Bill introduced into Colorado to allow prescription drug outlet to distribute compounded drugs for office use to hospitals

SB14-095	Pharmacies Compounding Drugs For Hospitals
Amendments:
Date Introduced:	2014-01-22
Status:	02/11/2014 Introduced In House - Assigned to Health, Insurance, & Environment
Summary:	Under current law, a prescription drug outlet may only distribute compounded drugs for office use to practitioners who are authorized to prescribe drugs. The bill allows a prescription drug outlet to also distribute compounded drugs to a hospital located in Colorado.
Calendar Notification:	Tuesday, March 4 2014 Health, Insurance & Environment Upon Adjournment Room 0107 (1) in house calendar.
Sponsors:	KEFALAS / MCCANN

Baer Law Firm Explains law in Colorado Regarding Compounding Pharmacies and NonResident Compounding Pharmacies Since December 2012

by admin of Baer Law Firm on July 11th, 2013 at 8:33 pm

In late 2012, an outbreak of fungal meningitis brought national attention to compounding pharmacies, the sterility and regulation of their compounded products, and the potential patient risks associated with compounded medications.

At the heart of the outbreak was a medication called methylprednisolone acetate, a preservative free injectable steroid that was produced at the New England Compounding Center (NECC). The medication was later found to be contaminated with mold and resulted in the worst pharmaceutical related public health care crisis in United States history. To date, over 50 people have died and another 700 others sickened as a result of the incident.

Over the past two decades, pharmacy compounding has dramatically changed. Traditionally, pharmacy compounding occurred when a pharmacist combined, mixed or altered various drug ingredients to create a medication for an individual patient in response to a practitioner’s prescription.

Today, however, internet pharmacies and large compounding pharmacies provide new avenues for patients wishing to receive compounded medications. Internet pharmacies send medications to patients all over the United States who may have never been examined or counseled, while some large compounding pharmacies produce enormous amounts of medications that are exact copies of the commercially available products. In both instances, laws are likely being broken, but while the Food and Drug Administration (FDA) has authority to regulate the development and manufacture of new drugs, the states remain the primary regulators of the traditional pharmacy practice.

In response to the horrible fungal meningitis incident, the National Association of Boards of Pharmacy (NABP) launched a nationwide program to identify and inspect compounding pharmacies as it was determined that many states:

1. did not know which pharmacies engaged in compounding;
2. did not know whether pharmacies shipped compounded medications across state lines, and
3. did not know which pharmacies manufactured large quantities of compounded medications.

In December 2012, the Colorado State Board of Pharmacy (Board) mailed affidavits to each of its 566 nonresident pharmacies. In the affidavit, each pharmacy was to attest that they would only dispense and deliver prescriptions into Colorado pursuant to a valid, patient specific prescription order. Each nonresident pharmacy that did not respond had a case initiated against them and the Board requested information detailing the dispensation and/or distribution of all prescription drugs and controlled substances from each nonresident pharmacy for the prior two years.
Ultimately, all nonresident pharmacies must be in compliance with the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act. The nonresident pharmacies that are in violation may face fines in excess of $1,000 per violation

quoted from here.    Pharmacist Attorney
25521 E. Smoky Hill Road
Suite #120, Aurora, CO 80016
720.222.1276

Reminder: Colorado State Board of Pharmacy Meeting Tomorrow March 21, 2013 at 8:30

Agenda includes lots of items relating to compounding, including several complaints against compounders.

