Understanding of Pharma D course initiation requirements

To develop a thorough understanding of initiating a PharmD course, it's essential to conduct a comprehensive analysis, covering situation analysis, need analysis, feasibility study, area of employment, and acceptability. 

Here’s a detailed breakdown for each aspect:

1. Situation AnalysisObjective: Understand the current state of pharmacy education and healthcare needs.

Current Status of Pharmacy Education:What pharmacy programs are currently available in the region?

What is the enrollment rate and graduation rate of existing programs?

What is the perception of the quality of these programs among stakeholders (students, faculty, employers)?

Healthcare Landscape:

What are the major health issues in the region that require pharmacological intervention?

How is the healthcare system structured (public vs. private, primary care vs. specialty care)?

What role do pharmacists currently play in patient care within this system?

Regulatory Environment:

What are the national and local regulations regarding pharmacy education and practice?

Are there any anticipated changes in regulations that could impact the PharmD program?

2. Need AnalysisObjective: Identify the demand for the PharmD program and its relevance.Stakeholder Demand:

What is the level of interest from prospective students in pursuing a PharmD?

What do current pharmacy students and professionals think about the need for a PharmD program?

Healthcare Needs:

What gaps exist in the current healthcare delivery that a PharmD graduate could fill?

Are there any specific patient care areas that require more advanced pharmacological expertise?

Educational Gaps:

What deficiencies exist in current pharmacy programs that a PharmD could address?

How would the PharmD program align with global best practices in pharmacy education?

3. Feasibility StudyObjective: 

Assess the practicality of establishing a PharmD program.Institutional Capacity:

Does the institution have the necessary infrastructure (classrooms, laboratories, libraries) to support the program?

Is there a sufficient number of qualified faculty members to teach the PharmD courses?.

Financial Considerations:

What are the estimated costs of starting and running the PharmD program?

What funding sources are available (government grants, tuition fees, private investments)?

Market Analysis:

What is the projected enrollment for the PharmD program over the next 5-10 years?

How will the program be marketed to attract students?

4. Area of EmploymentObjective:

 Identify employment opportunities for PharmD graduates.

Healthcare Settings:

What are the primary areas of employment for PharmD graduates (hospitals, community pharmacies, clinics)?

Are there emerging roles for pharmacists in specialized fields (oncology, geriatrics, infectious diseases)?

Industry Opportunities:

What roles are available in the pharmaceutical industry (research and development, regulatory affairs, clinical trials)?

Are there opportunities in healthcare policy and administration?

Global Opportunities:

What international employment opportunities exist for PharmD graduates?

How does the PharmD degree from your institution compare with those from other countries?

5. AcceptabilityObjective: 

Determine the acceptance of the PharmD program among various stakeholders.

Student Acceptability:

Are prospective students aware of the benefits of the PharmD program?

What are their perceptions and expectations regarding the program?

Employer Acceptability:

How do potential employers view the value of a PharmD degree?

What are their expectations in terms of skills and competencies of PharmD graduates?

Regulatory and Professional Bodies:

What is the stance of regulatory and professional pharmacy bodies on the PharmD program?

Are there any accreditations or endorsements required from these bodies?

Public Perception:

How does the general public perceive the role of pharmacists in healthcare?

What steps can be taken to enhance the visibility and understanding of the PharmD program among the public?

Conducting a thorough analysis in these areas will help ensure that the PharmD program is well-conceived, relevant, and sustainable.

Has PCI done this exercise? 

# #PCI

#Montukumar Patel

#Secretary, PCI 

#Everyone

The IRDAI has made it compulsory for all insurance companies to cover every expense that falls under the definition of mental illness given by the Mental Health Act of 2017.15 Feb 2023

The IRDAI has made it compulsory for all insurance companies to cover every expense that falls under the definition of mental illness given by the Mental Health Act of 2017.15 Feb 2023

Controlled Substance

A controlled substance is generally a drug or chemical whose manufacture, possession and use is regulated by a government, such as illicitly used drugs or prescription medications that are designated by law. Some treaties, notably the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, provide internationally agreed-upon "schedules" of controlled substances, which have been incorporated into national laws; however, national laws usually significantly expand on these international conventions.

Some precursor chemicals used for the production of illegal drugs are also controlled substances in many countries, even though they may lack the pharmacological effects of the drugs themselves. Substances are classified according to schedules and consist primarily of potentially psychoactive substances and anabolic steroids. The controlled substances do not include many prescription items such as antibiotics.

Laws and enforcement

In the United States, the Drug Enforcement Administration is the federal government agency responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act, which regulates both the drugs themselves and certain precursors. Some U.S. states have additional restrictions for substances which might or might not be regulated by the federal government. During the Obama Administration, the federal government also voluntarily suspended enforcement of federal laws restricting marijuana where people were operating in compliance with state law.

Some states in the U.S. have statutes against health care providers self-prescribing and/or administering substances listed in the Controlled Substance Act schedules. This does not forbid licensed providers from self-prescribing medications not on the schedules.

The term Controlled Drug in the United Kingdom (CD) is used for substances governed by the Misuse of Drugs Act 1971.^[2] Other national drug prohibition laws include the Controlled Drugs and Substances Act (Canada) and the Misuse of Drugs Act 1975 (New Zealand), among many others.

Within Europe controlled substance laws are legislated at the national rather than by the EU itself, with significant variation between countries in which and how chemicals are classified as controlled. Only drug precursor laws are legislated for at the European level. 

Use in research

A common misunderstanding amongst researchers is that most national laws allow the use of small amounts of a controlled substance for non-clinical / non-in vivo research without licences. A typical use case might be having a few milligrams or microlitres of a controlled substance within larger chemical collections (often 10K's of chemicals) for in vitro screening. Researchers often believe that there is some form of “research exemption” for such small amounts. This incorrect view may be further re-enforced by R&D chemical suppliers often stating and asking scientists to confirm that anything bought is for research use only.

A further misconception is that controlled substances laws simply list a few hundred substances (e.g. MDMA, Fentanyl, Amphetamine, etc.) and compliance can be achieved via checking a CAS number, chemical name or similar identifier. However, the reality is that most countries enact “generic statement" or “chemical space” laws, which aim to control all chemicals similar to the “named” substance. These either provide detailed descriptions similar to Markushes, or simply state analogues are also controlled. In addition, control of most named substances is extended to control of all of their ethers, esters, salts and stereoisomers.

Due to this complexity in legislation the identification of controlled chemicals in research is often carried out computationally, either by in house systems maintained a company's sample logistics department or by the use commercial software solutions.^[3] Automated systems are often required as many research operations can often have chemical collections running into 10Ks of molecules at the 1–5 mg scale, which are likely to include controlled substances, especially within medicinal chemistry research. These may not have been controlled when created, but they have subsequently been declared controlled

Known research exemptions

Source:^[4]

Switzerland. 

Has limited exemptions to some Directory E substances, but which substances are covered and what the exemption allows depends on the substance, for example compounds similar to Fentanyl allow for “Von der Kontrolle ausgenommen ist die industrielle und die wissenschaftliche Verwendung. Der private Gebrauch ist nicht von der Kontrolle ausgenommen” or “Excluded from the control is the industrial and scientific use. Private use is not exempt from the control.” The exemption wording for Cyclohexylphenols is “Cyclohexylphenole sind von der Kontrolle nach den Kapiteln 5 und 6 der Verordnung über die Betäubungsmittelkontrolle vom 25. Mai 2011 ausgenommen, wenn sie von Unternehmen mit einer Betriebsbewilligung für den Umgang mit kontrollierten Substanzen des Verzeichnisses e industriell eingesetzt werden. Für Substanzmengen bis zu 100 g benötigen diese Unternehmen keine Ein- oder Ausfuhrbewilligung.” or “Cyclohexylphenols are exempted from the control under Chapters 5 and 6 of the Narcotics Control Ordinance of 25 May 2011 if they are used industrially by undertakings holding an operating license for the handling of controlled substances in Inventory e. For substance quantities of up to 100g, these companies do not require an import or export license”. In addition, import or export authorization is not required in case of controlled substances for analytical purpose in concentrations up to 1 mg/ml. (Art 23, Abs. 2b, BetmKV) ^[5]

Further qualifications apply e.g. yearly limits as well individual shipment limits

United Kingdom

There are no specific research exemptions in the Misuse of Drugs Act 1971. However, the associated Misuse of Drugs Regulations 2001^[6] does exempt products containing less than 1 mg of a controlled substance (1 ug for lysergide and derivatives) so long as a number of requirements are met, including that it cannot be recovered by readily applicable means, does not pose a risk to human health and is not meant for administration to a human or animal.

Although this does at first seem to allow research use, in most circumstances the sample, by definition, is “recoverable” - in order to prepare it for use the sample is ‘recovered’ into an assay buffer or solvent such as DMSO or water. In 2017 the Home Office also confirmed that the 1 mg limit applies to the total of all preparations across the entire container in the case of sample microtitre plates.  Given this, most companies and researchers choose not to rely on this exemption.

According to Home Office licensing, "University research departments generally do not require licences to possess and supply drugs in schedule 2 drug, schedule 3 drug, schedule 4 drug part I, part II and schedule 5, but they do require licences to produce any of those drugs and to produce, possess and/or supply drugs in schedule 1".

United States of America

In the US no general research exemptions are  known to exist, at least at the federal level and the Controlled Substances Act.

Germany

The Gesetz über den Verkehr mit Betäubungsmitteln (Betäubungsmittelgesetz - BtMG) / (Law on the Traffic in Narcotic Drugs (Narcotics Act - BtMG) has a partial exemption that might apply to certain research areas.

