Our examination appears that OPs utilize procedures that would be more reasonable for a product showcase than for drugs. These techniques separate concurring to assortment (brand or nonexclusive), quality, amount, and target gather. OPs are well mindful that the vacuum in the enactment permits them to reach a target of buyers that drug stores cannot ordinarily reach, such as those who would like to utilize the sedate without counseling a physician. Internet and e-commerce have significantly changed society, the economy, and the world of wellbeing care.

The web offers openings to move forward wellbeing, but it may too speak to a enormous wellbeing danger since it is a fundamentally unregulated advertise with exceptionally moo buyer security. In this paper we analyze promoting and estimating techniques of online pharmacies. Our examination appears that OPs utilize techniques that would be more reasonable for a product showcase than for Drugs.

These procedures separate concurring to assortment (brand or nonexclusive), quality, amount, and target bunch. OPs are well mindful that the vacuum in the enactment permits them to reach a target of shoppers that drug stores cannot regularly reach, such as those who would like to utilize the medicate without counseling a physician.

Internet and e-commerce have significantly changed society, the economy and the world of wellbeing care, not without moral and lawful results. Data approximately wellbeing care is far reaching, and a significant number of patients frequently utilize this device some time recently counseling a doctor and amid treatment.

The web increments the opportunity for patients to obtain data that may be utilized either to frame an conclusion on their wellbeing status or to decrease uneasiness.

A US overview found that 64% of the online populace had looked for wellbeing data at slightest once in the past 12 months, and a European study found 71% of Web clients had gotten to it for wellbeing purposes. “Drugs” (requiring medicine or over the counter) was the fifth wellbeing point looked for in the Web, in 37% of cases,.

Web has too expanded the opportunity for patients to buy drugs on line. In the nineties, a few drug stores started to work over the Web offering drugs without for all intents and purposes any control, indeed for dynamic standards requiring a medicine. Agreeing to the US Nourishment and Medicate Organization (FDA) there are at slightest 400 websites that both apportion and offer endorsing administrations and half of these destinations are found exterior the US. As detailed on the FDA site, it has been evaluated that the number of websites offering medicine drugs may presently be closer to 1000. The number of websites, be that as it may, varies from day to day and appears to be developing. A later overview of online drug stores (OPs) found that their space of enlistment was in 51% of the test in the USA, and in 22% in Europe

. It is exceptionally troublesome to gauge the number of individuals buying online, the volume of drugs exchanged and the financial degree of this commerce. A study conducted in the US by implies of phone interviews found that 4% of Americans had obtained medicine drugs on the Web. Back in 2000 the National Affiliation of Sheets of Drug store assessed that add up to deals of prescription-only drugs on the Web in the USA was $100 million, with an evaluated increment in all pharmaceutical deals to $1 billion by 2003.

Moreover, the web has no topographical obstructions and its worldwide measurement makes it troublesome to control virtual drug stores since there is no universal enactment directing this complex issue. The development of an unregulated worldwide drugs advertise may increment the chance of the spread of fake solutions, coming from nations where sedate generation is not subject to the same quality control as in the US, Canada and Europe. The World Wellbeing Organization has announced that “medicines obtained over the Web from locales that conceal their physical address are fake in over 50% of cases”.

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In expansion, numerous online drug stores offer the customer drugs without restorative medicine and this can uncover individuals to the dangers related with the admissions of improper drugs and can hurt the patient–doctor relationship, changing patients into buyers.

In reality, the medicine necessity points to protect patients from dangers related with superfluous drugs, and it allots obligation for cost/benefit evaluation to the specialist, the proficient who has the information to make this decision. This quick advancement of online drug stores is related to a few components. Web permits to reach providers around the world at any hour without having to visit shops and it may permit to get commodities at a lower cost.

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For online drug stores there is another imperative figure related to the questionable topic of direct-to-consumer promoting (DTCA) of medicine drugs, where defenders highlight the potential in terms of quiet strengthening, whereas adversaries claim that DTCA misshapes the patient–doctor relationship, producing request without prove of wellbeing benefits. In later a long time patients have expanded their inclusion in the decision-making handle concerning their wellbeing, a prepare that in the past was completely in the hands of the doctor, driving to common concern approximately the impact of such procedure on persistent wellbeing.

In a world where indeed the concept of wellbeing has changed, moving from the nonattendance of malady to well-being and wellness, pharmaceutical item special techniques may be pointed at making a request for drugs, creating consumers/patients. This is a exceptionally genuine risk which may be exacerbated by the deal of drugs through the Web. The deal online of drugs is open to everyone who has an Web get to and online drug stores offer all sorts of drugs, counting medicine drugs. To our information, the as it were taken a toll examination of online drugs was performed in the US, in a comparison between conventional drug stores and OPs which found no financial advantage in buying online, both in year 1999 and in 2006.

In our ponder we explore the financial highlights of online medicate deals, analyzing promoting and estimating techniques by online drug stores for a few “marker drugs” that were chosen either since of their tall inherent hazard if utilized improperly or since of their broad utilize. To our information, this is the to begin with consider which centers on the relationship between OP highlights and the estimating designs. Showcasing and cost procedures are examined utilizing expressive and econometric instruments.

<p>The post Overview on the operations and marketing strategies of various online pharmacies first appeared on PHARMA PUSH.</p>

You may have seen prescription abbreviations like qd, hs, or bid on your medication labels, which are derived from the latin words for “every day,” “at bedtime,” and “twice daily,” respectively. Perhaps one of the most common is Rx, which is the official symbol for “prescription.” Thought to be derived from the latin word for “recipe,” this abbreviation relays to pharmacists that a prescription is authorized to be filled.

This article will discuss the Latin abbreviations healthcare providers use on prescriptions and help you learn how to translate them. It will also discuss steps you can take to protect yourself from prescribing errors.

Assembling a comprehensive list of prescription abbreviations along with their interpretations provides valuable insight into the language and conventions used in medical practice.

The Origins of “Rx” as an Abbreviation for “Prescription”

Rx is an abbreviation for “prescription.” In the U.S. it is believed that the origin of the symbol is an abbreviation of the Latin word for “recipe,” which means “take.” In Europe, another suggestion of the origin of the symbol appears to represent the astronomical sign of the planet Jupiter. According to another theory, the Rx symbol is based on the Roman deity Jupiter. Jupiter’s symbol looked similar to the Rx symbol. The symbol may have been placed on a prescription to invoke Jupiter’s blessing.

The abbreviations may be written in capital letters or small letters, and may or may not include periods.

Here’s an extensive compilation of abbreviations commonly found in prescriptions, categorized by their usage and interpretation.