Colorado's Position As of December 18, 2012, as to Compounds Filled and Dispensed by Non-Resident Pharmacies

Colorado's Board of Pharmacy issued the following notice to non-resident pharmacies on December 18, 2012:

At its December 10, 2012 meeting, the Colorado State Board of Pharmacy ("Board") directed its staff to outreach to all of the nonresident pharmacies registered with the Board and explain that nonresident pharmacies may not distribute prescription drugs into Colorado. Colorado law only allows nonresident pharmacies to dispense aprescription for a patient and ship that finished prescription into Colorado. Nonresidentpharmacies may not distribute drugs, compounded or otherwise, into Colorado.If a pharmacy wishes to distribute drugs into Colorado, it must be registered as awholesaler in its state of residence and obtain a registration in Colorado as an Out-of-State Wholesaler. Additionally, if the pharmacy wishes to distribute compounded drugsinto Colorado, it must be registered with the Food and Drug Administration as amanufacturer.The Board has directed each nonresident pharmacy it registers to sign the attached affidavit to confirm the pharmacy is aware of Colorado law and will not distribute drugs into Colorado. Please ensure that this affidavit is signed and returned to the Board at the letterhead address or e-mailed to DORA_pharmacyboard@state.co.us no later than January 17,2013. 

To view the actual memo and a copy of the affidavit  Click here 

Colorado Rules That Became Effective January 2, 2013

to view these rules click here

Colorado Veterinary Medical Association Pharmacy Resources Page: Doesn't Every State's Veterinary Medical Association Need This Type of Resource Page for Their Vets?

Pharmacy Issues The following article was printed in the CVMA Voice newsletter in the Winter 2005 issue. Resource Materials for Veterinarians on Pharmacy Issuesfrom the CVMA Task Force on Pharmacy Issues Background CVMA members have expressed confusion and uncertainty in regard to pharmacy issues.  In particular, questions have been raised about the time interval between patient examination and subsequent prescribing of medication, Internet pharmacies, and drug compounding and piracy.  CVMA has developed the following resources to help answer these questions, and has identified other resources on the Internet for which links are provided. In particular, CVMA suggests visiting the AVMA Web site section on prescribing and dispensing at (http://www.avma.org/prescribing/default.asp). Interval between patient examination and subsequent prescribing of medicationCVMA members have asked whether the veterinarian-client-patient relationship (VCPR), as defined in the Colorado Veterinary Practice Act, should include a statement about the time interval between examining an animal patient and subsequently dispensing or refilling medications. The CVMA Task Force on Pharmacy Issues reviewed VCPR definitions from a number of sources and found no instances where such an interval is specified in the definitions.  The absence of a specific interval indicates that one solution does not necessarily fit all circumstances.  Veterinarians must consider an array of factors to make a complex medical decision when prescribing medications.  Dictating an interval might actually serve to diminish the importance of professional discretion. CVMA encourages veterinarians to develop a hospital policy on dispensing and refilling medications, and to communicate this policy to clients.  This policy should include elements such as: a discussion with the client about the disease process, concurrent diseases, and other medications already being administered (if any), the appropriate number of refills (if any), a schedule for re-check examinations, consideration of the accelerated rate of animal aging compared to humans, an understanding of appropriate dose and dosing frequency, and potential adverse effects.  Internet pharmacies A client's request for a written prescription to be filled elsewhere presents an educational opportunity.  The discussion should review the medical, legal, and business aspects of complying with the client's request.  To aid this discussion, CVMA has prepared a client education brochure on Internet pharmacies that can be downloaded atwww.colovma.com and duplicated in your practice.  Veterinarians should be familiar with, and discuss with clients, the "red flags" and risks associated with Internet pharmacies as presented in the client education brochure. In addition, the veterinarian should be aware of the following considerations:

Colorado State Board of Pharmacy Next Meeting Feb. 21, 2013; Agenda Due But Not Posted Yet

Colorado State Board of Pharmacy Meeting
Date:	02/21/2013
Time:	08:30 AM
Title:	Colorado State Board of Pharmacy Meeting
Location:	1560 Broadway Ste 1250C, Denver CO 80202

Colorado State Board of Pharmacy/Division of Professions and Occupations Webinar on Colorado Pharmacy Laws

News

Colorado State Board of Pharmacy Laws & Rules Webinar

This is an opportunity for pharmacists to review the Colorado State Board of Pharmacy Laws and Rules. Special emphasis will be given to laws that went into effect on 7/1/12 and rules that went into effect on 1/1/13. The pharmaceutical inspectors will present the webinar. No C.E.U. will be available for this class. 

