Good Pharmacy Practice: A Review

Mr.Anand M. Kudal

The Alma-Ata Declaration on Primary Health Care (1978) ¹ states that "...health is a fundamental human right and that the attainment of the highest possible level of health is a most important world-wide social goal". In addressing the main health problems in the community, Primary Health Care (PHC) must "provide promotive, preventive,curative and rehabilitative services".

The Declaration states that PHC includes at least " ... prevention and control of locally endemic diseases, appropriate treatment of common diseases and injuries and the provision of essential drugs". It recognises the role played by all health workers and the need for suitable training to enable these people to work as a health team to respond to the expressed needs of the community.

Clearly, an adequate pharmaceutical service, ideally provided by pharmacists, is a vital component of Primary Health Care. This is recognised by the World Health Organisation (WHO), and several subsequent publications of the WHO ^2,3,4 emphasise the role of the pharmacist in the Health Care System. Standards are an important part in the measurement of quality of service and at the International Pharmaceutical Federation (FIP) Congress in Japan in 1993 the Tokyo Declaration on Good Pharmacy Practice (GPP) was adopted. FIP has drawn up guidelines which can be used as the basis for the setting of national standards for pharmacy practice. The GPP document has been

subsequently reviewed by the WHO (primarily the Expert Committee on Specifications for Pharmaceutical Preparations) and it is anticipated that an agreed text on GPP could be included in the WHO Technical Report Series which would give the guidelines more formal status and ensure wider distribution.⁵

The International Pharmaceutical Federation first adopted the guidelines for Good Pharmaceutical Practice in 1993. These guidelines were developed as a reference to be used by national pharmaceutical organisations, governments, and international pharmaceutical organizations to set up nationally accepted standards of Good Pharmacy Practice.

The revised version of this document was endorsed by WHO in 1997 and subsequently approved by the FIP Council in 1997. The GPP Guidelines are based on the pharmaceutical care given by pharmacists. The guidelines recommend for national standards to be set:

•   The promotion of health;

•   The supply of medicines, medical devices, patient self-care;

•   Improving prescribing and medicine use by pharmacists’ activities.

These guidelines have been subsequently adapted and adopted in a wide number of developed countries. In certain cases, the national professional body has strived to adapt the guidelines and developed, in collaboration with the government, specific regulation/legislation on this matter. Conscious of the need to help developing countries achieve GPP, the FIP Community Pharmacy Section Executive Committee established a working group to produce guidelines in this area in 1992. The paper, entitled “GPP in Developing Countries – Guidelines for Implementation”, was endorsed by the FIP CPS Executive Committee in September 1998. Having realized the importance of continuing to increase awareness of GPP and stimulating its implementation, the FIP Bureau decided to request the BPP to focus on the theme and to develop a specific activity.

Pharmacy Profession

Over the past 60 years, in many parts of the  world, the profession has lost three of the four pillars of the structure that has traditionally been the mainstay of its work since the 8th century – that of drug procurement, storage and the compounding of drugs. For many, only the fourth and last function remains – the task of dispensing.­­­⁶. A fifth pillar,that of pharmaceutical care, has been added in recent years and will probably define the role of the pharmacist of the future.

Pharmacy has been defined as the science that deals with the study of the functions of the drugs interacting with the human body and pathogens so as to prevent diagnose and treat the diseases; to regulate the physiological mechanism of the human body and to promote human health ⁷.The scope of pharmacy would thus include:

•    Research and development.

•    Production and quality control.

•    Distribution and clinical application.

•    Pharmaceutical care.

Pharmacogenomics, pharmaceutical bio-technology and bioinformatics are but a few of the emerging technologies that will further change the practice of pharmacy and pharmaceutical sciences. From this, it is clear that although more than 90% of pharmacy students end up in community and hospital pharmacy settings, the education of pharmacists must include all the elements that define the profession. Scientific education and applicable research go hand in hand, and the reality of commercial exploitation of pharmaceutical research has become an accepted fact. Acknowledging this is the only practical means of achieving the desired end-point of all research programmes in the pharmaceutical sciences – achieving patient benefits ⁸

A strong scientific background, in areas like genetics, biochemistry, molecular biology and physiology, is thus more important than ever. The pharmacy curriculum should be constructed not only to train students for the current scope of pharmacy practice or a narrow field of expertise, but rather to enable them to be competitive and skilful in various areas of the pharmacist’s job market ⁹

Education

It remains a challenge to develop suitable curricula for the changing environment in a rapidly developing science. Pharmacy schools should take initiatives to ensure an environment for dynamic education to be able to equip graduates with technical knowledge and skills to fulfil the needs of pharmacy and the changing health-care system ⁹.. Though most pharmacy students go into community or hospital pharmacy, we have to remember that our graduates should also be able to work effectively in industry and academia – the pharmacy teachers of tomorrow will have to come from the pharmacy students of today.