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Dosage and Frequency:

1. OD: Once daily
2. BD: Twice daily
3. TDS: Three times daily
4. QDS: Four times daily
5. QID: Four times daily
6. HS: At bedtime (from Latin “hora somni”)
7. PC: After meals (from Latin “post cibum”)
8. AC: Before meals (from Latin “ante cibum”)
9. PRN: As needed (from Latin “pro re nata”)
10. QAM: Every morning
11. QPM: Every evening
12. Q4H, Q6H, Q8H, etc.: Every 4, 6, 8 hours, etc.
13. QOD: Every other day (from Latin “quaque altera die”)

Route of Administration:

14. PO: By mouth (from Latin “per os”)
15. IV: Intravenous
16. IM: Intramuscular
17. SQ: Subcutaneous
18. PR: Rectal (from Latin “per rectum”)
19. TOP: Topical
20. OTIC: Ear drops
21. OD: Right eye (from Latin “oculus dexter”)
22. OS: Left eye (from Latin “oculus sinister”)
23. OU: Both eyes (from Latin “oculi uterque”)
24. INH: Inhalation

Patient Instructions:

25. NR: No refills
26. UD: Use as directed
27. NP: Not to be refilled
28. DAW: Dispense as written
29. UD: Use as directed
30. Sig: Let it be labeled
31. UDD: Use as directed
32. UDHS: Use as directed, by the hour of sleep
33. ETOH: Alcohol
34. NPO: Nothing by mouth (from Latin “nil per os”)
35. SS: Half (from Latin “semis”)
36. NSS: Normal saline solution
37. SOS: If necessary (from Latin “si opus sit”)
38. ASAP: As soon as possible

Medical Conditions and States:

39. SOB: Shortness of breath
40. CVA: Cerebrovascular accident (stroke)
41. COPD: Chronic obstructive pulmonary disease
42. DM: Diabetes mellitus
43. HTN: Hypertension
44. CHF: Congestive heart failure
45. UTI: Urinary tract infection
46. GI: Gastrointestinal
47. GERD: Gastroesophageal reflux disease
48. IBS: Irritable bowel syndrome
49. CNS: Central nervous system
50. PVD: Peripheral vascular disease
51. PID: Pelvic inflammatory disease
52. PID: Pelvic inflammatory disease
53. UTI: Urinary tract infection
54. RA: Rheumatoid arthritis
55. OA: Osteoarthritis
56. TIA: Transient ischemic attack
57. MI: Myocardial infarction

Laboratory and Diagnostic Abbreviations:

58. CBC: Complete blood count
59. CMP: Comprehensive metabolic panel
60. UA: Urinalysis
61. ECG/EKG: Electrocardiogram
62. MRI: Magnetic resonance imaging
63. CT: Computed tomography
64. PT: Prothrombin time
65. PTT: Partial thromboplastin time
66. INR: International normalized ratio
67. HbA1c: Glycated hemoglobin (used for monitoring diabetes)
68. ESR: Erythrocyte sedimentation rate
69. CRP: C-reactive protein
70. BUN: Blood urea nitrogen
71. SCr: Serum creatinine
72. HDL: High-density lipoprotein
73. LDL: Low-density lipoprotein

Medication Names and Classes:

74. ASA: Acetylsalicylic acid (Aspirin)
75. APAP: Acetaminophen
76. NSAIDs: Nonsteroidal anti-inflammatory drugs
77. ACEI: Angiotensin-converting enzyme inhibitor
78. ARB: Angiotensin II receptor blocker
79. SSRI: Selective serotonin reuptake inhibitor
80. SNRI: Serotonin-norepinephrine reuptake inhibitor
81. MAOI: Monoamine oxidase inhibitor
82. BB: Beta-blocker
83. CCB: Calcium channel blocker
84. PPI: Proton pump inhibitor
85. H2RA: Histamine-2 receptor antagonist
86. SSA: Somatostatin analogs
87. SABA: Short-acting beta-agonist
88. LABA: Long-acting beta-agonist
89. SGLT2: Sodium-glucose cotransporter-2 inhibitors
90. GLP-1: Glucagon-like peptide-1 receptor agonists
91. DPP-4: Dipeptidyl peptidase-4 inhibitors
92. TZD: Thiazolidinediones
93. BMI: Body mass index
94. LFTs: Liver function tests
95. HRT: Hormone replacement therapy
96. NS: Normal saline
97. TPN: Total parenteral nutrition

Miscellaneous Abbreviations:

98. Rx: Prescription
99. OTC: Over-the-counter
100. POISON: Poison control hotline number
101. MEDWATCH: FDA’s safety information and adverse event reporting program
102. APAP: Acetaminophen
103. HRT: Hormone replacement therapy
104. TCA: Tricyclic antidepressant
105. SSRIs: Selective serotonin reuptake inhibitors
106. CYP: Cytochrome P450
107. SSRIs: Selective serotonin reuptake inhibitors

This compilation of prescription abbreviations and their interpretations provides insight into the language of medical practice and helps ensure clarity and accuracy in medication administration and communication among healthcare providers and patients. Always consult with healthcare professionals for accurate interpretation and use of prescription abbreviations.

Declining Use of Prescription Abbreviations

The Latin terms are still in use, but some healthcare providers are retiring them. It is becoming more common for healthcare providers to write prescription instructions in plain language. Readable prescriptions can help prevent medication errors. That is why many medical professionals believe written instructions should be used instead of hard-to-read abbreviations.

For example, the abbreviation qd, which means “daily,” could be mistaken for qid, which means “four times a day.” It could also be confused for od, which means “right eye.” Simply writing “daily” prevents confusion. E-prescribing, or electronic prescribing, can also help prevent medication errors. Instructions sent directly to the pharmacy electronically are less prone to human error. If your healthcare provider uses electronic prescribing, you may never see the abbreviations.

To avoid ambiguity, the following abbreviations are not recommended.

1. a.u., a.s., a.d. – Latin for both, left and right ears; the “a” can be misread to be an “o” and interpreted to mean both, right or left eyes
2. bt – intended to mean “bedtime”, but can be misread as “bid” or twice daily.
3. d/c – can mean “discontinue” or “discharge”
4. h.s. – can mean half strength or “hour of sleep”
5. IJ – intended to mean “injection”, but can be misread as “IV”
6. IN – intended to mean “intranasal”, but can be misread as “IM” or “IV”
7. IU – intended to mean “international unit”, but can be misread as “IV” or “10”
8. o.d., o.s., o.u. – the “o” can be misread as “a”.
9. o.d. – can mean “once daily” or “right eye”.
10. OJ – intended to mean “orange juice” but can be misread as “OD” or “OS”
11. q4PM – intended to mean “at 4 PM”, but can be misread as every 4 hours
12. q.d., q1d – intended to mean “every day” but can be misread as “q.i.d.” or 4 times a
    day
13. q.o.d. – meant “every other day” but the “o” can be interpreted as “.” or “i” resulting
    in double or eight times the frequency
14. SC – meant “subcutaneaous” but mistaken for “SL” for “sublingual”
15. SQ – meant “subcutaneaous” but mistaken for “5Q” or 5 every dose
16. ‘ss‘ – intended to mean “sliding scale” or “1/2”, but can be mistaken as “55”
17. ‘SSI, SSRI – intended to mean “sliding scale insulin” or “sliding scale regular insulin”,
    but can be mistaken as “strong solution of iodine” or “selective serotonin reuptake
    inhibitor
18. T.I.W – meant 3 times a week but mistaken for twice a week
19. U – meant “units” but mistaken for “0”, “4” (so “4U” can become “40” and the “U” is
    assumed), or misread as “cc” when poorly written; conversely cc can be mistaken
    for “U”
20. μg – meant “microgram” but mistaken for “mg”; this 1000-fold error can cause
    potentially fatal misunderstandings

<p>The post List out the various abbreviations, short forms used in prescriptions and their interpretation first appeared on PHARMA PUSH.</p>

A standard Operating procedure is a document which describes the regularly recurring operations relevant to the quality of service being rendered. The purpose of an SOPs is to carry out the operations correctly and always in the same manner. It should be available at the place where the work is done. An SOPs is a compulsory instruction. All changes in the instructions must be documented and reported to the authorities who are the only ones to authenticate and approve such variations.

OBJECTIVES OF DEVELOPMENT OF SOPs

The development of Standard Operating Procedures (SOPs) serves several crucial objectives across various domains, including industries, healthcare, research, and more. Here are some of the key objectives:

1. Consistency: SOPs ensure consistency in operations and processes within an organization. By providing standardized procedures, SOPs help maintain uniformity in the execution of tasks, reducing errors and variations.
2. Quality Assurance: SOPs outline best practices and quality standards that must be followed to achieve desired outcomes. They help maintain and improve product or service quality by ensuring that all tasks are performed to specified standards.
3. Compliance: SOPs help organizations comply with regulatory requirements and industry standards. By documenting procedures and guidelines, SOPs ensure that operations are conducted in accordance with legal and regulatory frameworks, reducing the risk of non-compliance and potential penalties.
4. Training and Onboarding: SOPs serve as valuable training materials for new employees. They provide a structured guide for employees to learn about their roles, responsibilities, and the standard procedures they need to follow to perform their tasks effectively.
5. Risk Management: SOPs help identify and mitigate risks associated with various processes and operations. By outlining safety protocols, emergency procedures, and risk mitigation strategies, SOPs contribute to the overall risk management efforts of an organization.
6. Efficiency and Productivity: SOPs streamline workflows and eliminate redundant or unnecessary steps, thereby improving operational efficiency and productivity. By providing clear guidelines and expectations, SOPs enable employees to perform tasks more effectively and minimize wasted time and resources.
7. Continuous Improvement: SOPs serve as a reference point for evaluating existing processes and identifying areas for improvement. By regularly reviewing and updating SOPs based on feedback, new insights, and changing requirements, organizations can continuously optimize their operations and adapt to evolving circumstances.
8. Communication and Collaboration: SOPs facilitate effective communication and collaboration among team members by providing a common framework and understanding of how tasks and processes should be performed. They help align individuals and teams towards common goals and objectives.

Areas covered by this SOPs include

Standard Operating Procedures (SOPs) can cover a wide range of areas within an organization. The specific areas covered by SOPs may vary depending on the nature of the organization, its industry, and its operations. However, here are some common areas that are typically addressed by SOPs:

1. SOPs for Drug Lists
2. SOPs for Procurement of Medicines
3. SOPs for Receiving Drugs into Pharmacy
4. SOPs for Drug Storage
5. SOPs for Vaccine Storage
6. SOPs for Temperature Control
7. SOPs for Issue and Delivery of Drugs to Dispensary/Satellite
8. Pharmacies/Wards /Other Units
9. SOPs for Dispensing /UDDS
10. SOPs for Patients Counseling
11. SOPs for Counseling of Handicapped Patients
12. SOPs for Compounding of Medicines
13. SOPs for Procurement, Dispensing and Distribution of Narcotic Drugs and
    Poisons.
14. SOPs for Disposal of Expired Drugs
15. SOPs for Clinical Ward Round
16. SOPs for Training of Intern Pharmacists
17. SOPs for Continuing Education
18. SOPs for Drug Revolving Fund (DRF) Scheme
19. SOPs for Drug Information Service (DIS)/Drug Information Center (DIC).
20. SOPs for Dress Code
21. SOPs for Therapeutic Drug Monitoring(TDM)
22. SOPs for Screening Prescriptions
23. SOPs for Preparing a Drug Formulary.

SOPs FOR DRUG LISTS

1. Prepare an advocacy plan for the SOP
2. Write a proposal to management for setting up of drug and therapeutic committee in line with requirements prescribed by the National Drug Policy.
3. Identify different categories of drugs required by the health facility based on the national essential drug list (EDL) / National Standard Treatment Guideline (NSTGs).
4. Draw up list using generic and international non-proprietary name (INN) of the drug.
5. Obtain approval for the management of the facility
6. Circulate approved list to stake holders within the facility.
7. Ensure strict compliance to the use of the ELD.

SOPs FOR PROCUREMENT MEDICINES/ CONSUMABLES

1. Prepare an advocacy plan for the sop
2. Confirm the availability of funds
3. Match needs with available funds
4. Identify and verify the suppliers
5. Qualify suppliers
6. Choose method of procurement
7. Prepare an order form
8. Contact suppliers to quote the returns and complete the form
9. State the date of submission of the tender document
10. Organize public bid openings and record proceedings
11. Conduct evaluations
12. Submit recommendations to tender committee for approval of awards
13. Forward copies of award document to the store and finance departments
14. Facilitate the signing of contract agreements
15. Monitor suppliers performance and sanction defaulters
16. Receive and store drugs
17. Facilitate prompt payment to suppliers
18. Commence preparation for next procurement cycle
19. Provide the names and strength of each drug in the following order: Name (generic), strength and form, e.g.
20. Provide a column for the expiry date of drug
21. Provide a column for the price of each item and a column for the total price
22. Provide a space for the name of the company, giving relevant details such as address, telephone number, e-mail address, name of the contact person.

SOPs FOR RECEIVING DRUG ITEMS INTO A PHARMACY BULK STORE

Developing a Standard Operating Procedure (SOP) for receiving drug items into a pharmacy bulk store is critical to maintaining regulatory compliance, ensuring inventory accuracy, and safeguarding the quality and integrity of pharmaceutical products. Here’s an outline for such an SOP:

1. Pre-Receiving Preparation:
   • Ensure that the receiving area is clean, organized, and free from clutter.
   • Verify that the temperature and humidity levels in the receiving area are within acceptable ranges for storing pharmaceutical products.
   • Ensure that necessary receiving equipment (e.g., gloves, masks, labels, barcode scanners) are available and in good working condition.
2. Receiving Process:
   • Upon receipt of a shipment, the receiving personnel must inspect the packaging for any signs of damage, tampering, or contamination.
   • Match the received shipment with the accompanying packing slip or purchase order to verify the accuracy of the items received.
   • Use a barcode scanner or manual entry to record each received item into the inventory management system.
   • Check the expiration dates and lot numbers of each received item to ensure compliance with regulatory requirements.
   • If discrepancies are found between the shipment and the packing slip, notify the supplier and the Pharmacy Manager immediately.
3. Quality Assurance Check:
   • The Quality Assurance Officer conducts a visual inspection of the received drug items to ensure they meet quality standards.
   • Inspect packaging integrity, labeling accuracy, and overall condition of the drug items.
   • Randomly select samples for further testing or analysis if deemed necessary.
4. Storage and Documentation:
   • Store received drug items in designated storage areas according to their specific storage requirements (e.g., temperature-sensitive items).
   • Label shelves, bins, or containers with the name, strength, lot number, and expiration date of each drug item.
   • Maintain accurate and up-to-date records of received items, including quantity, lot numbers, expiration dates, and storage locations.
   • Document any discrepancies, damages, or deviations from the standard receiving process in the appropriate records and notify the Pharmacy Manager.
5. Cleanup and Post-Receiving Procedures:
   • Dispose of packaging materials and any damaged or expired drug items according to established waste disposal protocols.
   • Clean and sanitize the receiving area after each receiving session to prevent cross-contamination and ensure compliance with hygiene standards.

