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!

FDA Wants Stronger Authority Over Compounding Pharmacies

The House of Representatives met on April 16th to address concerns from the FDA and their desire to have more regulatory authority over compounding pharmacies. Late last year, many cases of meningitis broke out due to non-sterile compounding practices by the now closed New England Compounding Center (NECC). Many people died and even more fell ill.  Since this tragedy, the FDA has been pushing for stricter, more powerful authority over compounding pharmacies. Hospitals have begun to rely on these pharmacies to produce many of their sterile products.  As a result, hospitals are buying their needed compounded medications from anywhere in the United States. This has led to an increase in the need for federal regulation due to the states' limited authority.
The FDA stated that the need for increased legislation is obvious and needed if they are to do their job properly.  The Democrats seem to be on the side of the FDA while the Republicans are not so convinced. A Republican from Texas stated that " new legislation takes a lot of time....especially with the current political environment. Don't blame your tools. Do your work."  The FDA commissioner fired right back saying, " We need new tools."
As of right now, it remains unclear whether new legislation will be passed, but I think one thing is clear- Americans can't afford another tragedy like this one.

USPS to Remain Delivering Meds on Saturdays

As many of you probably know, the United States Postal Service will not be delivering mail on Saturdays for much longer.  They mandated that all mail will still be delivered 6 days a week until September 30th of this year and after that date, move down to only delivering mail 5 days a week. Basically the only mail that won't be delivered on Saturdays is just the standard envelope mail (so remember to send your birthday cards for your loved ones a couple days earlier now). They will still be delivering express, priority, and first-class post and parcels, as well as, some international packages. With more and more people switching to mail-order pharmacies, the potential for delayed deliveries could pose a problem.  Currently, most mail delivered medications are delivered by one of the above mentioned routes so the problem may end there. The heads of US Department of Veterans Affairs of Consolidated Mail Outpatient Pharmacy met with the USPS heads and were assured that the USPS understands their position and will do their best to accommodate mail-order pharmacies' needs.
From my small town, mom and pop pharmacy position, I almost wish the USPS wouldn't have been so willing to bend to their needs.  Not that I want harm done to patients who need their medications, but the delay may allow for more business to return to our side.

New Vaccination Bill Put Into Law

IPA reported on March 29, 2013 that the proposed new immunization bill was successful signed by Governor Branstad on the 28th and put into law.  The new law will now allow certified pharmacists to adminiter a number of vaccines. 
One new portion of the bill now allows pharmacists to administer the influenza vaccine to anyone 6  years of age and older.  The older law only allowed people 18 and older to get the influenza vaccine without a prescription.  Now worried parents can bring their children into a participating pharmacy to get them vaccinated without the hassle of having to obtain a prescription from their physician beforehand.
The second main part of the new bill allows pharmacists to administer vaccines recommended by the United States centers for disease control and prevention advisory committee on the approved vaccination schedule for adults.  They also expanded this to include vaccines approved for international travel. 
Pharmacists will now also be able to adminster Tdap (tetnus, diptheria, acellular pertussis) booster vaccinations.  
There will be an official signing ceremony on April 5th.

Go pharmacists!
So come on down to your local pharmacy and see what we can do for you! 

CMS cuts reimbursement for DTS

According to APhA's Focus newsletter released March 19th, Medicare will drastically cut reimbursement for current diabetes testing supplies.  Starting July 1, 2013, the goal is to reduce reimbursement amounts to the national mail-service fee schedule.  This means the amount reimbursed will be $22.47 for 100 test strips and 100 lancets.  This reduction in reimbursement correlates with the expansion of Medicare's current Durable Medical Equipment into the new Durable Medical Equipment, Prosthestics, Orthotics, and Supplies (DMEPOS).  They have initiated their Competitive Bidding Program which apparently "has saved millions for taxpayers and beneficiaries".  However, this incredibly low reimbursement means that community pharmacies currently participating in the program may have to consider dropping it.  Most community pharmacies are paying more than the proposed reimbursement amount and would constantly be losing money on every transaction.  They will have to find a balance between pleasing patients and their bank accounts.  Moreover, July 1 will also mark the end to many community pharmacies being able to deliver to Medicare patients that are homebound or live in assisted-living facilities.  These patients will now only be able to receive their testing supplies through the mail by companies that have contracts with CMS to provide mail order service.  This creates another deficit to community pharmacies who serve assisted-living patients.  Not only will this change affect pharmacies, but patients as well.  Pharmacists are there to counsel patients, discuss testing strategies, as well as outcomes, and work with physicians to provide the optimal treatment plans.  This will no longer exist.  Yes patients will be receiving their diabetes testing supplies cheaper, but their optimal outcome may decline.
This change will have a severe impact on the community pharmacy I am currently working in and we will have to decide if we wish to continue the program or not.  Final decisions have to be made by April 15 of this year.  We also offer diabetes education services, but the reimbursement changes for these services is currently unknown.  Many community pharmacies may be opting out of the program altogether and the impact on patients is yet to be established.  Right now it is just a waiting game.