• Date: Tuesday, March 12, 2013
• Time: 9:00 - 11:00 a.m.

The following link can be used to register for this webinar. You will receive a confirmation email with further information.

Space is limited.
Reserve your Webinar Seat Now at:
https://www1.gotomeeting.com/register/992955240

System Requirements
PC-based attendees
Required: Windows® 7, Vista, XP or 2003 Server
Macintosh®-based attendees
Required: Mac OS® X 10.5 or newer
Mobile attendees
Required: iPhone®, iPad®, Android™ phone or Android tablet

Colorado Has Filed Complaint Against Brown's Compounding

Click here for link to agenda

News Colorado State Board of Pharmacy Laws & Rules Webinar

This is an opportunity for pharmacists to review the Colorado State Board of Pharmacy Laws and Rules. Special emphasis will be given to laws that went into effect on 7/1/12 and rules that went into effect on 1/1/13. The pharmaceutical inspectors will present the webinar. No C.E.U. will be available for this class. 

• Date: Tuesday, March 12, 2013
• Time: 9:00 - 11:00 a.m.

The following link can be used to register for this webinar. You will receive a confirmation email with further information.
Space is limited.
Reserve your Webinar Seat Now at:
https://www1.gotomeeting.com/register/992955240
System Requirements
PC-based attendees
Required: Windows® 7, Vista, XP or 2003 Server
Macintosh®-based attendees
Required: Mac OS® X 10.5 or newer
Mobile attendees
Required: iPhone®, iPad®, Android™ phone or Android tablet

Source found here

Colorado Veterinary Medical Association's Guidance on Pharmacy Issues, Including Compounding

Pharmacy Issues

The following article was printed in the CVMA Voice newsletter in the Winter 2005 issue.

Resource Materials for Veterinarians on Pharmacy Issues
from the CVMA Task Force on Pharmacy Issues

Background
CVMA members have expressed confusion and uncertainty in regard to pharmacy issues. In particular, questions have been raised about the time interval between patient examination and subsequent prescribing of medication, Internet pharmacies, and drug compounding and piracy. CVMA has developed the following resources to help answer these questions, and has identified other resources on the Internet for which links are provided. In particular, CVMA suggests visiting the AVMA Web site section on prescribing and dispensing at (http://www.avma.org/prescribing/default.asp).

Interval between patient examination and subsequent prescribing of medication
CVMA members have asked whether the veterinarian-client-patient relationship (VCPR), as defined in the Colorado Veterinary Practice Act, should include a statement about the time interval between examining an animal patient and subsequently dispensing or refilling medications.

The CVMA Task Force on Pharmacy Issues reviewed VCPR definitions from a number of sources and found no instances where such an interval is specified in the definitions. The absence of a specific interval indicates that one solution does not necessarily fit all circumstances. Veterinarians must consider an array of factors to make a complex medical decision when prescribing medications. Dictating an interval might actually serve to diminish the importance of professional discretion.

CVMA encourages veterinarians to develop a hospital policy on dispensing and refilling medications, and to communicate this policy to clients. This policy should include elements such as:

a discussion with the client about the disease process, concurrent diseases, and other medications already being administered (if any),
the appropriate number of refills (if any),
a schedule for re-check examinations,
consideration of the accelerated rate of animal aging compared to humans,
an understanding of appropriate dose and dosing frequency, and
potential adverse effects.

Internet pharmacies
A client's request for a written prescription to be filled elsewhere presents an educational opportunity. The discussion should review the medical, legal, and business aspects of complying with the client's request. To aid this discussion, CVMA has prepared a client education brochure on Internet pharmacies that can be downloaded atwww.colovma.com and duplicated in your practice. Veterinarians should be familiar with, and discuss with clients, the "red flags" and risks associated with Internet pharmacies as presented in the client education brochure.