This SOPs provides a framework for establishing standardized procedures for receiving drug items into a pharmacy bulk store, ensuring regulatory compliance, inventory accuracy, and product quality control. Adjustments may be necessary based on the specific requirements and operational context of the pharmacy.

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SOPs For Drug Storage

Standard Operating Procedures (SOPs) for drug storage are crucial to maintaining the integrity, safety, and efficacy of pharmaceutical products within a pharmacy or healthcare facility. Here’s an outline for creating SOPs for drug storage:

1. Storage Environment:
   • Ensure that the storage area is clean, well-ventilated, and free from environmental hazards such as excessive heat, humidity, and light exposure.
   • Maintain appropriate temperature and humidity levels within the storage area as per the manufacturer’s recommendations and regulatory guidelines.
   • Regularly monitor temperature and humidity levels using calibrated monitoring devices and record the readings as per the frequency specified in the SOP.
2. Storage Conditions:
   • Segregate drugs based on their storage requirements (e.g., refrigerated, ambient, controlled substances) and store them accordingly.
   • Use designated storage shelves, cabinets, or containers for different categories of drugs to prevent cross-contamination and ensure organization.
   • Store drugs in their original packaging or containers to maintain product integrity and protect them from light, moisture, and other external factors.
   • Clearly label shelves, bins, or containers with the name, strength, lot number, and expiration date of each drug product.
3. Inventory Management:
   • Conduct regular inventory checks to monitor stock levels, expiration dates, and storage conditions of drugs.
   • Rotate stock using the first-in, first-out (FIFO) method to ensure that older inventory is used before newer stock.
   • Perform routine inspections of drug products for signs of damage, deterioration, or tampering and take appropriate action if discrepancies are detected.
   • Maintain accurate and up-to-date records of inventory transactions, including receipts, withdrawals, transfers, and returns.
4. Security and Access Control:
   • Restrict access to the drug storage area to authorized personnel only and implement appropriate security measures to prevent unauthorized entry or theft.
   • Keep all controlled substances securely locked and maintain strict adherence to regulatory requirements for handling and storing controlled substances.
   • Conduct regular audits and inspections of the drug storage area to ensure compliance with security protocols and regulatory standards.
5. Emergency Procedures:
   • Develop and document procedures for responding to emergencies such as power outages, equipment failures, or environmental disasters that may impact drug storage conditions.
   • Establish contingency plans for relocating drugs to alternative storage facilities or implementing temporary measures to maintain storage integrity during emergencies.

SOPs For Storage of Vaccines

Standard Operating Procedures (SOPs) for the storage of vaccines are essential to maintaining their potency, efficacy, and safety. Here’s a comprehensive outline for developing SOPs for vaccine storage:

1. Storage Environment:
   • Designate a dedicated vaccine storage area that meets the recommended temperature and humidity requirements specified by vaccine manufacturers and regulatory agencies.
   • Ensure that the vaccine storage area is well-ventilated, clean, and free from environmental hazards such as direct sunlight, moisture, and temperature fluctuations.
   • Install calibrated temperature monitoring devices (e.g., digital data loggers) in the vaccine storage unit to continuously monitor and record temperature levels.
2. Temperature Monitoring:
   • Perform daily temperature checks using calibrated thermometers or digital data loggers to ensure that the storage temperature remains within the recommended range for each vaccine.
   • Record temperature readings at regular intervals and maintain accurate temperature logs as per regulatory requirements.
   • Take immediate corrective action if temperature excursions or deviations from the recommended range are detected, including notifying the Vaccine Coordinator and following established protocols for temperature troubleshooting.
3. Storage Practices:
   • Store vaccines in their original packaging or containers to maintain product integrity and protect them from light exposure, moisture, and contamination.
   • Arrange vaccines on designated shelves or storage units according to their storage requirements (e.g., refrigerated, frozen, ambient).
   • Rotate vaccine stock using the first-in, first-out (FIFO) method to ensure that vaccines with the earliest expiration dates are used first.
   • Regularly inspect vaccine vials or packages for signs of damage, leakage, or expiration and remove any compromised vaccines from inventory.
4. Inventory Management:
   • Maintain accurate and up-to-date records of vaccine inventory, including quantities received, lot numbers, expiration dates, and doses administered.
   • Conduct regular inventory audits and reconciliations to ensure that vaccine stock levels are accurately accounted for and discrepancies are promptly addressed.
   • Implement secure storage measures for vaccines, including access control, inventory tracking, and documentation of vaccine movements.
5. Emergency Procedures:
   • Develop and document procedures for responding to emergencies such as power outages, equipment failures, or natural disasters that may impact vaccine storage conditions.
   • Establish contingency plans for relocating vaccines to alternative storage facilities or implementing temporary measures to maintain storage integrity during emergencies.

SOPs For Temperature Control

Standard Operating Procedures (SOPs) for temperature control are essential for maintaining the quality, safety, and efficacy of temperature-sensitive products, including pharmaceuticals, vaccines, food items, and biological materials. Here’s a comprehensive outline for developing SOPs for temperature control:

Standard temperatures Chart: Here is a standard temperature chart outlining recommended temperature ranges for various purposes, including food storage, pharmaceuticals, vaccines, and laboratory samples:

1. Room temperature 15-30⁰C
2. Cool place below 15⁰C
3. Cold place below 8⁰C
4. Refrigerator 2-8⁰C
5. Freezer -20⁰C

It’s important to note that these are general temperature guidelines, and specific products or materials may have different temperature requirements. Always refer to manufacturer guidelines, regulatory requirements, or specific storage instructions for accurate temperature recommendations. Additionally, maintaining temperature logs and regularly monitoring storage conditions are essential practices to ensure compliance and product integrity.

Full Assignment Pdf : CLICK HERE

SOPs For Dispensing

Standard Operating Procedures (SOPs) for dispensing medications are critical to ensure accuracy, safety, and consistency in pharmaceutical practices. Here’s a generalized outline of SOPs for dispensing medications:

1. Prepare advocacy plan
2. Receive read and validate the prescription
3. Introduce yourself to the patient by saying “I am a pharmacist
4. Identify the prescribers intention for the patient
5. Confirm the ownership of the prescription in order to avoid dispensing to proxy
6. Find out if the medicine and/or other required items are available in the pharmacy
7. Cost the medicines prescribed
8. Inform patient of the cost implication of their medication (conduct with the physician for reviews if the need arises).
9. Direct the patient to make necessary payments and to present the appropriate receipt confirming payment of medicines/items dispensed.
10. Select the correct medicines /items in the pharmacy and read the label on the container (and/or package) before, during and after dispensing.
11. Write the label on each medicine, giving precise direction for use.
12. Put the medicine in the dispensing vial and place the label on the vial
13. Check the dispensed medicine and confirm that the medicine is what was prescribed
14. Hand the dispensed medicine to the patient or care giver/patient’s relation.
15. Counsel the patient giving details on how the medicine should be used
16. Give the patient a chance to ask questions and give the patient appropriate answers.
17. Say “thank you” to the patient before he leaves. This is to be done with a smile.
18. Keep all patient medication record.

