoothie Containing Probiotics
5. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best
6. Hospitals Agree to Pay Fees in Exchange for More Income, but Consumers in the Dark About What Theyll be Charged Under Nunez Plan
7. PA Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Perry County Dairy
8. Injuries, Deaths Tied to Consumer Drugs Rise Sharply
9. Highmark Blue Cross Blue Shield Introduces New Health Plan Comparison Tool for Consumers
10. Highmark Blue Shield Introduces New Health Plan Comparison Tool for Consumers
11. PA Department of Public Welfare Begins Outreach to Medical Assistance Consumers Following Burglary at State Office Building
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & ... (TGIG), has initiated cultivation and processing operations at its production facility, and opened ... , Puradigm is the manufacturer of a complete system of proactive air and ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors ... on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, ... to helping service members that have been wounded in battle and their families. Venture ...
(Date:6/24/2016)... ... June 24, 2016 , ... Finally, a bruise cream that ... dermaka cream can be incorporated into the post-surgical treatment plans of a variety of ... , dermaka cream is very effective for bruising and causes a rapid resolution of ...
(Date:6/24/2016)... New York (PRWEB) , ... June 24, 2016 , ... ... marijuana patients optimize the ingestion of their medication by matching users with high quality ... users to compare pieces with no commitment. , Inhale was founded by two brothers, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
(Date:6/23/2016)... BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a ... second affiliate in Latin America . ... ... ... ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
Breaking Medicine Technology: