E-DRUG: Orphan drugs of Pakistan
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Dear E-Druggers,
You might be familiar with the problem of missing essential drugs in Pakistan. Following is the abstract of one of my study I would like to share with you all.
ABSTRACT:
THE ORPHAN DRUGS OF PAKISTAN �THE DILEMMA OF MISSING ESSENTIAL DRUGS
Mrs. Huma Nouman, Mr. Khalid Saeed Bokhari, Prof. Muhammad Ali
OBJECTIVE: To document non-availability and short supply of clinically important drugs and to study the impact of these availability problems on patient care
DESIGN: A cross sectional analytical study
PLACE AND DURATION OF STUDY: The study was carried out at The Children�s Hospital and The Institute of Child Health Lahore was based on market survey covering city of Lahore. The surveys were carried out during the month of March 2003.
METHODOLOGY: A total of 56 drugs were included in the study these drugs were collected from the availability queries registered in the drug information centre, The Children�s Hospital and Institute of Child Health Lahore during the period of May 1999 till February 2003 (Fours Years). Two kinds of surveys were carried out for these drugs. Market survey by interview from Pharmacists of eight leading outlets of Lahore in which the availability status was collected and drugs were marked as short supply, not available, available. Clinical survey from senior clinicians of eight different departments of The Children�s Hospital was carried out. The information on Clinical importance and availability of alternate therapy were collected through this survey. Available and clinically not important items were excluded and status report of the missing drugs was carried out comparing the drugs for inclusion in WHO essential drug list 2002, National essential drug list of Pakistan 2001 and the registration status. The missing drugs were also classified for different clinical indications to study the severity of problem caused in the disease management.
RESULTS: Out of the 56 drugs studied 7 were found available and the rest 49 drugs were marked as �missing�. These missing drugs were put into further analysis. 18 registered missing drugs observed the status of inclusion in WHO and National Essential Drug list whereas 12 unregistered drugs also showed the same status. 2 unregistered drugs were included in WHO Essential Drug list but were not present in National Essential Drug List of Pakistan. Out of the 17 drugs not present in WHO Essential Drug list 12 were present in NEDL Pakistan. Only 7 out of these 12 drugs 12 drugs were registered. The remaining five out of seventeen clinically important drugs were neither registered nor included in WHO and National Essential Drug Lists. 18 of the missing drugs were those ones with no alternate therapy available only 5 out of the 17 were registered. 24 percent of the missing drugs were for use in cardiovascular indications and 17 percent of the missing drugs belonged to the class of drugs used in poisoning management.
CONCLUSION: There is severe lack of responsibility on part of Government in making the clinically important drugs available in Pakistan. Mere revisions of essential drug list and no responsibility over their access resulted in dilemma where the essential drugs have turned into Orphan drugs. No regulations and legal controls exist to protect the rights of people in this regard. It is suggested through this study that the stakeholders involved in the availability problems of these drugs that is regulatory authority, manufacturers and importers should be accountable for their negligence. More over the Orphan drug act be made by which state should take the responsibility of ensuring access to orphan, essential and clinically important drugs
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The reason I call these drugs orphan is this that we are facing continuous non-availability of various drugs of clinical importance since a long period of time. Despite meetings and revisions of the esteemed NEDL by government and NGOs less have been done for the availability. For our people even the clinically important drugs have taken the ORPHAN status. We have floated the proposal of formulating the ORPHAN DRUG ACT, as no such act exists in Pakistan. Unluckily the clinically important and essential drugs would top the charts in these orphan drugs. While the whole world researches for the availability of drug to be used in rare diseases we have our issues unresolved for the essential drugs and treatments for most prevalent illnesses.
As I work in a clinical setup it is very difficult for a responsible pharmacist to shut his eyes on the issue. The misery of patients are not solved by excuses neither they can wait for the time when government will realize. (Those who are interested in detail the copy of study can be sent and you can have a look for your self over the gravity of the problem). My colleagues and I are working on the availability of these drugs from international donor agencies especially regarding establishment of ANTIDOTE bank at the emergency pharmacy of our institute. You can see from the abstract that a large variety of antidotes don�t have registration status in Pakistan.
With the Pharmaceutical Industry of the country growing at the tremendous pace the very basic needs are still left unaddressed. People cannot be left in ignorance for a very long time perhaps the awareness of his rights by common man and not the scientific quest or government�s commitment is the right answer for us.
Your suggestions on formulation of Orphan Drug Act, donation of missing drugs, or links for arrangements of supplies would be highly appreciated.
Regards
Huma Nouman
Clinical Pharmacist
The Children's Hospital &The Institute of Child Health
Lahore-Pakistan
huma_rasheed@hotmail.com