[e-drug] Packaging of generic ARV medicines

e-drug
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E-Drug: Packaging of generic ARV medicines
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Dear e-druggers

The immense contribution of the Indian pharmaceutical industry in the fight against HIV/AIDS by supplying generic ARV medicines is greatly appreciated, especially in the developing countries. Special mention goes to Ranbaxy, Hetero, Matrix and Emcure. Needless to say, these companies have advanced access to ARV medicines by price reductions.

My small concern is about packaging of these generic products. Ranbaxy packages its products such as NVP 200mg, Avacomb-N, Coviro-LS, EFV 200mg, Triviro-LS among others in basically the same shape of container, same colour of container, same print/font of label and in some cases the size of the containers for different products are more or less the same. I am not sure if this kind of packaging has to do with branding their products or low production costs. There is a real risk of dispensing errors especially where pharmacists and their assistants, dispense to a large volume of patients in a single day. Some ARV clients identify their ARV medicine by the shape and colour of the container, therefore, with several medicines packaged similarly, clients are unable to provide these handy checks and balances.

Advances in access to ARV medicines, with the advent of initiatives such as "ARVs to the people", clients have begun accessing ARVs from their nearest clinic or outreach point/centre. Quite often these clinics or outreach points are ordinarily manned by the nursing staff, often understaffed and overwhelmed by responsibilities. This theoretically increases the risk of dispensing errors and other errors.

In developing countries, most facilities do not have suitable dispensing areas. Boxes containing ARV medicines are usually crammed in a small dispensing area where pharmacists and their assistants pick from. Some facilities see 150 to 300 clients in a single day, and this heavy workload compounds the risk of dispensing errors. These are real experiences in a developing country.

The appeal to Ranbaxy and other companies that may be doing the same is to consider using different colours, shapes, prints and container sizes to diminish the risk of dispensing errors by pharmacists and medication errors by ARV clients.

Tommy Makomeya
Pharmacist
Case Management- Global Fund/MOHSS
Katima Mulilo Hospital
Caprivi
Namibia
Tel: +264 66 251400
Mobile: +264 81 366 93 44

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E-drug: Packaging of generic ARV medicines (3)
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Dear e-druggers

Thank you Tommy Makomeya for your comments. We also have similar concerns here in Botswana and like you rightly stated, it is easy for the health care providers (Doctors, Pharmaceutical Officers and Nurses) to be confused and to make errors about the medicines if they are packaged in similar bottles.

The bigger concern is for the clients as well because it is easy for them to confuse the medicines if the bottles and the shapes of the tablets are exactly the same. For some people who can not read, we use all means to facilitate knowing the names of the medicines and understanding how to take them and we sometime have to use the shapes, colours and sizes of bottles and/or tablets. So if they are the same, it becomes a big struggle.

The other concern is providing unscored or film-coated tablets. One of the efforts to enhance adherence and ease to take the medicines by children is to switch them from liquid formulations to tablets as soon as they are able to swallow tablets. Major strides have been made in availing tablets in lower doses for paediatric use. However, for some tablets, we still depend on giving one-half (or half) tablet and it becomes much easier if the tablet is scored. As a result, I will like to appeal to the manufacturers to make scored tablets for medicines such as nevirapine, lamivudine.

Joyce Kgatlwane
Pharmacist
BHP Master Trainer Program
Botswana
Tel: 00267 3930552
Mobile: 00267 76083255
jkgatlwane@yahoo.com

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E-DRUG: Packaging of generic ARV medicines (2)
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Dear -druggers,

I agree with Tommy completely. Actually this issue of labeling, packaging
drugs in this manner does not only apply to ARVs only. It is a general
pharmacy manufacturing practice which seems to have disappeared over time! A
number of other companies seem not bother about this important aspect of
manufacturing. I have seen companies package 50 tablets in the same
container that can take 500 tablets! I think we should keep pointing out
such anomalies so that the concerned companies can change. What are the
Regulators/ inspectors doing?

Clement Mulenga Andala
Pharmacist
Ngansa Pharmaceuticals Limited
Lusaka , Zambia
"Clement Andala" <andalacm@ngansa.co.zm>

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E-DRUG: Packaging of generic ARV medicines (3)
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Dear e-druggers

Similarity of labels and containers is a very big problem, not only for ARVs
in developing countries. In US dispensing from bulk is the dominating way of
dispensing. One may discuss whether this is a result of free enterprise,
tradition, regulation or whatever. But the situation is that US, land of
private brands, is practically closed for branding profiles of medicines. No
colours - only black and white labels on containers of identical appearance.