For each schedule the act allows for

the preparations of the substances listed in this Appendix if they are not

a)      without being applied to or in the human or animal body, for diagnostic or analytical purposes only, and their content of one or more anesthetics not exceeding 0.001 per cent, or isotope-modified in the preparations, or

b)      are particularly excluded;

die Zubereitungen der in dieser Anlage aufgeführten Stoffe, wenn sie nicht

a)      ohne am oder im menschlichen oder tierischen Körper angewendet zu werden, ausschließlich diagnostischen oder analytischen Zwecken dienen und ihr Gehalt an einem oder mehreren Betäubungsmitteln jeweils 0,001 vom Hundert nicht übersteigt oder die Stoffe in den Zubereitungen isotopenmodifiziert oder

b)      besonders ausgenommen sind;

The exact percentage various for each schedule. Also whether the ‘0.001%’ allows the rest to be an assay solvent or medium, or whether a licence is needed if you have some solid, e.g. 1 mg of sample before its diluted is not clear

Digital Prescriptions are the solution

Handwritten prescriptions in India often pose significant risks due to their potential for misinterpretation. The diverse linguistic landscape of India, with multiple languages and scripts, adds to the complexity of deciphering these prescriptions accurately. Common issues include illegible handwriting, which can lead to confusion between drugs with similar names or incorrect dosing instructions. This is particularly problematic given the wide range of medications available and the critical importance of precise dosages.

Moreover, handwritten prescriptions sometimes lack essential information such as patient history, allergies, or specific instructions for drug administration. In a healthcare environment where pharmacists play a key role in the safe dispensing of medications, these omissions can lead to serious health risks.

The situation calls for a more robust system, possibly incorporating digital prescriptions, which can ensure clarity, accuracy, and traceability. Standardizing prescription formats and embracing electronic health records could greatly mitigate the risks associated with handwritten prescriptions, leading to safer and more effective patient care in the Indian context.

Consumer awareness towards medicine and its quality

AMR

One of the major health issues facing the whole world today is Antimicrobial Resistance (AMR). And this alone is not the health crisis of today's generation, because it is not handled on time, it will be the biggest health crisis for the next generation too. Experts in the field have already hoisted a red flag on the critical situation of a world without antibiological if necessary steps are not taken immediately. Even though AMR emerges naturally over time, blind use of antibiotics is one of the major reasons for AMR emerging. The hard fact is that antibiotic abuse and overuse is at risk of decades of medical advancements. It has often been found that over-the-counter availability cases of these lifesaving drugs makes worse as people buy antibiotic medicines for virus-causing diseases instead of bacteria. When antibiotics are so readily available, it's not necessary to take the necessary care. Another fact that AMR burden falls inequality on low and moderate income countries, where healthcare systems are overloaded and resources have increased. The seriousness of the situation that some reports can be estimated that India is likely to cause nearly 2 million deaths from AMR by 2050 as the country has the highest rate of antibiological immunity in bacteria generally causing infection. And the health facilities.

Naturally, the global community has declared AMR as a public health crisis and regulators around the world, along with Indian regulators, have already started measures to solve this problem at the war level as regulators seize this critical situation. Recently, the National Medical Commission has decided to create a general module on AMR control which will improve awareness and understanding of AMR among pregraduate, postgraduate medical students and teaching professionals in medical colleges. This is an appropriate step because there are some atrocious prescriptions from some doctors that write more antibiologically and unnecessarily. Commission's action in this regard is part of efforts to implement the National Action Scheme (NAP) on AMR which aims to reduce the spread of AMR in the country. Recently, the All India Chemist and Distributors Federation, an association of drug distributors and retailers across the country, has given an instruction to the government that the period or expiration date of use is required on the land of treatment use. Doctors prescription to stop the spread of AMR due to their overuse. The fact is that most often, people use old prescription for similar symptoms as previous diseases and take medications the doctor prescribed five years ago or six years ago. Doctors write the same antibiological at a specific time for a specific disease, but they still use the same prescription when the patient has the same disease after five years or six years. Undoubtedly, the medicine used by the patient five years ago may not be affected by his current disease. While the situation gets serious, experts have appealed drug regulators to play a vital role in countering the threat, as the main reason is misuse, overuse and less use of antibiotics. Regulators should literally implement a schedule H and H1 of drugs and cosmetics to stop OTC sales of antibiotics. Regulators shouldn't feel short in making sure pharmacists and hospitals are following the laws and selling schedule H and H1 drugs only on qualified doctors prescription. Delivering without pharmacists and selling without prescription should be stopped immediately to cover the risk of AMR. Government should pay attention to all these instructions and act fast as AMR is a ticking time bomb.

https://chat.whatsapp.com/ESnQA4VD8aRL8I87NxhJ73 

#QualityAssuranceToPatients - #QRCodeWhy not create a #QRCode on Medicine label to get Batch Quality Report?It would also prevent Black-Sheep Cos selling untested or failed batches.#Everyone

#QualityAssuranceToPatients - #QRCode

Why not create a #QRCode on Medicine label to get Batch Quality Report?

It would also prevent Black-Sheep Cos selling untested or failed batches.

#Everyone