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Packaging of medicines.

The packaging of medicines, in substandards containers, in scant disregard to human life, is a glaring example of apathy and callousness of the pharmaceutical companies and our health.

Specifically, the issue of packing injectable medicines in substandard vails, deserves our immediate attention. Injectable medicines are packed mostly in two different ways, either in ampoules or vials. Ampoules are for once-only use and after extracting the contents for injection, are discarded. On the other hand vials are normally for multiple use, and are as such used for more than once. This multiple use of vials is, at best, fraught with hazards. There are various reasons as to why the vials pose a serious health danger as discussed below:

1. Ampoules are made from a special glass which conforms to various international standards i.e. DIN, USP etc. The glass used for ampoule is USP Type-I, neutral glass. This type of glass is non-reacting i.e. it does not react with the solution inside. Ampoules are available in clear and amber (coloured) type. The amber ampoule has the added property of shielding the contained solution from light, thus protecting the photo-sensitive solutions. The glass from which these ampoules are manufactured in the form of long tubes. These tubes are imported or procured from a local manufacturer in Karachi. In both instances, it is of the international specification and does not react with medicinal solution. On the other hand, the vials which are used are of substandard glass and do not conform to any international standard. Most of the pharmaceutical companies, are using these substandard vials, the reason being that tubular vial manufactured from USP Type-I neutral glass tubes are expensive. To curtail their expenses, unethical companies, and unfortunately there are quite a few, resort to buying substandard vials. The liquid medicine contained in these vials starts reacting with inferior substandard glass and the unsuspecting patients, who are getting these injections, are unaware, that they are not only getting an injection of dubious therapeutic efficacy, but also getting a healthy dose of dissolved glass.

2. The other, even more hazardous outcome of using multidose vials, is the very real danger of cross-infection. We have all at one time or the other, come across hospitals and clinics. The level of sterilization and awareness of its importance is at best rudimentary. This is specially so in cases of half-trained paramedics and nurses. In most government hospitals, health centres etc., disposable syringes meant for single use are boiled and reused. The combination of these reused syringes and multidose vials is indeed a potentially lethal one. With AIDS, hepatitis and other such frightening infections rampant, we are indeed playing a dangerous game of roulette with our healths. The practise of using substandard vials should be banned forthwith, before there is a major breakout of some uncontrollable infectious disease.

In this context, the Ministry of Health should also be taken to task for allowing packaging of injectables in substandard vials. It is indeed surprising that MOH insists, that pharmaceutical companies use proper USP Type-I neutral glass in case of ampoules, but allows the same medicines to be dispensed in vials, which are not of neutral glass. In interest of public health this contradictory and paradoxical approach should be rectified forthwith. As a matter of fact a local ampoules manufacturer was able to move the Courts, in this regard, and the multidose vials were banned, a few years ago. The all-powerful PPMA was able to prevail and this ban was later lifted. The MOH should move to have the multidose vials banned and resist the inducements and pressure of the pharmaceutical companies in this matter.

A pertinent word of advise for the patient visiting hospital and clinics would be to make sure that before getting themselves injected, the syringe being used is a new one and the injection is taken from an ampoule which is discarded afterwards, and not vial which is used repeatedly causing a serious threat of infection.
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Author:Hameed, Fazal
Publication:Economic Review
Date:Aug 1, 1993
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