Senate Proposes Draft for Stricter Compounding Legislation

On April 26th, the Senate introduced a draft legislation that would give the FDA greater authority over compounding pharmacies.  The hope is to eliminate future occurrences of tragic outbreaks like the NECC meningitis events.  The legislation clearly distinguishes between compounding pharmacies and compounding manufacturers.  It also proposes a uniform set of rules for compounding manufacturers while preserving the states' role in traditional pharmacy regulation.  It defines compounding manufacturers as "entities that compound sterile drugs without patient-specific prescriptions and sell the drugs across state lines."  They are differentiating between compounding pharmacies which have that base their products on prescriptions for individual patients.  It further states taht compounding manufacturers are "any entity that pools steril products or repackages sterile, single-use, preservative-free vials."
Compounded drugs will now be considered new drugs that are subject to the Food, Drug, and Cosmetic Act.  Compounders will not be able to compound complex dosages or biologic products.  They also will not be allowed to compound variations of marketed FDA-approved drugs unless the products fulfill a specific patient need or drug shortages occur.  Compounding manufacturers will now be required to register with the FDA and inform them of what products they have made and only compound drugs under a direct pharmacist's oversight.  They also have to comply with current GMPs and label their products appropriately.  Also, only the compounding manufacturer that produced the product will be able to sell that product.
All licensing will still be done by each state, but the bill proposes for more communication between states.  All these changes are in hopes of protecting patients.  That is who we as pharmacists should be the most concerned about and as such, I agree with this new proposed legislation.

Plan B New Age Requirement

The FDA announced on April 30, 2013, that it approved Teva's application to market Plan B One-Step for use without a prescription by women 15 years of age and older. Currently Plan B and other products like it are sold behind pharmacy counters. Individuals must prove they are 17 or older to purchase the emergency contraception without a prescription. The approval of Teva’s application for Plan B One-Step does not affect the age requirements or prescription status of other generics of emergency contraceptives.

Plan B One-Step will now be labeled “not for sale to those under 15 years of age, proof of age required, not for sale where age cannot be verified.” It will also have a code in its label that will prompt the seller to ask for the age of the purchaser. The product will be available in local pharmacies and will be for sale during the retailer’s normal operating hours whether the pharmacy is open or not.

A federal judge's order in April of this year gave the agency 30 days to make the pill available to all girls and women without a prescription, regardless of age. The FDA says the new packaging has nothing to do with that decision. Pharmacists should stay informed on this hot topic to be able to accurately answer any patient concerns or questions about the changes.

New drug for Type II Diabetes

The FDA recently approved a new drug for the treatment of type II diabetes.  Its name: canagliflozin.  It has a novel mechanism for treating diabetes and is classified as a sodium-glucose contransporter 2 (SGLT-2) inhibitor.  It is now the only once daily medication available to improve glycemic control in adults with diabetes when used in conjunction with diet and exercise.  The side effects seem tolerable except the FDA is requiring 5 post-marketing studies on risk of infection associated with canagliflozin. 

Its mechanism allows a way for the patient to control their hyperglycemia without the use of insulin.  This means they won't experience hypoglycemia either from the overadministration of exogenous insulin. The SGLT-2 transporter is responsible for glucose reabsorption in the kidneys.  It also decreases the threshold for glucose in the kidneys and promotes glucose's excretion from the body.

Results from clinical trials showed that both the 100 and 300mg doses improved glycemic control and were associated with reductions in body weight and blood pressure. In addition, the agent was approved as a stand-alone therapy or in combination with other drugs for treating patients with type 2 diabetes, including pioglitazone, metformin, sulfonylurea, and insulin.

The main side effects besides the increase in urination were the infection risks.  Urinary tract infections and genital mycotic infections were seen at higher rates in patients taking canagliflozin.

Be on the lookout for other new drugs in this class of SGLT-2 inhibitors.  Many are in clinical trials currently!