DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20180111

Quest for good quality medicines in hospitals: a structured approach

Jayant Kumar Kairi

Abstract


Patients use medicines to gain speedy recovery from illness or to maintain wellbeing under the care of their physicians. For chronic illnesses, the pharmacotherapy may continue for the entire lifetime. Significant expenditure is incurred in sustaining this pharmacotherapy. Quite expectedly, the patients are concerned about the quality of medicines that they receive and consume. In recent times, the quality concerns have increased phenomenally due to media hype and overexposure all around. Ensuring quality of medicines in developing countries is not easy. Multi-pronged approaches are needed to ensure procurement of good quality medicines by institutional buyers. However, ensuring the procurement of good quality medicines is not enough. The quality of medicines has to be maintained till their consumption by patients and a rational, scientific method has to be adopted to ensure this goal. A structured approach in ensuring good quality medicines for optimum pharmacotherapy is being presented in this review.


Keywords


Counterfeit, Compliance-aids, Medicines, Quality

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References


Guidance for Industry- Quality Systems Approach to Pharmaceutical CGMP Regulations: U.S. Department of Health and Human Services Food and Drug Administration; 2006. Available at: https://www.fda.gov/ohrms/.../ac/.../2005-4136b1_05_pharmaceutical%20CGMP.pdf. Accessed on 11 Dec2017

Avorn J. The $2.6 Billion Pill - Methodologic and Policy Considerations. New England Journal of Medicine. 2015;372(20):1877-9.

Central Drug Standards Control Organisation, Govt. of India. Guidelines for Bioavailability & Bioequivalence Studies CDSCO, India; 2005. Available at: http://cdsco.nic.in/html/be%20guidelines%20draft%20ver10%20march%2016,%2005.pdfAccessed on 11 Dec2017

Reis A, Berardo B, Loureiro R. Quality of medicines in Portugal: a retrospective review of medicine recalls (2005-2015). PDA Journal of Pharmaceutical Science and Technology; 2017.

Almuzaini T, Sammons H, Choonara I. Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011). BMJ open. 2013;3(7).

Central Drug Standards Control Organisation, Govt. of India. Central Drugs Testing Laboratories: Ministry of Health, Govt of India; Available at: http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1425. Accessed on 11 Dec2017

Agyekum HHCK, Agyeiwaa A. Consumer Perception of Product Quality. Microeconomics and Macroeconomics. 2015;3(2):25-9.

Glass B. Quality Assurance of Medicines in Practice. In: Savsar PM, editor. Quality Assurance and Management: InTech; 2012.

Holloway KGTE. Drug and therapeutics committees- A practical guide. World Health Organisation. 2003. 1-155 p. Available at: http://apps.who.int/medicinedocs/en/d/Js4882e/ Accessed on 11 Dec2017

Gopalakrishnan S, Udayshankar PM, Rama R. Standard treatment guidelines in primary healthcare practice. Journal of family medicine and primary care. 2014;3(4):424-9.

Kumar KA, Kumar PA. How can a group of procurement experts select suppliers? An approach for group decision support. Journal of Enterprise Information Management. 2014;27(4):337-57.

Maxwell SR. Rational prescribing: the principles of drug selection. Clinical medicine. 2016;16(5):459-64.

Kairi JK, Sharma AK. Substitutes of Prescription Medicines - A Review of Concerns Relevant to Doctors and Patients. Journal of Clinical and Diagnostic Research. 2017;11(8): FE01-FE05

Kairi JK. Implementing therapeutic substitution in a busy tertiary care hospital and reflections on dispensing challenges for a year long period. World Journal of Pharmaceutical and Life Sciences. 2017;3(1):445-52.

Government of India. Defence Procurement Manual 2006. Available at: https://mod.gov.in/defence-procurement-manual. Accessed on 18 Nov 2017

World Health Organisation Counterfeit Drugs. Guidelines for the development of measures to combat counterfeit drugs. Geneva: World Health Organisation, Geneva; 1999.

Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ. The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. PLoS Medicine. 2005;2(4):e100.

Central Drug Standards Control Organisation, Govt. of India. Report on Countrywide Survey for Spurious Drugs. 2009 ed. Ministy of Health and Family Welfare, Government of India; 2009.

Royal Pharmacetical Society, London. Counterfeit Medicines Advice for Healthcare Professionals -Guidance for Pharmacists and Dispensing Doctors; 2009. Available at: https://www.fip.org/files/fip/counterfeit/national/UKCounterfeitadvice209.pdf. Accessed on 11 Dec2017

King A. Light-Sensitive Oral Prescription Drugs. Hospital Pharmacy. 2009;44(12):1112-4.

WHO Collaborating Centre for Patient Safety Solutions. Look-alike, Sound-alike medication names; 2007.

Pharmaceutical Services Division MoHM. Guide on Handling Look Alike, Sound Alike Medications: Pharmaceutical Services Division, Ministry of Health Malaysia; 2012.

U.S. Department of Health and Human Services FDA. Information Regarding Insulin Storage and Switching Between Products in an Emergency: U.S. Department of Health and Human Services, Food and Drug Administration.; 2017 Available at: https://www.fda.gov/Drugs/EmergencyPreparedness/ucm085213.htm. Accessed on 11 Dec2017

Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare, Govt of India. Guidelines On I.V Fluid’s Storage, Distribution and Administration 2011. Available at: www.cdsco.nic.in/.../final%20LVP%20draft%2028_new28-06-2011with%20waterma. Accessed on 11 Dec2017

Nunney FM, Raynor DKT. How are multi compartment compliance aids used in primary care? The Pharmaceutical Journal. 2001;267:784-89.

Royal Pharmaceutical Society, London. Pharmaceutical Issues when Crushing, Opening or Splitting Oral Dosage Forms 2011. Available at: https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Support/toolkit/pharmaceuticalissuesdosageforms-%282%29.pdf. Accessed on 11 Dec2017.