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Editorial: Looking Forward 2012, Part III

This is the third in our series on issues involving pharmacy and pharmacy compounding. In this issue, we will briefly discuss "MTM or MTM-Which one or both?"

Back in the 1970s (over 40 years ago) when clinical pharmacy began, we looked at the practice model between medicine and pharmacy where physicians (diagnosticians) would diagnose and pharmacists (therapeuticians) would prescribe and treat the patient. A lot of water has gone under the bridge since those days as the clinical pharmacy movement has slowly progressed. Today, TDM (Therapeutic Drug Management) has morphed into MTM, the terminology currently used. MTM can actually be used for both "Medication Therapy Management" and "Medication Therapy Monitoring," and it seems that many confuse the two, although they are somewhat related.

MTMonitoring has been a component of pharmacy dispensing practice since the middle of last century. With the introduction of computers in the dispensing process, along came the drug interaction checking software that has vastly improved this function and is still in use today. Computers allow for checking duplicate drugs, monitoring refill schedules, and many, many other monitoring activities. If anything out of the ordinary is detected, the patient or prescriber is contacted.

MTManagement is a term used to describe a broad range of healthcare services provided by pharmacists. It is defined as a service or group of services that optimize therapeutic outcomes for individual patients and include medication therapy reviews, pharmacotherapy consults, anticoagulation management, immunizations, health and wellness programs, and many other clinical services. (See http://www.pharmacist.com/AM/Template.cfm?section=MTM#nogo)

There is no doubt that pharmacists participate, in different degrees, in both MTMs. With the introduction and growth of massive mail-order and distant-pharmacies (Internet pharmacies), one wonders how some can actually perform MTMonitoring, much less MTManagement. This statement is based on the difficulty for some of these practice sites to have total access to all prescriptions and OTCs a patient may be receiving. It appears as if mail-order practice will continue to grow, at least in the foreseeable future.

Another aspect of concern is the reimbursement for both activities. Quite possibly the MTMonitoring reimbursement is considered to be a part of the dispensing fee as these are activities inherent in dispensing prescriptions. However, it has always been a question as to whether or not adequate and total reimbursement from patients or third-party payors for MTManagement is received. These services are not a part of the routine dispensing fee structure, and many pharmacists involved are either not getting reimbursed for these activities or are paid from an institution as a part of the pharmacy department budget.

It is interesting to note, as has been said in this column many times, that compounding pharmacists are often routinely involved in BOTH forms of MTM in their practice.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

Pharmacy Chain Now Offers Timer Caps to Enhance Compliance
Tops Markets are offering Rx Timer Caps to their customers. These caps are designed to function as a stopwatch. They include a digital clock to count up the minutes and hours since the bottle was last opened. The Rx Timer Caps work automatically by running up to 100 hours. When the container is opened, the time resets to zero. The caps can also help detect medication theft since the cap resets every time it's opened, and it is easy to tell the last time someone might have opened it.
http://www.goerie.com/article/20120123/LIFESTYLES07/301239988/Erie-pharmacy-chain-offers-timer-caps-for-prescription-bottles

Probe Finds Adulterated Drugs Amid Ranbaxy Manufacturing Violations
Indian manufacturer Ranbaxy Laboratories produced "adulterated, potentially unsafe" medicines that were illegal to sell, U.S. prosecutors said in a proposed settlement with the company. These violations include the following:

• Submitting false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed
• Failure to adequately separate the production of penicillin and non-penicillin drugs
• Failure to take adequate steps to prevent contamination of sterile medicines
• Failure to keep written records showing that drugs had been manufactured properly
• Failure to investigate evidence indicating that drugs didn't meet their specifications
• Inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date

The proposed settlement includes requirements that Ranbaxy remove false data contained in past drug applications; hire an outside expert to conduct a thorough internal review at the affected facilities and to audit applications containing data from those facilities; withdraw any applications found to contain false data; set up a separate office of data reliability within Ranbaxy; and hire an outside auditor to audit the affected facilities in the future.
http://www.bloomberg.com/news/2012-01-26/ranbaxy-reaches-agreement-with-u-s-over-alleged-violations-at-drug-plants.html

Pakistan Contaminated Cardiac Medicines' Scam: Drug Companies' Owners Arrested (and May Be Punished) and Facilities Sealed
The Pakistani Federal Investigation Agency has arrested owners of three pharmaceutical companies that were the main suppliers of substandard medicines to the Punjab Institute of Cardiology (PIC), which took several innocent lives. Meanwhile, fatalities from consumption of contaminated medicines reached 53 as 36 more deaths were reported.

The agency, on the instructions of the federal government, arrested the owners of Mega Pharma, Alfa Pharma, and Pharma, under charges of providing substandard medicines to PIC. The three major pharmaceutical companies were sealed as per the orders of the provincial and federal governments.

Addressing the press conference, Khan said five different medicines were given to cardiac patients in PIC. Study of those five medicines revealed that one of them had spots on it and a changed color, which raised the possibility of it being contaminated.

The Parliamentary Secretary for Health said that the Punjab government would send the samples of the faulty medicines to Singapore, Brussels, and France for tests, since there was no laboratory in Pakistan that could carry out relevant tests on these medicines. Also, the arrested officials of pharmaceutical companies would be presented in the drug courts and punished if found guilty.
http://www.dailytimes.com.pk/default.asp?page=2012%5C01%5C24%5Cstory_24-1-2012_pg13_2

Essentials of Pharmaceutical Chemistry
4th ed.
Cairns D.
Pharmaceutical Press; January 2012; $55.00; 320 pages; Paperback

NOT "Medicinal Chemistry," but "Pharmaceutical Chemistry." This is a great book detailing the basic chemistry of drugs. It discusses many aspects of pharmaceutics and includes chapters on (1) Chemistry of acids and bases, (2) Partition coefficient and biopharmacy, (3) Physicochemical properties of drugs, (4) Stereochemistry, (5) Drug metabolism, (6) Volumetric analysis of drugs, (7) Analytical spectroscopy, (8) Chromatographic methods of analysis, (9) Stability of drugs and medicines, (10) Kinetics of drug stability, (11) Licensing of drugs and the British Pharmacopoeia, (12) Medicinal chemistry: the science of rational drug design. Throughout the book there are problems that can be worked, and it includes the answers at the end of the book. It is very easy-to-read and has very good graphics to support the discussions. In addition to being a good text, it is a good refresher for those that would like to review this topic.

�that IJPC posts a "1derful Wednesday" marketing tip on both websites each week (www.ijpc.com and www.CompoundingToday.com)? These are provided by MuchMoore Marketing�check them out.

Marketing Resources
Marketing Tip! Need some professional pharmacy photos for advertising, marketing, etc. Check out the IJPC CDs, including the (1) Mortar and Pestle CD and the (2) Photo CD of different compounded dosage forms.

At intersections,
Look each way,
A harp sounds nice,
But it's hard to play.
      Burma Shave