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[e-drug] National and International failure - pharmaceutical sector of Kosovo

  • From: "Adnan Mustafa" <adnanmustafa18@hotmail.com>
  • Date: Mon, 28 Jun 2010 23:21:45 +0200

E-DRUG: National and International failure-pharmaceutical sector of Kosovo

International aid and national failure
Despite a long international presence (more than 11 years) and involvement of international organizations (UNMIK, WHO, UNDP, UNICEF, NGO’s, EU organizations) and last two years EULEX (European Rule of Law in Kosovo), situation in health sector in general and pharmaceutical sector in particular in the Republic of Kosovo remains chaotic and with no improvements. Health legislation is still lacking reforms and what happened all these years is what I called Frankensteinisation of the health system. This means that various national and international organizations attempted to develop and implement fragments of policies from a wide range of countries without looking closely at of the demographic, economic and social specifics including human resources and health conditions in Kosovo.

Pharmaceutical sector- crisis with no exemption
Establishment of Kosovo Drug Regulatory Agency (KDRA) in 2000 was manifested from the very beginning with lack of enforcement of regulations adopted at that time. These regulations consisted of import, wholesale, distribution and retail of pharmaceuticals.

However, since that time Kosovo Medicines Agency KMA (Kosovo Medicines Agency), formerly KDRA, never achieved the objective of closure of illegal pharmacies which are currently about 400 throughout Kosovo. Importation and distribution of medicines is still out of order due to smuggling through Kosovo’s very porous boundaries with corrupted officials as well as in central level. This can be seen through newspaper articles. Smuggling of counterfeit medicines was reported and police captured some of them, but until now no judicial measures were taken. Most smuggled medicines are the ones with no marketing authorization (MA) but also with MA since there is no price policy regulation so less expensive medicines from the region find their place in Kosovo through illegal ways.

Some attempts for price regulation of medicines were made by Kosova Pharmaceutical Society (KPS) in 2008, but with interference of wholesalers and maybe politicians this process was totally compromised.

Marketing authorization process started in 2003 with Provisional Marketing Authorization which would have lasted for 18 months. However, this process was delayed for several months and resulted in failure mostly because many medicines registered were of dubious quality, effectiveness and total lack of criteria for MA. After much delay, regular marketing authorization process started in 2006, but now this is characterized with extremely rigid regulations which led to refusal of reputable manufacturers to apply for MA with KMA. There are many cases that even three years after submission of dossiers, MA Holders did not receive a decision from the KMA, neither certificates nor a negative answer. In 2009 this process was a little bit simplified but lack of medicines is very common in pharmacies, which are in this way pushed to find illegal sources of supply. Now it is estimated that around 2000 (two thousand) medicines are illegally entering Kosovo drug market.

Licensing of pharmacists is one of the most compromised issues in pharmaceutical sector in Kosovo. At the time of establishment of KDRA, licensing of pharmacists was their responsibility. Since that time, this process is compromised due to lack of transparency of KDRA and Ministry of Health (MoH). Many cases of fake diplomas, ID cards and other documents were discovered by the KPS and submitted to KDRA, UNMIK officials, MoH, Commission for Health of Parliament of Kosova, UNMIK police, but with no results. Some of the persons with fake diplomas are still in the list of Licensed Pharmacist of the MoH. According to the MoH list of Licensed Pharmacists, it can be estimated that about 200 out of more than 780 licensed pharmacists are from neighboring countries and they are "selling" their licenses mostly to retailers but to wholesalers as well. This is very easy to prove since there are databases of respective institutions in Macedonia (most of them), Albania, Serbia, Montenegro, Turkey, etc. In this way Kosovo became "black hole" of "responsible pharmacists".

Public sector is lacking basic regulations. Only a few articles in Health Law are related to availability, accessibility, selection and financing of medicines. There is no regulation regarding: selection of Essential Medicines, Commission for selection of EML and financing of medicines. Reimbursement of medicines does not exist. Since January 2007, all medicines in primary health care are purchased out of pocket by patients in community pharmacies. The MoH is purchasing medicines for all levels of public health care through international tenders. Recently the MoH declared that prices of medicines purchased by the MoH are compared with British National Formulary (BNF) prices, contrary to the common practice of using lowest prices from the neighboring countries. According to this statement most of the drugs purchased (117) are cheaper than the ones from the BNF and 16 were more expensive.

In public primary health care, Family Medicine Health Centers (FMHC) provides injectables and medical consumables for injuries free of charge to all patients. Recently we can see that municipal authorities are purchasing medicines (for oral use mostly) with no respect to EML and against the Law on Medicinal Products and Medical Devices. Insulin is also supplied to patients through FMHC free of charge. Shortages of medicines are very common in all public health institution. A survey made in 2007 on medicines prices and availability of medicines, in University Clinical Center of Kosova (UCCK is the only public tertiary care hospital in Kosovo) showed very low availability of EM; only about 20%. A week ago when my friend had a surgery, in UCCK I saw a person with a little plastic bag with injectables purchased in private pharmacy. Bag contained: diclofenac, ranitidine and lincomycin ampoules. Diclofenac and ranitidine are in the EML of MoH. Lincomycin injection is not registered with KMA (see link: http://www.msh-ks.org/attachments/443_Produktet%20%20me%20të%20drejtë%20importi%2030.11.2009.xls); it was from illegal sources.

There are seven public hospitals. Hospital pharmacies in public health institutions are currently dealing as store houses for medicines with only two to three pharmacists available.

Law on Health Insurance was passed by Kosovo Parliament in 2003 but never entered into force. General opinion about this law: it was bad drafted law without consideration of economic and financial conditions in Kosovo. The International Monetary Fund (IMF) opposed this law also.

Buying a prescription only medicine in pharmacy – Free sale
In all pharmacies in Kosovo you can buy prescription only medicines without an actual prescription. Until recently I was thinking that narcotics were exempted. I was wrong.
A few weeks ago, on 23th of May 2010, my wife entered a pharmacy on the way to our cousin, to buy a cotton gauze for the cousin (she had a small surgery). When my wife called me to help her with choosing a dressing, at that moment I saw in the pharmacy shelves a pack of Fentanyl ampoules. At first I was thinking to warn the person (I don’t know if she was a pharmacist or not) that she must not keep narcotics outside the locked safe, but I changed my mind and instead asked her if I could have an ampoule of Fentanyl. She asked me which one I'd like, 100 micrograms or 500 micrograms. I said 100 microgram. She gave me an ampoule and I asked to pay and get a receipt. It costs me 1.5 euro and I got a bill. She didn’t ask for prescription at all!

Are we helpless and hopeless?
I still believe there is hope for us. But with people, politicians and pharmacists devoted to profession and human ethics.

Adnan Mustafa, Senior pharmacist
Prishtina, Republic of Kosova
28 June 2010 www.pharmaks.com
e-mail adnanmustafa18@hotmail.com