1. Introduction
Drug donations are usually given in response to acute emergencies, but they can also be part of development aid. Donations may be given directly by governments, by non-governmental organizations (NGOs), as corporate donations (direct or through private voluntary organizations), or as private donations to single health facility. Although there are legitimate differences between these donations, basic rules should apply to them all [1].
The contribution of medicines in the form of donations to developing countries or disaster situations is often reviewed by communities in developed countries, as a useful way to provide much needed pharmaceutical supplies. As the lack of medicines is often presented as a pressing problem, an immediate donation of drugs is often perceived as the most pragmatic and direct response [2]. Many international organizations usually respond with drug donations to help meet the emergencies. Although the act of donating drugs may seem philanthropic and often genuinely, but the effects of inappropriate donations or dumping can be downright dangerous on the receiving end. The quality requirements of drug products are different from those for other donated items, such as food and clothing. Drugs can be harmful if misused; they need to be identified easily through labels and written information using specially trained human resources, may need special storage conditions, and they should be destroyed in a professional way. Many donated drugs arrived unsorted and labeled in a language which is not easily understood. Some donated drugs came under trade names which are not registered for use in the recipient country, and without an International Nonproprietary Name (INN) or generic on the label. [3] Unfortunately, there are also many examples of drug donations which cause problems instead of being helpful. Hoen (1993) [4] had reported that eleven women in Lithuania temporary lost their eyesight after using a drug that had been provided through drug donations. The drug closantel was anthelmintic that should be used only in veterinary medicines but mistakenly given for the treatment of endometritis. Some donated drugs had been received without product information or package inserts, and doctors used to identify products by matching the names on the boxes with the names on the leaflets of other products. Beverley (2001) [5] had reported that in 1994, despite the existence of published Christian Medical Commission (CMC) guidelines for drug donations since 1980s; every emergency in Zaire produces new example of inappropriate donations. In Eastern Zaire, one relief organization chartered an airplane to deliver a huge shipment of commercial soft drink used by athletes, in the false belief that it could be used to treat people with cholera. In fact, this product can be dangerous if given to infants. In addition, the product was not only bulky and difficult to store, but caused considerable waste and was not cost-effective when compared with standard oral rehydration salt (ORS) therapies used to treat diarrhea. In Sudan, in 1990 a large consignment of drugs was sent from France to war-devastated Southern Sudan; each box contained a collection of small packets of drugs, some partly used. All were labeled in French, a language not spoken in Sudan. Most were inappropriate, some could be dangerous. There were: contact lens solutions, appetite stimulants, antidepressants and expired antibiotics and out of 50 boxes, 12 contained some of used drugs [3].
The prime objective of this Sudan first research attempt was to describe and to assess key aspects of pharmaceutical donations, the kinds of benefits and drawbacks associated with drug donations, and the government controlling role in the donation process.
2. Materials and Methods
2.1. Classification Study
The researchers were developed and illustrated a system for classifying donated drugs based on Sudan’s Essential Drug List, and some criteria from the WHO Guidelines for Drug Donations as “normative standards” and were applied the systems to donated drugs. Donated drug products were classified as listed on the National Essential Drug List (NEDL), if a drug with the same active ingredient and in the same dosage-form regardless of its strength. The drug is to be classified as “relevant” when enlisted to treat a local disease. Each donated drug was counted once, even if the same product was shifted multiple times. Donated drug products that labeled in International Nonproprietary Name (INN) were classified as “relevant”. Each donated drug was counted separately. Donated drugs that labeled in locally understood language were classified as “relevant”. WHO Guidelines for Drug Donations’ Provision No. 8, specified that donations should be supplied in tablet dosage form [2]. Donated drugs were classified as relevant when the proportion of the tablet dosage forms were greater than the syrups and injections dosage forms.
A donated drug sample was classified as “inappropriate”, when to be found as a returned one (drugs that been issued to patients and returned to a pharmacy or elsewhere).
Development of Relevant Indicator Form Sheets
A relevant indicators’ form sheet was proposed and developed for collecting data regarding relevance of donated drugs to the local disease patterns. Some criteria from WHO Guidelines for Drug Donation and NEDL were used to measure to how extend the donated drugs were relevant. Six selected nongovernmental organizations (NGOs) were proposed by the Ministry of Humanitarian Affairs, Sudan as organizations that handle large quantities of donated drugs on a regular basis in Khartoum State. These organizations asked to be anonymous. For classification study, 300 samples (50 samples from each NGO health facility) were examined for the relevance and for some aspects of quality. The collected data were analyzed by using SPSS, Version 14.
2.2. Qualitative Study
Quality indicators form sheet was developed for recording data regarding quality of donated drugs to show the date of arrival, expiry date and remaining shelf life of the donated item. Retrospective and prospective studies were conducted in the Federal Ministry of Health (FMOH) and NGOs to explore the problems associated with drug donations’ process in Khartoum State, within the period from Apr 2007 to Mar 2008. Inventory of receipt, shipment files and direct observation were made based on National Essential Drug List and some criteria from WHO Guidelines for Drug Donations as normative standards, a total of 2400 samples from two NGOs data base were collected. The two NGOs were chosen because they have good systems for recording data of the shipped items. Michael (1999) [6] Classification techniques were used to define the relevance of donated drugs.
Methods of Analysis
For classification study, the resultant values were modeled using Chi-square models to test the significances between different categories.
For quantitative study, the NGOs data aggregated into two-month time intervals to observe shifting patterns of drug donations and, in particular secular trends in the time to expiration of donations. For each of the twomonth time intervals; the median times between time of arrival and time to expiration for the donated products were calculated. These values were modeled using timesseries simple linear models to estimate any changes in median times that might have occurred over calendar time.
Standard list of key drugs was developed, which can be defined as standard list of the top ten drugs recommended for the treatment of most common health problems. The list based on specific essential drug list therapeutic category and applied the standard list of key drugs to the sampled donated products. The lists of sampled donated drugs were considered as “normative standard” when conforming to drug products represented therapies that were listed as top ten drugs.
2.3. Donation Policy Study
Face to face interviews were conducted with the medical coordinators for the six NGOs responded to the request at their premises, with the request for copies of their written donation policies. A set of questions were asked regarding criteria and procedures for product selection, donor-recipient communication, and logistics.
2.4. Field Survey Study
Face to face interviews and direct observation were conducted at NGOs health facilities, two persons were interviewed at each health facility one administrator and one health provider. Also other interviews were conducted with the Federal Ministry of Health and Central Medical Supplies: Director of International Health Department, Director of General Directorate of Pharmacy Administration, Director of Pharmacy Administration Khartoum State, and Deputy Director of Central Medical Supplies with the intention of including government officials involved in the drug donation process.
3. Results
The study showed that the mean proportion of donated drugs in NEDL was (91.8%), and the proportion of donated drugs labeled in generic name or INN was (91.5%). Most of the donated drugs in the current study were labeled in locally understood language (95.8%). The donated drugs in tablet dosage form were (90.2%), while that in syrup form were (5.6%) and the injectable dosage form were (4.2%). Out of the total donated drugs (99%) were not drug samples and not returned or used ones.
Regarding the expiration of donated drugs; the time prior to expiration was examined at two NGOs data bases. Table 1 present’s estimates of percentages of donated drugs with differing expiration times on arrival. The two NGOs were received somewhat shorter-dated drugs. Between 44.8% (NGO A) and 47.5% (NGO B) are said to have dating of less than one year on arrival which was not conforming to WHO Guidelines on Drug Donation.
Table 2 shows the results of more specific essential drug list therapeutic classification of NGO’s donations. The top ten drug products accounting a significant proportion from 40.5% (NGO B) to 48.7% (NGO A) of do-