While disciplinary excellence is vital, multi-disciplinary programmes are increasingly important. The main requirement in the market today is that graduates are well educated and trained in the fundamentals of their field and practised in applying these skills to real problems¹⁰. The challenge is thus to find the delicate balance between education in the basic sciences (the basis on which the recipient can continually question the status quo – life long learners) and training in specific fields (focussing on the currently accepted state of knowledge). Pharmacy graduates should thus be life long learners, able to solve multidisciplinary problems, use technology and apply non-disciplinary skills (communication, teamwork, leadership etc.). To obtain this it is no longer a question of ‘Are we doing things right’ but rather ‘Are we doing the right things ¹¹. The training programme for post-graduate training as suggested by Borchardt ¹² can then probably be adapted to form the basis of the outcomes based pharmacy curricula of the future as shown in Figure 1.

The pharmacy programme should thus be aimed at educating for competence and giving graduates the conviction, courage and confidence to champion the cause of pharmacy

pharmacy curriculum

Research

With the phenomenal rate of advances in the pharmaceutical and biomedical sciences, novel approaches to fundamental pharmaceutical issues are of the utmost importance. Here, the ideal situation would be for the university to create the cultural background and supply a constant stream of new ideas and young scientists. Industry should set the aims and offer financial support, as it is easier and cheaper to support ‘basic research’ at the university as an investment in the future than doing it ‘in house’ (Pepue, 1999)¹³. The development of ß-antagonists and H2-antagonists are examples of Academia supplying the ideas and industry setting the aims. Decades before the development of fluoxetine, the importance of 5-HT in the pathogenesis and therapy of depression was discovered and studied extensively in academic institutions.

Role of Academics

The role of academia should thus be:
•    Education and training of new pharmacists (scientists)
•    Promoting development of self-directed and life long learning skills
•    Breaking new scientific ground in ‘total’ freedom
•    Development and testing of new methods
•    To offer flexible, relatively low cost teams for special projects
•    To offer the expertise and insight of established scientists and
•    The creation of a cultural environment which is favourable to understanding and promoting the role of science in society.

To accomplish all of the above we will need to:
•    Interact with clients and understand and address their needs
•    Define partnerships between universities and between academia and industry-, hospital- and community pharmacy and government
•    Formulate education, research and practice agendas
•    Explore and exploit the knowledge market and
•    Enhance entrepreneurship to ensure that knowledge is appropriately transferred and applied.

Good pharmacy practice requires inter alia that: •   a pharmacist’s first concern must be the welfare of the patient in all settings and of the public in general;
•   the core of pharmacy activity is the supply and distribution of medicines and other health care products, provision of appropriate information and advice to the patient, ensuring the quality use of medicine and monitoring the effects of use of medicines (pharmaceutical care).

With regard to the prescribing of medicines, the applicable legislation is unequivocal in that this function is reserved for certain authorised prescribers, with exceptions being allowed in certain set circumstances. A pharmacist does have a prescribing role in terms of the lower scheduled medicines and is also expected, as far as other prescribing health professionals are concerned, to provide a prescription monitoring service to ensure that both prescribing and administration of medicines are regularly monitored; to ensure compliance with accepted practice and safer systems of work; and to encourage effective prescribing¹⁴.

Verified Internet Pharmacy Practice Sites™ (VIPPS^®)

VIPPS Program

The Verified Internet Pharmacy Practice Sites^™ (VIPPS^® ) program and its accompanying VIPPS seal of approval identifies to the public those online pharmacy practice sites that are appropriately licensed, are legitimately operating via the Internet, and that have successfully completed a rigorous criteria review and inspection.

NABP verification of the sites

Internet-based pharmacy practice sites wishing to become VIPPS-certified submit a detailed application to NABP, which includes the pharmacy’s policies and procedures addressing the VIPPS criteria. Licensure information is verified with applicable state boards of pharmacy. The VIPPS team reviews the application, policies, and applicant’s Web site, and performs an on-site inspection of the pharmacy’s facilities. Once the policies and procedures as well as the operations of the pharmacy appear to meet the intent of the VIPPS criteria, permission to display the VIPPS Seal is granted and the verified information about the pharmacy is posted on the VIPPS Web site. Clicking on the VIPPS Seal links the user to the VIPPS Web site that then verifies that the Seal is indeed posted on a VIPPS-certified site. If so, the user is then shown pharmacy-specific information, including licensure information.

