Medication Use Increases In Newly-Diagnosed Dementia Patients
Sydney, 22 April 2018: Researchers have found an increase in medication use by the patients who have been newly-diagnosed with dementia and they may consume unnecessary or inappropriate medicines that increase the risk of side effects.
WHO Recommends Testing Before Use Of Sanofi's Dengue Vaccine
PARIS/CHICAGO, 20 APRIL 2018: The World Health Organization (WHO) said on Thursday Sanofi's vaccine against dengue should only be used after testing on individuals to assess whether they have ever been exposed to the infection.
US FDA Finalizes ICH Q7 Questions And Answers On GMPs For APIs
Maryland, 19 April 2018: The US Food and Drug Administration (FDA) on Thursday finalized the International Council for Harmonisation’s (ICH) Q7 question and answer guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs).
US FDA Issues Guidance On Developing New Genetic Tests For Diagnosis And Treatment Of Disease
Maryland, 18 April 2018: The US Food and Drug Administration (FDA) has issued two sets of guidance to drive the design, development and validation of new genetic and genomic-based tests using next generation sequencing (NGS).
Alliance For Safe Online Pharmacies Launches ASOP Canada To Protect Canadians From Unsafe Medicine
Toronto, 6 April 2018: The Alliance for Safe Online Pharmacies (ASOP Global) has launched a local chapter in Canada to better protect Canadians from the illegal online sale of medical products. ASOP Canada joins ASOP Global's community in the United States, Europe, China, India and other regions to address illegal online sellers and protect consumers/patients from the sale of falsified, substandard and unapproved medicines by Health Canada.
Resources To Help Law Enforcement Offices Stay Safe From Fentanyl
April 23, 2018: Official figures for the human cost of the opioid crisis in 2017 are not yet in, but news reports from around the country make it clear that this crisis is far from over. The addition of fentanyl has increased the danger to members of the public and also to law enforcement officers. In response, law enforcement organizations have developed resources to help officers keep safe.
New Hampshire Couple Who Distributed Millions Of Misbranded Pills Headed To Jail
April 20, 2018: The U.S. Department of Justice (DOJ) announced the sentencing of a New Ipswich, New Hampshire couple for their roles in a scheme to distribute misbranded prescription drugs purchased from India to customers around the U.S. John Hayes received a 30-month sentence and Plabpleung Hayes will serve one year and one day in prison.
Frequently Asked Questions
Q. Does quality of medicines matter?
Ans: Yes, it matters.
Medicines including vaccines save lives and prevent diseases and epidemics only if they are safe, efficacious, of good quality and are used rationally. The use of unsafe, substandard, ineffective and Spurious/falsely-labelled/falsified/counterfeit medical products (SFFC) and vaccines can be harmful to the health and well being of the individual patient as well as to a wider section of the population. They also undermine confidence in the health service, health professionals who treat patients, prescribers, as well as those who manufacture, distribute and dispense/sale medicines.
The purchase of unsafe, substandard, ineffective and SFFC medicines is a waste of money for the government, the individual patient and the public.
Q. What should be done to ensure the safety, efficacy and quality of medicines?
Ans: Governments must regulate the manufacture, export, import, storage, distribution, supply and sale of medicines to ensure the safety, efficacy and quality of medicines.
Governments have to establish strong national medicines regulatory authorities (NMRAs). To enable the NMRAs to operate effectively, governments have to provide strong political support, adequate and sustainable human, financial and other resources, and legal power for enforcement. Ineffective regulation and control can result in the proliferation of unsafe, ineffective, substandard and SFFC medicines.
In addition, manufacturers have to produce medicines in accordance with good manufacturing practice (GMP) requirements and distributors have to store and distribute medicines in accordance with good storage and good distribution practices as provided in the WHO guidelines (Guide to good storage practices for pharmaceuticals, Annex 9, WHO Technical Report Series 908, 2003: http://whqlibdoc.who.int/trs/WHO_TRS_908.pdf#page=135 and Good distribution practices for pharmaceutical products, Annex 5, WHO Technical Report Series 937, 2006: http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf#page=191 )