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Editorial: Misrepresentations by the Press

Those keeping up with the events in Massachusetts have no doubt read many accounts of the events and the answers to questions posed to pharmacy leadership by the press. Most reporters have very little, if any, knowledge of pharmacy compounding and are either unaware or seemingly don't care if they are not accurate and complete in their reporting.

A specific comment I would like to address is that some reports have misquoted statements that say that compounders want lower standards. This is absolutely false! Pharmacists, pharmacy compounding leadership, and company CEOs involved in providing support to compounding pharmacies want strong quality standards, and they work hard for strong quality standards.

What many reporters do not understand is that there is a difference in Good Manufacturing Practices (GMPs) that are required for FDA-registered manufacturers and the legal standards for compounding developed by the United States Pharmacopeia (USP) and the state boards of pharmacy. USP standards are enforceable by both the FDA and the state boards of pharmacy.

GMP requirements are for those companies mass-producing very large batches of product, whereas pharmacy compounding standards are for individual or small batches. GMPs require extensive time, money, and personnel and have regulatory departments that maintain documentation, etc. for GMPs, which take a lot of time to validate, etc. For most compounding pharmacies, a patient has a prescription (or if the patient is hospitalized, a doctor's order) and is waiting for that medication and needs it NOW, not 12 months from NOW! Consequently, there is a difference in scale and time involved in separating manufacturing GMPs and compounding USP standards.

The USP compounding standards are developed by experts in the field (pharmacists, microbiologists, engineers, chemists, practitioners, etc.) and are open for review and comment to all interested parties. They are designed to protect the patient and the pharmacist and still provide medications to meet the needs of our complex healthcare system in a timely manner. The USP standards are constantly under review and are revised as necessary. If these standards are not followed, then adverse events, including death, can result.

The pharmacy compounding leadership strongly supports these standards and do NOT want them relaxed. It would be nice if the press knew what they were talking about before publishing their articles to millions of readers that are looking for the truth!


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington-The Science and Practice of Pharmacy

Lapses at PHARMA Factories Add to Danger and to Shortages
"Weevils floating in vials of heparin. Morphine cartridges that contain up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and—in one memorable case—a barrel of urine" have been reported from FDA inspections. These recent quality lapses at large PHARMA companies illustrate that contamination and shoddy practices extend well beyond compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.

In the last three years, six of the major FDA-registered manufacturers of sterile injectable drugs have been warned about serious violations of manufacturing rules. Four of them have either closed their plants or significantly slowed production to fix the problems. The Congressional Report states that nearly a third of the industry's manufacturing capacity is off line because of quality issues.

These shutdowns have contributed to a shortage of critical drugs and compounding pharmacies have stepped up to fill the gap. "In the industry, everyone knows that all of the factories are in terrible shape," said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. But the public, she said, is still in the dark. "I think people think this is a foreign outsourcing problem, but these factories are in our own country."
http://www.nytimes.com/2012/10/18/business/drug-makers-stalled-in-a-cycle-of-quality-lapses-and-shortages.html?_r=0

Global Supply Chain, Regulatory Gaps Raise Drug Safety Concerns Emphasized by the Meningitis Outbreak
Pharmaceuticals available in the U.S. could have come from anywhere, and everywhere, in the world. The active ingredient might have been sourced from China, and fillers, binders, and other inactive ingredients could have come from India. These ingredients could have been processed in Germany and sent through Canadian middlemen to the U.S. for final production and distribution.

So, current pharmaceuticals are the result of a vast, interconnected global web of raw materials suppliers, chemical producers, brokers, resellers, drug manufacturers, and distributors and is a system that operates largely outside of the public's consciousness, except when a breakdown puts lives at risk—such as the fungal meningitis outbreak linked to contaminated steroid injections.

The outbreak has prompted more questions such as: (1) Where do my medicines come from? and (2) How do I know they're safe? The answers are difficult and difficult to obtain as the pharmaceutical supply chain's sheer size and number of players, gaps in regulatory oversight, the government's inability to order recalls of unsafe drugs, and the lack of a tracking system all make it difficult for Americans to know exactly what's in the currently available medications.

Currently, about 80 percent of ingredients in U.S.-made drugs and 40 percent of finished medications Americans take come from abroad. PHARMA companies began turning to foreign sources in the 1980s for a variety of economic, regulatory, and logistical reasons. Recently, a GAO study reported that the FDA visits foreign sites about once every 11 years, but only once every 14 years for those in China and India, America's largest pharmaceutical suppliers. For comparison, U.S. facilities are inspected every 2.5 years or so.
http://www.tennessean.com/article/20121021/NEWS07/310210100/Global-supply-chain-regulatory-gaps-raise-drug-safety-concerns-?odyssey=tab%7Ctopnews%7Ctext%7CFRONTPAGE&nclick_check=1

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...the following:

The Board of Registration in Pharmacy reminds pharmacies and pharmacists who engage in compounding in the Commonwealth that Board Regulations (247 CMR) require that all actions be performed in accordance with United States Pharmacopeia (USP) Standards. 247 CMR 9.01(3). USP <795> addresses the practice for Nonsterile Compounding and USP Standard <797> addresses the practice for Sterile Compounding Preparations.

Massachusetts pharmacies and pharmacists are also reminded that Massachusetts General Law Chapter 94C, section 21, and Department of Public Health regulations (105 CMR 721.000) require that pharmacies and pharmacists dispense medications pursuant to a valid prescription from an authorized practitioner for a specific patient. This prescription must be valid as defined under Massachusetts statutes and regulations, not under the rules governing prescriptions in the recipient state.

Board licensees are advised to review USP standards and Board regulations 247 CMR 1.00 - 16.00 to assure that pharmacy practice is conducted in accordance with state and federal laws and regulations, as required by Massachusetts General Law Chapter 112, section 61 and Board regulation 247 CMR 9.01(1).

The Board advises that all compounding pharmacies and pharmacists should obtain and complete the respective USP Gap Analysis Tool(s) (©International Journal of Pharmaceutical Compounding), provided below, to determine preliminary compliance with the above-referenced USP standards.

Gap Analysis Tool - USP <795>
Gap Analysis Tool - USP <797>

http://library.constantcontact.com/download/get/file/1101987988062-55/ADVISO

The FDA does not approve "drug substances"�.they approve "drug products."

Substitutes are
Like a girdle,
They find some jobs
They just can't hurdle!
      Burma Shave

Online Veterinary Pharmacy Course for Pharmacy Students

The University of Florida College of Pharmacy is pleased to announce the continued availability of the Online Course in Veterinary Pharmacy for pharmacy students. The goal of this course is to assist students in developing new skills and a knowledge base in veterinary pharmacy so they can confidently provide care for animal patients. Students are welcome to take the course on an individual basis and transfer the elective credit back to their home school. To date, over 1800 pharmacy students have taken this course.

Registration for the spring 2013 course begins immediately and closes January 14th, 2013. The course begins January 14th and ends April 19th 2013. The course will be offered again in the summer of 2013.

For more information on course objectives, dates, tuition, or registration instructions visit
http://pharmchem.cop.ufl.edu/electives/vetpharm