In such similarity it is of basic importance that the labels are well
functioning.

* Clear identification. Name, strength, pharmaceutical formulation, and (in
the case of patient packs) pack size.
* Generic name
* Strength indicated as part of product name. ARVs and TBC medicine often
have more than one active ingredient. Milligrams separated by slash (e.g:
Coviro-LS 20/5).
* Critical information not disturbed by less important information.
* Labels distinguishable one meter from the shelf, by a 55 year old health
worker with normal vision.
* On dispensed medicine: Name of patient and dosage instruction.

It may be difficult for people who can't read, or have poor sight. But there
is still a way to go before medicine labels fill these basic criteria.

Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
www.lyftingsmo.no
"Stein Lyftingsmo" <stein@lyftingsmo.no>

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E-DRUG: Packaging of generic ARV medicines (5)
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In unpublished research which the Centre for Health Policy have undertaken
in labeling and packaging standards for international generic drug products
we have found that they are not equivalent to labeling and packaging
standards in the United States. Suggesting dissimilar and substandard
distribution processes compared with those in the United States, which in
turn presents a challenge to patient comprehension and health literacy and
may affect patient adherence to drug treatment regimens. Our findings have
strong implications for drug product quality, patient outcomes, therapeutic
effectiveness, and safety.

In addition findings suggest that packaging requirements for dispensing
drug products, special consideration should be made for the closure on the
prescription container. The closure must inhibit penetration of moisture and
contaminants that can have a deleterious effect on oral dosage forms. A
well-known example in pharmaceutics is the breakdown of aspirin into acetic
acid and salicylic acid in the presence of moisture.

Lastly, findings suggest that dissimilar and substandard distribution
processes comparing packaging and labeling standards between Africa and IP
countries such as United States , which in turn offer a greater challenge to
patient comprehension and health literacy and may affect patient adherence
to drug treatment regimens.

Regards,

Marco Gomes
Policy Advisor, Health and HIV
Centre for Health Policy and Innovation
"Marco Gomes " <marcogomes.healthpolicy@gmx.com>

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E-DRUG: Packaging of generic ARV medicines (4)
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Dear colleagues,
This is a timely discussion on this very basic part of pharmacy. The inputs so far indicate that there are (a) regulatory and legal requirements to have distinct labels as well as (b) patient treatment requirements to be met. Not so long ago, in another place, we managed to agree with a manufacturer to have colour- coded tablet bottles for the starter and continuous treatment ARVs. That, it was agreed with the recipient government, was the best way to safeguard the dispensing and use of the medicines. Of course, it probably did not help if one was colour- blind. However, the point here is that buyers (specifically governments) can request manufacturers to make clear distinctions between products to, in end, protect public health.

The fact that that is not happening may be pointing to naivety within the pharmaceutical procurement arrangements. As others have pointed out, traditionally pharmacy has always made these distinctions in medicines from any one source. If those that are buying are unaware of this practice, or are not consulting pharmacists on how to buy, then indeed there will be these mistakes. Industry, unfortunately, may come across as providing cost- saving services, or the buyer may feel that they must not spend too much on product design, etc. However, good practice within manufacturing sector includes being a bit proactive and preventing preventable accidents from happening.

The buyer must also ensure that the products in public health facilities are distinct in such as way as to prevent mistakes that would lead to poor treatment or worse, fatalities. So, both the buyer and manufacturer have certain expectations that they must put into practice. I would also agree with contribution from Mr Clement Andala that indeed the regulatory authority must also make provision to address this problem as part of their registration process, inspections, etc.

So, do chat with your manufacturers, and provide the specifications you want for your products (colour of labels, wording, etc). Will it cost an arm and a leg to have these arrangments made? Probably not.

Regards,
Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 41 83
Fax: +260 211 25 33 44
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: Packaging of generic ARV medicines (6)
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In response to Packaging of generic ARV medicines (5)
I don't exactly understand why US labeling and packaging standards are automatically believed to be superior in terms of patient comprehension, health literacy and patient adherence. Patients in the US have great difficulty understanding US labels in terms of readability and content and there are proposals for change. There's also, unfortunately, lots of evidence that the labels are not routinely read by patients and retail containers are notoriously hard to open. I understand comments about packaging that adversely affects product quality, but the rest of this post raises questions.

Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker@neu.edu