SOPs For Unit Dose Dispensing System (UDDS)

Standard Operating Procedures (SOPs) for a Unit Dose Dispensing System (UDDS) are essential to ensure the safe and efficient dispensing of medications in healthcare settings such as hospitals, long-term care facilities, and clinics. Here’s an outline of SOPs for a UDDS:

1. Prepare advocacy plan for the SOPs
2. Receive , read and validate prescription
3. Find out the prescriber’s intention for the patient
4. Find out whether the medicines (and / or other required items are available in the pharmacy)
5. Open the patient medication profile.
6. Cost the medicines
7. Direct the patient to make necessary payments and to present the appropriate receipt confirming payment of medicines/items dispensed.
8. Select the correct medicines /items in the pharmacy and read the
9. label on the container (and/or package) before, during and after dispensing.
10. Prepare the appropriate label which could contain the name, strength
11. and quantity of the medicine being dispensed. All necessary directions should comply with legal requirements (where applicable).
12. Include the expiry date for any product with limited shelf-life (where applicable).
13. Select the appropriate container and closure for dispensing medicines (where applicable). Plastic, amber dispensing vials for tablets and capsules are preferred.
14. Affix the written instructions (labels) on the container.
15. Ensure that all dispensed are put in patients respective cassettes and arranged in a trolley.
16. Deliver the trolley to the ward and give any necessary information to the nurses.
17. Initiate therapeutic drug monitoring (TDM) where necessary.
18. Document patients’ medication complaint(s) and discuss with the prescriber.
19. Reference must be made to the doctor’s prescription for every administration.
20. Pharmacist must be present at the ward to monitor the unit dose dispensing system (UDDS), improve in-patient dispensing and make the necessary therapeutic interventions.

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Note: The technical aspects of dispensing (such as counting tablets, pouring liquid and labeling containers) can properly be conducted by trained support staff under the supervision of a pharmacist. There is no alternative to the direct involvement of the pharmacist in the assessment of prescriptions and ensure that all necessary information is given to the patient or care-giver (i.e. patients’ relative) to achieve maximum therapeutic benefits.

SOPs For Patient Counselling

Patient counseling should be carried out in a room or space dedicated for such purpose. Such a room should be adequately equipped.

1. Prepare advocacy plan for the SOPs
2. Welcome the patient with a warm smile
3. Ensure the patient is comfortably seated before facing you
4. Introduce yourself to the patient by saying’ I am a pharmacist……………….. I am here to talk to u about your medication’’.
5. Ensure the patients identity matches that written on absentee patient. Counsel the patient’s representative in the absence of the patient. (This should not be encouraged).
6. Confirm if the patient has been counseled by the doctor (prescriber) or any other staff member of the hospital. Note what the patient had been told.
7. Confirm if it’s the 1st time the patient is receiving the medication on prescription.
8. Show the patient what the prescribed drug looks like.
9. Tell the patient the name(s) of the drug(s) prescribed and explain in a simple language, how the drug works.
10. Inform the patient of the dosage requirement, route of administration, duration of drug therapy.
11. Provide the patient with any information on the onset of action.

SOPs For Screening Prescription

1. Prepare an Advocacy Programme for the SOP.
2. Ascertain that all the legal requirements for the prescription are met, including full name of the patient, age and sex date on which the prescription was written, name and strength of the drug written generically, quantity of drug to be supplied, directions for use, and full name and signature of the prescriber in his own handwriting.
3. As certain that all prescriptions for narcotic drugs are written on a separate prescription sheet.
4. Ensure that quantity of drugs in a prescription are properly written e.g 3g not 3.0g, 500mg not 0.5g, 100micrograms not 0.1mg, mi not cc or cm3.
5. Ensure that unapproved abbreviations are not used in writing prescriptions e.g. PCM for Paracetamol.
6. Ensure that the quantities for each drug to be supplied is clearly stated, e.g. 100 Tablets or that the dose and directions are clearly stated e.g. one tablet every 8 hours for 5 days.
7. Ensure that prescription written for animals contain all the necessary information, including the name of the owner and that it is clearly marked ‘’for animal use only’.
8. Screen all prescriptions for any incompatibility.
9. Ensure that all alterations on the prescription are signed by the prescriber.
10. Ensure that prescriptions written in duplicate are clearly labeled e.g. “Original”, “Duplicate”.

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Combination products, also known as Fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. The Food and Drug Administration, USA defines a combination product as ‘a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product’. It is widely accepted that most drugs should be formulated as single compounds.

Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance . Fixed dose combination are highly popular in the Indian pharmaceutical market and have been particularly flourishing in the last few years. The rationality of Fixed dose combination should be based on certain aspects such as:

1. The drugs in the combination should act by different mechanisms.
2. The pharmacokinetics must not be widely different.
3. The combination should not have supra-additive toxicity of the ingredients.
4. Dosage alteration of one drug is not possible without alteration of the other drug.
5. Differing pharmacokinetics of constituent drugs pose the problem of frequency of administration of the formulation.
6. By simple logic there are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.

Unfortunately, many Fixed dose combination being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions, for instance, paediatric formulations of nimesulide + paracetamol. Nimesulide alone is more antipyretic than paracetamol, more anti-inflammatory than aspirin, and equivalent in analgesia to any of the NSAIDS alone, so efficacy gains are unlikely with added paracetamol. However, the patients may be subject to increased hepatotoxic effects from the combination.

Fixed dose combination of diclofenac + serratopeptidase do not offer any particular advantage over the individual drugs despite the claim that serratopeptidase promotes more rapid resolution of inflammation.

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On the other hand, the patient is exposed to greater risk of gastrointestinal (GI) irritation and serious bleeding from unsuspected peptic ulceration. Fixed dose combination of quinolones and nitroimidazoles (e.g. norfloxacin + metronidazole, ciprofloxacin + tinidazole, ofloxacin + ornidazole) have not been recommended in any standard books, but continue to be heavily prescribed drugs in GI infections, pelvic inflammatory disease, dental infection, etc., to cover up for diagnostic imprecision and the lack of access to laboratory facilities. Such injudicious use of antibiotic Fixed dose combination can rapidly give rise to resistant strains of organisms, which is a matter of serious concern to the health care situation in our resource poor country.

The Problems with Fixed Dose Combination

The Fixed dose combination formulated without due diligence can pose problems namely (a) pharmacodynamic mismatch between the two components, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced toxicity, (b) pharmacokinetic mismatch and having peak efficacy at different time, (c) chemical noncompatibility leading to decreased shelf life, (d) drug interactions because of the common metabolizing pathways, and (e) limitations of finer dosing titration of individual ingredients.

