QUALITY MANAGEMENT IN A PHARMACY

Presented by: Akhil Sood Pratosh Pandey Tanu Jaiswal Yawar Waqar

SCENARIO OF RETAIL PHARMACY IN INDIA

Fastest growing markets in the world. Current valuation of approximately USD 11 billion, Likely to be valued at USD 20 billion by 2015(among top ten) Growing at the rate of 18% annually. Ranked 13th in terms of value, and 4th in terms of volume Highly fragmented Unorganized channel of pharmaceuticals dominates this space commanding over 97% of the

Organised retail pharmacy however growing at an average of 25%, Expected to grow between 35 40% by 2020 15 players- 2000 stores KEY GROWTH DRIVERS Increase in the growth rates of the Domestic Pharma industry The industry over the last twelve months grew by a little over 20% as against 11.2% in the previous year Pharma sector in developed countries experienced growth rates of 5-6% during 2010

35 30 % of growth 25 20 India Developed Country

15 10
5 0 2009 10 8 6 4 2 0 2010 2011 2012 2013 2014 2015 2010 2011 2012 (E)

Column1 Column2 India

Source:

STANDARDS OF QUALITY
IN A PHARMACY IN INDIA

REGULATORY AFFAIRS

Laws: legal framework within which a pharmacy and its personnel can operate Ethic: professional regulations, which govern a pharmacist in operating a pharmacy. This module highlights the various legal compulsions that are binding upon pharmacists with regard to Various categories of medicines, Handling of prescriptions, Dispensing, Keeping records Operating in this framework by implementing Good Pharmacy Practice.

PROCUREMENT AND INVENTORY MANAGEMENT

Procurement: the process of acquiring supplies from licensed, authorized agencies, wholesalers/distributors. Effective procurement process ensures the availability of the right medicines in the right quantities, at reasonable prices, and at recognized standards of quality. The procurement cycle includes most of the decisions and actions that determine the specific quantities of medicines needed, medicines obtained, prices paid, and the quality of medicines

STORAGE AND STOCK MANAGEMENT

The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions, otherwise, products are likely to lose their potency before the actual date of expiry. A retail pharmacist is a vital link in the distribution chain for pharmaceutical products. The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies. Every community pharmacy, however large or small, needs to store and manage its medicine stocks effectively. There must be systems to ensure Secure storage. Clean and correct environmental conditions during storage. Accurate and effective record keeping. Effective stock rotation and expiry monitoring. Effective fire and theft prevention. Effective rodent/ pest control

DISPENSING

Pharmacy technician (under the direct supervision of the pharmacist) interprets the physician's requirements on the prescription and accordingly supplies medicines for the treatment of his patient(s). Good dispensing environment ensures that dispensing is carried out accurately and efficiently.

RATIONAL USE OF MEDICINE

Rational use of medicines is essential in today's situation, especially in a country like India, where there is a wide disparity in the availability of medicines amongst cities and villages. The concept of the rational use of medicines has not yet penetrated the minds of health care providers and the public, and as a result there is rampant irrationality in both the medicines available, as well as the medicines prescribed.

PATIENT INFORMATION

Since pharmacies are most accessible to the public, they are often the first point of contact for patients. Patients look up to pharmacists for information about health and medicines. Having access to adequate information enables patients to use medicines in an appropriate, safe, and judicious way. Knowledgeable pharmacists can play a vital role in providing this information. Incomplete and inadequate information leads to inappropriate use of medicines, leading to serious health and economic consequences for both individuals and the community at large.

STANDARDS OF QUALITY IN A PHARMACY IN DEVELOPED COUNTRIES

PRESCRIPTIONS AND REQUISITIONS

Assess the prescription and follow up use of medicines at customer/patient level from a pharmaceutical point of view have working routines that ensure customer/patient safety Give advice and counselling with the aim of making the customer/patient understand the purpose of his/her treatment

PREMISES Customers/patients easily can orientate themselves in relation to the pharmacys system for dispensing prescriptions To facilitate undisturbed conversation with the customer/patient

INTERACTION WITH CUSTOMERS/PATIENTS

Unprompted, and in dialogue with the patient, give information that is individually adapted in order to achieve rational use of medicines and promote the objective of the treatment Give advice and counselling in respect of generally accepted therapy recommendations

DOCUMENTATION Document and follow up the quality and safety of dispensing, any discrepancies, notifications of defects and customer/patient complaints Use quality-assuring IT support system when such are available within the pharmacies dispensing systems or document that equivalent quality is

REQUISITIONS FROM PROFESSIONAL END USERS

CUSTOMER CONTACTS Be available for contact and give follow-up advice and counselling on medicines issues Give advice and counselling about choice of medicines in respect of generally accepted therapy recommendations STORAGE AND HANDLING Set targets for and document their capability and safety of supply Receive and deal with the destruction of pharmaceutical waste and medicines returned from

GOOD PHARMACY PRACTICE

All practicing pharmacists are obliged to ensure that the service they provide to every patient is of appropriate quality Good pharmacy practice involves four main groups of activities: Activities associated with the promotion of good health, the avoidance of ill-health and the achievement of health objectives; Supply and use of medicines and of items for the administration of medicines or for other aspects of treatment

Including advice about and, where appropriate, the supply of a medicine or other treatment for symptoms of ailments that lend themselves to self-treatment Influencing the prescribing and use of medicines Promotion of health and prevention of illhealth Facilities for confidential conversation that cannot be overheard by others Provision of general advice on health matters Involvement of personnel in briefings for specific campaigns to ensure

Supply and use of prescribed medicines and other health care products National standards are needed for: facilities Procedure Personnel Information sources Competence of personnel Medication records efficacy and safety of products recommended; timing of referral to the medical practitioner and methods of follow-up.

sources of supply of medicines and other items; manufacture of medicines storage condition at time of supply to the patient; equipment required facilities and workplace required; preparation and quality assurance of extemporaneous preparations; disposal of unused pharmaceutical products

GOOD STORAGE PRACTICE

All medicines coming into the pharmacy should initially be quarantined, before they are checked for correctness of quantity, batch number, expiry, integrity etc. Transferred to their respective storage locations. All medicines should be stored at stipulated temperature areas, protected from excessive light, dust, and humidity. Temperatures should be recorded at predetermined periodicity Records should be preserved for a period of 2

The medicines and shelves should be maintained clean and dust free at all times by following cleaning schedules and SOPs. Prescription medicines should be kept in such a manner that they are out of reach of patients. All the medicines that are to be stored in a cold temperature should be kept in the refrigerator. Special care and arrangement should be made for the medicines which need to be stored at a prescribed temperature

Medicines and dosage forms that need special care while dispensing (e.g. medicines that fall in group Ka.) should be kept under lock and key. Records of purchases and sales of such medicines should be kept as per legal requirements. Shelves should be checked at a predetermined periodicity to ensure removal of medicines whose expiry date is approaching. The near expiry medicines should be stored separately for early disposal.

Medicines, which have already expired, should be stored separately in a locked shelf, bearing the label Expired Goods Not For Sale. Expired and damaged medicines should be returned to the supplier or destroyed as per inhouse procedures at the earliest. The unused and unopened medicines lying in the pharmacy should be listed and returned to the respective suppliers.

Pharmaceutical care concept is well received by the pharmacists around the world. Pharmacists in developed countries: Patient counselling: An important professional responsibility Mandatory United States Pharmacopoeia has identified and listed barriers Lack of knowledge lack of time lack of training lack of interest lack of remuneration

REGULATION OF COMMUNITY PHARMACY

Receiving a Controlled-Drug Prescription: Prescriptions for

controlled substances require special record-keeping procedures. Pharmacy technicians should be sure to follow any labeling requirements as determined under state and federal law.

CRITICAL PATH OF A PRESCRIPTION

The patient drops off the prescription The pharmacy technician Checks the prescription to make certain it is complete and authentic Verifies that the patient is in the pharmacy database If the patient is not in the pharmacy database, Obtains necessary demographic, insurance, and allergy information.

The pharmacy technician enters the prescription into the computer, bills the insurance company or the patient, and generates the medication label. The pharmacy technician asks the pharmacist to check the drug use review (DUR) or drug interaction warning screen when required. The pharmacy technician selects the appropriate medication and verifies the National Drug Code (NDC) number on the

The pharmacy technician prepares the medication Packages the medication in the appropriate container Labels the prescription container with the computer-generated medication label. Prepares the filled prescription for the pharmacist to check. The pharmacist checks the prescription(s)

Bags the approved prescription for patient sale and attaches an information sheet about the prescription, including indications, interactions, and possible side effects Returns the bulk product container to the shelf Delivers the packaged prescription to the cash register area for patient pickup and pharmacist counseling.

REGULATION IN INDIA

Ownership and practice legislation: Pharmacy Act 1948 Food and Drug Administration India (FDA) Pharmacy Registration / Licensing Food and Drug Administration India (FDA) (licensing). State Pharmacy Councils (Registration) reporting to National Pharmacy Council Drug sales / Prescription Legislation Pharmacy Act 1948 Drugs and Cosmetics Act 1940

REGULATION IN USA

FDAs goals are to assure that patients who require opioids for pain control maintain appropriate access to them through informed providers, while misuse, abuse and diversion of these products is limited to the extent possible. Given the broad scope of factors at issue, to achieve these goals it is essential that FDA work in concert with other government agencies, professional societies, patient advocacy groups, industry,

REGULATION IN EUROPE

Third-party payers (governments, statutory health insurance funds, private insurers) are responsible for the payment of medicines. They act on behalf of consumers or patients and take part in reimbursement decisions; Wholesalers are responsible for distributing pharmaceuticals from source to retail outlets (ie pharmacies), and in doing so they are interested in acquiring pharmaceuticals from the cheapest source;

Prescribing physicians make decisions on behalf of their patients, since the latter have neither the knowledge nor the information to decide which is the most suitable medicine for their condition; Dispensing pharmacists usually follow physicians instructions on what to dispense, but their dispensing behaviour can be influenced by the incentive structure of their payment method; the latter being directly related to the type of products they dispense; Ministries of Finance often levy VAT (usually at a lower than the standard rate) or any applicable consumption tax on prescribed and consumed medicines

REQUIREMENTS OF A PHARMACIST AS PER D&C ACT

In India, there are about 0.6 million pharmacists serving in the community. Diploma in Pharmacy (D. Pharm.): two-year course after 12 year of schooling. Majority of practicing pharmacists are confined to trade activities in the community and engage only in filling the prescriptions. Some pharmacists may provide medication usage information to the patients only on request.

As per section 42 of 1948 Pharmacy Act, only qualified persons are permitted to sell the pharmaceutical formulations. Pharmacy Council of India (PCI) introduced Educational Regulations (ER) in 1953 for standardizing Diploma in Pharmacy education. Many changes were brought in the curriculum of Diploma in Pharmacy over the last five decades Community pharmacy and health education, community pharmacy management, and hospital and clinical pharmacy were introduced at the Diploma in Pharmacy level in the latest ER-91.

Bachelor of Pharmacy (B. Pharm.) curriculum in many Indian Universities is predominantly industry focused In recent years, suitable and need based amendments were made in Bachelor of Pharmacy curriculum Introduction of pharmacy practice subjects with an aim to motivate new graduates to take up jobs in hospitals and community set up.

ROLE OF A PHARMACIST

Maintenance of records on what drugs and products have been issued Maintenance by the pharmacy department of a daily list of drugs in stock to inform prescribers which drugs are available thereby ensuring that only these drugs are prescribed A two prescription system, whereby two separate prescription are written: one for drugs available in the pharmacy, and one for those that are not but can be ordered this helps avoid rewriting of prescription

How to take the medicine (chewed, swallowed whole taken with plenty of water ) Correctly interpret any abbreviations used by the prescriber Confirm that the doses prescribed are in the normal range for the patient (noting gender and age ) Correctly perform any calculation of dose and issue quantity Identify any common drug-drug interactions Prepare items for issue Record the action taken Issue medicine to the patient with clear instruction and advice

When to take the medicine (particularly in relation to food and other medicines) How to store and care for the medicine Collect a container of an item, and check its expiry date. Label the package clearly with the patients name, date, name of the item, quantity dispensed, and written instructions for the patient

Educating the patient : by means of effective verbal and written communication with the patient Development of treatment plan with recognition of patients normal pattern of activities Open the container. Check the quality of its contents. Count the quantity needed in a clean, safe manner.