Regulation of online pharmacies

NABP does not regulate online pharmacies. Regulation of pharmacy practice, whether online or not, is primarily the jurisdiction of the state boards of pharmacy with some federal oversight. The VIPPS program is a voluntary certification program for which Internet pharmacy practice sites may apply. The value of the program to the patient and the Internet pharmacy is that it provides members of the public with a means to assure themselves that the Internet pharmacy they choose is a bonafide, fully licensed facility exercising competent Internet/interstate pharmacy practices.

Development of  VIPPS program

In 1999, NABP became aware of the need for this program when consumers contacted several state pharmacy boards to complain about illegal Internet prescribing and dispensing sites posing as legitimate pharmacies. The Association developed the VIPPS program in response to public and regulatory agency concerns regarding safety of Internet pharmacy practices in order to provide a means for the public to distinguish between legitimate and illegitimate online pharmacy practice sites.

Online pharmacies

Many pharmacies (usually those that offer online prescribing) open and close on a daily basis. One company posing as a legitimate pharmacy may have many URLs or Web addresses, creating the impression that there is a greater number of Internet pharmacies than actually exists. In addition, pharmacies may only register with select search engines. If these search engines are not utilized when performing a search then all pharmacies may not be counted.

Prescribing sites

The number of prescribing sites, using patient questionnaires and fee-based cyberspace consultations, as well as sites that sell prescription medications and controlled substances without requiring a “consult,” is difficult to estimate. NABP’s research indicates that the number of such rogue operators is less than the number of legitimate online dispensing pharmacies.

Disadvantages of Online Prescription.

First, Food and Drug Administration (FDA) restricts the distribution of certain drugs to a prescription-only basis because in certain medical situations they can be dangerous if not taken with ongoing medical consultation. Most regulatory authorities and professional organizations regard online prescribing to be unprofessional, and in some states it is illegal, unless it is done pursuant to a valid, ongoing patient-prescriber relationship that has included an in-person physical examination. Completing only an online questionnaire does not establish a valid patient-prescriber relationship. Moreover, without a physical examination you could receive inappropriate medication and worsen an underlying, undiagnosed, serious medical condition. ( e.g Viagra & Xenical)

As for increased privacy and confidentiality, evidence appears to indicate that illegitimate prescribing sites frequently sell their customer lists to other illegitimate online pharmacy operators and owners of Internet scam and pornography sites. By buying drugs from an illegitimate site you may be designating yourself as someone who is a good target for rip-off schemes.

Frequently, deceived consumers notify us of non-receipt of medications they ordered, and/or credit card charges that illegitimately operating pharmacies refuse to remove. Many also complain that they are unable to contact the pharmacies: phone lines are disconnected or no one answers.

Low prices

One of the great benefits to shopping online to fill your prescriptions is the ease with which you can comparison shop. Many pharmacies offer price comparisons between their charge and that of other legitimate pharmacies. This is one way to stretch your health care dollar. Many online pharmacies accept prescription benefit insurance coverage as well. In addition, legitimate online pharmacies often offer valuable health care information in a searchable format. VIPPS-certified pharmacies are required to offer their customers free phone consultation with a pharmacist, and many offer free ask-a-pharmacist e-mail service as well.

Advantages of ordering medications online

Convenience is a major advantage that online pharmacies provide over some of their pharmacy competitors. Consumers’ ability to order and receive medications without leaving their home is a tremendous time-saver. Often, drug information and price information may be accessed via the pharmacy’s Web site, or this information may be requested via e-mail so the consumer does not have to wait on the phone for an answer or travel to the pharmacy to ask for this information in person. In addition, online pharmacies may provide more privacy than traditional brick-and-mortar pharmacies. Consumers who are too embarrassed to purchase certain medications or health care products from the local pharmacy may find greater anonymity by ordering these products from an e-pharmacy where staff may not be able to put a “face to a name.”

Regulations

The state boards of pharmacy have primary responsibility for regulation of online pharmacies. Regulatory authority is mainly exercised by the state board of pharmacy of the state in which the pharmacy is physically located. In addition, most states protect their citizens by licensing “out-of-state pharmacies” that ship medications to patients in their jurisdictions. The same regulations that apply to traditional brick-and-mortar and mail-order pharmacies typically apply to online pharmacies. Federal agencies, such as FDA and Drug Enforcement Administration (DEA), are also partners with the state boards of pharmacy in this regulatory process. FDA, however, mainly regulates foreign-based sites and practitioners.