Although Fixed dose combination are available in almost all therapeutic categories, many of them are bizarre combinations. The therapeutic categories having high number of Fixed dose combination are cough, cold, and fever preparations; analgesics and muscle relaxants; antimicrobials; drugs for hypertension, dyslipidemia, diabetes, and psychiatric disorders; and vitamins and minerals. The Fixed dose combination formulation may have up to 5 or even more ingredients with or without rationality of their presence and in the quantity.

Very Few Fixed Dose Combinations in Essential List of Medicines

Essential medicines are those that satisfy the priority health care needs of the population and intended to be available at all times, in adequate amount and at affordable price. The list is prepared with due consideration to disease prevalence, efficacy, safety, and comparative cost-effectiveness of medicines. Out of the 414 medicines included in the 19^th list of WHO List of Essential Medicines, 27 are FDCs. We included 24 FDCs out of 376 entities in the National List of Essential Medicines of India (NLEM) 2015.

These Fixed dose combination were included after due deliberations in national consultations with scientific justifications. Majority of the Fixed dose combination in both the lists belong to antimalarial, antitubercular, antiretroviral drugs, which emphasize the importance of Fixed dose combination use in treatment adherence and prevention of drug resistance.

The Good, the Bad, and the Ugly of the Fixed Dose Combination in India

On the basis of the rationality of available FDCs in India, we are tempted to classify them as follows: The Good FDCs – having strong justification, for example, carbidopa + levodopa, sulfonamides + trimethoprim, antitubercular drugs, antiretroviral drugs, some antihypertensives, and some antidiabetic medications; the Bad FDCs – are formulated primarily with marketing interests and do not add any value to the therapeutic usefulness and whose justification is debatable. Majority of the available FDCs fall in this category.

Some examples are combinations of dual nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxant, and NSAIDs with H2 blockers; and the Ugly FDCs – those that have neither evidence nor theoretical justifications. There could be a possibility of adverse event because of wrongful administration of an unnecessary component, or where the dose titration is required. Some examples of such bizarre combinations are formulations having cough syrups with two or more antihistamines + decongestant + bronchodilator + cough suppressant + expectorant and antifungal + antibiotic + steroid + topical local anesthetic.

Due to the difficulties in developing new chemical entities, the pharmaceutical industry finds it easier to develop FDCs. India is primarily the market of generic drugs. As the patent expires, the intense competition among multiple manufacturers tempts them to give the product a new look claiming multiple advantages without scientific validation. By the Drug Price Control Orders 2013, the drugs included in the NLEM were brought under price control by the National Pharmaceutical Pricing Authority of India. To evade the price control, some companies reformulate the individual drugs into an FDC. This loophole has since been checked.

The Regulatory Response to Proliferating Irrational Fixed Dose Combinations

Many articles in print media and Nongovernmental Organizations questioned the rationality of FDCs. Drug regulator of India (CDSCO) came out with the policy guidelines for the approval of FDCs in 2013. CDSCO has periodically banned various FDCs due to reasons such as lack of rationale or evidence and potential safety concern. In 2007, the Drugs Controller General of India (DCG [I]) issued edicts to all SLAs to withdraw 294 FDCs which were not approved by CDSCO. However, the industry disputed the ban and the matter is currently subjudice.

The Parliamentary Standing Committee on Health and Family Welfare in its 59^th report pointed out that some SLAs have been issuing manufacturing licenses for FDCs without prior clearance from DCG (I). Subsequently, the DCG (I) issued a circular on January 15, 2013, directing the manufacturers to prove the safety and efficacy of FDCs licensed by the SLAs prior to October 1, 2012, within 18 months, failing which they would be considered for being prohibited from manufacture and marketing in India. The FDCs approved before year 1988 were exempted. In response, 6220 applications were received from the industry.

In September 16, 2014, Ministry of Health and Family Welfare (MOH and FW) constituted a committee for examining the applications for rationality, safety, and efficacy of the FDCs. The committee submitted its report to the MOH and FW on April 16, 2015. It classified FDCs into 4 categories: (i) Category “a” – FDCs considered as irrational and the show-cause notices were issued to the manufacturers; (ii) Category “b” – FDCs requiring further deliberations with subject experts; (iii) Category “c” – FDCs considered as rational and letter of approval was sent; (iv) Category “d” – FDCs requiring further generation of data.

Accordingly, letters were sent to submit phase four trial protocol to the manufacturers. Replies from manufacturers against show-cause notices with respect to 1083 irrational FDCs under category “a” were examined and the recommendations were submitted on February 10, 2016. Based on findings of the expert panel, on March 10, 2016, 344 FDCs were prohibited under Section 26A of Drugs and Cosmetics Act, 1940.

The industry moved the Hon’ble Delhi High Court seeking a stay on the ban notification citing the lack of regulatory power of the CDSCO to ban the manufacture of FDCs without revoking the license to manufacture given by the SLAs. Questions were raised on the procedure adopted by the DCG (I) such as not consulting Drugs Technical Advisory Board and Drugs Consultative Committee to decide on the prohibition. Despite all these, the original question of regulating and weeding out irrational the Bad FDCs and the Ugly FDCs is left in limbo among these technical and procedural convolutions.

What Interventions are Needed to Prevent Use of Irrational Fixed Dose Combinations?

To curb the irrational use of FDC in India, a multistep approach involving all stakeholders, for example, consumers, physicians, regulatory authority, industry, and the academicians, is needed. The enforcement mechanism by the regulators needs to be strengthened. Both the central and state regulators must harmonize their procedures for licensing FDCs. Good pharmacovigilance should be ensured to assess the performance of the product in clinical practice. Industry should act responsibly, ensuring the adequate rationale to develop FDC and generating robust efficacy and safety data.

National Formulary of India, NLEM, and Standard Treatment Guidelines should be adopted across different levels of health services. CMEs on drug information, training medical and pharmacy students with an orientation toward the public health implications of FDCs misuse and good prescribing and pharmacy practices will go a long way in addressing the knowledge, attitude, and practice gap of practicing physicians and pharmacists. A multipronged corrective approach involving regulator, academia, industry, physicians, and public is needed to correct the dismal FDC scenario in the country.

REFERENCES

1. Sreedhar D, Subramanian G, Udupa N. Combination drugs: are they rational? Curr Sci. 2006;91:406. [Google Scholar]
2. World Health Organization. The use of essential drugs. WHO Technical Report Series 825. Geneva: World Health Organization; 1992. [PubMed] [Google Scholar]
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6. CDSCO. Report of Expert Committee on Fixed Dose Combinations (FDCs) Licensed by SLAs for Manufacture without Approval of DCG (I), Applications of Which Received by CDSCO. 2015. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/fdcexpert%2019.1.2016.pdf
7. CDSCO. Policy Guidelines for the Approval of Fixed Dose Combinations (FDCs) in India. 2013. [Last accessed on 2016 Jun 18]. Available from: http://www.mohfw.nic.in/WriteReadData/l892s/6404452866Kokate%20Report.pdf
8. CDSCO. Prohibition of Fixed Dose Combination Drugs for Human Use Under Section 26A of Drugs and Cosmetics Act, 1940. 2016. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/SKM_12-03-2016.pdf

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A Patient Information Leaflet (PIL) is a document provided with medication or medical products to inform patients about their prescription, over-the-counter drugs, or medical devices. The purpose of the Patient Information Leaflet is to provide essential information regarding the medication or device in a clear and understandable format. It serves to educate patients about the product, its uses, potential side effects, dosage instructions, and other relevant safety information.

