Licencing & drug recall of 2014 & 2015

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Presentation on: LICENCING & DRUG RECALL OF 2014 2015 Presenting by: Tahira Sultana, Fariha Aziz, Aisha Faheem, Tasaduq, Hamed, Shibly Shakil IHM,DUHS Regulatory affairs

Transcript of Licencing & drug recall of 2014 & 2015

LISENCING & DRUG RECALL OF 2014 2015

Presentation on:LICENCING & DRUG RECALL OF 2014 2015

Presenting by: Tahira Sultana, Fariha Aziz, Aisha Faheem, Tasaduq, Hamed, Shibly ShakilIHM,DUHS

Regulatory affairs

Licensing

It indicates- all the proper checks and the benefits of a medicine believed to outweigh the risks.

Licenses are granted- when high standards of safety and quality are met during the development and manufacture of a medicine.

In the UK, licenses can be granted by:theMedicines and Healthcare Product Regulatory Agency (MHRA) grant licenses for medicines only in the UK.

Drug Regulatory Authority of Pakistan (DRAP) grant licenses for medicines in Pakistan.

What information does a license include?

The license for a medicineincludes information such as:what health condition it should be used to treatwhat dose should be usedwhat formit takessuch as a tablet or liquidwho can use the medicinefor example, only people above a certain agehow long treatment with that medicine should lastwarnings about known safety issuessuch as side effects and interactions with other medicineshow the medicine should be storedwhen the medicine expires

Unlicensed medicines

Unlicensed medicines are commonly used in some areas of medicine such as in pediatrics, psychiatry and palliative care. They are also used, less frequently, in other areas of medicine.

Off-label use means that the manufacturer of the medicine has not applied for a license for it to be used to treat your condition. In other words, the medicine has not undergone clinical trials to see if it is effective and safe in treating your condition.

Many experts will use an unlicensed medication if they think the medication is likely to be effective and the benefits of treatment outweigh any associated risk.

Types of License:Form-6 License:This type of Drug Sales license should be used for Retail sales of Medicines.

Form-8 License:This type of Drug Sales license should be used for Pharmacy type sales of Medicines.

Form-9 License:This type of Drug Sales license should be used for sales of Narcotics Medicines by all ways like (Retail, Whole sale or Manufacturer).

Form-7(a) License:This type of Drug Sales license should be used for the sales of Medicines by way of Whole Sale or Distribution.

Form-7 License:This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indenters and Manufacturers.

Drug Recall:-Actions taken by firm to remove drug from market.

Conduct by a firms own initiatives.

OR

May conduct by FDA order under statutory authority.

DRUG RECALL DATA OF 2014

1- HospiraDateBrand NameProduct DescriptionReasonCompany

12/23/2014HospiraMitoXANTRONEHospira Inc.

Due to confirmed sub potency and elevated impurity levels.

2-BaxterDateBrand NameProduct DescriptionReasonCompany12/11/20140.9% Sodium Chloride Injection USPContains Particulate Matter

BaxterBaxter International Inc.

3-GastrotecDateBrand NameProduct DescriptionReasonCompany

12/12/2014GastrotecCombination of Omeprazole and Misoprostol in a pasteNot approved for use as an animal drugTristar Equine Marketing, LLC.

4-Heart Sync Inc.DateBrand NameProduct DescriptionReasonCompany

11/26/2014Heart SyncMulti-function Defibrillation ElectrodesElectrodes will not connect with Philips FR3 or FRx AED units.Heart Sync Inc.

5- Forever Beautiful

DateBrand NameProduct DescriptionReasonCompany

11/19/2014Forever BeautifulDietary Supplement Unapproved new drugREFA Enterprises, LLC

6- Mayhem dietary supplement capsulesDateBrand NameProduct DescriptionReasonCompany

11/14/2014Mayhem dietary supplement capsulesDietary Supplement Unapproved new drugChaotic Labz

7- Sagent Pharmaceuticals

DateBrand NameProduct DescriptionReasonCompany

10/03/2014Sagent PharmaceuticalsKetorolac Tromethamine Injection, USP, 30mg/mL single-dose vials Due to labeling the product with the incorrect expiration date/The labeled expiration date is longer than the known stability of the product.Sagent Pharmaceuticals

8- Wyked Labs and Anabolic Science LabsDateBrand NameProduct DescriptionReasonCompany

12/12/2014Wyked Labs and Anabolic Science LabsDietary supplement capsules used for body building and weight lossUndeclared Synthetic Hormone/Prohormone IngredientWyked Labs

9- ABC Dophilus PowderDateBrand NameProduct DescriptionReasonCompany11/17/2014ABC Dophilus PowderDietary SupplementContains Rhizopus oryzaeSolgar, Inc.

10- SabaDateBrand NameProduct DescriptionReasonCompany10/17/2014SabaSalmonellaAMS Health Sciences, LLC

Shark Cartilage Complex Dietary Supplement

11- Pharmacy CreationsDateBrand NameProduct DescriptionReasonCompany09/06/2014Pharmacy CreationsAscorbic Acid, Glutathione, Magnesium Chloride, Tropi/Cyclo/Phenyl/Tobra/FlurbLack of sterility assurancePharmacy Creations

12- RegeneSlimDateBrand NameProduct DescriptionReasonCompany08/27/2014RegeneSlimAppetite control dietary supplement Presence of 1,3-dimethylamylamine (DMAA), methylhexanamine, or geranium extractRegeneca Worldwide, a division of VivaCeuticals, Inc.

