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Barcode Five Rights System

Use Barcode to prevent medication errors

ADERS ® is a barcode point of care, (BPOC), solution

Practical Compliance Solutions, Corp. helps care facilities reduce risk at the patient's bedside. Our five rights barcode solution is the easiest to implement. Our barcode point of care system can help prevent medication errors in hospitals, long term care facilities, and assisted living communities.

ADERS ® is our barcode solution for the healthcare industry. It helps eliminate medication errors by allowing caregivers to scan NDC barcodes at the patient's bedside, verifying right patient, right drug, right time, right dose, and right route of administration. For more information click the products menu or send us a web request from our Contact menu. Ask for a DEMO CD. It is the full product that is licensed for an evaluation period.

We are offering a 30 day no-obligation free trial of the ADERS ® software. Care facilities can easily determine if ADERS ® is right for them by using the software as a pilot for a single unit or ward. Click here to download a Microsoft Project plan showing how you can implement a five rights point of care barcode pilot in less than a week. If you Don't own MS Project 2003, then here is a PDF copy just to see.... Download Adobe PDF Data Sheet

View a PowerPoint Presentation of ADERS ®.

Get The Latest Patient Safety and Drug Safety Updates from the FDA

FDA Press Releases RSS Feed

Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions
Thu, 07/18/2019 - 13:59

A federal court ordered an Arkansas company to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.

FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes
Thu, 07/18/2019 - 12:20

“Remove the Risk” to raise awareness about proper disposal of prescription opioids

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids
Thu, 07/18/2019 - 12:15

Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections
Wed, 07/17/2019 - 08:34

FDA approved Recarbrio, an antibacterial drug to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes
Mon, 07/15/2019 - 15:12

FDA issues statement on actions to tackle youth vaping epidemic and court ruling on application deadlines for certain tobacco products, including e-cigarettes

FDA approves new treatment for refractory multiple myeloma
Wed, 07/03/2019 - 12:43

FDA grants accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other form

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards
Tue, 07/02/2019 - 10:20

FDA has issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice (CGMP) requirements

Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear
Mon, 07/01/2019 - 09:15

FDA is issuing two new draft guidances on drug labeling, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format and Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic

FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps
Thu, 06/27/2019 - 14:58

FDA warns patients and providers that certain Medtronic MiniMed insulin pumps are recalled due to potential cybersecurity risks and recommends patients switch to models better equipped to protect against these potential risks.

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system
Thu, 06/27/2019 - 13:51

FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease
Thu, 06/27/2019 - 11:51

This press release highlights an update on the FDA’s investigation into a potential connection between certain diets and cases of canine heart disease

FDA approves first treatment for chronic rhinosinusitis with nasal polyps
Wed, 06/26/2019 - 13:42

FDA approves Dupixent to treat adults with nasal polyps accompanied by chronic rhinosinusitis or prolonged inflammation of the sinuses and nasal cavity.

Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products
Tue, 06/25/2019 - 15:20

Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses
Tue, 06/25/2019 - 14:20

FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC– for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women
Fri, 06/21/2019 - 17:09

FDA approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
Fri, 06/21/2019 - 13:05

FDA expanded the indication for Symdeko for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.

Statement on agency’s efforts to increase transparency in medical device reporting
Fri, 06/21/2019 - 11:14

The FDA is taking a number of important steps to update its Medical Device Reporting Program.

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics
Thu, 06/20/2019 - 09:36

FDA issues a new draft guidance on the application of the benefit-risk assessment framework for evaluating applications for opioids.

Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products
Wed, 06/19/2019 - 11:00

This is a statement regarding the FDA’s new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products.

Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
Tue, 06/18/2019 - 14:22

FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).

What's New: Drugs RSS Feed

Some Medicines and Driving Don’t Mix
Thu, 07/18/2019 - 18:05

Most medications won’t affect your ability to drive safely. But some do. The FDA advises to make sure you know if your prescription or over-the-counter medication can cause side-effects that may make it unsafe to drive.

Hospira Issues A Voluntary Nationwide Recall For Labetalol Hydrochloride Injection, USP, Due To The Potential Of Cracked Glass At The Rim Surface Of The Vials
Thu, 07/18/2019 - 16:10

Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus® (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.

Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
Thu, 07/18/2019 - 14:50

Guidance clarifying the requirements of FDA regulations on human subject protection (21 CFR part 50) and IRBs (21 CFR part 56) and the Department of Health and Human Services' Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”).

CDER Small Business & Industry Assistance (SBIA)
Thu, 07/18/2019 - 14:50

This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience.

What's New Related to Drugs
Thu, 07/18/2019 - 14:45

Want to know what's new? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Piperacillin and Tazobactam For Injection 3.375 Grams Per Vial, Due to Presence of Glass Particulates
Thu, 07/18/2019 - 14:45

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.