Designation of specific items of day at which medication is to be taken Monitoring therapy Patient motivation

ADDITIONAL ROLES

Communication with physician Treatment guidelines Research on prescribing and utilization Consumer education Procurement Distribution Prescribing Information

ROLE OF A PHARMACIST IN USA

Drug monitoring and disease management for defined conditions Participating in multidisciplinary clinical care teams Consulting on drug utilization programs Supporting health services research on outcomes of care Providing drug information Patient education Formulary management Furthering public health initiatives such as smoking cessation programs Diabetes education Immunizations

PRIMARY RESEARCH
1) What services do you provide to your customers?
30 25 25 20 20

Discounts
15 Memberships Home Delivery

10
5 2 0 0

8 4

8 4 2 0 0

Guidance for usage

Unorganised

Organised

Hospital Pharmacy

What percentage of discount do you provide?

20 18 16 14 12 10 8 6 6 4 4 2 2 0 0 Unorganised Organised Hospital Pharmacy 0 0 2 2 10% 20% 30% more than 30% 19

Do you have take stocks from company approved stockist?

Yes
0 4 Unorganised Pharmacy Organised 8 18 Hospital Pharmacy 4 Unorganised Pharmacy Organised Hospital Pharmacy

No

Don't Know
0 Unorganised Pharmacy Organised

Hospital Pharmacy 6

Do you have enough storage capacity & good storage facilities for drugs?
30 28 25

20

15

YES NO

10
8

0 Unorganised Organised Hospital Pharmacy

How do you maintain enough inventory?

18 17 16 14

12

10

Log books Inspections

7
6

Computer Softwares

6
4 4 2

2
0 0 Unorganised Organised

1 0 Hospital Pharmacy

Do you employ qualified pharmacist?

Yes
4 8 Unorganised Organised Hospital pharmacy 28

Do you educate your customers for the adverse effects and other patient care Yes services?
4 Unorganised Organised Hospital pharmacy 28

Do you dispense/sell medicine without prescriptions?

30 25 24

20

15

YES NO

10
7 5 4 1 0 0 Unorganised Organised Hoapital Pharmacy 4

Do you sell ......?

16 15 14

12 10 10 Brand 8 Generic and Brand FMCG 6 5 4 3 2 2 1 0 0 Unorganised Organised Hospital Pharmacy 2 2

Do you check monthly for the expired drugs?

Yes
4

8 Unorganised Organised Hospital pharmacy

28

LOOPHOLES
1)

Despite efforts by statutory bodies, registration and regulatory authorities, pharmacists in community pharmacies are still confined themselves to trade than blending the trade with profession. Many Indian community pharmacists consider pharmacy is only trade rather the profession. India is a country with significant drug related problems drug duplication under dose over dose

potential drug interactions Illiteracy Inadequate information about medications usages 2) Selling of drugs without prescriptions by the Pharmacist: Antibiotics, Narcotics 3) Huge amount of discounts 4) Semi Regulated

RECOMMENDATIONS

Due to heavy patients load, doctor's consultancy limits to the issue of prescriptions to patients with very limited or no information about medications and their use. Pharmacists who are supposed to be the information providers and should act as vital link between patients and the prescribers are remaining as the prescription fillers Pharmacists must get fully integrated in the health care team as part of the national health and drug policies. This should be facilitated by recognizing the pharmacists as human resource for health in the national policies.

Policy makers should view pharmacies as part of the health care sector and pharmacists as health care professionals providing health care services and focus on them as they do with other health care professionals The National Rural Health Mission (NRHM) is a new initiative by the government to provide health services in rural areas wherein pharmacists should get connectivity with the rural health systems and become a part of community of carers

Pharmacists should be utilized for improving access to essential medicines and their rational use in proper selection of medicines, ensuring their quality, improving logistics of their procurement, storage and distribution and providing information on medicines to the patients, physicians and nurses The services of community pharmacists should be utilized in referring, counseling and participation in DOTS strategy of the Revised National Tuberculosis Control Programme

Following the proper method of dispensing the drug Dispensing only prescribed drugs

INITIATIVES BY GOVERNMENT
Seven Global Initiatives Globally, the efforts for the development of community and hospital pharmacy haveMbeen concurrently spearheaded by FIP and WHO and were linked to the development of Good Pharmacy Practices (GPP). These developments can be identified by following seven landmarks: 1. Defining Role of Pharmacists 2. Development of GPP Guidelines 3. Pharmacy Curriculum Reform 4. Concept of Pharmaceutical Care 5. Important WHO Resolutions 6. Bangkok Declaration 7. Basel Statements on the Future of Hospital Pharmacy.