13- Vibrant Health

DateBrand NameProduct DescriptionReasonCompany08/01/2014Vibrant HealthDietary Supplements: Green Vibrance and Rainbow VibranceSalmonellaNew England Greens LLC

14- American Health PackagingDateBrand NameProduct DescriptionReasonCompany07/21/2014American Health PackagingIbuprofen Tablets, 600 mg & Oxcarbazepine Tablets, 300 mg mislabeled inner unit dose blister packagingAmerican Health Packaging

15- B-LipoDateBrand NameProduct DescriptionReasonCompany12/19/2014B-LipoDietary supplement capsules used for weight loss Undeclared Drug IngredientBethel Nutritional Consulting, Inc.

DRUG RECALL DATA OF 2015

DateBrand NameProduct DescriptionReasonCompany12/01/2015OmniPodOmniPod Insulin Management System Failure to deploy or delay in the deployment of the needle mechanismInsulet Corporation

16-Omni Pod

DateBrand NameProduct DescriptionReasonCompany06/12/2015PyrolaAdvanced Joint Formula capsules undeclared diclofenac and chlorpheniramineG&C Natura

17-Pyrola

DateBrand NameProduct DescriptionReasonCompany06/03/2015Smart LipoSmart Lipo (800, 900, 950 mg) capsules Undeclared sibutramine, desmethylsibutramine, and phenolphthalein.SmartLipo365

18-Smart Lipo

DateBrand NameProduct DescriptionReasonCompany04/22/2015Mucinex Fast-MaxMucinex Fast-Max Incorrect labeling - Undeclared levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or DiphenhydramineRB (formerly Reckitt Benckiser)

19-Mucinex Fast-Max

DateBrand NameProduct DescriptionReasonCompany11/25/2015Glades DrugsCompounded Multivitamins Contains high amounts of Vitamin D3Glades Drugs

20-Glades Drugs

DateBrand NameProduct DescriptionReasonCompany10/30/2015Auvi-QEpinephrine injection, USP (0.15 mg and 0.3 mg) Potential Inaccurate Dosage DeliverySanofi US

21-Auvi-Q

DateBrand NameProduct DescriptionReasonCompany10/09/2015Medline Industries, Inc.Over the counter Acetaminophen tablets. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets.Medline Industries, Inc.

22-Medline Industries, Inc.

DateBrand NameProduct DescriptionReasonCompany07/30/2015UnichemHydrochlorothiazide Tablets 25 mg 1000-count bottle Potential presence of foreign tabletsUnichem Pharmaceuticals (USA), Inc.

23-Unichem

DateBrand NameProduct DescriptionReasonCompany07/13/2015Mylan Institutional LLCCalcium Chloride Intravenous Infusion 10% in 10 mL prefilled glass syringes Incompatibility between syringe and needleless adaptersMylan Institutional LLC

24-Mylan Institutional LLC

25- Medline Industries, Inc.DateBrand NameProduct DescriptionReasonCompany10/09/2015Medline Industries, Inc.Over the counter Acetaminophen tablets. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets.Medline Industries,

26- REFRESH, FML and BlephamideDateBrand NameProduct DescriptionReasonCompany08/24/2015REFRESH, FML and BlephamideREFRESH Lacri-Lube, REFRESH P.M., FML (fluorometholone ophthalmic ointment) and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) Contains particulate matterAllergan plc

27- Teva Parenteral Medicines Inc.

DateBrand NameProduct DescriptionReasonCompany07/24/2015Teva Parenteral Medicines Inc.Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) Potential presence of particulate matterTeva Parenteral Medicines Inc.

28- Akttive

DateBrand NameProduct DescriptionReasonCompany07/23/2015AkttiveHigh Performance Fat Burner Gold capsules Undeclared Drug IngredientsLife & More, LLC

29-PharMEDiumDateBrand NameProduct DescriptionReasonCompany12/31/2015

PharMEDium

Norepinephrine Bitartrate added to Sodium Chloride

Discoloration

PharMEDium Services, LLC

DateBrand NameProduct DescriptionReasonCompanyDec 2015Effexor XRAntidepressant(venlafaxine HCl)packaging mix-up /capsule of the (dofetilide) was found in a bottle of antidepressant Effexor XR pfizer

30-pfizer

The government should develop the infrastructure and expertise required for basic drug manufacturing. it should ensure local production of drugs whose patents have run out to lower the prices of drugs. it should allow import of basic raw materials from India in view of the latter's expertise in this sector till Pakistan's pharmaceutical industry comes of age. Despite of all this, many developing WTO member countries have granted compulsory licenses for patented essential medicines .it is crucial time that Pakistan must ensure that drugs are available in domestic markets at affordable prices as lives and health of millions of its people depend on access to these medicines.conclusion

It'stoo easy for drug manufacturers to continue to save dollars instead of lives

It's difficult to inform patients when drugs are are recalled.We can all likely agree we're lucky drugs aren't recalled as frequently as cars.But when the Food and Drug Administration or a manufacturer recallsmedicine, it's particularly troublesome because getting to the patient who is prescribed that medicine is not as easy as informing people who drive a Chevy Cobalt with a faulty ignition, or one of 34 million owners with defective air bags.