[e-drug] Pharmaceutical Compounding and Access to Medicines (3)

e-drug
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E-DRUG: Pharmaceutical Compounding and Access to Medicines (3)
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Dear Colleagues

Pharmacy compounding, as it is known in the US, is a two edged sword. It is certainly appealing from the standpoint of both patients and compounding pharmacists that compounded products cost less. This is clearly important in developing countries. However, pharmacy compounded products are not approved by the US-FDA for any purpose. This is because they have not been tested for safety or efficacy and are not produced in facilities that meet Good Manufacturing Practice (GMP) standards.

Readers are referred to background information on pharmacy compounded products written for patients on the FDA's Web site http://www.fda.gov/consumer/updates/compounding053107.html .

Pharmacy compounding in the US has unfortunately evolved from its traditional definition to the small scale manufacturing of unapproved new drugs. What has happened in the US, and the risk in developing countries, is the creation of parallel pharmaceutical industries – one regulated and one operating outside of regulations.

The profits in selling unregulated drugs are substantial and deaths have been reported in association with the use of various pharmacy compounded drugs. When a high profit margin is being pursued the incentive may be to buy less expensive lower quality starting materials that also may be unregulated only to increase the margin.

There are certainly rare circumstances when pharmacy compounding is medically necessary. Collegues and patients should be aware that there are special risk associated with pharmacy compounded drugs.

Best regards,

Larry

Larry D. Sasich, Pharm.D., MPH, FASHP
Consultant, Saudi Food and Drug Authority
Riyadh, Saudi Arabia
+966-1-275-9222 Ext. 1376
lsasich@sfda.gov.sa
www.sfda.gov.sa
Chairman, Department of Pharmacy Practice
LECOM School of Pharmacy
Erie, PA, USA
814-866-8467
lsasich@lecom.edu
www.lecom.edu
[Pharmaceutical compounding as described by Robert Chana is traditionally within the mandate of professional pharmacists and compounding medicines according to recognised pharmaceutical formularies for individual patients has always been a part of pharmacists' training and skills.

The products prepared for individuals according to formularies or prescriptions were not regulated as described by Larry, but controlled by professional standards. The standards of premises and tools (hygiene and accuracy etc) are proscribed. Compounding individual prescriptions has become more exceptional these days because there are so many ready prepared dosage forms but that does not mean there is no place for it as described by Robert. BS Moderator.]

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E-DRUG: Pharmaceutical Compounding and Access to Medicines (4)
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Dear Colleagues

I agree with previous contributors that pharmaceutical compounding is an
essential service, more so to the extend that it bridges the medicines
access gap. This is especially so for medicines for children. The
availability of age appropriate formulation for children is a problem
especially in developing countries. Often there is no oral liquid
formulation, and even when available, are priced way out of the purchasing
power of patients. A case in point is acyclovir syrup which is available
only as the originator brand, which is often unavailable.

Compounding is therefore a practice that should be encouraged. However,
compounding in developing countries is faced with various challenges, key
among them is:
-Quality assurance
- Lack of knowledge and skills and
- Availability of requisite equipments and ingredients.

Questions have been raised, and deservedly so, about the hygiene measures
taken, the stability profiles of compounded medicines and the assurance of
potency for these compounded formulations. The pharmaceutical staff often
lack adequate training on *practical* pharmaceutical compounding(a failure
of the training curriculum) and reagents like suspenders, preservatives and
sweeteners are either not commercially available or costly.

The practice also operates without regulation and standards and therefore
pharmacies or hospitals that compound do not have a reference point for
standards and Good Compounding Practice(GCP) guidelines to comply with.

Solutions include:
-Requisite practical training of pharmacy staff
-Regulation - adoption of GCP guidelines and ensuring that all compounding
facilities comply
-Developing and adoption of evidence based compounding formularies
-Encouraging research to develop locally available and cheap reagents for
use in compounig as opposed to using either commercially avaiable *expensive
* reagents, or locally avaiable *untested* reagents

If well adopted, pharmaceutical compouning will go a long way in enhancing
access to essential medicines especially for 'special need' groups notably
children and the elderly especialy in resource limited countries

Edwine

Dr Barasa W. Edwine BPharm MPSK
Child and Newborn Health Group
Centre for Geographic Medicine
KEMRI-University of Oxford-Wellcome Trust Collaborative Research Programme
Kenyatta National Hospital Grounds (Behind NASCOP)
P.O. Box 43640 – 00100
Nairobi, Kenya
Tel: +254 20 2715160 or 2720163 or 2719936
Fax: +254 20 2711673
Cell: +254 722 129 757