In addition, the veterinarian should be aware of the following considerations:
Consider asking the client if there is some concern or problem that can be addressed to the client's satisfaction. For example, an interest in perceived cost savings might be readily addressed by offering to match the Internet pharmacy's price (including the shipping and handling fees).
Any medically indicated drug therapy should be initiated by the attending veterinarian in the context of a valid VCPR. It is within the veterinarian's purview, not the pharmacist's, to determine the medical criteria whereby a drug is indicated.
Drugs may be prescribed rather than dispensed. The American Veterinary Medical Association and the Colorado State Board of Veterinary Medicine both recommend that veterinarians honor client requests to prescribe rather than dispense medications. In Colorado, prescriptions are considered to be part of the medical record to which the client has reasonable access.
When honoring client requests to prescribe rather than dispense medications, veterinarians should provide a written prescription that the client can present to the pharmacy – rather than providing a voice or fax authorization directly to the pharmacy.
A prescription must be written by the veterinarian who has most recently seen the animal for the medical condition necessitating that particular prescription, since prescriptions require a valid VCPR.
Review appropriate dose, dosing frequency and number of refills with the client. Consider no refills to encourage client communication.
As with any prescription, a written record should be maintained. Consider a prescription pad that provides a duplicate copy for the medical record.
You should suggest the client verify that an Internet pharmacy is properly licensed with the Colorado Board of Pharmacy (go towww.dora.state.co.us/pharmacy/Index.htm and click on Automated License Verification).
Advise the client if he or she purchases a whole bottle of a prescription medication to be sure that the original labeling is intact, including a NADA (New Animal Drug Approval) number.
When honoring a client's request for a prescription, the fact that the prescription will be filled elsewhere does not relieve the prescribing veterinarian of the responsibility to discuss proper use, adverse effects, side effects, need for follow-up appointments or blood work, etc.
Charging for writing a prescription is a gray zone. On one hand, writing a prescription takes time for which the veterinarian should be properly compensated. On the other hand, while Colorado law does not prohibit such a practice, the Colorado Veterinary Practice Act indicates that "obtaining fees for unnecessary services" can be considered unprofessional or unethical.
If you have a concern about the activities of an Internet pharmacy, the AVMA has developed a complaint form (http://www.avma.org/prescribing/complaint_form.pdf) to convey concerns to the Food and Drug Administration and state authorities.


Other helpful resources:
AVMA Position Statement on Internet Pharmacies http://www.avma.org/policies/internet_pharmacies.asp
AVMA White Paper on Rogue Internet Pharmacies http://www.avma.org/prescribing/white_paper.asp
AVMA Prescribing and Dispensing Complaint Form http://www.avma.org/prescribing/complaint_form.pdf


Compounding
Compounding is defined as any manipulation to produce a dosage from a drug other than that manipulation provided for in the directions for use on the label of the approved drug product. A few examples include combining drug agents for anesthesia, incorporating a pill into liquid or capsule forms, or creating certain antidotes.

There is a legitimate need for compounding, which is governed by the Animal Medicinal Drug Use Clarification Act (AMDUCA) since compounding is an extralabel use. Legal compounding can only begin with FDA-approved drugs, yet veterinarians recognize rare instances where unapproved drugs are needed to treat specific non-food animal patients. An excellent brochure explaining veterinary compounding has been produced by AVMA, the Animal Health Institute, and the American Veterinary Distributors Association at http://www.avma.org/compounding/brochures.asp.

Colorado Veterinary Statutes, Regulations and Policies Relating to Dispensing and Prescribing Drugs

Colorado Statutes 12-64-111. Discipline of licensees provide that:


(1) Upon receipt of a signed complaint by a complainant or upon its own motion, the board may proceed to a hearing in conformity with section 12-64-112. After a hearing, and by a concurrence of a majority of members, the board may deny a license to an applicant or revoke or suspend the license of, place on probation, or otherwise discipline or fine, a licensed veterinarian for any of the following reasons:

***

(aa) Administering, dispensing, distributing, or prescribing any prescription drug other than in the course of a veterinarian-client-patient relationship, except in accordance with section 12-64-104(2)(b);

Colorado Regulations:


8. Prescription Drugs
Veterinarians may only prescribe medication when they have a VCPR with the patient. Under federal and state law, veterinarians may not sell, distribute, dispense or participate in or arrange for the sale of prescription medicines in any fashion except through a VCPR or in compliance with Rule V. Veterinarians are charged with knowledge of the pharmacy practice act provisions that apply to their practice, as well as the laws and regulations of the federal food and drug administration. When a client requests a copy of a prescription for their animal under current treatment, the veterinarian must provide it to the client.