Here’s a breakdown of what a typical Patient Information Leaflet might contain:

1. Introduction: The leaflet usually starts with a brief introduction, outlining its purpose and encouraging patients to read it carefully before using the medication or device.
2. Product Description: This section provides details about the medication or medical device, including its brand name, generic name, active ingredients, and what it is used for.
3. Indications and Uses: It explains the medical conditions or symptoms that the medication or device is intended to treat or manage.
4. Dosage and Administration: This section outlines the recommended dosage, frequency of use, and instructions on how to administer the medication or use the device correctly.
5. Warnings and Precautions: Important safety information is provided here, including potential side effects, interactions with other medications or substances, and precautions to be taken while using the product.
6. Contraindications: This section lists situations or conditions in which the medication or device should not be used due to potential risks.
7. Adverse Reactions: It details potential side effects that may occur while using the medication or device and what actions to take if they occur.
8. Storage and Handling: Instructions on how to store the medication or device properly to maintain its effectiveness and safety.
9. Expiration Date: Information on the expiry date of the product and what to do with it after it has expired.
10. Manufacturer Information: Details about the company that manufactures or distributes the medication or device, including contact information for reporting adverse reactions or seeking further assistance.
11. Additional Information: Sometimes, additional details such as clinical trial information, references, or resources for further reading may be included.

The Patient Information Leaflet plays a crucial role in empowering patients to make informed decisions about their healthcare and to use medications or medical devices safely and effectively. It serves as a valuable tool for promoting patient safety and improving health outcomes.

Abstract

A patient information leaflet is an educational material for educating patients regarding a disease, medications and lifestyle modifications for better care. The present study aimed at preparing, validating and user-testing of diabetes and hypertension information leaflets in different languages among patients. The patient information leaflets on diabetes and hypertension were prepared by referring to the primary, secondary and tertiary resources. The content of the leaflet was validated by an expert committee. The readability of leaflets has been assessed by Flesch Reading Ease and Flesch-Kincaid Grade Level scores using MS Office 2007.

The patient information leaflets were translated into Kannada and Malayalam languages with the help of language experts. During the user-testing, baseline knowledge was assessed before providing the patient information leaflet followed by provision of leaflets to the patients. After allowing the patients to read the leaflet for a period of 20 min, patients have again been administered with a set of questions to assess their knowledge. The Flesch Reading Ease and Flesch-Kincaid Grade Level readability scores achieved for diabetes leaflets are 70.4 and Flesch-Kincaid Grade Level score achieved is 6.3 and for hypertension leaflets, the Flesch Reading Ease score is 68.3 and Flesch-Kincaid Grade Level score achieved is 6.9.

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User testing of the patient information leaflets on diabetes and hypertension in different languages have been carried out on 40 each diabetic and hypertensive patients using knowledge based questionnaire. Knowledge assessment after providing patient information leaflet, the mean scores have significantly risen from 44.80 to 87.99 and 63.19 to 90.13 with p<0.0001, respectively in diabetes and hypertensive patients. It showed that patient education added with a well-designed patient information leaflet has a greater impact on knowledge of the patients towards their disease management, so that the medication adherence is improved.

Patient information leaflet (PIL) is an educational material for conveying patient education regarding disease, medications and lifestyle modifications for better patient outcomes. A PIL is a legal document included in every medicine package to present written information about the medication use. Patient education is one of the major management strategies for curing or preventing the progression of many chronic diseases. Patient information leaflet are the best-utilized tools for the patients with chronic disorders such as diabetes, hypertension (HTN), asthma, chronic obstructive pulmonary disease, and rheumatoid arthritis.

Materials and Methods

He present study has been conducted for a period of eight months between August 2014 and March 2015 at a tertiary health care hospital in south Karnataka. Approval of the Institutional Ethics Committee (Ref. no. IEC 503/2014) has been obtained prior to the initiation of the study.

Preparation, validation, and translation of PILs on diabetes and HTN

Patient information leaflet were prepared for diabetes and HTN diseases and common drugs used for the treatment by referring primary, secondary and tertiary resources. The content of the leaflet includes information on diabetes/ HTN such as definition, risk factors, normal values of blood sugar level/blood pressure, complications, dietary requirements, exercise, lifestyle modifications and controlling blood sugar levels/blood pressure to overcome further complications and the information of commonly prescribed medications.

The content of the PIL was validated by an expert committee consisting of a physician and four academic pharmacists. The changes were affected as per the directions of the expert committee and the leaflet has been prepared accordingly. Prepared PILs were assessed for Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FK-GL) scores by using MS Office 2007. Readability of the leaflets as per FRE and FK-GL depends on the use of polysyllables, sentence length. Taking these issues into consideration, certain modifications were made in the leaflet in order to improve the scores of the leaflet.

The score between 60 and 70 is largely considered acceptable. The following scale is used to assess the ease of readability in a document. Very easy (90-100), easy (80-89), fairly easy (70-79), standard (60-69), fairly difficult (50-59), difficult (30-49) and very confusing (0-29).

Readability testing of PILs on the patients

Readability testing of Patient information leaflet on diabetes and HTN was performed on diabetic and hypertensive patients, who visited outpatient medical department of the hospital during the study period. Patients with minimum primary educational background have been selected from the three outpatient medicine units. The inclusion criterion was based on the patients who were diagnosed with diabetes and HTN more than 18 year of age with a written informed consent. The demographic details such as age, gender, and educational status, the length of disease, prescribed medications, and social habits of the all the included patients were documented in patient profile form.

Statistical analysis

Descriptive statistics was used to summarize the data and the user-testing data of baseline and after 20 min, scores were calculated by using paired student t-test with a p-value less than 0.05 considered as statistically significant. Data were analysed using SPSS version 15 software.

Results and Discussion

Patient information leaflet on diabetes, HTN and related medications were prepared in English version according to the guidelines. The prepared PILs were validated with the expert committee. After validation, the PILs were assessed for readability by FRE and FK-GL scores, and layout and design using BALD. The Patient information leaflet were then translated into Kannada and Malayalam languages with the help of language experts. The translated Patient information leaflet is validated with the experts and modifications have affected according to their suggestions. The final version of diabetes and HTN Patient information leaflet in English, Kannada and Malayalam languages was assessed for user-testing in patients with diabetes and HTN.

After the preparation of English version of diabetes and HTN PIL, The Patient information leaflet readability was assessed by using FRE and FK-GL scores. After the assessment of readability scores, to improve the scores, the leaflets were modified and readability scores were assessed, which have recorded improvement after each modification. The final FRE score achieved was 70.4 and FK-GL score achieved was 6.3 for diabetes Patient information leaflet and both the scores, rates the diabetes leaflet as ‘fairly easy’. The final FRE score achieved for HTN PIL was 68.3 and FK-GL score achieved was 6.9 and both the scores rate the HTN leaflet as ‘standard’.