Security of patient information for online pharmacies

Care professionals regarding online pharmacy services. State and federal laws such as the Health Insurance Portability Security, confidentiality, and privacy are among the chief concerns of patients and health and Accountability Act (HIPAA) protect patient identifiable information. VIPPS and other voluntary certification programs require participating organizations to adhere to and post their privacy policies. In addition, NABP has published guidelines regarding the confidentiality of patient health care information.

Prescription

Generally state laws require faxed prescriptions to be received directly from the prescriber (not the patient) to be valid. Online sites that do not protect the integrity of the original prescription, or that do not verify the authenticity of suspect prescriptions may be in violation of the law. In addition, VIPPS-certified pharmacies must have policies and procedures in place that address these issues. Before you entrust your health to anyone online, look for the VIPPS Seal, and click to verify.

Conclusion:

Good Pharmacy Practice is a  recently  emerging branch  for the care and welfare of the  patient designed  in an order, that  will give best of its possible services to mankind including, Patient Councelling, VIPPS Program, Online pharmacy and along with other branches like research, quality control,and clinical pharmacy will climb the height of success in the near future. A further insight is needed in this field considering the three criterias namely safety,efficasy and economy and the field is futher open for changes and development for the care and weifare of the society.

References

1) Primary Health Care - Report of the International Conference on Primary Health Care, Alma-Ata, USSR 1978

2)The Role of the Pharmacist in the Health Care System - Report of a WHO Consultative Group, New Delhi,

India 1993

3)Role of the Pharmacist in Support of the WHO Revised Drug Strategy, 47th World Health Assembly, 1994

4)Revised Drug Strategy, 49th World Health Assembly, 1996

5)Good Pharmacy Practice in Community and Hospital Settings, WHO 1997

6) Morgall, J.M. & Almarsdottir, A.B. 1999. No struggle, no strength: how pharmacists lost their monopoly. Social Science & Medicine, 48(9):1247-1258.

7)Wu, X.M. 2000. Deepening the reform of higher pharmaceutical education for the 21st century. American Journal of Pharmaceutical Education, 64(3):324-326.

8)Woolfson, A.D. 1999. Breaking out of the Ivory tower: from academia to clinic. Journal of Pharmacy and Pharmacology, 51(8)899-903.

9) Vizirianakis, I.S. 2002. Pharmaceutical education in the wake of genomic technologies for drug development and personalized medicine. European Journal of Pharmaceutical Sciences, 15:243-250.

10)Mooney, K.G. 2001. Challenges faced by the pharmaceutical industry: training graduates for employment in pharmaceutical R&D. European Journal of Pharmaceutical Sciences, 12:353-359.

11)Breimer, D.D. 2001. Future training needs in the pharmaceutical sciences: Academia – Industry. European Journal of Pharmaceutical Sciences, 12:347-352.

12)Borchardt, R.T. 1998. Future of Pharmaceutical Education. Plenary lecture at Annual meeting of AAPS, San Francisco

13)Pepue, G. 1999. Is there still a role for Academia? Drug discovery Today, 305-306.

14)Ref- Medpharm publications July2002

15) www.nabp.net/vipps/consumer/faq.asp - 27k - 13 Jun 2006

About Authors

Mr.Anand M. Kudal*

Working as Lecturer at MAEER’s,Maharastra Institute of Pharmacy, MIT Campus, Pune. He has completed M.Pharm in Medicinal and Pharmaceutical Chemistry from Department of Pharmacy, SGSITS,Indore, RGPV, Bhopal. Email:anand_kudal@yahoo.com, Cell-09371182099

Mr. Satish A. Polshettiwar

Working as Lecturer at MAEER’s, Maharashtra Institute of Pharmacy, MIT Campus, Pune. He has done his M.Pharm in Quality Assurance from Nagpur university. He is a Life member of APTI. He has published and presented several research articles in national level.
E.Mail:contact_psatish@yahoo.co.in, Cell No. 09422842838

Mr. Abhijeet V. Motiwale

Working as Lectuter at MAEER’s ,Maharastra Institute of Pharmacy,MIT campus,Pune.He has done his M.Pharm in Pharmaceutics from Rajiv Gandhi University,Karnataka. He has also done his MBA from Indore.

Mr. Manish S. Wani

Working as Lecturer at MAEER’s ,Maharastra Institute of Pharmacy,MIT campus,Pune.He has done his M.Pharm in Pharmaceutics from Pune University. He has also done his MBA from Pune University