RULE V. WAIVER OF VETERINARIAN-CLIENT-PATIENT RELATIONSHIP FOR ADMINISTERING, DISTRIBUTING, DISPENSING, OR PRESCRIBING IN AN EMERGENCY SITUATION ONLY
(Adopted November 3, 2011, Effective December 30, 2011)
A. If a licensed veterinarian who has an established veterinarian-client-patient relationship (VCPR) with a patient prescribes a prescription drug that the licensed veterinarian does not have in stock and is not available at a local pharmacy, then in an emergency situation ONLY another licensed veterinarian who does not have a VCPR with that same patient may administer, distribute, or dispense a prescription drug to that patient based on the examining veterinarian’s expertise and established VCPR with the patient as long as the following requirements are met:


1. The examining veterinarian with the VCPR must document the emergency and the immediate need for the prescription drug;
2. The examining veterinarian with the VCPR must document his or her efforts to obtain the prescription drug from a local pharmacy, including documentation of contact with at least 1 pharmacy in the general proximity of the examination location that does not have the prescription drug immediately available;
3. The examining veterinarian must provide a written prescription;
4. The examining veterinarian must have direct communication with the dispensing veterinarian; and
5. The licensed veterinarian who administers, distributes, or dispenses the prescription drug on behalf of the examining veterinarian must document the date the prescription is administered, distributed, or dispensed.

B. "Emergency" as defined in Rule I.C is limited in application to this rule

The regulations provide the following fines for the failure to provide a written prescription:


3. Failure to Provide a Written Prescription
a. $250 for the 1st violation
b. $500 for the 2nd violation
c. Up to $1,000 for the 3rd or subsequent violation





Colorado State Board of Veterinary Medicine
Policies & Guidelines Effective: June 2011
Page 8
Board Guideline Regarding Prescription Medications
The Colorado State Board of Veterinary Medicine believes that the appropriate prescribing, dispensing, and administration of prescription and other medications is a crucial element in the treatment of animal patients. Veterinarians should only prescribe medications for animals with which they have a veterinary-client-patient relationship. Veterinarians may dispense medications for the animals under their care. Should a client ask for a written prescription for an animal being seen by a veterinarian, the veterinarian should supply that written prescription, as it is a part of the animal’s medical record, and the owner has a right to that record pursuant to C.R.S. 12-64-120 (2003). However, at any time, if supplying the prescription would compromise or risk the animal’s health, the veterinarian should decline to provide it and inform the owner what is required in order to address the animal’s health concerns. Internet pharmacy sale of prescription medications is legal if the veterinarian involved has a valid client patient relationship with the animal for which he is supplying the medications. In addition, he must have prescribed an appropriate medication for that animal, which is always the case whether by internet or other means. Veterinarians are authorized providers under the law and may procure, store, and dispense whatever medications they prescribe for their patients. Whether or not internet business constitutes a “pharmacy” under state law is an issue for the Colorado State Board of Pharmacy to determine. The sale of nonprescription drugs in Colorado is largely unregulated. Internet pharmacy sale of such medications is legal, as is sales of these medications in any animal supply store.

Colorado Board of Pharmacy Disciplinary Action

The Colorado Board of Pharmacy Disciplinary Action can be viewed here.  The actions are arranged by month and year.

New Pharmacy Rules in Colorado

In Colorado, the Pharmacy Sunset bill, HB 1311, passed House and Senate and was signed by the Governor. Most law changes went into effect on July 1, 2012.  To review the Pharmacy Sunset Bill, HB 1311, (which is 144 pages) click here.