Newly Added Guidance Documents
Thu, 07/18/2019 - 14:45

Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

All Guidances for Drugs
Thu, 07/18/2019 - 14:40

All Guidances for Drugs

Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document
Thu, 07/18/2019 - 14:38

Electronic Submissions and Clinical/Antimicrobial.

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement - 10/23/2018 - 10/24/2018
Thu, 07/18/2019 - 14:15

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Hospira Issues a Voluntary Nationwide Recall for Hydromorphone HCL Injection, USP CII Due to The Potential for Empty or Cracked Glass Vials
Thu, 07/18/2019 - 14:10

Hospira, Inc., a Pfizer company, is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results
Thu, 07/18/2019 - 14:05

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals.

Drug Master Files (DMFs)
Thu, 07/18/2019 - 13:35

Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. FDA provides info on DMF list, status of DMF, types of DMF, and more.

Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products
Thu, 07/18/2019 - 12:50

Bayer is voluntarily recalling Alka-Seltzer Plus® packages that:

• Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018.
• Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall (please see attached photos).

The affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton.


BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes
Thu, 07/18/2019 - 12:10

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it is updating the instructions for use of certain BD Vacutainer® tubes as part of its quality process to ensure that customers understand the appropriate uses of these products.

Emergency Use Authorization
Thu, 07/18/2019 - 11:45

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

N-Molecular Inc. d.b.a. SOFIE - 553833 - 09/24/2018
Thu, 07/18/2019 - 11:15

CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

N-Molecular Inc. d.b.a. SOFIE - 553833 - 07/02/2019
Thu, 07/18/2019 - 11:10

CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

Hangzhou Facecare Cosmetics Co., Ltd. - 537146 - 06/28/2019
Thu, 07/18/2019 - 11:10

CGMP/Finished Pharmaceuticals/Adulterated

Recently Issued Guidance Documents
Thu, 07/18/2019 - 10:25

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Whats New Vaccines Blood Biologics RSS Feed

Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
Thu, 07/18/2019 - 14:50

Guidance clarifying the requirements of FDA regulations on human subject protection (21 CFR part 50) and IRBs (21 CFR part 56) and the Department of Health and Human Services' Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”).

What’s New for Biologics
Thu, 07/18/2019 - 13:00

Latest news from the Center for Biologics Evaluation and Research

Emergency Use Authorization
Thu, 07/18/2019 - 11:45

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

Roster of the Cellular, Tissue and Gene Therapies Advisory Committee
Thu, 07/18/2019 - 10:30

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

Recently Issued Guidance Documents
Thu, 07/18/2019 - 10:25

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Application Submissions Guidances
Thu, 07/18/2019 - 10:20

This page lists Application Submissions Guidance documents.

Jobs at the Center for Biologics Evaluation and Research (CBER)
Thu, 07/18/2019 - 09:15

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

Consumer Updates
Wed, 07/17/2019 - 15:35

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

Antimicrobial Resistance Information from FDA
Wed, 07/17/2019 - 12:40

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

Workshops, Meetings & Conferences (Biologics)
Wed, 07/17/2019 - 09:40

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop - 09/16/2019 - 09/17/2019
Wed, 07/17/2019 - 09:22

The purpose of the public workshop is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for use in the development of preventive vaccines for infectious diseases indications.

ALPROLIX
Wed, 07/17/2019 - 08:40

Product approval information is indicated for adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes, (2) Perioperative management, (3) Routine prophylaxis to reduce the frequency of bleeding episodes.

Senior Staff Fellow/Visiting Scientist – Molecular Virologist (Biologist), RG-0401
Wed, 07/17/2019 - 08:35

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), Division of Emerging and Transfusion Transmitted Diseases (DETTD) is recruiting to fill a Senior Staff Fellow position to serve as a Principal Investigator in the Laboratory Molecular Virology

MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Tue, 07/16/2019 - 13:45

MedWatch home page

Testing for Biotin Interference in In Vitro Diagnostic Devices
Tue, 07/16/2019 - 13:45

Testing for Biotin Interference in In Vitro Diagnostic Devices, Draft Guidance for Industry, CBER, Biologics

Blood Guidances
Tue, 07/16/2019 - 12:55

This page contains a listing of Blood Guidances guidances.

FluMist Quadrivalent
Tue, 07/16/2019 - 12:40

For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack
Tue, 07/16/2019 - 11:32

For the in vitro detection of antibodies to Human Immunodeficiency virus types 1 and/or 2 in human serum and plasma.

Clinical Investigator Inspection List A-D
Tue, 07/16/2019 - 11:32

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

Clinical Investigator Status (Biologics)
Tue, 07/16/2019 - 11:31

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER


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