INVESTIGATIONAL DRUGS IN HOSPITAL PHARMACY ; No. 3/4［장일부］

[정 세]

(註; Investigational Drugs in Hospital Pharmacy 글을 실을때 현재 우리 동문중에 
NIH 에서 근무하시고 계시는 이 보영 동문의 Specialty가 IDS Pharmacist 라는 
특수 전문 약사라는것을 동문들에게 알리고 싶으며 이 또한 우리 성약9회의 
자랑입니다. 이 보영 동문 계속 분투바랍니다. / 장일부)


INVESTIGATIONAL DRUGS IN HOSPITAL PHARMACY

		           		  Ilboo jang ,  President
				Korean American Pharmacists Association of U.S.A.


Investigational drugs are defined as those that are being considered for but have
not as yet received marketing approval by the Food and Drug Administration for 
human use and those drugs that have FDA approval for at least one indication 
but are being studied as research medications for new indications,
new route of administration or new dosage forms.



The hospital or other organized health-care settings, being the primary centers 
for clinical studies using investigational drugs must ensure that policies 
and procedures for safe use of those drugs established and followed.



Procedures for the use of investigational drugs should be based on the following
basic principles: 

1.	The setting for investigational drug studies must ensure that such studies
contain adequate safeguards for itself, its staff, the scientific integrity 
of the study and especially, the patient.


2.	All investigational drug studies must meet accepted ethical, legal and
 scientific standards and be conducted by appropriately qualified investigators.

3.	All patients who participate in investigational drug studies must freely
 consents, usually in writing, to treatment with the drugs.



The following recommendations will serve as a guide to the development of 
investigational drug policies and procedures in keeping with the aforementioned
basic principles:


1.	As required by federal regulation, clinical research performed in 
health care settings or institutions must be reviewed and approved
 by an Institutional Review Board (IRB), often titled a “Committee 
in Human Investigators”or “Clinical Research Committee”

.
2.	Investigational drugs must be used only under the supervision of the
 principal investigator or authorized co-investigators, all of whom must be 
members of the professional staff.


3.	The principal investigator is responsible for obtaining the informed 
consent of the patient to participate in the study.


4.	The principal investigator is responsible for the proper maintenance
 of case report forms and all other records required in the study by the site, 
drug sponsor or FDA.


5.	The organization’s drug use control system must contain the following 
elements with respect to investigational drugs:


       
      a)	Drugs must be properly packaged in accordance with all applicable 
standards  and regulations. 

      b)	Drugs must be labeled properly so as to ensure their safe use by 
the nursing staff and patient.

      c)	There must be a mechanism to ensure that sufficient supplies of 
the drugs are always available for the duration of the study.

      d)	A mechanism must be in place to allow the pharmacist or other 
designated health-care provider to break the blinding code and reveal 
the identity of the study drug to other health-care professionals 
in a medical emergency.

      e)	Nurse, pharmacists and physicians called on to administer or dispense 
investigational drugs should have adequate written information about their 
pharmacology, storage requirements, method of dose preparation, 
administration,disposal of unused drugs,precautions to be taken, authorized 
prescribers and patient monitoring guidelines.

      f)	Bulk supplies of the drug must be properly stored and adequately secured.

      g)	Only authorized practitioners can prescribe the drug and that all patients
 who receive it have provided the necessary consent.

      h) Records of the amounts of drugs received from the sponsor and of its 
disposition must be maintained.

      i) 	If the patient is to receive the drug at another facility, suitable 
arrangements for its transfer must be made.
      j)	The institution’s records on investigational drug studies should be 
designed so that various descriptive reports may be generated conveniently 
and expeditiously.



The drug control responsibilities previously described should be assigned to 
the pharmacy department. In addition, pharmacists may serve as principal 
investigators or co-investigators, drug procurement, preparation of codes 
for blinded studies,patient education and monitoring, education of nursing 
and other personnel,data collection and analysis, and special dosage form 
and packaging developments.




Guidelines for Pharmacists



The pharmacist is responsible for ensuring that procedures for the control of 
investigational drug use, as previously described, are developed and 
implemented,suggestions to accomplish this follow, drugs according 
to the sponsor.



1.	A copy of the IRB approved research protocol and investigator's 
brochure of drug data sheet, or both, should be kept in the pharmacy.


2.	The pharmacy should prepare an investigational drug data sheet that
 concisely summarizes for the medical, nursing and pharmacy staff information 
pertinent to use of the drug.


3.	Investigational drug supplies should be stored in the pharmacy.

4.	The dispensing of investigational drugs should be integrated with 
the rest of the drug distribution and control system, 
including, but not limited to, packaging, labeling, other review, 
profile maintenance, delivery and quality assurance procedure.


5.	Patient education and monitoring of therapy should be provided 
in a coordinated fashion by the pharmacy and nursing staffs 
and authorized investigators.


6.	At the conclusion of the study, the pharmacy should return, transfer or
 dispose of all unused drugs according to the specific instructions provided 
by the sponsor.


7.	The pharmacy should prepare an annual or semiannual descriptive 
summary of investigational drug use. 
This summary should include the number of drug
 studies in progress and a list of all drugs studied during the previous period.


8.	Drug costs and other expenses with investigational drug studies 
should be properly allocated and reimbursed.


9.	Policies and procedures should address the role of the department of 
pharmacy in billing patients and third party payers for investigational services,
 ancillary goods and investigational drug agents.




References:  American Society of Hospital Pharmacists.

                     American Journal Hospital Pharmacy.







	 					
	

[정 세]

Investigational Drugs in Hospital Pharmacy 글을 실을때 현재 우리 동문중에 NIH 에서 근무하시고 계시는 이 보영 동문의 Specialty가 IDS Pharmacist라는 특수 전문 약사라는것을 동문들에게 알리고 싶으며 이 또한 우리 성약9회의 자랑입니다. 이 보영 동문 계속 분투바랍니다. / 장일부

[baeksong]

이보영 동기는 2009년에 동양의학에 심취하여 그 곳 워싱톤에서 한방을 활용한 침구 자격도 얻어 양방과 한방 활용으로 21세기의 건강 지킴이 역활 수행에 최선을 다하고 있음은 <성약 9회> 동기들의 자랑이 아닐 수 없습니다.