Conclusion

Patient information leaflets can contribute to better patient understanding of chronic disease and its treatment. Information leaflets developed by pharmacists can play an important role in improving patient understanding not just of medications, but of disease conditions. It was also observed that pharmacist provided patient education together with information leaflets had a significant (p<0.05) impact on knowledge, attitude, and practice of the patients towards their disease management. The developed leaflets were found to be very useful by patients.

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A Patient Information Leaflet (PIL) is a document provided with prescription and non-prescription medications to inform patients about the medicine they are taking. It typically includes essential details such as the medicine’s name, its purpose or indications, dosage instructions, precautions, possible side effects, interactions with other medications or substances, and additional information for safe and effective use.

The Patient Information Leaflet serves as a guide for patients to understand how to take their medication responsibly and what to expect while using it. It aims to promote informed decision-making and adherence to treatment plans while ensuring patient safety.

Abstract

The purpose of patient information leaflets (PILs) is to inform patients about the administration, precautions and potential side effects of their prescribed medication. Despite European Commission guidelines aiming at increasing readability and comprehension of PILs little is known about the potential risk information has on patients. This article explores patients’ reactions and subsequent behavior towards risk information conveyed in PILs of commonly prescribed drugs by general practitioners (GPs) for the treatment of Type 2 diabetes, hypertension or hypercholesterolemia; the most frequent cause for consultations in family practices in Germany.

Background

A patient information leaflet is a technical document included in every medicine package to offer written information about the medication. Patient information leaflets (PILs) are provided by the manufacturer following a standard template consisting of the same types of information for every medication. Their main purpose is to inform patients about their medication regarding its administration, precautions and potential side effects. As required by Article 11 of Directive 2001/83/EC, the content of Patient Information Leaflet ought to be unbiased, evidence-based and presented in a clear, understandable and well-readable way to suit laypersons.

In 2004, the amended Directive 2004/27/EC demanded readability and comprehension testing of PILs. The European Commission issued the “Guideline on the readability of the label and package leaflet of medicinal products for human use”, which provides guidance on how to produce accessible and understandable package leaflets. More specifically, the guideline provides advice on the presentation of the content, design and layout including guidance on consultations with target patient groups and a way of undertaking a test of a package leaflet in order to optimize its usability. Specific recommendations for blind and partially-sighted patients are also provided.

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As of November 2005 the European Commission guideline led to the introduction of readability user tests to demonstrate the readability and usefulness of the package leaflet to patients. Such tests became obligatory for newly authorized medicinal products.The purpose of user testing is to achieve legible, clear and easy to use package leaflets. Member states and the European Medicines Agency agreed on harmonized Quality Review of Documents (QRD) templates for package leaflets to ensure linguistic clarity, consistency and accuracy of PILs.

Discussion

The findings of our focus groups showed that Patient Information Leaflet – despite European Commission guidelines and those of other legislative bodies – still have considerable need for (linguistic) improvements. It has been demonstrated that PILs included in medicine prescribed for the treatment of Type 2 diabetes, hypertension or hypercholesterolemia have a deterrent effect on patients. Patient Information Leaflet contained too much risk information which was conveyed in a way that led to reduced patient compliance. Instead of PILs contributing to providing a sense of security or reassurance for patients, they provoked negative emotions which – among other reactions – led participants to discontinuing their medication or altering the dosage without prior consultation of their GPs.

There was a strong emphasis in the focus groups that GPs were considered the best source and enjoyed participants’ trust in providing general drug information as well as patient-tailored knowledge about side effects and drug interactions. Even pharmacists were not accepted as an equally competent source of delivering this information. Similar results have been obtained by Lee et al. where GPs trusted unquestioningly and were regarded as the primary provider of information about prescribed medications, followed by community pharmacists. This is contrary to the findings by Nair et al. who found that most patients consider pharmacists as the primary source of information since access was the main factor in determining from whom information was sought.

It is important to note that the majority of respondents in our study preferred a more passive role in the decision making process in the sense that respondents expressed a greater preference for their GPs to make all or most decisions. Despite evidence suggesting that active patient involvement in medical decision making may result in increased treatment adherence and improved outcomes, research on patient and provider characteristics associated with patient decision-making role preferences found that patients receiving lower levels of provider communication about decision making as well as patients being very satisfied with their care are more likely to prefer provider-made decisions.

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Although GPs enjoyed a high degree of patients’ trust, on a daily basis they fell short of their expectations since they often provided minimal or no instructions when prescribing medication. Thus patients were left to their own devices to seek for information from sources that are more readily available then GPs; however, at times these were less reliable sources such as the internet.

Conclusions

The findings of our qualitative study have shown that current Patient Information Leaflet convey risk information in a way that provoked feelings of fear and anxiety in the reader. Such negative emotions cause patients to make alterations to their prescribed treatment regimen without prior consultation of their GPs. The raison d’être of PILs is to inform patients about application and risks of the prescribed medication in a clear, understandable and readily readable way. Yet, our results suggest that reading Patient Information Leaflet is associated with a decrease in medication adherence.

The challenge in designing future Patient Information Leaflet is to develop presentations which allow the conveyance of risk information in a way that is perceived as less frightening by patients but will still provide vital information necessary to make an informed decision on whether or not to take the prescribed medication. An informed decision not to take a specific medicine is an acceptable outcome. From the patients’ point of view, spoken information provided by their GPs is preferred to reading PILs. This holds true especially for the conveyance of risk information.

The quality and the extent of the patient-physician relationship may also contribute to calming down frightened patients. Yet physicians are also encouraged to welcome patients who make use of written information in order to evoke questions that can be discussed during consultation with their GPs.

To improve Patient Information Leaflet further it is suggested that regulators and producers of such written information consider greater involvement of target patient groups at all stages of the production process. More precisely, during the production process specific emphasis should be placed on testing the degree of emotional arousal provoked in patients when reading certain risk information.

Future generations of Patient Information Leaflet should aim at providing information about possible side effects and drug interactions in a language of risk that is causing less anxiety in order to diminish or – if at all possible – avoid typical “knee-jerk reactions” such as altering the dosage or discontinuing the prescribed medication. This is vital because Hartley & Phelps conclude from their review on the relationship between anxiety and decision-making that: “anxiety increases the attention to negative choice options, the likelihood that ambiguous options will be interpreted negatively and the tendency to avoid potential negative outcomes even at the cost of missing potential gains.”

References

1. European Parliament and the Council of the European Union . Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use. 2004. [Google Scholar]
2. 2. European Parliament and the Council of the European Union . Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. 2004. [Google Scholar]
3. European Commission . Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1. 2009. [Google Scholar]
4. Quality Review of Documents Group . QRD Annotated Template: Revision of the Product Information. London: European Medicines Agency; 2010. [Google Scholar]
5. Quality Review of Documents . Draft Version of the QRD Annotated Template for External Consultation. 2009. [Google Scholar]

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